Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2024 | Aug. 12, 2024 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
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 | 111 S. Wood Avenue, Unit #100 | |
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 | 23,655,636 | |
Entity Central Index Key | 0001649989 | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets (un
Consolidated Balance Sheets (unaudited) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 32,024,387 | $ 23,391,982 |
Prepaid expenses and other current assets | 13,593,261 | 7,587,216 |
Total current assets | 45,617,648 | 30,979,198 |
Operating lease right-of-use assets, net | 286,462 | 26,172 |
Equity method investment | 708,388 | 793,932 |
Other assets | 479,229 | 501,299 |
Total assets | 47,091,727 | 32,300,601 |
Current liabilities: | ||
Unsecured convertible promissory note | 32,432,000 | 35,551,000 |
Finance lease liabilities | 4,267 | |
Current portion of operating lease liabilities | 31,801 | |
Accounts payable | 5,552,484 | 6,574,523 |
Accrued expenses | 2,680,914 | 2,745,740 |
Income taxes payable | 1,856,629 | 1,856,629 |
Total current liabilities | 42,553,828 | 46,732,159 |
Operating lease liabilities | 260,395 | |
Warrant liability | 87,950,992 | 6,219 |
Total liabilities | 130,765,215 | 46,738,378 |
Commitments and contingencies (Note 8) | ||
Stockholders' deficit: | ||
Preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding | ||
Common stock, par value $0.01 per share; 60,000,000 shares authorized; 23,405,637 and 13,012,833 shares issued and outstanding at June 30, 2024 and September 30, 2023, respectively | 234,057 | 130,128 |
Additional paid-in capital | 465,068,636 | 453,350,281 |
Accumulated deficit | (548,976,181) | (467,918,186) |
Total stockholders' deficit | (83,673,488) | (14,437,777) |
Total liabilities, convertible preferred stock and stockholders' deficit | $ 47,091,727 | $ 32,300,601 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (unaudited) (Parentheticals) - $ / shares | Jun. 30, 2024 | Sep. 30, 2023 |
Consolidated Balance Sheets (unaudited) | ||
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
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 | 60,000,000 | 60,000,000 |
Common stock, shares issued | 23,405,637 | 13,012,833 |
Common stock, shares outstanding | 23,405,637 | 13,012,833 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses: | ||||
Research and development | $ 11,201,754 | $ 11,101,504 | $ 29,240,046 | $ 21,508,876 |
General and administrative | 8,360,933 | 7,039,901 | 19,585,738 | 19,158,487 |
Total operating expenses | 19,562,687 | 18,141,405 | 48,825,784 | 40,667,363 |
Loss from operations | (19,562,687) | (18,141,405) | (48,825,784) | (40,667,363) |
Loss on equity method investment | 57,497 | 7,188 | 85,544 | 2,648 |
Interest income | (404,593) | (395,537) | (666,199) | (665,459) |
Interest expense | 303 | 3,156,964 | 2,531,022 | |
Loss on extinguishment of debt | 577,659 | |||
Change in fair value of promissory notes | (7,563,000) | 2,910,000 | 1,949,153 | 2,913,000 |
Warrant related expenses (Note 9) | 3,392,444 | 37,490,012 | ||
Change in fair value of warrant liability | (59,454,222) | 11,749 | (9,786,063) | (37,126) |
Income (loss) before income taxes | 44,409,187 | (20,675,108) | (81,055,195) | (45,989,107) |
Income tax expense | 2,800 | 2,800 | ||
Net income (loss) | $ 44,409,187 | $ (20,675,108) | $ (81,057,995) | $ (45,991,907) |
Per share information: | ||||
Net income (loss) per share of common stock, basic (in dollars per share) | $ 1.91 | $ (1.61) | $ (4.82) | $ (3.73) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.89) | $ (1.61) | $ (4.82) | $ (3.73) |
Weighted average shares outstanding, basic (in shares) | 23,227,069 | 12,844,079 | 16,822,774 | 12,343,951 |
Weighted average shares outstanding, diluted (in shares) | 25,476,438 | 12,844,079 | 16,822,774 | 12,343,951 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity (unaudited) - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2022 | $ 113,655 | $ 417,558,434 | $ (408,935,518) | $ 8,736,571 |
Balance, beginning (in shares) at Sep. 30, 2022 | 11,365,528 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Sale of common stock, net of issuance costs | $ 14,678 | 24,277,482 | 24,292,160 | |
Sale of common stock, net of issuance costs (in shares) | 1,467,802 | |||
Stock-based compensation expense | 1,392,393 | 1,392,393 | ||
Net Income (Loss) | (18,662,513) | (18,662,513) | ||
Balance at Dec. 31, 2022 | $ 128,333 | 443,228,309 | (427,598,031) | 15,758,611 |
Balance, ending (in shares) at Dec. 31, 2022 | 12,833,330 | |||
Balance at Sep. 30, 2022 | $ 113,655 | 417,558,434 | (408,935,518) | 8,736,571 |
Balance, beginning (in shares) at Sep. 30, 2022 | 11,365,528 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Net Income (Loss) | (45,991,907) | |||
