10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended March 31, 2019

Commission File Number: 001-36081

NANOVIRICIDES, INC.

(Exact name of Company as specified in its charter)

NEVADA	76-0674577
(State or other jurisdiction)	(IRS Employer Identification No.)
of incorporation or organization)

1 Controls Drive

Shelton, Connecticut 06484

(Address of principal executive offices and zip code)

(203) 937-6137

(Company’s telephone number, including area code)

Indicate by check mark whether the Company (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x   No  ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  x    No  ¨

Indicate by check mark whether the Company is a larger accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	¨	Accelerated filer	¨
Non-accelerated filer	x	Smaller reporting company	¨
		Emerging growth company	¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the Company is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes  ¨    No  x

Securities registered pursuant to Section 12(b) of the Act:

Title of each class:	Trading Symbol(s)	Name of each exchange on which registered:
Common Stock	NNVC	NYSE-American

As of May 15, 2019, there were approximately 76,735,000 shares of common stock of the registrant issued and outstanding.

NanoViricides, Inc.

FORM 10-Q

INDEX

PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets at March 31, 2019 (Unaudited) and June 30, 2018	3
Statements of Operations for the Three and Nine Months Ended March 31, 2019 and 2018 (Unaudited)	4
Statements of Changes in Stockholders’ Equity for the period from July 1, 2018 through March 31, 2019 (Unaudited) and from July 1, 2017 through March 31, 2018 (Unaudited)	5-6
Statements of Cash Flows for the Nine Months Ended March 31, 2019 and 2018 (Unaudited)	7
Notes to the Financial Statements (Unaudited)	8
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.   Quantitative and Qualitative Disclosures About Market Risk	51
Item 4.   Controls and Procedures	51
PART II OTHER INFORMATION
Item 1.   Legal Proceedings	54
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds	54
Item 3.   Defaults Upon Senior Securities	52
Item 4.   Mine Safety Disclosures	52
Item 5.   Other Information	54
Item 6.   Exhibits and Reports on Form 8-K	54
Signatures	55
Certifications

2

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

NanoViricides, Inc.

Balance Sheets

	March 31, 2019			June 30, 2018
	(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	4,236,845		$	7,081,771
Prepaid expenses		393,238			240,257
Total current assets		4,630,083			7,322,028
PROPERTY AND EQUIPMENT
Property and equipment		14,082,522			14,018,383
Accumulated depreciation		(3,692,576	)		(3,177,290	)
Property and equipment, net		10,389,946			10,841,093
TRADEMARK AND PATENTS
Trademark and patents		458,954			458,954
Accumulated amortization		(90,229	)		(84,025	)
Trademark and patents, net		368,725			374,929
OTHER ASSETS
Security deposits		3,515			3,515
Service agreements		2,502			4,647
Other assets		6,017			8,162
Total assets	$	15,394,771		$	18,546,212
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	246,702		$	223,339
Accounts payable – related party		730,063			107,468
Derivative liability - warrants		-			298,092
Accrued expenses		107,466			253,049
Total current liabilities		1,084,231			881,948
LONG TERM LIABILITIES:
Derivative liability - warrants		1,593,117			-
Total liabilities		2,677,348			881,948
STOCKHOLDERS' EQUITY:
Series A Convertible Preferred stock, $0.001 par value, 8,500,000 shares designated, 5,106,328 and 4,531,394 shares issued and outstanding, at March 31, 2019 and June 30, 2018, respectively.		5,106			4,531
Common stock, $0.001 par value; 150,000,000 shares authorized, 76,735,074 and 69,171,740 shares issued and outstanding at March 31, 2019 and June 30, 2018, respectively		76,735			69,172
Additional paid-in capital		102,540,013			101,282,707
Accumulated deficit		(89,904,431	)		(83,692,146	)
Total stockholders' equity		12,717,423			17,664,264
Total liabilities and stockholders' equity	$	15,394,771		$	18,546,212

See accompanying notes to the financial statements

3

Nanoviricides, Inc.

Statements of Operations

(Unaudited)

	For the Three Months Ended						For the Nine Months Ended
	March 31,						March 31,
	2019			2018			2019			2018
OPERATING EXPENSES
Research and development	$	1,310,326		$	1,291,303		$	4,335,105		$	4,382,852
General and administrative		772,561			1,126,964			2,156,078			2,659,642
Total operating expenses		2,082,887			2,418,267			6,491,183			7,042,494
LOSS FROM OPERATIONS		(2,082,887	)		(2,418,267	)		(6,491,183	)		(7,042,494	)
OTHER INCOME (EXPENSE):
Interest income		8,915			23,769			46,664			73,133
Interest expense on convertible debenture		-			-			-			(185,275	)
Loss on extinguishment of debt		-			-			-			(1,348,247	)
Discount on convertible debenture		-			-			-			(359,214	)
Change in fair value of derivative		(65,858	)		284,536			232,234			1,949,686
Other (expense) income		(56,943	)		308,305			278,898			130,083
LOSS BEFORE INCOME TAX PROVISION		(2,139,830	)		(2,109,962	)		(6,212,285	)		(6,912,411	)
INCOME TAX PROVISION		-			-			-			-
NET LOSS	$	(2,139,830	)	$	(2,109,962	)	$	(6,212,285	)	$	(6,912,411	)
Net loss per common share- basic and diluted	$	(0.03	)	$	(0.03	)	$	(0.09	)	$	(0.11	)
Weighted average common shares outstanding- basic and diluted		71,955,909			64,068,378			70,162,244			63,566,719

See accompanying notes to the financial statements 

4

NanoViricides, Inc.

Statement of Changes in Stockholders' Equity

For the period from July 1, 2018 through March 31, 2019

	Series A Preferred				Common Stock:
	Stock: Par $0.001				Par $0.001
	Number of				Number of				Additional Paid-in		Accumulated			Total Stockholders'
	Shares		Amount		Shares		Amount		Capital		Deficit			Equity
Balance, June 30, 2018		4,531,394	$	4,531		69,171,740	$	69,172	$	101,282,707	$	(83,692,146	)	$	17,664,264
Series A Preferred Stock issued for employee stock compensation		532,716		533		-		-		54,494		-			55,027
Common stock issued for consulting and legal services rendered		-		-		191,510		192		79,268		-			79,460
Stock options issued for compensation		-		-		-		-		11,920		-			11,920
Warrants issued to Scientific Advisory Board		-		-		-		-		1,543		-			1,543
Common shares issued for Directors fees		-		-		19,310		19		7,481		-			7,500
Net loss		-		-		-		-		-		(1,841,463	)		(1,841,463	)
Balance, September 30, 2018		5,064,110		5,064		69,382,560		69,383		101,437,413		(85,533,609	)		15,978,251
Series A Preferred Stock issued for employee stock compensation		7,716		8		-		-		53,613		-			53,621
Common stock issued for consulting and legal services rendered		-		-		83,943		84		26,916		-			27,000
Warrants issued to Scientific Advisory Board		-		-		-		-		1,429		-			1,429
Common shares issued for Directors fees		-		-		34,851		35		11,215		-			11,250
Net loss		-		-		-		-		-		(2,230,992	)		(2,230,992	)
Balance, December 31, 2018		5,071,826	$	5,072		69,501,354	$	69,502	$	101,530,586	$	(87,764,601	)	$	13,840,559
Series A Preferred Stock issued for employee stock compensation		34,502		34		-		-		77,054		-			77,088
Net proceeds from issuance of common stock in connection with equity financing		-		-		6,944,446		6,944		815,797		-			822,741
Common stock issued for employee compensation		-		-		71,430		71		28,501		-			28,572
Common stock issued for consulting and legal services rendered		-		-		183,723		184		75,316		-			75,500
Warrants issued to Scientific Advisory Board		-		-		-		-		1,543		-			1,543
Common shares issued for Directors fees		-		-		34,121		34		11,216		-			11,250
Net loss		-		-		-		-		-		(2,139,830	)		(2,139,830	)
Balance, March 31, 2019		5,106,328	$	5,106		76,735,074	$	76,735	$	102,540,013	$	(89,904,431	)	$	12,717,423

See accompanying notes to the financial statements

5

NanoViricides, Inc.

Statement of Changes in Stockholders' Equity

For the period from July 1, 2017 through March 31, 2018

(Unaudited)

	Series A Preferred						Common Stock:
	Stock: Par $0.001						Par $0.001
	Number of						Number of				Additional Paid-in		Accumulated			Total Stockholders'
	Shares			Amount			Shares		Amount		Capital		Deficit			Equity
Balance, June 30, 2017		4,348,744		$	4,349			63,306,774	$	63,305	$	95,382,979	$	(75,128,691	)	$	20,321,942
Series A Preferred Stock issued for employee stock compensation		7,716			8			-		-		158,791		-			158,799
Common stock issued for consulting and legal services rendered		-			-			20,062		20		26,980		-			27,000
Warrants issued to Scientific Advisory Board		-			-			-		-		5,773		-			5,773
Common shares issued for Directors fees		-			-			8,358		8		11,242		-			11,250
Net loss		-			-			-		-		-		(2,005,555	)		(2,005,555	)
Balance, September 30, 2017		4,356,460			4,357			63,335,194		63,333		95,585,765		(77,134,246	)		18,519,209
Series A Preferred Stock issued for employee stock compensation		7,716			7			-		-		153,401		-			153,408
Common stock issued for consulting and legal services rendered		-			-			26,468		27		26,973		-			27,000
Warrants issued to Scientific Advisory Board		-			-			-		-		4,401		-			4,401
Common shares issued for Directors fees		-			-			11,019		11		11,239		-			11,250
Net loss		-			-			-		-		-		(2,796,894	)		(2,796,894	)
Balance, December 31, 2017		4,364,176			4,364			63,372,681		63,371		95,781,779		(79,931,140	)		15,918,374
Series A Preferred Stock issued for employee stock compensation		34,502			35			-		-		131,678		-			131,713
Series A Preferred Stock issued for Series C Debenture		150,000			150							314,193					314,343
Common stock issued for Series C Debentures		-			-			5,500,000		5,500		4,724,500		-			4,730,000
Common stock issued for employee compensation		-			-			71,430		71		65,645		-			65,716
Series A Preferred Stock forfeited in Separation Agreement		(25,000	)		(25	)		-		-		25		-			-
Common stock issued for consulting and legal services rendered		-			-			29,128		29		26,971		-			27,000
Warrants issued to Scientific Advisory Board and for services		-			-			-		-		57,708		-			57,708
Common shares issued for Directors fees		-			-			12,136		13		11,237		-			11,250
Net loss		-			-			-		-		-		(2,109,962	)		(2,109,962	)
Balance, March 31, 2018		4,523,768		$	4,524			68,985,375	$	68,984	$	101,113,736	$	(82,041,102	)	$	19,146,142

See accompanying notes to the financial statements

6

Nanoviricides, Inc.

Statements of Cash Flows

(Unaudited)

	For the Nine Months ended
	March 31, 2019			March 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(6,212,285	)	$	(6,912,411	)
Adjustments to reconcile net loss to net cash used in operating activities
Preferred shares issued as compensation		185,736			443,920
Common shares issued as compensation and for services		240,532			180,466
Warrants granted to Scientific Advisory Board		4,515			14,382
Options granted as compensation		11,920			-
Warrants issued for severance agreement		-			53,500
Common shares issued for debenture interest		-			60,274
Depreciation		515,286			501,378
Amortization		6,204			6,202
Change in fair value of derivative liabilities		(232,234	)		(1,949,686	)
Amortization of debt discount on convertible debenture		-			359,214
Loss on extinguishment of Series C debenture		-			1,348,247
Changes in operating assets and liabilities:
Prepaid expenses		(152,981	)		(142,746	)
Other assets		2,145			41,786
Accounts payable		23,363			59,754
Accounts payable - related party		622,595			1,348,168
Accrued expenses		(145,583	)		372,800
Deferred interest payable		-			(41,667	)
NET CASH USED IN OPERATING ACTIVITIES		(5,130,787	)		(4,256,419	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		(64,139	)		(225,205	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock and warrants		2,350,000			-
NET CHANGE IN CASH AND CASH EQUIVALENTS		(2,844,926	)		(4,481,624	)
Cash and cash equivalents at beginning of period		7,081,771			15,099,461
Cash and cash equivalents at end of period	$	4,236,845		$	10,617,837
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Interest paid	$	-		$	166,667
Non-cash Financing and Investing Activities:
Common shares issued for Series C Debenture	$	-		$	4,605,000
Common shares issued for deferred interest	$	-		$	125,000
Series A Preferred Shares issued for Series C Debenture	$	-		$	314,343
Stock warrants classified as a liability issued in connection with registered direct offering	$	1,527,259		$	-

See accompanying notes to the financial statements

7

NANOVIRICIDES, INC.

March 31, 2019 AND 2018

NOTES TO THE FINANCIAL STATEMENTS

(Unaudited)

Note 1 - Organization and Nature of Business

NanoViricides, Inc. (the Company”) is a nano-biopharmaceutical research and development company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides is also unique in the bio-pharma field in that it possesses its own state of the art facilities for the design, synthesis, analysis and characterization of the nanomedicines that we develop, as well as for production scale-up, and c-GMP-like production in quantities needed for human clinical trials, where our design, development, and production work is performed. The biological studies such as the effectiveness, safety, bio-distribution and Pharmacokinetics/Pharmacodynamics on our drug candidates are performed by external collaborators and contract organizations.

We are a company with several drugs in various stages of early development. In our lead antiviral program against herpes viruses, i.e. the HerpeCide™ program alone, we have drug candidates against at least five indications at different stages of development. Of these, the Company is advancing the shingles drug candidate towards human clinical trials. The IND-enabling Safety/Toxicology studies required for doing so have begun as of the end of December 2018 at the contract research organization (“CRO”) BASi, Indiana. Typically these studies may last six to nine months. If successful, the Company intends to file an IND after receiving a formal report on these studies from BASi. In addition, our drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced studies and are expected to follow the shingles drug candidate into human clinical trials. Shingles in adults and chicken pox in children is caused by the same virus, namely VZV (Varicella-zoster virus, aka HHV-3 or human herpesvirus-3). There are estimated to be approximately 120,000-150,000 annual chickenpox cases in the USA in the post-vaccination-era, i.e. since childhood vaccination with the live attenuated varicella virus Oka strain has become standard. In addition, we have drugs in development against all influenzas in our FluCide™ program, as well as drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.

Our drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), to which we have broad, exclusive licenses in perpetuity. The first license agreement we executed with TheraCour on September 1, 2005, gave us an exclusive, worldwide license for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Influenza and Asian Bird Flu Virus. On February 15, 2010, the Company executed an Additional License Agreement with TheraCour.  Pursuant to the Additional License Agreement, the Company was granted exclusive licenses, in perpetuity, for technologies, developed by TheraCour, for the development of drug candidates for the treatment of Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes.  In addition, the Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. A draft of the license agreement is currently in review. We are working to exchange drafts of the proposed license agreement with Theracour. To date, TheraCour has not withheld any licenses for antiviral nanomedicines that NanoViricides has asked for, and we anticipate that the licenses to the remaining herpes viruses including VZV will be executed once the due diligence process is completed.

8

Note 2 - Summary of Significant Accounting Policies

Basis of Presentation – Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting.  Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented.  Interim results are not necessarily indicative of the results for the full year.  The accompanying financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the fiscal year ended June 30, 2018 filed with the SEC on October 13, 2018.

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2018 filed on October 13, 2018.

Reclassifications and Prior Year Adjustments

Certain prior year amounts have been reclassified for consistency with current year presentation. These reclassifications had no effect on the reported results of operations. The Company reclassified $262,365 and $812,551 of expenses for the three and nine months ended March 31, 2018, respectively, related to the Company’s laboratory facilities from general and administrative expenses into research and development expenses for consistency with current year presentation. The reclassifications had no impact on the reported results of operations and net loss reported for the three and nine months ended March 31, 2018.

Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock, and convertible debenture.

The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:

	Potentially Outstanding Dilutive Common Shares
	For the		For the
	Nine Months		Nine Months
	Ended		Ended
	March 31, 2019		March 31, 2018
Options and Warrants		8,051,681		6,958,162
Total potentially outstanding dilutive common shares		8,051,681		6,958,162

The Company has also issued 5,106,328 shares of Series A Preferred Stock to investors and others as of March 31, 2019. Only in the event of a “change of control” of the Company, each Series A preferred share is convertible to 3.5 shares of its new common stock. A “Change of Control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a Change of Control event, the Series A Convertible Preferred Stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At March 31, 2019, the number of potentially dilutive shares of the Company’s common stock into which these Series A Preferred shares can be converted into is 17,872,148, and is not included in diluted earnings per share since the shares are contingently convertible only upon a Change of Control.

9

The following table represents the basic and diluted per share calculations for loss per share:

	For the three months ended March 31,						For the nine months ended March 31,
	2019			2018			2019			2018
Calculation of basic and diluted loss per share of common stock:
Net loss attributable to common stockholders	$	(2,139,830	)	$	(2,109,962	)	$	(6,212,285	)	$	(6,912,411	)
Denominator for basic weighted average shares of common stock		71,955,909			64,068,378			70,162,244			63,566,719
Basic and diluted loss per share of common stock	$	(0.03	)	$	(0.03	)	$	(0.09	)	$	(0.11	)

The Series C debenture was redeemed for Common Stock effective November 13, 2017. See Note 7. The Series C debenture was excluded from the loss per share calculation for the nine months ended March 31, 2018 because the impact is antidilutive.

Recently Issued Accounting Pronouncements

In August 2018, the SEC issued the final rule on Disclosures About Changes in Stockholder’s Equity For filings on Form 10-Q, which extends to interim periods the annual requirement in SEC Regulation S-X, Rule 3-04,2 to disclose (1) changes in stockholders’ equity and (2) the amount of dividends per share for each class of shares (as opposed to common stock only, as previously required). Pursuant to the final rule, registrants must now analyze changes in stockholders’ equity, in the form of reconciliation, for “the current and comparative year-to-date [interim] periods, with subtotals for each interim period,” i.e., a reconciliation covering each period for which an income statement is presented. Rule 3-04 permits the disclosure of changes in stockholders’ equity (including dividend-per-share amounts) to be made either in a separate financial statement or in the notes to the financial statements. The final rule is effective for all filings made on or after November 5, 2018. The staff of the SEC has indicated it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its form 10-Q for the quarter that begins after the effective date of the amendments. The Company conformed to this rule in its Form 10-Q since the quarter ending December 31, 2018.

In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions. The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The standard will be effective for the Company in the first quarter of fiscal year 2020, although early adoption is permitted (but no sooner than the adoption of Topic 606). The Company does not expect that the adoption of this ASU will have a significant impact on its financial statements.

In July 2017, the FASB issued Accounting Standards Update (“ASU”) No. 2017-11. “Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. ASU 2017-11 revises the guidance for instruments with down round features in Subtopic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, which is considered in determining whether an equity-linked financial instrument qualifies for a scope exception from derivative accounting. An entity still is required to determine whether instruments would be classified in equity under the guidance in Subtopic 815-40 in determining whether they qualify for that scope exception. If they do qualify, freestanding instruments with down round features are no longer classified as liabilities. ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, and early adoption is permitted, including adoption in an interim period. ASU 2017-11 provides that upon adoption, an entity may apply this standard retrospectively to outstanding financial instruments with a down round feature by means of a cumulative-effect adjustment to the opening balance of retaining earnings in the fiscal year and interim period adoption. The Company has adopted ASU 2017-11 retrospectively for the quarter ending March 31, 2019. The adoption of this ASU did not have a significant impact on its financial statements.

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Note 3 - Liquidity and Going Concern

The Company’s financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the financial statements, the Company has an accumulated deficit at March 31, 2019 of approximately $89.9 million and a net loss of approximately $6.2 million and net cash used in operating activities of approximately $5.1 million for the nine months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of March 31, 2019, the Company had available cash and cash equivalents of approximately $4.2 million. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Management adjusted its planned expenditures, activities, and programs, in accordance with budgetary constraints and in accordance with its expectations of obtaining additional financing.

The Company has made several adjustments to its past expenditures in the ensuing annual budget, eliminating several expenses including a reduction in workforce and consultants to the extent feasible without affecting its program of drug development. In addition, the Company has focused its efforts primarily on a single lead program to minimize cost outlays, namely taking the shingles drug candidate against VZV into human clinical trials. Management’s budget indicates that these changes have freed up sufficient funds to allow for the ensuing costs of the external advanced IND-enabling studies of this drug candidate. Management has considered several options for obtaining additional funds that will be needed for future human clinical trials and to obtain the additional license from TheraCour for VZV and the remaining human herpes viruses. The Company is also evaluating the possibility of obtaining a mortgage on its fully owned cGMP-capable laboratory facility in Shelton, CT, in order to free up a portion of the fixed capital for usage as liquid working capital.

In addition, the Company believes that it has several important milestones that it expects to achieve in the ensuing year. Management assumes that as it achieves these milestones, the Company would experience substantial improvement in the liquidity of the Company’s stock, and would significantly improve the Company’s ability to raise funds on the public markets at terms that may be substantially superior to the terms we are offered at present.

On February 27, 2019, the Company entered into a Securities Purchase Agreement with certain institutional investors for a registered direct offering in which the Company raised $2,500,000 less placement agents’ fees of $125,000 and placement agent legal fees of $25,000.

Management is actively exploring additional required funding through debt or equity financing pursuant to its plan. There is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company to fund continuing operations. Management believes that as a result of the management plan, the Company’s existing resources and access to the capital markets will permit the Company to fund planned operations and expenditures. However, the Company cannot provide assurance that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.

The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

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Note 4 - Related Party Transactions

Related Parties

Related parties with whom the Company had transactions are:

Related Parties	Relationship
Anil R. Diwan	Chairman, President, significant stockholder and Director
TheraCour Pharma, Inc.	An entity owned and controlled by a significant stockholder
Milton Boniuk, MD	Significant stockholder

	As of
	March 31, 2019		June 30, 2018
Account Payable – Related Party
Pursuant to an Exclusive License Agreement we entered into with TheraCour, the Company was granted exclusive licenses in perpetuity for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. In consideration for obtaining this exclusive license, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) we will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on our behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour; (4) to pay an advance payment equal to twice the amount of the previous month’s invoice to be applied as a prepayment towards expenses. On October 2, 2018, the Company entered into an agreement with TheraCour Pharma, Inc. for a waiver of the two months worth of prepaid balance advance of anticipated invoicing until the filing of an IND and the application of the current advance as a credit against current open invoices. Additionally, TheraCour has agreed to defer $25,000 per month of development fees for twelve months, beginning with July 2018. Accounts payable due TheraCour on the reporting date was	$	730,063	$	107,468

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Property and Equipment
During the reporting period, TheraCour Pharma, Inc. acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company	$	6,603	$	12,705	$	14,011	$	12,705

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Research and Development Costs Paid to Related Parties
Development fees and other costs charged by TheraCour pursuant to exclusive License Agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at March 31, 2019 and June 30, 2018	$	574,853	$	529,031	$	2,320,726	$	2,299,712

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Debenture Interest Payable to a Director

Coupon interest expense on the $5,000,000 Series C Debenture paid to Dr. Milton Boniuk for the three and nine months ended March 31, 2018 was $0 and $185,274, respectively. The Series C debenture was redeemed for Common Stock effective November 13, 2017. See Note 7.

Note 5 - Property and Equipment

Property and equipment, stated at cost, less accumulated depreciation consisted of the following:

	March 31,  2019			June 30,  2018
GMP Facility	$	8,020,471		$	8,011,230
Land		260,000			260,000
Office Equipment		57,781			57,781
Furniture and Fixtures		5,607			5,607
Lab Equipment		5,738,663			5,683,765
Total Property and Equipment		14,082,522			14,018,383
Less Accumulated Depreciation		(3,692,576	)		(3,177,290	)
Property and Equipment, Net	$	10,389,946		$	10,841,093

Depreciation expense for the three months ended March 31, 2019 and 2018 were $172,151 and $168,457, respectively, and for the nine months ended March 31, 2019 and 2018 were $515,286 and $501,378, respectively.

Note 6 - Trademark and Patents

Trademark and patents, stated at cost, less accumulated amortization consisted of the following:

	March 31, 2019			June 30, 2018
Trademarks and Patents	$	458,954		$	458,954
Less Accumulated Amortization		(90,229	)		(84,025	)
Trademarks and Patents, Net	$	368,725		$	374,929

Amortization expense amounted to $2,068 and $2,067 for the three months ended March 31, 2019 and 2018, respectively, and $6,204 and $6,202 for the nine months ended March 31, 2019 and 2018, respectively.

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Note 7 - Convertible Debenture and Derivatives 

Debenture - Series C

The Company’s Series C Convertible Debenture, in the amount of $5,000,000, was redeemed on November 13, 2017.

 For the three months ended March 31, 2018, no interest was paid to the Holder of the Company’s redeemed Series C Convertible Debenture. For the nine months ended March 31, 2018, the Holder elected to receive $60,274 (through November 13, 2017) of its coupon interest payment and $125,000 of deferred interest payment in common stock of the Company and $125,000 of its coupon interest payment and $41,667 of its deferred interest payment in cash.

The Company’s Series C Debenture in the amount of $5,000,000 was due to mature on June 30, 2018. On November 13, 2017, the Company entered into a Debenture Redemption Agreement (the “Agreement”) with the Holder, to redeem (the “Redemption”) its $5,000,000 Series C Convertible Debenture (the “Debenture”) for an aggregate of 5,500,000 shares of the Company’s $0.001 par value Common Stock (“Purchase Price”) comprising 5,000,000 shares for the principal of the Debenture and 500,000 shares for unpaid coupon interest from October 1, 2017 through June 30, 2018. The unpaid interest included $60,274 of accrued interest through November 13, 2017, $314,726 in coupon interest through June 30, 2018 and $125,000 of unpaid deferred interest. The price per share was equal to the closing price of the Company’s stock on Friday, November 10, 2017 of one ($1.00) dollar per share. The Holder waived all early redemption penalty payments provided for in the Debenture for consideration of 150,000 shares of the Company’s $0.001 par value Series A Convertible Preferred Stock. The Company did not incur placement agent fees in redemption of the Series C Convertible Debenture. The Company recognized a non-cash loss on extinguishment of debt of $1,348,247 on the extinguishment of the aforesaid principal attributable to the Series C Debenture into the Company’s common and preferred stock. The loss on extinguishment arises from, the obligation to issue 150,000 shares of the Company’s Series A Preferred shares with a fair value of $364,337, as of November 13, 2017, obligation to issue 314,726 shares of the Company’s $0.001 par value Common Stock with a fair value of $314,726 as of November 13, 2017, in consideration of Debenture coupon interest from the redemption date through June 30, 2018, and unamortized discount of $684,633 as of the redemption date, offset by the derivative liability of ($15,449) as of the redemption date. 

Pursuant to the redemption agreement for the Company’s Series C Debenture, the Company issued 5,500,000 shares of its registered Common Stock from its shelf registration and the 150,000 shares of its Series A Preferred Stock upon receiving consent to issue the shares pursuant to New York Stock Exchange (“NYSE”) regulations. The Company submitted a request for authorization to issue the Common Stock and Series A Preferred Shares to the NYSE, which was authorized on March 18, 2018 and the shares were issued on March 21, 2018.

On July 2, 2014, in conjunction with the issuance of the Company’s Series C Convertible Debenture, the Company issued 187,000 shares of its Series A Convertible Preferred Stock (the “Series A”) to Dr. Milton Boniuk, pursuant to the terms of the Debenture. Proceeds received in a financing transaction are allocated to the instruments issued prior to evaluating hybrid contracts for bifurcation of embedded derivatives. Since the Series A Convertible Preferred Stock is classified as equity, the proceeds allocated to the Preferred Stock are recorded at relative fair value. The fair value of the Series A was $1,645,606 at issuance and the relative fair value was calculated as $1,152,297. The remaining amount of the proceeds was allocated to the Debenture and a debt discount of $1,152,297 was recorded to offset the amount of the proceeds allocated to the Series A. Then, the embedded derivative was bifurcated at its fair value of $1,879,428 with the remaining balance allocated to the host instrument (Debenture). The total debt discount was amortized over the actual term of the Debenture using the effective interest method.

