Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2022 | Aug. 08, 2022 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-37759 | |
Entity Registrant Name | OUTLOOK THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 38-3982704 | |
Entity Address, Address Line One | 485 Route 1 South | |
Entity Address, Address Line Two | Building F, Suite 320 | |
Entity Address, City or Town | Iselin | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08830 | |
City Area Code | 609 | |
Local Phone Number | 619-3990 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | OTLK | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 226,144,634 | |
Entity Central Index Key | 0001649989 | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 26,021,429 | $ 14,477,324 |
Prepaid expenses and other current assets | 11,491,956 | 7,030,823 |
Total current assets | 37,513,385 | 21,508,147 |
Property and equipment, net | 40,906 | 163,625 |
Operating lease right-of-use assets, net | 80,924 | 111,429 |
Equity method investment | 812,156 | 853,660 |
Other assets | 140,356 | 174,590 |
Total assets | 38,587,727 | 22,811,451 |
Current liabilities: | ||
Current portion of long-term debt | 10,459,372 | 904,200 |
Current portion of finance lease liabilities | 14,354 | 26,464 |
Current portion of operating lease liabilities | 38,203 | 42,854 |
Accounts payable | 2,480,871 | 2,196,349 |
Accrued expenses | 3,580,535 | 1,725,721 |
Income taxes payable | 1,856,629 | 1,856,629 |
Total current liabilities | 18,429,964 | 6,752,217 |
Long-term debt | 10,885,854 | |
Finance lease liabilities | 7,349 | 16,018 |
Operating lease liabilities | 26,995 | |
Warrant liability | 68,319 | 522,918 |
Total liabilities | 18,505,632 | 18,204,002 |
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; 225,942,719 and 176,461,628 shares issued and outstanding at June 30, 2022 and September 30, 2021, respectively | 2,259,427 | 1,764,616 |
Additional paid-in capital | 412,413,161 | 345,726,087 |
Accumulated deficit | (394,590,493) | (342,883,254) |
Total stockholders' equity | 20,082,095 | 4,607,449 |
Total liabilities, convertible preferred stock and stockholders' equity | 38,587,727 | 22,811,451 |
Series A convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Convertible Preferred Stock Series A-1 | ||
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 | Jun. 30, 2022 | Sep. 30, 2021 |
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 | 225,942,719 | 176,461,628 |
Common stock, shares outstanding | 225,942,719 | 176,461,628 |
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 |
Convertible Preferred Stock Series A-1 | ||
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 | 9 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 11,249,191 | $ 8,545,279 | $ 33,341,333 | $ 29,023,253 |
General and administrative | 5,774,769 | 2,929,717 | 15,741,888 | 9,267,962 |
Loss from operations | (17,023,960) | (11,474,996) | (49,083,221) | (38,291,215) |
Loss on equity method investment | 11,805 | 435,346 | 41,504 | 435,346 |
Interest expense, net | 356,947 | 256,873 | 1,126,808 | 666,945 |
Loss on extinguishment of debt | 1,025,402 | |||
Change in fair value of unsecured convertible promissory note | 376,963 | 882,903 | ||
Change in fair value of warrant liability | (229,714) | 29,332 | (454,599) | 363,476 |
Loss before income taxes | (17,539,961) | (12,196,547) | (51,705,239) | (39,756,982) |
Income tax expense | 2,000 | 2,000 | ||
Net loss | $ (17,539,961) | $ (12,196,547) | $ (51,707,239) | $ (39,758,982) |
Per share information: | ||||
Net loss per share of common stock, basic (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.25) | $ (0.27) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.25) | $ (0.27) |
Weighted average shares outstanding, basic (in shares) | 220,497,826 | 168,420,675 | 209,108,090 | 146,860,652 |
Weighted average shares outstanding, diluted (in shares) | 220,497,826 | 168,420,675 | 209,108,090 | 146,860,652 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
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] | ||||
Stock-based compensation expense | 1,154,641 | 1,154,641 | ||
Net loss | (14,455,914) | (14,455,914) | ||
Balance at Dec. 31, 2020 | $ 1,271,831 | 292,429,007 | (304,175,820) | (10,474,982) |
Balance, ending (in shares) at Dec. 31, 2020 | 127,183,109 | |||
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] | ||||
Net loss | (39,758,982) | |||
Balance at Jun. 30, 2021 | $ 1,748,133 | 340,479,991 | (329,478,888) | 12,749,236 |
Balance, ending (in shares) at Jun. 30, 2021 | 174,813,326 | |||
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 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Sale of common stock, net of issuance costs | $ 12,075 | 3,084,152 | 3,096,227 | |
Sale of common stock, net of issuance costs (in shares) | 1,207,519 | |||
Stock-based compensation expense | 1,198,384 | 1,198,384 | ||
Net loss | (12,196,547) | (12,196,547) | ||
Balance at Jun. 30, 2021 | $ 1,748,133 | 340,479,991 | (329,478,888) | 12,749,236 |
Balance, ending (in shares) at Jun. 30, 2021 | 174,813,326 | |||
Balance at Sep. 30, 2021 | $ 1,764,616 | 345,726,087 | (342,883,254) | 4,607,449 |
Balance, beginning (in shares) at Sep. 30, 2021 | 176,461,628 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with exercise of stock options | $ 250 | 17,500 | 17,750 | |
Issuance of common stock in connection with exercise of stock options (in shares) | 25,000 | |||
Sale of common stock, net of issuance costs | $ 477,740 | 56,979,163 | 57,456,903 | |
Sale of common stock, net of issuance costs (in shares) | 47,773,974 | |||
Stock-based compensation expense | 1,204,048 | 1,204,048 | ||
Net loss | (14,462,729) | (14,462,729) | ||
Balance at Dec. 31, 2021 | $ 2,242,606 | 403,926,798 | (357,345,983) | 48,823,421 |
Balance, ending (in shares) at Dec. 31, 2021 | 224,260,602 | |||
Balance at Sep. 30, 2021 | $ 1,764,616 | 345,726,087 | (342,883,254) | 4,607,449 |
Balance, beginning (in shares) at Sep. 30, 2021 | 176,461,628 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (51,707,239) | |||
Balance at Jun. 30, 2022 | $ 2,259,427 | 412,413,161 | (394,590,493) | 20,082,095 |
Balance, ending (in shares) at Jun. 30, 2022 | 225,942,719 | |||
Balance at Dec. 31, 2021 | $ 2,242,606 | 403,926,798 | (357,345,983) | 48,823,421 |
Balance, beginning (in shares) at Dec. 31, 2021 | 224,260,602 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with exercise of warrants | $ 157 | 187,943 | 188,100 | |
Issuance of common stock in connection with exercise of warrants (in shares) | 15,675 | |||
Sale of common stock, net of issuance costs | $ 15,164 | 2,877,750 | 2,892,914 | |
Sale of common stock, net of issuance costs (in shares) | 1,516,465 | |||
Stock-based compensation expense | 3,762,795 | 3,762,795 | ||
Net loss | (19,704,549) | (19,704,549) | ||
Balance at Mar. 31, 2022 | $ 2,257,927 | 410,755,286 | (377,050,532) | 35,962,681 |
Balance, ending (in shares) at Mar. 31, 2022 | 225,792,742 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Sale of common stock, net of issuance costs | $ 1,500 | 290,001 | 291,501 | |
Sale of common stock, net of issuance costs (in shares) | 149,977 | |||
Stock-based compensation expense | 1,367,874 | 1,367,874 | ||
Net loss | (17,539,961) | (17,539,961) | ||
Balance at Jun. 30, 2022 | $ 2,259,427 | $ 412,413,161 | $ (394,590,493) | $ 20,082,095 |
Balance, ending (in shares) at Jun. 30, 2022 | 225,942,719 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
OPERATING ACTIVITIES | ||
Net loss | $ (51,707,239) | $ (39,758,982) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 153,224 | 211,466 |
Loss on extinguishment of debt | 1,025,402 | |
