10-Q/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q/A

(Amendment No.1)

 (Mark One)

☒            QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF

THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2019

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 001-11889

CEL-SCI CORPORATION

Colorado	84-0916344
State or other jurisdiction incorporation	(IRS) Employer Identification Number

 8229 Boone Boulevard, Suite 802

 Vienna, Virginia 22182

 Address of principal executive offices

 (703) 506-9460

 Registrant's telephone number, including area code

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 file such reports) and (2) had been subject to such filing requirements for the past 90 days.

Yes ☒                                                                           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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

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

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

Class of Stock	No. Shares Outstanding	Date
Common	33,702,852	May 9, 2019

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

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

Explanatory Note

The purpose of the Amendment No. 1 on Form 10–Q/A to CEL-SCI CORPORATION’s annual report of Form 10–Q for the period ended March 31, 2019, filed with the Securities and Exchange Commission on May 14, 2019 (the “Form 10–Q”), is solely to furnish Exhibit 101 to the Form 10–Q in accordance with Rule 405 of Regulation S–T.

No other changes have been made to the Form 10–Q. This Amendment No. 1 speaks as of the original filing date of the Form 10–Q, does not reflect events that may have occurred subsequent to the original filing date and does not modify or update in any way disclosures made in the original Form 10–Q.

ITEM 6. Exhibits

Number              Exhibit

31                       

Rule 13a-14(a) Certifications

32                       

Section 1350 Certifications

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.

	CEL-SCI CORPORATION
Date: May 14, 2019	By:	/s/ Geert Kersten
		Geert Kersten
		Principal Executive Officer*

* Also signing in the capacity of the Principal Accounting and Financial Officer.

EX-31.1

  Exhibit 31.1

CERTIFICATIONS

I, Geert Kersten, certify that:

1.            

I have reviewed this amended quarterly report on Form 10-Q/A of CEL-SCI Corporation;

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, considering 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 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, 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 cause 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 the 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 significant role in the registrant’s internal control over financial reporting.

May 14, 2019	By:	/s/  Geert Kersten
		Geert Kersten
		Principal Executive Officer

CERTIFICATIONS

I, Geert Kersten, certify that:

1.            

I have reviewed this amended quarterly report on Form 10-Q/A of CEL-SCI Corporation;

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, considering 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 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, 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 cause 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 the 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 significant role in the registrant’s internal control over financial reporting.

 

May 14, 2019	By:	/s/   Geert Kersten
		Geert Kersten
		Principal Financial Officer

EX-32.1

 Exhibit 32

In connection with the Amendment No.1 to Quarterly Report of CEL-SCI Corporation (the “Company”) on Form 10-Q/A for the period ended March 31, 2019 as filed with the Securities and Exchange Commission (the “Report”), Geert Kersten, the Principal Executive and Financial Officer of the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(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 the Company.

                                                                                                       By:/s/ Geert Kersten                                                                     

Geert Kersten

Principal Executive and

Principal Financial Officer

May 14, 2019

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Document and Entity Information - shares	6 Months Ended
	Mar. 31, 2019	May 09, 2019
Document And Entity Information
Entity Registrant Name	CEL SCI CORP
Entity Central Index Key	0000725363
Document Type	10-Q
Document Period End Date	Mar. 31, 2019
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Common Stock, Shares Outstanding		33,702,852
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2019

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BALANCE SHEETS - USD ($)	Mar. 31, 2019	Sep. 30, 2018
CURRENT ASSETS:
Cash and cash equivalents	$ 5,514,013	$ 10,310,044
Receivables	123,236	118,657
Prepaid expenses	355,948	364,622
Inventory used for R&D and manufacturing	761,012	645,238
Total current assets	6,754,209	11,438,561
Plant, property and equipment, net	16,086,828	16,218,851
Patent costs, net	243,253	258,093
Deposits	1,670,917	1,670,917
Total Assets	24,755,207	29,586,422
CURRENT LIABILITIES:
Accounts payable	4,158,732	5,743,913
Accrued expenses	287,890	205,310
Due to employees	1,010,015	764,941
Derivative instruments, current portion	0	2,498,606
Other current liabilities	13,984	14,029
Total current liabilities	5,470,621	9,226,799
Derivative instruments - net of current portion	4,727,929	6,818,458
Lease Liability	13,444,394	13,379,962
Deferred income	126,849	126,795
Other liabilities	29,892	33,492
Total liabilities	23,799,685	29,585,506
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding	0	0
Common stock, $.01 par value - 600,000,000 shares authorized; 29,951,628 and 28,034,487 shares issued and outstanding at March 31, 2019 and September 30, 2018, respectively	299,517	280,346
Additional paid-in capital	337,449,398	331,312,184
Accumulated deficit	(336,793,393)	(331,591,614)
Total stockholders' equity	955,522	916
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 24,755,207	$ 29,586,422

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BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2019	Sep. 30, 2018
Stockholders Equity
Preferred Stock Shares Par Value	$ 0.01	$ 0.01
Preferred Stock Shares Authorized	200,000	200,000
Preferred Stock Shares Issued	0	0
Preferred Stock Shares Outstanding	0	0
Common Stock Shares Par Value	$ 0.01	$ 0.01
Common Stock Shares Authorized	600,000,000	600,000,000
Common Stock Shares Issued	29,951,628	28,034,487
Common Stock Shares Outstanding	29,951,628	28,034,487

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STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Income Statement [Abstract]
Grant income	$ 150,769	$ 114,271	$ 277,183	$ 210,586
Operating Expenses:
Research and development	2,525,460	2,962,297	5,657,648	5,288,311
General & administrative	1,931,909	1,375,410	3,960,597	4,074,723
Total operating expenses	4,457,369	4,337,707	9,618,245	9,363,034
Operating loss	(4,306,600)	(4,223,436)	(9,341,062)	(9,152,448)
Other income	18,216	17,691	36,127	35,273
(Loss) gain on derivative instruments	(967,171)	1,154,815	4,589,135	196,585
Other non-operating gain (loss)	(730,823)	(768,810)	421,353	(22,109)
Interest expense, net	(461,303)	(888,395)	(907,332)	(1,953,266)
Net loss available to common shareholders	$ (6,447,681)	$ (4,708,135)	$ (5,201,779)	$ (10,895,965)
Net loss per common share
Basic	$ (0.22)	$ (0.31)	$ (0.18)	$ (0.81)
Diluted	$ (0.22)	$ (0.31)	$ (0.19)	$ (0.81)
Weighted average common shares outstanding
Basic	29,113,910	15,210,296	28,543,417	13,403,878
Diluted	29,113,910	15,210,296	28,548,818	13,403,878

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STATEMENTS OF CASH FLOWS - USD ($)	6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (5,201,779)	$ (10,895,965)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization	316,083	308,259
Share-based payments for services	511,424	157,991
Equity based compensation	1,104,490	1,727,915
Common stock contributed to 401(k) plan	72,124	72,400
Shares issued for settlement of clinical research costs	1,290,000	1,247,400
Gain on derivative instruments	(4,589,135)	(196,585)
Amortization of debt discount	0	1,023,084
Capitalized lease interest	64,432	83,564
(Increase)/decrease in assets:
Receivables	(4,579)	81,698
Prepaid expenses	(74,741)	42,748
Inventory used for R&D and manufacturing	(115,774)	42,211
Deposits	0	150,000
Increase/(decrease) in liabilities:
Accounts payable	(1,489,234)	(541,767)
Accrued expenses	82,580	(33,966)
Due to employees	245,074	360,972
Other liabilities	(1,057)	2,638
Net cash used in operating activities	(7,790,092)	(6,367,403)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of equipment	(160,920)	0
Expenditures for patent costs	(67,661)	(1,113)
Net cash used in investing activities	(228,581)	(1,113)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants	0	7,127,141
Payments of stock issuance costs	(80,224)	(62,004)
Proceeds from exercise of warrants	3,305,387	0
Payments on obligations under capital lease	(2,521)	(3,870)
Net cash provided by financing activities	3,222,642	7,061,267
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(4,796,031)	692,751
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	10,310,044	2,369,438
CASH AND CASH EQUIVALENTS, END OF PERIOD	5,514,013	3,062,189
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Capitalizable patent costs included in accounts payable	0	8,137
Capital lease obligation included in accounts payable	428	402
Stock issuance costs included in accounts payable	10,000	68,374
Prepaid consulting services paid with issuance of common stock	(83,415)	95,911
Notes payable converted into common shares	0	184,300
Cash paid for interest expense	$ 902,091	$ 872,087

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A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2018.

In the opinion of management, the accompanying unaudited condensed financial statements contain all accruals and adjustments (each of which is of a normal recurring nature) necessary for a fair presentation of the Company’s financial position as of March 31, 2019 and the results of its operations for the six and three months then ended. The condensed balance sheet as of September 30, 2018 is derived from the September 30, 2018 audited financial statements. Significant accounting policies have been consistently applied in the interim financial statements. The results of operations for the six and three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the entire year.