The Company recognized amortization of this discount as an additional interest charge to “Discount on convertible debenture” of $359,214 for the nine months ended March 31, 2018.

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Note 8 – Accrued expenses

Accrued expenses consisted of the following:

	March 31,  2019		June 30,  2018
Severance payment- Eugene Seymour	$	-	$	233,333
Accrued payroll		11,466		19,716
Professional services		30,000		-
Severance payment- Irach Taraporewala		66,000		-
Accrued expenses	$	107,466	$	253,049

Note 9 - Equity Transactions

On February 27, 2019, the Company entered into a Securities Purchase Agreement (the “Agreement”) with certain institutional investors (the “Purchasers”), for a registered direct offering (the “Offering”) of 6,944,446 shares of Common Stock (“Shares”) at the purchase price of $0.36 (“Purchase Price”) per share for an aggregate of $2,500,000.

The offer and sale of the Shares in the registered direct offering was registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s shelf registration statement on Form S-3, as amended (File No. 333-216345), which became effective on April 25, 2017. Pursuant to Rule 424(b) under the Securities Act, the Company has filed a prospectus supplement in connection with such offering.

In a concurrent private placement, the Purchasers received warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

The Company accounted for the proceeds of the Offering at February 27, 2019 as follows:

Gross proceeds	$	2,500,000
Less: Offering costs		150,000
Net proceeds		2,350,000
Portion allocated to derivative liability - warrants		(1,527,259	)
Net proceeds from issuance of common stock	$	822,741

The exercise price of the Warrants is subject to adjustment in the case of customary events such as stock dividends or other distributions on shares of Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock, stock splits, stock combinations, reclassifications or similar events affecting our Common Stock, and also, subject to limitations, upon any distribution of assets, including cash, stock or other property to our stockholders. The exercise of the Warrants is subject to certain beneficial ownership and other limitations set forth in the Warrants. The Company will receive proceeds from the concurrent private placement transaction solely to the extent the Warrants are exercised for cash.

In connection with the Offering and the concurrent private placement, the Company engaged Chardan Capital Markets, LLC (the “Placement Agent”) to act as its exclusive placement agent. The Company agreed to pay the Placement Agent a cash placement fee equal to 5% of the aggregate purchase price for the Common Stock sold in the offering, plus $25,000 in legal fees. The net proceeds from the offering were $2,350,000.

The Company determined the fair value of the Warrants at February 27, 2019 to be $1,527,259. The Company used a lattice model to calculate the fair value of the derivative warrants based on a probability weighted discounted cash flow model. This model is based on future projections of the various potential outcomes. The features that were analyzed and incorporated into the model included the exercise and full reset features. Under applicable accounting guidance of ASU 2017-11, adopted by the Company on January 1, 2019, stock warrants are to be accounted for as equity if the warrants contain full-ratchet anti-dilution provisions. The warrants described above contained a full-ratchet anti-dilution feature but also contained other adjustment features which required that the warrants be classified as a derivative liability.

The Warrants were valued as of February 27, 2019 and March 31, 2019 with the following assumptions:

- The 5.5-year warrants were issued on February 27, 2019 with an exercise price of $.61 (subject to adjustments-full ratchet reset).

- The stock price would fluctuate with the Company’s projected volatility.

- The Holder would exercise the warrants as they become exercisable (effective registration at issuance) at target prices of the higher of 2 times the projected exercise/reset price or 2 times the stock price.

- The risk free rate at February 27, 2019 and March 31, 2019 were  2.48% and 2.21% respectively..

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- The next capital raise is projected to occur during 2020 (annually 12 months from issuance) at prices approximating 100% market triggering a reset event and exercise price adjustment. 

- The  stock price would fluctuate with an annual volatility. The projected volatility curve was based on historical volatilities of the Company for the valuation period. The projected annual volatility for the valuation date is:

1 Year
2/27/19	75	%
3/31/19	77	%

The primary factors driving the economic value of options are stock price; stock volatility; reset events and exercise behavior. Projections of these variables over the remaining term of the warrant are either derived or based on industry averages. Based on the above, a probability was assigned to each scenario for each future period, and the appropriate derivative value was determined for each scenario. The option value was then probability weighted and discounted to the present.

On July 11, 2018 the Board of Directors approved an extension of the employment agreement with Dr. Anil Diwan, the Company’s President. Pursuant to the terms of the employment agreement, the Company’s Board of Directors authorized the issuance of 525,000 of the Company’s Series A Convertible Preferred Stock to Dr. Anil Diwan. The shares shall be vested in one-third increments on June 30, 2019, June 30, 2020 and June 30, 2021 and are subject to forfeiture. The Company recognized non-cash compensation expense related to the issuance of the Series A Preferred stock of $47,260 and $141,780, respectively, for the three and nine months ended March 31, 2019. The balance of $418,912 will be recognized as the shares vest and service is rendered.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 34,502 and 49,934, respectively, fully vested shares of its Series A Convertible Preferred Stock for employee compensation. The Company recorded expense of $29,828 and $43,956, respectively, for the three and nine months ended March 31, 2019 related to these issuances.

The fair value of the Series A Preferred stock was the following for the dates indicated:

Date	Shares		Value
7/11/2018		525,000	$	560,690
7/31/2018		2,572		2,795
8/31/2018		2,572		2,374
9/30/2018		2,572		2,598
10/31/2018		2,572		2,233
11/30/2018		2,572		1,883
12/31/2018		2,572		2,245
1/31/2019		2.572		1,203
2/28/2019		2,572		1,949
3/01/2019		26,786		24,340
3/31/2019		2,572		2,336
		574,934	$	604,646

There is currently no market for the shares of Series A Convertible Preferred Stock and they can only be converted into shares of Common Stock upon a Change of Control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A Convertible Preferred Stock granted to various employees and others on the date of grant. The Series A Convertible Preferred Stock fair value is based on the greater of i) the converted value to common at a ratio of 1:3.5; or ii) the value of the voting rights since the Holder would lose the voting rights upon conversion. The conversion of the shares is triggered by a Change of Control. The valuations of the Series A Convertible Preferred Stock at each issuance used the following inputs:

a. The common stock price was in the range $.20 to $.58;

b. The calculated weighted average number of shares of common stock in the period;

c. A 26.63% premium over the common shares for the voting preferences;

d. The calculated weighted average number of total voting shares and the monthly shares representing voting rights of 19.28% to 19.52% of the total;

e. The conversion value is based on an assumption for calculation purposes only of a Change of Control in 4 years from October 31, 2016 and a remaining restricted term of 1.75 to 1.59 years;

f. 31.25% to 33.16% restricted stock discount (based on a restricted stock analysis and call-put analysis curve: 79.2% to 90.60% volatility, 2.50% to 2.44% risk free rate) applied to the converted common shares.

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On July 19, 2018, the Company entered into an Employment Agreement with Dr. Irach Taraporewala as Chief Executive Officer of the Company beginning on September 1, 2018. Dr. Taraporewala was granted options to purchase up to 300,000 shares of the Company’s Common Stock, par value $0.001 per share at an exercise price equal to 20% above the closing bid price of $0.41 of the Common Stock on September 1, 2018 (“Effective Date”). The options shall vest in three, equal, annual installments commencing on the Effective Date. The grant date fair value of the options was $35,761 of which $11,920 was recognized and recorded as compensation expense for both the three and nine months ended March 31, 2019. On January 24, 2019, Dr. Taraporewala resigned as the Chief Executive Officer of NanoViricides, Inc. (the “Company”) for personal reasons. See Note 12.

The Company estimated the fair value of the options granted to Dr. Taraporewala on the date of grant using a lattice simulation model that values the options based upon a stock price modeled such that it follows a geometric Brownian motion with constant drift and volatility.

For the three months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.47 per share expiring in February 2023. For the nine months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.41 per share expiring in August 2022, 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.41 per share expiring in November 2022 and 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.47 per share expiring in February 2023. The fair value of the warrants was $1,543 for the three months and $4,515 for the nine months ended March 31, 2019 and was recorded as consulting expense.

The Company estimated the fair value of the warrants granted to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following weighted-average assumptions:

Expected life (year)	4
Expected volatility	47.99-55.12	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.51-2.93	%

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 71,430 fully vested shares of its common stock for employee compensation. The Company recognized compensation expense of $28,572 for the three and nine months ended March 31, 2019.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 183,723 and 459,176, respectively fully vested shares of its common stock with a restrictive legend for consulting services. The Company recorded an expense of $75,500 and $181,960 for the three and nine months ended March 31, 2019, respectively, which was the fair value on the dates of issuance. 

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 34,121 and 88,282, respectively, fully vested shares of its common stock with a restrictive legend for Director Services. The Company recorded an expense of $11,250 and $30,000 for the three and nine months, respectively, which was the fair value on the dates of issuance.

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Note 10 - Stock Warrants and Options

Stock Warrants

Stock Warrants	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding and exercisable at June 30, 2018		6,969,588	$	4.80		.53	$	-
Granted		6,978,742		.61		-		-
Expired		5,996,649		5.08		-		-
Outstanding and exercisable at March 31, 2019		7,951,681	$	.91		4.94	$	-

Of the above warrants, 620,051 expire in fiscal year ending June 30, 2020, 57,160 expire in fiscal year ending June 30, 2021, 45,728 expire in the fiscal year ending June 30, 2022, 284,296 warrants expire in the fiscal year ending June 30, 2023 and 6,944,446 expire in the fiscal year ending June 30, 2025.

Stock Options

Stock Options	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at June 30, 2018		-	$	-		-	$	-
Granted		300,000		.50		-		-
Forfeited		200,000		.50		-		-
Outstanding at March 31, 2019		100,000		.50		2.41		-

Of the above options, 100,000 became vested and exercisable on September 1, 2018. The options expire on August 31, 2021. On January 24, 2019, Dr. Taraporewala’s resigned as the Chief Operating Officer of the Company and the 200,000 remaining unvested options were forfeited. See Note 12.

The Company estimated the fair value of the options granted to Dr. Taraporewala on the date of grant using a lattice model that values the options based upon a stock price modeled such that it follows a geometric Brownian motion with constant drift and volatility:

Expected life (year)	3
Expected volatility	55.09	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.71	%

Expected forfeiture (attrition) rate (%) 5.00 %

Expected volatility is based on historical volatility of the Company’s common stock and the expected life of options. The Company estimates forfeitures at the time of valuation and reduces expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ or are expected to differ, from the previous estimate.

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Note 11 - Fair Value Measurement

Fair value measurements 

At March 31, 2019 and June 30, 2018 the estimated fair values of the liabilities measured on a recurring basis are as follows:

	Fair Value Measurements at
	March 31, 2019:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	1,593,117

	Fair Value Measurements at
	June 30, 2018:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	298,092

In a concurrent private placement to the Offering on February 27, 2019, the Purchasers received warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

In conjunction with the Company’s registered direct offerings of Units, consisting of the Company’s common stock and warrants, on September 12, 2013 and January 24, 2014, the Company issued an aggregate of 5,425,363 warrants, of which -0- and 5,290,006, are outstanding at March 31, 2019 and June 30, 2018, respectively. Additionally, the Company issued 135,216 warrants to the placement agents of which -0- and 135,216, are also outstanding at March 31, 2019 and June 30, 2018, respectively, for a total number of -0- and 5,425,222 warrants outstanding and issued as of March 31, 2019 and June 30, 2018, respectively, pursuant to the aforesaid registered direct offerings.

The Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting guidance of ASU 2017-11, adopted by the Company January 1, 2019, stock warrants are to be accounted for as equity if the warrants contain full-ratchet anti-dilution provisions. The warrants issued on February 27, 2019, contained a full-ratchet anti-dilution feature and also contained other adjustment features which required that the warrants be classified as a derivative liability.

The Company used a lattice model to calculate the fair value of the derivative warrants based on a probability weighted discounted cash flow model. This model is based on future projections of the various potential outcomes. The features that were analyzed and incorporated into the model included the exercise and full reset features.

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The Warrants issued on September 12, 2013 and January 24, 2014 expired on January 24, 2019 and were valued as of June 30, 2018 with the following assumptions:

- The 5-year warrants issued on 9/12/13 and 1/24/14 included Investor and Placement Agent Warrants with an exercise price of $5.25 and $6.05 (subject to adjustments-full ratchet reset).

- The stock price would fluctuate with the Company projected volatility.

- The Holder would exercise the warrant as they become exercisable (effective registration at issuance) at target prices of the higher of 2 times the projected exercise/reset price or 2 times the stock price.

- The next capital raise would fluctuate with an annual volatility. The projected volatility curve was based on historical volatilities of the Company for the valuation periods. The projected annual volatility for the valuation dates are:

1 Year
6/30/18	56	%

The primary factors driving the economic value of options are stock price; stock volatility; reset events and exercise behavior. Projections of these variables over the remaining term of the warrant are either derived or based on industry averages. Based on the above, a probability was assigned to each scenario for each future period, and the appropriate derivative value was determined for each scenario. The option value was then probability weighted and discounted to the present.

The following tables present the activity for liabilities measured at estimated fair value using unobservable inputs for the three months ended March 31, 2019:

Fair Value Measurement

	Fair Value Measurement
	Using Significant Unobservable Inputs
	Derivative Liability- Warrant
Beginning balance at July 1, 2018	$	298,092
Additions during the year		1,527,259
Change in fair value		(232,234	)
Balance at March 31, 2019	$	1,593,117

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Note 12 - Commitments and Contingencies

Legal Proceedings

There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge, no action, suit or proceeding has been threatened against the Company.

Employment Agreements

The Company and Dr. Diwan, President and Chairman of the Board of Directors, entered into an extension of employment agreement effective July 1, 2018 for a term of three years. Dr. Diwan’s will be paid an annual base salary of $400,000. Additionally, Dr. Diwan was awarded a grant of 525,000 shares of the Company’s Series A Preferred Stock. 175,000 shares vest equally on June 30, 2019, 2020 and 2021. Any unvested shares are subject to forfeiture.

The Company and Dr. Irach Taraporewala, the Company’s Chief Executive Officer, entered into an employment agreement effective September 1, 2018, for a term of three years. Dr. Taraporewala would be paid an annual base salary of $360,000. Additionally, Dr. Taraporewala was awarded a grant of 300,000 options to purchase shares of the Company’s Common Stock. 100,000 options vested on September 1, 2018 and the remainder of the options would vest over the two-year vesting period and are subject to forfeiture. On January 24, 2019, Dr. Taraporewala resigned as the Chief Executive Officer of NanoViricides, Inc. (the “Company”) for personal reasons.  Also on that date, the Company and Dr. Taraporewala agreed that Dr. Taraporewala would become a consultant for the Company for a period of two years.  In connection with his resignation and new consulting services, the Company and Dr. Taraporewala entered into a Confidential Separation and Consulting Agreement and General Release (the “Agreement”) pursuant to which the Company will pay Dr. Taraporewala monthly consulting payments of $3,000 from February 1, 2019, the effective date of the Agreement, through January 31, 2021.  The Agreement includes a general release of claims against the Registrant, obligations of confidentiality, non-disclosure, non-disparagement and other customary provisions found in similar agreements. The remaining 200,000 options not vested upon resignation have been forfeited.

On March 3, 2010, the Company entered into an employment agreement with Dr. Jayant Tatake to serve as Vice President of Research and Development.  The employment agreement provides for a term of four years with a base salary of $150,000.  In addition, the Company issued 26,786 shares of Series A Preferred Stock and 35,715 shares of common stock upon entering into the agreement, and issued an additional 26,786 shares of Series A Preferred Stock and 35,715 shares of common stock on each anniversary date of the agreement. The shares of Series A Preferred Stock were issued in recognition of Dr. Tatake’s work towards the achievement of several patents by the Company. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

On March 3, 2010, the Company entered into an employment agreement with Dr. Randall Barton to serve as Chief Scientific Officer.  The employment agreement provided for a term of four years with a base salary of $150,000.  In addition, the Company issued 35,715 shares of common stock upon entering into the agreement, and issued an additional 35,715 shares of common stock on each anniversary date of the agreement. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

On May 30, 2013, the Company entered into an Employment Agreement with Meeta Vyas to serve as its Chief Financial Officer.  The employment agreement provided for a term of three years with a base salary of $9,000 per month and 2,572 shares of Series A Preferred Stock, also on a monthly basis. On January 1, 2015, her cash compensation was increased to $10,800 per month. The Agreement is renewable on an annual basis. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

License Agreements

The Company is dependent upon its license agreement with TheraCour (See Note 4). If the Company lost the right to utilize any of the proprietary information that is the subject of the TheraCour license agreement on which it depends, the Company will incur substantial delays and costs in development of its drug candidates. The Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. We are working to exchange drafts of the proposed license agreement with Theracour shortly. TheraCour has not withheld any licenses for antiviral nanomedicines sought by the Company and we anticipate that the licenses for VZV will be executed once the due diligence process is completed.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the information contained in the financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2018, and the Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in the Company’s Annual Report on Form 10-K for the year ended June 30, 2018. Readers should carefully review the risk factors disclosed in this Form 10-Q, Form 10-K and other documents filed by the Company with the SEC.

As used in this report, the terms “Company”, “we”, “our”, “us” and “NNVC” refer to NanoViricides, Inc., a Nevada corporation.

PRELIMINARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Report contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact made in this report are forward looking. In particular, the statements herein regarding industry prospects and future results of operations or financial position are forward-looking statements. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “Company believes,” “management believes” and similar language. These forward-looking statements can be identified by the use of words such as “believes,” “estimates,” “could,” “possibly,” “probably,” “anticipates,” “projects,” “expects,” “may,” “will,” or “should,” or other variations or similar words. No assurances can be given that the future results anticipated by the forward-looking statements will be achieved. Forward-looking statements reflect management’s current expectations and are inherently uncertain. The forward-looking statements are based on the current expectations of NanoViricides, Inc. and are inherently subject to certain risks, uncertainties and assumptions, including those set forth in the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. Actual results may differ materially from results anticipated in these forward-looking statements.

Investors are also advised to refer to the information in our previous filings with the Securities and Exchange Commission (SEC), especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more detail various important factors that could cause actual results to differ from expected or historic results. It is not possible to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive statement of all risks and uncertainties or potentially inaccurate assumptions.

Recent Developments

NanoViricides is pioneering a unique platform for developing anti-viral drugs based on the “bind-encapsulate-destroy” principles. Viruses would not be able to escape a properly designed nanoviricide® drug by mutations because in doing so they would lose the ability to bind their cognate cellular receptor(s) and thus fail to infect productively, becoming incompetent.

NanoViricides is a unique pre-clinical pharma company in that it fully owns its own lab and cGMP-capable flexible custom manufacturing facility where any of our drug candidates can be produced in multi-kilogram quantities to support corresponding IND-enabling tox package studies as well as initial human clinical trials. We believe this will enable rapid translation of our drug candidates to the clinic, saving years of manufacturing translation and set-up activities, as well as saving several millions of dollars of external costs, while ensuring requisite quality assurance, as compared to using a contract manufacturing organization (“CMO”) for our complex nanomedicine drugs.

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The Company’s Drug Programs in Brief

Since its founding in 2005, the Company has developed drug candidates against a number of different viruses. In particular, in the FluCide™ program, the Company has previously demonstrated extremely high effectiveness in animal models against two unrelated influenza viruses, namely H1N1 and H3N2. In the HIVCide™ program, in the standard SCID-hy Thy/Liv mouse model of HIV infection, the Company’s drug candidates were found to maintain viral load to the same level as an approved triple combination drug therapy, beyond 40 days after the nanoviricide treatment was discontinued, although the combo therapy was continued daily. The Company intends to reactivate these programs upon appropriate collaborations or funding. The Company has also demonstrated preliminary successes in developing drug candidates against Dengue viruses, and Ebola virus, among others.

In December 2012, the Company purchased at cost the nanomedicines research and cGMP production facility that was designed and built by Dr. Diwan, its co-founder, who had used his personal funds and his privately raised financing. With this purchase, the Company became a unique company in the industry with its own cGMP manufacturing capability, and end-to-end discovery-to-drug-product drug development capability that is rare in the biopharma industry.

Since then, the Company has focused on drug programs that it believes it can execute on with the limited financing that it believes it can bring in to support the projects. Thus the Company decided to focus on the HerpeCide™ program. In particular, the Company decided to develop dermal topical treatments (skin creams) for HSV-1 and HSV-2. When the Company’s internal research showed that, surprisingly, the same drug candidates were effective against the VZV virus in cell culture, the Company extended the HerpeCide program to include VZV studies. Further, the Company has also demonstrated that some of these drug candidates were effective in viral-ARN (“Acute Retinal Necrosis”) in an animal model. Thus the Company has three immediate drug programs, namely dermal topical treatments for HSV-1, HSV-2 and VZV, and two additional drug programs, namely eye drops for treatment of Herpes Keratitis (an infection of the external eye), and intra-vitreal injection for the treatment of vARN, in the HerpeCide program alone.

The Company intends to take the VZV (shingles) treatment into clinical trials first, followed by topical treatment for HSV-1 and HSV-2. Additional indications for the same drugs are expected to expand the pipeline wider. As these programs mature, the Company intends to re-engage its FluCide and HIVCide programs.

The market size for HerpeCide programs is in several tens of billions of dollars because neither cures nor very effective treatments are available. Approved treatments have limited effectiveness, demonstrating a significant unmet medical need. The market size for Influenza drugs is estimated to be in tens of billions of dollars. The market size for HIV drugs is estimated to be more than $40 billions.

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Thus the Company’s technology has substantial capabilities and applications, and the potential to attack as-yet-unsolved problems caused by viral infection, and thus lead to a great health benefit to individuals and societies. The Company has a bright future with expanding a pipeline, as we further the research programs driving towards cures beyond our current objectives of effective treatments.

The Company's most advanced pre-clinical drug candidate is our anti-VZV nanoviricide for the topical treatment of shingles, being developed as a skin cream. In cell culture studies, it was as much as five times more effective than acyclovir, the current standard of care. These anti-VZV drug candidates have also shown strong effectiveness in studies involving VZV infection of human skin patches ex vivo. These studies were conducted by Professor Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized expert on varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. The work was presented at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.

There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy for shingles has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine. Of note, the Shingrix vaccine has been found to cause significant, debilitating, side effects in as many as 15%-20% of the persons receiving it. Given that shingles is not a life-threatening disease (except under certain conditions), the uptake of such a vaccine with high incidence of adverse effects may be far more limited than what was originally estimated. Additionally, Shingrix is not yet widely available.

The Company is also developing drugs against HSV-1 “cold sores” and HSV-2 “genital ulcers”, both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications as of now.

Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, unlike HSV-1 and HSV-2, VZV does not have an effective TK enzyme that is required for producing active forms from the acyclovir class of drugs, requiring frequent administration of very large doses to treat shingles. While shingles presents with a debilitating “pins-and-needles” pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries.

Limiting initial viral load is expected to minimize the occurrence of such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia (“PHN”), which is defined as persistent pain six months or longer after the initial rash has subsided. Thus, we anticipate that NV-HHV-101 would have significant impact in reducing PHN incidence rates. We anticipate extending the NV-HHV-101 indication to include PHN after obtaining marketing approval for the first indication, namely effect on shingles rash. 

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The Company is pleased to note that it has been executing on all milestones towards the IND filing for its first clinical candidate along a reasonable projected timeline, and is doing so with highly conservative expenditures. These continuing developments are substantially dependent on external collaborations as well as on continuing to achieve successful results.

The Company reported on February, 4, 2019 that it has formally commenced the IND-Enabling Non-GLP Safety/Toxicology studies for its first drug candidate in the HerpeCide™ Program. These studies are being conducted by BASi, Indiana, a Contract research Organization (“CRO”). The start of these IND-enabling studies marks a major milestone for the Company and an important step in establishing our nanoviricide® platform technology and validity of our approach. 

The drug candidate selected for advancing towards human clinical studies is designated as NV-HHV-101. The Company is presently advancing this selected drug candidate as a treatment for shingles rash. Shingles and chickenpox are caused by the same virus, namely Varicella Zoster Virus (“VZV”). Additionally, NV-HHV-101 or a closely related drug candidate is expected to be advanced as a clinical drug candidate against HSV-1 “cold sores” and against HSV-2 “genital ulcers” as these programs mature. All of these current candidates are being developed as skin creams for dermal topical applications. 

The Company has repeatedly demonstrated in a human skin organ culture model of VZV infection that NV-HHV-101 and several related candidates were highly effective against VZV infection in this ex vivo model of the VZV viral infection. These studies are being performed by Professor Jennifer Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. Dr. Moffat is a leading researcher in this field and has developed this model based on infection of human skin. Since this model is based on human skin, it is anticipated to be predictive of effectiveness in human clinical trials. Additionally, the Company believes that the ex vivo and animal model effectiveness data that we obtain against a virus should be predictive of effectiveness in human clinical trials. This is because our nanoviricide® drug candidates are designed to attack the virus particle itself, and complete the task of dismantling or rendering the virus ineffective, irrespective of the host, whether animal or human. While these are reasonable expectations, there can be no assurance that they hold true in human clinical trials.

The Company has previously found that dermally applied nanoviricide drug candidates led to full survival of lethally infected animals in a severe infection with the highly pathogenic, neurotropic strain of HSV-1, namely H129c. Thus the nanoviricide drug candidates applied topically appear to demonstrate strong efficacy. Topical application has the advantage of being able to deliver very high drug concentrations locally to completely eradicate the virus. In contrast, the local concentrations and therefore effectiveness of orally delivered medications is limited by the toxicity and bioavailability of the oral drug, as is known for the existing antiviral therapies for HSV-1, HSV-2, and VZV. Therefore, treating the HSV-1 cold sores, HSV-2 genital ulcers, or VZV chicken pox lesions or shingles rash using dermal topical creams is expected to be highly beneficial.

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM (“herpesvirus entry mediator”) receptor on human cells. This drug candidate is composed of a flexible polymeric micelle “backbone” to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV (or HSV-1 or HSV-2) virus particle via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This “Bind, Encapsulate, Destroy” nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV, HSV-1, and HSV-2.

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NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour Pharma, Inc. NanoViricides holds licenses for developing drugs against several different viruses from TheraCour, including HSV-1 and HSV-2. In addition, the Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. A draft of the license agreement is currently in review. We are working to exchange drafts of the proposed license agreement with Theracour. TheraCour is owned substantially by the Company’s President and Executive Chairman of the Board, Anil R. Diwan, Ph.D. As of this writing, a draft of the ensuing license agreement is being prepared by the Company’s attorneys. The draft is expected to be provided to TheraCour’s attorney for further deliberations. 

The anti-VZV drug development program has moved rapidly towards clinical candidate declaration stage because of several factors, namely (a) that it was simply the existing HSV-1 drug program in which the existing candidates were re-tested for effectiveness against VZV, (b) that we have had a highly successful collaboration with Dr. Moffat Lab at SUNY Syracuse with rapid turnaround times, and (c) the drug candidates were found to be highly effective against VZV in these studies.

The first part of the IND-enabling Safety/Toxicology studies for the shingles drug candidate began towards the end of December, 2018. These studies are being conducted Bioanalytical Systems, Inc. (“BASi”) ,, Indiana, a Contract Research Organization specialized in IND-enabling safety/toxicology studies. The first of these studies, namely non-GLP Safety/Tolerability and Toxicity using Dermal Exposure in Mini-Pigs, began at the very end of December, 2018. Following initial observations on this mini-pigs study, the next non-GLP studies for Systemic Exposure using sub-cutaneous administration in Rats began in the second week of January, 2019. Another study of Systemic Exposure using sub-cutaneous administration in Dogs began around the same time.

