0001477932-17-000773.txt : 20170214 0001477932-17-000773.hdr.sgml : 20170214 20170214172321 ACCESSION NUMBER: 0001477932-17-000773 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 46 CONFORMED PERIOD OF REPORT: 20161231 FILED AS OF DATE: 20170214 DATE AS OF CHANGE: 20170214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Citius Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001506251 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 273425913 STATE OF INCORPORATION: NV FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-55532 FILM NUMBER: 17610509 BUSINESS ADDRESS: STREET 1: 11 COMMERCE DRIVE STREET 2: 1ST FLOOR CITY: CRANFORD STATE: NJ ZIP: 07016 BUSINESS PHONE: (908) 967-6676 MAIL ADDRESS: STREET 1: 11 COMMERCE DRIVE STREET 2: 1ST FLOOR CITY: CRANFORD STATE: NJ ZIP: 07016 FORMER COMPANY: FORMER CONFORMED NAME: Trail One, Inc. DATE OF NAME CHANGE: 20110314 FORMER COMPANY: FORMER CONFORMED NAME: TrailOne, Inc. DATE OF NAME CHANGE: 20101119 10-Q 1 ctxr_10q.htm FORM 10-Q ctxr_10q.htm

 

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One) 

x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: December 31, 2016

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ______________ to ______________

 

Commission File Number 333-170781

 

 Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada

27-3425913

(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)

 

11 Commerce Drive, First Floor, Cranford, NJ 07016

(Address of principal executive offices and zip code)

 

(908) 967-6677

(Registrant’s telephone number, including area code)

 

_______________________________________________________________

(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filed 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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files). Yes x No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

 

Large accelerated filer

¨

Accelerated filer

¨

Non-accelerated filer

¨

Smaller reporting company

x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

 

As of January 31, 2017, there were 74,558,992 shares of common stock, $0.001 par value, of the registrant issued and outstanding.

 
 
 

Citius Pharmaceuticals, Inc.

FORM 10-Q

TABLE OF CONTENTS

December 31, 2016

 

Page

PART I.

FINANCIAL INFORMATION:

Item 1.

Financial Statements (Unaudited)

4

Condensed Consolidated Balance Sheets at December 31, 2016 and September 30, 2016

4

Condensed Consolidated Statements of Operations for the Three Months Ended December 31, 2016 and 2015

5

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the Three Months Ended December 31, 2016

6

Condensed Consolidated Statements of Cash Flows for the Three Months Ended December 31, 2016 and 2015

7

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

18

Item 4.

Controls and Procedures

18

PART II.

OTHER INFORMATION

Item 1.

Legal Proceedings

19

Item 1A.

Risk Factors

19

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

19

Item 3.

Defaults Upon Senior Securities

19

Item 4.

Mine Safety Disclosures

19

Item 5.

Other Information

19

Item 6.

Exhibits

20

SIGNATURES

21

 

 
2
 

 

EXPLANATORY NOTE

 

In this Quarterly Report on Form 10-Q, and unless the context otherwise requires the “Company,” “we,” “us” and “our” refer to Citius Pharmaceuticals, Inc. and its wholly owned subsidiaries, Citius Pharmaceuticals, LLC and Leonard-Meron Biosciences, Inc., taken as a whole.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in this report and in other documents which we file with the Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to:

 

· our ability to raise funds for general corporate purposes and operations, including our clinical trials;

 

· the commercial feasibility and success of our technology;

 

· our ability to recruit qualified management and technical personnel;

 

· the success of our clinical trials;

 

· our ability to obtain and maintain required regulatory approvals for our products; and

 

· the other factors discussed in the “Risk Factors” section and elsewhere in this report.

 

The foregoing list does not contain all of the risks and uncertainties. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws; we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the filing date of this report.

 

 
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PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

December 31,

 

 

September 30,

 

 

 

2016

 

 

2016

 

ASSETS

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$ 46,764

 

 

$ 294,351

 

Prepaid expenses

 

 

443,526

 

 

 

598,484

 

Total Current Assets

 

 

490,290

 

 

 

892,835

 

 

 

 

 

 

 

 

 

 

Property and Equipment, Net of Accumulated Depreciation of $5,452 and $4,780

 

 

3,070

 

 

 

3,742

 

 

 

 

 

 

 

 

 

 

Other Assets:

 

 

 

 

 

 

 

 

Deposits

 

 

2,167

 

 

 

2,167

 

Deferred offering costs

 

 

 

 

 

64,801

 

In-process research and development

 

 

19,400,000

 

 

 

19,400,000

 

Goodwill

 

 

1,586,796

 

 

 

1,586,796

 

Total Other Assets

 

 

20,988,963

 

 

 

21,053,764

 

 

 

 

 

 

 

 

 

 

Total Assets

 

$ 21,482,323

 

 

$ 21,950,341

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$ 985,865

 

 

$ 909,156

 

Accrued expenses

 

 

1,847,062

 

 

 

958,101

 

Accrued compensation

 

 

1,010,500

 

 

 

903,250

 

Accrued interest

 

 

44,099

 

 

 

30,871

 

Notes payable – related parties

 

 

1,492,970

 

 

 

672,970

 

Derivative warrant liability

 

 

910,578

 

 

 

1,681,973

 

Due to related party

 

 

27,637

 

 

 

27,637

 

Total Current Liabilities

 

 

6,318,711

 

 

 

5,183,958

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

Preferred stock – $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding

 

 

 

 

 

 

Common stock – $0.001 par value; 200,000,000 shares authorized; 74,113,060 and 73,138,060 shares issued and outstanding at December 31, 2016 and September 30, 2016, respectively

 

 

74,113

 

 

 

73,138

 

Additional paid-in capital

 

 

34,601,644

 

 

 

34,029,492

 

Accumulated deficit

 

 

(19,512,145 )

 

 

(17,336,247 )

Total Stockholders’ Equity

 

 

15,163,612

 

 

 

16,766,383

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

 

$ 21,482,323

 

 

$ 21,950,341

 

 

See notes to unaudited condensed consolidated financial statements.

 

 
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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited)

 

 

 

Three Months Ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

Revenues

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

Research and development

 

 

1,411,159

 

 

 

829,156

 

General and administrative

 

 

1,132,183

 

 

 

294,221

 

Stock-based compensation – general and administrative

 

 

241,514

 

 

 

121,299

 

Total Operating Expenses

 

 

2,784,856

 

 

 

1,244,676

 

 

 

 

 

 

 

 

 

 

Operating Loss

 

 

(2,784,856 )

 

 

(1,244,676 )

 

 

 

 

 

 

 

 

 

Other Income (Expense), Net

 

 

 

 

 

 

 

 

Interest income

 

 

 

 

 

15

 

Gain on revaluation of derivative warrant liability

 

 

622,186

 

 

 

23,940

 

Interest expense

 

 

(13,228 )

 

 

 

Total Other Income (Expense), Net

 

 

608,958

 

 

 

23,955

 

 

 

 

 

 

 

 

 

 

Loss before Income Taxes

 

 

(2,175,898 )

 

 

(1,220,721 )

Income tax benefit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$ (2,175,898 )

 

$ (1,220,721 )

 

 

 

 

 

 

 

 

 

Net Loss Per Share - Basic and Diluted

 

$ (0.03 )

 

$ (0.04 )

 

 

 

 

 

 

 

 

 

Weighted Average Common Shares Outstanding

 

 

 

 

 

 

 

 

Basic and diluted

 

 

73,551,375

 

 

 

34,414,988

 

 

See notes to unaudited condensed consolidated financial statements.

 

 
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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THE THREE MONTHS ENDED DECEMBER 31, 2016

(Unaudited)

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Preferred

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders'

 

 

 

Stock

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, October 1, 2016

 

$

 

 

 

73,138,060

 

 

$ 73,138

 

 

$ 34,029,492

 

 

$ (17,336,247 )

 

$ 16,766,383

 

Issuance of common stock in private placements, net of costs

 

 

 

 

 

975,000

 

 

 

975

 

 

 

181,429

 

 

 

 

 

 

182,404

 

Reclassification of derivative warrant liability to additional paid-in capital

 

 

 

 

 

 

 

 

 

 

 

149,209

 

 

 

 

 

 

149,209

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

241,514

 

 

 

 

 

 

241,514

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,175,898 )

 

 

(2,175,898 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2016

 

$

 

 

 

74,113,060

 

 

$ 74,113

 

 

$ 34,601,644

 

 

$ (19,512,145 )

 

$ 15,163,612

 

 

See notes to unaudited condensed consolidated financial statements.

 

 
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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited)

 

 

 

2016

 

 

2015

 

Cash Flows From Operating Activities:

 

 

 

 

 

 

Net loss

 

$ (2,175,898 )

 

$ (1,220,721 )

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Gain on revaluation of derivative warrant liability

 

 

(622,186 )

 

 

(23,940 )

Stock-based compensation expense

 

 

241,514

 

 

 

121,299

 

Depreciation

 

 

672

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

154,958

 

 

 

 

Accounts payable

 

 

76,709

 

 

 

(100,464 )

Accrued expenses

 

 

888,961

 

 

 

526,740

 

Accrued compensation

 

 

107,250

 

 

 

 

Accrued interest

 

 

13,228

 

 

 

 

Net Cash Used In Operating Activities

 

 

(1,314,792 )

 

 

(697,086 )

 

 

 

 

 

 

 

 

 

Cash Flows From Financing Activities:

 

 

 

 

 

 

 

 

Proceeds from notes payable - related parties

 

 

820,000

 

 

 

 

Net proceeds from private placements

 

 

247,205

 

 

 

302,438

 

Net Cash Provided By Financing Activities

 

 

1,067,205

 

 

 

302,438

 

 

 

 

 

 

 

 

 

 

Net Change in Cash and Cash Equivalents

 

 

(247,587 )

 

 

(394,648 )

Cash and Cash Equivalents - Beginning of Period

 

 

294,351

 

 

 

676,137

 

 

 

 

 

 

 

 

 

 

Cash and Cash Equivalents - End of Period

 

$ 46,764

 

 

$ 281,489

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosures Of Cash Flow Information and Non-cash Transactions:

 

 

 

 

 

 

 

 

Interest paid

 

$

 

 

$

 

Income taxes paid

 

$

 

 

$

 

Fair value of warrants recorded as derivative warrant liability

 

$

 

 

$ 157,984

 

Reclassification of derivative warrant liability to additional paid-in capital

 

$ 149,209

 

 

$

 

 

See notes to unaudited condensed consolidated financial statements.

 

 
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CITIUS PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited)

 

1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Business

 

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting unmet needs with a focus on anti-infectives, cancer care and unique prescription products. The Company was founded as Citius Pharmaceuticals, LLC, a Massachusetts limited liability company, on January 23, 2007. On September 12, 2014, Citius Pharmaceuticals, LLC entered into a Share Exchange and Reorganization Agreement with Citius Pharmaceuticals, Inc. (formerly Trail One, Inc.), a publicly traded company incorporated under the laws of the State of Nevada. Citius Pharmaceuticals, LLC became a wholly-owned subsidiary of Citius.

 

On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary (see “Acquisition of Leonard-Meron Biosciences, Inc.” below).

 

The Company had one approved product, Suprenza (phentermine hydrochloride), which it licensed out for promotion in the United States, Canada and Mexico. On July 1, 2016, the Company announced that it was discontinuing Suprenza. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital.

 

Citius is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius or its competitors of research and development stage products, market acceptance of its products, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing and the Company’s compliance with governmental and other regulations.