The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations, which are expected for the foreseeable future, and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B.

Summary of Significant Accounting Policies:

Research and Office Equipment and Leasehold Improvements – The leased manufacturing facility is recorded at total project costs incurred and is depreciated over the 20-year useful life of the building. Research and office equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. The fixed assets are reviewed on a quarterly basis to determine if any of the assets are impaired.

Patents - Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment in the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Research and Development Costs - Research and development costs are expensed as incurred. Management accrues Clinical Research Organization (“CRO”) expenses and clinical trial study expenses based on services performed and relies on the CROs to provide estimates of those costs applicable to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. The Company charges revisions to estimated expense in the period in which the facts that give rise to the revision become known.

Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized.  A full valuation allowance was recorded against the deferred tax assets as of March 31, 2019 and September 30, 2018.

On December 22, 2017, the “Tax Cuts and Jobs Act” (the “Tax Act"), was signed into law by the President of the United States (U.S.). The Tax Act includes significant changes to corporate taxation, including reduction of the U.S. corporate tax rate from 35% to 21%, effective January 1, 2018, limitation of the tax deduction for interest expense to 30% of earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks. The Company has accounted for the income tax effects of the Act in applying FASB ASC 740 to the current reporting period. Because the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the amounts reported in the Company’s financial statements resulting from the Tax Act.

Derivative Instruments – The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities.” In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are re-measured at fair value at the end of each interim period.

Deferred Rent– Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

Leases – Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet.

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718 “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight-line allocation method as expense over the requisite service or vesting period.

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non-Employees.” Accordingly, compensation is recognized when goods or services are received and is measured using the Black-Scholes valuation model. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

New Accounting Pronouncements

In June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation—Stock Compensation (Topic 718), (“ASU 2018-7”), which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost. Under current GAAP, non-employee share-based payment awards are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever can be more reliably measured. Under ASU 2018-07, non-employee share-based payments would be measured at the grant-date fair value of the equity instruments an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied. Under current GAAP, the measurement date for equity classified non-employee share-based payment awards is the earlier of the date at which a commitment for performance by the counterparty is reached or the date at which the counterparty’s performance is complete. Under ASU 2018-07, equity-classified nonemployee share-based payment awards are measured at the grant date. The definition of the term grant date is amended to generally state the date at which a grantor and a grantee reach a mutual understanding of the key terms and conditions of a share-based payment award. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. An entity should only remeasure liability-classified awards that have not been settled by the date of adoption and equity classified awards for which a measurement date has not been established through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. Upon transition, the entity is required to measure these non-employee awards at fair value as of the adoption date. The entity must not remeasure awards that are completed. The Company is currently evaluating the impact the adoption of the standard will have on the Company’s financial position and results of operations.

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (except of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented.  As permitted by the guidance, the Company has an option to retain the original lease classification and historical accounting for initial direct costs for leases existing prior to the adoption date. Furthermore, the Company will not have to reassess contracts entered into prior to the adoption date for the existence of a lease. The Company also has an option not to restate prior periods for the impact of the adoption of the new standard and may instead recognize a cumulative-effect adjustment to beginning retained earnings as of October 1, 2019 for any prior period income statement effects identified. The Company will evaluate the effect that adoption of this new standard will have on the Company’s financial statements. The Company will evaluate the effect that adoption of this new standard on its financial statements and related disclosures.

The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

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B. OPERATIONS AND FINANCING

6 Months Ended

Mar. 31, 2019

B. Operations And Financing

B. OPERATIONS AND FINANCING

The Company has incurred significant costs since its inception for the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials.  The Company has funded such costs with proceeds from loans and the public and private sale of its common stock.  The Company will be required to raise additional capital or find additional long-term financing to continue with its research efforts.  The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company is taking cost-cutting initiatives, as well as exploring other sources of funding, to finance operations over the next 12 months. The Company believes that there is a high likelihood that it will continue to receive funds from warrant conversions in a way similar to the way it has substantial funds for the past 12 months. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations.

The Company is currently in the final stages of its large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. To finance the study beyond the next twelve months, the Company plans to raise additional capital in the form of corporate partnerships, debt issuances and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because Multikine is a product in the Phase 3 clinical trial stage. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all.  If the Company does not raise the necessary amounts of money, it may have to curtail its operations until it can raise the required funding.

The financial statements have been prepared assuming the Company will continue as a going concern, but due to the Company’s recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Since the Company launched its Phase 3 clinical trial for Multikine, the Company has incurred expenses of approximately $53.5 million as of March 31, 2019 on direct costs for the Phase 3 clinical trial. The Company estimates it will incur additional expenses of approximately $6.3 million for the remainder of the Phase 3 clinical trial. It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g., the manufacturing of the drug. This number may be affected by the rate of death accumulation in the study, foreign currency exchange rates, and many other factors, some of which cannot be foreseen today. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated.

Nine hundred twenty-eight (928) head and neck cancer patients have been enrolled and have completed treatment in the Phase 3 study. The study end point is a 10% increase in overall survival of patients between the two main comparator groups in favor of the group receiving the Multikine treatment regimen. The determination if the study end point has been met will occur when there are a total of 298 deaths in those two groups.

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C. STOCKHOLDERS EQUITY

6 Months Ended

Mar. 31, 2019

Equity [Abstract]

C. STOCKHOLDERS' EQUITY

The changes in stockholders’ equity during the six months ended March 31, 2019 are as follows:

							Additional
	Common			Stock			Paid-In			Accumulated
	Shares			Amount			Capital			Deficit			Total
BALANCES AT OCTOBER 1, 2018		28,034,487		$	280,346		$	331,312,184		$	(331,591,614	)	$	916
Warrant exercises		298,682			2,987			646,766			-			649,753
401(k) contributions paid in common stock		12,279			123			35,118			-			35,241
Stock issued to nonemployees for service		62,784			628			201,752			-			202,380
Shares returned for settlement of clinical research costs		(564,905	)		(5,649	)		5,649			-			-
Equity based compensation - employees		-			-			573,660			-			573,660
Net income		-			-			-			1,245,902			1,245,902
BALANCES AT DECEMBER 31, 2018		27,843,327			278,435			332,775,129			(330,345,712	)		2,707,852
Warrant exercises		1,523,933			15,239			2,640,395			-			2,655,634
401(k) contributions paid in common stock		10,419			104			36,779			-			36,883
Stock issued to nonemployees for service		77,449			774			224,855			-			225,629
Equity based compensation - employees		(3,500	)		(35	)		530,865			-			530,830
Shares issued for settlement of clinical research costs		500,000			5,000			1,285,000			-			1,290,000
Stock issuance costs		-			-			(43,625	)		-			(43,625	)
Net loss		-			-			-			(6,447,681	)		(6,447,681	)
BALANCES AT MARCH 31, 2019		29,951,628		$	299,517		$	337,449,398		$	(336,793,393	)	$	955,522

The changes in stockholders’ equity during the six months ended March 31, 2018 are as follows:

					Additional
	Common		Stock		Paid-In			Accumulated
	Shares		Amount		Capital			Deficit			Total
BALANCES AT OCTOBER 1, 2017		11,903,133	$	119,031	$	296,298,401		$	(299,754,409	)	$	(3,336,977	)
Sale of common stock		1,289,478		12,895		2,437,105			-			2,450,000
401(k) contributions paid in common stock		18,984		190		35,690			-			35,880
Stock issued to nonemployees for service		13,705		137		25,270			-			25,407
Equity based compensation - employees		-		-		1,448,098			-			1,448,098
Net loss		-		-		-			(6,187,830	)		(6,187,830	)
BALANCES AT DECEMBER 31, 2017		13,258,051		132,581		300,975,618			(305,942,239	)		(4,834,040	)
Sale of common stock		2,501,145		25,011		4,652,130			-			4,667,141
401(k) contributions paid in common stock		25,901		259		36,261			-			36,520
Stock issued to nonemployees for service		124,082		1,241		227,254			-			228,495
Equity based compensation - employees		-		-		279,817			-			279,817
Conversion of notes payable and interest to common stock		55,373		554		108,746			-			109,300
Shares issued for settlement of clinical research costs		660,000		6,600		1,240,800			-			1,247,400
Stock issuance cost		-		-		(94,773	)		-			(94,773	)
Net loss		-		-		-			(4,708,135	)		(4,708,135	)
BALANCES AT MARCH 31, 2018		16,624,552	$	166,246	$	307,425,853		$	(310,650,374	)	$	(3,058,275	)

Stock options, stock bonuses and compensation granted by the Company as of March 31, 2019 are as follows:

Name of Plan	Total Shares Reserved Under Plans		Shares Reserved for Outstanding Options		Shares Issued		Remaining Options/Shares Under Plans
Incentive Stock Options Plans		138,400		123,558		N/A		385
Non-Qualified Stock Option Plans		3,387,200		3,010,476		N/A		335,619
Stock Bonus Plans		783,760		N/A		322,928		460,799
Stock Compensation Plan		134,000		N/A		115,590		18,410
Incentive Stock Bonus Plan		640,000		N/A		620,500		16,000

Stock options, stock bonuses and compensation granted by the Company as of September 30, 2018 are as follows:

Name of Plan	Total Shares Reserved Under Plans		Shares Reserved for Outstanding Options		Shares Issued		Remaining Options/Shares Under Plans
Incentive Stock Option Plans		138,400		123,558		N/A		385
Non-Qualified Stock Option Plans		3,387,200		3,036,569		N/A		309,526
Stock Bonus Plans		783,760		N/A		297,230		486,497
Stock Compensation Plan		134,000		N/A		118,590		15,410
Incentive Stock Bonus Plan		640,000		N/A		624,000		16,000

Stock option activity:

	Six Months Ended March 31,
	2019	2018
Granted	500	10,300
Expired	2,400	24,379
Forfeited	24,193	1,393

	Three Months Ended March 31,
	2019	2018
Granted	-	-
Expired	-	584
Forfeited	24,193	6,856

Employee stock based compensation expense includes the expense related to options issued or vested and restricted stock. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of their service contracts. Stock based compensation expense is included in general and administrative expenses on the statements of operations.