The Company achieved large scale production in well controlled manufacturing processes for these non-GLP studies at a scale of approximately 100g-200g drug substance, with several steps already scaled to kilogram quantities. The Company achieved this in its own facilities with internal resources, thereby establishing itself as a leading expert in the field of nanomedicines manufacture. The Company developed final formulation of the drug substance into drug product in a highly scalable process in short time period of just about six weeks. This rapid formulation development was enabled by the very design characteristics of the TheraCour® polymeric micelles that form the backbone of the nanoviricides® drugs.

On March 5, 2019, the Company announced that its first drug candidate has successfully completed the first of the Safety/Toxicology studies moving towards human clinical trials. In this dermal safety/tolerability study, all dosage levels of the nanoviricide® drug product, including the maximum feasible dose, were well tolerated in all treated animals. All of the parameters evaluated in the study remained within normal ranges, and showed no adverse effects from the drug treatment.

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On March 12, 2019, the Company announced that its first drug candidate has successfully completed another important step in its Safety/Toxicology studies moving towards human clinical trials. The broad-spectrum anti-herpes clinical candidate in the HerpeCide™ program, namely NV-HHV-101, was tested in this additional non-GLP study, formulated as a subcutaneous injection, to determine potential systemic safety and toxicological effects. While NV-HHV-101 is designed and developed as a dermal topical cream, it is important to determine if any systemically absorbed portion of the drug can have deleterious effects. NV-HHV-101 administered subcutaneously was well tolerated and there were no NV-HHV-101-related findings in this escalating dose study at all dosages up to the maximum feasible dose in dogs. This study was conducted at BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies. This study was completed in February, 2019.

These strong safety results are consistent with our previous studies on two related drug candidates during drug candidate optimization. The Company has previously tested two related development candidates in the HerpeCide™ program in non-GLP Safety and Tolerability study in rats for dermal exposure as well as systemic exposure by subcutaneous and intravenous routes of administration. The Company previously reported that those candidates were both found to be safe based on multiple parameters in the completed non-GLP Tolerability study.

The success of these non-GLP studies allows advancing the drug candidate into the GLP portion of the Safety/Toxicology studies that are required for filing an IND. Safety Pharmacology studies are designed to investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.

On March 26, 2019, the Company announced that it has requested a pre-IND meeting with the US FDA, as it progresses its lead drug candidate towards human clinical trials. The Company has submitted a request for a
“Type B” Pre-IND Meeting with the US FDA for this drug candidate. The Company believes that the resulting pre-IND meeting will provide valuable information for designing the Company’s clinical program for this drug candidate. The initial indication of this drug candidate will be for the treatment of shingles rash.

The Company is developing its clinical program for NV-HHV-101, formulated as a skin cream for topical application, with the help of regulatory affairs experts from the Biologics Consulting Group, Inc., Alexandria, VA.

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The Company has conducted a drug candidate optimization program using an ex vivo human skin organ culture (“SOC”) model of VZV infection, together with cell culture based VZV infection studies, to arrive at NV-HHV-101. The SOC model of VZV infection has been developed by Professor Jennifer Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. It is the only pre-clinical model suitable for evaluating a topical therapy against shingles because VZV infects only humans. There is no animal model available for the evaluation of topical drugs against VZV infection.

NV-HHV-101 is formulated as a dermal cream to be applied topically on the rash. It is expected to reduce viral load at the site, thereby arresting the progress of the shingles rash, and minimizing damage to nerve endings in the area. It is generally believed that the damage to nerve endings caused by VZV that is replicated locally after it is released from the nerves initially leads to the severe “pins-and-needles” debilitating pain of shingles. Thus NV-HHV-101 is expected to minimize the entire pathology of shingles, including the rash, skin damage, nerve damage, and associated pain. The Company intends to focus the initial clinical studies to evaluate the effect of application of NV-HHV-101 on the shingles rash.

Existing antivirals against VZV include oral derivatives of acyclovir. These drugs require activation by a viral enzyme, thymidilate kinase (vTK), for further cellular conversion to the active triphosphate form that interferes with the viral DNA polymerase. However, the vTK encoded by VZV has an extremely poor activity (compared to vTK from HSV-1 or HSV-2), and thus these drugs have very poor activity against VZV, and large oral dosages over extended periods are needed to be given for relatively small clinical benefit. Additionally, a dermal topical cream formulation of cidofovir is employed in very severe cases of shingles. Cidofovir is highly toxic, particularly towards kidneys. A safer, effective, drug is thus an unmet medical need for VZV.

Zostavax and other attenuated VZV (Oka strain) vaccines for chickenpox are available, but not widely adopted. These vaccines may lead to a less severe form of shingles in adulthood or at a later age, compared to the “wild type” chickenpox virus (“rebound shingles”). A new vaccine, Shingrix® has been introduced by GSK recently, based on subunits or protein fragments of the virus, which cannot lead to rebound shingles, but suffers from a very severe side effects profile, and has limited availability at present.

On April 9, 2019, the Company reported that US FDA has responded to its request for a pre-IND meeting and has asked for the briefing documents to be submitted by April 19th. In addition, consistent with current protocol, the FDA stated that they will provide a written response to the Company’s submission. This written response will guide the Company’s IND submission for this drug candidate and indication.

On April 16, 2019, the Company reported that it has submitted the required pre-IND Briefing Documents for its lead drug candidate NV-HHV-101 to the US FDA, ahead of schedule. Consultants from the Biologics Consulting Group, Inc., Alexandria, VA, helped the Company develop the briefing documents including the clinical studies plan presented by the Company.

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On May 13th, 2019, the Company also reported that it has completed production of the drug product for the upcoming GLP Safety/Toxicology studies of its lead drug candidate in the HerpeCide™ program, namely NV-HHV-101. This production batch for the GLP studies was manufactured using cGMP-compliant procedures.

The Company reported that it has successfully completed the scale-up of the chemistries and production of kg-scale quantities of the drug substance or API, NV-HHV-101. The Company further reported that it has successfully scaled up and manufactured about 10kg of the drug product. All of the production, including that of the API and of the drug products was performed under stringent conditions meeting regulatory requirements for the GLP Tox Package study. 

The entire production was accomplished at the Company’s own cGMP-capable manufacturing facility at Shelton, CT. The Company has now demonstrated that it has multi-kilogram per batch drug production capability.

The Company has now demonstrated that it has unique expertise in the industry of performing cGMP manufacture of complex nanomedicine drugs, including cGMP manufacture of (a) drug substance from simple chemical starting materials, (b) the formulated drug product, and (c) the final packaged drug.

This establishment and execution of cGMP manufacturing is an extremely significant milestone for the Company. Our current multi-kg per batch scale of cGMP manufacturing capacity is expected to be more than sufficient for the anticipated Phase I and Phase II human clinical trials. In addition, we believe that this facility can supply required quantities of the drug for Phase III clinical trials as well. Thus, this in-house cGMP production capability is expected to result in significant cost savings across all our programs.

Manufacture of nanomedicines, especially under cGMP conditions, has been identified as a strong risk, and has led to failure of several nanomedicines programs. NanoViricides co-founder Dr. Diwan and his team have employed considerations for cGMP manufacture of our nanomedicines right from the design, development and optimization of the drug candidates, the polymers and ligands that go into them, as well as the processes employed right from the small research scale to the initial process verification batches. The rapid success of translating the research scale production of several grams drug substance in early CY-2018 to kg-scale cGMP manufacture in early CY-2019 was a result of the tremendous subject matter expertise of the team. External contract manufacturing organizations would likely have required at least three years to scale up these complex products, based on certain discussions we have had.

Thus the Company has been executing rapidly and efficiently, as well as in a cost-effective and productive manner, towards its goal of advancing the first drug candidate into human clinical trials as soon as possible. We believe that taking our first drug candidate into initial human clinical trials will be a very important milestone in that it would essentially validate our entire platform technology as being capable of producing drug candidates worthy of human clinical trials, and potentially of success in those clinical trials.

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While the Company has been focused on cGMP production, scale-up, and establishment of required characterization and analytical tools, the Company had not raised any additional capital since mid-2014, except for conversion of certain convertible debt instruments into equity. With stringent execution, we have held down the cash burn rate to less than $8 Million per year. The burn rate has remained low due to reduction in workforce and due to stopping work on all other programs except the HerpeCide program. Nevertheless, our cash reserves are dwindling and therefore the Company performed an equity-based financing in February, 2019.

On February 27, 2019, the Company entered into a Securities Purchase Agreement (the “Agreement”) with certain institutional investors (the “Purchasers”), for a registered direct offering (the “Offering”) of 6,944,446 shares of Common Stock (“Shares”) at the purchase price of $0.36 (“Purchase Price”) per share for an aggregate of $2,500,000. The net proceeds were $2,35,000 after accounting for placement fees and legal expenses paid. The offer and sale of the Shares in the registered direct offering was registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s shelf registration statement on Form S-3, as amended (File No. 333-216345), which became effective on April 25, 2017. Pursuant to Rule 424(b) under the Securities Act, the Company has filed a prospectus supplement in connection with such offering. In a concurrent private placement, the Purchasers received warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

With this raise, we believe that we now have sufficient cash in hand to enable us to file our first IND. The Company believes that it will need to raise additional capital by way of equity, debt, debentures, or other methods, to support the upcoming clinical trials and operational expenses.

Irach Taraporewala, PhD, resigned as CEO effective February 1, 2019 for personal reasons. As a result, Anil R. Diwan, PhD, President and Chairman, was elevated by the Board to the position of Executive Chairman. The Company has retained Dr. Taraporewala as a consultant to help with drug development into the regulatory stage for a period of two years.

Additionally, management has continued its efforts at investor outreach and communications.

Dr. Anil Diwan, President and Executive Chairman, presented the Company at the Planet Microcap Conference and Showcase in Las Vegas, NV, on May 1, 2019, subsequent to the reporting period. He also held meetings with several interested investors. The Planet MicroCap Showcase brings together the most promising companies and the top dealmakers in MicroCap Finance for three days of company presentations, one-on-one meetings, and networking in the nation’s #1 destination for meetings and entertainment.

On February 12, 2019, Dr. Diwan gave a corporate presentation at the BIO CEO & Investor Conference held at the New York Marriott Marquis. BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies.

Dr. Irach B. Taraporewala, then Chief Executive Officer of the Company, presented a corporate overview and discussed the Company’s progress in taking its first drug candidate into human clinical trials at the Biotech Showcase Meeting held in San Francisco, in parallel to the JP Morgan Life Sciences Conference, on January 7, 2019. Previous to that, he presented the Company overview at the MicroCap Investment Conference, held on October 1-2, 2018 at the Essex House Hotel in New York City.

Previously, the Company has reported that we have engaged The Money Channel NYC for the purpose of investor and brokerage outreach. The Company has elected to continue this engagement. 

Background - The Nanoviricide® Platform Technology

NanoViricides, Inc. is a globally leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.

Our anti-viral therapeutics, that we call “nanoviricides®” are designed to appear to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. Viruses would not be able to escape the nanoviricide by viral mutations since they continue to bind to the same cellular receptor and thus would be captured by the nanoviricide. Virus escape by mutations is a major problem in the treatment of viral diseases using conventional drugs.  

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The Company develops its class of drugs, that we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a “biomimetic” - it is designed to “look like” the cell surface to the virus. To accomplish this, we have developed a polymeric micelle structure composed of PEG and fatty acids that is designed to create a surface like the cell membrane, with the fatty acids going inside of the micelle. On this surface, we chemically attach, at regular intervals, virus-binding ligands. The virus is believed to be attracted to the nanomicelle by these ligands, and thereby binds to the nanoviricide using the same glycoproteins that it uses for binding to a host cell. Upon such binding, a “lipid mixing” interaction between the lipid envelope of the virus and the nanomicelle is thought to take place, leading to the virus attempting to enter the nanomicelle. We believe many different kinds of viruses are likely to get destroyed in this process.

We engineer the ligands to “mimic” the same site on the cell surface protein to which the virus binds. These sites do not change no matter how much a given virus mutates. Thus, we believe that if a virus so mutates that it is not attacked by our nanoviricide, then it also would not bind to the human host cell receptor effectively and therefore would be substantially reduced in its pathogenicity. Our success at developing broad-spectrum nanoviricides depends upon how successfully we can design decoys of the cell surface receptor as ligands, among other factors.

NanoViricides, Inc. is one of a few bio-pharma companies that has all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. At our campus at 1 Controls Drive, Shelton, CT, we possess state of the art nanomedicines characterization facilities that we believe enable us to perform pre-IND nanomedicine analysis and characterization studies of any of our various drug candidates in house. In addition, we believe we now have the ability to scale up production of any of our drug candidates, and implement state of the art in-process controls as well as post-process analysis controls in order to establish robust c-GMP-capable production methodologies. We also have a Biological Safety Level 2 (BSL2) certified virological cell culture lab at this campus. We are able to perform initial cell culture based screening of large numbers of drug candidates for effectiveness and safety against certain of the viruses that we have targeted for drug development. This capability boosts our drug development capabilities significantly. Other than this limited initial screening, all of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO). In particular, all of the animal studies are performed by our collaborators and CROs.

Our Product Pipeline

We have focused our efforts almost exclusively on the HerpeCide™ program, given our budgets and current financial condition.

We currently have at least 9 different drug development programs, attesting to the strength of our platform technology. Of these, 5 of the indications are under the HerpeCide™ program. We are currently working on 3 of these indications (VZV, HSV-1 and HSV-2) in parallel, as explained below (priority level 1). The HK program and v-ARN program (see below) are at a lower priority level. In addition, we continue to work on the FluCide™ program at the lower priority 3. HIVCide™ program is at priority level 4. We will continue to seek funding for further development in the remaining programs, namely Dengue and Ebola/Marburg antivirals.

The potential broad-spectrum nature of our anti-HSV drug candidates is enabling several anti-Herpes indications under our HerpeCide™ program. Of these, the (i) Topical Treatment for Shingles (VZV) is currently moving most rapidly towards clinical stage. We believe that the other anti-Herpes drug candidates, would follow this lead drug to the clinical stage, namely, (ii) skin cream for the treatment of orolabial herpes (“cold sores”) and recurrent herpes labialis (RHL) mostly caused by HSV-1, and (iii) skin cream for the treatment of genital herpes caused by HSV-2.

In addition, a fourth indication, (iv) ocular eye drops treatment for external eye herpes keratitis (HK), caused by HSV-1 or HSV-2, is expected to follow into further drug development. Further, we have announced that we have begun preclinical drug development work on a fifth indication under the HerpeCide program, namely (v) viral Acute Retinal Necrosis (v-ARN), intravitreal injection.

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A preliminary safety and toxicology evaluation (Safety and Tolerability study) of the Company’s optimized nanoviricides® drug candidates in the HerpeCide™ program was performed at AR Biosystems, Beverly, MA in Dec 2017-March 2018. This preliminary safety/toxicology study in the rat animal model is an important step in the drug development pathway. It was conducted in order to provide information for designing the IND enabling non-GLP and GLP safety/toxicology (“Tox Package”) studies. It was designed to (i) evaluate the direct effects of topical delivery of the drug candidates on the skin, (ii) assess if the drugs attain detectable levels in the blood, and also (iii) evaluate whether there are any effects on the blood and primary organs, in uninfected animals. Dermal topical treatment of rats with formulated drug candidates was evaluated in this study as a primary objective, since skin is the primary breakout site of HSV-1, HSV-2, and VZV infections.

As a result of the success of its drug lead optimization process, the Company selected two clinical development candidates for further evaluation in this initial safety/toxicology study.

No clinically observable adverse safety and toxicology effects were seen in this study of the Company’s optimized topical dermal drug candidates. There were no adverse effects on the skin at the treatment sites. Equally importantly, the results of the non-GLP safety and toxicology study showed that there were no overall observable systemic effects either. There were no observable direct effects on the primary organ function whether the drug was administered to the skin or administered systemically. This includes liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity.

These results are consistent with the positive findings in a model of VZV (the shingles virus) infection of human skin in which no safety or toxicology concerns have been observed, further demonstrating the safety of these drug candidates.

Moreover, these drug candidates have shown strong effectiveness in the human skin organ culture model of VZV infection studies as well, as previously reported. Further, these candidates have demonstrated strong anti-viral activities against HSV-1, HSV-2, and VZV in cell culture studies using multiple cell lines.

These studies established that our optimized drug candidates were worthy of further development in the regulatory pathway for approval. Since then, we engaged in production scale-up and chemistry, manufacture and control studies (“CMC” studies) at our Shelton facility. This c-GMP capable facility has been designed to be able to manufacture any of our nanoviricides drug candidates from scratch in research quantities to multi-kilogram production quantities that would be needed for the regulatory Tox Package studies as well as for human clinical trials.

The success of our drug candidates in this preliminary rat safety/toxicology study cleared the path for taking these candidates into formal GLP safety/toxicology studies that are required for filing an IND. We believe that, additionally, the results of this preliminary rat safety/toxicology study give us confidence that the dermal topical treatments we are developing for the treatment of HSV-1 cold sores, and HSV-2 genital ulcers should also exhibit similar strong safety characteristics.

We have already begun to scale up production of these tested candidates to the larger amounts as estimated to be required for the ensuing Tox Package studies. We have estimated the amount of the candidate that will be needed to be supplied for such a study, based on discussions with BASi, Inc., IN, the service provider, and Biologics Consulting Group, VA, our regulatory consultants. We have increased the scale of production to meet this required quantity and have the ability to produce multi-kilogram quantities of materials. We are also working on detailed optimization of the manufacture and characterization of the materials at different synthetic steps as will be needed for the Chemistry, Manufacture, and Controls (CMC) section of an IND application.

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The market size for an effective anti-shingles drug is currently estimated to be in the range of several billions of dollars, even after a new shingles vaccine, Shingrix® (GlaxoSmithKline) has been approved, based on a recent report by Dr. Myers of BioEnsemble, LLC, pharma industry consultants, commissioned by the Company. The current vaccine for prevention of chicken pox in children, i.e. the varicella vaccine, is based on the live attenuated virus derived from the Oka strain. Un-vaccinated children usually develop chicken pox at some point in their childhood, and the wild-type virus then remains latent in their bodies, in nerve ganglia. Similarly, Varicella vaccinated children may develop mild syndrome when vaccinated and the weakened Oka strain remains latent in their bodies, All of these children can develop shingles later in life. It is generally believed that the intensity of such disease would be much less severe with the weakened vaccine strain than with the natural or wild type strain. Nevertheless, the severity of the symptoms and overall effects depend upon the immune status of the individual. Pre-vaccination era, (i.e. before varicella vaccination was widely adopted in the USA), there were 3-4 million cases of chicken pox per year (matching the birth rate). Post-vaccination era, this rate has dropped to about 120,000-150,000 cases in the USA. However, in several developing and underdeveloped countries, the rates of chicken pox remain high due to limited access to the vaccine or limited adoption of the vaccine. As stated earlier, nearly every person may be expected to get shingles at some point in their lives, with varying severity. A preventive vaccine for adults, namely Zostavax® is available, based on the attenuated Oka strain. Its effectiveness is variously estimated at around 60-70%. Its coverage remains low, as most people do not get this vaccine. Shingrix is a subunit vaccine, that is it does not contain intact living virus particles but only certain proteins derived from the virus. As such, it is expected to not have the issue of “breakthrough disease” which occurs when the live latent virus from the vaccine itself causes disease. However, Shingrix has significantly greater severe side-effects than Zostavax in more than 10-15% of the persons taking it. This may keep its adoption rate much lower than expected by the manufacturer GSK. Currently, Shingrix is unavailable in most markets because the manufacturer has apparently not scaled up production more than one year since its introduction. Thus it appears that a significant market would continue to exist for an anti-shingles drug, at least for several years.

More specifically, the report estimated that the anti-shingles drug candidate could reach peak annual sales of as much as $2 Billion, depending upon the effectiveness determined in clinical trials, at an assumed 50% market penetration, if it is effective in reducing incidence of post-herpetic neuralgia (PHN). Based on current pre-clinical data, we believe that there is a very strong probability that the shingles treatment would significantly minimize the shingles pain, accelerate healing, and minimize nerve damage, thereby minimizing the occurrence and severity of post-herpetic neuralgia (PHN). Our pre-clinical drug design efforts have been aimed at developing a treatment for shingles that would have pain reduction effects as well as healing effects on skin.

Initially, we plan on performing clinical trials based on VZV related biomarkers and clinical pathology, which we believe would be sufficient for a first indication for approval of the drug for treatment of shingles by the US FDA. Sales of an effective drug against shingles with this limited indication are projected to reach several hundreds of millions of dollars. We plan on performing observations regarding PHN in these clinical trials so that an informed PHN clinical trial may be performed later to extend the drug indication.

We have developed strong chemical manufacturing process controls that enable us to produce the backbone polymers with highly restricted and reproducible molecular size range. In fact, we have achieved highly reproducible and scalable processes that have yielded the same polymer molecular sizes across production scales from 10g to 500g. In other words, we are now able to control the length of the backbone polymer to within one monomer unit, irrespective of production scale, at least up to about 1 kg scale.

We believe that this is a remarkable and possibly unmatched achievement in the field of nanomedicines. We have scaled up the production of the polymer backbone “nanomicelle” to kilogram scales, and do not anticipate any manufacturing constraints at present. We have also achieved kilogram-scale manufacture of the ligand in NV-HHV-101, and have further scaled up production of the nanoviricide NV-HHV-101, which is chemical conjugate of the ligand to the nanoviricide, in a well defined manner to kilogram scale. Additionally we have scaled up formulation of the resulting drug substance into the skin cream to multi-kilogram scales. The production of the drug substance and the drug product is achieved in a cGMP compatible fashion at our own facility.   

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Our polymer backbone itself is designed based on the route of application. In the case of the shingles drug candidate, as well as for HSV-1 cold sores, and for HSV-2 genital ulcers, the route is dermal topical application.

In addition to VZV, we are also developing dermal topical drugs against HSV-1 cold sores and HSV-2 genital ulcers. Dr. Brandt’s Lab at CORL, the University of Wisconsin, Madison, WI, is validating animal models for the study and evaluation of relative efficacies of different treatments for HSV-1 infection in mice as well as for HSV-2 infection in mice. The goal of these developments is to develop animal models that would be able to discriminate an experimental drug that is more effective than the current standard of care drugs, from the standard of care. At present the existing animal models show maximal effectiveness with the standard of care and therefore cannot discriminate a drug that might be superior. If their animal models are successful in differentiating effectiveness of different drug candidates, then we will be able to evaluate our drug candidates for the treatment of HSV-1 cold sores as well as for the treatment of HSV-2 genital ulcers, in addition to the VZV testing being performed.

The ligands currently in use for the nanoviricide drug candidates against VZV shingles were actually developed using computer models of HSV binding to its cellular receptor, and not against VZV itself. Our program shifted to advance a VZV candidate as our first indication due to various considerations that led to the prioritization of the different drug indications. The Company identified certain advantages that would enable earlier entry into clinical trials for the shingles candidates. The shingles drug development program has been moving rapidly primarily because of the quick turnaround time and high responsiveness of the Dr. Moffat Lab at SUNY Syracuse, our critical collaborator for human skin effectiveness studies of our drug candidates. The Company is currently negotiating for a license for VZV, Shingles Virus, from the Company’s licensor, TheraCour Pharma, Inc. (“TheraCour”).

One of the advantages of the shingles program is that the pre-clinical drug development is performed directly in a human skin model, bypassing any animal model, providing significant confidence that a human clinical studies outcome would parallel the preclinical study outcome. VZV does not infect animals other than humans.  

Thus, we have made significant and substantial progress in the reporting quarter towards the goal of filing our first IND application, and we continue to build on this progress.

NanoViricides, Inc. reported in July 2017, that its anti-shingles nanoviricides® drug candidates achieved dramatic reduction in infection of human skin by the varicella-zoster virus (VZV), the shingles virus. These findings corroborate the previously reported findings of inhibition of VZV infection of human cells in culture. VZV is restricted to human tissue and only infects and replicates in human tissue.

Over the time course of VZV infection, the nanoviricides® drug candidates showed marked inhibition of VZV infection, replication and spread in human skin cultured ex vivo. The data suggest that select nanoviricides® drug candidates may have direct virucidal activity based on their antiviral effects within the first 24 hours after viral infection.

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The antiviral effect of certain nanoviricide drug candidates was substantially greater than the effect of the standard positive control of cidofovir added into media. Even more remarkably, the effect of these nanoviricides drug candidates was equivalent to a topical formulation of 1% cidofovir applied directly onto the skin patch. A topical skin cream containing 2% cidofovir is clinically used in very severe cases of shingles. However, the cytotoxicity of cidofovir is known to cause ulceration of the skin to which it is applied, followed by natural wound healing.

Histopathology studies have demonstrated a lack of VZV-associated lesions in nanoviricide-treated skin patches. This work was presented as a poster presentation by the Moffat group at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal, (https://www.isar-icar.com/page/31icar).

Since VZV causes skin lesions as a result of direct attack of the re-awakened virus released from nerve endings onto the human skin cells, this ex vivo human skin patch model involving VZV infection of cultured human skin ex vivo is considered to be a close representation of natural course of shingles.

The Company has previously reported that these same nanoviricides® compounds displayed potent inhibition of VZV infection of a human retinal epithelial pigment cell line in an in vitro cell culture virus infection model with no evidence of toxicity to the cells. These ex vivo and in vitro studies are a critical step in the selection of final clinical drug development candidates for safety and toxicology studies with the goal of an IND submission to the FDA for the topical treatment of shingles in humans.

These human skin studies were performed in the laboratory of Dr. Jennifer Moffat at SUNY Upstate Medical University in Syracuse, NY. The Company previously reported the collaboration with Dr. Moffat, an internationally recognized expert on varicella-zoster virus. She has extensive experience in varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. The National Institutes of Health has a contract with Dr. Moffat’s lab for evaluating anti-viral compounds against VZV, although the Company chose to set up a direct collaboration with Dr. Moffat rather than going through the NIH program.

Dr. Vivien Boniuk, then Consultant in Ophthalmology at the Company, presented the successful results of certain anti-herpes nanoviricide treatments for v-ARN at the 2017 Annual meeting of the Ocular Microbiology and Immunology Group (OMIG) of the American Academy of Ophthalmology held in New Orleans, LA, on November 10, 2017. In this study, HSV-2 infection was given to mice as a single injection to cause v-ARN. The mice that received either of two nanoviricides drug candidates simultaneously with the virus in this single injection, showed significant improvements using a number of parameters. In contrast, mice that received foscarnet injection simultaneously with the virus did not show any improvements. Of note, foscarnet is a current standard of treatment, although the treatment is long in duration and arduous, being multiple intravitreal injections. In addition, another group of HSV-2 infected animals received acyclovir by intraperitoneal injection (50mg/kg), twice daily for 7 days, as a positive control. Acyclovir and its derivatives are also used currently for treating v-ARN, although the clinical efficacy is limited and generally requires long durations of treatment. Vehicle treated and untreated negative controls also were employed. These studies were performed in the lab of Dr. Curtis Brandt at CORL, University of Wisconsin, Madison, WI.

Both nanoviricides tested showed remarkable efficacy using multiple parameters.  In both nanoviricide A and nanoviricide B groups, the retina was protected fully from viral damage, which is very significant. In contrast, the acyclovir treated group showed retinal damage approximately similar to the vehicle treated group, in spite of reduced viral load in the acyclovir group, indicating that acyclovir may have been toxic. These results were also confirmed by histological staining of retinal sections. Both nanoviricide A and nanoviricide B had substantial effectiveness in protecting the retina, in spite of the high infectious dose of HSV-2 employed in this model. Significantly, they were both substantially more effective than foscarnet (single injection) or acyclovir (bid 7 days) in this particular study. If these results are reproducible, then the Company would be able to identify a clinical candidate for v-ARN as well.