Non-cash interest expense | 1,199,697 | 640,215 |
Stock-based compensation | 6,334,717 | 3,482,772 |
Change in fair value of unsecured convertible promissory note | 882,903 | |
Change in fair value of warrant liability | (454,599) | 363,476 |
Gain on settlement of lease termination obligation | (552,340) | |
Loss on equity method investment | 41,504 | 435,346 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (4,461,133) | (6,904,417) |
Other assets | 298,523 | |
Operating lease liability | (31,646) | (140,272) |
Accounts payable | 284,522 | 194,029 |
Accrued expenses | 308,776 | (3,532,940) |
Net cash used in operating activities | (46,423,872) | (45,263,124) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of issuance costs | 60,675,552 | 42,514,237 |
Proceeds from debt | 10,000,000 | 10,000,000 |
Payment of debt issuance costs | (8,032) | |
Proceeds from exercise of common stock warrants | 188,100 | 3,585,809 |
Proceeds from exercise of stock options | 17,750 | |
Payments of finance lease obligations | (20,779) | (23,098) |
Repayment of debt | (12,292,646) | (3,649,743) |
Payment of financing costs | (600,000) | |
Net cash provided by financing activities | 57,967,977 | 52,419,173 |
Net increase in cash and cash equivalents | 11,544,105 | 7,156,049 |
Cash and cash equivalents at beginning of period | 14,477,324 | 12,535,986 |
Cash and cash equivalents at end of period | 26,021,429 | 19,692,035 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,556,088 | 17,915 |
Supplemental schedule of non-cash financing activities: | ||
Deferred offering costs amortization | $ 34,234 | $ 82,654 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Jun. 30, 2022 | |
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 pre-commercial 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 ongoing 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 development activities are currently active in support of the Company’s 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 any 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 nine months ended June 30, 2022 were not significantly impacted by COVID-19. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2022 | |
Liquidity | |
Liquidity | 2. Liquidity The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $394,590,493 as of June 30, 2022. As of June 30, 2022, the Company had $10,847,966 of principal and accrued interest due under an unsecured promissory note maturing on January 1, 2023. As a result, there is 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 and cash equivalents as of June 30, 2022 will be sufficient to fund its operations into the first calendar quarter of 2023. 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 such as continuing to access capital through the current ATM Offering (as defined below) and negotiating a potential extension of maturity for notes that are scheduled to mature in January 2023. Refer to Note 10 for further details on the ATM Offering. These strategies may also include, but are not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, the issuance of equity securities, the issuance of additional debt, 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 successfully begin marketing of its product candidates or complete revenue-generating partnerships with other 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 | 9 Months Ended |
Jun. 30, 2022 | |
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 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 June 30, 2022 and its results of operations for the three and nine months ended June 30, 2022 and 2021, cash flows for the nine months ended June 30, 2022 and 2021, and stockholders’ equity (deficit) for the three and nine months ended June 30, 2022 and 2021. Operating results for the nine months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2022. The unaudited interim consolidated financial statements presented herein do not contain all of 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, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 23, 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. Fair value option As permitted under ASC 825, Financial Instruments 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. Potentially dilutive securities include warrants, performance-based stock options and units, 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 loss per share and diluted loss per share: Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Net loss attributable to common stockholders $ (17,539,961) $ (12,196,547) $ (51,707,239) $ (39,758,982) Common stock shares outstanding (weighted average) 220,497,826 168,420,675 209,108,090 146,860,652 Basic and diluted net loss per share $ (0.08) $ (0.07) $ (0.25) $ (0.27) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2022, and 2021, as they would be antidilutive: As of June 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 — Stock options 20,099,581 12,010,781 Common stock warrants 6,812,794 5,129,460 Recently issued accounting pronouncements In January 2020, FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815) In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) — Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2022 | |
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 liabilities that are measured at fair value on a recurring basis: June 30, 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 68,319 September 30, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 522,918 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 unsecured convertible promissory note for the nine months ended June 30, 2022: Unsecured Convertible Promissory Note Warrants Balance at October 1, 2021 $ — $ 522,918 Fair value at issuance date 12,051,581 — Change in fair value 882,903 (454,599) Repayment (12,934,484) — Balance at June 30, 2022 $ — $ 68,319 As further described in Note 8, the Company elected the fair value option to account for its amended unsecured convertible promissory note. The fair value of the amended unsecured convertible promissory note at issuance was estimated using a discounted cash flow model. Significant estimates in the cash flow model include the discount rate and the probability and timing of redemption. The warrants issued in connection with the convertible senior secured notes originally issued pursuant to a certain Note and Warrant Purchase Agreement dated December 22, 2017 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: June 30, 2022 September 30, 2021 Risk-free interest rate 2.96 % 0.62 % Remaining contractual term of warrant (years) 2.6 3.4 Expected volatility 100.3 % 124.7 % Annual dividend yield — % — % Fair value of common stock (per share) $ 1.02 $ 2.17 Fair Value of Other Financial Instruments At June 30, 2022, the fair value and carrying value of the unsecured promissory note included in long-term debt on the consolidated balance sheet on June 30, 2022 was $10,647,000 and $10,459,372, respectively. The estimated fair value was based on discounted expected future cash flows using the prevailing interest rate that is a Level 3 input under the fair value hierarchy. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Jun. 30, 2022 | |
Property and Equipment, Net | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, consists of: June 30, 2022 September 30, 2021 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation (1,026,445) (903,726) $ 40,906 $ 163,625 Depreciation expense was $40,906 for the three months ended June 30, 2022 and 2021, and $122,719 and $122,718 for the nine months ended June 30, 2022 and 2021, respectively. |
Equity Method Investment
Equity Method Investment | 9 Months Ended |
Jun. 30, 2022 | |