Balance at Jun. 30, 2023 | $ 129,352 | 449,295,234 | (454,927,425) | (5,502,839) |
Balance, ending (in shares) at Jun. 30, 2023 | 12,935,189 | |||
Balance at Dec. 31, 2022 | $ 128,333 | 443,228,309 | (427,598,031) | 15,758,611 |
Balance, beginning (in shares) at Dec. 31, 2022 | 12,833,330 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 1,383,405 | 1,383,405 | ||
Net Income (Loss) | (6,654,286) | (6,654,286) | ||
Balance at Mar. 31, 2023 | $ 128,333 | 444,611,714 | (434,252,317) | 10,487,730 |
Balance, ending (in shares) at Mar. 31, 2023 | 12,833,330 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Sale of common stock, net of issuance costs | $ 1,019 | 3,301,715 | 3,302,734 | |
Sale of common stock, net of issuance costs (in shares) | 101,859 | |||
Stock-based compensation expense | 1,381,805 | 1,381,805 | ||
Net Income (Loss) | (20,675,108) | (20,675,108) | ||
Balance at Jun. 30, 2023 | $ 129,352 | 449,295,234 | (454,927,425) | (5,502,839) |
Balance, ending (in shares) at Jun. 30, 2023 | 12,935,189 | |||
Balance at Sep. 30, 2023 | $ 130,128 | 453,350,281 | (467,918,186) | (14,437,777) |
Balance, beginning (in shares) at Sep. 30, 2023 | 13,012,833 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 1,272,611 | 1,272,611 | ||
Net Income (Loss) | (11,178,239) | (11,178,239) | ||
Balance at Dec. 31, 2023 | $ 130,128 | 454,622,892 | (479,096,425) | (24,343,405) |
Balance, ending (in shares) at Dec. 31, 2023 | 13,012,833 | |||
Balance at Sep. 30, 2023 | $ 130,128 | 453,350,281 | (467,918,186) | (14,437,777) |
Balance, beginning (in shares) at Sep. 30, 2023 | 13,012,833 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Net Income (Loss) | (81,057,995) | |||
Balance at Jun. 30, 2024 | $ 234,057 | 465,068,636 | (548,976,181) | (83,673,488) |
Balance, ending (in shares) at Jun. 30, 2024 | 23,405,637 | |||
Balance at Dec. 31, 2023 | $ 130,128 | 454,622,892 | (479,096,425) | (24,343,405) |
Balance, beginning (in shares) at Dec. 31, 2023 | 13,012,833 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Sale of common stock, net of issuance costs | $ 85,714 | 85,714 | ||
Sale of common stock, net of issuance costs (in shares) | 8,571,423 | |||
Issuance of common stock in connection with conversion of convertible promissory note | $ 4,286 | 2,995,714 | 3,000,000 | |
Issuance of common stock in connection with conversion of convertible promissory note (in shares) | 428,571 | |||
Stock-based compensation expense | 1,310,507 | 1,310,507 | ||
Net Income (Loss) | (114,288,943) | (114,288,943) | ||
Balance at Mar. 31, 2024 | $ 220,128 | 458,929,113 | (593,385,368) | (134,236,127) |
Balance, ending (in shares) at Mar. 31, 2024 | 22,012,827 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Sale of common stock, net of issuance costs | $ 7,143 | 7,143 | ||
Sale of common stock, net of issuance costs (in shares) | 714,286 | |||
Issuance of common stock in connection with conversion of convertible promissory note | $ 6,786 | 4,743,214 | 4,750,000 | |
Issuance of common stock in connection with conversion of convertible promissory note (in shares) | 678,524 | |||
Stock-based compensation expense | 1,396,309 | 1,396,309 | ||
Net Income (Loss) | 44,409,187 | 44,409,187 | ||
Balance at Jun. 30, 2024 | $ 234,057 | $ 465,068,636 | $ (548,976,181) | $ (83,673,488) |
Balance, ending (in shares) at Jun. 30, 2024 | 23,405,637 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
OPERATING ACTIVITIES | |||
Net loss | $ 44,409,187 | $ (81,057,995) | $ (45,991,907) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 85,062 | 32,971 | |
Loss on extinguishment of debt | 577,659 | ||
Non-cash interest expense | 2,681,847 | 2,529,830 | |
Stock-based compensation | 3,979,427 | 4,157,603 | |
Change in fair value of promissory notes | (7,563,000) | 1,949,153 | 2,913,000 |
Warrant related expenses (Note 9) | 3,392,444 | 37,490,012 | |
Change in fair value of warrant liability | (59,454,222) | (9,786,063) | (37,126) |
Loss on equity method investment | 57,497 | 85,544 | 2,648 |
Interest paid on debt | (1,158,609) | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (6,006,045) | 827,163 | |
Other assets | (28,866) | (232,220) | |
Operating lease liabilities | (2,220) | (26,995) | |
Accounts payable | (1,136,993) | 1,324,184 | |
Accrued expenses | (64,826) | 4,849,715 | |
Net cash used in operating activities | (51,811,963) | (30,232,084) | |
FINANCING ACTIVITIES | |||
Proceeds from the sale of common stock and warrants to purchase common stock, net of issuance costs | 60,448,635 | 27,596,910 | |
Proceeds from debt | 30,000,000 | ||
Payments of finance lease obligations | (4,267) | (8,669) | |
Repayment of debt | (10,220,000) | ||
Payment of financing costs | (823,894) | ||
Net cash provided by financing activities | 60,444,368 | 46,544,347 | |