Non-employee stock based compensation expense includes the value of shares and options issued under consulting arrangements. At March 31, 2019 and September 30, 2018, approximately $124,000 and $207,000, respectively, are included in prepaid expenses.

Warrants and Non-Employee Options

The following chart represents the warrants and non-employee options outstanding at March 31, 2019:

Warrant	Issue Date	Shares Issuable upon Exercise of Warrants		Exercise Price		Expiration Date
Series N	8/18/2008		85,339	$	3.00	2/18/2020
Series V	5/28/2015		810,127	$	19.75	5/28/2020
Series UU	6/11/2018		187,562	$	2.80	6/11/2020
Series W	10/28/2015		688,930	$	16.75	10/28/2020
Series X	1/13/2016		120,000	$	9.25	1/13/2021
Series Y	2/15/2016		26,000	$	12.00	2/15/2021
Series ZZ	5/23/2016		20,000	$	13.75	5/18/2021
Series BB	8/26/2016		16,000	$	13.75	8/22/2021
Series Z	5/23/2016		264,000	$	13.75	11/23/2021
Series FF	12/8/2016		68,048	$	3.91	12/1/2021
Series CC	12/8/2016		680,480	$	5.00	12/8/2021
Series HH	2/23/2017		20,000	$	3.13	2/16/2022
Series AA	8/26/2016		200,000	$	13.75	2/22/2022
Series JJ	3/14/2017		30,000	$	3.13	3/8/2022
Series LL	4/30/2017		26,398	$	3.59	4/30/2022
Series MM	6/22/2017		893,491	$	1.86	6/22/2022
Series NN	7/24/2017		539,300	$	2.52	7/24/2022
Series OO	7/31/2017		60,000	$	2.52	7/31/2022
Series QQ	8/22/2017		3,500	$	2.50	8/22/2022
Series GG	2/23/2017		200,000	$	3.00	8/23/2022
Series II	3/14/2017		216,500	$	3.00	9/14/2022
Series RR	10/30/2017		555,370	$	1.65	10/30/2022
Series KK	5/3/2017		213,870	$	3.04	11/3/2022
Series SS	12/19/2017		794,740	$	2.09	12/18/2022
Series TT	2/5/2018		1,210,827	$	2.24	2/5/2023
Series PP	8/28/2017		112,500	$	2.30	2/28/2023
Series WW	7/2/2018		69,225	$	1.63	6/28/2023
Series VV	7/2/2018		2,515,000	$	1.75	1/2/2024
Consultants	7/1/16 - 7/28/17		28,000	$	2.18-$11.50	6/30/2019- 7/27/2027

* No current period changes to these warrants

1. Derivative Liabilities

The table below presents the fair value of the warrant liabilities at the balance sheet dates:

	March 31, 2019		September 30, 2018
Series S warrants	$	-	$	33
Series V warrants		275,584		770,436
Series W warrants		383,053		999,081
Series Z warrants		372,936		487,767
Series ZZ warrants		21,577		34,215
Series AA warrants		287,206		380,474
Series BB warrants		20,720		28,456
Series CC warrants		1,440,026		1,779,724
Series DD warrants		-		1,249,287
Series EE warrants		-		1,249,287
Series FF warrants		154,318		188,921
Series GG warrants		500,478		607,228
Series HH warrants		48,174		58,816
Series II warrants		544,792		660,135
Series JJ warrants		72,716		88,642
Series KK warrants		543,463		656,930
Series LL warrants		62,886		77,632
Total warrant liabilities	$	4,727,929	$	9,317,064

The table below presents the gains/(losses) on the warrant liabilities for the six months ended March 31:

	2019		2018
Series S warrants	$	33	$	11,927
Series V warrants		494,852		(3,547	)
Series W warrants		616,028		(24,131	)
Series Z warrants		114,831		8,095
Series ZZ warrants		12,638		189
Series AA warrants		93,268		8,676
Series BB warrants		7,736		293
Series CC warrants		339,698		41,919
Series DD warrants		1,249,287		5,456
Series EE warrants		1,249,287		5,456
Series FF warrants		34,603		7,301
Series GG warrants		106,750		37,419
Series HH warrants		10,642		2,683
Series II warrants		115,343		50,608
Series JJ warrants		15,926		4,010
Series KK warrants		113,467		36,924
Series LL warrants		14,746		3,307
Net gain on warrant liabilities	$	4,589,135	$	196,585

The table below presents the gains/(losses) on the warrant liabilities for the three months ended March 31:

	2019			2018
Series S warrants	$	-		$	(1,141	)
Series V warrants		(61,480	)		94,766
Series W warrants		(10,822	)		105,336
Series Z warrants		(89,290	)		63,630
Series ZZ warrants		(1,685	)		3,532
Series AA warrants		(63,951	)		56,036
Series BB warrants		(4,374	)		2,924
Series CC warrants		(325,908	)		238,740
Series DD warrants		-			(27	)
Series EE warrants		-			(27	)
Series FF warrants		(34,459	)		25,348
Series GG warrants		(106,032	)		152,551
Series HH warrants		(10,309	)		8,345
Series II warrants		(115,246	)		229,414
Series JJ warrants		(15,536	)		12,552
Series KK warrants		(114,628	)		151,951
Series LL warrants		(13,451	)		10,885
Net (loss)/gain on warrant liabilities	$	(967,171	)	$	1,154,815

The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded.

In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss.

Expiration of Derivative Liabilities

On December 10, 2018, 1,360,960 Series DD and 1,360,960 Series EE warrants, with an exercise price of $4.50, expired.

On October 11, 2018, 327,729 Series S warrants, with an exercise price of $31.25, expired.

No derivative liabilities expired during the three months ended March 31, 2019.

   2.             Securities Purchase Agreement

The Company has entered into several Securities Purchase Agreements (SPAs) with Ergomed plc, one of its Clinical Research Organizations responsible for managing the Phase 3 clinical trial, to facilitate a partial payment of amounts due Ergomed. Under the Agreements, the Company issued Ergomed shares of common stock as a forbearance fee in exchange for Ergomed’s agreement to provisionally forbear collection of the payables in an amount equal to the net proceeds from the resales of the shares issued to Ergomed. Upon issuance, the Company expenses the full value of the shares as Other Non-Operating Gain/Loss and subsequently offsets the expense as amounts are realized through the resale by Ergomed and reduces accounts payable to Ergomed. Any amounts received from the resell of the shares in excess of the payables will be applied towards the satisfaction of any future amounts owed.

On December 31, 2018, the prior SPA expired. Pursuant to that arrangement, Ergomed returned all 564,905 unsold shares for cancellation. The par value of those shares was reclassed from Common Stock to Additional Paid-In Capital on the balance sheet.

On January 9, 2019, the Company entered into a new SPA under which it issued Ergomed 500,000 restricted shares of the Company’s common stock valued at approximately $1.3 million. This current SPA expires on December 31, 2019.

During the six months ended March 31, 2019 and 2018, respectively, the Company decreased Accounts Payable by approximately $1.7 million and $1.2 million through the resale of 545,324 and 684,541 shares.

The following table summarizes the Other Non-Operating Gains (Loss) for the six and three months ended March 31, 2019 and 2018 relating to these agreements:

	Six Months Ended					Three Months Ended
	3/31/2019		3/31/2018			3/31/2019			3/31/2018
Amount realized through the resale of shares	$	1,711,353	$	1,225,291		$	559,177		$	478,590
Fair value of shares upon issuance		1,290,000		1,247,400			1,290,000			1,247,400
Other non-operating gain (loss)	$	421,353	$	(22,109	)	$	(730,823	)	$	(768,810	)

As of March 31, 2019, Ergomed holds 308,671 shares and may resell the shares or return the shares to the Company for cancellation until December 31, 2019.