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Of note, both nanoviricides tested against v-ARN are closely chemically related to those that have shown significant efficacy against varicella zoster virus (VZV) in the human skin patch model in Professor Moffat’s lab at the Upstate Medical Center, SUNY, Syracuse, NY. We have previously shown that closely chemically related nanoviricides were also effective against HSV-1 in animal models as well as in cell culture models. This is important because about 50% of v-ARN cases are caused by VZV, about 40+% caused by HSV-2, with HSV-1 and CMV accounting for a small percentage of cases. VZV does not infect mice, and therefore the HSV-2 v-ARN model should be indicative model for our drug development. Thus the broad-spectrum activity of our nanoviricides against multiple different herpesvirus types has been instrumental in rapid expansion of our HerpeCide program.

Additional successful studies on v-ARN are expected to add a fifth indication to the Company’s growing portfolio of anti-herpes drug indications, further expanding the potential market. The Company intends to maximize shareholder value from its broad-spectrum anti-herpes nanoviricides asset by aggressively expanding its portfolio of herpesvirus indications.

v-ARN is a disease of the retina of the eye caused by various herpes viruses that leads to severe loss of vision and blindness. The infecting agent in this study was herpes simplex virus-2 (HSV-2), the type of herpes virus that also causes genital herpes.

Acute Retinal Necrosis is characterized by severe ocular inflammation, retinal necrosis, and a high incidence of retinal detachment (RD) leading to visual loss and blindness. This disease is caused by members of the herpesvirus family, including, herpes simplex virus-2 (HSV-2), varicella zoster virus (VZV), and herpes simplex virus (HSV-1). An estimated 50,000 new and recurrent cases of ocular herpes per year are reported in the United States alone, and in a small proportion of the patients, the disease escalates to v-ARN. We anticipate that ocular herpes or v-ARN may qualify for an orphan disease indication.

Our current development has focused on API suitable for formulating into a skin ointment for the treatment of VZV shingles, HSV-1 cold sores, or HSV-2 genital ulcers. As these drug candidates advance further, we plan on performing fully integrated drug development for developing eye drops for treatment of external eye infections such as herpes keratitis (a disease of the external eye). Thereafter we plan on undertaking the development of suitable materials for intravitreous or sub-retinal injections for the treatment of certain viral diseases involving the retina.

We have recently reported that we have extended the contracts with both the Moffat Lab, UMC, SUNY Syracuse, as well as the Brandt Lab, CORL, UW, Madison to continue to perform more advanced studies in preparation of an IND for shingles topical treatment and for v-ARN intravitreal treatment, respectively.

In addition, we have continued work on our other drug candidates albeit at a very low priority. These include (vi) Injectable FluCide™ for hospitalized patients with severe influenza, (vii) Oral FluCide™ for out-patients, (viii) DengueCide™, a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS), and (ix) HIVCide™ for HIV/AIDS. In addition, the Company has research programs, enabled by the robust nanoviricides platform technology, to develop drugs against Rabies virus, Ebola and Marburg viruses, and other viruses.

To date, the Company does not have any commercialized products. The Company continues to add to its existing portfolio of products through our internal discovery and clinical development programs and also seeks to do so through an in-licensing strategy.

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The Company received an “Orphan Drug Designation” for our DengueCide™ drug from the USFDA as well as the European Medicines Agency (EMA). This orphan drug designation carries significant economic benefits for the Company, upon approval of a drug.

We believe we have demonstrated that we can rapidly develop different types of formulations for different routes of administration, such as injectable, skin cream, lotion, gel, and even oral, because of the inherent strength of the nanoviricide platform tailorable technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.

All of our drug programs are established to target what we believe are unmet medical needs.

Herpes simplex viral infections cause keratitis of the eye, and severe cases of infection may sometimes necessitate corneal transplants. Oral and genital herpes is also a well-known disease, with no cure and existing treatments that are not very effective. Shingles, caused by VZV, a herpesvirus, does not have an effective treatment at present, although some drugs are approved for use in shingles. Adenoviral Epidemic Kerato-Conjunctivitis (EKC) is a severe pink eye disease that may lead to blurry vision in certain patients after recovery. The epidemic and pandemic potential as well as the constantly changing nature of influenza viruses is well known. The HIV/AIDS worldwide epidemic and the “curse of slow death” nature of HIV viral infection are also well known. Dengue viral infection is also known as “breakbone fever”. What is worse, is that when a patient is infected with a dengue virus a second time, if the virus is a different serotype, then it can cause a severe dengue disease, or dengue hemorrhagic syndrome, with very high morbidity and a high rate of fatality. This is because, the patient’s immune system mounts an attack, but the antibodies that it generates, directed at the previous infecting virus, are not effective against the new infection, and instead the new infecting virus uses them to hitch a ride into host cells that it infects more severely. This phenomenon is called “Antibody-Dependent Enhancement” or “ADE” for short. 

In the United States alone, approximately 1 million cases of shingles (i.e. zoster) occur annually. The risk of zoster increases with age, and with decreased immune system function, such as occurs in diabetics. Zoster is characterized by pain and rash. Discrete cutaneous lesions occur in groups on the skin. The Company believes that this presentation enables topical therapy for control of the viral outbreak.

One in four patients develop zoster-related pain that lasts more than 30 days. If it persists more than 3 months, it is called post-herpetic neuralgia (PHN), and may persist for years. It is thought that zoster-associated pain and PHN is a result of chronic ganglionitis, i.e. continued low-grade production of the virus in the infected ganglia and related immune response. The Company believes that effective control of the virus production would minimize or eliminate PHN, a debilitating morbidity of zoster.

Zoster occurs mostly in the abdominal region. However, in 20% of cases, it occurs in the head area, with reactivation involving trigeminal distribution. These cases of zoster can lead to serious complications including hemorrhagic stroke (VZV vasculopathy), VZV encephalitis, ophthalmic complications, and may result in fatalities. 

Currently available anti-herpes drugs have had limited impact on zoster. Thus, an effective drug with a good safety profile could have a dramatic impact on zoster as well as possibly PHN.

External eye infections with HSV-1 have been reported to be the leading cause of infectious blindness in the developed world, with recurrent episodes of viral reactivation leading to progressive scarring and opacity of the cornea. HSV epithelial keratitis afflicts the epithelium of the cornea. In some cases, the disease progresses to HSV stromal keratitis, which is a serious condition. HSV stromal keratitis involves the stroma, the layer of tissue in the cornea, which is deeper in the eye than the epithelium. Its pathology disease involves the HSV infection of stromal cells, and also involves the inflammatory response to this infection. It can lead to permanent scarring of the cornea resulting in diminished vision. More serious cases require corneal replacement surgery. About 75% of corneal replacements are known to fail in a 20-year time frame, due to graft versus host disease (i.e. rejection of the foreign implant by the body), requiring a new procedure, or resulting in blindness.

Herpes keratitis incidence rates in the USA alone are reported to be in the range of 65,000 to 150,000 patients per year. Of these approximately 10,000 per year may be estimated as requiring corneal transplants. The estimates of incidence rates vary widely based on source, and are also assumed to be underreported. A corneal transplant costs approximately $15,000 to $25,000 for the surgery, with additional costs for follow on drugs and treatments.

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This scenario exists in spite of available drugs, namely the acyclovir class of drugs, trifluridine, and others, that are used for treatment of herpes keratitis. The failure of these drugs is primarily due to limited safety resulting in insufficient drug availability at the site of infection.

In addition, the Company is developing broad-spectrum eye drop formulations that are expected to be effective against a majority of the viral infections of the external eye. Most of these viral infections are from adenoviruses or from herpesviruses. The Company has shown excellent efficacy of its drug candidates against EKC (adenoviral epidemic kerato-conjunctivitis) in an animal model. Further, our anti-HSV drug candidates have shown excellent efficacy in cell culture studies, as well as in a lethal skin infection animal model.

Thus, an effective drug with a good safety profile could have a dramatic impact on ocular viral infections. Merit-based compensation for the herpes keratitis treatment would enable strong financial incentive and could result in potential revenues in the several hundreds of millions range, depending upon the effectiveness of the drug. The Company believes that it has sufficient production capacity at its current site to supply the US requirement of the drug for treatment of (ocular) herpes keratitis upon drug licensure.

Topical treatment of herpesvirus infections is important because of the disfiguring nature of herpesvirus breakouts, the associated local pain, and the fact that the virus grows in these breakouts to expand its domain within the human host further. Topical treatment can deliver much higher local levels of drugs than a systemic treatment can, and thus can be more effective and safer at the same time. Systemic drug treatment results in side effects because of the high systemic drug concentrations that need to be achieved and the large drug quantities that must be administered. Since the virus remains mostly localized in the area of the rash and connected nerve apparatus, using high concentrations of drugs delivered in small quantities topically would allow maximizing the effectiveness while minimizing the side effects.

Herpesviruses become latent in neuronal cells or in ganglia, and cause periodic localized breakouts that appear as skin rashes and lesions. Systemic drug treatment results in side effects because of the high systemic drug concentrations that need to be achieved and the large drug quantities that must be administered. Since the virus remains mostly localized in the area of the rash and connected nerve apparatus, using high concentrations of drugs delivered in small quantities topically would allow maximizing the effectiveness while minimizing the side effects, leading to minimizing viral production at the site. Such effective local control of the virus titer is expected to lead to reduction in recurrence of herpesvirus “cold sores” or genital ulcers, and reduction in shingles related PHN.

The potential broad-spectrum nature of our anti-HSV drug candidates is expected to enable several antiviral indications. Thus, HSV-1 primarily affects skin and mucous membranes causing “cold sores”. HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases. In addition, human herpesvirus-3 (HHV-3), a.k.a. varicella-zoster virus (VZV), causes chickenpox in children and when reactivated in adults, causes shingles. Shingles breakouts are amenable to topical treatment, as are the HSV cold sores, genital lesions, and herpes keratitis of the eye. Most of these indications do not have satisfactory treatments at present, if any. Further, the treatment of herpesvirus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need. Drugs with mechanisms of action other than DNA-polymerase inhibitors (such as acyclovir) are needed for effective treatment.

The childhood chickenpox vaccine (varicella vaccine) has reduced the cases of chickenpox, but this is a live attenuated virus vaccine that persists in the body. All adults who have had chickenpox in childhood continue to harbor the chickenpox virus, and are expected to develop shingles at some time, with the risk of shingles increasing with age or weakening of the immune system surveillance. In addition to the shingles breakout itself, post-herpetic neuralgia (pain) (PHN) is a significant morbidity of shingles, and to a lesser extent, of oral and genital herpes. PHN is initially caused probably by the inflammation and immune response related to the local virus expansion, but persists well after the virus has subsided, the blisters have scabbed off, and the skin has recovered, due to the nerve damage that results from the local large viral load during infection. Current PHN treatments are symptomatic, affecting the pain signaling circuit (such as novocaine, pramoxine, capsaicin, etc.), and do not produce lasting control. An effective therapy that results in strong local control of the virus production during the breakout itself is expected to minimize the resulting immune responses and nerve damage, and thereby minimize or possibly eliminate PHN.

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The Company thus believes that it can develop its broad-spectrum anti-herpes drug candidate towards at least five topical indications, namely, (a) shingles, (b) oral herpes (“cold sores”), (c) genital herpes, (d) herpes keratitis (external eye infection), and (e) ocular herpes including v-ARN (internal eye infection). As the HerpeCide™ program progresses, it is likely that additional herpesvirus related pathologies may become amenable to treatment with our herpesvirus drug candidates.

Our nanoviricides in the HerpeCide™ program at present are designed as topical treatment for the breakout of shingles or herpes sores. Our animal studies results are very significant considering that topical acyclovir in the form of a cream as well as an ointment, are approved for the treatment of cold sores. We believe our strong anti-herpes nanoviricide® drug candidates are capable of reaching approval as a drug for topical use against herpes cold sores, based on these datasets. Further drug development is necessary towards the goal of drug approval.

Currently, valacyclovir (Valtrex®) is approved as an oral drug for the treatment of severe shingles, but it has limited effectiveness. Another oral drug known as “FV-100” was studied in clinical trials for the treatment of shingles by Bristol-Myers Squibb, and later by Contravir. FV-100 works only against VZV and does not work against other herpesviruses. A Phase 3 study with PHN as end-point was completed in November 2017. Further development appears to have been stopped for FV-100.

There is also a new preventive vaccine for shingles, “Shingrix”. Given the number of cases of severe shingles, we believe that there is an unmet medical need for developing a topical skin cream for the treatment of shingles, even with a successful introduction of this vaccine. The Shingrix vaccine has been recently also been shown to produce adverse effects such as painful injection site reactions and pain in a significant number of patients. Local application of a nanoviricide drug should enable delivery of stronger, local doses of medicine, with a stronger patient benefit, than oral systemic dosing allows.

Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection. Available topical treatments, including formulations containing acyclovir or chemically related anti-HSV drugs, are not very effective. Currently, there is no cure for herpes infection. Brincidofovir (CMX001) is being developed by Chimerix. It failed in a Phase 3 clinical trial for hCMV in organ transplants, and its Phase1/2 clinical trial for HSV in neonates was withdrawn recently. Cidofovir is a known highly effective but also toxic, broad-spectrum nucleoside analog drug that was modified with a lipidic chain structure to create brincidofovir. Pritelivir, by AiCuris, is a DNA Helicase/Primase inhibitor (HSV-1 and HSV-2) that has successfully completed certain Phase 2 clinical trials, and its indication in immune-compromised patients has received a fast track status from the US FDA. Letermovir (Merck/AiCuris), a terminase complex inhibitor, is effective only against hCMV and has entered a Phase 3 clinical study in kidney transplant patients.

Both the safety and effectiveness of any new drug has to be determined experimentally. The safety of a nanoviricide drug is expected to depend upon the safety of the nanomicelle portion as well as the safety of the antiviral ligand. We have observed excellent safety of our injectable anti-influenza drug candidates. This leads us to believe that the nanomicelle backbones of these drug candidates that were evaluated in preliminary safety studies should be safe in most if not all routes of administration.

The current market size for drugs for the treatment of various herpes infections is well over $4 billion. Similarly, the current market size for the treatment of influenza infections is in excess of $4 billion, and that for HIV treatments is in excess of $40 billion. The total market sizes for the drug development programs we have in progress are estimated at around $100 billion.

We believe that when effective topical treatments against VZV shingles, HSV-1 cold sores and HSV-2 genital ulcers are introduced, their market sizes are likely to expand substantially, as has been demonstrated in the case of HIV as well as Hepatitis C.

Our timelines depend upon several assumptions, many of which are outside the control of the Company, and thus are subject to delays.

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We are currently focused on topical drug development against several indications related to infections by herpes family viruses. The Company recognized, after consultations with its FDA regulatory advisors, namely Biologics Consulting Group (of Alexandria, VA), and several other experts in the field, that the development of these topical drug candidates towards human clinical trials is likely to be considerably faster than the development of our anti-influenza systemic (injectable) drug candidate.

Management Discussion - Current Drug Development Strategy

During the reported quarter we have continued to focus our drug development work plans primarily on our lead anti-shingles and anti-Herpes-virus programs. In particular, we have focused on a work plan towards clinical development candidate for the topical skin ointment for the treatment of shingles outbreak. Because of the broad-spectrum nature of our anti-herpes drug candidates, we have also simultaneously continued further development of our drug candidates for four additional indications in the HerpeCide™ project, namely, cold sores, genital ulcers, external ocular viral infections, and viral acute retinal necrosis.. We have prioritized our resources with the goal of filing our first IND in the shortest possible timeframe.

The Company has continued the development of anti-HSV-1 and anti-HSV-2 drug candidates, and has tested the same against VZV in cell cultures, in addition to against HSV-1 and HSV-2. Since the candidates showed preliminary efficacy against VZV as well, the Company added shingles as an additional indication to pursue under the HerpeCide™ program.

Our earlier animal studies for efficacy testing of HSV-1 drug candidates in a mouse dermal model of the infection were performed by Professor Ken Rosenthal’s Lab at NEOUCOM/NEOMED. Professor Rosenthal has retired and his lab has closed.

We therefore engaged Dr. Brandt’s Lab at CORL, University of Wisconsin, Madison, WI, to further develop their animal models of dermal HSV-1 and HSV-2 infections in mice and to make them suitable for screening of drugs for relative efficacy. They are working on validating their HSV-1 mouse model for discriminative efficacy of different existing drugs. Once they can establish that the model distinguishes different effective drugs, we will be able to use the model for testing our HerpeCide drug candidates against HSV-1, and optimizing the same only if necessary. Following HSV-1 model development, we have commissioned Dr. Brandt’s Lab to perform similar studies for their HSV-2 genital infection mouse model as well. Dr. Brandt’s Lab developed the mouse model of viral Acute Retinal Necrosis (v-ARN) caused by HSV-1 that we have tested some of our drug candidates in as reported elsewhere.

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Our discussions with our regulatory advisors and consultants indicate that the shingles drug candidate may be likely to reach the human clinical evaluation phase earliest compared to the other drug candidates. Other drug candidates in the HerpeCide project are expected to follow into clinical stage rapidly thereafter. This is primarily because of the topical treatment nature of the drug candidates we have chosen to develop in these indications.

Animal model studies of lethal herpesvirus infection using the highly pathogenic and neurotropic HSV-1 H129 strain in two different sites resulted in 85% to 100% survival in animals treated with certain anti-HSV nanoviricide drug candidates, while control animals uniformly died. We reported on these studies in April 2015, from Professor Emeritus Ken Rosenthal’s lab at NEOMED, and in August 2015, from TransPharm Preclinical Solutions, LLC, Jackson, MI (TransPharm), a CRO. Previously, we have improved the anti-HSV drug candidates in cell culture studies and were able to achieve significant effectiveness before engaging into animal studies. We re-designed the anti-HSV drug candidates so that the solutions would not run off the skin when applied. With this redesign, our drug candidates demonstrated complete survival of HSV-1 H129 lethally infected animals.

The Company thus has achieved animal studies efficacy proof of concept for HSV-1 skin topical treatment. The Company believes that the broad-spectrum nature of these drug candidates should allow effectiveness against related herpesvirus types such as HSV-2 as well as the more distantly related HHV-3 aka VZV or chickenpox/shingles virus.

The Company has established additional collaborations towards IND-enabling development of drug candidates against the four indications listed earlier. We now have collaboration agreements with the CORL at the University of Wisconsin, the Campbell Lab at the University of Pittsburgh, and, the Moffat Lab at SUNY Upstate Medical Center, for the evaluation of our nanoviricides® drug candidates in models of ocular herpesvirus and adenovirus infections as well as VZV infections in in vitro and ex vivo models. The Company also now has the ability to perform initial screening of our drug candidates in our BSL2 certified Virology Lab in Shelton, CT, against several viruses that include various strains and subtypes of HSV-1, HSV-2, VZV, and Influenza.

The Company has previously reported the successes of its nanoviricides drug candidates in pre-clinical studies of dermal herpes virus infections in mouse models. The studies in Dr. Brandt’s laboratory, namely CORL, at the University of Wisconsin will be critical in optimizing our anti-herpes drug candidates against ocular herpes virus infections. The goal of these studies will be to identify a drug development candidate as a treatment for ocular keratitis in humans caused by herpes simplex virus infections. We anticipate undertaking these studies as we are testing our HerpeCide drug candidates developed as skin ointment/cream against all three of dermal HSV-1, genital HSV-2, and VZV models. The treatment of ocular keratitis requires an eye drops formulation. We have tested certain of our polymer backbones in eye drop formulation application successfully previously. However, we are at present constrained by resource availability and the workload of moving our first drug candidate into IND stage.

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The Company believes that its anti-herpes drug candidates for the treatment of cold sores and for genital lesions should lead to effective control of the cold sores rapidly, and may also lead to a long lag time before a new recurrence episode occurs. This is because it is believed that recurrence rates increase by virtue of further infection of new nerve endings from the site of the herpesvirus outbreak, which result in additional nerve cells harboring the virus. If this in situ re-infection is limited, which we believe is the primary mechanism of nanoviricide drugs, then it is expected that the number of HSV harboring reservoir cells should decrease, and recurrence rate should go down.

The Company believes that it will be able to expand its anti-herpes portfolio in the future to include many other herpesviruses such as cytomegalovirus (CMV), HHV-6A, HHV-6B, KSHV, and Epstein-Barr virus (EBV, cause of mononucleosis). This would lead to a very large number of therapeutic indications beyond the four or five indications we are currently targeting.

The Company thus continues to expand its portfolio of opportunities, while also making progress towards the clinical trials stage.

The Company continues to work on its anti-influenza drug candidates in parallel to its HerpeCide program. We are developing Injectable FluCide™ for hospitalized patients with severe influenza as our first, broad-spectrum anti-influenza drug candidate. We have demonstrated the very first effective orally available nanomedicine, namely oral FluCide™ for outpatients with influenza. The development of Oral FluCide is expected to follow behind Injectable FluCide. These programs are being conducted at a much lower priority, with the highest priority being given to the various indications in the HerpeCide programs. Development of an anti-Influenza drug candidate has been estimated to be an extremely expensive process with a long drug development timeframe. This is because of the large number of virus types and subtypes that change rapidly within and over seasons. The Company at present does not have the resources to engage into a full-fledged anti-Influenza drug development program. Additionally, Xofluza®, a new drug with a novel mechanism of action (an endonuclease inhibitor) was very recently approved in the USA (Roche/Genentech). While it reduced viral load significantly in clinical trials, it did not have a significant effect on the time course of the clinical pathology of influenza infection in the clinical trials that led to its approval. Xofluza is approved for uncomplicated influenza. Information on its usage and effectiveness in the field in the current influenza seasonal cycle in the USA is not yet available.

Thus, an effective therapy for patients hospitalized with severe influenza continues to be an unmet need. In addition, a single injection treatment of non-hospitalized patients would be a viable drug if it provides superior benefits to existing therapies.

Because of our limited resources, we have now assigned lower development priorities to our other drug candidates in our pipeline such as DengueCide™ (a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS)) and HIVCide™ (a potential “Functional Cure” for HIV/AIDS).

We believe we have demonstrated that we can rapidly develop different types of formulations for different routes of administration, such as injectable, skin cream, lotion, gel, and even oral, because of the inherent strength of the nanoviricide platform tailorable technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.

Our Campus in Shelton, CT

Our campus at Shelton, CT, is now fully operative. With our R&D discovery labs, Analytical Labs, the Bio labs for virology R&D, the Process Scale-Up production facility, and the cGMP-capable manufacturing facility established at our new Shelton campus, we are in a strong position than ever to move our drug development programs into the clinic rapidly. Staff is being trained to achieve full cGMP compliance to support clinical trial manufacture.

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Process Scale-Up Production Capability

The Process Scale-up area is operational at kilogram to multi-kg scales for different chemical synthesis and processing steps now. It comprises reactors and process vessels on chassis or skids, ranging from 1L to 50L capacities, as needed. Many of the reactors or vessels have been designed by us for specific tasks related to our unique manufacturing processes.

cGMP Production Capability

Our versatile, customizable cGMP-capable manufacturing facility is designed to support the production of multi-kilogram-scale quantities of any of our nanoviricides drugs. In addition, it is designed to support the production of the drug in any formulation such as injectable, oral, skin cream, eye drops, lotions, etc. The production scale is designed so that clinical batches for Phase I, Phase II, and Phase III can be made in this facility. The clean room suite contains areas suitable for the production of sterile injectable drug formulations, which require special considerations.

We plan to produce multiple batches of a drug product and satisfy that said drug product is within our own defined specifications. If we are satisfied with such strong reproducibility of our processes, we plan to register the facility as a cGMP manufacturing facility with the US FDA.

At present, we plan on moving operations to our cGMP-capable manufacturing suite as the operational steps are developed to the level needed for moving them into this facility. This requires the development of draft-level Standard Operating Procedures, training, and drill-through of operations. We will also need to establish a Quality Assurance and Quality Control Department. Our current staff is busy developing our pre-clinical HerpeCide programs. Given our limited financing, we have not been able to attract the necessary talent for replacing the lost staff and for building out additional resources for QA/QC. We are working with available staff, training them further in cGMP requirements and operations, as well as in QA/QC. This inherently leads to serialization of efforts, and can lead to extending the timeline. We have been working diligently to meet our goals in the shortest timeframe possible given these constraints.

We operate in a completely novel area of medicines, which is broadly described as polymeric-micelle based drug conjugates and complex nanomedicines. Our technologies are also completely novel, and unmatched in the industry. As such, we anticipate a longer training period for new employees than in normal small chemical or biological drugs. We continue to seek talented scientists and engineers with specialized training. However, it is difficult to attract such talent for a small, pre- revenue pharma company such as ours.

We employ the same team that developed the small-scale synthesis chemistry for translation of those chemical syntheses into clinical-scale processes, and also to perform the related chemical engineering, quality control, quality assurance, and regulatory tasks along the way. Because of the small size of our scientific staff, this results in significant serialization of efforts. However, the personnel cost, as well as the time and expense cost of transfer of knowledge and training of a separate dedicated team is avoided because the same expert scientists who have developed the chemistries are also involved in scaling them up into process scale. To enable such extensive multi-tasking, we have a continuous training program in place, with both formal and informal components. We believe that this approach helps us keep drug development costs as low as possible.

Our BSL-2 Certified Virology Lab

We have significantly enhanced our internal anti-viral cell culture testing capabilities at our Shelton campus. We have achieved BSL-2 (Biological Safety Level 2) certification from the State of Connecticut for our Virology suite at the new campus. This suite comprises three individual virology workrooms, enabling us to work on several different viruses and strains at the same time. This facility is designed only for cell culture studies on viruses, and no animal studies can be conducted at any of our own facilities. We have brought in Brian Friedrich, Ph.D. as the Company’s Virologist. Dr. Friedrich has previously performed drug screening of hundreds of candidates against several viruses including alphaviruses, bunyaviruses, and filoviruses (namely, Ebola and Marburg, which are BSL-4), to discover potential therapeutics, while he was at United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Brian has also worked extensively on Flaviviruses, specifically West Nile Virus, while at University of Texas Medical Branch (UTMB). He has also worked on HIV as part of his PhD thesis. Dengue viruses as well as the Zika virus belong to the Flavivirus family.

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Dr. Friedrich has established several different types of assays for screening of candidates against VZV, HSV-1 and HSV-2 in our lab, and is establishing assays for Influenza viruses and HIV. We believe that having developed the internal capabilities for cell culture testing of our ligands and nanoviricides against a variety of viruses has substantially strengthened and accelerated our drug development programs. We believe that this internal screening enables speedy evaluation of a much larger number of candidates than external collaborations allow. This has significantly improved our ability of finding highly effective ligands and performing structure-activity-relationship studies of the same in a short time period.

NanoViricides Business Strategy in Brief

NanoViricides, Inc. intends to perform the regulatory filings and own all the regulatory licenses for the drugs it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour Pharma, Inc., the exclusive source for these nanomaterials. The Company plans to market these drugs either on its own or in conjunction with marketing partners. The Company also plans to actively pursue co-development, as well as other licensing agreements with other Pharmaceutical companies. Such agreements may entail up-front payments, milestone payments, royalties, and/or cost sharing, profit sharing and many other instruments that may bring early revenues to the Company. Such licensing and/or co-development agreements may shape the manufacturing and development options that the Company may pursue. There can be no assurance that the Company will be able to enter into co-development or other licensing agreements.

The Company has kept its capital expenditures to a minimum in the past, and we intend to continue to do the same, in order to conserve our cash for drug development purposes, and in order to minimize additional capital requirements.

