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. |