Equity Method Investment | |
Equity Method Investment | 6. Equity Method Investment 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, Beijing Syntone Biopharma Ltd (“Syntone”), that is 80% owned by Syntone PRC and 20% owned by the Company. As the Company can exert significant influence over, but does not control, Syntone’s operations through voting rights or representation on Syntone’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone in April 2021, the Company entered into a royalty-free license with Syntone 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 and expects to be required to make an additional capital contribution to Syntone of approximately $2,100,000, 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. The maximum exposure to a loss as a result of the Company’s involvement in Syntone is limited to the initial investment and the future capital contributions of approximately $2,100,000. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Jun. 30, 2022 | |
Accrued Expenses | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consists of: June 30, 2022 September 30, 2021 Compensation $ 1,324,246 $ 753,808 Research and development 1,455,024 808,780 Interest payable — 12,909 Professional fees 586,649 — Other accrued expenses 214,616 150,224 $ 3,580,535 $ 1,725,721 |
Debt
Debt | 9 Months Ended |
Jun. 30, 2022 | |
Debt | |
Debt | 8. Debt Debt consists of: June 30, 2022 September 30, 2021 Unsecured promissory note $ 10,847,966 10,938,145 Paycheck Protection Program term loan — 904,200 Total debt 10,847,966 11,842,345 Less: unamortized loan costs (388,594) (52,291) Total debt, net of unamortized loan costs 10,459,372 11,790,054 Less: current portion (10,459,372) (904,200) Long-term debt $ — $ 10,885,854 Unsecured convertible promissory note On November 5, 2020, the Company received $10,000,000 in net proceeds from the issuance of an unsecured promissory note with a face amount of $10,220,000, which was amended in November 2021 and became convertible. Debt issuance costs totaling $228,032 were recorded as debt discount and were deducted from the principal in the accompanying consolidated balance sheets. The debt discount was amortized as a component of interest expense over the 14-month term of the underlying debt using the effective interest method. The note bore interest at a rate of 7.5% per annum and was due to mature January 1, 2022. On November 16, 2021, the Company entered into a note amendment, which, among other things, (i) extended the maturity date to January 1, 2023, (ii) increased the interest rate from 7.5% per annum to 10% per annum beginning on January 1, 2022, and (iii) provided for the lender’s right to redeem some or all of the outstanding balance of the note for shares of the Company’s common stock beginning July 1, 2022, subject to certain limitations. The amendment was accounted for as an extinguishment of the old promissory note. As a result, the Company recorded a loss on debt extinguishment of $1,025,402, which is the difference between the fair value of the amended promissory note and the net carrying value of the old promissory note, which includes $26,488 of unamortized debt discount and lender fees of $552,633. The amended promissory note included redemption options whereby beginning on July 1, 2022, the holder had the option to redeem up to $2,000,000 of outstanding principal and accrued and unpaid interest per calendar month for shares of the Company’s common stock at a redemption price equal to 75% of the lowest closing bid price in the three trading days immediately preceding the date the holder delivers written notice. The Company elected to account for the amended promissory note at fair value (Note 4) and was not required to bifurcate the redemption options as derivatives. The Company prepaid the note in full on June 30, 2022 by paying 105% of the outstanding balance. The total payment was $12,934,484, which included interest of $1,546,038. Unsecured promissory note On November 16, 2021, the Company received $10,000,000 in net proceeds from the issuance of an unsecured promissory note with a face amount of $10,220,000. Debt issuance costs totaling $820,000 were 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 term of the underlying debt using the effective interest method. The note bears interest at a rate of 9.5% per annum compounding daily and matures January 1, 2023. 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 months ended June 30, 2022 and 2021, the Company recognized $436,593 and $242,816, respectively, of interest expense related to the unsecured promissory notes of which $179,228 and $48,801, respectively, are related to the amortization of debt discount. During the nine months ended June 30, 2022 and 2021, the Company recognized $1,199,697 and $640,215, respectively, of interest expense related to the unsecured promissory notes of which $457,208 and $125,229, respectively, are related to the amortization of debt discount. 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 began 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 loan was fully repaid on May 2, 2022. Aggregate interest expense on the PPP loan for the three months ended June 30, 2022 and 2021 was $131 and $2,279, respectively, and for the nine months ended June 30, 2022 and 2021 was $2,726 and $6,763, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Jun. 30, 2022 | |
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 paid in April 2021; and an additional payment of $750,000, which was accrued at March 31, 2022 and paid in April 2022. There are no remaining future financial obligations. Leases Corporate office In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and does not have remaining future obligations. In March 2021, the Company entered into a new three-year term corporate office lease in Iselin, New Jersey that commenced on April 23, 2021. 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% per annum. 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 nine months ended June 30, 2022 and 2021 are as follows: Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Lease cost: Amortization of right-of-use assets $ — $ — $ — $ — Interest on lease liabilities 723 1,210 2,547 3,997 Total finance lease cost 723 1,210 2,547 3,997 Operating lease cost 11,217 8,413 33,650 95,663 Total lease cost $ 11,940 $ 9,623 $ 36,197 $ 99,660 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: June 30, 2022 September 30, 2021 Operating leases: Right-of-use asset $ 80,924 $ 111,429 Operating lease liabilities 38,203 69,849 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 21,703 42,482 Weighted-average remaining lease term (years): Operating leases 1.8 2.6 Finance leases 1.3 1.7 Weighted-average discount rate: Operating leases 7.5% 7.5% Finance leases 11.8% 9.5% Other information related to leases for the nine months ended June 30, 2022 and 2021 are as follows: Nine months ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 2,547 $ 3,997 Operating cash flows from operating leases 34,791 147,187 Financing cash flows from finance leases 20,779 23,098 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 128,473 Future minimum lease payments under non-cancelable leases as of June 30, 2022 are as follows for the years ending September 30: Operating leases Finance leases 2022 (remaining three months) $ 11,861 $ 6,279 2023 27,675 13,149 2024 — 4,383 Total undiscounted lease payments $ 39,536 $ 23,811 Less: Imputed interest 1,333 2,108 Total lease obligations $ 38,203 $ 21,703 |
Common Stock and Stockholders'
Common Stock and Stockholders' Equity (Deficit) | 9 Months Ended |
Jun. 30, 2022 | |
Common Stock and Stockholders' Equity (Deficit) | |