 

Acquisition of Leonard-Meron Biosciences, Inc.

 

On March 30, 2016, the Company acquired all of the outstanding stock of Leonard-Meron Biosciences, Inc. (“LMB”) by issuing 29,136,839 shares of its common stock. As of March 30, 2016, the stockholders of LMB received approximately 41% of the issued and outstanding common stock of the Company. In addition, the Company converted the outstanding common stock warrants of LMB into 3,645,297 common stock warrants of the Company and converted the outstanding common stock options of LMB into 1,158,770 common stock options of the Company.

 

The Company acquired tangible assets consisting of cash of $255,748, prepaid expenses of $20,544, property and equipment of $5,085, deposits of $2,167, and identifiable intangible assets of $19,400,000 related to in-process research and development. The Company assumed accounts payable of $244,776, accrued expenses of $598,659, accrued compensation of $615,000, accrued interest of $23,862, and notes payable of $772,970. Accordingly, the net assets acquired amounted to $17,428,277.

 

The fair value of LMB’s net assets acquired on the date of the acquisition, based on management’s analysis of the fair value of the 29,136,839 shares of the Company’s common stock issued for LMB’s outstanding stock, the 3,645,297 Company common stock warrants issued for LMB’s outstanding common stock warrants, and the vested portion of the 1,158,770 Company common stock options issued for LMB’s outstanding common stock options was $19,015,073. The fair value of the common stock issued was estimated at $17,482,093, the fair value of the warrants issued was estimated at $1,071,172 and the fair value of the vested options was estimated at $461,808.

 

The Company recorded goodwill of $1,586,796 for the excess of the purchase price of $19,015,073 over the net assets acquired of $17,428,277.

 

In-process research and development represents the value of LMB’s leading drug candidate which is an antibiotic solution used to treat catheter-related bloodstream infections (Mino-Lok™) and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment.

 

 
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Unaudited pro forma operating results for the three months ended December 31, 2015, assuming the acquisition of LMB had been made as of October 1, 2015, are as follows:

 

 

 

2015

 

Revenues

 

$

 

Net loss

 

$ (1,640,688 )

Net loss per share – basic and diluted

 

$ (0.03 )

 

Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Preparation — The accompanying consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., and its wholly-owned subsidiaries, Citius Pharmaceuticals, LLC, and LMB since the March 30, 2016 acquisition. All significant inter-company balances and transactions have been eliminated in consolidation.

 

The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, without being audited, pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments considered necessary to make the financial statements not misleading have been included. Operating results for the three months ended December 31, 2016 are not necessarily indicative of the results that may be expected for the year ending September 30, 2017. The unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2016 filed with the Securities and Exchange Commission.

 

Use of Estimates — Our accounting principles require our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include the accounting for acquisitions, stock-based compensation, valuation of warrants, and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

 

Basic and Diluted Net Loss per Common Share — Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of options, warrants and convertible securities were not included in the calculation of the diluted loss per share because they were anti-dilutive.

 

Recently Issued Accounting Standards

 

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, in an effort to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The amendments of this ASU are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on our consolidated financial statements.

 

In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350). This ASU eliminates step 2 from the goodwill impairment test by comparing the fair value of a reporting unit with the carrying amount of the reporting unit. If the carrying amount exceeds the fair value, an impairment charge for the excess is recorded. The amendments of this ASU are effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the impact of the adoption of this ASU on the consolidated financial statements.

 

2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S PLAN

 

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company experienced negative cash flows from operations of $1,314,792 and $697,086 for the three months ended December 31, 2016 and 2015, respectively. At December 31, 2016, the Company had a working capital deficit of $5,828,421. The Company has no revenue and has relied on proceeds from equity transactions and debt to finance its operations. At December 31, 2016, the Company had limited capital to fund its operations. This raises substantial doubt about the Company’s ability to continue as a going concern.

 

 
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The Company plans to raise capital through equity financings from outside investors as well as raise additional funds from existing investors and continued borrowings under related party debt agreements. There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to the Company.

 

The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of the above uncertainty.

 

3. BUSINESS AGREEMENTS

 

Alpex Pharma S.A.

 

On June 12, 2008, the Company entered into a collaboration and license agreement (the “Alpex Agreement”) with Alpex Pharma S.A. (“Alpex”), in which Alpex granted the Company an exclusive right and license to use certain Alpex intellectual property in order to develop and commercialize orally disintegrating tablet formulations of pharmaceutical products in United States, Canada and Mexico. In addition, Alpex manufactures Suprenza, the Company’s commercialized pharmaceutical product, on a contract basis. The agreement was amended on November 15, 2011 as part of an Amendment and Coordination Agreement (see the “Three-Party Agreement” below).

 

Under the terms of the Alpex Agreement, as amended by the Three-Party Agreement dated November 15, 2011 (see below), Alpex is entitled to a payment per tablet manufactured and a percentage of all milestone, royalty and other payments received by the Company from Prenzamax, LLC, pursuant to a sublicense agreement (see below). In addition, under the terms of the Alpex Agreement, Alpex retained the right to use the clinical data generated by the Company to file for regulatory approval and market Suprenza in the rest of the world. In the event that Alpex has such sales, Alpex will pay the Company a percentage royalty on net sales, as defined (“Alpex Revenue”). No milestone, royalty or other payments were earned or received by the Company except for the reimbursement of certain regulatory fees under the Three-Party Agreement.

 

On July 1, 2016, the Company announced that it notified the Food and Drug Administration (“FDA”) and Alpex that it was discontinuing Suprenza.

 

Prenzamax, LLC

 

On November 15, 2011, the Company entered into an exclusive license agreement (the “Sublicense Agreement”) with Prenzamax, LLC (“Prenzamax”), in which the Company granted Prenzamax and its affiliates the exclusive right to commercialize Suprenza in the United States. Prenzamax is an affiliate of Akrimax, a related party (see Note 7) and was formed for the specific purpose of managing the Sublicense Agreement. Under the terms of the Sublicense Agreement, Prenzamax is to pay the Company a percentage of the product’s EBITDA, as defined (“Profit Share Payments”). In addition, Prenzamax is to reimburse the Company directly for certain development costs. These payments are to commence once Prenzamax has achieved profitability, as defined in the Sublicense Agreement. Further, under the terms of the Sublicense Agreement, Prenzamax is required to share in the royalty payment due to Alpex under the Alpex Agreement. In addition, Prenzamax is entitled to a percentage of the Alpex Revenue received by the Company. The Company has not been reimbursed for any development costs nor has it earned any Profit Share Payments.

 

On July 1, 2016, the Company announced that it notified Prenzamax that it was discontinuing Suprenza.

 

Three-Party Agreement

 

On November 15, 2011, the Company, Alpex and Prenzamax entered into the Three-Party Agreement wherein the terms of the Alpex Agreement were modified and Prenzamax and the Company agreed to each pay a portion of certain regulatory filing fees for as long as Prenzamax is purchasing Suprenza from Alpex pursuant to the Three-Party Agreement. During the three months ended March 31, 2016, the Company received $292,575 from Alpex as reimbursement for regulatory filing fees that were previously expensed during the three months ended December 31, 2015. The reimbursement was recorded as a reduction of research and development expenses.

 

On July 1, 2016, the Company announced that it notified Alpex and Prenzamax that it was discontinuing Suprenza.

 

 
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Patent and Technology License Agreement

 

LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc., (“NAT”) to develop and commercialize Mino-Lok™ on an exclusive, worldwide (except for South America), sub licensable basis. Since May 2014, LMB has paid an annual maintenance fee of $30,000 that increases over five years to $90,000, until commercial sales of a product subject to the license. LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low-single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to $1,050,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees.

 

4. NOTES PAYABLE – RELATED PARTIES

 

On March 30, 2016, the Company assumed $772,970 of demand notes payable in the acquisition of LMB. The principal balance of the notes payable to our Chairman, Leonard Mazur, was $760,470 and the principal balance of the notes payable to our Chief Executive Officer, Myron Holubiak, was $12,500. Notes with a principal balance of $704,000 accrue interest at the prime rate plus 1.0% per annum and notes with a principal balance of $68,970 accrue interest at 12% per annum. In April 2016, $600,000 of the prime rate plus 1.0% demand notes payable and accrued interest of $1,985 was repaid to Leonard Mazur.

 

The Board of Directors has authorized revolving demand promissory notes with Leonard Mazur in an aggregate principal amount of up to $2,500,000, of which $1,320,000 is outstanding at December 31, 2016.

 

On September 7, 2016, the Company issued a $500,000 demand promissory note to our Chairman, Leonard Mazur which matures on demand by the lender. The Company then issued $820,000 of additional demand promissory notes to Leonard Mazur during the three months ended December 31, 2016 which mature on the earlier of December 31, 2017 or demand by the lender. These notes accrue interest at the prime rate plus 1%.

 

Interest expense on notes payable – related parties was $13,228 for the three months ended December 31, 2016.

 

5. DERIVATIVE WARRANT LIABILITY

 

Derivative financial instruments are recognized as a liability on the consolidated balance sheet and measured at fair value. At December 31, 2016 and September 30, 2016, the Company had outstanding warrants to purchase 4,033,334 shares and 4,616,668 shares, respectively, of its common stock that are considered to be derivative instruments since the agreements contain “down round” provisions whereby the exercise price of the warrants is subject to adjustment in the event that the Company issues common stock for less than $0.60 per share within one-year of the original issuance of the warrants (see Note 6).

 

The Company performs valuations of the warrants using the Black-Scholes option pricing model which value was also compared to a Binomial Option Pricing Model for reasonableness. The Black-Scholes option pricing model requires input of assumptions including the risk-free interest rates, volatility, expected life and dividends. Selection of these inputs involves management’s judgment and may impact net loss. Due to our limited operating history and limited number of sales of our common stock, we estimate our volatility based on a number of factors including the volatility of comparable publicly traded pharmaceutical companies. The volatility factor used in the Black-Scholes option pricing model has a significant effect on the resulting valuation of the derivative liabilities on our balance sheet. The volatility calculated at December 31, 2016 was 76%. We used a risk-free interest rate of 1.93%, estimated lives of 4.02 to 4.32 years, which are the remaining contractual lives of the warrants subject to “down round” provisions, and no dividends to our common stock. The volatility calculated at September 30, 2016 was 73%. We used a risk-free interest rate of 1.14%, estimated lives of 4.10 to 4.57 years, which are the remaining contractual lives of the warrants subject to “down round” provisions, and no dividends to our common stock.

 

During the three months ended December 31, 2016, anti-dilution rights related to warrants to purchase 583,334 shares of common stock expired which resulted in a reclassification from derivative warrant liability to additional paid-in capital of $149,209.

 

The table below presents the changes in the derivative warrant liability, which is measured at fair value on a recurring basis and classified as Level 3 in the fair value hierarchy:

 

 

 

Three Months

Ended

December 31,

2016

 

 

Three Months

Ended

December 31,

2015

 

Derivative warrant liability, beginning of period

 

$ 1,681,973

 

 

$ 738,955

 

Fair value of warrants issued

 

 

 

 

 

157,984

 

Total realized/unrealized gains included in net loss

 

 

(622,186 )

 

 

(23,940 )

Reclassification of liability to additional paid-in capital

 

 

(149,209 )

 

 

 

Derivative warrant liability, end of period

 

$ 910,578

 

 

$ 872,999

 

 

 
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6. COMMON STOCK, STOCK OPTIONS AND WARRANTS

 

Common Stock

 

On September 15, 2016, the stockholders approved an increase in the number of shares of authorized common stock from 90,000,000 shares to 200,000,000 shares. In addition, the stockholders granted the Board of Directors the authority to affect a reverse stock split of our common stock by a ratio of not less than 1-for-8 and not more than 1-for-20 at any time prior to September 15, 2017.