Net increase in cash and cash equivalents | 8,632,405 | 16,312,263 | |
Cash and cash equivalents at beginning of period | 23,391,982 | 17,396,812 | |
Cash and cash equivalents at end of period | $ 32,024,387 | 32,024,387 | 33,709,075 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 475,000 | 1,159,008 | |
Supplemental schedule of non-cash financing activities: | |||
Convertible promissory note converted into common stock | 7,750,000 | ||
Recognition of warrant liability | 97,730,836 | ||
Common stock issuance costs in accounts payable and accrued expenses | 114,954 | 223,760 | |
Deferred offering costs amortization | $ 131,944 | ||
Right-of-use asset and lease liability recognized for new operating lease liabilities | $ 294,416 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Jun. 30, 2024 | |
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 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. In May 2024 the Company received Marketing Authorization from the European Commission for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (“AMD”) in the European Union (“EU”). Additionally, in July 2024 the Company also received marketing authorization for LYTENAVA™ (bevacizumab gamma) in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK. In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial following discussions with the U.S. Food and Drug Administration (“FDA”) in support of the Company’s Biologics License Application (“BLA”) for ONS-5010. In December 2023, the Company submitted a Special Protocol Assessment (“SPA”) to the FDA for this study (NORSE EIGHT) seeking confirmation that, if successful, it will address the FDA’s requirement for a second adequate and well-controlled clinical trial to support its planned resubmission of the ONS-5010 BLA. In January 2024, the Company received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA and that, if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (“CRL”). The first subject was enrolled in NORSE EIGHT in January 2024. In addition, through a Type A meeting and additional interactions, the Company has identified the approaches needed to resolve the chemistry, manufacturing and controls (“CMC”) comments in the CRL. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2024 | |
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 $548,976,181 as of June 30, 2024, which raises 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 does not believe that the existing cash and cash equivalents as of June 30, 2024 are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, there is substantial doubt about the Company’s ability to continue as a going concern and additional financing will be needed by the Company to fund its operations in the future and to commercially develop ONS-5010 and to develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations, including but not limited to, the exercise of outstanding warrants to purchase shares of the Company’s common stock (subject to meeting the requirements for calling such warrants), proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, sale of the development and commercial rights to the Company’s drug product candidates in regions outside of the U.S., the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offering agreements (refer to Note 9 for further details), and revenues from potential future product sales, if any. There can be no assurance that these future funding efforts will be successful. However, management does believe that the existing cash and cash equivalents as of June 30, 2024, when combined with the expected proceeds from the full exercise of warrants to purchase shares of common stock (subject to meeting the requirements for calling such warrants), would be sufficient to support the Company’s operations through 2025. For further details on the warrants to purchase shares of common stock, refer to Note 9. The Company’s consolidated financial statements do not include any adjustments that might be necessary if it is unable to continue as a going concern. 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, 2024 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2024 and its results of operations for the three and nine months ended June 30, 2024 and 2023, cash flows for the nine months ended June 30, 2024 and 2023, and stockholders’ equity for the three and nine months ended June 30, 2024 and 2023. Operating results for the nine months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2024. 