3. Incentive Stock Bonus Plan

During the six and three months ended March 31, 2019, 3,500 shares of common stock issued from the 2014 Incentive Stock Bonus Plan were forfeited.

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D. FAIR VALUE MEASUREMENTS

6 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

D. FAIR VALUE MEASUREMENTS

In accordance with ASC 820-10, “Fair Value Measurements,” the Company determines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to those future amounts.

ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows:

●  Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities

●  Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets

●  Level 3 – Unobservable inputs that reflect management’s assumptions

For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels.

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at March 31, 2019:

	Quoted Prices in Active Markets for Identical Assets or Liabilities  (Level 1)	Significant Other Observable Inputs  (Level 2)	Significant Unobservable Inputs  (Level 3)	Total
Derivative instruments	$ -	$ -	$4,727,929	$4,727,929

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2018:

	Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)	Significant Other Observable Inputs (Level 2)	Significant Unobservable Inputs (Level 3)	Total
Derivative instruments	$33	$ -	$9,317,031	$9,317,064

The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the three months ended March 31, 2019 and the year ended September 30, 2018:

	Six Months Ended			Year Ended
	March 31, 2019			September 30, 2018
Beginning balance	$	9,317,031		$	2,020,629
Issuances		-			-
Exercises		-			(595,780	)
Realized and unrealized (gains) and losses		(4,589,102	)		7,892,182
Ending balance	$	4,727,929		$	9,317,031

The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.

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E. COMMITMENTS AND CONTINGENCIES

6 Months Ended

Mar. 31, 2019

Commitments and Contingencies Disclosure [Abstract]

E. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreements 

Under co-development and revenue sharing agreements with Ergomed, Ergomed agreed to contribute up to $12 million towards the Company’s Phase 3 Clinical Trial in the form of discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. The Company accounted for the co-development and revenue sharing agreements in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the inception of the agreement with Ergomed, the Company has incurred research and development expenses of approximately $29.6million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $9.9 million. During the six months ended March 31, 2019 and 2018, the Company recorded, net of Ergomed’s discount, approximately $1.5 million and $1.7 million, respectively, as research and development expense related to Ergomed’s services. During the three months ended March 31, 2019 and 2018, the Company recorded, net of Ergomed’s discount, approximately $0.7 million and $0.8 million, respectively, as research and development expense related to Ergomed’s services.

Lease Agreements

The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease. The Company contributed approximately $9.3 million towards the tenant-directed improvements, of which $3.2 million is being refunded during years six through twenty through reduced rental payments. The landlord paid approximately $11.9 million towards the purchase of the building, land and the tenant-directed improvements. The Company placed the building in service in October 2008.

The Company was deemed to be the owner of the building for accounting purpose under the build-to-suit guidance in ASC 840-40-55. In addition to tenant improvements the Company incurred, the Company also recorded an asset for tenant-directed improvements and for the costs paid by the lessor to purchase the building and to perform improvements, as well as a corresponding liability for the landlord costs. Upon completion of the improvements, the Company did not meet the “sale-leaseback” criteria under ASC 840-40-25, Accounting for Lease, Sale-Leaseback Transactions, and therefore, treated the lease as a financing obligation. Thus, the asset and corresponding liability were not de-recognized. As of March 31, 2019 and September 30, 2018, the leased building asset has a net book value of approximately $15.8 and $16.1 million, respectively, and the landlord liability has a balance of approximately $13.4 million as of both balance sheet dates. The leased building is being depreciated using a straight-line method over the 20-year lease term to a residual value. The landlord liability is being amortized over the 20 years using the effective interest method. Lease payments allocated to the landlord liability are accounted for as debt service payments on that liability using the finance method of accounting per ASC 840-40-55.

The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at March 31, 2019 and September 30, 2018.

Approximate future minimum lease payments under the San Tomas lease as of March 31, 2019 are as follows:

Six months ending September 30, 2019	$	907,000
Year ending September 30,
2020		1,872,000
2021		1,937,000
2022		2,004,000
2023		2,073,000
2024		2,145,000
Thereafter		9,540,000
Total future minimum lease obligation		20,478,000
Less imputed interest on financing obligation		(7,034,000	)
Net present value of lease financing obligation	$	13,444,000

The Company subleases a portion of its rental space on a month-to-month term lease, which requires a 30-day notice for termination. The sublease rental income for each of the six months ended March 31, 2019 and 2018 was approximately $36,000. The sublease rental income for each of the three months ended March 31, 2019 and 2018 was approximately $18,000.

The Company leases its research and development laboratory under a 60-month lease which expires February 28, 2022. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month term of the lease at the rate of approximately $13,000 per month. As of March 31, 2019 and September 30, 2018, the Company has recorded a deferred rent liability of approximately $14,000 and $12,000, respectively.

The Company leases its office headquarters under a 60-month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month term of the lease at the rate approximately $8,000 per month. As of March 31, 2019 and September 30, 2018, the Company has recorded a deferred rent liability of approximately $11,000 and $14,000, respectively.

As of March 31, 2019, material contractual obligations, excluding the San Tomas lease, consisting of non-cancelable operating lease payments are as follows:

Six months ending September 30, 2019	$	130,000
Year ending September 30,
2020		238,000
2021		163,000
2022		69,000
Total	$	600,000

The Company leases office equipment under a capital lease arrangement. The term of the capital lease is 60 months and expires on October 31, 2021. The monthly lease payment is $505. The lease bears interest at an annual interest rate of 6.25%.

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F. PATENTS

6 Months Ended

Mar. 31, 2019

Intangible Assets, Net (Excluding Goodwill) [Abstract]

F. PATENTS

During the six months ended March 31, 2019 and 2018, no patent impairment charges were recorded. For the six and three months ended March 31, 2019, amortization of patent costs totaled approximately $23,000 and $11,000, respectively. For the six and three months ended March 31, 2018, amortization of patent costs totaled approximately $19,000 and $9,000, respectively. Approximate estimated future amortization expense is as follows:

Six months ending September 30, 2019	$	20,000
Year ending September 30,
2020		39,000
2021		36,000
2022		31,000
2023		21,000
2024		18,000
Thereafter		78,000
Total	$	243,000

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G. LOSS PER COMMON SHARE

6 Months Ended

Mar. 31, 2019

Net loss per common share

G. LOSS PER COMMON SHARE

The following tables provide the details of the basic and diluted loss per-share computations:

	Six months ended March 31,						Three months ended March 31,
	2019			2018			2019			2018
Loss per share - basic
Net loss available to common shareholders - basic	$	(5,201,779	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Weighted average shares outstanding - basic		28,543,417			13,403,878			29,113,910			15,210,296
Basic loss per common share	$	(0.18	)	$	(0.81	)	$	(0.22	)	$	( 0.31	)
Loss per share - diluted
Net loss available to common shareholders - basic	$	(5,201,779	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Gain on derivatives (1)		(335,560	)		-			-			-
Net loss available to common shareholders - diluted	$	(5,537,339	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Weighted average shares outstanding - basic		28,543,417			13,403,878			29,113,910			15,210,296
Incremental shares underlying dilutive "in the money" warrants (1)		5,401			-			-			-
Weighted average shares outstanding - diluted		28,548,818			13,403,878			29,113,910			15,210,296
Diluted loss per common share	$	(0.19	)	$	(0.81	)	$	(0.22	)	$	(0.31	)

(1) Includes series GG, II and KK for the six months ended March 31, 2019.

The gain on derivatives priced lower than the average market price during the period is excluded from the numerator and the related shares are excluded from the denominator in calculating diluted loss per share.

In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share, the calculation of diluted net earnings (loss) per share excludes the following securities because their inclusion would have been anti-dilutive as of March 31:

	2019	2018
Options and Warrants	10,576,881	12,381,730
Unvested Restricted Stock	308,500	312,000
Convertible debt	-	1,077,982
Total	10,885,381	13,771,712

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H. SUBSEQUENT EVENTS

6 Months Ended

Mar. 31, 2019

Subsequent Events [Abstract]

H. SUBSEQUENT EVENTS

Between April 1, 2019 and May 13, 2019, the Company received approximately $7.6 million through the exercise of options and warrants to purchase shares of the Company’s common stock.

On May 7, 2019, the Company received security purchase agreements for the purchase of 30,612 restricted shares of the Company’s common stock at the closing price on May 6, 2019 of $6.86 in the principal amount of approximately $210,000 from five officers and directors of the Company.

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A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)

6 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Basis of Presentation

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2018.

In the opinion of management, the accompanying unaudited condensed financial statements contain all accruals and adjustments (each of which is of a normal recurring nature) necessary for a fair presentation of the Company’s financial position as of March 31, 2019 and the results of its operations for the six and three months then ended. The condensed balance sheet as of September 30, 2018 is derived from the September 30, 2018 audited financial statements. Significant accounting policies have been consistently applied in the interim financial statements. The results of operations for the six and three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the entire year.

