Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Mar. 31, 2021 | May 12, 2021 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Entity Registrant Name | OUTLOOK THERAPEUTICS, INC. | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 173,605,807 | |
Entity Central Index Key | 0001649989 | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Common Stock | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock | |
Trading Symbol | OTLK | |
Security Exchange Name | NASDAQ | |
Series A Warrants | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Series A Warrants | |
Trading Symbol | OTLKW | |
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Current assets: | ||
Cash | $ 37,168,854 | $ 12,535,986 |
Prepaid expenses and other current assets | 6,623,987 | 5,407,882 |
Total current assets | 43,792,841 | 17,943,868 |
Property and equipment, net | 245,437 | 327,249 |
Operating lease right-of-use assets, net | 166,986 | |
Other assets | 1,073,536 | 1,294,448 |
Total assets | 45,111,814 | 19,732,551 |
Current liabilities: | ||
Current portion of long-term debt | 11,184,734 | 50,285 |
Current portion of finance lease liabilities | 26,972 | 29,778 |
Current portion of operating lease liabilities | 187,486 | |
Stockholder notes | 3,612,500 | |
Accounts payable | 6,332,256 | 2,394,818 |
Accrued expenses | 4,497,209 | 7,757,310 |
Income taxes payable | 1,856,629 | 1,856,629 |
Total current liabilities | 23,897,800 | 15,888,806 |
Long-term debt | 129,171 | 904,200 |
Finance lease liabilities | 28,755 | 42,482 |
Warrant liability | 404,916 | 70,772 |
Total liabilities | 24,460,642 | 16,906,260 |
Commitments and contingencies (Note 9) | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Common stock, par value $0.01 per share; 325,000,000 shares authorized; 173,605,807 shares issued and outstanding at March 31, 2021 and 127,183,109 shares issued and outstanding at September 30, 2020 | 1,736,058 | 1,271,831 |
Additional paid-in capital | 336,197,455 | 291,274,366 |
Accumulated deficit | (317,282,341) | (289,719,906) |
Total stockholders' equity | 20,651,172 | 2,826,291 |
Total liabilities, convertible preferred stock and stockholders' equity | 45,111,814 | 19,732,551 |
Series A convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Series A-1 convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Series B convertible preferred stock | ||
Stockholders’ equity: | ||
Preferred stock, value |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2021 | Sep. 30, 2020 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 7,300,000 | 7,300,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 325,000,000 | 325,000,000 |
Common stock, shares issued | 173,605,807 | 127,183,109 |
Common stock, shares outstanding | 173,605,807 | 127,183,109 |
Series A convertible preferred stock | ||
Convertible stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock outstanding | 0 | 0 |
Series A-1 convertible preferred stock | ||
Convertible stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 200,000 | 200,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock outstanding | 0 | 0 |
Series B convertible preferred stock | ||
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Operating expenses: | ||||
Research and development | $ 8,529,393 | $ 4,383,214 | $ 20,477,974 | $ 10,230,516 |
General and administrative | 4,095,891 | 1,957,175 | 6,338,245 | 4,293,899 |
Impairment of property and equipment | 423,328 | 423,328 | ||
Total operating expenses | 12,625,284 | 6,763,717 | 26,816,219 | 14,947,743 |
Loss from operations | (12,625,284) | (6,763,717) | (26,816,219) | (14,947,743) |
Interest expense, net | 250,409 | 696,151 | 410,072 | 1,293,816 |
Loss on extinguishment of debt | 8,060,580 | |||
Change in fair value of redemption feature | (1,759,037) | (1,796,982) | ||
Change in fair value of warrant liability | 228,828 | (764) | 334,144 | (202,142) |
Loss before income taxes | (13,104,521) | (5,700,067) | (27,560,435) | (22,303,015) |
Income tax expense | 2,000 | 2,000 | ||
Net loss | (13,106,521) | (5,700,067) | (27,562,435) | (22,303,015) |
Series A-1 convertible preferred stock dividends and related settlement | (166,133) | |||
Deemed dividend upon modification of warrants | (1,431,406) | (3,140,009) | ||
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock | (10,328,118) | (10,328,118) | ||
Net loss attributable to common stockholders | $ (13,106,521) | $ (17,459,591) | $ (27,562,435) | $ (35,937,275) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.09) | $ (0.36) | $ (0.20) | $ (0.93) |
Weighted average shares outstanding, basic and diluted (in shares) | 150,730,191 | 47,895,771 | 136,080,637 | 38,849,364 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) | Preferred StockSeries A-1 convertible preferred stock | Common StockMTTR, LLC (“MTTR”) | Common Stock | Additional Paid-in CapitalMTTR, LLC (“MTTR”) | Additional Paid-in Capital | Accumulated Deficit | Series A-1 convertible preferred stock | Total |
Balance at Sep. 30, 2019 | $ 5,359,404 | $ 286,100 | $ 238,064,947 | $ (254,480,408) | $ (16,129,361) | |||
Balance, beginning (in shares) at Sep. 30, 2019 | 66,451 | 28,609,995 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with exercise of warrants | $ 130,034 | 1,008,866 | 1,138,900 | |||||
Issuance of common stock in connection with exercise of warrants (in shares) | 13,003,414 | |||||||
Issuance of common stock in connection with conversion of stockholder notes | $ 14,753 | 1,533,673 | 1,548,426 | |||||
Issuance of common stock in connection with conversion of stockholder notes (in shares) | 1,475,258 | |||||||
Sale of common stock, net of issuance costs | $ 72,447 | $ 100,591 | $ (72,447) | 9,096,357 | $ 9,196,948 | |||
Sale of common stock, net of issuance costs (in shares) | 7,244,739 | 10,059,056 | ||||||
Issuance of vested restricted stock units | $ 1 | (1) | ||||||
Issuance of vested restricted stock units (in shares) | 109 | 109 | ||||||
Series A-1 convertible preferred stock dividends and related settlement | $ 166,133 | (166,133) | $ (166,133) | |||||
Series A-1 convertible preferred stock dividends and related settlement (in shares) | 1,661 | 1,661 | ||||||
Conversion of Series A-1 convertible preferred stock to common stock | $ (5,525,537) | $ 293,586 | 5,231,951 | 5,525,537 | ||||
Conversion of Series A-1 convertible preferred stock to common stock (in shares) | (68,112) | 29,358,621 | ||||||
Stock-based compensation expense | 664,016 | 664,016 | ||||||
Net loss | (22,303,015) | (22,303,015) | ||||||
Balance at Mar. 31, 2020 | $ 897,512 | 255,361,229 | (276,783,423) | (20,524,682) | ||||
Balance, ending (in shares) at Mar. 31, 2020 | 89,751,192 | |||||||
Balance at Dec. 31, 2019 | $ 5,525,537 | $ 384,309 | 239,766,786 | (271,083,356) | (30,932,261) | |||
Balance, beginning (in shares) at Dec. 31, 2019 | 68,112 | 38,430,924 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with exercise of warrants | $ 46,579 | 1,034,043 | 1,080,622 | |||||
Issuance of common stock in connection with exercise of warrants (in shares) | 4,657,852 | |||||||
Sale of common stock, net of issuance costs | $ 72,447 | $ 100,591 | $ (72,447) | 9,096,357 | 9,196,948 | |||
Sale of common stock, net of issuance costs (in shares) | 7,244,739 | 10,059,056 | ||||||
Conversion of Series A-1 convertible preferred stock to common stock | $ (5,525,537) | $ 293,586 | 5,231,951 | 5,525,537 | ||||
Conversion of Series A-1 convertible preferred stock to common stock (in shares) | (68,112) | 29,358,621 | ||||||
Stock-based compensation expense | 304,539 | 304,539 | ||||||
Net loss | (5,700,067) | (5,700,067) | ||||||
Balance at Mar. 31, 2020 | $ 897,512 | 255,361,229 | (276,783,423) | (20,524,682) | ||||
Balance, ending (in shares) at Mar. 31, 2020 | 89,751,192 | |||||||
Balance at Sep. 30, 2020 | $ 1,271,831 | 291,274,366 | (289,719,906) | 2,826,291 | ||||
Balance, beginning (in shares) at Sep. 30, 2020 | 127,183,109 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with exercise of warrants | $ 38,153 | 3,547,656 | 3,585,809 | |||||
Issuance of common stock in connection with exercise of warrants (in shares) | 3,815,304 | |||||||
Sale of common stock, net of issuance costs | $ 426,074 | 39,091,045 | 39,517,119 | |||||
Sale of common stock, net of issuance costs (in shares) | 42,607,394 | |||||||
Stock-based compensation expense | 2,284,388 | 2,284,388 | ||||||
Net loss | (27,562,435) | (27,562,435) | ||||||
Balance at Mar. 31, 2021 | $ 1,736,058 | 336,197,455 | (317,282,341) | 20,651,172 | ||||
Balance, ending (in shares) at Mar. 31, 2021 | 173,605,807 | |||||||
Balance at Dec. 31, 2020 | $ 1,271,831 | 292,429,007 | (304,175,820) | (10,474,982) | ||||
Balance, beginning (in shares) at Dec. 31, 2020 | 127,183,109 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with exercise of warrants | $ 38,153 | 3,547,656 | 3,585,809 | |||||
Issuance of common stock in connection with exercise of warrants (in shares) | 3,815,304 | |||||||
Sale of common stock, net of issuance costs | $ 426,074 | 39,091,045 | 39,517,119 | |||||
Sale of common stock, net of issuance costs (in shares) | 42,607,394 | |||||||
Stock-based compensation expense | 1,129,747 | 1,129,747 | ||||||
Net loss | (13,106,521) | (13,106,521) | ||||||
Balance at Mar. 31, 2021 | $ 1,736,058 | $ 336,197,455 | $ (317,282,341) | $ 20,651,172 | ||||
Balance, ending (in shares) at Mar. 31, 2021 | 173,605,807 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
OPERATING ACTIVITIES | ||
Net loss | $ (27,562,435) | $ (22,303,015) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 163,283 | 351,623 |
Loss on extinguishment of debt | 8,060,580 | |
Non-cash interest expense | 392,028 | 135,787 |
Stock-based compensation | 2,284,388 | 664,016 |
Change in fair value of redemption feature | (1,796,982) | |
Change in fair value of warrant liability | 334,144 | (202,142) |
Impairment of property and equipment | 423,328 | |
Gain on settlement of lease termination obligation | (552,340) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,323,108) | 229,616 |
Other assets | 137,579 | (83,358) |
Operating lease liability | (91,721) | (80,572) |
Accounts payable | 3,685,278 | 1,028,736 |
Accrued expenses | (2,537,903) | (233,806) |
Other liabilities | 49,455 | |