Common Stock and Stockholders' Equity (Deficit) | 10. Common Stock and Stockholders’ Equity (Deficit) Common stock In November 2021, the Company issued 46,000,000 shares of common stock in an underwritten public offering at a purchase price per share of $1.25 for $53,968,057 in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures and Investments (“GMS Ventures”), the Company’s largest stockholder and strategic partner, purchased an aggregate of 16,000,000 shares of common stock in the public offering at the public offering price per share. In connection with the underwritten public offering, the Company issued the underwriter warrants to purchase up to an aggregate of 2,100,000 shares of common stock at an exercise price of $1.5625 per share, which warrants have a five-year term. H.C. Wainwright & Co. At-the-Market Offering Agreement On March 26, 2021, the Company entered into an At-the-Market Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., as sales agent (“Wainwright” or the “Agent”), under which the Company may issue and sell shares of its common stock from time to time through Wainwright as sales agent (the “ATM Offering”). The Company filed a prospectus supplement, dated March 26, 2021, with the Securities and Exchange Commission pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to up to $40,000,000 from time to time through Wainwright. The Company incurred financing costs of $197,654, which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of June 30, 2022, $127,763 of such deferred costs are included in other assets on the consolidated balance sheets. Under the Agreement, the Company pays Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Agreement. The offering of common stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms. During the nine months ended June 30, 2022, the Company sold 3,440,416 shares of common stock under the ATM Offering and generated $6,929,743 in gross proceeds. The Company paid fees to the Agent and other issuance costs of $222,249. Common stock warrants As of June 30, 2022, 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 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 $ 1.51875 January 28, 2026 2,116,364 $ 1.25000 November 23, 2026 2,100,000 $ 1.56250 6,812,794 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 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. During the nine months ended June 30, 2022, warrants to purchase an aggregate of 400,360 shares of common stock with a weighted average exercise price of $12.00 expired; and warrants to purchase an aggregate of 15,675 shares of common stock with a weighted average exercise price of $12.00 were exercised for cash. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2022 | |
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. As of June 30, 2022, PSUs representing 2,470 shares of the Company’s common stock were outstanding under the 2011 Plan. Effective with 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 34,565,837. As of June 30, 2022, 13,571,604 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 The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three and nine months ended June 30, 2022 and 2021: Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Research and development $ 205,410 $ 239,231 $ 2,278,067 $ 707,442 General and administrative 1,162,464 959,153 4,056,650 2,775,330 $ 1,367,874 $ 1,198,384 $ 6,334,717 $ 3,482,772 Stock options As of June 30, 2022 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, 2021 16,110,015 $ 1.46 Granted 4,014,566 1.60 Exercised (25,000) 0.71 $ 38,960 Balance at June 30, 2022 20,099,581 1.49 8.5 $ 2,768,083 Exercisable 6,748,589 1.35 8.0 $ 1,275,638 Vested and expected to vest at June 30, 2022 20,099,581 $ 1.49 8.5 $ 2,768,083 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 nine months ended June 30, 2022 and 2021 was $1.23 and $0.57 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: Nine months ended June 30, 2022 2021 Risk-free interest rate 1.77 % 0.40 % Expected term (years) 6.0 6.0 Expected volatility 95.2 % 95.4 % Expected dividend yield — — As of June 30, 2022, there was $12,368,234 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.85 years. Performance-based stock options The Company granted certain officers of the Company option awards whose vesting is contingent upon meeting company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 10 years. The fair value of each option grant under the performance share option plan was estimated on the date of grant using the same option valuation model used for non-statutory options above. Compensation expense for performance-based stock options is only recognized when management determines it is probable that the awards will vest. A summary of the activity under the performance share option plan as of June 30, 2022 and changes during the nine months then ended are presented below. Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2021 1,000,000 $ 2.42 Granted 1,900,000 1.44 Forfeited or expired (2,200,000) 1.89 Balance at June 30, 2022 700,000 $ 1.44 9.48 $ — Exercisable 700,000 $ 1.44 9.48 $ — Vested and expected to vest at June 30, 2022 700,000 $ 1.44 9.48 $ — The weighted average grant date fair value of the performance stock options awarded during the nine months ended June 30, 2022 was $1.03 per option. During the nine months ended June 30, 2022, an aggregate of 700,000 performance-based stock options vested as a result of achieving one of the set performance conditions related to the Company’s BLA submission that resulted in the Company recognizing stock-based compensation expense of $718,950 during the nine months ended June 30, 2022. During the nine months ended June 30, 2022, an aggregate of 2,200,000 performance-based stock options were forfeited because certain performance conditions were not achieved. As of June 30, 2022, there were no remaining performance conditions. 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: Nine months ended June 30, 2022 Risk-free interest rate 1.26 % Expected term (years) 5.22 Expected volatility 91.46 % Expected dividend yield — There were no performance-based stock options granted during the nine months ended June 30, 2021. Performance-based stock units The Company has issued PSUs, which generally have a ten-year term 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 nine months ended June 30, 2022: Weighted Average Number Base Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2021 2,470 $ 49.97 Forfeitures — — Balance at June 30, 2022 2,470 49.97 3.0 $ — Vested and exercisable at June 30, 2022 2,470 49.97 3.0 $ — Vested and expected to vest at June 30, 2022 2,470 $ 49.97 3.0 $ — 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 TWO 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. 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. The compensation expense was accelerated during the nine months ended June 30, 2022 as a result of the Company achieving certain performance conditions related to the Company’s BLA submission that make it probable that the repurchase rights will lapse. During the three months ended 2021, the Company recognized compensation expense related to the restricted stock of $151,764. During the nine months ended June 30, 2022 and 2021, the Company recognized compensation expense related to the restricted stock of $2,003,946 and $455,293, respectively. As of June 30, 2022, there was no unrecognized compensation expense related to the restricted stock. |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Jun. 30, 2022 | |