The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations, which are expected for the foreseeable future, and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B.

Research and Office Equipment and Leasehold Improvements

Research and Office Equipment and Leasehold Improvements – The leased manufacturing facility is recorded at total project costs incurred and is depreciated over the 20-year useful life of the building. Research and office equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. The fixed assets are reviewed on a quarterly basis to determine if any of the assets are impaired.

Patents

Patents - Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment in the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Research and Development Costs

Research and Development Costs - Research and development costs are expensed as incurred. Management accrues Clinical Research Organization (“CRO”) expenses and clinical trial study expenses based on services performed and relies on the CROs to provide estimates of those costs applicable to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. The Company charges revisions to estimated expense in the period in which the facts that give rise to the revision become known.

Income Taxes

Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized.  A full valuation allowance was recorded against the deferred tax assets as of March 31, 2019 and September 30, 2018.

On December 22, 2017, the “Tax Cuts and Jobs Act” (the “Tax Act"), was signed into law by the President of the United States (U.S.). The Tax Act includes significant changes to corporate taxation, including reduction of the U.S. corporate tax rate from 35% to 21%, effective January 1, 2018, limitation of the tax deduction for interest expense to 30% of earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks. The Company has accounted for the income tax effects of the Act in applying FASB ASC 740 to the current reporting period. Because the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the amounts reported in the Company’s financial statements resulting from the Tax Act.

Derivative Instruments

Derivative Instruments – The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities.” In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are re-measured at fair value at the end of each interim period.

Deferred Rent

Deferred Rent– Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

Leases

Leases – Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet.

Stock-Based Compensation

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718 “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight-line allocation method as expense over the requisite service or vesting period.

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non-Employees.” Accordingly, compensation is recognized when goods or services are received and is measured using the Black-Scholes valuation model. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

New Accounting Pronouncements

In June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation—Stock Compensation (Topic 718), (“ASU 2018-7”), which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost. Under current GAAP, non-employee share-based payment awards are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever can be more reliably measured. Under ASU 2018-07, non-employee share-based payments would be measured at the grant-date fair value of the equity instruments an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied. Under current GAAP, the measurement date for equity classified non-employee share-based payment awards is the earlier of the date at which a commitment for performance by the counterparty is reached or the date at which the counterparty’s performance is complete. Under ASU 2018-07, equity-classified nonemployee share-based payment awards are measured at the grant date. The definition of the term grant date is amended to generally state the date at which a grantor and a grantee reach a mutual understanding of the key terms and conditions of a share-based payment award. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. An entity should only remeasure liability-classified awards that have not been settled by the date of adoption and equity classified awards for which a measurement date has not been established through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. Upon transition, the entity is required to measure these non-employee awards at fair value as of the adoption date. The entity must not remeasure awards that are completed. The Company is currently evaluating the impact the adoption of the standard will have on the Company’s financial position and results of operations.

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (except of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented.  As permitted by the guidance, the Company has an option to retain the original lease classification and historical accounting for initial direct costs for leases existing prior to the adoption date. Furthermore, the Company will not have to reassess contracts entered into prior to the adoption date for the existence of a lease. The Company also has an option not to restate prior periods for the impact of the adoption of the new standard and may instead recognize a cumulative-effect adjustment to beginning retained earnings as of October 1, 2019 for any prior period income statement effects identified. The Company will evaluate the effect that adoption of this new standard will have on the Company’s financial statements. The Company will evaluate the effect that adoption of this new standard on its financial statements and related disclosures.

The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

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C. STOCKHOLDERS EQUITY (Tables)

6 Months Ended

Mar. 31, 2019

Equity [Abstract]

Changes in stockholders' equity

							Additional
	Common			Stock			Paid-In			Accumulated
	Shares			Amount			Capital			Deficit			Total
BALANCES AT OCTOBER 1, 2018		28,034,487		$	280,346		$	331,312,184		$	(331,591,614	)	$	916
Warrant exercises		298,682			2,987			646,766			-			649,753
401(k) contributions paid in common stock		12,279			123			35,118			-			35,241
Stock issued to nonemployees for service		62,784			628			201,752			-			202,380
Shares returned for settlement of clinical research costs		(564,905	)		(5,649	)		5,649			-			-
Equity based compensation - employees		-			-			573,660			-			573,660
Net income		-			-			-			1,245,902			1,245,902
BALANCES AT DECEMBER 31, 2018		27,843,327			278,435			332,775,129			(330,345,712	)		2,707,852
Warrant exercises		1,523,933			15,239			2,640,395			-			2,655,634
401(k) contributions paid in common stock		10,419			104			36,779			-			36,883
Stock issued to nonemployees for service		77,449			774			224,855			-			225,629
Equity based compensation - employees		(3,500	)		(35	)		530,865			-			530,830
Shares issued for settlement of clinical research costs		500,000			5,000			1,285,000			-			1,290,000
Stock issuance costs		-			-			(43,625	)		-			(43,625	)
Net loss		-			-			-			(6,447,681	)		(6,447,681	)
BALANCES AT MARCH 31, 2019		29,951,628		$	299,517		$	337,449,398		$	(336,793,393	)	$	955,522

The changes in stockholders’ equity during the six months ended March 31, 2018 are as follows:

					Additional
	Common		Stock		Paid-In			Accumulated
	Shares		Amount		Capital			Deficit			Total
BALANCES AT OCTOBER 1, 2017		11,903,133	$	119,031	$	296,298,401		$	(299,754,409	)	$	(3,336,977	)
Sale of common stock		1,289,478		12,895		2,437,105			-			2,450,000
401(k) contributions paid in common stock		18,984		190		35,690			-			35,880
Stock issued to nonemployees for service		13,705		137		25,270			-			25,407
Equity based compensation - employees		-		-		1,448,098			-			1,448,098
Net loss		-		-		-			(6,187,830	)		(6,187,830	)
BALANCES AT DECEMBER 31, 2017		13,258,051		132,581		300,975,618			(305,942,239	)		(4,834,040	)
Sale of common stock		2,501,145		25,011		4,652,130			-			4,667,141
401(k) contributions paid in common stock		25,901		259		36,261			-			36,520
Stock issued to nonemployees for service		124,082		1,241		227,254			-			228,495
Equity based compensation - employees		-		-		279,817			-			279,817
Conversion of notes payable and interest to common stock		55,373		554		108,746			-			109,300
Shares issued for settlement of clinical research costs		660,000		6,600		1,240,800			-			1,247,400
Stock issuance cost		-		-		(94,773	)		-			(94,773	)
Net loss		-		-		-			(4,708,135	)		(4,708,135	)
BALANCES AT MARCH 31, 2018		16,624,552	$	166,246	$	307,425,853		$	(310,650,374	)	$	(3,058,275	)

Stock options, stock bonuses and compensation granted by the Company

Stock options, stock bonuses and compensation granted by the Company as of March 31, 2019 are as follows:

Name of Plan	Total Shares Reserved Under Plans		Shares Reserved for Outstanding Options		Shares Issued		Remaining Options/Shares Under Plans
Incentive Stock Options Plans		138,400		123,558		N/A		385
Non-Qualified Stock Option Plans		3,387,200		3,010,476		N/A		335,619
Stock Bonus Plans		783,760		N/A		322,928		460,799
Stock Compensation Plan		134,000		N/A		115,590		18,410
Incentive Stock Bonus Plan		640,000		N/A		620,500		16,000

Stock options, stock bonuses and compensation granted by the Company as of September 30, 2018 are as follows:

Name of Plan	Total Shares Reserved Under Plans		Shares Reserved for Outstanding Options		Shares Issued		Remaining Options/Shares Under Plans
Incentive Stock Option Plans		138,400		123,558		N/A		385
Non-Qualified Stock Option Plans		3,387,200		3,036,569		N/A		309,526
Stock Bonus Plans		783,760		N/A		297,230		486,497
Stock Compensation Plan		134,000		N/A		118,590		15,410
Incentive Stock Bonus Plan		640,000		N/A		624,000		16,000

Stock option activity

	Six Months Ended March 31,
	2019	2018
Granted	500	10,300
Expired	2,400	24,379
Forfeited	24,193	1,393

	Three Months Ended March 31,
	2019	2018
Granted	-	-
Expired	-	584
Forfeited	24,193	6,856