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, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 22, 2023. Reverse stock split Effective on March 14, 2024, the Company amended its amended and restated certificate of incorporation to implement a one-for-twenty 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, such as the current macroeconomic environment, including as a result of inflation, high interest rates or ongoing overseas conflict, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Net income (loss) per share Basic net income (loss) per share of common stock is computed by dividing net income (loss) common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants, performance-based stock options and units, and stock options using the treasury stock method, which would result in the issuance of incremental shares of common stock. 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. 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, 2024 2023 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 44,409,187 $ (20,675,108) $ (81,057,995) $ (45,991,907) Effect of dilutive securities: Change in fair value of warrant liability (59,393,374) — — — Change in fair value of promissory notes (7,563,000) — — — Adjusted net loss attributable to common stockholders $ (22,547,187) $ (20,675,108) $ (81,057,995) $ (45,991,907) Denominator: Weighted average shares outstanding, basic 23,227,069 12,844,079 16,822,774 12,343,951 Effect of dilutive securities: Common stock warrants 562,685 — — — Convertible promissory notes 1,686,684 — — — Dilutive effect of stock options — — — — Weighted average shares outstanding, diluted 25,476,438 12,844,079 16,822,774 12,343,951 Basic net income (loss) per share $ 1.91 $ (1.61) $ (4.82) $ (3.73) Diluted net loss per share $ (0.89) $ (1.61) $ (4.82) $ (3.73) 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, 2024 and 2023, as they would be antidilutive: As of June 30, 2024 2023 Performance-based stock units — 123 Performance-based stock options 532,367 95,000 Stock options 1,928,646 1,181,563 Common stock warrants 279,060 366,427 Convertible debt — 835,074 (i) (i) The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7. Recently issued accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2024 | |
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, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 32,432,000 Warrant liability — — 87,950,992 Total $ — $ — $ 120,382,992 September 30, 2023 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 35,551,000 Warrant liability — — 6,219 Total $ — $ — $ 35,557,219 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, 2024: Unsecured Convertible Promissory Note Warrants Balance at October 1, 2023 $ 35,551,000 $ 6,219 Issued in connection with sale of common stock — 97,730,836 Promissory note maturity extension fee added to outstanding balance 2,681,847 — Principal and accrued interest converted to common stock (7,750,000) — Change in fair value 1,949,153 (9,786,063) Balance at June 30, 2024 $ 32,432,000 $ 87,950,992 As further described in Note 7, the Company elected the fair value option to account for an unsecured convertible promissory note issued in December 2022 (the “December 2022 Note”). The fair value of the December 2022 Note is estimated using a binomial lattice model, which evaluates the payouts under hold, convert or call decisions. Significant estimates in the binomial lattice model include the Company’s stock price, volatility, risk-free rate of return, and credit-adjusted discount rate. The fair value of the December 2022 Note was estimated using a binomial lattice model with the following assumptions: June 30, 2024 September 30, 2023 Term (years) 1.0 0.3 Stock price $ 7.38 $ 4.40 Volatility 163.0 % 71.0 % Risk-free rate 5.1 % 5.5 % Dividend yield — % — % Credit-adjusted discount rate 22.7 % 22.8 % The warrants issued in connection with the convertible senior secured notes originally issued pursuant to that certain Note and Warrant Purchase Agreement dated December 22, 2017 and warrants issued in connection with private placements that closed on March 18, 2024 and April 15, 2024, are classified as liabilities on the accompanying unaudited interim consolidated balance sheets. The warrants related to the Note and Warrant Purchase Agreement dated December 22, 2017 are classified as liabilities as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrants issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are classified as liabilities as the Company assessed that they are not indexed to the Company’s own stock and must be classified as liabilities. For further details on the evaluation refer to Note 9. The above warrant liabilities are revalued each reporting period with the change in fair values recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair values of the warrant liabilities are estimated using the Black-Scholes option pricing model using the following weighted average assumptions: June 30, 2024 September 30, 2023 Risk-free interest rate 4.36 % 5.30 % Remaining contractual term of warrants (years) 4.7 1.4 Expected volatility 130.2 % 158.3 % Annual dividend yield — % — % Fair value of common stock (per share) $ 7.38 $ 4.40 |