Net cash used in operating activities | (25,070,807) | (13,756,734) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 39,779,507 | 9,457,400 |
Proceeds from debt | 10,000,000 | |
Payment of debt issuance costs | (8,032) | |
Proceeds from exercise of common stock warrants | 3,585,809 | 1,138,900 |
Payments of finance lease obligations | (16,533) | (178,757) |
Repayment of debt | (3,637,076) | (23,414) |
Net cash provided by financing activities | 49,703,675 | 10,394,129 |
Net increase (decrease) in cash | 24,632,868 | (3,362,605) |
Cash at beginning of period | 12,535,986 | 8,015,528 |
Cash at end of period | 37,168,854 | 4,652,923 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 10,490 | 718,521 |
Supplemental schedule of non-cash financing activities: | ||
Unsecured notes and accrued interest converted into common stock | 1,548,426 | |
Issuance of exchange notes at estimated fair value | 7,050,206 | |
Issuance of redemption feature at estimated fair value | 8,264,451 | |
Series A-1 convertible preferred stock dividends and related settlement | 166,133 | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses | $ 262,388 | $ 260,452 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Mar. 31, 2021 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Iselin, New Jersey. The Company has been actively monitoring the novel coronavirus (“COVID-19”) pandemic and its impact globally. Given the Company’s current infrastructure needs and current strategy, the Company was able to transition to remote working with limited impact on productivity, as shelter-in-place and similar government orders were imposed. All clinical and chemistry, manufacturing and control activities are currently active for NORSE TWO, the Company’s remaining clinical trials under its Biologics License Application (“BLA”) registration program for ONS-5010 for wet age-related macular degeneration (“wet AMD”). The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. Management believes the financial results for the six months ended March 31, 2021 were not significantly impacted by COVID-19. |
Liquidity
Liquidity | 6 Months Ended |
Mar. 31, 2021 | |
Liquidity | |
Liquidity | 2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception. As of March 31, 2021, the Company had $10.5 million of principal and accrued interest due under an unsecured promissory note maturing on January 1, 2022, and a $0.9 million loan granted pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which matures on May 2, 2022. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Management believes that the Company’s existing cash as of March 31, 2021 will be sufficient to fund its operations through November 2021. Substantial additional financing will be needed by the Company to fund its operations in the future and to commercially develop ONS-5010 and any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are not limited to proceeds from potential licensing and/or marketing arrangements with pharmaceutical companies, the issuance of equity securities, and the issuance of additional debt, potential collaborations and revenues from potential future product sales, if any. There can be no assurance that these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to complete revenue-generating partnerships with pharmaceutical companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately; (v) regulatory approval and market acceptance of the Company’s proposed future products. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10‑Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2021 and its results of operations for the three and six months ended March 31, 2021 and 2020, cash flows for the six months ended March 31, 2021 and 2020, and convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended March 31, 2021 and 2020. Operating results for the three and six months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2021. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2020 included in the Company’s Annual Report on Form 10‑K filed with the Securities and Exchange Commission (“SEC”) on December 23, 2020 and amended on January 28, 2021. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, including as a result of the ongoing COVID-19 pandemic, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Net loss per share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Net loss attributable to common stockholders $ (13,106,521) $ (17,459,591) $ (27,562,435) $ (35,937,275) Common stock outstanding (weighted average) 150,730,191 47,895,771 136,080,637 38,849,364 Basic and diluted net loss per share $ (0.09) $ (0.36) $ (0.20) $ (0.93) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2021 and 2020, as they would be antidilutive: As of March 31, 2021 2020 Performance-based stock units 2,470 2,470 Stock options 12,010,781 2,218,551 Common stock warrants 5,129,460 6,463,338 Recently issued and adopted accounting pronouncements In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820) : Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018-13"), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The Company adopted ASU 2018-13 on October 1, 2020 and the adoption of this standard did not have a material impact to the Company’s financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Mar. 31, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: · Level 1 - Quoted prices in active markets for identical assets or liabilities. · Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: March 31, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 404,916 September 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 70,772 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability and redemption feature for the six months ended March 31, 2021: Warrants Balance at October 1, 2020 $ 70,772 Change in fair value 334,144 Balance at March 31, 2021 $ 404,916 The warrants issued in connection with the convertible senior secured notes (see Note 8) are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following assumptions: March 31, 2021 September 30, 2020 Risk-free interest rate 0.60 % 0.24 % Remaining contractual life of warrant 3.9 years 4.4 years Expected volatility 98.8 % 94.7 % Annual dividend yield — % — % Fair value of common stock $ 2.25 per share $ 0.72 per share Fair Value of Other Financial Instruments The fair value and carrying value of the PPP loan included in long-term debt on the consolidated balance sheets on March 31, 2021, was $868,000 and $904,200, respectively. The fair value and carrying value of the unsecured promissory note included in long-term debt on the consolidated balance sheets on March 31, 2021, was $10,546,000 and $10,383,996, respectively. The estimated fair values were based on discounted expected future cash flows using prevailing interest rates that are Level 3 inputs under the fair value hierarchy. |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Mar. 31, 2021 | |
Property and Equipment, Net | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, consists of: March 31, 2021 September 30, 2020 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation and amortization (821,914) (740,102) $ 245,437 $ 327,249 Depreciation expense was $40,906 and $63,775 for the three months ended March 31, 2021 and 2020, respectively |
Other Assets
Other Assets | 6 Months Ended |
Mar. 31, 2021 | |
Other Assets | |
Other Assets | 6. Other Assets Other assets consist of: March 31, 2021 September 30, 2020 Investment in PRC joint venture $ 900,000 $ 900,000 Other assets 173,536 394,448 $ 1,073,536 $ 1,294,448 In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone Ventures”), the U.S. based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Syntone Biopharma Ltd, that will be 80% owned by Syntone PRC and 20% owned by the Company. Upon formation of the PRC joint venture in April 2021, the Company entered into a royalty-free license with the PRC joint venture for the development, commercialization and manufacture of ONS-5010 in the greater China market, which includes Hong Kong, Taiwan and Macau. The Company made the initial investment of $900,000 in June 2020. The Company expects to be required to make an additional capital contribution to the PRC joint venture of approximately $2.1 million, which will be made within four years after the establishment date in accordance with the development plan contemplated in the license agreement or on such other terms within such four-year period. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Mar. 31, 2021 | |
Accrued Expenses | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consists of: March 31, 2021 September 30, 2020 Compensation $ 854,263 $ 579,618 Severance and related costs — 9,521 Research and development 3,167,136 2,890,333 Interest payable 8,175 3,691 Professional fees 326,335 132,085 Lease termination obligation — 3,971,111 Other accrued expenses 141,300 170,951 $ 4,497,209 $ 7,757,310 |
Debt
Debt | 6 Months Ended |
Mar. 31, 2021 | |
Debt | |