 

Private Offerings

 

On September 12, 2014, the Company sold 3,400,067 Units for a purchase price of $0.60 per Unit for gross proceeds of $2,040,040. Each Unit consists of one share of common stock and one five-year warrant (the “Investor Warrants”) to purchase one share of common stock at an exercise price of $0.60 (the “Private Offering”). The Investor Warrants will be redeemable by the Company at a price of $0.001 per Investor Warrant at any time subject to the conditions that (i) the common stock has traded for twenty (20) consecutive trading days with a closing price of at least $1.50 per share with an average trading volume of 50,000 shares per day and (ii) the Company provides 20 trading days prior notice of the redemption and the closing price of the common stock is not less than $1.17 for more than any 3 days during such notice period and (iii) the underlying shares of common stock are registered.

 

The Company issued the Placement Agent and their designees five-year warrants (the “Placement Agent Unit Warrants”) to purchase 680,013 Units at an exercise price of $0.60 per Unit. The Placement Agent Unit Warrants are exercisable on a cash or cashless basis with respect to purchase of the Units, and will be exercisable only for cash with respect to warrants received as part of the Units.

 

In addition, the Placement Agent was issued warrants to purchase 1,000,000 shares of common stock exercisable for cash at $0.60 per share for investment banking services provided in connection with the transaction (the “Placement Agent Share Warrants”).

 

In connection with the Private Offering, the Company entered into a Registration Rights Agreement pursuant to which the Company filed a registration statement, registering for resale all shares of common stock (i) included in the Units; and (ii) issuable upon exercise of the Investor Warrants. The Company filed the Registration Statement on September 11, 2015 and it was declared effective on January 21, 2016.

 

During the year ended September 30, 2015, the Company sold an additional 2,837,037 Units for a purchase price of $0.54 per Unit and 200,000 Units for a purchase price of $0.60 per Unit for gross proceeds of $1,652,000. Each Unit consists of one share of common stock and one Investor Warrant (see description above).

 

During the year ended September 30, 2016, the Company sold an additional 4,350,001 Units for a purchase price of $0.54 per Unit and 266,667 Units for a purchase price of $0.60 per Unit for gross proceeds of $2,509,000. Each Unit consists of one share of common stock and one Investor Warrant (see description above). On May 12, 2016, the Company announced that it had completed the final phase of the Private Offering.

 

On March 22, 2016, the Company sold 5,000,000 shares of common stock at $0.60 per share to its Chairman of the Board, Leonard Mazur, for gross proceeds of $3,000,000. There were no expenses related to this placement.

 

In October 2016, the Company commenced an offering (the “2016 Offering”) of up to 15,000,000 Units at a price of $0.40 per Unit (the “2016 Offering Units”), each 2016 Offering Unit consists of (i) one share of common stock and (ii) a warrant to purchase one share of common stock (the “2016 Offering Warrants”) for gross proceeds of up to $6,000,000 with an over-subscription allotment of up to $2,000,000. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance. The Placement Agent will receive a 10% cash commission on the gross proceeds of each sale of the 2016 Offering Units. In addition, on each closing the Placement Agent will also receive (i) an expense allowance equal to 3% of the proceeds of the sale, and (ii) warrants to purchase a number of shares of common stock equal to 10% of the 2016 Offering Units sold at an exercise price of $0.55 per share.

 

On November 23, 2016, the Company sold 975,000 2016 Offering Units for gross proceeds of $390,000. The estimated fair value of the warrants included in the 2016 Offering Units sold to the investors was $234,505. Additionally, a warrant to purchase 97,500 shares of common stock was granted to the Placement Agent pursuant to the above pricing terms. The estimated fair value of the warrant granted to the Placement Agent was $23,451. The Placement agent was paid commissions and an expense allowance of $50,700. Other costs of the placement were $156,896.

 

 
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Stock Options

 

On September 12, 2014, the Board of Directors adopted the 2014 Stock Incentive Plan (the “2014 Plan”) and reserved 13,000,000 shares of common stock for issuance to employees, directors and consultants. On September 12, 2014, the stockholders approved the plan. Pursuant to the 2014 Plan, the Board of Directors (or committees and/or executive officers delegated by the Board of Directors) may grant stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards and cash-based awards. As of December 31, 2016, there were options to purchase an aggregate of 8,732,770 shares of common stock outstanding under the 2014 Plan and 4,267,230 shares available for future grants.

 

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Due to its limited operating history and limited number of sales of its Common Stock, the Company estimated its volatility in consideration of a number of factors including the volatility of comparable public companies. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the consolidated financial statements, to estimate option exercises and employee terminations within the valuation model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term.

 

A summary of option activity under the 2014 Plan as of December 31, 2016 and the changes during the three months then ended is presented below:

 

Options

 

Shares

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value

 

Outstanding at October 1, 2016

 

 

8,732,770

 

 

$ 0.54

 

 

8.59 years

 

$ 1,355,924

 

Granted

 

 

 

 

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding at December 31, 2016

 

 

8,732,770

 

 

$ 0.54

 

 

8.34 years

 

$ 468,958

 

Exercisable at December 31, 2016

 

 

5,286,654

 

 

$ 0.45

 

 

7.91 years

 

$ 336,484

 

 

Stock-based compensation expense for the three months ended December 31, 2016 and 2015 was $241,514 and $121,299, respectively.

 

At December 31, 2016, unrecognized total compensation cost related to unvested awards of $1,145,334 is expected to be recognized over a weighted average period of 1.58 years.

 

Warrants

 

The Company has reserved 19,131,595 shares of common stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at December 31, 2016:

 

Exercise price

Number

Expiration Dates

Investor Warrants

$

0.60

3,400,067

September 12, 2019

Placement Agent Unit Warrants

0.60

680,013

September 12, 2019

Warrants underlying Placement Agent

Unit Warrants

0.60

680,013

September 12, 2019

Placement Agent Share Warrants

0.60

1,000,000

September 12, 2019

Investor Warrants

0.60

2,145,371

March 19, 2020 – June 26, 2020

Investor Warrants

0.60

891,666

July 2, 2020 – September 14, 2020

Investor Warrants

0.60

583,334

November 5, 2020 – November 20, 2020

Investor Warrants

0.60

2,133,334

(1)

January 7, 2021 – March 21, 2021

Investor Warrants

0.60

1,900,000

(1)

April 15, 2021 – April 25, 2021

LMB Warrants

0.41

1,352,266

June 12, 2019 - March 2, 2021

LMB Warrants

0.66

122,319

September 30, 2019 - January 8, 2020

LMB Warrants

1.38

265,814

November 3, 2019 - March 6, 2020

LMB Warrants

0.50

1,108,249

August 18, 2020 – March 14, 2021

LMB Warrants

0.91

796,649

March 24, 2022 – April 29, 2022

Financial Advisor Warrants

0.20

1,000,000

August 15, 2021

2016 Offering Warrants

0.55

975,000

November 23, 2021

2016 Offering Placement Agent Warrants

0.55

97,500

November 23, 2021

19,131,595

__________

(1) Fair value of these warrants are included in the derivative warrant liability

 

 
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On November 23, 2016, the Company sold 975,000 2016 Offering Units, at a price of $0.40 per Unit, consisting of (i) one share of common stock and (ii) a warrant to purchase one share of common stock. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance. Additionally, a warrant to purchase 97,500 shares of common stock was granted to the Placement Agent pursuant to the above pricing terms.

 

At December 31, 2016, the weighted average remaining life of all of the outstanding warrants is 3.59 years, all warrants are exercisable, and the aggregate intrinsic value for the warrants outstanding was $280,568.

 

7. RELATED PARTY TRANSACTIONS

 

As of December 31, 2016 and September 30, 2016, the Company owed $27,637 to a company affiliated through common ownership for the expenses the related party paid on the Company’s behalf and services performed by the related party.

 

Our Chairman of the Board, Leonard Mazur, is the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products (see Note 3).

 

Our Chairman of the Board, Leonard Mazur, and our Chief Executive Officer, Myron Holubiak, were co-founders and significant shareholders in LMB. In connection with the acquisition of LMB, our Chairman purchased an additional 5,000,000 shares of the Company.

 

The Company has outstanding debt due to Leonard Mazur and Myron Holubiak (see Note 4).

 

General and administrative expense for each of the three months ended December 31, 2016 and 2015 includes $12,000 paid to a financial consultant who is a stockholder of the Company.

 

8. OPERATING LEASE

 

LMB leases office space from Akrimax (see Note 7) in Cranford, New Jersey at a monthly rental rate of $2,167 pursuant to an agreement which currently expires on October 31, 2017. Rent expense for the three months ended December 31, 2016 was $6,501. There was no rent expense for the three months ended December 31, 2015.

 

9. SUBSEQUENT EVENTS

 

During January 2017, the Company issued additional demand notes to its Chairman in the aggregate amount of $260,000 under the same terms as the notes issued during the three months ending December 31, 2016.

 

During January 2017, the Company issued 445,932 shares of its common stock for investor relations services.

 

During February 2017, the Company sold an additional 399,750 Offering Units for gross proceeds of $159,900. Additionally, a warrant to purchase 39,975 shares of common stock was granted to the Placement Agent pursuant to the 2016 Offering pricing terms.

  

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

 

The following discussion and analysis of our financial condition and results of operations for the three months ended December 31, 2016 should be read together with our unaudited consolidated financial statements and related notes included elsewhere in this report and in conjunction with the audited financial statements of Citius Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2016. The following discussion contains “forward-looking statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that assumptions, expectations, projections, intentions or beliefs about future events may, and often do, vary from actual results and the differences can be material. Please see “Cautionary Note Regarding Forward-Looking Statements.”

 

Historical Background

 

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting unmet needs with a focus on anti-infectives, cancer care and unique prescription products. On September 12, 2014, we acquired Citius Pharmaceuticals, LLC as a wholly-owned subsidiary.

 

Citius Pharmaceuticals, LLC was founded in Massachusetts in January 2007. Activities since Citius Pharmaceuticals, LLC’s inception through December 31, 2016 were devoted primarily to the development and commercialization of therapeutic products for large and growing markets using innovative patented or proprietary formulations and novel drug delivery technology.

 

On March 30, 2016, the Company acquired all of the outstanding stock of Leonard-Meron Biosciences, Inc. (“LMB”) by issuing 29,136,839 shares of its common stock. As of March 30, 2016, the stockholders of LMB received approximately 41% of the issued and outstanding common stock of the Company. In addition, the Company converted the outstanding common stock warrants of LMB into 3,645,297 common stock warrants of the Company and converted the outstanding common stock options of LMB into 1,158,770 common stock options of the Company. Management estimated the fair value of the purchase consideration to be $19,015,073.

 

In connection with the acquisition, the Company acquired net assets of $17,428,277, including identifiable intangible assets of $19,400,000 related to in-process research and development and other assets and liabilities. The Company recorded goodwill of $1,586,796 for the excess of the purchase price over the net assets acquired.

 

In-process research and development represents the value of LMB’s leading drug candidate, which is an antibiotic solution used to treat catheter-related bloodstream infections. Goodwill represents the value of LMB’s industry relationships and its assembled workforce. In-process research and development is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill will not be amortized, but will be tested at least annually for impairment.