Collaborations, Agreements and Contracts

Our strategy is to minimize capital expenditure. We therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous collaborators. We also seek to engage with additional collaborators, as necessitated for the progress of our programs.

We have signed a collaboration agreement with the Professor Moffat Lab at SUNY Upstate Medical Center, Syracuse, NY, for evaluating safety and effectiveness studies of drug candidates in cell culture and in animal models for shingles VZV infections.

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We have signed a collaboration agreement with the CORL at the University of Wisconsin, Madison, WI, for HSV-1 and HSV-2, with focus on small animal models for ocular disease.

We have engaged Biologics Consulting Group, Inc., to help us with the US FDA regulatory submissions. We are also engaged with Australian Biologics Pty, Ltd to help us with clinical trials and regulatory approvals in Australia. We believe that cGMP-like manufactured product is acceptable for entering human clinical trials in Australia.

We anticipate completing master services agreements, after performing our due diligence, with additional parties in furtherance of our anti-viral drug development programs.

We have continued to achieve significant milestones in our drug development activities. All of our drug development programs are presently at pre-clinical or advanced pre-clinical stage. We believe we are advancing these programs at a faster pace than industry peers. We continue to test several drug candidates under each program even though we may achieve extremely strong results with some of the candidates 

Patents, Trademarks, Proprietary Rights: Intellectual Property

The nanomedicine technologies licensed from TheraCour Pharma, Inc. (“TheraCour”) serve as the foundation for our intellectual property. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus. The Company has entered into an Additional License Agreement with TheraCour granting NanoViricides the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types: Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses.

These licenses are not limited to underlying patents, but also include the know-how, trade secrets, and other important knowledge base that is utilized for developing the drugs and making them successful.

In addition, these extremely broad licenses are not limited to some specific chemical structures, but comprise all possible structures that we could deploy against the particular virus, based on these technologies. In addition, the licenses are held in perpetuity by NanoViricides for worldwide use. The licenses are also exclusively provided to NanoViricides for the licensed products so NanoViricides is the only party that can further sublicense the resulting drugs to another party, if it so desires. The licenses can revert only in the case of a default by NanoViricides. The terms of default are such that, effectively, TheraCour would be able to take the licenses back only in the event that NanoViricides files bankruptcy or otherwise declares insolvency and the inability to conduct its business.

A fundamental Patent Cooperation Treaty (“PCT”) patent application, on which the nanoviricides® technology is based, has resulted in additional issued patents in Europe and Korea. As with issuances in other countries including the United States, these patents have been allowed with a very broad range of claims to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and uses of the same. The corresponding original “pi-polymer” international application, namely, PCT/US06/01820, was filed under the Patent Cooperation Treaty (PCT) system in 2006. Several other patents have already been granted previously in this patent family in various countries and regions, including Australia, ARIPO, Canada, China, Hong Kong, Indonesia, Israel, Japan, Mexico, New Zealand, OAPI, Philippines, Singapore, Vietnam, South Africa, and the USA. Prosecution in several other countries continues. In May 2012, the US Patent (No. 8,173,764) was granted for “Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers.” The US patent term is expected to last through October 1, 2028, including anticipated extensions in compensation for time spent in clinical trials. This US Patent has been allowed with a very broad range of claims to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and uses of the same. The disclosed structures enable self-assembling, biomimetic nanomedicines. Estimated expiry dates for these patents range nominally from 2027 to 2029 with various extensions accounting for delays in clinical trials. Additional issuances are expected in Europe, and in several other countries around the world. 

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In addition to this basic PCT application that covers the “pi-polymer” structure itself, another PCT application, PCT/US2007/001607, that discloses making antiviral agents from the TheraCour family of polymers and such structures is in various stages of prosecution in several countries, and has already issued in at least seven countries and regions. The counterparts of the international PCT application have issued as a granted patent in Australia, Japan, China, ARIPO, Mexico, New Zealand, OAPI, Pakistan, and, South Africa to date. Additional issuances are expected in Europe, USA, and in several other countries around the world. This patent application covers antivirals based on the TheraCour polymeric micelle technologies, their broad structures and compositions of matter, pharmaceutical compositions, methods of making the same, and their uses. The nominal expiry dates are expected to range from 2027 to 2029.

More than 61 patents have been issued globally on the basis of the two international PCT patent families that cover the fundamental aspects of our platform technology. Additional patent grants are expected to continue as the applications progress through prosecution processes. All of the resulting patents have substantially broad claims.

The patents are issued to the inventors Anil R. Diwan, PhD, Jayant G. Tatake, PhD, and Ann L. Onton, all of who are among the founders of NanoViricides, Inc. The patents have been assigned to AllExcel, Inc., the Company at which the groundbreaking work was performed. AllExcel, Inc. has contractually transferred this intellectual property to TheraCour Pharma, Inc.

NanoViricides has entered into a Memorandum of Understanding with TheraCour, whereby TheraCour will initiate discovery and development for drug candidates for a new virus or indication upon request. If the resulting drug candidates are worthy of further drug development, NanoViricides may determine that it should enter into a licensing agreement with TheraCour. In such a case, NanoViricides would obtain an independent asset valuation for the asset(s) to be licensed from a party experienced in such valuations. NanoViricides and TheraCour would thereafter negotiate the terms of compensation for the new license agreement. However, there can be no assurance that an agreement for licenses for new viruses will be entered into on terms that are favorable to NanoViricides. We believe this process has been generally beneficial for NanoViricides, since this process saves NanoViricides from the cost of acquiring and paying for licenses that it may not want to pursue further. At present, TheraCour has licensed to NanoViricides HSV-1 and HSV-2, but has not licensed the VZV area, nor has it licensed any of the remaining herpesviruses. Licensing of these assets is currently in process as described earlier. However there can be no assurance that the Company will be able to enter into an agreement with TheraCour for such license or that the agreement will be on terms that are favorable to the Company.

Patents and other proprietary rights are essential for our operations. If we have a properly designed and enforceable patent, it can be more difficult for our competitors to use our technology to create competitive products and more difficult for our competitors to obtain a patent that prevents us from using technology we create. As part of our business strategy, we actively seek patent protection both in the United States and internationally and intend to file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology. We also rely on trade secrets, internal know-how, technological innovations and agreements with third parties to develop, maintain and protect our competitive position. Our ability to be competitive will depend on the success of this strategy.

The Company believes that the drugs by themselves, Shingles antiviral topical treatment, HerpeCide for Cold Sores, HerpeCide for genital ulcers, antiviral nanoviricide eye drops, Injectable FluCide, Oral FluCide, DengueCide, HIVCide, RabiCide, and others, may be eligible for patent protection. The Company plans on filing patent applications for protecting these drugs when we have definitive results from in-vitro or in-vivo studies that enable further drug development and IND application filing. 

The issued patents have nominal expiry dates in 2026 to 2029. The dates can be further extended in several countries and regions for the additional allowances due to the regulatory burden of drug development process, or other local considerations, such as licensing to a local majority held company. Many countries allow up to five years extension for regulatory delays.

No patent applications have been filed for the actual drug candidates that we intend to develop as drugs as of now. We intend to file the patent application for FluCide and HerpeCide compounds before entering human clinical trials. The estimated expiry date for the FluCide and HerpeCide patents, if and when issued, would be no earlier than 2038.

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We may obtain patents for our compounds many years before we obtain marketing approval for them. Because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited. However, we may be able to apply for patent term extensions, based on delays experienced in marketing products due to regulatory requirements. There is no assurance we would be able to obtain such extensions. The Company controls the research and work TheraCour performs on its behalf and no costs may be incurred without the prior authorization or approval of the Company.

Patents relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds and processes such as those that cover our existing compounds, products and processes and those that we will likely file in the future, do not always provide complete or adequate protection. Future litigation or reexamination proceedings regarding the enforcement or validity of our licensor, TheraCour Pharma Inc.’s existing patents or any future patents, could invalidate TheraCour’s patents or substantially reduce their protection. In addition, the pending patent applications and patent applications filed by TheraCour, may not result in the issuance of any patents or may result in patents that do not provide adequate protection. As a result, we may not be able to prevent third parties from developing the same compounds and products that we have developed or are developing. In addition, certain countries do not permit enforcement of our patents, and manufacturers are able to sell generic versions of our products in those countries.

We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. In particular, a great deal of our material manufacturing expertise, which is a key component of our core material technology, is not covered by patents but is instead protected as a trade secret. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. These agreements provide that all confidential information developed or made known to an individual during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees, the agreements provide that all inventions made by the individual while employed by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors.

Trademarks

On April 20, 2010, the United States Patent and Trademark Office granted trademark registration number 3,777,001 to the Company for the standard character mark “nanoviricides” (the “Mark”) for International Class 5, pharmaceutical preparation for the treatment of viral diseases. The Mark was registered on the Principal Register and is protected in all its letter forms, including corresponding plural and singular forms, various forms of capitalization, and fonts and designs.

Analysis of Financial Condition, and Result of Operations

As of March 31, 2019, we had cash and cash equivalents of $4,236,845, prepaid expenses of $393,238 and net property and equipment of $10,389,946. Accounts payable and accrued expenses were $1,084,231. At March 31, 2019, we reported a long term derivative liability of $1,593,117 arising from warrants issued in conjunction with its registered direct offering. Stockholders’ equity was $12,717,423 at March 31, 2019.

In comparison, as of June 30, 2018, we had cash and cash equivalents of $7,081,771, $240,257 in prepaid expenses, and net property and equipment of $10,841,093. Accounts payable and accrued expenses were $583,856 and current derivative liability-warrants was $298,092. Stockholders’ equity was $17,664,264 at June 30, 2018.

During the nine-month period ended March 31, 2019 we used approximately $5,130,000 in cash toward operating activities. During the nine-month period ended March 31, 2018 we used approximately $4,256,000 in cash toward operating activities.

We do not anticipate any major capital costs going forward in the near future.

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The Company believes that our spending continues to be in line with our estimates. Management is actively exploring additional required funding through debt or equity financing pursuant to its plan. There is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company to fund continuing operations. Management believes that it will have to raise additional capital to fund and perform additional projected work, which is beyond normal pre-clinical development operations, leading towards an Investigational New Drug Application (IND) filing with the U.S. Food and Drug Administration (FDA), to continue.

The Company does not currently have any revenue. All of the Company’s products are in the development stage and require successful development through regulatory processes before commercialization. We have generated funding through the issuances of debt and private placement of common stock and also the sale of our registered securities. The Company does not currently have any long-term debt. We have not generated any revenues and we may not be able to generate revenues in the near future. We may not be successful in developing our drugs and start selling our products when planned, or we may not become profitable in the future. We have incurred net losses in each fiscal period since inception of our operations.

Research and Development Costs

The Company does not maintain separate accounting line items for each project in development. The Company maintains aggregate expense records for all research and development conducted. Because at this time all of the Company’s projects share a common core material, the Company allocates expenses across all projects at each period-end for purposes of providing accounting basis for each project. Project costs are allocated based upon labor hours performed for each project. Far fewer man-hours are spent on the projects at low priority than the projects at high priority. In this quarter, we have focused primarily on our HerpeCide program drug candidates.

The Company has signed several cooperative research and development agreements with different agencies and institutions. The Company expects to enter into additional cooperative agreements with other governmental and non-governmental, academic, or commercial, agencies, institutions, and companies. There can be no assurance that a final agreement may be achieved and that the Company will execute any of these agreements. However, should any of these agreements materialize, the Company will need to implement a system to track these costs by project and account for these projects as customer-sponsored activities and show these project costs separately.

The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development.

We believe that this coming year’s work plan will lead us to obtain certain information about the safety and efficacy of one of the drugs under development in animal models. If our studies are not successful, we will have to develop additional drug candidates and perform further studies. If our studies are successful, then we expect to be able to undertake further studies in animal models to obtain necessary data regarding the pharmaco-kinetic and pharmaco-dynamic profiles of our drug candidates, provided that appropriate levels of funding become available. We believe this data will enable us to file an Investigational New Drug Application, towards the goal of obtaining FDA approval for testing the drugs in human patients.

Results of Operations

The Company is a biopharmaceutical company and did not have any revenue for the three and nine month periods ended March 31, 2019 and 2018.

Revenues – The Company is currently a non-revenue producing entity.

48

Research and Development Expenses – Research and development expenses for the three months ended March 31, 2019 increased $19,023 to $1,310,326 from $1,291,303 for the three months ended March 31, 2018, and for the nine months ended March 31, 2019 decreased $47,747 to $4,335,105 from $4,382,852 for the nine months ended March 31, 2018. The increase in the cost of research and development for the three months ended March 31, 2019 is largely attributable to the increase in outside laboratory fees to collaborators, lab supplies and materials during the three month period ended March 31, 2019. The Company began laboratory studies with its collaborators in the quarter ended March 31, 2019. The decrease in research and development expenses for the nine months ended March 31, 2019 results from a decrease in laboratory payroll, and related expenses, and patent fees offset by an increase in lab supplies and chemical expenses.

General and Administration Expenses – General and administrative expenses for the three months ended March 31, 2019 decreased $354,403 to $772,561 from $1,126,964 for the three months ended March 31, 2018 and for the nine months ended March 31, 2019 decreased $503,564 to $2,156,078 from $2,659,642 for the nine months ended March 31, 2018. The decrease over the three month period ended March 31, 2019 compared to the prior period resulted primarily from decreases in officers compensation arising from the resignation of the Company’s former Chief Executive Officer in January 2018, travel expense and operating expenses in general. The decreased expenses were offset by increases in professional fees and insurance expenses. The decrease over the nine month period ended March 31, 2019 compared to the prior period resulted primarily from decreases in officers compensation arising from the resignation of the Company’s Chief Executive Officer in January 2018, travel expense, office salary, office expenses and operating expenses in general. The decreased expenses were offset by increases in professional fees and insurance expenses.

Interest Income – Interest income decreased $14,854 to $8,915 for the three months ended March 31, 2019 from $23,769 for the three months ended March 31, 2018. Interest income decreased $26,469 to $46,664 for the nine months ended March 31, 2019 from $73,133 for the nine months ended March 31, 2018. Interest income included interest on cash equivalent deposits in interest-bearing accounts at market rates. The decrease is due to a decrease in the account balances.

Interest Expense on Convertible Debenture  – There was no interest expense for the three months ended March 31, 2019 and March 31, 2018. Interest expense decreased $185,275 to $-0- for the nine months ended March 31, 2019 from $185,275 for the nine months ended March 31, 2018. The decrease is a result of the redemption of the Company’s Series C Debenture on November 13, 2017.

Other Expenses – There was no discount on convertible debenture for the three months ended March 31, 2019 and March 31, 2018. Discount on convertible debenture for the nine months ended March 31, 2019 decreased $359,214 to $-0- from $359,214 for the nine months ended March 31, 2018. The decrease in amortization is a result of the redemption of the Company’s Series C Debenture on November 13, 2017. There was no extinguishment loss on the redemption of the debenture for the three months ended March 31, 2019 and March 31, 2018. The Company recorded an extinguishment loss of ($1,348,247) on the redemption of the Series C Debenture on November 13, 2017 for the nine months ended March 31, 2018 

Change in fair value of derivative – Change in fair value of derivative for the three months ended March 31, 2019 increased $350,394 to $(65,858) from $284,536 for the three months ended March 31, 2018. Change in fair value of derivative for the nine months ended March 31, 2019 decreased $1,717,452 to $232,234 from $1,949,686 for the nine months ended March 31, 2018.

Income Taxes – There is no provision for income taxes due to ongoing operating losses.

Net Loss - For the three months ended March 31, 2019, the Company had a net loss of ($2,139,830), or $ ($0.03) per share on a fully diluted basis compared to a net loss of ($2,109,962) or ($0.03) per share on a fully diluted basis for the three months ended March 31, 2018. The increase in the reported loss for the three-month period ended March 31, 2019 is attributable mainly to an increase in the Change in fair value of derivatives of approximately $350,394 offset by a decrease of Operating expenses expenses of $335,380, and a decrease in Interest income of $14,854. Additionally the cost of compensation paid in Company securities was reduced. For the nine months ended March 31, 2019, the Company had a net loss of ($6,212,285), or $ ($0.09) per share compared to a net loss of ($6,912,411) or ($0.011) per share for the nine months ended March 31, 2018. The decrease in the reported loss for the nine-month period ended March 31, 2019 is attributable mainly to a decrease in operating expenses of approximately $551,311, and a decrease of expenses related to the Company’s convertible debenture which were redeemed on November 13, 2017. These decreased expenses were offset by a decrease in the gain on the change in fair value of derivative for the nine months ended March 31, 2019 of $1,717,452. Additionally the cost of compensation paid in Company securities was reduced. The Company recorded a loss of ($1,348,247) on the redemption of the Series C Debenture for the nine months ended March 31, 2018. No loss on the redemption was recognized for the three and nine months ended March 31, 2019.

49

Liquidity and Capital Reserves

The Company had cash and cash equivalents of $4,236,845 as of March 31, 2019 and current liabilities of $1,084,231, inclusive of account payables of $730,063 to a related party, TheraCour Pharma, Inc.

Since inception, the Company has expended substantial resources on research and development. Consequently, we have sustained substantial losses. The Company has an accumulated deficit of approximately $89,904,000 at March 31, 2019.

Management is actively exploring additional required funding through debt or equity financing pursuant to its plan. There is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company to fund continuing operations. Management believes that the Company’s existing resources and access to the capital markets will permit the Company to fund planned operations and expenditures. Management does believe that the current available funds are sufficient to enable us to file our first IND with the U.S. Food and Drug Administration (FDA). The Company believes that it will need to raise additional capital by way of equity, debt, debentures, or other methods, to support the upcoming clinical trials and operational expenses.

The Company, therefore, has engaged investment banks to advise it as to raising further funding as the Company progresses towards human clinical trials. The Company believes that it can adjust its business plan according to its available resources. Further, the Company believes that it will be able to raise additional funding at an opportune time as it progresses towards human clinical trials. However, the Company cannot provide assurance that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. Further, the Company cannot provide assurances that it will continue as a going concern or be able to raise additional funding in a timely manner, and if it can, that it will be on terms favorable for the Company’s current shareholders. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.

While the Company continues to incur significant operating losses with significant capital requirements, the Company has been able to finance its business through sale of its securities. The Company has in the past adjusted its priorities and goals in line with the cash on hand and capital availability. The Company believes it can adjust its priorities of drug development and its plan of operations as necessary, if it is unable to raise additional funds. 

We anticipate undertaking additional expenditures towards the goal of filing at least one Investigational New Drug application (IND) with the US FDA or another regulatory agency. We anticipate that we will need to raise additional funds to support these activities as well as the human clinical trials that would follow. Further development of other drug candidates in our drug pipeline will depend upon the availability of appropriate levels of additional funding. The Company believes it will continue to be able to successfully raise financing as needed. If we are unable to obtain additional financing, our business plan will be significantly delayed.

Our estimates for external costs are based on various preliminary discussions and “soft” quotes from contract research organizations that provide pre-clinical and clinical studies support. The estimates are also based on certain time estimates for achievement of various objectives. If we miss these time estimates or if the actual costs of the development are greater than the early estimates we have at present, our drug development cost estimates may be substantially greater than anticipated now. In that case, we may have to re-prioritize our programs and/or seek additional funding.

The Company does not have direct experience in taking a drug through human clinical trials. In addition, we depend upon external collaborators, service providers and consultants for much of our drug development work.

Management intends to use capital and debt financing, as required, to fund the Company’s operations. Management also intends to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies. There can be no assurance that the Company will be able to obtain such additional capital resources or that such financing will be on terms that are favorable to the Company.

50

Off Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements during the three and nine months ended March 31, 2019.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Market risk is the risk of loss arising from adverse changes in market rates and prices, such as interest rates, foreign currency exchange rates and commodity prices. We currently have no foreign operations and are not exposed to foreign currency fluctuations. Our primary exposure to market risk is interest rate risk associated with our short-term cash equivalent investments, which the Company deems to be non-material. The Company does not have any financial instruments held for trading or other speculative purposes and does not invest in derivative financial instruments, interest rate swaps or other investments that alter interest rate exposure. The Company does not have any credit facilities with variable interest rates.  

ITEM 4. CONTROLS AND PROCEDURES

Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission (the “SEC”). Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act is accumulated and communicated to our management, including our chief executive officer and our chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Due to the inherent limitations of control systems, not all misstatements may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.

As of March 31, 2019, an evaluation was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(f) under the Securities Exchange Act of 1934). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were not effective as of March 31, 2019 due to material weaknesses in internal control described in Part II, Item 9A of our 10-K for the fiscal year ended June 30, 2018. These material weaknesses remain unremediated as of March 31, 2019.

Management’s Report on Internal Control Over Financial Reporting

Changes in Internal Control Over Financial Reporting

Other than what was described below, there were no material changes in our system of internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934) during the reporting period ended March 31, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. However, as noted below, we have begun to implement changes in our internal control over financial reporting to address the material weaknesses described above.

51

Remediation Plan

We are remediating the material weaknesses by, among other things, implementing a process of enhanced review of all financial transactions. The actions that we are taking are subject to ongoing senior management review and Audit Committee oversight.

Effective September 1, 2018, the Company has appointed Dr. Irach Taraporewala as Chief Executive Officer, an experienced pharmaceutical industry executive, to provide additional management review of financial reporting and the period-end closing processes identified. As of February 1, 2019, Dr. Taraporewala resigned for personal reasons. As such, the period-end closing reviews were conducted by Mr. Stan Glick, Chairman of the Audit Committee of our Board of Directors.

The Company will provide additional training and development classes for management, accounting and finance staff regarding current changes in accounting for income taxes and deferred income taxes, pursuant to ASC 740, to enhance their current skills and understanding of the components of deferred taxation and accounting for income taxes. 

Management believes the foregoing efforts will effectively remediate the material weakness identified above. As we continue to evaluate and work to improve our internal control over financial reporting, management may execute additional measures to address potential control deficiencies or modify the remediation plan described above and will continue to review and make necessary changes to the overall design of our internal controls.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

From time to time, we may be a party to legal proceedings in the ordinary course of our business in addition to those described below. We do not, however, expect such other legal proceedings to have a material adverse effect on our business, financial condition or results of operations.

There are no legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge, no action, suit or proceeding has been threatened against the Company.  

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

On February 27, 2019, the Company entered into a Securities Purchase Agreement (the “Agreement”) with certain institutional investors (the “Purchasers”), for a registered direct offering (the “Offering”) of 6,944,446 shares (the “Shares”) at the purchase price of $0.36 (“Purchase Price”) per share.

The offer and sale of the Shares in the registered direct offering was registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s shelf registration statement on Form S-3, as amended (File No. 333-216345), which became effective on April 25, 2017. Pursuant to Rule 424(b) under the Securities Act, the Company has filed a prospectus supplement in connection with such offering.

In a concurrent private placement, the Purchasers were issued warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

52

The exercise price of the Warrants is subject to adjustment in the case of customary events such as stock dividends or other distributions on shares of common stock or any other equity or equity equivalent securities payable in shares of common stock, stock splits, stock combinations, reclassifications or similar events affecting our Common Stock, and also, subject to limitations, upon any distribution of assets, including cash, stock or other property to our stockholders. The exercise of the Warrants is subject to certain beneficial ownership and other limitations set forth in the Warrants. The Company will receive proceeds from the concurrent private placement transaction solely to the extent the Warrants are exercised for cash. 

In connection with the Offering and the concurrent private placement, the Company engaged Chardan Capital Markets, LLC (the “Placement Agent”) to act as its exclusive placement agent. The Company agreed to pay the Placement Agent a cash placement fee equal to 5% of the aggregate purchase price for the common stock sold in the offering, plus $25,000 in legal fees.

For the three and nine months ended March 31, 2019 the Company’s Board of Directors authorized the issuance of 34,502 and 49,934 respectively, fully vested shares of its Series A Convertible Preferred stock for employee compensation. The Company recorded expense of $29,828 and $43,956, respectively, for the three and nine months ended March 31, 2019 related to these issuances. There is currently no market for the shares of Series A Preferred Stock and they can only be converted into shares of common stock upon a Change of Control of the Company as more fully described in the Certificate of Designation.

For the three months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.47 per share expiring in February 2023. For the nine months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.41 per share expiring in August 2022, 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.41 per share expiring in November 2022 and. 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.47 per share expiring in February 2023.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 71,430 fully vested shares of its common stock for employee compensation.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 183,723 and 459,176, respectively fully vested shares of its common stock with a restrictive legend for consulting services.

53

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 34,121 and 88,282, respectively, fully vested shares of its common stock with a restrictive legend for Director Services.

All of the unregistered securities set forth above were issued by the Company pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, or the provisions of Rule 504 of Regulation D promulgated under the Securities Act. All such shares issued contained a restrictive legend and the holders confirmed that they were acquiring the shares for investment and without intent to distribute the shares. All of the purchasers were experienced in making speculative investments, understood the risks associated with investments, and could afford a loss of the entire investment. Except as set forth above, the Company did not utilize an underwriter or a placement agent for any of these offerings of its securities. 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None. 

ITEM 6.  EXHIBITS

Exhibit No.	Description
31.1	Rule 13(a)-14(a)/15(d)-14(a) Certification of Chief Executive Officer
31.2	Rule 13(a)-14(a)/15(d)-14(a) Certification of Chief Financial Officer
32.1	Section 1350 Certification of Chief Executive Officer
32.2	Section 1350 Certification of Chief Financial Officer
101.INS	XBRL Instance Document
101.SCH	XBRL Taxonomy Extension Schema Document
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	XBRL Taxonomy Extension Label Linkbase Document
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document

54

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	NANOVIRICIDES, INC.
	/s/ Anil R. Diwan
Dated: May 15, 2019	Name:	Anil R. Diwan
	Title:	President, Chairman of the Board
	(Principal Executive Officer)
	/s/ Meeta Vyas
Dated: May 15, 2019	Name:	Meeta Vyas
	Title:	Chief Financial Officer
	(Principal Financial Officer)

55

EX-31.1

Exhibit 31.1

Certification

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Anil Diwan, certify that:

1. I have reviewed this quarterly report on Form 10-Q of NanoViricides, Inc.;

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal over financial reporting;

5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2019
	/s/ Anil Diwan
	Name: Anil Diwan
	Title: President
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

Certification

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Meeta Vyas, certify that:

1. I have reviewed this quarterly report on Form 10-Q of NanoViricides, Inc.;

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal over financial reporting;

5. The registrant’s other certifying officer and I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2019
	/s/ Meeta Vyas
	Name: Meeta Vyas
	Title: Chief Financial Officer,
	(Principal Accounting and Financial Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. §1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q (the “Report”) of NanoViricides, Inc. (the “Company”) for the quarter ended March 31, 2019, the undersigned Anil Diwan, Interim Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of the undersigned’s knowledge and belief:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2019	/s/ Anil Diwan
	Name: Anil Diwan
	Title: President,
	(Principal Executive Officer)

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and is not being “filed” as part of the Form 10-Q or as a separate disclosure document for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section. This certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act except to the extent that this Exhibit 32.1 is expressly and specifically incorporated by reference in any such filing.

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. §1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q (the “Report”) of NanoViricides, Inc. (the “Company”) for the quarter ended March 31, 2019, the undersigned Meeta Vyas, the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of the undersigned’s knowledge and belief:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2019	/s/ Meeta Vyas
	Name: Meeta Vyas
	Title: Chief Financial Officer,
	(Principal Financial and Accounting Officer)

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and is not being “filed” as part of the Form 10-Q or as a separate disclosure document for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section. This certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act except to the extent that this Exhibit 32.2 is expressly and specifically incorporated by reference in any such filing.