Debt | 8. Debt Debt consists of: March 31, 2021 September 30, 2020 Unsecured promissory note $ 10,535,601 $ — Paycheck Protection Program term loan 904,200 904,200 Equipment loans 25,709 50,285 Total debt 11,465,510 954,485 Less: unamortized loan costs (151,605) — Total debt, net of unamortized loan costs 11,313,905 954,485 Less: current portion (11,184,734) (50,285) Long-term debt $ 129,171 $ 904,200 Unsecured promissory note On November 5, 2020, the Company received $10.0 million in net proceeds from issuance of an unsecured promissory note with face amount of $10.2 million. Debt issuance costs totaling $228,032 are recorded as debt discount and are deducted from the principal in the accompanying consolidated balance sheets. The debt discount is amortized as a component of interest expense over the 14-month term of the underlying debt using the effective interest method. The note bears interest at a rate of 7.5% per annum and matures January 1, 2022. The Company may prepay all or a portion of the note at any time by paying 105% of the outstanding balance elected for pre-payment. During the three and six months ended March 31, 2021, the Company recognized $242,819, and $392,028, respectively, of interest expense related to the unsecured promissory note. Paycheck Protection Program term loan On May 4, 2020, the Company received $904,200 in proceeds from a loan granted pursuant to the PPP of the CARES Act. The PPP term loan is evidenced by a promissory note containing the terms and conditions for repayment of the PPP term loan. The PPP term loan provides for an initial six-month deferral of payments and any amount owed on the loan has a two-year maturity (May 2022), with an interest rate of 1% per annum. Commencing October 15, 2021, the Company is required to pay the lender equal monthly payments of principal and interest as required to fully amortize any principal amount outstanding on the PPP term loan as of October 15, 2021 by May 2, 2022. The Company has the right to prepay any amounts outstanding under this loan at any time and from time to time, in whole or in part, without penalty. Aggregate interest expense on the PPP loan for the three and six months ended March 31, 2021 was $2,205, and $4,484, respectively. Senior secured notes In December 2019, the Company entered into an exchange agreement with the holders of its $7,254,077 outstanding aggregate principal amount and accrued interest of senior secured notes (the “Old Senior Notes”) originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017, as amended on April 13, 2017, November 5, 2018, and June 28, 2019 (the “Exchange Agreement”). Pursuant to the Exchange Agreement, the holders of the Old Senior Notes exchanged the entire outstanding principal and accrued interest for new senior secured notes having an aggregate outstanding original principal amount of $7,589,027 which included an aggregate exchange fee of $334,950. The new senior secured notes were substantially similar to the Old Senior Notes, as amended through the date of the Exchange Agreement, bore interest at a rate of 12.0% per annum and would have matured December 31, 2020 (subject to extension to June 30, 2021 at the Company’s option upon payment of an extension fee equal to 3% of the outstanding balance and being in compliance with applicable Nasdaq listing requirements). The new senior secured notes were convertible, at the option of the holder, beginning April 1, 2020, into shares of the Company’s common stock at a conversion price equal to 90% of the two lowest closing bid prices in the 20 trading days immediately preceding such conversion, subject to a floor price of $0.232 per share. The conversion feature was determined to be a redemption feature and was bifurcated from the debt instrument. The estimated fair value of the redemption feature was $8,264,451 at issuance. The Exchange Agreement was accounted for as an extinguishment of debt. The Company recognized a loss on extinguishment of convertible senior secured notes for the Exchange Agreement during the three months ended December 31, 2019 of $8,060,580, which amount was equal to the excess fair value of the notes and bifurcated redemption feature over the notes’ net carrying value. The fair value of the redemption feature was estimated by using a Monte Carlo simulation model and a with-and-without perspective, where the fair value of debt instrument was measured with the derivative and without the derivative and the difference is the implied fair value of the redemption feature. The value of the debt instrument with the redemption feature depended on the daily stock price path followed by the Company’s common stock price. This model simulated daily common stock prices from the issuance date through the maturity date for the debt instrument. At issuance, the Company utilized a volatility estimate of 130% based upon the observed historical volatility of both the Company and peer group for 1-year and 2-year periods. Risk-free interest rate was based upon US treasury yields. During the year ended September 30, 2020, the holder of the new senior secured notes converted the entire outstanding principal and accrued interest and as of September 30, 2020, there were no longer any new senior secured notes outstanding. Aggregate interest expense on the Old Senior Notes and the new senior secured notes for the three and six months ended March 31, 2020 was $348,541, and $550,062, respectively. Unsecured notes On March 7, 2019, the Company entered into a forbearance and exchange agreement with Iliad Research and Trading, L.P., a Utah limited partnership (the “Lender”). Concurrently with the execution of this agreement, the Lender purchased two stockholder notes issued by the Company previously in the original principal amount of $1,000,000 with an aggregate outstanding balance as of March 7, 2019 of $1,947,133, including accrued interest. The stockholder notes were accruing interest at the rate of 2.5% per month. The Lender agreed to refrain and forbear from bringing any action to collect under the stockholder notes until March 7, 2020 and to reduce the interest rates currently in effect to 12.0% per annum simple interest during such forbearance period. The Company also agreed to, at Lender’s election, repay or exchange the stockholder notes (or portions thereof) for shares of the Company's common stock at an exchange rate of $13.44 per share or, beginning September 2019, at 95% of the average of the two lowest closing bid prices in the prior twenty trading days, as applicable. During the three months ended December 31, 2019, the remaining unsecured notes with an aggregate carrying amount of $977,966 and accrued interest of $570,460 were exchanged for 1,475,258 shares of the Company’s common stock at an average exchange price of $1.10. As of December 31, 2019, these unsecured notes were no longer outstanding. During the six months ended March 31, 2020, the Company recognized $12,997 of interest expense related to the unsecured notes. No interest expense related to the unsecured notes was recognized during the three months ended March 31, 2020. Stockholder notes March 31, 2021 September 30, 2020 Restricted stock repurchase notes $ — $ 800,000 Common stock repurchase note — 2,812,500 — 3,612,500 Less: current portion — (3,612,500) $ — $ — The Company previously repurchased shares of its restricted stock in exchange for notes in the amount of $800,000 that did not bear interest and were due on demand. These notes were paid in full in November 2020. The Company had a $2,812,500 note payable related to the previous repurchase of common stock that did not bear interest and was due on demand. This note was paid in full in November 2020. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. Commitments and Contingencies Litigation On July 20, 2020, Laboratorios Liomont S.A. de C.V. (“Liomont”), filed a complaint against the Company in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under the June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045 claiming $3,000,000 in damages. On March 30, 2021, the Company entered into a confidential settlement agreement with Liomont, and the complaint was dismissed on April 11, 2021. The Company agreed to make an initial settlement payment of $625,000 that was recorded in accounts payable at March 31, 2021, and paid in April 2021; and an additional payment of $750,000, which is contingent upon the occurrence of certain future events. Leases Corporate office and warehouse leases In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and as of March 31, 2021, did not have remaining future obligations. Upon assignment, the Company recognized a gain of $10,250. In March 2021, the Company entered into a new three-year term corporate office lease in Iselin, New Jersey which commenced on April 23, 2021. The future minimum lease payments for the new lease total $135,535. On May 6, 2020, the Company terminated its lease agreement for approximately 66,000 square feet of office, manufacturing and laboratory space located in Cranbury, New Jersey, which previously served as its headquarters, and relocated its corporate office to Monmouth Junction, New Jersey, a site previously used as a warehouse location. The Company’s Monmouth Junction, New Jersey lease matures in September 2021. In consideration for the termination of the Cranbury lease, the Company agreed to make payments to the landlord totaling $981,987, payable in eight monthly installments commencing May 1, 2020. In November 2020 the remaining portion of the liability was paid in full. On September 30, 2020, the lease termination obligation was included in accounts payable on the consolidated balance sheet. A rollforward of the charges incurred to general and administrative expense for the six months ended March 31, 2021 is as follows: Balance Expensed / Accrued Cash Non-cash Balance October 1, 2020 Expense Payments Adjustments March 31, 2021 Lease termination payments $ 356,987 $ — $ (356,987) $ — $ — Equipment leases The Company has equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bear interest between 4.0% and 13.0%. Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include minimum payments that the Company is obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense is recorded as research and development or general and administrative based on the use of the leased asset. The components of lease cost for the three and six months ended March 31, 2021 and 2020 are as follows: Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets $ — $ 75,000 $ — $ 150,000 Interest on lease liabilities 1,005 361,033 2,787 733,256 Total finance lease cost 1,005 436,033 2,787 883,256 Operating lease cost 43,625 43,625 87,250 87,250 Total lease cost $ 44,630 $ 479,658 $ 90,037 $ 970,506 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: March 31, 2021 September 30, 2020 Operating leases: Right-of-use asset $ — $ 166,986 Operating lease liabilities — 187,486 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 55,727 72,260 Weighted-average remaining lease term (years): Operating leases — 1.0 Finance leases 2.2 2.4 Weighted-average discount rate: Operating leases — Finance leases Other information related to leases for the six months ended March 31, 2021 are as follows: Six months ended March 31, 2021 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 2,787 $ 713,364 Operating cash flows from operating leases 97,500 93,750 Financing cash flows from finance leases 16,533 178,757 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ — Finance leases — — Future minimum lease payments under non-cancelable leases as of March 31, 2021 are as follows for the years ending September 30: Finance leases 2021 (remaining six months) 15,551 2022 29,605 2023 13,149 2024 4,383 Total undiscounted lease payments $ 62,688 Less: Imputed interest 6,961 Total lease obligations $ 55,727 Office and laboratory lease termination obligation In August 2018, the Company entered into a lease termination agreement effective September 1, 2018, to terminate the lease for unutilized office and laboratory space in Cranbury, New Jersey. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling up to $5.8 million, which included (i) $287,615 upon execution of the termination agreement, (ii) $50,000 per month for up to 30 months, commencing September 1, 2018, and (iii) a $4.0 million payment, in any event, on or before February 1, 2021. The Company and landlord agreed that the $174,250 security deposit will be used to pay the 7th, 8th, 9th and a portion of the 10th monthly payments. In November 2020, the Company fully settled the remaining lease termination payments for a one-time cash payment of $3,250,000 and $190,336 security deposit from the terminated Cranbury, New Jersey corporate office lease. Upon settlement, the Company recognized a gain of $542,090 in general and administrative expenses which represented the difference between the carrying value of the liability at the time of settlement and the settlement amounts. A roll forward of the charges incurred to general and administrative expense for the six months ended March 31, 2021 is as follows: Balance Expensed / Accrued Cash Non-cash Balance October 1, 2020 Expense Payments Adjustments March 31, 2021 Lease termination payments $ 3,971,111 $ 111,315 $ (3,540,336) $ (542,090) $ — |
Common Stock, Convertible Prefe
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | 6 Months Ended |
Mar. 31, 2021 | |
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | |
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | 10. Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Common stock In February 2021, the Company issued in an underwritten public offering, including partial exercise of the underwriters’ overallotment option, an aggregate of 38,593,767 shares of common stock at a purchase price per share of $1.00 for $36.0 million in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures and Investments (“GMS Ventures”), an affiliate of BioLexis Pte. Ltd. (“BioLexis”), the Company’s largest stockholder and strategic partner, purchased an aggregate of 8,360,000 shares of common stock in the public offering at the public offering price per share. In a separate concurrent private placement, the Company issued 3,000,000 shares of common stock to Syntone Ventures at a purchase price of $1.00 per share for aggregate gross proceeds of $3.0 million. Following partial exercise of the underwriters’ overallotment option subsequent to the initial closing, and pursuant to the Investor Rights Agreement dated as of September 11, 2017 and as amended, by and among the Company, BioLexis and GMS Ventures, the Company sold an additional 1,013,627 shares of common stock to GMS Ventures in a private placement for aggregate gross proceeds to the Company of $1.0 million at the public offering price per share of $1.00. In connection with the underwritten public offering (including the partial exercise of the overallotment option) the Company issued the underwriter warrants to purchase up to an aggregate of 2,116,364 shares of common stock at an exercise price of $1.25 per share, which warrants have a 5-year term. On March 24, 2021, following receipt of stockholder approval at the Company’s 2021 annual meeting of stockholders, the number of authorized shares of common stock was increased from 200,000,000 shares to 325,000,000 shares. In February 2020, the Company issued, in a registered direct offering, an aggregate of 7,598,426 shares of common stock and, in a concurrent private placement to the same investors, warrants to purchase up to an aggregate of 3,799,213 shares of common stock at a combined purchase price per share and accompanying warrant of $1.016 for approximately $6.7 million in net proceeds after payment of placement agent fees and other offering costs. In a separate concurrent private placement, the Company issued 2,460,630 shares of common stock and warrants to purchase up to an aggregate of 1,230,315 shares of common stock to GMS Ventures, at a combined purchase price per share and accompanying warrant of $1.016 for $2.5 million. The warrants issued were exercisable immediately at an exercise price of $0.9535 per share and will expire four years from the issuance date. In connection with the registered direct offering and concurrent private placement of warrants to those investors, the Company issued placement agent warrants to purchase up to an aggregate of 531,890 shares of common stock, on substantially the same terms as the concurrent private placement warrants, at an exercise price of $1.27 per share and a 5-year term. Effective March 19, 2020, following approval of the Company’s stockholders, the Company issued an aggregate of 7,244,739 shares of its common stock to the four former principals (who include two of its named executive officers, Messrs. Dagnon and Evanson) of MTTR, LLC (“MTTR”) pursuant to their respective consulting agreements that were entered into on January 27, 2020 concurrent with the termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Refer to Note 11 for the accounting of the restricted stock issued and Note 12 for further details on the terminated MTTR strategic partnership agreement. During the six months ended March 31, 2020, the Company issued 109 shares of common stock, respectively, upon the vesting of RSUs. Series A‑1 convertible preferred stock A total of 200,000 shares of Series A-1 Convertible Preferred Stock (the “Series A-1”) were authorized for issuance under the Certificate of Designation of Series A-1 Convertible Preferred Stock of the Company (the “Certificate of Designation”). The shares of Series A-1 had a stated value of $100.00 per share, and ranked senior to all junior securities (as defined in the Certificate of Designation). On March 23, 2020, the Company issued 29,358,621 shares of its common stock upon conversion of all 68,112 shares of Series A-1 outstanding by BioLexis, pursuant to an agreement entered on January 27, 2020 with BioLexis, whereby the effective conversion rate of the Series A-1 was increased from the $18.89797 per share to $431.03447263 per share, (or an effective conversion rate of $0.232 per share) following stockholder approval of the amended terms on March 19, 2020. The amendment to the Series A-1 was deemed an extinguishment for accounting purposes. The excess fair value of common stock received over the net carrying value of the Series A-1 was $10,328,118 and reflected as a deemed dividend in the consolidated statements of operations for purposes of presenting net loss attributable to common stockholders when calculating basic and diluted loss per share. As of March 31, 2021 and September 30, 2020, there were no shares of Series A-1 outstanding. The Series A-1 accrued dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A-1. During the six months ended March 31, 2020, the Company issued 1,661 shares of Series A-1 to settle the related dividends that were due on a quarterly basis. Common stock warrants As of March 31, 2021, shares of common stock issuable upon the exercise of outstanding warrants were as follows: Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 18, 2022 416,666 $ 12.00 December 22, 2024 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 172,864 $ 1.27 February 26, 2024 1,747,047 $ 0.9535 June 22, 2025 191,268 $ 1.5188 January 28, 2026 2,116,364 $ 1.2500 5,129,460 (i) The warrants were issued in connection with the convertible senior secured notes (see Note 8) and are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. On December 23, 2019, the Company amended the terms of its outstanding 15-month warrants and five-year warrants issued April 12, 2019 (the “April 2019 Warrants”), which originally had an exercise price of $2.90 per share of the Company’s common stock. The exercise price of all outstanding April 2019 Warrants was reduced to $0.2320 per share and the exercise period was amended such that all April 2019 Warrants expire on December 24, 2019. Immediately prior to expiration, all then unexercised April 2019 Warrants were automatically net exercised pursuant to the amended provisions. The estimated change in fair value of warrants amended during the three and six months ended March 31, 2020 was $1,431,406 and $3,140,009, respectively, and reflected as a deemed dividend in the consolidated statements of operations for purposes of presenting net loss attributable to common stockholders when calculating basic and diluted loss per share. During the six months ended March 31, 2021, warrants to purchase an aggregate of 3,641,507 shares of common stock with a weighted averaged exercise price of $0.9847 were exercised for aggregate gross proceeds to the Company of $3,585,809. In addition, warrants to purchase an aggregate of 397,251 shares of common stock with a weighted averaged exercise price of $1.51875 were exercised on a cashless basis. During the six months ended March 31, 2020, warrants to purchase an aggregate of 15,085,240 shares of common stock with a weighted averaged exercise price of $0.232 were exercised for an aggregate 13,003,414 shares of the Company's common stock; and warrants to purchase an aggregate of 80,797 shares of common stock with a weighted averaged exercise price of $0.08 expired. In aggregate, 10,157,050 of the exercised warrants were April 2019 Warrants, described above, exercised pursuant to the net exercise provisions therein, as amended. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Mar. 31, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 11. Stock-Based Compensation 2011 Equity Incentive Plan The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, RSUs, performance-based awards (“PSUs”), cash-based awards or to grant stock options for the purchase of common stock to officers, employees, consultants and directors of the Company. The 2011 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board. The number of shares of common stock reserved for issuance under the 2011 Plan is 106,490. As of March 31, 2021, PSUs representing 2,470 shares of the Company’s common stock were outstanding under the 2011 Plan. In light of the December 2015 adoption of the 2015 Equity Incentive Plan, (the “2015 Plan”) no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Plan. The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Company’s 2015 Plan is 27,838,019. As of March 31, 2021, 15,657,586 shares remained available for grant under the 2015 Plan. Stock options and RSUs are granted under the Company’s 2015 Plan and generally vest over a period of one to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period. The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three and six months ended March 31, 2021 and 2020: Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Research and development $ 228,240 $ 41,148 $ 468,211 $ 148,938 General and administrative 901,507 263,391 1,816,177 515,078 $ 1,129,747 $ 304,539 $ 2,284,388 $ 664,016 Stock options As of March 31, 2021, options to purchase common stock of the Company outstanding under the 2015 Plan were as follows: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2020 3,762,143 $ 2.01 Granted 8,361,645 0.74 Forfeited or expired (113,007) 0.73 Balance at March 31, 2021 12,010,781 1.14 9.3 $ 15,228,082 Vested and exercisable 1,726,016 1.93 8.8 $ 1,739,158 Vested and expected to vest at March 31, 2021 12,010,781 $ 1.14 9.3 The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The weighted average grant date fair value of the options awarded to employees for the six months ended March 31, 2021 and 2020 was $0.56 and $0.72 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Six months ended March 31, 2021 2020 Risk-free interest rate 0.39 % 1.13 % Expected life (years) 6.01 5.71 Expected volatility 95.4 % 89.2 % Expected dividend yield — — As of March 31, 2021, there was $5,851,014 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.58 years. Performance-based stock units The Company has issued PSUs, which generally have a ten-year life from the date of grant. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. The following table summarizes the activity related to PSUs during the three months ended March 31, 2021: Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2020 2,470 $ 49.97 Forfeitures — — Balance at March 31, 2021 2,470 49.97 3.8 Vested and exercisable at March 31, 2021 2,470 49.97 3.8 Vested and expected to vest at March 31, 2021 2,470 $ 49.97 3.8 Restricted stock In connection with the consulting agreements entered into by the Company and four former principals of MTTR, in March 2020, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 12 for further details on the consulting agreements and terminated strategic partnership agreement. These shares may not be sold until the earlier of (i) six months following FDA approval of ONS-5010, (ii) the date the Company publicly announces not to pursue development of ONS-5010, (iii) a change in control or (iv) January 2025. In addition, the Company has the right to repurchase the shares for $0.01 per share if the consultant terminates his agreement other than for good reason or the Company terminates the agreement for cause. The repurchase right lapses, in tiered percentages, based upon the completion of enrollment of the Company’s NORSE 2 clinical trial of ONS-5010 by certain dates. The repurchase right may also lapse as to 50% or 100% of the shares if the Company enters into certain agreements pertaining to ONS-5010 that meet certain value thresholds or the Company’s share price meets certain predefined targets. The repurchase right also lapses as to 100% of the shares upon the earliest to occur of (i) filing of the BLA for ONS-5010, (ii) termination of the agreement by the consultant for good reason or by the Company other than for cause. (iii) in the event of disability, or (iv) upon a change in control. As of March 31, 2021, 1,811,184 shares of common stock were vested and not subject to repurchase rights. The grant date fair value of the restricted shares was $0.54 per share and equal to the closing stock price of the Company’s common stock at the time of grant. Compensation expense is recognized over the shorter of the explicit service period or derived service period, which was determined to be 4.8 years at the time of grant. Compensation expense may be accelerated when certain performance conditions become probable and the corresponding purchase right has lapsed. During the three and six months ended March 31, 2021, the Company recognized compensation expense related to the restricted stock of $151,764 and $303,529, respectively. During the three and six months ended March 31, 2020, the Company recognized compensation expense related to the restricted stock of $78,984. As of March 31, 2021, there was $2,307,477 of unrecognized compensation expense related to the restricted stock. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Mar. 31, 2021 | |
Related-Party Transactions | |
Related-Party Transactions | 12. Related-Party Transactions MTTR - strategic partnership agreement (ONS-5010) In February 2018, the Company entered into a strategic partnership agreement with MTTR to advise on regulatory, clinical and commercial strategy and assist in obtaining approval of ONS-5010, the Company's bevacizumab therapeutic product candidate for ophthalmic indications. In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operating Officer, and Mr. Jeff Evanson as Chief Commercial Officer. Both Mr. Dagnon and Mr. Evanson initially provided services to the Company pursuant to the February 2018 strategic partnership agreement with MTTR, as amended. Mr. Dagnon and Mr. Evanson were both principals in MTTR. The Company did not pay Mr. Dagnon or Mr. Evanson any direct compensation as consultants or as employees during the three months ended December 31, 2019 nor during the period from October 1, 2019 through March 19, 2020. Both Mr. Dagnon and Mr. Evanson were compensated directly by MTTR for services provided to the Company as the Company's Chief Operating Officer and Chief Commercial Officer, respectively, pursuant to the strategic partnership agreement until such agreement, as amended, was terminated effective March 19, 2020. The Company began compensating Mr. Dagnon and Mr. Evanson directly as consultants effective March 19, 2020 pursuant to their respective consulting agreements with the Company, which became effective March 19, 2020 following stockholder approval of the share issuances contemplated therein. Mr. Dagnon and Mr. Evanson have also agreed to provide consulting services to an affiliate of BioLexis pursuant to a separate arrangement. On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson), an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000, upon effectiveness of the agreement. Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement, and the consulting agreements, became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 11 for the accounting of the restricted stock issued and compensation expense recognized. During the three months ended March 2021 and 2020, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $73,572 and $169,347, respectively; and $541,225 and $780,911 during the six months ended March 31, 2021 and 2020, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 11). As of March 31, 2021, and September 30, 2020 an aggregate $90,476 and $89,762, respectively, was due to the former MTTR principals as consultants, which is included in accounts payable in the accompanying consolidated balance sheets. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of presentation | Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10‑Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2021 and its results of operations for the three and six months ended March 31, 2021 and 2020, cash flows for the six months ended March 31, 2021 and 2020, and convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended March 31, 2021 and 2020. Operating results for the three and six months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2021. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2020 included in the Company’s Annual Report on Form 10‑K filed with the Securities and Exchange Commission (“SEC”) on December 23, 2020 and amended on January 28, 2021. |
Use of estimates | Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, including as a result of the ongoing COVID-19 pandemic, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. |
Net loss per share | Net loss per share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Net loss attributable to common stockholders $ (13,106,521) $ (17,459,591) $ (27,562,435) $ (35,937,275) Common stock outstanding (weighted average) 150,730,191 47,895,771 136,080,637 38,849,364 Basic and diluted net loss per share $ (0.09) $ (0.36) $ (0.20) $ (0.93) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2021 and 2020, as they would be antidilutive: As of March 31, 2021 2020 Performance-based stock units 2,470 2,470 Stock options 12,010,781 2,218,551 Common stock warrants 5,129,460 6,463,338 |
Recently issued accounting pronouncements | Recently issued and adopted accounting pronouncements In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820) : Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018-13"), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The Company adopted ASU 2018-13 on October 1, 2020 and the adoption of this standard did not have a material impact to the Company’s financial statements. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Schedule of computation of basic earnings per share and diluted earnings per share | Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Net loss attributable to common stockholders $ (13,106,521) $ (17,459,591) $ (27,562,435) $ (35,937,275) Common stock outstanding (weighted average) 150,730,191 47,895,771 136,080,637 38,849,364 Basic and diluted net loss per share $ (0.09) $ (0.36) $ (0.20) $ (0.93) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of March 31, 2021 2020 Performance-based stock units 2,470 2,470 Stock options 12,010,781 2,218,551 Common stock warrants 5,129,460 6,463,338 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on a recurring basis | March 31, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 404,916 September 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 70,772 |