 

Through December 31, 2016, the Company has devoted substantially all of its efforts to product development, raising capital, building infrastructure through strategic alliances and coordinating activities relating to its first commercial product Suprenza. On July 1, 2016, the Company announced that it was discontinuing Suprenza and was focusing on the Phase 3 development of Mino-Lok™, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, and the Phase 2b development of Hydro-Lido for hemorrhoids. The Company has not yet realized any revenues from its planned principal operations.

 

Patent and Technology License Agreement

 

In May 2014, LMB entered into a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc., (“NAT”) to develop and commercialize Mino-Lok™ on an exclusive, worldwide (except for South America), sub licensable basis. Since May 2014, LMB has paid an annual maintenance fee of $30,000 that increases over five years to $90,000, until commercial sales of a product subject to the license. LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low-single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to $1,050,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees.

 

 
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RESULTS OF OPERATIONS

 

Three months ended December 31, 2016 compared with the three months ended December 31, 2015

 

 

 

Three Months

Ended

December 31,

2016

 

 

Three Months

Ended

December 31,

2015

 

Revenues

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

1,411,159

 

 

 

829,156

 

General and administrative

 

 

1,132,183

 

 

 

294,221

 

Stock-based compensation

 

 

241,514

 

 

 

121,299

 

Total operating expenses

 

 

2,784,856

 

 

 

1,244,676

 

Operating loss

 

 

(2,784,856 )

 

 

(1,244,676 )

Interest income

 

 

 

 

 

15

 

Gain on revaluation of derivative warrant liability

 

 

622,186

 

 

 

23,940

 

Interest expense

 

 

(13,228 )

 

 

 

Net loss

 

$ (2,175,898 )

 

$ (1,220,721 )

 

Revenues

 

We did not generate any revenues for the three months ended December 31, 2016 and 2015.

 

Research and Development Expenses

 

For the three months ended December 31, 2016, research and development expenses were $1,411,159 as compared to $829,156 during the three months ended December 31, 2015. The $582,003 increase in 2016 was primarily due to the $1,343,635 in costs incurred by LMB on the development of Mino-Lok™ offset by a decrease of $761,632 in costs incurred in the development of our product for the treatment of hemorrhoids and costs related to Suprenza. We are actively seeking to raise additional capital in order to fund our research and development efforts.

 

General and Administrative Expenses

 

For the three months ended December 31, 2016, general and administrative expenses were $1,132,183 as compared to $294,221 during the three months ended December 31, 2015. The $837,962 increase in 2016 was primarily due to the acquisition of LMB which resulted in increased compensation costs, increased consulting fees incurred for financing activities and corporate development services, and increased investor relations fees.

 

Stock-based Compensation Expense

 

For the three months ended December 31, 2016, stock-based compensation expense was $241,514 as compared to $121,299 for the three months ended December 31, 2015. The $120,215 increase in expense includes the expense for options assumed in the acquisition of LMB, as well as recent grants to new directors and new employees.

 

Other Income (Expense)

 

There was no interest income earned on our cash balances for the three months ended December 31, 2016 and only $15 in interest income earned for the three months ended December 31, 2015.

 

Gain on revaluation of derivative warrant liability for the three months ended December 31, 2016 was $622,186 compared to $23,940 for the three months ended December 31, 2015. The fair value of the derivative warrant liability fluctuates with changes in our stock price, volatility, remaining lives of the warrants, and interest rates. The gain for the three months ended December 31, 2016 was primarily due to a decrease in the fair value of our stock from $0.63 per share at September 30, 2016 to $0.44 per share at December 31, 2016.

 

Interest expense on the notes payables acquired in the acquisition of LMB and recent borrowings from our Chairman was $13,228 for the three months ended December 31, 2016. There was no interest expense for the three months ended December 31, 2015.

 

 
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Net Loss

 

For the three months ended December 31, 2016, we incurred a net loss of $2,175,898 compared to a net loss for the three months ended December 31, 2015 of $1,220,721. The $955,177 increase in the net loss was primarily due to the $582,003 increase in research and development expenses and the increase of $837,962 in general and administrative expenses offset by the $598,246 increase in the gain on the revaluation of derivative warrant liability.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Going Concern Uncertainty and Working Capital

 

Citius has incurred operating losses since inception and incurred a net loss of $2,175,898 for the three months ended December 31, 2016. At December 31, 2016, Citius had an accumulated deficit of $19,512,145. Citius’ net cash used in operations during the three months ended December 31, 2016 was $1,314,792.

 

As of December 31, 2016, Citius had a working capital deficit of $5,828,421. The working capital deficit was attributable to the operating losses incurred by the Company since inception offset by our capital raising activities. At December 31, 2016, Citius had cash and cash equivalents of $46,764 available to fund its operations. The Company’s primary sources of cash flow since inception have been from financing activities. During the three months ended December 31, 2016, the Company received net proceeds of $247,205 from the issuance of equity and $820,000 from the issuance of notes payable to our Chairman, Leonard Mazur. Our primary uses of operating cash were for product development and commercialization activities, regulatory expenses, employee compensation, consulting fees, legal and accounting fees, insurance and travel expenses.

 

On September 7, 2016, the Company issued a $500,000 demand promissory note to our Chairman, Leonard Mazur which matures on demand by the lender. The Company issued $820,000 of additional demand promissory notes to Leonard Mazur during the three months ended December 31, 2016 which mature on the earlier of December 31, 2017 or demand by the lender. These notes accrue interest at the prime rate plus 1%. The Board of Directors has authorized additional revolving demand promissory notes with Leonard Mazur on substantially similar terms in an aggregate principal amount of up to $2,500,000, of which $1,320,000 is outstanding at December 31, 2016.

 

In October 2016, the Company commenced an offering (the “2016 Offering”) of up to 15,000,000 units at a price of $0.40 (the “2016 Offering Units”), each 2016 Offering Unit consists of (i) one share of common stock and (ii) a warrant to purchase one share of common stock (the “2016 Offering Warrants”) for gross proceeds of up to $6,000,000 with an over-subscription allotment of up to $2,000,000. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance. The Placement Agent will receive a 10% cash commission on the gross proceeds of each sale of the 2016 Offering Units. In addition, on each closing the Placement Agent will also receive (i) an expense allowance equal to 3% of the proceeds of the sale, and (ii) warrants to purchase a number of shares of common stock equal to 10% of the 2016 Offering Units sold at an exercise price of $0.55 per share.

 

On November 23, 2016, the Company sold 975,000 2016 Offering Units for gross proceeds of $390,000. Additionally, a warrant to purchase 97,500 shares of common stock was granted to the Placement Agent pursuant to the above pricing terms. The Placement agent was paid commissions and an expense allowance of $50,700. Other costs of the placement were $156,896.

 

We expect that we will have sufficient funds to continue our operations for the next three months. We plan to raise additional capital in the future to support our operations. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in a timely manner to fully support our operations.

 

Inflation

 

Our management believes that inflation has not had a material effect on our results of operations.

 

Off Balance Sheet Arrangements

 

We do not have any off balance sheet arrangements.

 

 
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Critical Accounting Policies and Estimates

 

The preparation of our financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities as of the date of the financial statements and the amounts of revenues and expenses recorded during the reporting periods. We base our estimates on historical experience, where applicable and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from our estimates under different assumptions or conditions.

 

Our critical accounting policies and use of estimates are discussed in, and should be read in conjunction with, the annual consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2016 as filed with the SEC.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the specified time periods and accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding disclosure.

 

Our Chief Executive Officer and Principal Financial Officer (“CEO”), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of December 31, 2016. In designing and evaluating disclosure controls and procedures, we recognize that any disclosure controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objective. As of December 31, 2016, based on the evaluation of these disclosure controls and procedures, and in light of the material weaknesses found in our internal controls, the CEO concluded that our disclosure controls and procedures were not effective. In our assessment of the effectiveness of internal control over financial reporting as of December 31, 2016, we determined that control deficiencies existed that constituted material weaknesses, as described below:

 

 

1) lack of documented policies and procedures;

 

 

 

 

2) the financial reporting function is carried out by consultants; and

 

 

 

 

3) ineffective separation of duties due to limited staff.

 

In light of the conclusion that our internal controls over financial reporting were ineffective as of December 31, 2016, we have applied procedures and processes as necessary to ensure the reliability of our financial reporting in regards to this quarterly report on Form 10-Q. Accordingly, the Company believes, based on its knowledge, that: (i) 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 they were made, not misleading with respect to the periods covered by this report; and (ii) the financial statements, and other financial information included in this quarterly report, fairly present in all material respects our financial condition, results of operations and cash flows as of and for the periods presented in this quarterly report.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2016 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 
18
Table of Contents

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

There has been no change in the Company’s risk factors since the Company’s Form 10-K filed with the SEC on December 23, 2016.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

On November 23, 2016, the Company sold 975,000 2016 Offering Units for a purchase price of $0.40 per unit for gross proceeds of $390,000.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

 
19
Table of Contents

 

Item 6. Exhibits

 

All references to registrant’s Forms 8-K, 10-K and 10-Q include reference to File No. 333-170781

 

31.1

Certification of the Principal Executive and Financial Officer pursuant to Exchange Act Rule 13a-14(a).*

32.1

Certification of the Principal Executive and Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.*

 

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XBRL INSTANCE DOCUMENT

 

 

 

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XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT

 

 

 

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XBRL TAXONOMY EXTENSION CALCULATION LINKBASE

 

 

 

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XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

 

 

 

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XBRL TAXONOMY EXTENSION LABELS LINKBASE

 

 

 

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XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

_______ 

* Filed herewith.

 

 
20
Table of Contents

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

CITIUS PHARMACEUTICALS, INC.

Date: February 14, 2017

By:

/s/ Myron Holubiak

Myron Holubiak

Chief Executive Officer,

Principal Executive Officer and Principal Financial Officer

 

 

21

 

EX-31.1 2 ctxr_311.htm CERTIFICATION ctxr_311.htm

EXHIBIT 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE

SARBANES-OXLEY ACT OF 2002

 

I, Myron Holubiak, certify that:

 

1.

I have reviewed this report on Form 10-Q of Citius Pharmaceuticals, Inc.;

2.

Based on my knowledge, this 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 report;

3.

Based on my knowledge, the financial statements, and other financial information included in this 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 report;

4.

The registrant’s other certifying officer(s) 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 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 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 control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the 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: February 14, 2017

By:

/s/ Myron Holubiak

Myron Holubiak

Chief Executive Officer,

Principal Executive Officer and Principal Financial Officer


 

EX-32.1 3 ctxr_321.htm CERTIFICATION ctxr_321.htm

EXHIBIT 32.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Citius Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended December 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Myron Holubiak, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(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.

