C. STOCKHOLDERS EQUITY

9 Months Ended

Jun. 30, 2019

Equity [Abstract]

C. STOCKHOLDERS' EQUITY

The changes in stockholders’ equity during the nine months ended June 30, 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 services		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 services		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
Warrant exercises		4,014,109			40,141			10,212,680			-			10,252,821
401(k) contributions paid in common stock		4,339			43			36,318			-			36,361
Stock issued to nonemployees for services		20,825			208			140,062			-			140,270
Equity based compensation - employees		(4,000	)		(40	)		1,521,861			-			1,521,821
Option exercises		42,770			428			96,862			-			97,290
Purchase of stock by officers and directors		37,243			372			234,625			-			234,997
Stock issuance costs		-			-			(8,010	)		-			(8,010	)
Net loss		-			-			-			(12,084,768	)		(12,084,768	)
BALANCES AT JUNE 30, 2019		34,066,914		$	340,669		$	349,683,796		$	(348,878,161	)	$	1,146,304

The changes in stockholders’ deficit during the nine months ended June 30, 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 services		13,705		137		25,270			-			25,407
Equity based compensation - employees		-		-		1,448,098			-			1,448,098
Warrants issued with notes payable		-		-		656,382			-			656,382
Conversion of notes payable to common stock		32,751		328		74,672			-			75,000
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			-			4,677,141
401(k) contributions paid in common stock		25,901		259		36,261			-			36,520
Stock issued to nonemployees for services		124,082		1,241		227,254			-			228,495
Equity based compensation - employees		-		-		279,817			-			279,817
Conversion of notes payable 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	)
Warrant exercises		1,117,644		11,177		2,906,619			-			2,917,796
401(k) contributions paid in common stock		39,862		399		36,274			-			36,673
Stock issued to nonemployees for services		81,604		816		208,387			-			209,203
Equity based compensation - employees		-		-		465,487			-			465,487
Conversion of notes payable and interest to common stock		1,106,806		11,068		2,179,648			-			2,190,716
Shares issued for settlement of clinical research costs		600,000		6,000		1,704,000			-			1,710,000
Warrants issued with notes payable		-		-		291,234			-			291,234
Net loss		-		-		-			(6,014,568	)		(6,014,568	)
BALANCES AT JUNE 30, 2018		19,570,468	$	195,706	$	315,217,502		$	(316,664,942	)	$	(1,251,734	)

Underlying share information for equity compensation plans as of June 30, 2019 is 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		99,962		N/A		385
Non-Qualified Stock Option Plans		6,387,200		6,193,237		N/A		115,156
Stock Bonus Plans		783,760		N/A		327,267		456,460
Stock Compensation Plan		634,000		N/A		122,221		493,369
Incentive Stock Bonus Plan		640,000		N/A		616,500		23,500

Underlying share information for equity compensation plans as of September 30, 2018 is 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:

	Nine Months Ended June 30,
	2019		2018
Granted		3,268,862		1,858,108
Exercised		42,770		-
Expired		29,322		26,395
Forfeited		63,698		1,393

	Three Months Ended June 30,
	2019		2018
Granted		3,268,362		1,847,808
Exercised		42,770		-
Expired		26,922		2,016
Forfeited		39,505		-

During the quarter ended June 30, 2019, the Company adopted the 2019 Stock Compensation Plan, which authorized the issuance of up to 500,000 shares of common stock to officers, directors, employees and consultants.

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 June 30, 2019 and September 30, 2018, approximately $88,000 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 June 30, 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		163,544	$	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		611,463	$	5.00	12/8/2021
Series HH	2/23/2017		6,500	$	3.13	2/16/2022
Series AA	8/26/2016		200,000	$	13.75	2/22/2022
Series JJ	3/14/2017		9,450	$	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		473,798	$	2.52	7/24/2022
Series OO	7/31/2017		60,000	$	2.52	7/31/2022
Series II	3/14/2017		95,000	$	3.00	9/14/2022
Series RR	10/30/2017		495,326	$	1.65	10/30/2022
Series SS	12/19/2017		514,476	$	2.09	12/18/2022
Series TT	2/5/2018		760,758	$	2.24	2/5/2023
Series PP	8/28/2017		112,500	$	2.30	2/28/2023
Series WW	7/2/2018		1,950	$	1.63	6/28/2023
Series VV	7/2/2018		90,000	$	1.75	1/2/2024
Consultants	7/28/17		10,000	$	2.18	7/27/2027