Schedule of changes in the fair value of Level 3 valuation for the warrant liability | Warrants Balance at October 1, 2020 $ 70,772 Change in fair value 334,144 Balance at March 31, 2021 $ 404,916 |
Schedule of fair value of the warrant liability | March 31, 2021 September 30, 2020 Risk-free interest rate 0.60 % 0.24 % Remaining contractual life of warrant 3.9 years 4.4 years Expected volatility 98.8 % 94.7 % Annual dividend yield — % — % Fair value of common stock $ 2.25 per share $ 0.72 per share |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Property and Equipment, Net | |
Schedule of property and equipment | March 31, 2021 September 30, 2020 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation and amortization (821,914) (740,102) $ 245,437 $ 327,249 |
Other Assets (Tables)
Other Assets (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Other Assets | |
Schedule of other assets | March 31, 2021 September 30, 2020 Investment in PRC joint venture $ 900,000 $ 900,000 Other assets 173,536 394,448 $ 1,073,536 $ 1,294,448 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Accrued Expenses | |
Schedule of accrued expenses | March 31, 2021 September 30, 2020 Compensation $ 854,263 $ 579,618 Severance and related costs — 9,521 Research and development 3,167,136 2,890,333 Interest payable 8,175 3,691 Professional fees 326,335 132,085 Lease termination obligation — 3,971,111 Other accrued expenses 141,300 170,951 $ 4,497,209 $ 7,757,310 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Debt | |
Schedule of debt | March 31, 2021 September 30, 2020 Unsecured promissory note $ 10,535,601 $ — Paycheck Protection Program term loan 904,200 904,200 Equipment loans 25,709 50,285 Total debt 11,465,510 954,485 Less: unamortized loan costs (151,605) — Total debt, net of unamortized loan costs 11,313,905 954,485 Less: current portion (11,184,734) (50,285) Long-term debt $ 129,171 $ 904,200 |
Schedule of stockholder notes | March 31, 2021 September 30, 2020 Restricted stock repurchase notes $ — $ 800,000 Common stock repurchase note — 2,812,500 — 3,612,500 Less: current portion — (3,612,500) $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Long-term Purchase Commitment [Line Items] | |
Schedule of lease information | The components of lease cost for the three and six months ended March 31, 2021 and 2020 are as follows: Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets $ — $ 75,000 $ — $ 150,000 Interest on lease liabilities 1,005 361,033 2,787 733,256 Total finance lease cost 1,005 436,033 2,787 883,256 Operating lease cost 43,625 43,625 87,250 87,250 Total lease cost $ 44,630 $ 479,658 $ 90,037 $ 970,506 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: March 31, 2021 September 30, 2020 Operating leases: Right-of-use asset $ — $ 166,986 Operating lease liabilities — 187,486 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 55,727 72,260 Weighted-average remaining lease term (years): Operating leases — 1.0 Finance leases 2.2 2.4 Weighted-average discount rate: Operating leases — Finance leases Other information related to leases for the six months ended March 31, 2021 are as follows: Six months ended March 31, 2021 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 2,787 $ 713,364 Operating cash flows from operating leases 97,500 93,750 Financing cash flows from finance leases 16,533 178,757 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ — Finance leases — — |
Schedule of finance lease future minimum payments | Finance leases 2021 (remaining six months) 15,551 2022 29,605 2023 13,149 2024 4,383 Total undiscounted lease payments $ 62,688 Less: Imputed interest 6,961 Total lease obligations $ 55,727 |
Cranbury NJ, May 2020 lease termination | |
Long-term Purchase Commitment [Line Items] | |
Schedule of future termination payment derecognized | Balance Expensed / Accrued Cash Non-cash Balance October 1, 2020 Expense Payments Adjustments March 31, 2021 Lease termination payments $ 356,987 $ — $ (356,987) $ — $ — |
Cranbury NJ, August 2018 lease termination | |
Long-term Purchase Commitment [Line Items] | |
Schedule of future termination payment derecognized | Balance Expensed / Accrued Cash Non-cash Balance October 1, 2020 Expense Payments Adjustments March 31, 2021 Lease termination payments $ 3,971,111 $ 111,315 $ (3,540,336) $ (542,090) $ — |
Common Stock, Convertible Pre_2
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | |
Schedule of warrants outstanding | Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 18, 2022 416,666 $ 12.00 December 22, 2024 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 172,864 $ 1.27 February 26, 2024 1,747,047 $ 0.9535 June 22, 2025 191,268 $ 1.5188 January 28, 2026 2,116,364 $ 1.2500 5,129,460 (i) The warrants were issued in connection with the convertible senior secured notes (see Note 8) and are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three months ended March 31, Six months ended March 31, 2021 2020 2021 2020 Research and development $ 228,240 $ 41,148 $ 468,211 $ 148,938 General and administrative 901,507 263,391 1,816,177 515,078 $ 1,129,747 $ 304,539 $ 2,284,388 $ 664,016 |
Schedule of stock option activity | Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2020 3,762,143 $ 2.01 Granted 8,361,645 0.74 Forfeited or expired (113,007) 0.73 Balance at March 31, 2021 12,010,781 1.14 9.3 $ 15,228,082 Vested and exercisable 1,726,016 1.93 8.8 $ 1,739,158 Vested and expected to vest at March 31, 2021 12,010,781 $ 1.14 9.3 |
Schedule of option assumptions | Six months ended March 31, 2021 2020 Risk-free interest rate 0.39 % 1.13 % Expected life (years) 6.01 5.71 Expected volatility 95.4 % 89.2 % Expected dividend yield — — |
Schedule of performance-based stock units activity | Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2020 2,470 $ 49.97 Forfeitures — — Balance at March 31, 2021 2,470 49.97 3.8 Vested and exercisable at March 31, 2021 2,470 49.97 3.8 Vested and expected to vest at March 31, 2021 2,470 $ 49.97 3.8 |
Liquidity (Details)
Liquidity (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Liquidity | ||
Debt carrying amount | $ 11,465,510 | $ 954,485 |
Paycheck Protection Program | ||
Liquidity | ||
Debt carrying amount | 900,000 | |
Unsecured promissory note | ||
Liquidity | ||
Debt carrying amount | $ 10,535,601 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Basic and diluted earnings per share: | ||||
Net loss attributable to common stockholders | $ (13,106,521) | $ (17,459,591) | $ (27,562,435) | $ (35,937,275) |
Common stock outstanding (weighted average) | 150,730,191 | 47,895,771 | 136,080,637 | 38,849,364 |
Basic and diluted net loss per share (in dollars per share) | $ (0.09) | $ (0.36) | $ (0.20) | $ (0.93) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,470 | 2,470 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 12,010,781 | 2,218,551 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 5,129,460 | 6,463,338 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Liabilities | ||
Warrant liability | $ 404,916 | $ 70,772 |
Fair value measurements recurring basis | Level 3 | ||
Liabilities | ||
Warrant liability | $ 404,916 | $ 70,772 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in fair value (Details) - Common stock warrants | 6 Months Ended |
Mar. 31, 2021USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, beginning | $ 70,772 |
Change in fair value | 334,144 |
Balance, ending | $ 404,916 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions (Details) | Mar. 31, 2021$ / sharesUSD ($) | Sep. 30, 2020$ / sharesUSD ($) |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 0.60 | 0.24 |
Remaining contractual life of warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | $ | 3.9 | 4.4 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 98.8 | 94.7 |
Annual dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 0 | 0 |
Fair value of common stock | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | $ / shares | 2.25 | 0.72 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying value | $ 11,313,905 | $ 954,485 |
Paycheck Protection Program | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 868,000 | |
Carrying value | 904,200 | |
Unsecured promissory note | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 10,546,000 | |
Carrying value | $ 10,383,996 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | |
Property and Equipment, Net | |||||
Property and equipment, gross | $ 1,067,351 | $ 1,067,351 | $ 1,067,351 | ||
Less: accumulated depreciation and amortization | (821,914) | (821,914) | (740,102) | ||
Property and equipment, net | 245,437 | 245,437 | $ 327,249 | ||
Depreciation expense | $ 40,906 | $ 63,775 | $ 81,812 | $ 127,551 |
Other Assets (Details)
Other Assets (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Other Assets | ||
Investment in PRC joint venture | $ 900,000 | $ 900,000 |
Other assets | 173,536 | 394,448 |
Total other assets | $ 1,073,536 | $ 1,294,448 |
Other Assets - Additional infor
Other Assets - Additional information (Details) - P R C Joint Venture - USD ($) | May 22, 2020 | Jun. 30, 2020 |
Schedule of Equity Method Investments [Line Items] | ||
Ownership percentage | 20.00% | |
Payments to Acquire Interest in Joint Venture | $ 900,000 | |
Expected future investment | $ 2,100,000 | |
Contract period | 4 years | |
Syntone | ||
Schedule of Equity Method Investments [Line Items] | ||
Ownership percentage | 80.00% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Accrued Expenses | ||
Compensation | $ 854,263 | $ 579,618 |
Severance and related costs | 9,521 | |
Research and development | 3,167,136 | 2,890,333 |
Interest payable | 8,175 | 3,691 |
Professional fees | 326,335 | 132,085 |
Lease termination obligation | 3,971,111 | |
Other accrued expenses | 141,300 | 170,951 |
Accrued expenses, total | $ 4,497,209 | $ 7,757,310 |
Debt - Indebtedness Summary (De
Debt - Indebtedness Summary (Details) - USD ($) | Mar. 31, 2021 | Nov. 05, 2020 | Sep. 30, 2020 |
Debt Instrument [Line Items] | |||
Debt carrying amount | $ 11,465,510 | $ 954,485 | |
Less: unamortized loan costs | (151,605) | ||
Total debt | 11,313,905 | 954,485 | |