Derivative liabilities, warrants and other options

Warrant	Issue Date	Shares Issuable upon Exercise of Warrants		Exercise Price		Expiration Date
Series N	8/18/2008		85,339	$	3.00	2/18/2020
Series V	5/28/2015		810,127	$	19.75	5/28/2020
Series UU	6/11/2018		187,562	$	2.80	6/11/2020
Series W	10/28/2015		688,930	$	16.75	10/28/2020
Series X	1/13/2016		120,000	$	9.25	1/13/2021
Series Y	2/15/2016		26,000	$	12.00	2/15/2021
Series ZZ	5/23/2016		20,000	$	13.75	5/18/2021
Series BB	8/26/2016		16,000	$	13.75	8/22/2021
Series Z	5/23/2016		264,000	$	13.75	11/23/2021
Series FF	12/8/2016		68,048	$	3.91	12/1/2021
Series CC	12/8/2016		680,480	$	5.00	12/8/2021
Series HH	2/23/2017		20,000	$	3.13	2/16/2022
Series AA	8/26/2016		200,000	$	13.75	2/22/2022
Series JJ	3/14/2017		30,000	$	3.13	3/8/2022
Series LL	4/30/2017		26,398	$	3.59	4/30/2022
Series MM	6/22/2017		893,491	$	1.86	6/22/2022
Series NN	7/24/2017		539,300	$	2.52	7/24/2022
Series OO	7/31/2017		60,000	$	2.52	7/31/2022
Series QQ	8/22/2017		3,500	$	2.50	8/22/2022
Series GG	2/23/2017		200,000	$	3.00	8/23/2022
Series II	3/14/2017		216,500	$	3.00	9/14/2022
Series RR	10/30/2017		555,370	$	1.65	10/30/2022
Series KK	5/3/2017		213,870	$	3.04	11/3/2022
Series SS	12/19/2017		794,740	$	2.09	12/18/2022
Series TT	2/5/2018		1,210,827	$	2.24	2/5/2023
Series PP	8/28/2017		112,500	$	2.30	2/28/2023
Series WW	7/2/2018		69,225	$	1.63	6/28/2023
Series VV	7/2/2018		2,515,000	$	1.75	1/2/2024
Consultants	7/1/16 - 7/28/17		28,000	$	2.18-$11.50	6/30/2019- 7/27/2027

Tabular disclosure of derivative liabilities at fair value

	March 31, 2019		September 30, 2018
Series S warrants	$	-	$	33
Series V warrants		275,584		770,436
Series W warrants		383,053		999,081
Series Z warrants		372,936		487,767
Series ZZ warrants		21,577		34,215
Series AA warrants		287,206		380,474
Series BB warrants		20,720		28,456
Series CC warrants		1,440,026		1,779,724
Series DD warrants		-		1,249,287
Series EE warrants		-		1,249,287
Series FF warrants		154,318		188,921
Series GG warrants		500,478		607,228
Series HH warrants		48,174		58,816
Series II warrants		544,792		660,135
Series JJ warrants		72,716		88,642
Series KK warrants		543,463		656,930
Series LL warrants		62,886		77,632
Total warrant liabilities	$	4,727,929	$	9,317,064

Schedule of gains and (losses) on derivative liabilities

The table below presents the gains/(losses) on the warrant liabilities for the six months ended March 31:

	2019		2018
Series S warrants	$	33	$	11,927
Series V warrants		494,852		(3,547	)
Series W warrants		616,028		(24,131	)
Series Z warrants		114,831		8,095
Series ZZ warrants		12,638		189
Series AA warrants		93,268		8,676
Series BB warrants		7,736		293
Series CC warrants		339,698		41,919
Series DD warrants		1,249,287		5,456
Series EE warrants		1,249,287		5,456
Series FF warrants		34,603		7,301
Series GG warrants		106,750		37,419
Series HH warrants		10,642		2,683
Series II warrants		115,343		50,608
Series JJ warrants		15,926		4,010
Series KK warrants		113,467		36,924
Series LL warrants		14,746		3,307
Net gain on warrant liabilities	$	4,589,135	$	196,585

The table below presents the gains/(losses) on the warrant liabilities for the three months ended March 31:

	2019			2018
Series S warrants	$	-		$	(1,141	)
Series V warrants		(61,480	)		94,766
Series W warrants		(10,822	)		105,336
Series Z warrants		(89,290	)		63,630
Series ZZ warrants		(1,685	)		3,532
Series AA warrants		(63,951	)		56,036
Series BB warrants		(4,374	)		2,924
Series CC warrants		(325,908	)		238,740
Series DD warrants		-			(27	)
Series EE warrants		-			(27	)
Series FF warrants		(34,459	)		25,348
Series GG warrants		(106,032	)		152,551
Series HH warrants		(10,309	)		8,345
Series II warrants		(115,246	)		229,414
Series JJ warrants		(15,536	)		12,552
Series KK warrants		(114,628	)		151,951
Series LL warrants		(13,451	)		10,885
Net (loss)/gain on warrant liabilities	$	(967,171	)	$	1,154,815

Other non-operating gain (loss)

	Six Months Ended					Three Months Ended
	3/31/2019		3/31/2018			3/31/2019			3/31/2018
Amount realized through the resale of shares	$	1,711,353	$	1,225,291		$	559,177		$	478,590
Fair value of shares upon issuance		1,290,000		1,247,400			1,290,000			1,247,400
Other non-operating gain (loss)	$	421,353	$	(22,109	)	$	(730,823	)	$	(768,810	)

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D. FAIR VALUE MEASUREMENTS (Tables)

6 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

Measured at fair value on a recurring basis

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at March 31, 2019:

	Quoted Prices in Active Markets for Identical Assets or Liabilities  (Level 1)	Significant Other Observable Inputs  (Level 2)	Significant Unobservable Inputs  (Level 3)	Total
Derivative instruments	$ -	$ -	$4,727,929	$4,727,929

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2018:

	Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)	Significant Other Observable Inputs (Level 2)	Significant Unobservable Inputs (Level 3)	Total
Derivative instruments	$33	$ -	$9,317,031	$9,317,064

Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)

	Six Months Ended			Year Ended
	March 31, 2019			September 30, 2018
Beginning balance	$	9,317,031		$	2,020,629
Issuances		-			-
Exercises		-			(595,780	)
Realized and unrealized (gains) and losses		(4,589,102	)		7,892,182
Ending balance	$	4,727,929		$	9,317,031

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E. COMMITMENTS AND CONTINGENCIES (Tables)

6 Months Ended

Mar. 31, 2019

Commitments and Contingencies Disclosure [Abstract]

Future minimum lease payments under the San Tomas lease

Six months ending September 30, 2019	$	907,000
Year ending September 30,
2020		1,872,000
2021		1,937,000
2022		2,004,000
2023		2,073,000
2024		2,145,000
Thereafter		9,540,000
Total future minimum lease obligation		20,478,000
Less imputed interest on financing obligation		(7,034,000	)
Net present value of lease financing obligation	$	13,444,000

Schedule of future minimum payments under operating leases

Six months ending September 30, 2019	$	130,000
Year ending September 30,
2020		238,000
2021		163,000
2022		69,000
Total	$	600,000

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F. PATENTS (Tables)

6 Months Ended

Mar. 31, 2019

Intangible Assets, Net (Excluding Goodwill) [Abstract]

Schedule of total estimated future amortization

Six months ending September 30, 2019	$	20,000
Year ending September 30,
2020		39,000
2021		36,000
2022		31,000
2023		21,000
2024		18,000
Thereafter		78,000
Total	$	243,000

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G. LOSS PER COMMON SHARE (Tables)

6 Months Ended

Mar. 31, 2019

Net loss per common share

Computation of dilutive net loss per share

	Six months ended March 31,						Three months ended March 31,
	2019			2018			2019			2018
Loss per share - basic
Net loss available to common shareholders - basic	$	(5,201,779	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Weighted average shares outstanding - basic		28,543,417			13,403,878			29,113,910			15,210,296
Basic loss per common share	$	(0.18	)	$	(0.81	)	$	(0.22	)	$	( 0.31	)
Loss per share - diluted
Net loss available to common shareholders - basic	$	(5,201,779	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Gain on derivatives (1)		(335,560	)		-			-			-
Net loss available to common shareholders - diluted	$	(5,537,339	)	$	(10,895,965	)	$	(6,447,681	)	$	(4,708,135	)
Weighted average shares outstanding - basic		28,543,417			13,403,878			29,113,910			15,210,296
Incremental shares underlying dilutive "in the money" warrants (1)		5,401			-			-			-
Weighted average shares outstanding - diluted		28,548,818			13,403,878			29,113,910			15,210,296
Diluted loss per common share	$	(0.19	)	$	(0.81	)	$	(0.22	)	$	(0.31	)

Antidilutive securities

	2019	2018
Options and Warrants	10,576,881	12,381,730
Unvested Restricted Stock	308,500	312,000
Convertible debt	-	1,077,982
Total	10,885,381	13,771,712