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

	June 30, 2019		September 30, 2018
Series S warrants	$	-	$	33
Series V warrants		1,249,835		770,436
Series W warrants		2,131,237		999,081
Series Z warrants		1,172,626		487,767
Series ZZ warrants		72,185		34,215
Series AA warrants		963,990		380,474
Series BB warrants		64,256		28,456
Series CC warrants		3,699,989		1,779,724
Series DD warrants		-		1,249,287
Series EE warrants		-		1,249,287
Series FF warrants		433,091		188,921
Series GG warrants		-		607,228
Series HH warrants		44,050		58,816
Series II warrants		660,020		660,135
Series JJ warrants		64,252		88,642
Series KK warrants		-		656,930
Series LL warrants		177,299		77,632
Total warrant liabilities	$	10,732,830	$	9,317,064

The table below presents the gains/(losses) on the warrant liabilities for the nine months ended June 30:

	2019			2018
Series S warrants	$	33		$	(756,261	)
Series V warrants		(479,399	)		22,842
Series W warrants		(1,132,156	)		18,478
Series Z warrants		(684,859	)		34,682
Series ZZ warrants		(37,970	)		2,103
Series AA warrants		(583,516	)		28,337
Series BB warrants		(35,800	)		1,988
Series CC warrants		(2,007,287	)		181,244
Series DD warrants		1,249,287			5,492
Series EE warrants		1,249,287			5,492
Series FF warrants		(244,170	)		23,119
Series GG warrants		195,228			170,131
Series HH warrants		(22,859	)		7,962
Series II warrants		(593,960	)		250,578
Series JJ warrants		(32,954	)		11,970
Series KK warrants		(55,622	)		169,808
Series LL warrants		(99,667	)		10,002
Net (loss) gain on warrant liabilities	$	(3,316,384	)	$	187,967

The table below presents the gains/(losses) on the warrant liabilities for the three months ended June 30:

	2019			2018
Series S warrants	$	-		$	(768,188	)
Series V warrants		(974,251	)		26,389
Series W warrants		(1,748,184	)		42,609
Series Z warrants		(799,690	)		26,587
Series ZZ warrants		(50,608	)		1,914
Series AA warrants		(676,784	)		19,661
Series BB warrants		(43,536	)		1,695
Series CC warrants		(2,346,985	)		139,325
Series DD warrants		-			36
Series EE warrants		-			36
Series FF warrants		(278,773	)		15,818
Series GG warrants		88,478			132,712
Series HH warrants		(33,501	)		5,279
Series II warrants		(709,303	)		199,970
Series JJ warrants		(48,880	)		7,960
Series KK warrants		(169,089	)		132,884
Series LL warrants		(114,413	)		6,695
Net loss on warrant liabilities	$	(7,905,519	)	$	(8,618	)

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. The expiration dates of these warrants had been previously extended and such modifications were reflected in the fair value measurements of the warrants on the dates of modification.

On October 11, 2018, 327,729 Series S warrants, with an exercise price of $31.25, expired. The exercise price of these warrants had been previously repriced under temporarily revised terms. During the quarter ended June 30, 2018 and under the revised terms, 709,391 previously outstanding warrants were exercised for total proceeds of approximately $1.2 million,

2. Securities Purchase Agreements

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 sales 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 sale by Ergomed and reduces accounts payable to Ergomed. Any amounts received from the sale 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 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 nine months ended June 30, 2019 and 2018, respectively, the Company decreased Accounts Payable by approximately $3.2 million and $2.8 million through the sale of 808,769 and 1,538,129 shares, respectively, by Ergomed.

The following table summarizes the Other Non-Operating Gains (Loss) for the nine and three months ended June 30, 2019 and 2018 relating to these agreements:

	Nine Months Ended					Three Months Ended
	6/30/2019		6/30/2018			6/30/2019		6/30/2018
Amount realized through the sale of shares	$	3,167,197	$	2,785,932		$	1,455,844	$	1,560,641
Fair value of shares upon issuance		1,290,000		2,957,400			-		1,710,000
Other non-operating gain (loss)	$	1,877,197	$	(171,468	)	$	1,455,844	$	( 149,359	)

As of June 30, 2019, Ergomed holds 45,226 shares and may sell the shares or return the shares to the Company for cancellation until December 31, 2019.

3. Incentive Stock Bonus Plan

During the nine and three months ended June 30, 2019, respectively, 7,500 and 4,000 shares of common stock issued from the 2014 Incentive Stock Bonus Plan were forfeited.