 

Date: February 14, 2017

By:

/s/ Myron Holubiak

Myron Holubiak

Chief Executive Officer,

Principal Executive Officer and Principal Financial Officer

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Document and Entity Information - shares
3 Months Ended
Dec. 31, 2016
Jan. 31, 2017
Document And Entity Information    
Entity Registrant Name Citius Pharmaceuticals, Inc.  
Entity Central Index Key 0001506251  
Document Type 10-Q  
Document Period End Date Dec. 31, 2016  
Amendment Flag false  
Current Fiscal Year End Date --09-30  
Is Entity a Well-known Seasoned Issuer? No  
Is Entity a Voluntary Filer? No  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   74,558,992
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2017  
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CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
Dec. 31, 2016
Sep. 30, 2016
Current Assets    
Cash and cash equivalents $ 46,764 $ 294,351
Prepaid expenses 443,526 598,484
Total Current Assets 490,290 892,835
Property and Equipment, Net of Accumulated Depreciation of $5,452 and $4,780 3,070 3,742
Other Assets    
Deposits 2,167 2,167
Deferred offering costs 64,801
In-process research and development 19,400,000 19,400,000
Goodwill 1,586,796 1,586,796
Total Other Assets 20,988,963 21,053,764
Total Assets 21,482,323 21,950,341
Current liabilities:    
Accounts payable 985,865 909,156
Accrued expenses 1,847,062 958,101
Accrued compensation 1,010,500 903,250
Accrued interest 44,099 30,871
Notes payable - related parties 1,492,970 672,970
Derivative warrant liability 910,578 1,681,973
Due to related party 27,637 27,637
Total Current Liabilities 6,318,711 5,183,958
Commitments and contingencies
Stockholders' Equity    
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Common stock - $0.001 par value; 200,000,000 shares authorized; 74,113,060 and 73,138,060 shares issued and outstanding at December 31, 2016 and September 30, 2016, 74,113 73,138
Additional paid-in capital 34,601,644 34,029,492
Accumulated deficit (19,512,145) (17,336,247)
Total Stockholders' Equity 15,163,612 16,766,383
Total Liabilities and Stockholders' Equity $ 21,482,323 $ 21,950,341
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Dec. 31, 2016
Sep. 30, 2016
ASSETS    
Property and Equipment, Net of Accumulated Depreciation $ 5,452 $ 4,780
Stockholders' Equity (Deficit)    
Preferred Stock Par Value $ 0.001 $ 0.001
Preferred Stock Shares Authorized 10,000,000 10,000,000
Preferred Stock Shares Issued 0 0
Preferred Stock Shares Outstanding 0 0
Common Stock Par Value $ 0.001 $ 0.001
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Condensed Consolidated Statements Of Operations    
Revenues
Operating Expenses    
Research and development 1,411,159 829,156
General and administrative 1,132,183 294,221
Stock-based compensation - general and administrative 241,514 121,299
Total Operating Expenses 2,784,856 1,244,676
Operating Loss (2,784,856) (1,244,676)
Other Income (Expense), Net:    
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Gain on revaluation of derivative warrant liability 622,186 23,940
Interest expense (13,228)
Total Other Income (Expense), Net 608,958 23,955
Loss before Income Taxes (2,175,898) (1,220,721)
Income tax benefit
Net Loss $ (2,175,898) $ (1,220,721)
Net Loss Per Share - Basic and Diluted $ (0.03) $ (0.04)
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CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' DEFICIT (Unaudited) - 3 months ended Dec. 31, 2016 - USD ($)
Preferred Stock
Common Stock
Additional Paid-In Capital
Accumulated Deficit
Total
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Beginning balance, Shares at Sep. 30, 2016 73,138,060      
Issuance of common stock in private placement, net of costs, Amount $ 975 181,429 182,404
Issuance of common stock in private placement, net of costs, Shares 975,000      
Reclassification of derivative warrant liability to additional paid-in capital 149,209 149,209
Stock-based compensation 241,514 241,514
Net loss (2,175,898) (2,175,898)
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Ending balance, Shares at Dec. 31, 2016 74,113,060      
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Cash Flows From Operating Activities:    
Net loss $ (2,175,898) $ (1,220,721)
Adjustments to reconcile net loss to net cash used in operating activities:    
Gain on revaluation of derivative warrant liability (622,186) (23,940)
Stock-based compensation expense 241,514 121,299
Depreciation 672
Changes in operating assets and liabilities    
Prepaid expenses 154,958
Accounts payable 76,709 (100,464)
Accrued expenses 888,961 526,740
Accrued compensation 107,250
Accrued interest 13,228
Net Cash Used In Operating Activities (1,314,792) (697,086)
Cash Flows From Financing Activities:    
Proceeds from notes payable - related parties 820,000
Net proceeds from private placement 247,205 302,438
Net Cash Provided by Financing Activities 1,067,205 302,438
Net Change in Cash and Cash Equivalents (247,587) (394,648)
Cash and Cash Equivalents - Beginning of Period 294,351 676,137
Cash and Cash Equivalents - End of Period 46,764 281,489
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:    
Interest paid
Income taxes paid
Fair value of private placement warrants recorded as derivative warrant liability 157,984
Reclassification of derivative warrant liability to additional paid-in capital $ 149,209
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NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Business

 

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting unmet needs with a focus on anti-infectives, cancer care and unique prescription products. The Company was founded as Citius Pharmaceuticals, LLC, a Massachusetts limited liability company, on January 23, 2007. On September 12, 2014, Citius Pharmaceuticals, LLC entered into a Share Exchange and Reorganization Agreement with Citius Pharmaceuticals, Inc. (formerly Trail One, Inc.), a publicly traded company incorporated under the laws of the State of Nevada. Citius Pharmaceuticals, LLC became a wholly-owned subsidiary of Citius.

 

On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary (see “Acquisition of Leonard-Meron Biosciences, Inc.” below).

 

The Company had one approved product, Suprenza (phentermine hydrochloride), which it licensed out for promotion in the United States, Canada and Mexico. On July 1, 2016, the Company announced that it was discontinuing Suprenza. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital.

 

Citius is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius or its competitors of research and development stage products, market acceptance of its products, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing and the Company’s compliance with governmental and other regulations.

 

Acquisition of Leonard-Meron Biosciences, Inc.

 

On March 30, 2016, the Company acquired all of the outstanding stock of Leonard-Meron Biosciences, Inc. (“LMB”) by issuing 29,136,839 shares of its common stock. As of March 30, 2016, the stockholders of LMB received approximately 41% of the issued and outstanding common stock of the Company. In addition, the Company converted the outstanding common stock warrants of LMB into 3,645,297 common stock warrants of the Company and converted the outstanding common stock options of LMB into 1,158,770 common stock options of the Company.

 

The Company acquired tangible assets consisting of cash of $255,748, prepaid expenses of $20,544, property and equipment of $5,085, deposits of $2,167, and identifiable intangible assets of $19,400,000 related to in-process research and development. The Company assumed accounts payable of $244,776, accrued expenses of $598,659, accrued compensation of $615,000, accrued interest of $23,862, and notes payable of $772,970. Accordingly, the net assets acquired amounted to $17,428,277.

 

The fair value of LMB’s net assets acquired on the date of the acquisition, based on management’s analysis of the fair value of the 29,136,839 shares of the Company’s common stock issued for LMB’s outstanding stock, the 3,645,297 Company common stock warrants issued for LMB’s outstanding common stock warrants, and the vested portion of the 1,158,770 Company common stock options issued for LMB’s outstanding common stock options was $19,015,073. The fair value of the common stock issued was estimated at $17,482,093, the fair value of the warrants issued was estimated at $1,071,172 and the fair value of the vested options was estimated at $461,808.

 

The Company recorded goodwill of $1,586,796 for the excess of the purchase price of $19,015,073 over the net assets acquired of $17,428,277.

 

In-process research and development represents the value of LMB’s leading drug candidate which is an antibiotic solution used to treat catheter-related bloodstream infections (Mino-Lok™) and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment.

 

Unaudited pro forma operating results for the three months ended December 31, 2015, assuming the acquisition of LMB had been made as of October 1, 2015, are as follows:

 

    2015  
Revenues   $  
Net loss   $ (1,640,688 )
Net loss per share – basic and diluted   $ (0.03 )

 

Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Preparation — The accompanying consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., and its wholly-owned subsidiaries, Citius Pharmaceuticals, LLC, and LMB since the March 30, 2016 acquisition. All significant inter-company balances and transactions have been eliminated in consolidation.

 

The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, without being audited, pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments considered necessary to make the financial statements not misleading have been included. Operating results for the three months ended December 31, 2016 are not necessarily indicative of the results that may be expected for the year ending September 30, 2017. The unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2016 filed with the Securities and Exchange Commission.

 

Use of Estimates — Our accounting principles require our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include the accounting for acquisitions, stock-based compensation, valuation of warrants, and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

 

Basic and Diluted Net Loss per Common Share — Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of options, warrants and convertible securities were not included in the calculation of the diluted loss per share because they were anti-dilutive.

 

Recently Issued Accounting Standards

 

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, in an effort to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The amendments of this ASU are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on our consolidated financial statements.

 

In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350). This ASU eliminates step 2 from the goodwill impairment test by comparing the fair value of a reporting unit with the carrying amount of the reporting unit. If the carrying amount exceeds the fair value, an impairment charge for the excess is recorded. The amendments of this ASU are effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the impact of the adoption of this ASU on the consolidated financial statements.

XML 17 R8.htm IDEA: XBRL DOCUMENT v3.6.0.2
GOING CONCERN UNCERTAINTY AND MANAGEMENT'S PLAN
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 2. GOING CONCERN UNCERTAINTY AND MANAGEMENT'S PLAN

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company experienced negative cash flows from operations of $1,314,792 and $697,086 for the three months ended December 31, 2016 and 2015, respectively. At December 31, 2016, the Company had a working capital deficit of $5,828,421. The Company has no revenue and has relied on proceeds from equity transactions and debt to finance its operations. At December 31, 2016, the Company had limited capital to fund its operations. This raises substantial doubt about the Company’s ability to continue as a going concern.

 

The Company plans to raise capital through equity financings from outside investors as well as raise additional funds from existing investors and continued borrowings under related party debt agreements. There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to the Company.

 

The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of the above uncertainty.

XML 18 R9.htm IDEA: XBRL DOCUMENT v3.6.0.2
BUSINESS AGREEMENTS
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 3. BUSINESS AGREEMENTS

Alpex Pharma S.A.

 

On June 12, 2008, the Company entered into a collaboration and license agreement (the “Alpex Agreement”) with Alpex Pharma S.A. (“Alpex”), in which Alpex granted the Company an exclusive right and license to use certain Alpex intellectual property in order to develop and commercialize orally disintegrating tablet formulations of pharmaceutical products in United States, Canada and Mexico. In addition, Alpex manufactures Suprenza, the Company’s commercialized pharmaceutical product, on a contract basis. The agreement was amended on November 15, 2011 as part of an Amendment and Coordination Agreement (see the “Three-Party Agreement” below).

 

Under the terms of the Alpex Agreement, as amended by the Three-Party Agreement dated November 15, 2011 (see below), Alpex is entitled to a payment per tablet manufactured and a percentage of all milestone, royalty and other payments received by the Company from Prenzamax, LLC, pursuant to a sublicense agreement (see below). In addition, under the terms of the Alpex Agreement, Alpex retained the right to use the clinical data generated by the Company to file for regulatory approval and market Suprenza in the rest of the world. In the event that Alpex has such sales, Alpex will pay the Company a percentage royalty on net sales, as defined (“Alpex Revenue”). No milestone, royalty or other payments were earned or received by the Company except for the reimbursement of certain regulatory fees under the Three-Party Agreement.

 

On July 1, 2016, the Company announced that it notified the Food and Drug Administration (“FDA”) and Alpex that it was discontinuing Suprenza.

 

Prenzamax, LLC

 

On November 15, 2011, the Company entered into an exclusive license agreement (the “Sublicense Agreement”) with Prenzamax, LLC (“Prenzamax”), in which the Company granted Prenzamax and its affiliates the exclusive right to commercialize Suprenza in the United States. Prenzamax is an affiliate of Akrimax, a related party (see Note 7) and was formed for the specific purpose of managing the Sublicense Agreement. Under the terms of the Sublicense Agreement, Prenzamax is to pay the Company a percentage of the product’s EBITDA, as defined (“Profit Share Payments”). In addition, Prenzamax is to reimburse the Company directly for certain development costs. These payments are to commence once Prenzamax has achieved profitability, as defined in the Sublicense Agreement. Further, under the terms of the Sublicense Agreement, Prenzamax is required to share in the royalty payment due to Alpex under the Alpex Agreement. In addition, Prenzamax is entitled to a percentage of the Alpex Revenue received by the Company. The Company has not been reimbursed for any development costs nor has it earned any Profit Share Payments.