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. 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. 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. 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 June 30, 2022 and 2021, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $58,069 and $271,583 , respectively, and $471,435 and $812,808 during the nine months ended June 30, 2022 and 2021, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 11). As of June 30, 2022 and September 30, 2021, an aggregate $18,333 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. On December 21, 2021, the Company entered into employment agreements with each of Mr. Dagnon and Mr. Evanson, which superseded and replaced their prior consulting agreements. Pursuant to their new employment agreements, each of Mr. Dagnon and Mr. Evanson will receive a base salary of $450,000 and a discretionary annual cash bonus with a target amount equal to 50% of his respective base salary. In connection with their entry into the employment agreements, each of Mr. Dagnon and Mr. Evanson received a grant of 800,000 options to purchase common stock, one quarter of which will vest on the first anniversary of the grant and the remainder of which will vest in monthly installments over the succeeding three years, subject to their continued service through each vesting date. In addition, each of Mr. Dagnon and Mr. Evanson received a performance grant of 200,000 options to purchase common stock, which will vest upon the Company’s achievement of certain milestones. An aggregate of 200,000 performance-based stock options vested as a result of achieving the performance condition related to the Company’s BLA submission. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2022 | |
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 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 June 30, 2022 and its results of operations for the three and nine months ended June 30, 2022 and 2021, cash flows for the nine months ended June 30, 2022 and 2021, and stockholders’ equity (deficit) for the three and nine months ended June 30, 2022 and 2021. Operating results for the nine months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2022. The unaudited interim consolidated financial statements presented herein do not contain all of 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, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 23, 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. |
Fair value option | Fair value option As permitted under ASC 825, Financial Instruments |
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. Potentially dilutive securities include warrants, performance-based stock options and units, 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 loss per share and diluted loss per share: Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Net loss attributable to common stockholders $ (17,539,961) $ (12,196,547) $ (51,707,239) $ (39,758,982) Common stock shares outstanding (weighted average) 220,497,826 168,420,675 209,108,090 146,860,652 Basic and diluted net loss per share $ (0.08) $ (0.07) $ (0.25) $ (0.27) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2022, and 2021, as they would be antidilutive: As of June 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 — Stock options 20,099,581 12,010,781 Common stock warrants 6,812,794 5,129,460 |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In January 2020, FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815) In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) — Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
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 June 30, Nine months ended June 30, 2022 2021 2022 2021 Net loss attributable to common stockholders $ (17,539,961) $ (12,196,547) $ (51,707,239) $ (39,758,982) Common stock shares outstanding (weighted average) 220,497,826 168,420,675 209,108,090 146,860,652 Basic and diluted net loss per share $ (0.08) $ (0.07) $ (0.25) $ (0.27) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of June 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 — Stock options 20,099,581 12,010,781 Common stock warrants 6,812,794 5,129,460 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on a recurring basis | June 30, 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 68,319 September 30, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 522,918 |
Schedule of changes in the fair value of Level 3 valuation for the warrant liability | Unsecured Convertible Promissory Note Warrants Balance at October 1, 2021 $ — $ 522,918 Fair value at issuance date 12,051,581 — Change in fair value 882,903 (454,599) Repayment (12,934,484) — Balance at June 30, 2022 $ — $ 68,319 |
Schedule of fair value of the warrant liability | June 30, 2022 September 30, 2021 Risk-free interest rate 2.96 % 0.62 % Remaining contractual term of warrant (years) 2.6 3.4 Expected volatility 100.3 % 124.7 % Annual dividend yield — % — % Fair value of common stock (per share) $ 1.02 $ 2.17 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Property and Equipment, Net | |
Schedule of property and equipment | June 30, 2022 September 30, 2021 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation (1,026,445) (903,726) $ 40,906 $ 163,625 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, 2022 September 30, 2021 Compensation $ 1,324,246 $ 753,808 Research and development 1,455,024 808,780 Interest payable — 12,909 Professional fees 586,649 — Other accrued expenses 214,616 150,224 $ 3,580,535 $ 1,725,721 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Debt | |
Schedule of debt | June 30, 2022 September 30, 2021 Unsecured promissory note $ 10,847,966 10,938,145 Paycheck Protection Program term loan — 904,200 Total debt 10,847,966 11,842,345 Less: unamortized loan costs (388,594) (52,291) Total debt, net of unamortized loan costs 10,459,372 11,790,054 Less: current portion (10,459,372) (904,200) Long-term debt $ — $ 10,885,854 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies. | |
Schedule of lease information | The components of lease cost for the three and nine months ended June 30, 2022 and 2021 are as follows: Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Lease cost: Amortization of right-of-use assets $ — $ — $ — $ — Interest on lease liabilities 723 1,210 2,547 3,997 Total finance lease cost 723 1,210 2,547 3,997 Operating lease cost 11,217 8,413 33,650 95,663 Total lease cost $ 11,940 $ 9,623 $ 36,197 $ 99,660 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: June 30, 2022 September 30, 2021 Operating leases: Right-of-use asset $ 80,924 $ 111,429 Operating lease liabilities 38,203 69,849 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 21,703 42,482 Weighted-average remaining lease term (years): Operating leases 1.8 2.6 Finance leases 1.3 1.7 Weighted-average discount rate: Operating leases 7.5% 7.5% Finance leases 11.8% 9.5% Other information related to leases for the nine months ended June 30, 2022 and 2021 are as follows: Nine months ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 2,547 $ 3,997 Operating cash flows from operating leases 34,791 147,187 Financing cash flows from finance leases 20,779 23,098 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 128,473 |
Schedule of operating lease future minimum payments | Future minimum lease payments under non-cancelable leases as of June 30, 2022 are as follows for the years ending September 30: Operating leases Finance leases 2022 (remaining three months) $ 11,861 $ 6,279 2023 27,675 13,149 2024 — 4,383 Total undiscounted lease payments $ 39,536 $ 23,811 Less: Imputed interest 1,333 2,108 Total lease obligations $ 38,203 $ 21,703 |