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C. STOCKHOLDERS EQUITY (Details) - USD ($)	3 Months Ended				6 Months Ended
	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Dec. 31, 2017	Mar. 31, 2019	Mar. 31, 2018
Common Stock
Beginning balance	$ 278,435	$ 280,346	$ 132,581	$ 119,031	$ 280,346	$ 119,031
Beginning balance, shares	27,843,327	28,034,487	13,258,051	11,903,133	28,034,487	11,903,133
Sale of common stock			$ 25,011	$ 12,895
Sale of common stock, shares			2,501,145	1,289,478
Warrant exercises	$ 15,239	$ 2,987
Warrant exercises, shares	1,523,933	298,682
401(k) contributions paid in common stock	$ 104	$ 123	$ 259	$ 190
401(k) contributions paid in common stock, shares	10,419	12,279	25,901	18,984
Stock issued to nonemployees for service	$ 774	$ 628	$ 1,241	$ 137
Stock issued to nonemployees for service, shares	77,449	62,784	124,082	13,705
Conversion of notes payable and interest to common stock			$ 554
Conversion of notes payable and interest to common stock, shares			55,373
Shares issued (returned) for settlement of clinical research costs	$ 5,000	$ (5,649)	$ 6,600
Shares issued (returned) for settlement of clinical research costs, shares	500,000	(564,905)	660,000
Equity based compensation - employees	$ (35)
Equity based compensation - employees, shares	(3,500)
Ending balance	$ 299,517	$ 278,435	$ 166,246	$ 132,581	$ 299,517	$ 166,246
Ending balance, shares	29,951,628	27,843,327	16,624,552	13,258,051	29,951,628	16,624,552
Additional Paid-In Capital
Beginning balance	$ 332,775,129	$ 331,312,184	$ 300,975,618	$ 296,298,401	$ 331,312,184	$ 296,298,401
Sale of common stock			4,652,130	2,437,105
Warrant exercises	2,640,395	646,766
401(k) contributions paid in common stock	36,779	35,118	36,261	35,690
Stock issued to nonemployees for service	224,855	201,752	227,254	25,270
Conversion of notes payable and interest to common stock			108,746
Shares issued (returned) for settlement of clinical research costs	1,285,000	5,649	1,240,800
Equity based compensation - employees	530,865	573,660		1,448,098
Stock issuance cost	(43,625)		(94,773)
Ending balance	337,449,398	332,775,129	307,425,853	300,975,618	337,449,398	307,425,853
Accumulated Deficit
Beginning balance	(330,345,712)	(331,591,614)	(305,942,239)	(299,754,409)	(331,591,614)	(299,754,409)
Net income (loss)	(6,447,681)	1,245,902	(4,708,135)	(6,187,830)
Ending balance	(336,793,393)	(330,345,712)	(310,650,374)	(305,942,239)	(336,793,393)	(310,650,374)
Beginning balance	2,707,852	916	(4,834,040)	(3,336,977)	916	(3,336,977)
Sale of common stock			4,667,141	2,450,000
Warrant exercises	2,655,634	649,753
401(k) contributions paid in common stock	36,883	35,241	36,520	35,880	72,124	72,400
Stock issued to nonemployees for service	225,629	202,380	228,495	25,407
Conversion of notes payable and interest to common stock			109,300
Shares issued (returned) for settlement of clinical research costs	1,290,000	0	1,247,400
Equity based compensation - employees	530,830	573,660		1,448,098
Stock issuance cost	(43,625)		(94,773)
Net income (loss)	(6,447,681)	1,245,902	(4,708,135)	(6,187,830)	(5,201,779)	(10,895,965)
Ending balance	$ 955,522	$ 2,707,852	$ (3,058,275)	$ (4,834,040)	$ 955,522	$ (3,058,275)

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C. STOCKHOLDERS EQUITY (Details 1) - shares	Mar. 31, 2019	Sep. 30, 2018
Incentive Stock Option Plans
Total shares reserved under plans	138,400	138,400
Shares reserved for outstanding options	123,558	123,558
Shares issued	0	0
Remaining options/shares under plans	385	385
Non Qualified Stock Option Plans
Total shares reserved under plans	3,387,200	3,387,200
Shares reserved for outstanding options	3,010,476	3,036,569
Shares issued	0	0
Remaining options/shares under plans	335,619	309,526
Stock Bonus Plans
Total shares reserved under plans	783,760	783,760
Shares reserved for outstanding options	0	0
Shares issued	322,928	297,230
Remaining options/shares under plans	460,799	486,497
Stock Compensation Plan
Total shares reserved under plans	134,000	134,000
Shares reserved for outstanding options	0	0
Shares issued	115,590	118,590
Remaining options/shares under plans	18,410	15,410
Incentive Stock Bonus Plan
Total shares reserved under plans	640,000	640,000
Shares reserved for outstanding options	0	0
Shares issued	620,500	624,000
Remaining options/shares under plans	16,000	16,000

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C. STOCKHOLDERS EQUITY (Details 2) - shares	3 Months Ended		6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Equity [Abstract]
Granted	0	0	500	10,300
Expired	0	584	2,400	24,379
Forfeited	24,193	6,856	24,193	1,393

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C. STOCKHOLDERS EQUITY (Details 3)	6 Months Ended
	Mar. 31, 2019 $ / shares shares
Series N [Member]
STOCKHOLDERS' EQUITY
Issue date	8/18/2008
Shares issuable upon exercise of warrant | shares	85,339
Exercise price	$ 3.00
Expiration date	2/18/2020
Series V [Member]
STOCKHOLDERS' EQUITY
Issue date	5/28/2015
Shares issuable upon exercise of warrant | shares	810,127
Exercise price	$ 19.75
Expiration date	5/28/2020
Series UU [Member]
STOCKHOLDERS' EQUITY
Issue date	6/11/2018
Shares issuable upon exercise of warrant | shares	187,562
Exercise price	$ 2.80
Expiration date	6/11/2020
Series W [Member]
STOCKHOLDERS' EQUITY
Issue date	10/28/2015
Shares issuable upon exercise of warrant | shares	688,930
Exercise price	$ 16.75
Expiration date	10/28/2020
Series X [Member]
STOCKHOLDERS' EQUITY
Issue date	1/13/2016
Shares issuable upon exercise of warrant | shares	120,000
Exercise price	$ 9.25
Expiration date	1/13/2021
Series Y [Member]
STOCKHOLDERS' EQUITY
Issue date	2/15/2016
Shares issuable upon exercise of warrant | shares	26,000
Exercise price	$ 12.00
Expiration date	2/15/2021
Series ZZ [Member]
STOCKHOLDERS' EQUITY
Issue date	5/23/2016
Shares issuable upon exercise of warrant | shares	20,000
Exercise price	$ 13.75
Expiration date	5/18/2021
Series BB [Member]
STOCKHOLDERS' EQUITY
Issue date	8/26/2016
Shares issuable upon exercise of warrant | shares	16,000
Exercise price	$ 13.75
Expiration date	8/22/2021
Series Z [Member]
STOCKHOLDERS' EQUITY
Issue date	5/23/2016
Shares issuable upon exercise of warrant | shares	264,000
Exercise price	$ 13.75
Expiration date	11/23/2021
Series FF [Member]
STOCKHOLDERS' EQUITY
Issue date	12/8/2016
Shares issuable upon exercise of warrant | shares	68,048
Exercise price	$ 3.91
Expiration date	12/1/2021
Series CC [Member]
STOCKHOLDERS' EQUITY
Issue date	12/8/2016
Shares issuable upon exercise of warrant | shares	680,480
Exercise price	$ 5.00
Expiration date	12/8/2021
Series HH [Member]
STOCKHOLDERS' EQUITY
Issue date	2/23/2017
Shares issuable upon exercise of warrant | shares	20,000
Exercise price	$ 3.13
Expiration date	2/16/2022
Series AA [Member]
STOCKHOLDERS' EQUITY
Issue date	8/26/2016
Shares issuable upon exercise of warrant | shares	200,000
Exercise price	$ 13.75
Expiration date	2/22/2022
Series JJ [Member]
STOCKHOLDERS' EQUITY
Issue date	3/14/2017
Shares issuable upon exercise of warrant | shares	30,000
Exercise price	$ 3.13
Expiration date	3/8/2022
Series LL [Member]
STOCKHOLDERS' EQUITY
Issue date	4/30/2017
Shares issuable upon exercise of warrant | shares	26,398
Exercise price	$ 3.59
Expiration date	4/30/2022
Series MM [Member]
STOCKHOLDERS' EQUITY
Issue date	6/22/2017
Shares issuable upon exercise of warrant | shares	893,491
Exercise price	$ 1.86
Expiration date	6/22/2022
Series NN [Member]
STOCKHOLDERS' EQUITY
Issue date	7/24/2017
Shares issuable upon exercise of warrant | shares	539,300
Exercise price	$ 2.52
Expiration date	7/24/2022
Series OO [Member]
STOCKHOLDERS' EQUITY
Issue date	7/31/2017
Shares issuable upon exercise of warrant | shares	60,000
Exercise price	$ 2.52
Expiration date	7/31/2022
Series QQ [Member]
STOCKHOLDERS' EQUITY
Issue date	8/22/2017
Shares issuable upon exercise of warrant | shares	3,500
Exercise price	$ 2.50
Expiration date	8/22/2022
Series GG [Member]
STOCKHOLDERS' EQUITY
Issue date	2/23/2017
Shares issuable upon exercise of warrant | shares	200,000
Exercise price	$ 3.00
Expiration date	8/23/2022
Series II [Member]
STOCKHOLDERS' EQUITY
Issue date	3/14/2017
Shares issuable upon exercise of warrant | shares	216,500
Exercise price	$ 3.00
Expiration date	9/14/2022
Series RR [Member]
STOCKHOLDERS' EQUITY
Issue date	10/30/2017
Shares issuable upon exercise of warrant | shares	555,370
Exercise price	$ 1.65
Expiration date	10/30/2022
Series KK [Member]
STOCKHOLDERS' EQUITY
Issue date	5/3/2017
Shares issuable upon exercise of warrant | shares	213,870
Exercise price	$ 3.04
Expiration date	11/3/2022
Series SS [Member]
STOCKHOLDERS' EQUITY
Issue date	12/19/2017
Shares issuable upon exercise of warrant | shares	794,740
Exercise price	$ 2.09
Expiration date	12/18/2022
Series TT [Member]
STOCKHOLDERS' EQUITY
Issue date	2/5/2018
Shares issuable upon exercise of warrant | shares	1,210,827
Exercise price	$ 2.24
Expiration date	2/5/2023
Series PP [Member]
STOCKHOLDERS' EQUITY
Issue date	8/28/2017
Shares issuable upon exercise of warrant | shares	112,500
Exercise price	$ 2.30
Expiration date	2/28/2023
Series WW [Member]
STOCKHOLDERS' EQUITY
Issue date	7/2/2018
Shares issuable upon exercise of warrant | shares	69,225
Exercise price	$ 1.63
Expiration date	6/28/2023
Series VV [Member]
STOCKHOLDERS' EQUITY
Issue date	7/2/2018
Shares issuable upon exercise of warrant | shares	2,515,000
Exercise price	$ 1.75
Expiration date	1/2/2024
Consultants [Member]
STOCKHOLDERS' EQUITY
Issue date	7/1/16 - 7/28/17
Shares issuable upon exercise of warrant | shares	28,000
Exercise price minimum	$ 2.18
Exercise price maximum	$ 11.50
Expiration date	6/30/2019- 7/27/2027