 

On July 1, 2016, the Company announced that it notified Prenzamax that it was discontinuing Suprenza.

 

Three-Party Agreement

 

On November 15, 2011, the Company, Alpex and Prenzamax entered into the Three-Party Agreement wherein the terms of the Alpex Agreement were modified and Prenzamax and the Company agreed to each pay a portion of certain regulatory filing fees for as long as Prenzamax is purchasing Suprenza from Alpex pursuant to the Three-Party Agreement. During the three months ended March 31, 2016, the Company received $292,575 from Alpex as reimbursement for regulatory filing fees that were previously expensed during the three months ended December 31, 2015. The reimbursement was recorded as a reduction of research and development expenses.

 

On July 1, 2016, the Company announced that it notified Alpex and Prenzamax that it was discontinuing Suprenza.

 

Patent and Technology License Agreement

 

LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc., (“NAT”) to develop and commercialize Mino-Lok™ on an exclusive, worldwide (except for South America), sub licensable basis. Since May 2014, LMB has paid an annual maintenance fee of $30,000 that increases over five years to $90,000, until commercial sales of a product subject to the license. LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low-single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to $1,050,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees.

XML 19 R10.htm IDEA: XBRL DOCUMENT v3.6.0.2
NOTES PAYABLE RELATED PARTIES
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 4. NOTES PAYABLE RELATED PARTIES

On March 30, 2016, the Company assumed $772,970 of demand notes payable in the acquisition of LMB. The principal balance of the notes payable to our Chairman, Leonard Mazur, was $760,470 and the principal balance of the notes payable to our Chief Executive Officer, Myron Holubiak, was $12,500. Notes with a principal balance of $704,000 accrue interest at the prime rate plus 1.0% per annum and notes with a principal balance of $68,970 accrue interest at 12% per annum. In April 2016, $600,000 of the prime rate plus 1.0% demand notes payable and accrued interest of $1,985 was repaid to Leonard Mazur.

 

The Board of Directors has authorized revolving demand promissory notes with Leonard Mazur in an aggregate principal amount of up to $2,500,000, of which $1,320,000 is outstanding at December 31, 2016.

 

On September 7, 2016, the Company issued a $500,000 demand promissory note to our Chairman, Leonard Mazur which matures on demand by the lender. The Company then issued $820,000 of additional demand promissory notes to Leonard Mazur during the three months ended December 31, 2016 which mature on the earlier of December 31, 2017 or demand by the lender. These notes accrue interest at the prime rate plus 1%.

 

Interest expense on notes payable – related parties was $13,228 for the three months ended December 31, 2016.

XML 20 R11.htm IDEA: XBRL DOCUMENT v3.6.0.2
DERIVATIVE WARRANT LIABILITY
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 5. DERIVATIVE WARRANT LIABILITY

Derivative financial instruments are recognized as a liability on the consolidated balance sheet and measured at fair value. At December 31, 2016 and September 30, 2016, the Company had outstanding warrants to purchase 4,033,334 shares and 4,616,668 shares, respectively, of its common stock that are considered to be derivative instruments since the agreements contain “down round” provisions whereby the exercise price of the warrants is subject to adjustment in the event that the Company issues common stock for less than $0.60 per share within one-year of the original issuance of the warrants (see Note 6).

 

The Company performs valuations of the warrants using the Black-Scholes option pricing model which value was also compared to a Binomial Option Pricing Model for reasonableness. The Black-Scholes option pricing model requires input of assumptions including the risk-free interest rates, volatility, expected life and dividends. Selection of these inputs involves management’s judgment and may impact net loss. Due to our limited operating history and limited number of sales of our common stock, we estimate our volatility based on a number of factors including the volatility of comparable publicly traded pharmaceutical companies. The volatility factor used in the Black-Scholes option pricing model has a significant effect on the resulting valuation of the derivative liabilities on our balance sheet. The volatility calculated at December 31, 2016 was 76%. We used a risk-free interest rate of 1.93%, estimated lives of 4.02 to 4.32 years, which are the remaining contractual lives of the warrants subject to “down round” provisions, and no dividends to our common stock. The volatility calculated at September 30, 2016 was 73%. We used a risk-free interest rate of 1.14%, estimated lives of 4.10 to 4.57 years, which are the remaining contractual lives of the warrants subject to “down round” provisions, and no dividends to our common stock.

 

During the three months ended December 31, 2016, anti-dilution rights related to warrants to purchase 583,334 shares of common stock expired which resulted in a reclassification from derivative warrant liability to additional paid-in capital of $149,209.

 

The table below presents the changes in the derivative warrant liability, which is measured at fair value on a recurring basis and classified as Level 3 in the fair value hierarchy:

 

   

Three Months

Ended

December 31,

2016

   

Three Months

Ended

December 31,

2015

 
Derivative warrant liability, beginning of period   $ 1,681,973     $ 738,955  
Fair value of warrants issued           157,984  
Total realized/unrealized gains included in net loss     (622,186 )     (23,940 )
Reclassification of liability to additional paid-in capital     (149,209 )      
Derivative warrant liability, end of period   $ 910,578     $ 872,999  

XML 21 R12.htm IDEA: XBRL DOCUMENT v3.6.0.2
COMMON STOCK, STOCK OPTIONS AND WARRANTS
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 6. COMMON STOCK, STOCK OPTIONS AND WARRANTS

Common Stock

 

On September 15, 2016, the stockholders approved an increase in the number of shares of authorized common stock from 90,000,000 shares to 200,000,000 shares. In addition, the stockholders granted the Board of Directors the authority to affect a reverse stock split of our common stock by a ratio of not less than 1-for-8 and not more than 1-for-20 at any time prior to September 15, 2017.

 

Private Offerings

 

On September 12, 2014, the Company sold 3,400,067 Units for a purchase price of $0.60 per Unit for gross proceeds of $2,040,040. Each Unit consists of one share of common stock and one five-year warrant (the “Investor Warrants”) to purchase one share of common stock at an exercise price of $0.60 (the “Private Offering”). The Investor Warrants will be redeemable by the Company at a price of $0.001 per Investor Warrant at any time subject to the conditions that (i) the common stock has traded for twenty (20) consecutive trading days with a closing price of at least $1.50 per share with an average trading volume of 50,000 shares per day and (ii) the Company provides 20 trading days prior notice of the redemption and the closing price of the common stock is not less than $1.17 for more than any 3 days during such notice period and (iii) the underlying shares of common stock are registered.

 

The Company issued the Placement Agent and their designees five-year warrants (the “Placement Agent Unit Warrants”) to purchase 680,013 Units at an exercise price of $0.60 per Unit. The Placement Agent Unit Warrants are exercisable on a cash or cashless basis with respect to purchase of the Units, and will be exercisable only for cash with respect to warrants received as part of the Units.

 

In addition, the Placement Agent was issued warrants to purchase 1,000,000 shares of common stock exercisable for cash at $0.60 per share for investment banking services provided in connection with the transaction (the “Placement Agent Share Warrants”).

 

In connection with the Private Offering, the Company entered into a Registration Rights Agreement pursuant to which the Company filed a registration statement, registering for resale all shares of common stock (i) included in the Units; and (ii) issuable upon exercise of the Investor Warrants. The Company filed the Registration Statement on September 11, 2015 and it was declared effective on January 21, 2016.

 

During the year ended September 30, 2015, the Company sold an additional 2,837,037 Units for a purchase price of $0.54 per Unit and 200,000 Units for a purchase price of $0.60 per Unit for gross proceeds of $1,652,000. Each Unit consists of one share of common stock and one Investor Warrant (see description above).

 

During the year ended September 30, 2016, the Company sold an additional 4,350,001 Units for a purchase price of $0.54 per Unit and 266,667 Units for a purchase price of $0.60 per Unit for gross proceeds of $2,509,000. Each Unit consists of one share of common stock and one Investor Warrant (see description above). On May 12, 2016, the Company announced that it had completed the final phase of the Private Offering.

 

On March 22, 2016, the Company sold 5,000,000 shares of common stock at $0.60 per share to its Chairman of the Board, Leonard Mazur, for gross proceeds of $3,000,000. There were no expenses related to this placement.

 

In October 2016, the Company commenced an offering (the “2016 Offering”) of up to 15,000,000 Units at a price of $0.40 per Unit (the “2016 Offering Units”), each 2016 Offering Unit consists of (i) one share of common stock and (ii) a warrant to purchase one share of common stock (the “2016 Offering Warrants”) for gross proceeds of up to $6,000,000 with an over-subscription allotment of up to $2,000,000. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance. The Placement Agent will receive a 10% cash commission on the gross proceeds of each sale of the 2016 Offering Units. In addition, on each closing the Placement Agent will also receive (i) an expense allowance equal to 3% of the proceeds of the sale, and (ii) warrants to purchase a number of shares of common stock equal to 10% of the 2016 Offering Units sold at an exercise price of $0.55 per share.

 

On November 23, 2016, the Company sold 975,000 2016 Offering Units for gross proceeds of $390,000. The estimated fair value of the warrants included in the 2016 Offering Units sold to the investors was $234,505. Additionally, a warrant to purchase 97,500 shares of common stock was granted to the Placement Agent pursuant to the above pricing terms. The estimated fair value of the warrant granted to the Placement Agent was $23,451. The Placement agent was paid commissions and an expense allowance of $50,700. Other costs of the placement were $156,896.

 

Stock Options

 

On September 12, 2014, the Board of Directors adopted the 2014 Stock Incentive Plan (the “2014 Plan”) and reserved 13,000,000 shares of common stock for issuance to employees, directors and consultants. On September 12, 2014, the stockholders approved the plan. Pursuant to the 2014 Plan, the Board of Directors (or committees and/or executive officers delegated by the Board of Directors) may grant stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards and cash-based awards. As of December 31, 2016, there were options to purchase an aggregate of 8,732,770 shares of common stock outstanding under the 2014 Plan and 4,267,230 shares available for future grants.

 

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Due to its limited operating history and limited number of sales of its Common Stock, the Company estimated its volatility in consideration of a number of factors including the volatility of comparable public companies. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the consolidated financial statements, to estimate option exercises and employee terminations within the valuation model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term.

 

A summary of option activity under the 2014 Plan as of December 31, 2016 and the changes during the three months then ended is presented below:

 

Options   Shares    

Weighted-

Average

Exercise

Price

   

Weighted-

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value

 
Outstanding at October 1, 2016     8,732,770     $ 0.54     8.59 years   $ 1,355,924  
Granted                        
Exercised                        
Forfeited or expired                        
Outstanding at December 31, 2016     8,732,770     $ 0.54     8.34 years   $ 468,958  
Exercisable at December 31, 2016     5,286,654     $ 0.45     7.91 years   $ 336,484  

 

Stock-based compensation expense for the three months ended December 31, 2016 and 2015 was $241,514 and $121,299, respectively.

 

At December 31, 2016, unrecognized total compensation cost related to unvested awards of $1,145,334 is expected to be recognized over a weighted average period of 1.58 years.