Schedule of finance lease future minimum payments | Operating leases Finance leases 2022 (remaining three months) $ 11,861 $ 6,279 2023 27,675 13,149 2024 — 4,383 Total undiscounted lease payments $ 39,536 $ 23,811 Less: Imputed interest 1,333 2,108 Total lease obligations $ 38,203 $ 21,703 |
Common Stock and Stockholders_2
Common Stock and Stockholders' Equity (Deficit) (Tables) | 9 Months Ended |
Jun. 30, 2022 | |
Common Stock and Stockholders' Equity (Deficit) | |
Schedule of warrants outstanding | As of June 30, 2022, 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 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 $ 1.51875 January 28, 2026 2,116,364 $ 1.25000 November 23, 2026 2,100,000 $ 1.56250 6,812,794 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 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) | 9 Months Ended |
Jun. 30, 2022 | |
Share-based Compensation | |
Schedule of stock-based compensation expense | Three months ended June 30, Nine months ended June 30, 2022 2021 2022 2021 Research and development $ 205,410 $ 239,231 $ 2,278,067 $ 707,442 General and administrative 1,162,464 959,153 4,056,650 2,775,330 $ 1,367,874 $ 1,198,384 $ 6,334,717 $ 3,482,772 |
Schedule of performance-based stock units activity | Weighted Average Number Base Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2021 2,470 $ 49.97 Forfeitures — — Balance at June 30, 2022 2,470 49.97 3.0 $ — Vested and exercisable at June 30, 2022 2,470 49.97 3.0 $ — Vested and expected to vest at June 30, 2022 2,470 $ 49.97 3.0 $ — |
Stock options | |
Share-based Compensation | |
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, 2021 16,110,015 $ 1.46 Granted 4,014,566 1.60 Exercised (25,000) 0.71 $ 38,960 Balance at June 30, 2022 20,099,581 1.49 8.5 $ 2,768,083 Exercisable 6,748,589 1.35 8.0 $ 1,275,638 Vested and expected to vest at June 30, 2022 20,099,581 $ 1.49 8.5 $ 2,768,083 |
Schedule of option assumptions | Nine months ended June 30, 2022 2021 Risk-free interest rate 1.77 % 0.40 % Expected term (years) 6.0 6.0 Expected volatility 95.2 % 95.4 % Expected dividend yield — — |
Performance-based stock options | |
Share-based Compensation | |
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, 2021 1,000,000 $ 2.42 Granted 1,900,000 1.44 Forfeited or expired (2,200,000) 1.89 Balance at June 30, 2022 700,000 $ 1.44 9.48 $ — Exercisable 700,000 $ 1.44 9.48 $ — Vested and expected to vest at June 30, 2022 700,000 $ 1.44 9.48 $ — |
Schedule of option assumptions | Nine months ended June 30, 2022 Risk-free interest rate 1.26 % Expected term (years) 5.22 Expected volatility 91.46 % Expected dividend yield — |
Liquidity (Details)
Liquidity (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Liquidity | ||
Accumulated deficit | $ 394,590,493 | $ 342,883,254 |
Total debt | 10,847,966 | $ 11,842,345 |
Unsecured promissory notes-aggregate | ||
Liquidity | ||
Total debt | $ 10,847,966 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Basic and diluted earnings per share: | ||||
Net loss attributable to common stockholders | $ (17,539,961) | $ (12,196,547) | $ (51,707,239) | $ (39,758,982) |
Basic Earnings Per Share | ||||
Weighted average shares outstanding, basic (in shares) | 220,497,826 | 168,420,675 | 209,108,090 | 146,860,652 |
Net loss per share of common stock, basic (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.25) | $ (0.27) |
Diluted Earnings Per Share | ||||
Weighted average shares outstanding, diluted (in shares) | 220,497,826 | 168,420,675 | 209,108,090 | 146,860,652 |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.25) | $ (0.27) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
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 |
Performance-based stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 700,000 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 20,099,581 | 12,010,781 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 6,812,794 | 5,129,460 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Fair value measurements recurring basis | Level 3 | ||
Liabilities | ||
Warrant liability | $ 68,319 | $ 522,918 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in fair value (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Change in fair value | $ (376,963) | $ (882,903) |
Unsecured convertible promissory note | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value at issuance date | 12,051,581 | |
Change in fair value | 882,903 | |
Repayment | (12,934,484) | |
Warrant liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning | 522,918 | |
Change in fair value | (454,599) | |
Balance, ending | $ 68,319 | $ 68,319 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions (Details) | Jun. 30, 2022 $ / shares Y | Sep. 30, 2021 Y $ / shares |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 2.96 | 0.62 |
Remaining contractual term of warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | Y | 2.6 | 3.4 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 100.3 | 124.7 |
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 | 1.02 | 2.17 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Fair value | ||
Carrying value | $ 10,459,372 | $ 11,790,054 |
Unsecured promissory note (2021) | ||
Fair value | ||
Debt fair value | 10,647,000 | |
Carrying value | $ 10,459,372 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Sep. 30, 2021 | |
Property and Equipment, Net | |||||
Laboratory equipment | $ 1,067,351 | $ 1,067,351 | $ 1,067,351 | ||
Less: accumulated depreciation | (1,026,445) | (1,026,445) | (903,726) | ||
Property and equipment, net | 40,906 | 40,906 | $ 163,625 | ||
Depreciation expense | $ 40,906 | $ 40,906 | $ 122,719 | $ 122,718 |
Equity Method Investment - Synt
Equity Method Investment - Syntone (Details) - PRC Joint Venture - USD ($) | 1 Months Ended | |
May 22, 2020 | Jun. 30, 2020 | |
Schedule of Equity Method Investments [Line Items] | ||
Ownership percentage | 20% | |
Investment 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% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Accrued Expenses | ||
Compensation | $ 1,324,246 | $ 753,808 |
Research and development | 1,455,024 | 808,780 |
Interest payable | 12,909 | |
Professional fees | 586,649 | |
Other accrued expenses | 214,616 | 150,224 |
Accrued expenses, total | $ 3,580,535 | $ 1,725,721 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Jun. 30, 2022 | Nov. 16, 2021 | Sep. 30, 2021 | Nov. 05, 2020 |
Debt Instrument [Line Items] | ||||
Total debt | $ 10,847,966 | $ 11,842,345 | ||
Less: unamortized loan costs | (388,594) | (52,291) | ||
Total debt, net of unamortized loan costs | 10,459,372 | 11,790,054 | ||
Less: current portion | (10,459,372) | (904,200) | ||
Long-term debt | 10,885,854 | |||
Unsecured promissory note (2021) | ||||
Debt Instrument [Line Items] | ||||
Total debt | 10,847,966 | |||
Less: unamortized loan costs | $ (820,000) | |||
Total debt, net of unamortized loan costs | $ 10,459,372 | |||
Unsecured promissory note (2020) | ||||
Debt Instrument [Line Items] | ||||
Total debt | 10,938,145 | |||
Less: unamortized loan costs | $ (26,488) | $ (228,032) | ||
Paycheck Protection Program | ||||
Debt Instrument [Line Items] | ||||
Total debt | $ 904,200 |
Debt - Information (Details)
Debt - Information (Details) | 3 Months Ended | 9 Months Ended | |||||||
Jun. 30, 2022 USD ($) | Nov. 16, 2021 USD ($) D | Nov. 05, 2020 USD ($) | May 04, 2020 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Sep. 30, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||||||
Proceeds from loan | $ 10,000,000 | $ 10,000,000 | |||||||
Unamortized discount | $ 388,594 | $ 388,594 | 388,594 | $ 52,291 | |||||
Gain (loss) on extinguishment of debt | (1,025,402) | ||||||||
Payment of lender fees | 600,000 | ||||||||