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C. STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018	Sep. 30, 2018
Equity [Abstract]
Series S warrants	$ 0		$ 0		$ 33
Series V warrants	275,584		275,584		770,436
Series W warrants	383,053		383,053		999,081
Series Z warrants	372,936		372,936		487,767
Series ZZ warrants	21,577		21,577		34,215
Series AA warrants	287,206		287,206		380,474
Series BB warrants	20,720		20,720		28,456
Series CC warrants	1,440,026		1,440,026		1,779,724
Series DD warrants	0		0		1,249,287
Series EE warrants	0		0		1,249,287
Series FF warrants	154,318		154,318		188,921
Series GG warrants	500,478		500,478		607,228
Series HH warrants	48,174		48,174		58,816
Series II warrants	544,792		544,792		660,135
Series JJ warrants	72,716		72,716		88,642
Series KK warrants	543,463		543,463		656,930
Series LL warrants	62,886		62,886		77,632
Total warrant liabilities	4,727,929		4,727,929		$ 9,317,064
Series S warrants	0	$ (1,141)	33	$ 11,927
Series V warrants	(61,480)	94,766	494,852	(3,547)
Series W warrants	(10,822)	105,336	616,028	(24,131)
Series Z warrants	(89,290)	63,630	114,831	8,095
Series ZZ warrants	(1,685)	3,532	12,638	189
Series AA warrants	(63,951)	56,036	93,268	8,676
Series BB warrants	(4,374)	2,924	7,736	293
Series CC warrants	(325,908)	238,740	339,698	41,919
Series DD warrants	0	(27)	1,249,287	5,456
Series EE warrants	0	(27)	1,249,287	5,456
Series FF warrants	(34,459)	25,348	34,603	7,301
Series GG warrants	(106,032)	152,551	106,750	37,419
Series HH warrants	(10,309)	8,345	10,642	2,683
Series II warrants	(115,246)	229,414	115,343	50,608
Series JJ warrants	(15,536)	12,552	15,926	4,010
Series KK warrants	(114,628)	151,951	113,467	36,924
Series LL warrants	(13,451)	10,885	14,746	3,307
Net (loss)/gain on warrant liabilities	$ (967,171)	$ 1,154,815	$ 4,589,135	$ 196,585

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C. STOCKHOLDERS EQUITY (Details 5) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Equity [Abstract]
Amount realized through the resale of shares	$ 559,177	$ 478,590	$ 1,711,353	$ 1,225,291
Fair value of shares upon issuance	1,290,000	1,247,400	1,290,000	1,247,400
Other non-operating gain (loss)	$ (730,823)	$ (768,810)	$ 421,353	$ (22,109)

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C. STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Dec. 31, 2017
Equity [Abstract]
Consulting agreement expense	$ 225,629	$ 202,380	$ 228,495	$ 25,407

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D. FAIR VALUE MEASUREMENTS (Details) - USD ($)	Mar. 31, 2019	Sep. 30, 2018
Derivative instruments	$ 4,727,929	$ 9,317,064
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)
Derivative instruments	0	33
Significant Other Observable Inputs (Level 2)
Derivative instruments	0	0
Significant Unobservable Inputs (Level 3)
Derivative instruments	$ 4,727,929	$ 9,317,031

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D. FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	6 Months Ended	12 Months Ended
	Mar. 31, 2019	Sep. 30, 2018
Fair Value Disclosures [Abstract]
Beginning balance	$ 9,317,031	$ 2,020,629
Issuances	0	0
Exercises	0	(595,780)
Realized and unrealized (gains) and losses	(4,589,102)	7,892,182
Ending balance	$ 4,727,929	$ 9,317,031

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E. COMMITMENTS AND CONTINGENCIES (Details)	Mar. 31, 2019 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Six months ending March 31, 2019	$ 907,000
2020	1,872,000
2021	1,937,000
2022	2,004,000
2023	2,073,000
2024	2,145,000
Thereafter	9,540,000
Total future minimum lease obligation	20,478,000
Less imputed interest on financing obligation	(7,034,000)
Net present value of lease financing obligation	$ 13,444,000

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E. COMMITMENTS AND CONTINGENCIES (Details 1)	Mar. 31, 2019 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Six months ending March 31, 2019	$ 130,000
2020	238,000
2021	163,000
2022	69,000
Total	$ 600,000

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E. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	Mar. 31, 2019	Sep. 30, 2018
Research and Development Lab
Deferred rent liability	$ 14,000	$ 12,000
Headquarters
Deferred rent liability	$ 11,000	$ 14,000

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F. PATENTS (Details) - USD ($)	Mar. 31, 2019	Sep. 30, 2018
Intangible Assets, Net (Excluding Goodwill) [Abstract]
Six months ending March 31, 2019	$ 20,000
2020	39,000
2021	36,000
2022	31,000
2023	21,000
2024	18,000
Thereafter	78,000
Total	$ 243,253	$ 258,093

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F. PATENTS (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Intangible Assets, Net (Excluding Goodwill) [Abstract]
Amortization of patent costs	$ 11,000	$ 9,000	$ 23,000	$ 19,000

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G. LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended				6 Months Ended
	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Dec. 31, 2017	Mar. 31, 2019	Mar. 31, 2018
Net loss per common share
Net loss available to common shareholders, basic	$ (6,447,681)	$ 1,245,902	$ (4,708,135)	$ (6,187,830)	$ (5,201,779)	$ (10,895,965)
Weighted average shares outstanding, basic	29,113,910		15,210,296		28,543,417	13,403,878
Basic loss per common share	$ (0.22)		$ (0.31)		$ (0.18)	$ (0.81)
Net loss available to common shareholders, basic	$ (6,447,681)		$ (4,708,135)		$ (5,201,779)	$ (10,895,965)
Gain on derivatives	0		0		(335,560)	0
Net loss available to common shareholders, diluted	$ (6,447,681)		$ (4,708,135)		$ (5,537,339)	$ (10,895,965)
Weighted average shares outstanding - basic	29,113,910		15,210,296		28,543,417	13,403,878
Incremental shares underlying dilutive "in the money" warrants (1)	0		0		5,401	0
Weighted average shares outstanding - diluted	29,113,910		15,210,296		28,548,818	13,403,878
Diluted loss per common share	$ (0.22)		$ (0.31)		$ (0.19)	$ (0.81)

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G. LOSS PER COMMON SHARE (Details 1) - shares	6 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Antidilutive securities	10,885,381	13,771,712
Options and Warrants
Antidilutive securities	10,576,881	12,381,730
Unvested Restricted Stock
Antidilutive securities	308,500	312,000
Convertible debt
Antidilutive securities	0	1,077,982