Less: current portion | (11,184,734) | (50,285) | |
Long-term debt | 129,171 | 904,200 | |
Unsecured promissory note | |||
Debt Instrument [Line Items] | |||
Debt carrying amount | 10,535,601 | ||
Less: unamortized loan costs | $ (228,032) | ||
Total debt | 10,383,996 | ||
Paycheck Protection Program | |||
Debt Instrument [Line Items] | |||
Debt carrying amount | 904,200 | 904,200 | |
Total debt | 904,200 | ||
Equipment loan | |||
Debt Instrument [Line Items] | |||
Debt carrying amount | $ 25,709 | $ 50,285 |
Debt - Indebtedness - Informati
Debt - Indebtedness - Information (Details) - USD ($) | Nov. 05, 2020 | May 04, 2020 | Mar. 31, 2021 | Mar. 31, 2021 |
Debt Instrument [Line Items] | ||||
Proceeds from loan | $ 10,000,000 | |||
Unamortized discount | $ 151,605 | 151,605 | ||
Unsecured promissory note | ||||
Debt Instrument [Line Items] | ||||
Proceeds from loan | $ 10,000,000 | |||
Original principal amount | 10,200,000 | |||
Unamortized discount | $ 228,032 | |||
Debt Instrument, term | 14 months | |||
Interest rate (as a percent) | 7.50% | |||
Redemption price (as a percent) | 105.00% | |||
Interest expense | 242,819 | 392,028 | ||
Paycheck Protection Program | ||||
Debt Instrument [Line Items] | ||||
Proceeds from loan | $ 904,200 | |||
Debt Instrument, term | 2 years | |||
Interest rate (as a percent) | 1.00% | |||
Interest expense | $ 2,205 | $ 4,484 |
Debt - Senior Secured (Details)
Debt - Senior Secured (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2019USD ($)Ditem | Mar. 31, 2020USD ($) | Mar. 31, 2021USD ($)$ / shares | Mar. 31, 2020USD ($) | Sep. 30, 2020USD ($) | |
Debt Instrument [Line Items] | |||||
Loss on extinguishment of debt | $ (8,060,580) | ||||
Debt outstanding | $ 11,313,905 | $ 954,485 | |||
Senior Notes | |||||
Debt Instrument [Line Items] | |||||
Interest expense | $ 348,541 | $ 550,062 | |||
Old Senior notes | |||||
Debt Instrument [Line Items] | |||||
Carrying value of notes exchanged | $ 7,254,077 | ||||
Interest rate (as a percent) | 12.00% | ||||
Extension fee (as a percent) | 3.00% | ||||
New Senior secured notes | |||||
Debt Instrument [Line Items] | |||||
Amount of debt as converted | $ 7,589,027 | ||||
Bank exchange fee | $ 334,950 | ||||
Stock price threshold (as a percent) | 90.00% | ||||
Number of lowest closing bid prices | item | 2 | ||||
Trading day threshold | D | 20 | ||||
Floor price | $ / shares | $ 0.232 | ||||
Redemption feature | $ 8,264,451 | ||||
Loss on extinguishment of debt | $ (8,060,580) | ||||
Debt outstanding | $ 0 | ||||
New Senior secured notes | Expected volatility | |||||
Debt Instrument [Line Items] | |||||
Redemption feature input | 130 |
Debt - Unsecured Notes (Details
Debt - Unsecured Notes (Details) | Mar. 07, 2019USD ($)Ditem$ / shares | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Mar. 31, 2020USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020USD ($) |
Debt Instrument [Line Items] | ||||||
Debt outstanding | $ 11,313,905 | $ 954,485 | ||||
Unsecured notes | ||||||
Debt Instrument [Line Items] | ||||||
Original principal amount | $ 1,000,000 | |||||
Debt outstanding | $ 1,947,133 | |||||
Monthly stated interest rate | 2.50% | |||||
Interest rate (as a percent) | 12.00% | |||||
Conversion rate per share | $ / shares | $ 13.44 | |||||
Stock price threshold (as a percent) | 95.00% | |||||
Number of lowest closing bid prices | item | 2 | |||||
Trading day threshold | D | 20 | |||||
Carrying value of notes exchanged | $ 977,966 | |||||
Accrued interest of notes exchanged | $ 570,460 | |||||
Common stock issued up on conversion of stockholder notes (in shares) | shares | 1,475,258 | |||||
Interest expense | $ 0 | $ 12,997 | ||||
Unsecured notes | Weighted average | ||||||
Debt Instrument [Line Items] | ||||||
Conversion rate per share | $ / shares | $ 1.10 |
Debt - Stockholder Notes (Detai
Debt - Stockholder Notes (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Nov. 30, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | |
Debt Instrument [Line Items] | ||||
Stockholder notes | $ 3,612,500 | |||
Less: current portion | (3,612,500) | |||
Repayment of debt | $ 3,637,076 | $ 23,414 | ||
Restricted stock purchase notes | ||||
Debt Instrument [Line Items] | ||||
Stockholder notes | 800,000 | |||
Repayment of debt | $ 800,000 | |||
Common stock repurchase note | ||||
Debt Instrument [Line Items] | ||||
Stockholder notes | $ 2,812,500 | |||
Repayment of debt | $ 2,812,500 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | Mar. 30, 2021 | Apr. 30, 2021 | Mar. 31, 2021 |
Other Commitments [Line Items] | |||
Loss Contingency, Damages Sought, Value | $ 3,000,000 | ||
Initial settlement payment | $ 625,000 | ||
Additional payment on contingent future events | $ 750,000 | ||
Accounts Payable | |||
Other Commitments [Line Items] | |||
Settlement payable | $ 625,000 |
Commitments and Contingencies -
Commitments and Contingencies - Lease termination (Details) | May 06, 2020USD ($)ft² | Mar. 31, 2021USD ($) | Nov. 30, 2020USD ($) | Aug. 31, 2018USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020USD ($) |
Commitment | ||||||
Gain recognized | $ 552,340 | |||||
Finance leases, Lease obligation | $ 55,727 | $ 55,727 | $ 72,260 | |||
Lease termination obligation | 3,971,111 | |||||
Corporate Office Lease, Monmouth Junction, New Jersey | ||||||
Commitment | ||||||
Gain recognized | $ 10,250 | |||||
Corporate Office Lease, Iselin, New Jersey | ||||||
Commitment | ||||||
Lease term | 3 years | 3 years | ||||
Finance leases, Lease obligation | $ 135,535 | $ 135,535 | ||||
Cranbury NJ, May 2020 lease termination | ||||||
Commitment | ||||||
Net rentable area | ft² | 66,000 | |||||
Lease termination obligation | $ 981,987 | 356,987 | ||||
Terms of payment for lease | 8 months | |||||
Cranbury NJ, August 2018 lease termination | ||||||
Commitment | ||||||
Gain recognized | $ 542,090 | |||||
Lease termination obligation | $ 5,800,000 | $ 3,971,111 | ||||
Terms of payment for lease | 30 months | |||||
Amount of execution of termination agreement | $ 287,615 | |||||
Payment for lease per month | 50,000 | |||||
Lease payment in any event | 4,000,000 | |||||
Termination Of Lease | $ 3,250,000 | |||||
Security deposit | $ 190,336 | $ 174,250 |
Commitments and Contingencies_3
Commitments and Contingencies - Lease termination rollforward (Details) | 6 Months Ended |
Mar. 31, 2021USD ($) | |
Leases | |
Balance, beginning | $ 3,971,111 |
Cranbury NJ, May 2020 lease termination | |
Leases | |
Balance, beginning | 356,987 |
Cash payments | (356,987) |
Cranbury NJ, August 2018 lease termination | |
Leases | |
Balance, beginning | 3,971,111 |
Expensed accrued expense | 111,315 |
Cash payments | (3,540,336) |
Non-cash Adjustments | $ (542,090) |
Commitments and Contingencies_4
Commitments and Contingencies - Lease cost (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Lease cost | ||||
Amortization of right-of-use assets | $ 75,000 | $ 150,000 | ||
Interest on lease liabilities | $ 1,005 | 361,033 | $ 2,787 | 733,256 |
Total finance lease cost | 1,005 | 436,033 | 2,787 | 883,256 |
Operating lease cost | 43,625 | 43,625 | 87,250 | 87,250 |
Total lease cost | $ 44,630 | $ 479,658 | $ 90,037 | $ 970,506 |
Minimum | ||||
Leases | ||||
Finance lease term | 12 months | 12 months | ||
Finance lease interest (as a percent) | 4.00% | 4.00% | ||
Maximum | ||||
Leases | ||||
Finance lease term | 36 months | 36 months | ||
Finance lease interest (as a percent) | 13.00% | 13.00% |
Commitments and Contingencies_5
Commitments and Contingencies - Lease balance sheet (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Leases | ||
Operating leases, Right-of-use asset | $ 166,986 | |
Operating leases, Lease obligation | 187,486 | |
Finance leases, Lease obligation | $ 55,727 | $ 72,260 |
Operating leases, Weighted-average remaining lease term | 1 year | |
Finance leases, Weighted-average remaining lease term | 2 years 2 months 12 days | 2 years 4 months 24 days |
Operating leases, Weighted-average discount rate (as a percent) | 9.00% | |
Finance leases, Weighted-average discount rate (as a percent) | 9.00% | 8.50% |
Commitments and Contingencies_6
Commitments and Contingencies - Lease cashflow (Details) - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Leases | ||
Operating cash flows from finance leases | $ 2,787 | $ 713,364 |
Operating cash flows from operating leases | 97,500 | 93,750 |
Financing cash flows from finance leases | $ 16,533 | $ 178,757 |
Commitments and Contingencies_7
Commitments and Contingencies - Lease minimum payments (Details) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Finance leases | ||
2021 (remaining six months) | $ 15,551 | |
2022 | 29,605 | |
2023 | 13,149 | |
2024 | 4,383 | |
Total undiscounted lease payments | 62,688 | |
Less: Imputed interest | 6,961 | |
Total lease obligations | $ 55,727 | $ 72,260 |
Common Stock, Convertible Pre_3
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Common Stock (Details) - USD ($) | Mar. 23, 2020 | Mar. 19, 2020 | Sep. 11, 2017 | Feb. 28, 2021 | Feb. 29, 2020 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 24, 2021 | Mar. 23, 2021 | Sep. 30, 2020 | Mar. 22, 2020 | Dec. 23, 2019 | Apr. 12, 2019 |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Issuance of vested restricted stock units (in shares) | 109 | |||||||||||||
Number of share issued | 7,244,739 | |||||||||||||
Shares of common stock issuable upon exercise of warrants | 5,129,460 | |||||||||||||
Proceeds from issuance of stock | $ 39,779,507 | $ 9,457,400 | ||||||||||||
Number of shares issued upon vesting of restricted stock units (in shares) | 109 | |||||||||||||
Common stock, shares authorized | 325,000,000 | 325,000,000 | 200,000,000 | 325,000,000 | ||||||||||
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock | $ 10,328,118 | $ 10,328,118 | ||||||||||||
Direct registered offering | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 7,598,426 | |||||||||||||
Shares of common stock issuable upon exercise of warrants | 3,799,213 | |||||||||||||
Shares issued, price per share | $ 1.016 | |||||||||||||
Proceeds from issuance of stock | $ 6,700,000 | |||||||||||||
Private Placement | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 3,000,000 | 2,460,630 | ||||||||||||
Shares of common stock issuable upon exercise of warrants | 1,230,315 | |||||||||||||