Debt outstanding | $ 10,459,372 | 10,459,372 | 10,459,372 | $ 11,790,054 | |||||
Unsecured convertible promissory note | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate (as a percent) | 10% | ||||||||
Redemption price (as a percent) | 105% | 75% | |||||||
Trading day threshold | D | 3 | ||||||||
Repayments of unsecured debt | $ 12,934,484 | ||||||||
Interest expense | 1,546,038 | ||||||||
Unsecured convertible promissory note | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of notes exchanged | $ 2,000,000 | ||||||||
Unsecured promissory notes-aggregate | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest expense | 436,593 | $ 242,816 | 1,199,697 | 640,215 | |||||
Amortization of debt issuance costs | 179,228 | 48,801 | 457,208 | 125,229 | |||||
Unsecured promissory note (2020) | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from loan | $ 10,000,000 | ||||||||
Original principal amount | 10,220,000 | ||||||||
Unamortized discount | 26,488 | $ 228,032 | |||||||
Debt Instrument, term | 14 months | ||||||||
Interest rate (as a percent) | 7.50% | ||||||||
Gain (loss) on extinguishment of debt | (1,025,402) | ||||||||
Payment of lender fees | 552,633 | ||||||||
Unsecured promissory note (2021) | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from loan | 10,000,000 | ||||||||
Original principal amount | 10,220,000 | ||||||||
Unamortized discount | $ 820,000 | ||||||||
Interest rate (as a percent) | 9.50% | ||||||||
Redemption price (as a percent) | 105% | ||||||||
Debt outstanding | $ 10,459,372 | 10,459,372 | 10,459,372 | ||||||
Paycheck Protection Program | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from loan | $ 904,200 | ||||||||
Debt Instrument, term | 2 years | ||||||||
Interest rate (as a percent) | 1% | ||||||||
Interest expense | $ 131 | $ 2,279 | $ 2,726 | $ 6,763 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | |||
Jul. 20, 2020 | Apr. 30, 2022 | Apr. 30, 2021 | Jun. 30, 2022 | |
Commitments and Contingencies. | ||||
Loss contingency damages due to third party | $ 3,000,000 | |||
Settlement payment | $ 750,000 | $ 625,000 | ||
Settlement payable | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Lease termination (Details) | Mar. 31, 2021 |
Corporate Office Lease, Iselin, New Jersey | |
Commitment | |
Lease term | 3 years |
Commitments and Contingencies_3
Commitments and Contingencies - Lease cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Lease cost | ||||
Interest on lease liabilities | $ 723 | $ 1,210 | $ 2,547 | $ 3,997 |
Total finance lease cost | 723 | 1,210 | 2,547 | 3,997 |
Operating lease cost | 11,217 | 8,413 | 33,650 | 95,663 |
Total lease cost | $ 11,940 | $ 9,623 | $ 36,197 | $ 99,660 |
Minimum | ||||
Leases | ||||
Finance lease term | 12 months | 12 months | ||
Finance lease interest (as a percent) | 4% | 4% | ||
Maximum | ||||
Leases | ||||
Finance lease term | 36 months | 36 months | ||
Finance lease interest (as a percent) | 13% | 13% |
Commitments and Contingencies_4
Commitments and Contingencies - Lease balance sheet (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Leases | ||
Operating leases, Right-of-use asset | $ 80,924 | $ 111,429 |
Operating leases, Lease obligation | 38,203 | 69,849 |
Finance leases, Lease obligation | $ 21,703 | $ 42,482 |
Operating leases, Weighted-average remaining lease term | 1 year 9 months 18 days | 2 years 7 months 6 days |
Finance leases, Weighted-average remaining lease term | 1 year 3 months 18 days | 1 year 8 months 12 days |
Operating leases, Weighted-average discount rate (as a percent) | 7.50% | 7.50% |
Finance leases, Weighted-average discount rate (as a percent) | 11.80% | 9.50% |
Commitments and Contingencies_5
Commitments and Contingencies - Lease cashflow (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Leases | ||
Operating cash flows from finance leases | $ 2,547 | $ 3,997 |
Operating cash flows from operating leases | 34,791 | 147,187 |
Financing cash flows from finance leases | $ 20,779 | 23,098 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 128,473 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease minimum payments (Details) - USD ($) | Jun. 30, 2022 | Sep. 30, 2021 |
Operating leases | ||
2022 (remaining three months) | $ 11,861 | |
2023 | 27,675 | |
Total undiscounted lease payments | 39,536 | |
Less: Imputed interest | 1,333 | |
Total lease obligations | 38,203 | $ 69,849 |
Finance leases | ||
2022 (remaining three months) | 6,279 | |
2023 | 13,149 | |
2024 | 4,383 | |
Total undiscounted lease payments | 23,811 | |
Less: Imputed interest | 2,108 | |
Total lease obligations | $ 21,703 | $ 42,482 |
Common Stock and Stockholders_3
Common Stock and Stockholders' Equity (Deficit) - Common Stock (Details) - USD ($) | 1 Months Ended | 9 Months Ended | ||
Mar. 26, 2021 | Nov. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||
Shares of common stock issuable upon exercise of warrants | 6,812,794 | |||
Proceeds from issuance of stock | $ 60,675,552 | $ 42,514,237 | ||
Warrants exercise term | 5 years | |||
Underwritten Public Offering | ||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||
Number of share issued | 46,000,000 | |||
Shares of common stock issuable upon exercise of warrants | 2,100,000 | |||
Shares issued price (in dollars per share) | $ 1.25 | |||
Proceeds from issuance of stock | $ 53,968,057 | |||
Exercise price per share | $ 1.5625 | |||
GMS Ventures & Investments | ||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||
Number of share issued | 16,000,000 | |||
ATM Offering | ||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||
Number of share issued | 3,440,416 | |||
Proceeds from issuance of stock | $ 6,929,743 | |||
Aggregate offering price | $ 40,000,000 | |||
Amount reclassified on additional paid in capital | $ 197,654 | |||
Deferred costs | 127,763 | |||
Percentage of commission on sale of common stock | 3% | |||
Payment of fees to sales agent | $ 222,249 |
Common Stock and Stockholders_4
Common Stock and Stockholders' Equity (Deficit) - Warrants (Details) | 9 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 6,812,794 |
February 18, 2022 | |
Warrants | |
Exercise price per share | $ / shares | $ 12 |
Warrant expired (in shares) | 400,360 |
Warrants expired (in dollars per share) | $ / shares | $ 12 |
Issuance of common stock in connection with exercise of warrants (in shares) | 15,675 |
December 22, 2024 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 277,128 |
Exercise price per share | $ / shares | $ 12 |
April 13, 2025 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 145,686 |
Exercise price per share | $ / shares | $ 12 |
May 31, 2025 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 62,437 |
Exercise price per share | $ / shares | $ 12 |
February 24, 2025 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 172,864 |
Exercise price per share | $ / shares | $ 1.27 |
February 26, 2024 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 1,747,047 |
Exercise price per share | $ / shares | $ 0.9535 |
June 22, 2025 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 191,268 |
Exercise price per share | $ / shares | $ 1.51875 |
January 28, 2026 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 2,116,364 |
Exercise price per share | $ / shares | $ 1.25000 |
November 23, 2026 | |
Warrants | |
Shares of common stock issuable upon exercise of warrants | 2,100,000 |
Exercise price per share | $ / shares | $ 1.56250 |
Stock-Based Compensation - Info
Stock-Based Compensation - Information (Details) - 2015 Equity Incentive Plan | 9 Months Ended |
Jun. 30, 2022 shares | |
Share-based Compensation | |
Aggregate number of common stock authorized for issuance | 34,565,837 |