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

XML

Document and Entity Information - shares	9 Months Ended
	Mar. 31, 2019	May 15, 2019
Document and Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q3
Entity Registrant Name	NANOVIRICIDES, INC.
Entity Central Index Key	0001379006
Current Fiscal Year End Date	--06-30
Entity Filer Category	Non-accelerated Filer
Trading Symbol	NNVC
Entity Common Stock, Shares Outstanding		76,735,000
Entity Emerging Growth Company	false
Entity Small Business	false

XML

Balance Sheets - USD ($)	Mar. 31, 2019	Jun. 30, 2018
CURRENT ASSETS:
Cash and cash equivalents	$ 4,236,845	$ 7,081,771
Prepaid expenses	393,238	240,257
Total current assets	4,630,083	7,322,028
PROPERTY AND EQUIPMENT
Property and equipment	14,082,522	14,018,383
Accumulated depreciation	(3,692,576)	(3,177,290)
Property and equipment, net	10,389,946	10,841,093
TRADEMARK AND PATENTS
Trademark and patents	458,954	458,954
Accumulated amortization	(90,229)	(84,025)
Trademark and patents, net	368,725	374,929
OTHER ASSETS
Security deposits	3,515	3,515
Service agreements	2,502	4,647
Other assets	6,017	8,162
Total assets	15,394,771	18,546,212
CURRENT LIABILITIES:
Accounts payable	246,702	223,339
Accounts payable – related party	730,063	107,468
Derivative liability - warrants	0	298,092
Accrued expenses	107,466	253,049
Total current liabilities	1,084,231	881,948
LONG TERM LIABILITIES:
Derivative liability - warrants	1,593,117	0
Total liabilities	2,677,348	881,948
STOCKHOLDERS' EQUITY:
Common stock, $0.001 par value; 150,000,000 shares authorized, 76,735,074 and 69,171,740 shares issued and outstanding at March 31, 2019 and June 30, 2018, respectively	76,735	69,172
Additional paid-in capital	102,540,013	101,282,707
Accumulated deficit	(89,904,431)	(83,692,146)
Total stockholders' equity	12,717,423	17,664,264
Total liabilities and stockholders' equity	15,394,771	18,546,212
Series A Convertible Preferred Stock [Member]
STOCKHOLDERS' EQUITY:
Series A Convertible Preferred stock, $0.001 par value, 8,500,000 shares designated, 5,106,328 and 4,531,394 shares issued and outstanding, at March 31, 2019 and June 30, 2018, respectively.	$ 5,106	$ 4,531

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Balance Sheets [Parenthetical] - $ / shares	Mar. 31, 2019	Jun. 30, 2018
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	8,500,000	8,500,000
Preferred stock, shares issued	5,106,328	4,531,394
Preferred stock, shares outstanding	5,106,328	4,531,394
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	76,735,074	69,171,740
Common stock, shares, outstanding	76,735,074	69,171,740

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Statements of Operations - USD ($)	3 Months Ended		9 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
OPERATING EXPENSES
Research and development	$ 1,310,326	$ 1,291,303	$ 4,335,105	$ 4,382,852
General and administrative	772,561	1,126,964	2,156,078	2,659,642
Total operating expenses	2,082,887	2,418,267	6,491,183	7,042,494
LOSS FROM OPERATIONS	(2,082,887)	(2,418,267)	(6,491,183)	(7,042,494)
OTHER INCOME (EXPENSE):
Interest income	8,915	23,769	46,664	73,133
Interest expense on convertible debenture	0	0	0	(185,275)
Loss on extinguishment of debt	0	0	0	(1,348,247)
Discount on convertible debenture	0	0	0	(359,214)
Change in fair value of derivative	(65,858)	284,536	232,234	1,949,686
Other (expense) income	(56,943)	308,305	278,898	130,083
LOSS BEFORE INCOME TAX PROVISION	(2,139,830)	(2,109,962)	(6,212,285)	(6,912,411)
INCOME TAX PROVISION	0	0	0	0
NET LOSS	$ (2,139,830)	$ (2,109,962)	$ (6,212,285)	$ (6,912,411)
Net loss per common share- basic and diluted	$ (0.03)	$ (0.03)	$ (0.09)	$ (0.11)
Weighted average common shares outstanding- basic and diluted	71,955,909	64,068,378	70,162,244	63,566,719

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Statement of Changes in Stockholders' Equity - USD ($)	Total	Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]
Balance at Jun. 30, 2017	$ 20,321,942	$ 4,349	$ 63,305	$ 95,382,979	$ (75,128,691)
Balance (in shares) at Jun. 30, 2017		4,348,744	63,306,774
Series A Preferred Stock issued for employee stock compensation	158,799	$ 8	$ 0	158,791	0
Series A Preferred Stock issued for employee stock compensation (in shares)		7,716	0
Common stock issued for consulting and legal services rendered	27,000	$ 0	$ 20	26,980	0
Common stock issued for consulting and legal services rendered (in shares)			20,062
Warrants issued to Scientific Advisory Board	5,773	0	$ 0	5,773	0
Common shares issued for Directors fees	11,250	0	$ 8	11,242	0
Common shares issued for Directors fees (in shares)			8,358
Net loss	(2,005,555)	0	$ 0	0	(2,005,555)
Balance at Sep. 30, 2017	18,519,209	$ 4,357	$ 63,333	95,585,765	(77,134,246)
Balance (in shares) at Sep. 30, 2017		4,356,460	63,335,194
Balance at Jun. 30, 2017	20,321,942	$ 4,349	$ 63,305	95,382,979	(75,128,691)
Balance (in shares) at Jun. 30, 2017		4,348,744	63,306,774
Net loss	(6,912,411)
Balance at Mar. 31, 2018	19,146,142	$ 4,524	$ 68,984	101,113,736	(82,041,102)
Balance (in shares) at Mar. 31, 2018		4,523,768	68,985,375
Balance at Sep. 30, 2017	18,519,209	$ 4,357	$ 63,333	95,585,765	(77,134,246)
Balance (in shares) at Sep. 30, 2017		4,356,460	63,335,194
Series A Preferred Stock issued for employee stock compensation	153,408	$ 7	$ 0	153,401	0
Series A Preferred Stock issued for employee stock compensation (in shares)		7,716	0
Common stock issued for consulting and legal services rendered	27,000	$ 0	$ 27	26,973	0
Common stock issued for consulting and legal services rendered (in shares)			26,468
Warrants issued to Scientific Advisory Board	4,401	0	$ 0	4,401	0
Common shares issued for Directors fees	11,250	0	$ 11	11,239	0
Common shares issued for Directors fees (in shares)			11,019
Net loss	(2,796,894)	0	$ 0	0	(2,796,894)
Balance at Dec. 31, 2017	15,918,374	$ 4,364	$ 63,371	95,781,779	(79,931,140)
Balance (in shares) at Dec. 31, 2017		4,364,176	63,372,681
Series A Preferred Stock issued for employee stock compensation	131,713	$ 35	$ 0	131,678	0
Series A Preferred Stock issued for employee stock compensation (in shares)		34,502	0
Common stock issued for consulting and legal services rendered	27,000	$ 0	$ 29	26,971	0
Common stock issued for consulting and legal services rendered (in shares)			29,128
Common stock issued for Series C Debentures	4,730,000	$ 0	$ 5,500	4,724,500	0
Common stock issued for Series C Debentures (in shares)		0	5,500,000
Common stock issued for employee compensation	65,716	$ 0	$ 71	65,645	0
Common stock issued for employee compensation (in shares)		0	71,430
Series A Preferred Stock forfeited in Separation Agreement	0	$ (25)	$ 0	25	0
Series A Preferred Stock forfeited in Separation Agreement (in shares)		(25,000)	0
Series A Preferred stock issued for Series C debenture	314,343	$ 150		314,193
Series A Preferred stock issued for Series C debenture (in shares)		150,000
Warrants issued to Scientific Advisory Board	57,708	$ 0	$ 0	57,708	0
Common shares issued for Directors fees	11,250	0	$ 13	11,237	0
Common shares issued for Directors fees (in shares)			12,136
Net loss	(2,109,962)	0	$ 0	0	(2,109,962)
Balance at Mar. 31, 2018	19,146,142	$ 4,524	$ 68,984	101,113,736	(82,041,102)
Balance (in shares) at Mar. 31, 2018		4,523,768	68,985,375
Balance at Jun. 30, 2018	17,664,264	$ 4,531	$ 69,172	101,282,707	(83,692,146)
Balance (in shares) at Jun. 30, 2018		4,531,394	69,171,740
Series A Preferred Stock issued for employee stock compensation	55,027	$ 533	$ 0	54,494	0
Series A Preferred Stock issued for employee stock compensation (in shares)		532,716	0
Common stock issued for consulting and legal services rendered	79,460	$ 0	$ 192	79,268	0
Common stock issued for consulting and legal services rendered (in shares)		0	191,510
Warrants issued to Scientific Advisory Board	1,543	$ 0	$ 0	1,543	0
Common shares issued for Directors fees	7,500	$ 0	$ 19	7,481	0
Common shares issued for Directors fees (in shares)		0	19,310
Stock options issued for compensation	11,920	$ 0	$ 0	11,920	0
Net loss	(1,841,463)	0	0	0	(1,841,463)
Balance at Sep. 30, 2018	15,978,251	$ 5,064	$ 69,383	101,437,413	(85,533,609)
Balance (in shares) at Sep. 30, 2018		5,064,110	69,382,560
Balance at Jun. 30, 2018	17,664,264	$ 4,531	$ 69,172	101,282,707	(83,692,146)
Balance (in shares) at Jun. 30, 2018		4,531,394	69,171,740
Net proceeds from issuance of common stock in connection with equity financing			$ 5,500,000
Net loss	(6,212,285)
Balance at Mar. 31, 2019	12,717,423	$ 5,106	$ 76,735	102,540,013	(89,904,431)
Balance (in shares) at Mar. 31, 2019		5,106,328	76,735,074
Balance at Sep. 30, 2018	15,978,251	$ 5,064	$ 69,383	101,437,413	(85,533,609)
Balance (in shares) at Sep. 30, 2018		5,064,110	69,382,560
Series A Preferred Stock issued for employee stock compensation	53,621	$ 8	$ 0	53,613	0
Series A Preferred Stock issued for employee stock compensation (in shares)		7,716	0
Common stock issued for consulting and legal services rendered	27,000	$ 0	$ 84	26,916	0
Common stock issued for consulting and legal services rendered (in shares)		0	83,943
Warrants issued to Scientific Advisory Board	1,429	$ 0	$ 0	1,429	0
Common shares issued for Directors fees	11,250	$ 0	$ 35	11,215	0
Common shares issued for Directors fees (in shares)		0	34,851
Net loss	(2,230,992)	$ 0	$ 0	0	(2,230,992)
Balance at Dec. 31, 2018	13,840,559	$ 5,072	$ 69,502	101,530,586	(87,764,601)
Balance (in shares) at Dec. 31, 2018		5,071,826	69,501,354
Series A Preferred Stock issued for employee stock compensation	77,088	$ 34	$ 0	77,054	0
Series A Preferred Stock issued for employee stock compensation (in shares)		34,502	0
Net proceeds from issuance of common stock in connection with equity financing	822,741	$ 0	$ 6,944	815,797	0
Net proceeds from issuance of common stock in connection with equity financing (in shares)		0	6,944,446
Common stock issued for consulting and legal services rendered	75,500	$ 0	$ 184	75,316	0
Common stock issued for consulting and legal services rendered (in shares)		0	183,723
Common stock issued for employee compensation	28,572	$ 0	$ 71	28,501	0
Common stock issued for employee compensation (in shares)		0	71,430
Warrants issued to Scientific Advisory Board	1,543	$ 0	$ 0	1,543	0
Common shares issued for Directors fees	11,250	$ 0	$ 34	11,216	0
Common shares issued for Directors fees (in shares)		0	34,121
Net loss	(2,139,830)	$ 0	$ 0	0	(2,139,830)
Balance at Mar. 31, 2019	$ 12,717,423	$ 5,106	$ 76,735	$ 102,540,013	$ (89,904,431)
Balance (in shares) at Mar. 31, 2019		5,106,328	76,735,074

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Statements of Cash Flows - USD ($)	9 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (6,212,285)	$ (6,912,411)
Adjustments to reconcile net loss to net cash used in operating activities
Preferred shares issued as compensation	185,736	443,920
Common shares issued as compensation and for services	240,532	180,466
Warrants granted to Scientific Advisory Board	4,515	14,382
Options granted as compensation	11,920	0
Warrants Issued for Severance Agreement	0	53,500
Common shares to be issued for debenture interest	0	60,274
Depreciation	515,286	501,378
Amortization	6,204	6,202
Change in fair value of derivative liabilities	(232,234)	(1,949,686)
Amortization of debt discount on convertible debenture	0	359,214
Loss on extinguishment of Series C debenture	0	1,348,247
Changes in operating assets and liabilities:
Prepaid expenses	(152,981)	(142,746)
Other assets	2,145	41,786
Accounts payable	23,363	59,754
Accounts payable - related party	622,595	1,348,168
Accrued expenses	(145,583)	372,800
Deferred interest payable	0	(41,667)
NET CASH USED IN OPERATING ACTIVITIES	(5,130,787)	(4,256,419)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment	(64,139)	(225,205)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock and warrants	2,350,000	0
NET CHANGE IN CASH AND CASH EQUIVALENTS	(2,844,926)	(4,481,624)
Cash and cash equivalents at beginning of period	7,081,771	15,099,461
Cash and cash equivalents at end of period	4,236,845	10,617,837
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Interest paid	0	166,667
Non-cash Financing and Investing Activities:
Common shares issued for Series C Debenture	0	4,605,000
Common shares issued for deferred interest	0	125,000
Series A Preferred Shares issued for Series C Debenture	0	314,343
Warrant [Member]
Non-cash Financing and Investing Activities:
Common shares issued for deferred interest	$ 1,527,259	$ 0

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Organization and Nature of Business

9 Months Ended

Mar. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Nature of Operations [Text Block]

Note 1 - Organization and Nature of Business

NanoViricides, Inc. (the Company”) is a nano-biopharmaceutical research and development company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides is also unique in the bio-pharma field in that it possesses its own state of the art facilities for the design, synthesis, analysis and characterization of the nanomedicines that we develop, as well as for production scale-up, and c-GMP-like production in quantities needed for human clinical trials, where our design, development, and production work is performed. The biological studies such as the effectiveness, safety, bio-distribution and Pharmacokinetics/Pharmacodynamics on our drug candidates are performed by external collaborators and contract organizations.

We are a company with several drugs in various stages of early development. In our lead antiviral program against herpes viruses, i.e. the HerpeCide™ program alone, we have drug candidates against at least five indications at different stages of development. Of these, the Company is advancing the shingles drug candidate towards human clinical trials. The IND-enabling Safety/Toxicology studies required for doing so have begun as of the end of December 2018 at the contract research organization (“CRO”) BASi, Indiana. Typically these studies may last six to nine months. If successful, the Company intends to file an IND after receiving a formal report on these studies from BASi. In addition, our drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced studies and are expected to follow the shingles drug candidate into human clinical trials. Shingles in adults and chicken pox in children is caused by the same virus, namely VZV (Varicella-zoster virus, aka HHV-3 or human herpesvirus-3). There are estimated to be approximately 120,000-150,000 annual chickenpox cases in the USA in the post-vaccination-era, i.e. since childhood vaccination with the live attenuated varicella virus Oka strain has become standard. In addition, we have drugs in development against all influenzas in our FluCide™ program, as well as drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.

Our drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), to which we have broad, exclusive licenses in perpetuity. The first license agreement we executed with TheraCour on September 1, 2005, gave us an exclusive, worldwide license for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Influenza and Asian Bird Flu Virus. On February 15, 2010, the Company executed an Additional License Agreement with TheraCour.  Pursuant to the Additional License Agreement, the Company was granted exclusive licenses, in perpetuity, for technologies, developed by TheraCour, for the development of drug candidates for the treatment of Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes.  In addition, the Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. A draft of the license agreement is currently in review. We are working to exchange drafts of the proposed license agreement with Theracour. To date, TheraCour has not withheld any licenses for antiviral nanomedicines that NanoViricides has asked for, and we anticipate that the licenses to the remaining herpes viruses including VZV will be executed once the due diligence process is completed.

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Summary of Significant Accounting Policies

9 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Significant Accounting Policies [Text Block]

Note 2 - Summary of Significant Accounting Policies

Basis of Presentation – Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting.  Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented.  Interim results are not necessarily indicative of the results for the full year.  The accompanying financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the fiscal year ended June 30, 2018 filed with the SEC on October 13, 2018.

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2018 filed on October 13, 2018.

Reclassifications and Prior Year Adjustments

Certain prior year amounts have been reclassified for consistency with current year presentation. These reclassifications had no effect on the reported results of operations. The Company reclassified $262,365 and $812,551 of expenses for the three and nine months ended March 31, 2018, respectively, related to the Company’s laboratory facilities from general and administrative expenses into research and development expenses for consistency with current year presentation. The reclassifications had no impact on the reported results of operations and net loss reported for the three and nine months ended March 31, 2018.

Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock, and convertible debenture.

The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:

	Potentially Outstanding Dilutive Common Shares
	For the		For the
	Nine Months		Nine Months
	Ended		Ended
	March 31, 2019		March 31, 2018
Options and Warrants		8,051,681		6,958,162
Total potentially outstanding dilutive common shares		8,051,681		6,958,162

The Company has also issued 5,106,328 shares of Series A Preferred Stock to investors and others as of March 31, 2019. Only in the event of a “change of control” of the Company, each Series A preferred share is convertible to 3.5 shares of its new common stock. A “Change of Control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a Change of Control event, the Series A Convertible Preferred Stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At March 31, 2019, the number of potentially dilutive shares of the Company’s common stock into which these Series A Preferred shares can be converted into is 17,872,148, and is not included in diluted earnings per share since the shares are contingently convertible only upon a Change of Control.

The following table represents the basic and diluted per share calculations for loss per share:

	For the three months ended March 31,						For the nine months ended March 31,
	2019			2018			2019			2018
Calculation of basic and diluted loss per share of common stock:
Net loss attributable to common stockholders	$	(2,139,830	)	$	(2,109,962	)	$	(6,212,285	)	$	(6,912,411	)
Denominator for basic weighted average shares of common stock		71,955,909			64,068,378			70,162,244			63,566,719
Basic and diluted loss per share of common stock	$	(0.03	)	$	(0.03	)	$	(0.09	)	$	(0.11	)

The Series C debenture was redeemed for Common Stock effective November 13, 2017. See Note 7. The Series C debenture was excluded from the loss per share calculation for the nine months ended March 31, 2018 because the impact is antidilutive.

Recently Issued Accounting Pronouncements

In August 2018, the SEC issued the final rule on Disclosures About Changes in Stockholder’s Equity For filings on Form 10-Q, which extends to interim periods the annual requirement in SEC Regulation S-X, Rule 3-04,2 to disclose (1) changes in stockholders’ equity and (2) the amount of dividends per share for each class of shares (as opposed to common stock only, as previously required). Pursuant to the final rule, registrants must now analyze changes in stockholders’ equity, in the form of reconciliation, for “the current and comparative year-to-date [interim] periods, with subtotals for each interim period,” i.e., a reconciliation covering each period for which an income statement is presented. Rule 3-04 permits the disclosure of changes in stockholders’ equity (including dividend-per-share amounts) to be made either in a separate financial statement or in the notes to the financial statements. The final rule is effective for all filings made on or after November 5, 2018. The staff of the SEC has indicated it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its form 10-Q for the quarter that begins after the effective date of the amendments. The Company conformed to this rule in its Form 10-Q since the quarter ending December 31, 2018.

In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions. The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The standard will be effective for the Company in the first quarter of fiscal year 2020, although early adoption is permitted (but no sooner than the adoption of Topic 606). The Company does not expect that the adoption of this ASU will have a significant impact on its financial statements.

In July 2017, the FASB issued Accounting Standards Update (“ASU”) No. 2017-11. “Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. ASU 2017-11 revises the guidance for instruments with down round features in Subtopic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, which is considered in determining whether an equity-linked financial instrument qualifies for a scope exception from derivative accounting. An entity still is required to determine whether instruments would be classified in equity under the guidance in Subtopic 815-40 in determining whether they qualify for that scope exception. If they do qualify, freestanding instruments with down round features are no longer classified as liabilities. ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, and early adoption is permitted, including adoption in an interim period. ASU 2017-11 provides that upon adoption, an entity may apply this standard retrospectively to outstanding financial instruments with a down round feature by means of a cumulative-effect adjustment to the opening balance of retaining earnings in the fiscal year and interim period adoption. The Company has adopted ASU 2017-11 retrospectively for the quarter ending March 31, 2019. The adoption of this ASU did not have a significant impact on its financial statements.

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Liquidity and Going Concern

9 Months Ended

Mar. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Substantial Doubt about Going Concern [Text Block]

Note 3 - Liquidity and Going Concern

The Company’s financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the financial statements, the Company has an accumulated deficit at March 31, 2019 of approximately $89.9 million and a net loss of approximately $6.2 million and net cash used in operating activities of approximately $5.1 million for the nine months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of March 31, 2019, the Company had available cash and cash equivalents of approximately $4.2 million. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Management adjusted its planned expenditures, activities, and programs, in accordance with budgetary constraints and in accordance with its expectations of obtaining additional financing.

The Company has made several adjustments to its past expenditures in the ensuing annual budget, eliminating several expenses including a reduction in workforce and consultants to the extent feasible without affecting its program of drug development. In addition, the Company has focused its efforts primarily on a single lead program to minimize cost outlays, namely taking the shingles drug candidate against VZV into human clinical trials. Management’s budget indicates that these changes have freed up sufficient funds to allow for the ensuing costs of the external advanced IND-enabling studies of this drug candidate. Management has considered several options for obtaining additional funds that will be needed for future human clinical trials and to obtain the additional license from TheraCour for VZV and the remaining human herpes viruses. The Company is also evaluating the possibility of obtaining a mortgage on its fully owned cGMP-capable laboratory facility in Shelton, CT, in order to free up a portion of the fixed capital for usage as liquid working capital.

In addition, the Company believes that it has several important milestones that it expects to achieve in the ensuing year. Management assumes that as it achieves these milestones, the Company would experience substantial improvement in the liquidity of the Company’s stock, and would significantly improve the Company’s ability to raise funds on the public markets at terms that may be substantially superior to the terms we are offered at present.

On February 27, 2019, the Company entered into a Securities Purchase Agreement with certain institutional investors for a registered direct offering in which the Company raised $2,500,000 less placement agents’ fees of $125,000 and placement agent legal fees of $25,000.

Management is actively exploring additional required funding through debt or equity financing pursuant to its plan. There is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company to fund continuing operations. Management believes that as a result of the management plan, the Company’s existing resources and access to the capital markets will permit the Company to fund planned operations and expenditures. However, the Company cannot provide assurance that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.

The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

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Related Party Transactions

9 Months Ended

Mar. 31, 2019

Related Party Transactions [Abstract]

Related Party Transactions Disclosure [Text Block]

Note 4 - Related Party Transactions

Related Parties

Related parties with whom the Company had transactions are:

Related Parties	Relationship
Anil R. Diwan	Chairman, President, significant stockholder and Director
TheraCour Pharma, Inc.	An entity owned and controlled by a significant stockholder
Milton Boniuk, MD	Significant stockholder

	As of
	March 31, 2019		June 30, 2018
Account Payable – Related Party
Pursuant to an Exclusive License Agreement we entered into with TheraCour, the Company was granted exclusive licenses in perpetuity for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. In consideration for obtaining this exclusive license, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) we will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on our behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour; (4) to pay an advance payment equal to twice the amount of the previous month’s invoice to be applied as a prepayment towards expenses. On October 2, 2018, the Company entered into an agreement with TheraCour Pharma, Inc. for a waiver of the two months worth of prepaid balance advance of anticipated invoicing until the filing of an IND and the application of the current advance as a credit against current open invoices. Additionally, TheraCour has agreed to defer $25,000 per month of development fees for twelve months, beginning with July 2018. Accounts payable due TheraCour on the reporting date was	$	730,063	$	107,468

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Property and Equipment
During the reporting period, TheraCour Pharma, Inc. acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company	$	6,603	$	12,705	$	14,011	$	12,705

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Research and Development Costs Paid to Related Parties
Development fees and other costs charged by TheraCour pursuant to exclusive License Agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at March 31, 2019 and June 30, 2018	$	574,853	$	529,031	$	2,320,726	$	2,299,712

Debenture Interest Payable to a Director

Coupon interest expense on the $5,000,000 Series C Debenture paid to Dr. Milton Boniuk for the three and nine months ended March 31, 2018 was $0 and $185,274, respectively. The Series C debenture was redeemed for Common Stock effective November 13, 2017. See Note 7.

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Property and Equipment

9 Months Ended

Mar. 31, 2019

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment Disclosure [Text Block]

Note 5 - Property and Equipment

Property and equipment, stated at cost, less accumulated depreciation consisted of the following:

	March 31,  2019			June 30,  2018
GMP Facility	$	8,020,471		$	8,011,230
Land		260,000			260,000
Office Equipment		57,781			57,781
Furniture and Fixtures		5,607			5,607
Lab Equipment		5,738,663			5,683,765
Total Property and Equipment		14,082,522			14,018,383
Less Accumulated Depreciation		(3,692,576	)		(3,177,290	)
Property and Equipment, Net	$	10,389,946		$	10,841,093

Depreciation expense for the three months ended March 31, 2019 and 2018 were $172,151 and $168,457, respectively, and for the nine months ended March 31, 2019 and 2018 were $515,286 and $501,378, respectively.

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Trademark and Patents

9 Months Ended

Mar. 31, 2019

Goodwill and Intangible Assets Disclosure [Abstract]

Intangible Assets Disclosure [Text Block]

Note 6 - Trademark and Patents

Trademark and patents, stated at cost, less accumulated amortization consisted of the following:

	March 31, 2019			June 30, 2018
Trademarks and Patents	$	458,954		$	458,954
Less Accumulated Amortization		(90,229	)		(84,025	)
Trademarks and Patents, Net	$	368,725		$	374,929

Amortization expense amounted to $2,068 and $2,067 for the three months ended March 31, 2019 and 2018, respectively, and $6,204 and $6,202 for the nine months ended March 31, 2019 and 2018, respectively.

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Convertible Debenture and Derivatives

9 Months Ended

Mar. 31, 2019

Debt Disclosure [Abstract]

Debt Disclosure [Text Block]

Note 7 - Convertible Debenture and Derivatives 

Debenture - Series C

The Company’s Series C Convertible Debenture, in the amount of $5,000,000, was redeemed on November 13, 2017.

 For the three months ended March 31, 2018, no interest was paid to the Holder of the Company’s redeemed Series C Convertible Debenture. For the nine months ended March 31, 2018, the Holder elected to receive $60,274 (through November 13, 2017) of its coupon interest payment and $125,000 of deferred interest payment in common stock of the Company and $125,000 of its coupon interest payment and $41,667 of its deferred interest payment in cash.

The Company’s Series C Debenture in the amount of $5,000,000 was due to mature on June 30, 2018. On November 13, 2017, the Company entered into a Debenture Redemption Agreement (the “Agreement”) with the Holder, to redeem (the “Redemption”) its $5,000,000 Series C Convertible Debenture (the “Debenture”) for an aggregate of 5,500,000 shares of the Company’s $0.001 par value Common Stock (“Purchase Price”) comprising 5,000,000 shares for the principal of the Debenture and 500,000 shares for unpaid coupon interest from October 1, 2017 through June 30, 2018. The unpaid interest included $60,274 of accrued interest through November 13, 2017, $314,726 in coupon interest through June 30, 2018 and $125,000 of unpaid deferred interest. The price per share was equal to the closing price of the Company’s stock on Friday, November 10, 2017 of one ($1.00) dollar per share. The Holder waived all early redemption penalty payments provided for in the Debenture for consideration of 150,000 shares of the Company’s $0.001 par value Series A Convertible Preferred Stock. The Company did not incur placement agent fees in redemption of the Series C Convertible Debenture. The Company recognized a non-cash loss on extinguishment of debt of $1,348,247 on the extinguishment of the aforesaid principal attributable to the Series C Debenture into the Company’s common and preferred stock. The loss on extinguishment arises from, the obligation to issue 150,000 shares of the Company’s Series A Preferred shares with a fair value of $364,337, as of November 13, 2017, obligation to issue 314,726 shares of the Company’s $0.001 par value Common Stock with a fair value of $314,726 as of November 13, 2017, in consideration of Debenture coupon interest from the redemption date through June 30, 2018, and unamortized discount of $684,633 as of the redemption date, offset by the derivative liability of ($15,449) as of the redemption date. 

