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.