 

Warrants

 

The Company has reserved 19,131,595 shares of common stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at December 31, 2016:

 

  Exercise price     Number   Expiration Dates  
Investor Warrants $ 0.60     3,400,067   September 12, 2019  
Placement Agent Unit Warrants   0.60     680,013   September 12, 2019  

Warrants underlying Placement Agent

Unit Warrants

  0.60     680,013   September 12, 2019  
Placement Agent Share Warrants   0.60     1,000,000   September 12, 2019  
Investor Warrants   0.60     2,145,371   March 19, 2020 – June 26, 2020  
Investor Warrants   0.60     891,666   July 2, 2020 – September 14, 2020  
Investor Warrants   0.60     583,334   November 5, 2020 – November 20, 2020  
Investor Warrants   0.60     2,133,334 (1) January 7, 2021 – March 21, 2021  
Investor Warrants   0.60     1,900,000 (1) April 15, 2021 – April 25, 2021  
LMB Warrants   0.41     1,352,266   June 12, 2019 - March 2, 2021  
LMB Warrants   0.66     122,319   September 30, 2019 - January 8, 2020  
LMB Warrants   1.38     265,814   November 3, 2019 - March 6, 2020  
LMB Warrants   0.50     1,108,249   August 18, 2020 – March 14, 2021  
LMB Warrants   0.91     796,649   March 24, 2022 – April 29, 2022  
Financial Advisor Warrants   0.20     1,000,000   August 15, 2021  
2016 Offering Warrants   0.55     975,000   November 23, 2021  
2016 Offering Placement Agent Warrants   0.55     97,500   November 23, 2021  
          19,131,595      

__________

(1) Fair value of these warrants are included in the derivative warrant liability

 

On November 23, 2016, the Company sold 975,000 2016 Offering Units, at a price of $0.40 per Unit, consisting of (i) one share of common stock and (ii) a warrant to purchase one share of common stock. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance. Additionally, a warrant to purchase 97,500 shares of common stock was granted to the Placement Agent pursuant to the above pricing terms.

 

At December 31, 2016, the weighted average remaining life of all of the outstanding warrants is 3.59 years, all warrants are exercisable, and the aggregate intrinsic value for the warrants outstanding was $280,568.

XML 22 R13.htm IDEA: XBRL DOCUMENT v3.6.0.2
RELATED PARTY TRANSACTIONS
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 7. RELATED PARTY TRANSACTIONS

As of December 31, 2016 and September 30, 2016, the Company owed $27,637 to a company affiliated through common ownership for the expenses the related party paid on the Company’s behalf and services performed by the related party.

 

Our Chairman of the Board, Leonard Mazur, is the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products (see Note 3).

 

Our Chairman of the Board, Leonard Mazur, and our Chief Executive Officer, Myron Holubiak, were co-founders and significant shareholders in LMB. In connection with the acquisition of LMB, our Chairman purchased an additional 5,000,000 shares of the Company.

 

The Company has outstanding debt due to Leonard Mazur and Myron Holubiak (see Note 4).

 

General and administrative expense for each of the three months ended December 31, 2016 and 2015 includes $12,000 paid to a financial consultant who is a stockholder of the Company.

XML 23 R14.htm IDEA: XBRL DOCUMENT v3.6.0.2
OPERATING LEASE
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 8. OPERATING LEASE

LMB leases office space from Akrimax (see Note 7) in Cranford, New Jersey at a monthly rental rate of $2,167 pursuant to an agreement which currently expires on October 31, 2017. Rent expense for the three months ended December 31, 2016 was $6,501. There was no rent expense for the three months ended December 31, 2015.

XML 24 R15.htm IDEA: XBRL DOCUMENT v3.6.0.2
SUBSEQUENT EVENTS
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
NOTE 9. SUBSEQUENT EVENTS

During January 2017, the Company issued additional demand notes to its Chairman in the aggregate amount of $260,000 under the same terms as the notes issued during the three months ending December 31, 2016.

 

During January 2017, the Company issued 445,932 shares of its common stock for investor relations services.

 

During February 2017, the Company sold an additional 399,750 Offering Units for gross proceeds of $159,900. Additionally, a warrant to purchase 39,975 shares of common stock was granted to the Placement Agent pursuant to the 2016 Offering pricing terms. 

XML 25 R16.htm IDEA: XBRL DOCUMENT v3.6.0.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
3 Months Ended
Dec. 31, 2016
Summary Of Significant Accounting Policies Policies  
Basis of Preparation

The accompanying consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., and its wholly-owned subsidiaries, Citius Pharmaceuticals, LLC, and LMB since the March 30, 2016 acquisition. All significant inter-company balances and transactions have been eliminated in consolidation.

 

The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, without being audited, pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments considered necessary to make the financial statements not misleading have been included. Operating results for the three months ended December 31, 2016 are not necessarily indicative of the results that may be expected for the year ending September 30, 2017. The unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2016 filed with the Securities and Exchange Commission.

Use of Estimates

Our accounting principles require our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include the accounting for acquisitions, stock-based compensation, valuation of warrants, and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

Basic and Diluted Net Loss per Common Share

Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of options, warrants and convertible securities were not included in the calculation of the diluted loss per share because they were anti-dilutive.

Recently Issued Accounting Standards

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, in an effort to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The amendments of this ASU are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on our consolidated financial statements.

 

In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350). This ASU eliminates step 2 from the goodwill impairment test by comparing the fair value of a reporting unit with the carrying amount of the reporting unit. If the carrying amount exceeds the fair value, an impairment charge for the excess is recorded. The amendments of this ASU are effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the impact of the adoption of this ASU on the consolidated financial statements.

XML 26 R17.htm IDEA: XBRL DOCUMENT v3.6.0.2
NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
3 Months Ended
Dec. 31, 2016
Nature Of Operations Basis Of Presentation And Summary Of Significant Accounting Policies Tables  
Acquisition Pro forma information

    2015  
Revenues   $  
Net loss   $ (1,640,688 )
Net loss per share – basic and diluted   $ (0.03 )

XML 27 R18.htm IDEA: XBRL DOCUMENT v3.6.0.2
DERIVATIVE WARRANT LIABILITY (Tables)
3 Months Ended
Dec. 31, 2016
Derivative Warrant Liability Tables  
Schedule of derivative warrant liabilities

   

Three Months

Ended

December 31,

2016

   

Three Months

Ended

December 31,

2015

 
Derivative warrant liability, beginning of period   $ 1,681,973     $ 738,955  
Fair value of warrants issued           157,984  
Total realized/unrealized gains included in net loss     (622,186 )     (23,940 )
Reclassification of liability to additional paid-in capital     (149,209 )      
Derivative warrant liability, end of period   $ 910,578     $ 872,999  

XML 28 R19.htm IDEA: XBRL DOCUMENT v3.6.0.2
COMMON STOCK, STOCK OPTIONS AND WARRANTS (Tables)
3 Months Ended
Dec. 31, 2016
Common Stock Stock Options And Warrants Tables  
Schedule of stock option activity

Options   Shares    

Weighted-

Average

Exercise

Price

   

Weighted-

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value

 
Outstanding at October 1, 2016     8,732,770     $ 0.54     8.59 years   $ 1,355,924  
Granted                        
Exercised                        
Forfeited or expired                        
Outstanding at December 31, 2016     8,732,770     $ 0.54     8.34 years   $ 468,958  
Exercisable at December 31, 2016     5,286,654     $ 0.45     7.91 years   $ 336,484  

Schedule of Warrants

  Exercise price     Number   Expiration Dates  
Investor Warrants $ 0.60     3,400,067   September 12, 2019  
Placement Agent Unit Warrants   0.60     680,013   September 12, 2019  

Warrants underlying Placement Agent

Unit Warrants

  0.60     680,013   September 12, 2019  
Placement Agent Share Warrants   0.60     1,000,000   September 12, 2019  
Investor Warrants   0.60     2,145,371   March 19, 2020 – June 26, 2020  
Investor Warrants   0.60     891,666   July 2, 2020 – September 14, 2020  
Investor Warrants   0.60     583,334   November 5, 2020 – November 20, 2020  
Investor Warrants   0.60     2,133,334 (1) January 7, 2021 – March 21, 2021  
Investor Warrants   0.60     1,900,000 (1) April 15, 2021 – April 25, 2021  
LMB Warrants   0.41     1,352,266   June 12, 2019 - March 2, 2021  
LMB Warrants   0.66     122,319   September 30, 2019 - January 8, 2020  
LMB Warrants   1.38     265,814   November 3, 2019 - March 6, 2020  
LMB Warrants   0.50     1,108,249   August 18, 2020 – March 14, 2021  
LMB Warrants   0.91     796,649   March 24, 2022 – April 29, 2022  
Financial Advisor Warrants   0.20     1,000,000   August 15, 2021  
2016 Offering Warrants   0.55     975,000   November 23, 2021  
2016 Offering Placement Agent Warrants   0.55     97,500   November 23, 2021  
          19,131,595      