Pursuant to the redemption agreement for the Company’s Series C Debenture, the Company issued 5,500,000 shares of its registered Common Stock from its shelf registration and the 150,000 shares of its Series A Preferred Stock upon receiving consent to issue the shares pursuant to New York Stock Exchange (“NYSE”) regulations. The Company submitted a request for authorization to issue the Common Stock and Series A Preferred Shares to the NYSE, which was authorized on March 18, 2018 and the shares were issued on March 21, 2018.

On July 2, 2014, in conjunction with the issuance of the Company’s Series C Convertible Debenture, the Company issued 187,000 shares of its Series A Convertible Preferred Stock (the “Series A”) to Dr. Milton Boniuk, pursuant to the terms of the Debenture. Proceeds received in a financing transaction are allocated to the instruments issued prior to evaluating hybrid contracts for bifurcation of embedded derivatives. Since the Series A Convertible Preferred Stock is classified as equity, the proceeds allocated to the Preferred Stock are recorded at relative fair value. The fair value of the Series A was $1,645,606 at issuance and the relative fair value was calculated as $1,152,297. The remaining amount of the proceeds was allocated to the Debenture and a debt discount of $1,152,297 was recorded to offset the amount of the proceeds allocated to the Series A. Then, the embedded derivative was bifurcated at its fair value of $1,879,428 with the remaining balance allocated to the host instrument (Debenture). The total debt discount was amortized over the actual term of the Debenture using the effective interest method.

The Company recognized amortization of this discount as an additional interest charge to “Discount on convertible debenture” of $359,214 for the nine months ended March 31, 2018.

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Accrued expenses

9 Months Ended

Mar. 31, 2019

Payables and Accruals [Abstract]

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

Note 8 – Accrued expenses

Accrued expenses consisted of the following:

	March 31, 2019		June 30, 2018
Severance payment- Eugene Seymour	$	-	$	233,333
Accrued payroll		11,466		19,716
Professional services		30,000		-
Severance payment- Irach Taraporewala		66,000		-
Accrued expenses	$	107,466	$	253,049

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Equity Transactions

9 Months Ended

Mar. 31, 2019

Stockholders' Equity Note [Abstract]

Stockholders' Equity Note Disclosure [Text Block]

Note 9 - Equity Transactions

On February 27, 2019, the Company entered into a Securities Purchase Agreement (the “Agreement”) with certain institutional investors (the “Purchasers”), for a registered direct offering (the “Offering”) of 6,944,446 shares of Common Stock (“Shares”) at the purchase price of $0.36 (“Purchase Price”) per share for an aggregate of $2,500,000.

The offer and sale of the Shares in the registered direct offering was registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s shelf registration statement on Form S-3, as amended (File No. 333-216345), which became effective on April 25, 2017. Pursuant to Rule 424(b) under the Securities Act, the Company has filed a prospectus supplement in connection with such offering.

In a concurrent private placement, the Purchasers received warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

The Company accounted for the proceeds of the Offering at February 27, 2019 as follows:

Gross proceeds	$	2,500,000
Less: Offering costs		150,000
Net proceeds		2,350,000
Portion allocated to derivative liability - warrants		(1,527,259	)
Net proceeds from issuance of common stock	$	822,741

The exercise price of the Warrants is subject to adjustment in the case of customary events such as stock dividends or other distributions on shares of Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock, stock splits, stock combinations, reclassifications or similar events affecting our Common Stock, and also, subject to limitations, upon any distribution of assets, including cash, stock or other property to our stockholders. The exercise of the Warrants is subject to certain beneficial ownership and other limitations set forth in the Warrants. The Company will receive proceeds from the concurrent private placement transaction solely to the extent the Warrants are exercised for cash.

In connection with the Offering and the concurrent private placement, the Company engaged Chardan Capital Markets, LLC (the “Placement Agent”) to act as its exclusive placement agent. The Company agreed to pay the Placement Agent a cash placement fee equal to 5% of the aggregate purchase price for the Common Stock sold in the offering, plus $25,000 in legal fees. The net proceeds from the offering were $2,350,000.

The Company determined the fair value of the Warrants at February 27, 2019 to be $1,527,259. The Company used a lattice model to calculate the fair value of the derivative warrants based on a probability weighted discounted cash flow model. This model is based on future projections of the various potential outcomes. The features that were analyzed and incorporated into the model included the exercise and full reset features. Under applicable accounting guidance of ASU 2017-11, adopted by the Company on January 1, 2019, stock warrants are to be accounted for as equity if the warrants contain full-ratchet anti-dilution provisions. The warrants described above contained a full-ratchet anti-dilution feature but also contained other adjustment features which required that the warrants be classified as a derivative liability. 

The Warrants were valued as of February 27, 2019 and March 31, 2019 with the following assumptions:

- The 5.5-year warrants were issued on February 27, 2019 with an exercise price of $.61 (subject to adjustments-full ratchet reset).

- The stock price would fluctuate with the Company’s projected volatility.

- The Holder would exercise the warrants as they become exercisable (effective registration at issuance) at target prices of the higher of 2 times the projected exercise/reset price or 2 times the stock price.

- The risk free rate at February 27, 2019 and March 31, 2019 were  2.48% and 2.21% respectively.. 

- The next capital raise is projected to occur during 2020 (annually 12 months from issuance) at prices approximating 100% market triggering a reset event and exercise price adjustment. 

- The  stock price would fluctuate with an annual volatility. The projected volatility curve was based on historical volatilities of the Company for the valuation period. The projected annual volatility for the valuation date is:

1 Year
2/27/19	75	%
3/31/19	77	%

The primary factors driving the economic value of options are stock price; stock volatility; reset events and exercise behavior. Projections of these variables over the remaining term of the warrant are either derived or based on industry averages. Based on the above, a probability was assigned to each scenario for each future period, and the appropriate derivative value was determined for each scenario. The option value was then probability weighted and discounted to the present.  

On July 11, 2018 the Board of Directors approved an extension of the employment agreement with Dr. Anil Diwan, the Company’s President. Pursuant to the terms of the employment agreement, the Company’s Board of Directors authorized the issuance of 525,000 of the Company’s Series A Convertible Preferred Stock to Dr. Anil Diwan. The shares shall be vested in one-third increments on June 30, 2019, June 30, 2020 and June 30, 2021 and are subject to forfeiture. The Company recognized non-cash compensation expense related to the issuance of the Series A Preferred stock of $47,260 and $141,780, respectively, for the three and nine months ended March 31, 2019. The balance of $418,912 will be recognized as the shares vest and service is rendered.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 34,502 and 49,934, respectively, fully vested shares of its Series A Convertible Preferred Stock for employee compensation. The Company recorded expense of $29,828 and $43,956, respectively, for the three and nine months ended March 31, 2019 related to these issuances.

The fair value of the Series A Preferred stock was the following for the dates indicated:

Date	Shares		Value
7/11/2018		525,000	$	560,690
7/31/2018		2,572		2,795
8/31/2018		2,572		2,374
9/30/2018		2,572		2,598
10/31/2018		2,572		2,233
11/30/2018		2,572		1,883
12/31/2018		2,572		2,245
1/31/2019		2.572		1,203
2/28/2019		2,572		1,949
3/01/2019		26,786		24,340
3/31/2019		2,572		2,336
		574,934	$	604,646

There is currently no market for the shares of Series A Convertible Preferred Stock and they can only be converted into shares of Common Stock upon a Change of Control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A Convertible Preferred Stock granted to various employees and others on the date of grant. The Series A Convertible Preferred Stock fair value is based on the greater of i) the converted value to common at a ratio of 1:3.5; or ii) the value of the voting rights since the Holder would lose the voting rights upon conversion. The conversion of the shares is triggered by a Change of Control. The valuations of the Series A Convertible Preferred Stock at each issuance used the following inputs:

a. The common stock price was in the range $.20 to $.58;

b. The calculated weighted average number of shares of common stock in the period;

c. A 26.63% premium over the common shares for the voting preferences;

d. The calculated weighted average number of total voting shares and the monthly shares representing voting rights of 19.28% to 19.52% of the total;

e. The conversion value is based on an assumption for calculation purposes only of a Change of Control in 4 years from October 31, 2016 and a remaining restricted term of 1.75 to 1.59 years;

f. 31.25% to 33.16% restricted stock discount (based on a restricted stock analysis and call-put analysis curve: 79.2% to 90.60% volatility, 2.50% to 2.44% risk free rate) applied to the converted common shares.

On July 19, 2018, the Company entered into an Employment Agreement with Dr. Irach Taraporewala as Chief Executive Officer of the Company beginning on September 1, 2018. Dr. Taraporewala was granted options to purchase up to 300,000 shares of the Company’s Common Stock, par value $0.001 per share at an exercise price equal to 20% above the closing bid price of $0.41 of the Common Stock on September 1, 2018 (“Effective Date”). The options shall vest in three, equal, annual installments commencing on the Effective Date. The grant date fair value of the options was $35,761 of which $11,920 was recognized and recorded as compensation expense for both the three and nine months ended March 31, 2019. On January 24, 2019, Dr. Taraporewala resigned as the Chief Executive Officer of NanoViricides, Inc. (the “Company”) for personal reasons. See Note 12.

The Company estimated the fair value of the options granted to Dr. Taraporewala on the date of grant using a lattice simulation model that values the options based upon a stock price modeled such that it follows a geometric Brownian motion with constant drift and volatility.

For the three months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.47 per share expiring in February 2023. For the nine months ended March 31, 2019, the Scientific Advisory Board (SAB) was granted fully vested warrants to purchase 11,432 shares of common stock with an exercise price of $.41 per share expiring in August 2022, 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.41 per share expiring in November 2022 and 11,432 fully vested warrants to purchase shares of common stock with an exercise price of $.47 per share expiring in February 2023. The fair value of the warrants was $1,543 for the three months and $4,515 for the nine months ended March 31, 2019 and was recorded as consulting expense.

The Company estimated the fair value of the warrants granted to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following weighted-average assumptions:

Expected life (year)	4
Expected volatility	47.99-55.12	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.51-2.93	%

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 71,430 fully vested shares of its common stock for employee compensation. The Company recognized compensation expense of $28,572 for the three and nine months ended March 31, 2019.

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 183,723 and 459,176, respectively fully vested shares of its common stock with a restrictive legend for consulting services. The Company recorded an expense of $75,500 and $181,960 for the three and nine months ended March 31, 2019, respectively, which was the fair value on the dates of issuance. 

For the three and nine months ended March 31, 2019, the Company’s Board of Directors authorized the issuance of 34,121 and 88,282, respectively, fully vested shares of its common stock with a restrictive legend for Director Services. The Company recorded an expense of $11,250 and $30,000 for the three and nine months, respectively, which was the fair value on the dates of issuance.

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Stock Warrants and Options

9 Months Ended

Mar. 31, 2019

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

Disclosure of Compensation Related Costs, Share-based Payments [Text Block]

Note 10 - Stock Warrants and Options

Stock Warrants

Stock Warrants	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding and exercisable at June 30, 2018		6,969,588	$	4.80		.53	$	-
Granted		6,978,742		.61		-		-
Expired		5,996,649		5.08		-		-
Outstanding and exercisable at March 31, 2019		7,951,681	$	.91		4.94	$	-

Of the above warrants, 620,051 expire in fiscal year ending June 30, 2020, 57,160 expire in fiscal year ending June 30, 2021, 45,728 expire in the fiscal year ending June 30, 2022, 284,296 warrants expire in the fiscal year ending June 30, 2023 and 6,944,446 expire in the fiscal year ending June 30, 2025.

Stock Options

Stock Options	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at June 30, 2018		-	$	-		-	$	-
Granted		300,000		.50		-		-
Forfeited		200,000		.50		-		-
Outstanding at March 31, 2019		100,000		.50		2.41		-

Of the above options, 100,000 became vested and exercisable on September 1, 2018. The options expire on August 31, 2021. On January 24, 2019, Dr. Taraporewala’s resigned as the Chief Operating Officer of the Company and the 200,000 remaining unvested options were forfeited. See Note 12.

The Company estimated the fair value of the options granted to Dr. Taraporewala on the date of grant using a lattice model that values the options based upon a stock price modeled such that it follows a geometric Brownian motion with constant drift and volatility:

Expected life (year)	3
Expected volatility	55.09	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.71	%

Expected forfeiture (attrition) rate (%) 5.00 %

Expected volatility is based on historical volatility of the Company’s common stock and the expected life of options. The Company estimates forfeitures at the time of valuation and reduces expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ or are expected to differ, from the previous estimate.

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Fair Value Measurement

9 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

Fair Value Disclosures [Text Block]

Note 11 - Fair Value Measurement

Fair value measurements 

At March 31, 2019 and June 30, 2018 the estimated fair values of the liabilities measured on a recurring basis are as follows:

	Fair Value Measurements at
	March 31, 2019:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	1,593,117

	Fair Value Measurements at
	June 30, 2018:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	298,092

In a concurrent private placement to the Offering on February 27, 2019, the Purchasers received warrants (the “Warrants”) to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

In conjunction with the Company’s registered direct offerings of Units, consisting of the Company’s common stock and warrants, on September 12, 2013 and January 24, 2014, the Company issued an aggregate of 5,425,363 warrants, of which -0- and 5,290,006, are outstanding at March 31, 2019 and June 30, 2018, respectively. Additionally, the Company issued 135,216 warrants to the placement agents of which -0- and 135,216, are also outstanding at March 31, 2019 and June 30, 2018, respectively, for a total number of -0- and 5,425,222 warrants outstanding and issued as of March 31, 2019 and June 30, 2018, respectively, pursuant to the aforesaid registered direct offerings.

The Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting guidance of ASU 2017-11, adopted by the Company January 1, 2019, stock warrants are to be accounted for as equity if the warrants contain full-ratchet anti-dilution provisions. The warrants issued on February 27, 2019, contained a full-ratchet anti-dilution feature and also contained other adjustment features which required that the warrants be classified as a derivative liability.

The Company used a lattice model to calculate the fair value of the derivative warrants based on a probability weighted discounted cash flow model. This model is based on future projections of the various potential outcomes. The features that were analyzed and incorporated into the model included the exercise and full reset features.

The Warrants issued on September 12, 2013 and January 24, 2014 expired on January 24, 2019 and were valued as of June 30, 2018 with the following assumptions:

- The 5-year warrants issued on 9/12/13 and 1/24/14 included Investor and Placement Agent Warrants with an exercise price of $5.25 and $6.05 (subject to adjustments-full ratchet reset).

- The stock price would fluctuate with the Company projected volatility.

- The Holder would exercise the warrant as they become exercisable (effective registration at issuance) at target prices of the higher of 2 times the projected exercise/reset price or 2 times the stock price.

- The next capital raise would fluctuate with an annual volatility. The projected volatility curve was based on historical volatilities of the Company for the valuation periods. The projected annual volatility for the valuation dates are:

1 Year
6/30/18	56	%

The primary factors driving the economic value of options are stock price; stock volatility; reset events and exercise behavior. Projections of these variables over the remaining term of the warrant are either derived or based on industry averages. Based on the above, a probability was assigned to each scenario for each future period, and the appropriate derivative value was determined for each scenario. The option value was then probability weighted and discounted to the present.

The following tables present the activity for liabilities measured at estimated fair value using unobservable inputs for the three months ended March 31, 2019:

Fair Value Measurement

	Fair Value Measurement
	Using Significant Unobservable Inputs
	Derivative Liability- Warrant
Beginning balance at July 1, 2018	$	298,092
Additions during the year		1,527,259
Change in fair value		(232,234	)
Balance at March 31, 2019	$	1,593,117

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Commitments and Contingencies

9 Months Ended

Mar. 31, 2019

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies Disclosure [Text Block]

Note 12 - Commitments and Contingencies

Legal Proceedings

There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge, no action, suit or proceeding has been threatened against the Company.

Employment Agreements

The Company and Dr. Diwan, President and Chairman of the Board of Directors, entered into an extension of employment agreement effective July 1, 2018 for a term of three years. Dr. Diwan’s will be paid an annual base salary of $400,000. Additionally, Dr. Diwan was awarded a grant of 525,000 shares of the Company’s Series A Preferred Stock. 175,000 shares vest equally on June 30, 2019, 2020 and 2021. Any unvested shares are subject to forfeiture.

The Company and Dr. Irach Taraporewala, the Company’s Chief Executive Officer, entered into an employment agreement effective September 1, 2018, for a term of three years. Dr. Taraporewala would be paid an annual base salary of $360,000. Additionally, Dr. Taraporewala was awarded a grant of 300,000 options to purchase shares of the Company’s Common Stock. 100,000 options vested on September 1, 2018 and the remainder of the options would vest over the two-year vesting period and are subject to forfeiture. On January 24, 2019, Dr. Taraporewala resigned as the Chief Executive Officer of NanoViricides, Inc. (the “Company”) for personal reasons.  Also on that date, the Company and Dr. Taraporewala agreed that Dr. Taraporewala would become a consultant for the Company for a period of two years.  In connection with his resignation and new consulting services, the Company and Dr. Taraporewala entered into a Confidential Separation and Consulting Agreement and General Release (the “Agreement”) pursuant to which the Company will pay Dr. Taraporewala monthly consulting payments of $3,000 from February 1, 2019, the effective date of the Agreement, through January 31, 2021.  The Agreement includes a general release of claims against the Registrant, obligations of confidentiality, non-disclosure, non-disparagement and other customary provisions found in similar agreements. The remaining 200,000 options not vested upon resignation have been forfeited.

On March 3, 2010, the Company entered into an employment agreement with Dr. Jayant Tatake to serve as Vice President of Research and Development.  The employment agreement provides for a term of four years with a base salary of $150,000.  In addition, the Company issued 26,786 shares of Series A Preferred Stock and 35,715 shares of common stock upon entering into the agreement, and issued an additional 26,786 shares of Series A Preferred Stock and 35,715 shares of common stock on each anniversary date of the agreement. The shares of Series A Preferred Stock were issued in recognition of Dr. Tatake’s work towards the achievement of several patents by the Company. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

On March 3, 2010, the Company entered into an employment agreement with Dr. Randall Barton to serve as Chief Scientific Officer.  The employment agreement provided for a term of four years with a base salary of $150,000.  In addition, the Company issued 35,715 shares of common stock upon entering into the agreement, and issued an additional 35,715 shares of common stock on each anniversary date of the agreement. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

On May 30, 2013, the Company entered into an Employment Agreement with Meeta Vyas to serve as its Chief Financial Officer.  The employment agreement provided for a term of three years with a base salary of $9,000 per month and 2,572 shares of Series A Preferred Stock, also on a monthly basis. On January 1, 2015, her cash compensation was increased to $10,800 per month. The Agreement is renewable on an annual basis. The Compensation Committee of the Board of Directors has extended the current provisions of the Employment Agreement pending its review of current industry compensation arrangements and Employment agreements.

License Agreements

The Company is dependent upon its license agreement with TheraCour (See Note 4). If the Company lost the right to utilize any of the proprietary information that is the subject of the TheraCour license agreement on which it depends, the Company will incur substantial delays and costs in development of its drug candidates. The Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. We are working to exchange drafts of the proposed license agreement with Theracour shortly. TheraCour has not withheld any licenses for antiviral nanomedicines sought by the Company and we anticipate that the licenses for VZV will be executed once the due diligence process is completed.

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Summary of Significant Accounting Policies (Policies)

9 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation – Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting.  Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented.  Interim results are not necessarily indicative of the results for the full year.  The accompanying financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the fiscal year ended June 30, 2018 filed with the SEC on October 13, 2018.

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2018 filed on October 13, 2018.

Reclassification, Policy [Policy Text Block]

Reclassifications and Prior Year Adjustments

Certain prior year amounts have been reclassified for consistency with current year presentation. These reclassifications had no effect on the reported results of operations. The Company reclassified $262,365 and $812,551 of expenses for the three and nine months ended March 31, 2018, respectively, related to the Company’s laboratory facilities from general and administrative expenses into research and development expenses for consistency with current year presentation. The reclassifications had no impact on the reported results of operations and net loss reported for the three and nine months ended March 31, 2018.

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock, and convertible debenture.

The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:

	Potentially Outstanding Dilutive Common Shares
	For the		For the
	Nine Months		Nine Months
	Ended		Ended
	March 31, 2019		March 31, 2018
Options and Warrants		8,051,681		6,958,162
Total potentially outstanding dilutive common shares		8,051,681		6,958,162

The Company has also issued 5,106,328 shares of Series A Preferred Stock to investors and others as of March 31, 2019. Only in the event of a “change of control” of the Company, each Series A preferred share is convertible to 3.5 shares of its new common stock. A “Change of Control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a Change of Control event, the Series A Convertible Preferred Stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At March 31, 2019, the number of potentially dilutive shares of the Company’s common stock into which these Series A Preferred shares can be converted into is 17,872,148, and is not included in diluted earnings per share since the shares are contingently convertible only upon a Change of Control.

The following table represents the basic and diluted per share calculations for loss per share:

	For the three months ended March 31,						For the nine months ended March 31,
	2019			2018			2019			2018
Calculation of basic and diluted loss per share of common stock:
Net loss attributable to common stockholders	$	(2,139,830	)	$	(2,109,962	)	$	(6,212,285	)	$	(6,912,411	)
Denominator for basic weighted average shares of common stock		71,955,909			64,068,378			70,162,244			63,566,719
Basic and diluted loss per share of common stock	$	(0.03	)	$	(0.03	)	$	(0.09	)	$	(0.11	)

The Series C debenture was redeemed for Common Stock effective November 13, 2017. See Note 7. The Series C debenture was excluded from the loss per share calculation for the nine months ended March 31, 2018 because the impact is antidilutive.

New Accounting Pronouncements, Policy [Policy Text Block]

Recently Issued Accounting Pronouncements

In August 2018, the SEC issued the final rule on Disclosures About Changes in Stockholder’s Equity For filings on Form 10-Q, which extends to interim periods the annual requirement in SEC Regulation S-X, Rule 3-04,2 to disclose (1) changes in stockholders’ equity and (2) the amount of dividends per share for each class of shares (as opposed to common stock only, as previously required). Pursuant to the final rule, registrants must now analyze changes in stockholders’ equity, in the form of reconciliation, for “the current and comparative year-to-date [interim] periods, with subtotals for each interim period,” i.e., a reconciliation covering each period for which an income statement is presented. Rule 3-04 permits the disclosure of changes in stockholders’ equity (including dividend-per-share amounts) to be made either in a separate financial statement or in the notes to the financial statements. The final rule is effective for all filings made on or after November 5, 2018. The staff of the SEC has indicated it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its form 10-Q for the quarter that begins after the effective date of the amendments. The Company conformed to this rule in its Form 10-Q since the quarter ending December 31, 2018.

In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions. The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The standard will be effective for the Company in the first quarter of fiscal year 2020, although early adoption is permitted (but no sooner than the adoption of Topic 606). The Company does not expect that the adoption of this ASU will have a significant impact on its financial statements.

In July 2017, the FASB issued Accounting Standards Update (“ASU”) No. 2017-11. “Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. ASU 2017-11 revises the guidance for instruments with down round features in Subtopic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, which is considered in determining whether an equity-linked financial instrument qualifies for a scope exception from derivative accounting. An entity still is required to determine whether instruments would be classified in equity under the guidance in Subtopic 815-40 in determining whether they qualify for that scope exception. If they do qualify, freestanding instruments with down round features are no longer classified as liabilities. ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, and early adoption is permitted, including adoption in an interim period. ASU 2017-11 provides that upon adoption, an entity may apply this standard retrospectively to outstanding financial instruments with a down round feature by means of a cumulative-effect adjustment to the opening balance of retaining earnings in the fiscal year and interim period adoption. The Company has adopted ASU 2017-11 retrospectively for the quarter ending March 31, 2019. The adoption of this ASU did not have a significant impact on its financial statements.