Number of shares available for grant | 13,571,604 |
Term of award | 10 years |
Minimum | |
Share-based Compensation | |
Vesting period | 1 year |
Maximum | |
Share-based Compensation | |
Vesting period | 4 years |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,367,874 | $ 1,198,384 | $ 6,334,717 | $ 3,482,772 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 205,410 | 239,231 | 2,278,067 | 707,442 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,162,464 | $ 959,153 | $ 4,056,650 | $ 2,775,330 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Other option information | ||||
Stock-based compensation expense | $ 1,367,874 | $ 1,198,384 | $ 6,334,717 | $ 3,482,772 |
Stock options | ||||
Number of Shares | ||||
Balance, Beginning (in shares) | 16,110,015 | |||
Granted (in shares) | 4,014,566 | |||
Exercised (in shares) | (25,000) | |||
Balance, Ending (in shares) | 20,099,581 | 20,099,581 | ||
Exercisable (in shares) | 6,748,589 | 6,748,589 | ||
Vested and expected to vest (in shares) | 20,099,581 | 20,099,581 | ||
Weighted Average Exercise Price | ||||
Balance, Beginning (in dollars per share) | $ 1.46 | |||
Granted (in dollars per share) | 1.60 | |||
Exercised (in dollars per share) | 0.71 | |||
Balance, Ending (in dollars per share) | $ 1.49 | 1.49 | ||
Exercisable (in dollars per share) | 1.35 | 1.35 | ||
Vested and expected to vest (in dollars per share) | $ 1.49 | $ 1.49 | ||
Other option information | ||||
Balance-Remaining contractual term | 8 years 6 months | |||
Exercisable-Remaining contractual term | 8 years | |||
Vested and expected to vest-Remaining contractual term | 8 years 6 months | |||
Aggregate intrinsic value, Exercised | $ 38,960 | |||
Aggregate intrinsic value, Outstanding | $ 2,768,083 | 2,768,083 | ||
Aggregate intrinsic value, Exercisable | 1,275,638 | 1,275,638 | ||
Aggregate intrinsic value, Vested and expected to vest | $ 2,768,083 | $ 2,768,083 | ||
Grant date fair value of options (in dollars per share) | $ 1.23 | $ 0.57 | ||
Performance-based stock options | ||||
Share-based Compensation | ||||
Term of award | 10 years | |||
Number of Shares | ||||
Balance, Beginning (in shares) | 1,000,000 | |||
Granted (in shares) | 1,900,000 | 0 | ||
Forfeited or expired (in shares) | (2,200,000) | |||
Forfeited | (2,200,000) | |||
Balance, Ending (in shares) | 700,000 | 700,000 | ||
Exercisable (in shares) | 700,000 | 700,000 | ||
Vested and expected to vest (in shares) | 700,000 | 700,000 | ||
Weighted Average Exercise Price | ||||
Balance, Beginning (in dollars per share) | $ 2.42 | |||
Granted (in dollars per share) | 1.44 | |||
Forfeited or expired (in dollars per share) | 1.89 | |||
Balance, Ending (in dollars per share) | $ 1.44 | 1.44 | ||
Exercisable (in dollars per share) | 1.44 | 1.44 | ||
Vested and expected to vest (in dollars per share) | $ 1.44 | $ 1.44 | ||
Other option information | ||||
Balance-Remaining contractual term | 9 years 5 months 23 days | |||
Exercisable-Remaining contractual term | 9 years 5 months 23 days | |||
Vested and expected to vest-Remaining contractual term | 9 years 5 months 23 days | |||
Grant date fair value of options (in dollars per share) | $ 1.03 | |||
Stock-based compensation expense | $ 718,950 | |||
Number of stock options vested | 700,000 | |||
Stock options forfeited | 2,200,000 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Assumptions (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Stock options | ||
Share-based Compensation | ||
Risk-free interest rate | 1.77% | 0.40% |
Expected term (years) | 6 years | 6 years |
Expected volatility | 95.20% | 95.40% |
Expected dividend yield | 0% | 0% |
Unrecognized compensation expense | $ 12,368,234 | |
Unrecognized compensation exercise period | 2 years 10 months 6 days | |
Performance-based stock options | ||
Share-based Compensation | ||
Risk-free interest rate | 1.26% | |
Expected term (years) | 5 years 2 months 19 days | |
Expected volatility | 91.46% | |
Expected dividend yield | 0% |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-options (Details) - Performance-based stock units | 9 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-based Compensation | |
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 |
Balance, Ending | $ / shares | 49.97 |
Vested and exercisable | $ / shares | 49.97 |
Vested and expected to vest | $ / shares | $ 49.97 |
Weighted average remaining contractual term, Outstanding | 3 years |
Weighted average remaining contractual term, Vested and exercisable | 3 years |
Weighted average remaining contractual term, Vested and expected to vest | 3 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted stock (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jan. 27, 2020 item shares | Mar. 31, 2020 item $ / shares shares | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 1,367,874 | $ 1,198,384 | $ 6,334,717 | $ 3,482,772 | ||
MTTR, LLC ("MTTR") | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of principals | item | 4 | |||||
Shares issued during period | shares | 7,244,739 | |||||
Restricted Stock | MTTR, LLC ("MTTR") | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of principals | item | 4 | |||||
Shares issued during period | shares | 7,244,739 | |||||
Share repurchase price | $ / shares | $ 0.01 | |||||
Grant date fair value of share | $ / shares | $ 0.54 | |||||
Explicit service period | 4 years 9 months 18 days | |||||
Stock-based compensation expense | $ 151,764 | 2,003,946 | $ 455,293 | |||
Unamortized expense to be recognized of stock awards other than options | $ 0 | $ 0 | ||||
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% | |||||
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% |
Related-Party Transactions (Det
Related-Party Transactions (Details) | 3 Months Ended | 9 Months Ended | |||||
Dec. 21, 2021 USD ($) shares | Jan. 27, 2020 USD ($) individual item shares | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) shares | Jun. 30, 2021 USD ($) shares | Sep. 30, 2021 USD ($) | |
Performance-based stock options | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares granted | 1,900,000 | 0 | |||||
Number of stock options vested | 700,000 | ||||||
MTTR, LLC ("MTTR") | |||||||
Related Party Transaction [Line Items] | |||||||
Number of principals | item | 4 | ||||||
Number Of Executive Officers | individual | 2 | ||||||
Shares issued during period | 7,244,739 | ||||||
Contract termination settlement fee | $ | $ 110,000 | ||||||
Related party expense | $ | $ 58,069 | $ 271,583 | $ 471,435 | $ 812,808 | |||
Due to related party, current | $ | $ 18,333 | $ 18,333 | $ 89,762 | ||||
Employment agreement | Performance-based stock options | |||||||
Related Party Transaction [Line Items] | |||||||
Number of stock options vested | 200,000 | ||||||
Employment agreement | Terry Dagnon | |||||||
Related Party Transaction [Line Items] | |||||||
Base salary | $ | $ 450,000 | ||||||
Percentage of cash bonus | 50% | ||||||
Employment agreement | Terry Dagnon | Stock option | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares granted | 800,000 | ||||||
Employment agreement | Terry Dagnon | Performance-based stock options | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares granted | 200,000 | ||||||
Employment agreement | Jeff Evanson | |||||||
Related Party Transaction [Line Items] | |||||||
Base salary | $ | $ 450,000 | ||||||
Percentage of cash bonus | 50% | ||||||
Employment agreement | Jeff Evanson | Stock option | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares granted | 800,000 | ||||||
Employment agreement | Jeff Evanson | Performance-based stock options | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares granted | 200,000 |