XML 29 R20.htm IDEA: XBRL DOCUMENT v3.6.0.2
NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details)
3 Months Ended
Dec. 31, 2015
USD ($)
$ / shares
Nature Of Operations Basis Of Presentation And Summary Of Significant Accounting Policies Details  
Revenues
Net loss $ (1,640,688)
Net loss per share – basic and diluted | $ / shares $ (0.03)
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.6.0.2
NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Sep. 30, 2016
Mar. 30, 2016
Common stock shares issued 74,113,060   73,138,060  
Common stock warrants outstanding 74,113,060   73,138,060  
Prepaid expenses $ 443,526   $ 598,484  
Accounts payable 985,865   909,156  
Accrued expenses 1,847,062   958,101  
Accrued interest 44,099   30,871  
Notes payable 1,492,970   672,970  
Common stock options value outstanding 74,113   73,138  
Estimated fair value warrant issued $ 157,984    
Goodwill 1,586,796   $ 1,586,796  
Leonard-Meron Biosciences [Member]        
Common stock shares issued       29,136,839
Issued and outstanding common stock       41.00%
Common stock warrants outstanding       3,645,297
Common stock options outstanding       1,158,770
Tangible assets consisting of cash 255,748      
Prepaid expenses 20,544      
Property and equipment 5,085      
Deposits 2,167      
Intangible assets 19,400,000      
Accounts payable 244,776      
Accrued expenses 598,659      
Accrued compensation 615,000      
Accrued interest 23,862      
Notes payable $ 772,970      
Fair value of common stock shares issued 29,136,839      
Fair value of common stock warrants issued 3,645,297      
Vested portion of common stock options issued 1,158,770      
Common stock options value outstanding $ 19,015,073      
Estimated fair value 17,482,093      
Estimated fair value warrant issued 1,071,172      
Estimated vested options of fair value 461,808      
Goodwill 1,586,796      
Purchase price 19,015,073      
Assets acquired $ 17,428,277      
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.6.0.2
GOING CONCERN UNCERTAINTY AND MANAGEMENT'S PLAN (Details Narrative) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Going Concern Uncertainty And Managements Plan Details Narrative    
Cash flows from operations $ (1,314,792) $ (697,086)
Working capital deficit $ 5,828,421  
XML 32 R23.htm IDEA: XBRL DOCUMENT v3.6.0.2
BUSINESS AGREEMENTS (Details Narrative)
3 Months Ended
Mar. 31, 2016
USD ($)
Business Agreements Details Narrative  
Reimbursement $ 292,575
License annual maintenance fee 30,000
Increase in annual maintenance fee 90,000
Payable amount to NAT $ 1,050,000
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.6.0.2
NOTES PAYABLE RELATED PARTIES (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Apr. 30, 2016
Mar. 30, 2016
Dec. 31, 2016
Dec. 31, 2015
Sep. 07, 2016
Notes assumed   $ 772,970      
Principal amount     $ 2,500,000    
Outstanding amount     $ 1,320,000    
Percentage of accrued interest above prime rate     1.00%    
Interest expense     $ 13,228  
Additional notes payable     $ 820,000    
Chairman [Member]          
Percentage of accrued interest above prime rate 1.00%        
Repayment of principal amount $ 600,000        
Repayment of accured interest $ 1,985        
Notes Payable One [Member]          
Principal amount   $ 68,970      
Interest rate   12.00%      
Notes Payable [Member]          
Principal amount   $ 704,000      
Percentage of accrued interest above prime rate   1.00%      
Chairman [Member]          
Principal amount   $ 760,470      
Notes payable         $ 500,000
Chief Executive Officer [Member]          
Principal amount   $ 12,500      
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.6.0.2
DERIVATIVE WARRANT LIABILITY (Details) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Derivative Warrant Liability Details    
Derivative warrant liability, beginning of period $ 1,681,973 $ 738,955
Fair value of warrants issued 157,984
Total realized/unrealized losses included in net loss (622,186) (23,940)
Reclassification of liability to additional paid-in capital (149,209)
Derivative warrant liability, end of period $ 910,578 $ 872,999
XML 35 R26.htm IDEA: XBRL DOCUMENT v3.6.0.2
DERIVATIVE WARRANT LIABILITY (Details Narrative) - USD ($)
3 Months Ended 12 Months Ended
Dec. 31, 2016
Sep. 30, 2015
Outstanding warrants to purchase common stock 4,033,334 4,616,668
Exercise price of warrant $ 0.60  
Volatility rate 76.00% 73.00%
Risk-free interest rate 1.93% 1.14%
Anti dilution warrants expired 583,334  
Reclassification from derivative warrant liability to additional paid-in capital $ 149,209  
Minimum [Member]    
Estimated life 4 years 7 days 4 years 1 month 6 days
Maximum [Member]    
Estimated life 4 years 3 months 26 days 4 years 6 months 26 days
XML 36 R27.htm IDEA: XBRL DOCUMENT v3.6.0.2
COMMON STOCK, STOCK OPTIONS AND WARRANTS (Details) - Stock Options [Member]
3 Months Ended
Dec. 31, 2016
USD ($)
$ / shares
shares
Stock Options  
Outstanding, beginning balance | shares 8,732,770
Granted | shares
Assumed in acquisition | $
Exercised | shares
Forfeited or expired | shares
Outstanding, ending balance | shares 8,732,770
Exercisable, ending balance | shares 5,286,654
Weighted Average Exercise Price  
Outstanding, beginning balance $ 0.54
Granted
Assumed in acquisition
Exercised
Forfeited or expired
Outstanding, ending balance 0.54
Exercisable, ending balance $ 0.45
Weighted Average Remaining Contractual Life (years)  
Weighted Average Remaining Contractual Life (years), Beginning 8 years 7 months 2 days
Weighted Average Remaining Contractual Life (years), Ending 8 years 4 months 2 days
Exercisable Remaining Contractual Life (years) 7 years 10 months 28 days
Aggregate Intrinsic value  
Outstanding beginning balance | $ $ 1,355,924
Outstanding ending balance | $ 468,958
Exercisable ending balance | $ $ 336,484
XML 37 R28.htm IDEA: XBRL DOCUMENT v3.6.0.2
COMMON STOCK, STOCK OPTIONS AND WARRANTS (Details 1)
3 Months Ended
Dec. 31, 2016
$ / shares
shares
Investor Warrants [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 3,400,067
Expiration Date September 12, 2019
Placement Agent Unit Warrants [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 680,013
Expiration Date September 12, 2019
Warrants underlying Placement Agent Unit Warrants [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 680,013
Expiration Date September 12, 2019
Placement Agent Share Warrants [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 1,000,000
Expiration Date September 12, 2019
Investor Warrants One [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 2,145,371
Expiration Date March 19, 2020 - June 26, 2020
Investor Warrants Two [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 891,666
Expiration Date July 2, 2020 - September 14, 2020
Investor Warrants Three [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 583,334
Expiration Date November 5, 2020 - November 20, 2020
Investor Warrants Four [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 2,133,334 [1]
Expiration Date January 7, 2021 - March 21, 2021
Investor Warrants Five [Member]  
Exercise price | $ / shares $ 0.60
Number | shares 1,900,000 [1]
Expiration Date April 15, 2021 - April 25, 2021
LMB Warrants One [Member]  
Exercise price | $ / shares $ 0.41
Number | shares 1,352,266
Expiration Date June 12, 2019 - March 2, 2021
LMB Warrants Two [Member]  
Exercise price | $ / shares $ 0.66
Number | shares 122,319
Expiration Date September 30, 2019 - January 8, 2020
LMB Warrants Three [Member]  
Exercise price | $ / shares $ 1.38
Number | shares 265,814
Expiration Date November 3, 2019 - March 6, 2020
LMB Warrants Four [Member]  
Exercise price | $ / shares $ 0.50
Number | shares 1,108,249
Expiration Date August 18, 2020 - March 14, 2021
LMB Warrants Five [Member]  
Exercise price | $ / shares $ 0.91
Number | shares 796,649
Expiration Date March 24, 2022 - April 29, 2022
Financial Advisor Warrants [Member]  
Exercise price | $ / shares $ 0.20
Number | shares 1,000,000
Expiration Date August 15, 2021
Offering Warrants 2016 [Member]  
Exercise price | $ / shares $ 0.55
Number | shares 975,000
Expiration Date November 23, 2021
Offering Placement Agent Warrants 2016 [Member]  
Exercise price | $ / shares $ 0.55
Number | shares 97,500
Expiration Date November 23, 2021
[1] Fair value of these warrants are included in the derivative warrant liability
XML 38 R29.htm IDEA: XBRL DOCUMENT v3.6.0.2
COMMON STOCK, STOCK OPTIONS AND WARRANTS (Details Narrative)
1 Months Ended 3 Months Ended 12 Months Ended
Sep. 12, 2014
USD ($)
Unit
$ / shares
shares
Nov. 23, 2016
USD ($)
Unit
$ / shares
shares
Sep. 15, 2016
Dec. 31, 2016
USD ($)
Unit
$ / shares
shares
Dec. 31, 2015
USD ($)
Sep. 30, 2016
USD ($)
Unit
$ / shares
shares
Sep. 30, 2015
USD ($)
Unit
$ / shares
shares
Mar. 22, 2016
USD ($)
$ / shares
shares
Description of increase in authorized shares of common stock     Stockholders approved an increase in the number of shares of authorized common stock from 90,000,000 shares to 200,000,000 shares.          
Description of reverse stock split     Reverse stock split of our common stock by a ratio of not less than 1-for-8 and not more than 1-for-20 at any time prior to September 15, 2017.          
Stock-based compensation expense | $       $ 241,514 $ 121,299      
Additional warrant purchase       97,500        
Options to purchase of common stock       4,033,334     4,616,668  
Stock Options [Member] | Board of Directors [Member]                
Common stock reserved for employees 13,000,000              
Private Offering [Member]                
Common stock exercise price per share | $ / shares $ 0.001              
Description of warrant redeemable Common stock has traded for twenty (20) consecutive trading days with a closing price of at least $1.50 per share with an average trading volume of 50,000 shares per day and (ii) the Company provides 20 trading days prior notice of the redemption and the closing price of the common stock is not less than $1.17 for more than any 3 days during such notice period and (iii) the underlying shares of common stock are registered.              
Number of additional units sold | Unit       1,000,000   266,667 200,000  
Number of additional units sold, per unit | $ / shares       $ 0.60   $ 0.60 $ 0.60  
Number of units sold | Unit 3,400,067         4,350,001 2,837,037  
Number of units sold, per unit | $ / shares $ 0.60         $ 0.54 $ 0.54  
Number of units sold for gross proceeds | $ $ 2,040,040         $ 2,509,000 $ 1,652,000  
Stock sold               5,000,000
Stock sold per share price | $ / shares               $ 0.60
Stock sold for gross proceeds | $               $ 3,000,000
Offering Warrants 2016 [Member]                
Common stock exercise price per share | $ / shares       $ 0.55        
Common stock outstanding       975,000        
Weighted average remaining life       3 years 7 months 2 days        
Number of units sold | Unit   975,000            
Number of units sold, per unit | $ / shares   $ 0.40            
Number of unit offering | Unit       15,000,000        
Number of unit offering per share price | $ / shares       $ 0.40        
Number of units offering for gross proceeds | $       $ 6,000,000        
Percentage of cash commission on gross proceeds       0.10        
Additional warrant purchase   97,500            
Common stock reserved for employees       19,131,595        
Warrant offering description  

On November 23, 2016, the Company sold 975,000 2016 Offering Units, at a price of $0.40 per Unit, consisting of (i) one share of common stock and (ii) a warrant to purchase one share of common stock. Each 2016 Offering Warrant has an exercise price of $0.55 and is exercisable for five years from the date of issuance.

           
Warrants outstanding       280,568        
Stock Options [Member]                
Common stock outstanding       8,732,770   8,732,770    
Shares available for future grants       6,341,230        
Unrecognized total compensation cost related to unvested awards | $       $ 831,020        
Weighted average remaining life       1 year 15 days        
Average contractual term       P8Y4M2D        
Stock Options [Member] | 2014 Plan [Member]                
Shares available for future grants       4,267,230        
Stock-based compensation expense | $       $ 241,514 $ 121,299      
Unrecognized total compensation cost related to unvested awards | $       $ 1,145,334        
Weighted average remaining life       1 year 6 months 29 days        
Options to purchase of common stock       8,732,770        
Average contractual term       generally 10 years        
Warrant [Member]                
Estimated fair value | $       $ 234,505        
Placement Agent Unit Warrants [Member]                
Common stock exercise price per share | $ / shares       $ 0.60        
Common stock outstanding       680,013        
Number of units sold | Unit   975,000            
Number of units sold for gross proceeds | $   $ 390,000            
Estimated fair value | $   23,451            
Expense allowance | $   50,700            
Other cost | $   $ 156,896            
Options to purchase of common stock       1,000,000        
XML 39 R30.htm IDEA: XBRL DOCUMENT v3.6.0.2
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Sep. 30, 2016
General and administrative expense $ 1,132,183 $ 294,221  
Expenses paid by related party $ 27,637   $ 27,637
Chairman [Member]      
Additional stock purchased 5,000,000    
Financial Consultant [Member]      
General and administrative expense $ 12,000 $ 12,000  
XML 40 R31.htm IDEA: XBRL DOCUMENT v3.6.0.2
OPERATING LEASE (Details Narrative)
3 Months Ended
Dec. 31, 2016
USD ($)
Operating Lease Details Narrative  
Operating lease rent $ 2,167
Lease agreement expire date Oct. 31, 2017
Rent expense $ 6,501
XML 41 R32.htm IDEA: XBRL DOCUMENT v3.6.0.2
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
1 Months Ended
Feb. 28, 2017
Jan. 30, 2017
Investor Relations Services [Member]    
Common stock issued   445,932
Subsequent Event [Member]    
Additional offering units 399,750  
Number Of Units Sold For Gross Proceeds $ 159,900  
Subsequent Event [Member] | Chairman [Member]    
Additional demand notes   $ 260,000
Placement Agent [Member]    
Warrant to purchase common stock 39,975  
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