Shares issued, price per share | $ 1 | $ 1.016 | ||||||||||||
Proceeds from issuance of stock | $ 3,000,000 | |||||||||||||
Net proceeds from warrants | $ 2,500,000 | |||||||||||||
Exercise price per share | $ 0.9535 | |||||||||||||
Warrants exercise term | 4 years | |||||||||||||
Placement Agent | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Shares of common stock issuable upon exercise of warrants | 531,890 | |||||||||||||
Shares issued, price per share | $ 1.27 | |||||||||||||
Warrants exercise term | 5 years | |||||||||||||
Underwritten Public Offering | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 38,593,767 | |||||||||||||
Shares of common stock issuable upon exercise of warrants | 2,116,364 | |||||||||||||
Shares issued, price per share | $ 1 | |||||||||||||
Proceeds from issuance of stock | $ 36,000,000 | |||||||||||||
Exercise price per share | $ 1.25 | |||||||||||||
Warrants exercise term | 5 years | |||||||||||||
GMS Ventures & Investments | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 1,013,627 | 8,360,000 | ||||||||||||
Shares issued, price per share | $ 1 | |||||||||||||
Proceeds from issuance of stock | $ 1,000,000 | |||||||||||||
Common stock warrants | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 13,003,414 | |||||||||||||
Shares of common stock issuable upon exercise of warrants | 15,085,240 | 3,641,507 | 15,085,240 | |||||||||||
Proceeds from issuance of stock | $ 3,585,809 | |||||||||||||
Exercise price per share | $ 0.232 | $ 0.232 | $ 0.9847 | $ 0.232 | $ 0.2320 | $ 2.90 | ||||||||
Series A-1 convertible preferred stock | ||||||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||||||||
Number of share issued | 29,358,621 | |||||||||||||
Convertible preferred stock, shares authorized | 200,000 | 200,000 | ||||||||||||
Shares issued, price per share | $ 100 | |||||||||||||
Number of stock converted | 68,112 | |||||||||||||
Conversion rate per share | $ 431.03447263 | $ 18.89797 | ||||||||||||
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock | $ 10,328,118 | |||||||||||||
Convertible preferred stock outstanding | 0 | 0 | ||||||||||||
Accrued dividends rate | 10.00% | |||||||||||||
Preferred stock issued to settle dividends (in shares) | 1,661 |
Common Stock, Convertible Pre_4
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Warrants summary (Details) | Mar. 31, 2021$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 5,129,460 |
February 18, 2022 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 416,666 |
Exercise price per share | $ / shares | $ 12 |
December 22, 2024 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 277,128 |
Exercise price per share | $ / shares | $ 12 |
April 13, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 145,686 |
Exercise price per share | $ / shares | $ 12 |
May 31, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 62,437 |
Exercise price per share | $ / shares | $ 12 |
February 24, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 172,864 |
Exercise price per share | $ / shares | $ 1.27 |
February 26, 2024 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 1,747,047 |
Exercise price per share | $ / shares | $ 0.9535 |
June 22, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 191,268 |
Exercise price per share | $ / shares | $ 1.5188 |
January 28, 2026 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 2,116,364 |
Exercise price per share | $ / shares | $ 1.25 |
Common Stock, Convertible Pre_5
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Warrants (Details) - USD ($) | Mar. 19, 2020 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 23, 2020 | Dec. 23, 2019 | Apr. 12, 2019 |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Deemed dividend upon modification of warrants | $ 1,431,406 | $ 3,140,009 | |||||
Shares of common stock issuable upon exercise of warrants | 5,129,460 | ||||||
Proceeds from issuance of stock | $ 39,779,507 | $ 9,457,400 | |||||
Number of share issued | 7,244,739 | ||||||
Common stock warrants | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Exercise price per share | $ 0.232 | $ 0.9847 | $ 0.232 | $ 0.232 | $ 0.2320 | $ 2.90 | |
Shares of common stock issuable upon exercise of warrants | 15,085,240 | 3,641,507 | 15,085,240 | ||||
Proceeds from issuance of stock | $ 3,585,809 | ||||||
Warrants to purchase of common stock (in shares) | 397,251 | ||||||
Warrants to purchase of common stock exercise price (in dollars per share) | $ 1.51875 | ||||||
Number of share issued | 13,003,414 | ||||||
Warrant expired (in shares) | 80,797 | 80,797 | |||||
Warrants expired (in dollars per share) | $ 0.08 | $ 0.08 | |||||
Warrant, 15 Months | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Warrants exercise term | 15 months | ||||||
Shares of common stock issuable upon exercise of warrants | 10,157,050 | 10,157,050 | |||||
Warrant, 5 Years | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Warrants exercise term | 5 years |
Stock-Based Compensation - Info
Stock-Based Compensation - Information (Details) - $ / shares | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant date fair value of the options awarded to employees | $ 0.56 | $ 0.72 |
Performance-based stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of award | 10 years | |
2011 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares of common stock reserved for issuance | 106,490 | |
2011 Equity Incentive Plan | Performance-based stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards outstanding | 2,470 | |
2015 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate number of common stock authorized for issuance | 27,838,019 | |
Number of shares available for grant | 15,657,586 | |
Term of award | 10 years | |
2015 Equity Incentive Plan | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year | |
2015 Equity Incentive Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,129,747 | $ 304,539 | $ 2,284,388 | $ 664,016 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 228,240 | 41,148 | 468,211 | 148,938 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 901,507 | $ 263,391 | $ 1,816,177 | $ 515,078 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) | 6 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Number of Shares | |
Balance, Beginning | shares | 3,762,143 |
Granted | shares | 8,361,645 |
Forfeited or expired | shares | (113,007) |
Balance, Ending | shares | 12,010,781 |
Vested and exercisable | shares | 1,726,016 |
Vested and expected to vest | shares | 12,010,781 |
Weighted Average Exercise Price | |
Balance, Beginning | $ / shares | $ 2.01 |
Granted | $ / shares | 0.74 |
Forfeited or expired | $ / shares | 0.73 |
Balance, Ending | $ / shares | 1.14 |
Vested and exercisable | $ / shares | 1.93 |
Vested and expected to vest | $ / shares | $ 1.14 |
Other option information | |
Balance | 9 years 3 months 18 days |
Vested and exercisable | 8 years 9 months 18 days |
Vested and expected to vest | 9 years 3 months 18 days |
Aggregate intrinsic value | $ | $ 15,228,082 |
Aggregate intrinsic value, Vest and exercisable | $ | $ 1,739,158 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Assumptions (Details) - Stock options - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 0.39% | 1.13% |
Expected life (years) | 6 years 4 days | 5 years 8 months 16 days |
Expected volatility | 95.40% | 89.20% |
Expected dividend yield | 0.00% | 0.00% |
Unrecognized compensation expense | $ 5,851,014 | |
Weighted average exercise period of unrecognized compensation | 2 years 6 months 29 days |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance-Based (Details) - Performance-based stock units | 6 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Term of award | 10 years |
Number of PSUs | |
Balance, Beginning | shares | 2,470 |
Balance, Ending | shares | 2,470 |
Vested and exercisable | shares | 2,470 |
Vested and expected to vest | shares | 2,470 |
Weighted Average Base Price Per Unit | |
Balance, Beginning | $ / shares | $ 49.97 |
Vested and exercisable | $ / shares | 49.97 |
Balance, Ending | $ / shares | 49.97 |
Vested and expected to vest | $ / shares | $ 49.97 |
Weighted average remaining contractual term, Outstanding | 3 years 9 months 18 days |
Weighted average remaining contractual term, Vested and exercisable | 3 years 9 months 18 days |
Weighted average remaining contractual term, Vested and expected to vest | 3 years 9 months 18 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted stock (Details) - USD ($) | Mar. 19, 2020 | Jan. 27, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Issuance of vested restricted stock units (in shares) | 109 | |||||
Number of share issued | 7,244,739 | |||||
Stock-based compensation expense | $ 1,129,747 | $ 304,539 | $ 2,284,388 | $ 664,016 | ||
MTTR, LLC (“MTTR”) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of share issued | 7,244,739 | |||||
Restricted Stock | MTTR, LLC (“MTTR”) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of share issued | 7,244,739 | |||||
Term following the FDA approval | 6 months | |||||
Share repurchase price | $ 0.01 | |||||
Number of shares vested in period | 1,811,184 | |||||
Grant date fair value of share | $ 0.54 | |||||
Explicit service period | 4 years 9 months 18 days | |||||
Stock-based compensation expense | 151,764 | $ 78,984 | $ 303,529 | $ 78,984 | ||
Unamortized expense to be recognized of stock awards other than options | $ 2,307,477 | $ 2,307,477 | ||||
Restricted Stock | MTTR, LLC (“MTTR”) | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Repurchase right lapses on shares (as a percent) | 50.00% | |||||
Restricted Stock | MTTR, LLC (“MTTR”) | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Repurchase right lapses on shares (as a percent) | 100.00% |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) | Mar. 19, 2020 | Jan. 27, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 |
Related Party Transaction [Line Items] | |||||||
Shares issued during period | 7,244,739 | ||||||
MTTR, LLC (“MTTR”) | |||||||
Related Party Transaction [Line Items] | |||||||
Shares issued during period | 7,244,739 | ||||||
Contract termination settlement fee | $ 110,000 | ||||||
Related party expense | $ 73,572 | $ 169,347 | $ 541,225 | $ 780,911 | |||
Due to related party, current | $ 90,476 | $ 90,476 | $ 89,762 |