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Summary of Significant Accounting Policies (Tables)

9 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:

	Potentially Outstanding Dilutive Common Shares
	For the		For the
	Nine Months		Nine Months
	Ended		Ended
	March 31, 2019		March 31, 2018
Options and Warrants		8,051,681		6,958,162
Total potentially outstanding dilutive common shares		8,051,681		6,958,162

The following table represents the basic and diluted per share calculations for loss per share:

	For the three months ended March 31,						For the nine months ended March 31,
	2019			2018			2019			2018
Calculation of basic and diluted loss per share of common stock:
Net loss attributable to common stockholders	$	(2,139,830	)	$	(2,109,962	)	$	(6,212,285	)	$	(6,912,411	)
Denominator for basic weighted average shares of common stock		71,955,909			64,068,378			70,162,244			63,566,719
Basic and diluted loss per share of common stock	$	(0.03	)	$	(0.03	)	$	(0.09	)	$	(0.11	)

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Related Party Transactions (Tables)

9 Months Ended

Mar. 31, 2019

Related Party Transactions [Abstract]

Schedule of Related Party Transactions [Table Text Block]

	As of
	March 31, 2019		June 30, 2018
Account Payable – Related Party
Pursuant to an Exclusive License Agreement we entered into with TheraCour, the Company was granted exclusive licenses in perpetuity for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. In consideration for obtaining this exclusive license, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) we will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on our behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour; (4) to pay an advance payment equal to twice the amount of the previous month’s invoice to be applied as a prepayment towards expenses. On October 2, 2018, the Company entered into an agreement with TheraCour Pharma, Inc. for a waiver of the two months worth of prepaid balance advance of anticipated invoicing until the filing of an IND and the application of the current advance as a credit against current open invoices. Additionally, TheraCour has agreed to defer $25,000 per month of development fees for twelve months, beginning with July 2018. Accounts payable due TheraCour on the reporting date was	$	730,063	$	107,468

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Property and Equipment
During the reporting period, TheraCour Pharma, Inc. acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company	$	6,603	$	12,705	$	14,011	$	12,705

	For the three months ended				For the nine months ended
	March 31, 2019		March 31, 2018		March 31, 2019		March 31, 2018
Research and Development Costs Paid to Related Parties
Development fees and other costs charged by TheraCour pursuant to exclusive License Agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at March 31, 2019 and June 30, 2018	$	574,853	$	529,031	$	2,320,726	$	2,299,712

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Property and Equipment (Tables)

9 Months Ended

Mar. 31, 2019

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment [Table Text Block]

Property and equipment, stated at cost, less accumulated depreciation consisted of the following:

	March 31,  2019			June 30,  2018
GMP Facility	$	8,020,471		$	8,011,230
Land		260,000			260,000
Office Equipment		57,781			57,781
Furniture and Fixtures		5,607			5,607
Lab Equipment		5,738,663			5,683,765
Total Property and Equipment		14,082,522			14,018,383
Less Accumulated Depreciation		(3,692,576	)		(3,177,290	)
Property and Equipment, Net	$	10,389,946		$	10,841,093

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Trademark and Patents (Tables)

9 Months Ended

Mar. 31, 2019

Goodwill and Intangible Assets Disclosure [Abstract]

Schedule of Finite-Lived Intangible Assets [Table Text Block]

Trademark and patents, stated at cost, less accumulated amortization consisted of the following:

	March 31, 2019			June 30, 2018
Trademarks and Patents	$	458,954		$	458,954
Less Accumulated Amortization		(90,229	)		(84,025	)
Trademarks and Patents, Net	$	368,725		$	374,929

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Accrued expenses (Tables)

9 Months Ended

Mar. 31, 2019

Payables and Accruals [Abstract]

Schedule of Accrued Liabilities [Table Text Block]

Accrued expenses consisted of the following:

	March 31, 2019		June 30, 2018
Severance payment- Eugene Seymour	$	-	$	233,333
Accrued payroll		11,466		19,716
Professional services		30,000		-
Severance payment- Irach Taraporewala		66,000		-
Accrued expenses	$	107,466	$	253,049

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Equity Transactions (Tables)

9 Months Ended

Mar. 31, 2019

Stockholders' Equity Note [Abstract]

Schedule for proceeds of the offering [Table Text Block]

The Company accounted for the proceeds of the Offering at February 27, 2019 as follows:

Gross proceeds	$	2,500,000
Less: Offering costs		150,000
Net proceeds		2,350,000
Portion allocated to derivative liability - warrants		(1,527,259	)
Net proceeds from issuance of common stock	$	822,741

Schedule Of Fair Value Of Stock Classified By Issuance Date [Table Text Block]

The fair value of the Series A Preferred stock was the following for the dates indicated:

Date	Shares		Value
7/11/2018		525,000	$	560,690
7/31/2018		2,572		2,795
8/31/2018		2,572		2,374
9/30/2018		2,572		2,598
10/31/2018		2,572		2,233
11/30/2018		2,572		1,883
12/31/2018		2,572		2,245
1/31/2019		2.572		1,203
2/28/2019		2,572		1,949
3/01/2019		26,786		24,340
3/31/2019		2,572		2,336
		574,934	$	604,646

Schedule of Stockholders Equity [Table Text Block]

The Company estimated the fair value of the warrants granted to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following weighted-average assumptions:

Expected life (year)	4
Expected volatility	47.99-55.12	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.51-2.93	%

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Stock Warrants and Options (Tables)

9 Months Ended

Mar. 31, 2019

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

The Company estimated the fair value of the options granted to Dr. Taraporewala on the date of grant using a lattice model that values the options based upon a stock price modeled such that it follows a geometric Brownian motion with constant drift and volatility:

Expected life (year)	3
Expected volatility	55.09	%
Expected annual rate of quarterly dividends	0.00	%
Risk-free rate(s)	2.71	%

Expected forfeiture (attrition) rate (%) 5.00 %

Equity Option [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Share-based Compensation, Stock Options, Activity [Table Text Block]

Stock Options	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding at June 30, 2018		-	$	-		-	$	-
Granted		300,000		.50		-		-
Forfeited		200,000		.50		-		-
Outstanding at March 31, 2019		100,000		.50		2.41		-

Stock Warrants [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Share-based Compensation, Stock Options, Activity [Table Text Block]

Stock Warrants	Number of  Shares		Weighted  Average  Exercise Price  per share  ($)		Weighted Average  Remaining  Contractual Term (years)		Aggregate Intrinsic Value ($)
Outstanding and exercisable at June 30, 2018		6,969,588	$	4.80		.53	$	-
Granted		6,978,742		.61		-		-
Expired		5,996,649		5.08		-		-
Outstanding and exercisable at March 31, 2019		7,951,681	$	.91		4.94	$	-

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Fair Value Measurement (Tables)

9 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

Fair Value, Liabilities Measured on Recurring Basis [Table Text Block]

At March 31, 2019 and June 30, 2018 the estimated fair values of the liabilities measured on a recurring basis are as follows:

	Fair Value Measurements at
	March 31, 2019:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	1,593,117

	Fair Value Measurements at
	June 30, 2018:
	(Level 1)		(Level 2)		(Level 3)
Derivative liability - warrants	$	-	$	-	$	298,092

Schedule Of Projected Annual Volatility [Table Text Block]

1 Year
6/30/18	56	%

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

The following tables present the activity for liabilities measured at estimated fair value using unobservable inputs for the three months ended March 31, 2019:

Fair Value Measurement

	Fair Value Measurement
	Using Significant Unobservable Inputs
	Derivative Liability- Warrant
Beginning balance at July 1, 2018	$	298,092
Additions during the year		1,527,259
Change in fair value		(232,234	)
Balance at March 31, 2019	$	1,593,117

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Summary of Significant Accounting Policies (Details) - shares	9 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	8,051,681	6,958,162
Options and Warrants [Member]
Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	8,051,681	6,958,162

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Summary of Significant Accounting Policies (Details 1) - USD ($)	3 Months Ended						9 Months Ended
	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Mar. 31, 2019	Mar. 31, 2018
Calculation of basic and diluted loss per share of common stock:
Net loss attributable to common stockholders	$ (2,139,830)	$ (2,230,992)	$ (1,841,463)	$ (2,109,962)	$ (2,796,894)	$ (2,005,555)	$ (6,212,285)	$ (6,912,411)
Denominator for basic weighted average shares of common stock	71,955,909			64,068,378			70,162,244	63,566,719
Basic and diluted loss per share of common stock	$ (0.03)			$ (0.03)			$ (0.09)	$ (0.11)

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Summary of Significant Accounting Policies (Details Textual) - USD ($)	3 Months Ended	9 Months Ended
	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018	Jun. 30, 2018
Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount		8,051,681	6,958,162
Convertible Preferred Stock, Terms of Conversion		60% or less
Preferred Stock, Shares Issued		5,106,328		4,531,394
Reclassification of General and Administrative Expenses into Research and Development Expenses	$ 262,365		$ 812,551
Series A converteble preferred shares [Member]
Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount		17,872,148
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price		$ 3.5
Preferred Stock, Shares Issued		5,106,328

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Liquidity and Going Concern (Details Textual) - USD ($)		1 Months Ended	3 Months Ended						9 Months Ended
	Feb. 27, 2019	Feb. 27, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Mar. 31, 2019	Mar. 31, 2018	Jun. 30, 2018	Jun. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and Cash Equivalents, at Carrying Value			$ 4,236,845			$ 10,617,837			$ 4,236,845	$ 10,617,837	$ 7,081,771	$ 15,099,461
Retained Earnings (Accumulated Deficit)			(89,904,431)						(89,904,431)		$ (83,692,146)
Net Income (Loss) Attributable to Parent			$ (2,139,830)	$ (2,230,992)	$ (1,841,463)	$ (2,109,962)	$ (2,796,894)	$ (2,005,555)	(6,212,285)	(6,912,411)
Net Cash Provided by (Used in) Operating Activities									$ (5,130,787)	$ (4,256,419)
Proceeds from Issuance Initial Public Offering	$ 2,500,000	$ 2,350,000
Legal Fees		25,000
Professional Fees		$ 125,000

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Related Party Transactions (Details) - USD ($)		3 Months Ended		9 Months Ended
	Oct. 02, 2018	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018	Jun. 30, 2018
Research and development		$ 1,310,326	$ 1,291,303	$ 4,335,105	$ 4,382,852
Theracour Pharma Inc [Member]
Net Account Payable to related party		730,063		730,063		$ 107,468
Research and development	$ 25,000	574,853	529,031	2,320,726	2,299,712
Property, Plant and Equipment, Additions		$ 6,603	$ 12,705	$ 14,011	$ 12,705

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Related Party Transactions (Details Textual) - USD ($)		3 Months Ended		9 Months Ended
	Oct. 02, 2018	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Related Party Transaction [Line Items]
Related Party Transaction, Description of Transaction				costs (direct and indirect) plus no more than 30% of direct costs
Other General and Administrative Expense				$ 2,000
Interest Expense, Debt		$ 0	$ 0	$ 0	$ 185,275
Percentage Of Net Sales Allocated For Royalty Payments				15.00%
Research and Development Expense		1,310,326	1,291,303	$ 4,335,105	4,382,852
Theracour Pharma Inc [Member]
Related Party Transaction [Line Items]
Research and Development Expense	$ 25,000	$ 574,853	529,031	$ 2,320,726	2,299,712
Series C Convertible Debenture [Member]
Related Party Transaction [Line Items]
Interest Expense, Debt					5,000,000
Series C Convertible Debenture [Member] | Dr. Boniuk [Member]
Related Party Transaction [Line Items]
Interest Expense, Debt			$ 0		$ 185,274

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Property and Equipment (Details) - USD ($)	Mar. 31, 2019	Jun. 30, 2018
Property, Plant and Equipment [Line Items]
GMP Facility	$ 8,020,471	$ 8,011,230
Land	260,000	260,000
Office Equipment	57,781	57,781
Furniture and Fixtures	5,607	5,607
Lab Equipment	5,738,663	5,683,765
Total Property and Equipment	14,082,522	14,018,383
Less Accumulated Depreciation	(3,692,576)	(3,177,290)
Property and Equipment, Net	$ 10,389,946	$ 10,841,093

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Property and Equipment (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Property, Plant and Equipment [Line Items]
Depreciation	$ 172,151	$ 168,457	$ 515,286	$ 501,378
Other Research and Development Expense				$ 501,378

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Trademark and Patents (Details) - USD ($)	Mar. 31, 2019	Jun. 30, 2018
Trademarks And Patents [Line Items]
Trademarks and Patents	$ 458,954	$ 458,954
Less Accumulated Amortization	(90,229)	(84,025)
Trademarks and Patents, Net	$ 368,725	$ 374,929

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Trademark and Patents (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Trademarks And Patents [Line Items]
Amortization			$ 6,204	$ 6,202
Trademark and Patents [Member]
Trademarks And Patents [Line Items]
Amortization	$ 2,068	$ 2,067	$ 6,204	$ 6,202

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Convertible Debenture and Derivatives (Details Textual) - USD ($)			1 Months Ended		3 Months Ended		9 Months Ended		12 Months Ended
	Nov. 13, 2017	Jul. 02, 2014	Feb. 27, 2019	Mar. 21, 2018	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018	Jun. 30, 2018	Jul. 19, 2018
Debt Instrument [Line Items]
Debt Conversion, Converted Instrument, Shares Issued	150,000
Debt Conversion, Converted Instrument, Amount							$ 0	$ 4,605,000
Interest Expense, Debt					$ 0	$ 0	$ 0	185,275
Common Stock, Par or Stated Value Per Share					$ 0.001		$ 0.001		$ 0.001	$ 0.001
Gain (Loss) on Extinguishment of Debt					$ 0	$ 0	$ 0	(1,348,247)
Stock Issued During Period, Value, New Issues			$ 2,350,000		$ 822,741
Share price as per Redemption Agreement					$ 1.00		$ 1.00
Series Preferred Share Issued For Debenture Interest Shares Issued				150,000
Debt Conversion, Description	for an aggregate of 5,500,000 shares of the Company’s $0.001 par value Common Stock (“Purchase Price”) comprising 5,000,000 shares for the principal of the Debenture and 500,000 shares for unpaid coupon interest from October 1, 2017 through June 30, 2018.
Series A Preferred Stock [Member]
Debt Instrument [Line Items]
Debt Instrument, Unamortized Discount					$ 684,633		$ 684,633
Common Stock [Member]
Debt Instrument [Line Items]
Stock Issued During Period, Value, New Issues					$ 6,944		$ 5,500,000
Series B Convertible Debentures [Member]
Debt Instrument [Line Items]
Common Stock, Par or Stated Value Per Share	$ 0.001
Series A Convertible Preferred Stock [Member]
Debt Instrument [Line Items]
Amortization of Debt Discount (Premium)								359,214
Debt Conversion, Converted Instrument, Shares Issued	314,726	187,000
Proceeds from Convertible Debt		$ 1,645,606
Repayments of Other Debt		1,152,297
Debt Instrument, Unamortized Discount		1,152,297
Debt Conversion, Converted Instrument, Amount		$ 1,879,428
Common Stock, Par or Stated Value Per Share	$ 1,348,247
Gain (Loss) on Extinguishment of Debt	$ 0.001
Stock Issued During Period, Value, Conversion of Convertible Securities	$ 364,337
Stock Issued During Period, Shares, Other	314,726
Derivative Liability									$ 15,449
Stock Issued During Period, Value, Other	$ 150,000
Series C Convertible Debenture [Member]
Debt Instrument [Line Items]
Debt Conversion, Converted Instrument, Amount									5,000,000
Interest Expense, Debt	314,726
Common Stock Value Issued For Debt Instrument Periodic Interest Payment								60,274	$ 125,000
Deferred Interest Payment								125,000
Deferred Interest Payment in Cash								$ 41,667
Interest Payable, Current	500,000
Long-term Debt, Excluding Current Maturities	5,000,000
Interest Payable	$ 60,274

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Accrued expenses (Details) - USD ($)	Mar. 31, 2019	Jun. 30, 2018
Severance payment- Eugene Seymour	$ 0	$ 233,333
Accrued payroll	11,466	19,716
Professional services	30,000	0
Severance payment- Irach Taraporewala	66,000	0
Accrued expenses	$ 107,466	$ 253,049

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Equity Transactions (Details) - USD ($)	1 Months Ended	3 Months Ended
	Feb. 27, 2019	Mar. 31, 2019
Stockholders' Equity Note [Abstract]
Gross proceeds	$ 2,500,000
Less: Offering costs	150,000
Net proceeds	2,350,000	$ 822,741
Portion allocated to derivative liability - warrants	(1,527,259)
Net proceeds from issuance of common stock	$ 822,741

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Equity Transactions (Details 1)	Mar. 31, 2019	Feb. 27, 2019
Fair Value Warrants Valution Assumptions Expected Volatality Rate	77.00%	75.00%

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Equity Transactions (Details 2) - Series A Preferred Stock [Member]	9 Months Ended
	Mar. 31, 2019 USD ($) shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	574,934
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 604,646
Issuance Date One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	525,000
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 560,690
Issuance Date Two [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,795
Issuance Date Three [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,374
Issuance Date Four [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,598
Issuance Date Five [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,233
Issuance Date Six [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 1,883
Issuance Date Seven [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,245
Issuance Date Eight [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2.572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 1,203
Issuance Date Nine [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 1,949
Issuance Date Ten [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	26,786
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 24,340
Issuance Date Eleven [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock Issued During Period, Shares, Share-based Compensation, Gross | shares	2,572
Stock Issued During Period, Value, Share-based Compensation, Gross | $	$ 2,336

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Equity Transactions (Details 3)	1 Months Ended		9 Months Ended
	Mar. 31, 2019	Feb. 27, 2019	Mar. 31, 2019
Class of Stock [Line Items]
Expected life (year)			4 years
Risk-free rate(s), Minimum	2.21%	2.48%
Scientific Advisory Board [Member]
Class of Stock [Line Items]
Expected volatility, Minimum			47.99%
Expected volatility, Maximum			55.12%
Expected annual rate of quarterly dividends			0.00%
Risk-free rate(s), Minimum			2.51%
Risk-free rate(s), Maximum			2.93%

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Equity Transactions (Details Textual) - USD ($)		1 Months Ended			3 Months Ended	9 Months Ended
	Feb. 27, 2019	Mar. 31, 2019	Feb. 27, 2019	Jul. 19, 2018	Mar. 31, 2019	Mar. 31, 2019	Jul. 11, 2018	Jun. 30, 2018
Class of Stock [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized		71,430			71,430	71,430
Share-based Compensation						$ 11,920
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term						4 years
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross				300,000
Fair Value Measurement Significant Assumptions						a. The common stock price was in the range $.20 to $.58; b. The calculated weighted average number of shares of common stock in the period; c. A 26.63% premium over the common shares for the voting preferences; d. The calculated weighted average number of total voting shares and the monthly shares representing voting rights of 19.28% to 19.52% of the total; e. The conversion value is based on an assumption for calculation purposes only of a Change of Control in 4 years from October 31, 2016 and a remaining restricted term of 1.75 to 1.59 years; f. 31.25% to 33.16% restricted stock discount (based on a restricted stock analysis and call-put analysis curve: 79.2% to 90.60% volatility, 2.50% to 2.44% risk free rate) applied to the converted common.
Share Price				$ 0.41
Restricted Stock or Unit Expense					$ 29,828	$ 43,956
Common Stock, Par or Stated Value Per Share		$ 0.001		$ 0.001	$ 0.001	$ 0.001		$ 0.001
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent				20.00%
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period					34,502	49,934
Sharebased Compensation Arrangement by Sharebased Payment Award Options Grant Date in Period Fair Value						$ 35,761
Stock Repurchase Agreement Agent Fees Terms			a cash placement fee equal to 5% of the aggregate purchase price for the common stock sold in the offering, plus $25,000 in legal fees.
Warrants Not Settleable in Cash, Fair Value Disclosure	$ 1,527,259		$ 1,527,259
Warrants Assumptions Used In Fair Value Disclosure			The 5.5-year warrants were issued on February 27, 2019 with an exercise price of $.61 (subject to adjustments-full ratchet reset). The stock price would fluctuate with the Company projected volatility. The Holder would exercise the warrant as they become exercisable (effective registration at issuance) at target prices of the higher of 2 times the projected exercise/reset price or 2 times the stock price. The next capital raise is projected to occur during 2020 (annually 12 months from issuance) at prices approximating 100% market triggering a reset event and exercise price adjustment.
Non Cash ShareBasedCompensation					28,572	28,572
Proceeds from Issuance Initial Public Offering	$ 2,500,000		$ 2,350,000
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum		2.21%	2.48%
Purchase Agreement With Institutional Investors [Member]
Class of Stock [Line Items]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	6,944,446		6,944,446
Class of Warrant or Right, Exercise Price of Warrants or Rights1	$ 0.61		$ 0.61
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 0.61		$ 0.61
Stock Repurchase Program, Number of Shares Authorized to be Repurchased	6,944,446		6,944,446
Stock Repurchase Programme Purchase Price	$ 0.36
Warrants And Rights Outstanding Maturity Term			5 years
February 2022 [Member]
Class of Stock [Line Items]
Number Of Common Stock To Be Issued Upon Conversion Of Warrants					11,432
Class of Warrant or Right, Exercise Price of Warrants or Rights1		$ 47			$ 47	$ 47
Class of Warrant or Right, Exercise Price of Warrants or Rights		47			$ 47	$ 47
Warrant [Member]
Class of Stock [Line Items]
Number Of Common Stock To Be Issued Upon Conversion Of Warrants					11,432
Fair Value Adjustment of Warrants					$ 1,543	$ 4,515
Class of Warrant or Right, Exercise Price of Warrants or Rights1		0.47			$ 0.47	$ 0.47
Class of Warrant or Right, Exercise Price of Warrants or Rights		0.47			$ 0.47	$ 0.47
Warrant [Member] | August 2021
Class of Stock [Line Items]
Number Of Common Stock To Be Issued Upon Conversion Of Warrants						11,432
Warrant [Member] | November 2022
Class of Stock [Line Items]
Number Of Common Stock To Be Issued Upon Conversion Of Warrants					1,432
Class of Warrant or Right, Exercise Price of Warrants or Rights1		41			$ 41	$ 41
Class of Warrant or Right, Exercise Price of Warrants or Rights		41			41	41
Warrant [Member] | February 2022 [Member]
Class of Stock [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights1		0.41			0.41	0.41
Class of Warrant or Right, Exercise Price of Warrants or Rights		0.41			0.41	0.41
Warrant [Member] | February 2023 [Member]
Class of Stock [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights1		47			47	47
Class of Warrant or Right, Exercise Price of Warrants or Rights		47			47	47
Warrant [Member] | August 2022
Class of Stock [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights1		41			41	41
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 41			$ 41	$ 41
Director [Member]
Class of Stock [Line Items]
Share-based Compensation					$ 11,250	$ 30,000
Restricted common stock authorized for interest payable					34,121	88,282
President [Member]
Class of Stock [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized							525,000
Share-based Compensation					$ 47,260	$ 141,780
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options		$ 418,912			$ 418,912	$ 418,912
Consulting Services [Member]
Class of Stock [Line Items]
Restricted common stock authorized for interest payable					183,723	459,176
Series A Convertible Preferred Stock [Member] | Minimum [Member]
Class of Stock [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Discount for Postvesting Restrictions						31.25%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate						79.20%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate						2.44%
Series A Convertible Preferred Stock [Member] | Maximum [Member]
Class of Stock [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Discount for Postvesting Restrictions						33.16%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate						90.60%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate						2.50%
Series A Preferred Stock [Member]
Class of Stock [Line Items]
Stock Issued During Period, Value, Issued For Services					$ 75,500	$ 181,960
Share Based Compensation Arrangement By Share Based Payment Award, Voting Rights, Percentage						26.63%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term						4 years
Series A Preferred Stock [Member] | Minimum [Member]
Class of Stock [Line Items]
Share Based Compensation Arrangement By Share Based Payment Award, Voting Rights, Percentage						19.28%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term						1 year 7 months 2 days
Share Price		$ 0.20			$ 0.20	$ 0.20
Series A Preferred Stock [Member] | Maximum [Member]
Class of Stock [Line Items]
Share Based Compensation Arrangement By Share Based Payment Award, Voting Rights, Percentage						19.52%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term						1 year 9 months
Share Price		$ 0.58			$ 0.58	$ 0.58

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Stock Warrants and Options (Details) - USD ($)	1 Months Ended	9 Months Ended	12 Months Ended
	Jul. 19, 2018	Mar. 31, 2019	Jun. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Granted	300,000
Weighted Average Exercise Price per share, Granted (dollars per share)		$ 0.50
Equity Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Outstanding	6,969,588	6,969,588
Number of Shares, Granted		6,978,742
Number of Shares, Expired		5,996,649
Number of Shares, Outstanding		7,951,681	6,969,588
Weighted Average Exercise Price per share, Outstanding (dollars per share)	$ 4.80	$ 4.80
Weighted Average Exercise Price per share, Granted (dollars per share)		0.61
Weighted Average Exercise Price per share, Expired (dollars per share)		5.08
Weighted Average Exercise Price per share, Outstanding (dollars per share)		$ 0.91	$ 4.80
Weighted Average Remaining Contractual Term (years), Outstanding		4 years 11 months 8 days	6 months 10 days
Aggregate Intrinsic Value, Outstanding (in dollars)	$ 0	$ 0
Aggregate Intrinsic Value, Outstanding (in dollars)		$ 0	$ 0

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Stock Warrants and Options (Details 1) - USD ($)	1 Months Ended	9 Months Ended	12 Months Ended
	Jul. 19, 2018	Mar. 31, 2019	Jun. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Granted	300,000
Weighted Average Exercise Price per share, Granted (dollars per share)		$ 0.50
Weighted Average Exercise Price per share,Forfeited (dollars per share)		$ 0.50
Stock Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Outstanding			0
Number of Shares, Granted		300,000
Number of Shares, Forfeited		200,000
Number of Shares, Outstanding		100,000
Weighted Average Exercise Price per share, Outstanding (dollars per share)			$ 0
Weighted Average Exercise Price per share, Outstanding (dollars per share)		$ 0.50
Weighted Average Remaining Contractual Term (years), Outstanding		2 years 4 months 27 days
Aggregate Intrinsic Value, Outstanding (in dollars)		$ 0	$ 0
Aggregate Intrinsic Value, Forfeited (in dollars)		$ 0

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Stock Warrants and Options (Details 2)	9 Months Ended
	Mar. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected life (year)	4 years
Chief Executive Officer [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected life (year)	3 years
Expected volatility	55.09%
Expected annual rate of quarterly dividends	0.00%
Risk-free rate(s)	2.71%
Expected forfeiture (attrition) rate (%)	5.00%

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Stock Warrants and Options (Details Textual) - shares		9 Months Ended
	Jan. 24, 2019	Mar. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Number of Shares	200,000
Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number		100,000
June 30, 2020 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants Exercisable		620,051
June 30, 2021 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants Exercisable		57,160
June 30 2022 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants Exercisable		45,728
June 30, 2023 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants Exercisable		284,296
June 30, 2025 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants Exercisable		6,944,446

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Fair Value Measurement (Details) - USD ($)	Mar. 31, 2019	Jun. 30, 2018
Derivative Liability, Noncurrent	$ 1,593,117	$ 0
Fair Value, Inputs, Level 1 [Member] | Warrant [Member]
Derivative Liability, Noncurrent	0	0
Fair Value, Inputs, Level 2 [Member] | Warrant [Member]
Derivative Liability, Noncurrent	0	0
Fair Value, Inputs, Level 3 [Member] | Warrant [Member]
Derivative Liability, Noncurrent	$ 1,593,117	$ 298,092

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Fair Value Measurement (Details 1)	12 Months Ended
	Jun. 30, 2018
One Year Ended 6/30/18
Fair Value Assumption Expected Volatility Rate	56.00%

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Fair Value Measurement (Details 2) - Derivative liability - Warrants	9 Months Ended
	Mar. 31, 2019 USD ($)
Beginning balance	$ 298,092
Additions during the year	1,527,259
Change in fair value	(232,234)
Ending Balance	$ 1,593,117

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Fair Value Measurement (Details Textual) - $ / shares			4 Months Ended
	Jan. 24, 2014	Sep. 12, 2013	Jan. 24, 2014	Mar. 31, 2019	Feb. 27, 2019	Jun. 30, 2018
Class of Warrant or Right, Outstanding				0		5,290,006
Warrants Issued			5,425,363
Warrant [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights					$ 0.61
Class of Warrant or Right, Number of Securities Called by Warrants or Rights					6,944,446
Placement Agents [Member]
Class of Warrant or Right, Outstanding				0		135,216
Warrants Issued			135,216
Warrant Expiration Term	5 years	5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 6.05	$ 5.25	$ 6.05
Scientific Advisory Board [Member]
Class of Warrant or Right, Outstanding				0		5,425,222

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Commitments and Contingencies (Details Textual) - USD ($)			1 Months Ended			9 Months Ended
	Jan. 24, 2019	Sep. 01, 2018	Jan. 31, 2015	May 30, 2013	Mar. 03, 2010	Mar. 31, 2019	Jun. 30, 2018	Jan. 24, 2014
Commitments and Contingencies [Line Items]
Common stock, shares issued						76,735,074	69,171,740
Preferred stock, shares issued						5,106,328	4,531,394
Deferred Compensation Arrangement with Individual, Compensation Expense						$ 400,000
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance						525,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Number of Shares	200,000
Share-based Compensation Award, Tranche One [Member]
Commitments and Contingencies [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares						175,000
Chief Executive Officer [Member] | Year One [Member]
Commitments and Contingencies [Line Items]
Deferred Compensation Arrangement with Individual, Compensation Expense						$ 360,000
Chief Executive Officer [Member] | Year Two [Member]
Commitments and Contingencies [Line Items]
Deferred Compensation Arrangement with Individual, Compensation Expense						300,000
Chief Executive Officer [Member] | Year Three [Member]
Commitments and Contingencies [Line Items]
Deferred Compensation Arrangement with Individual, Compensation Expense						$ 100,000
Chief Scientific Officer [Member]
Commitments and Contingencies [Line Items]
Common stock, shares issued					35,715
Additional Common Stock Shares Issued					35,715
Increase In Base Salary					$ 150,000
Vice President [Member]
Commitments and Contingencies [Line Items]
Common stock, shares issued					35,715
Additional Common Stock Shares Issued					35,715
Preferred stock, shares issued					26,786
Additional Preferred Stock Shares Issued					26,786
Increase In Base Salary					$ 150,000
Chief Financial Officer [Member]
Commitments and Contingencies [Line Items]
Increase In Base Salary			$ 10,800	$ 9,000
Chief Financial Officer [Member] | Series A Convertible Preferred Stock [Member]
Commitments and Contingencies [Line Items]
Preferred stock, shares issued				2,572
Mr Taraporewala [Member]
Commitments and Contingencies [Line Items]
Consulting Services Payments								$ 3,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Number of Shares		200,000