Equity Method Investment
Equity Method Investment | 9 Months Ended |
Jun. 30, 2024 | |
Equity Method Investment | |
Equity Method Investment | 5. Equity Method Investment In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone”), the United States-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 JV”), 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 JV’s operations through voting rights or representation on Syntone JV’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone JV in April 2021, the Company entered into a royalty-free license with Syntone JV 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 is committed to making capital contributions to Syntone JV of approximately $2,100,000, based upon the development plan contemplated in the license agreement. The maximum exposure to a loss as a result of the Company’s involvement in Syntone JV is limited to the initial investment and the future capital contributions totaling approximately $2,100,000. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consists of: June 30, 2024 September 30, 2023 Compensation $ 895,177 $ 919,970 Professional fees 1,107,166 165,192 Research and development 399,853 1,234,192 Other accrued expenses 278,718 426,386 $ 2,680,914 $ 2,745,740 |
Debt
Debt | 9 Months Ended |
Jun. 30, 2024 | |
Debt | |
Debt | 7. Debt Debt consists of: June 30, 2024 September 30, 2023 Unsecured convertible promissory note (measured at fair value) $ 32,432,000 $ 35,551,000 Less: current portion (32,432,000) (35,551,000) Long-term debt $ — $ — December 2022 Note On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued the December 2022 Note with a face amount of $31,820,000 to Streeterville Capital, LLC (the “Lender”), the holder of the Company’s unsecured promissory note issued in November 2021 (the “November 2021 Note”). The December 2022 Note has an original issue discount of $1,820,000. The Company received net proceeds of $18,052,461 upon the closing on December 28, 2022 after deducting the Lender’s transaction costs in connection with the issuance and a full payment of the remaining outstanding principal and accrued interest on the November 2021 Note. The November 2021 Note was cancelled upon repayment. See below for additional disclosures relating to November 2021 Note. In December 2023, the Company extended the maturity of the December 2022 Note from January 1, 2024 to April 1, 2024. The Company incurred a $475,000 extension fee, which was expensed and included in interest expense in the unaudited interim consolidated statement of operations. The December 2022 Note bore interest at 9.5% per annum through April 1, 2024. The December 2022 Note contains customary covenants, including a restriction on the Company’s ability to pledge certain of the Company’s assets, subject to certain exceptions, without the Lender’s consent. Beginning on April 1, 2023, the Lender had the right to convert the December 2022 Note at the Conversion Price (as defined below). The principal amount and conversion price of the December 2022 Note were subject to adjustment upon certain triggering events. In addition, the Company had the right to convert all or any portion of the outstanding balance under the December 2022 Note into shares of common stock at the Conversion Price if certain conditions have been met at the time of conversion, including if at any time after the six-month anniversary of the closing date, the daily volume-weighted average price of the common stock on Nasdaq equals or exceeds $50.00 per share (subject to adjustments for stock splits and stock combinations) for a period of 30 consecutive trading days. Payments may be made by the Company (i) in cash, (ii) in shares of common stock, with the number of shares being equal to the portion of the applicable payment amount divided by the Conversion Price (as defined below), or (iii) a combination of cash and shares of common stock. Any payments made by the Company in cash, including prepayments or repayment at maturity, will be subject to an additional fee of 7.5%. Upon the occurrence of certain events described in the December 2022 Note, including, among others, the Company’s failure to pay amounts due and payable under the December 2022 Note, events of insolvency or bankruptcy, failure to observe covenants contained in the Securities Purchase Agreement and the December 2022 Note, breaches of representations and warranties in the Securities Purchase Agreement, and the occurrence of certain transactions without the Lender’s consent (each such event, a “Trigger Event”), the Lender shall have the right, subject to certain exceptions, to increase the balance of the December 2022 Note by 10% for a Major Trigger Event (as defined in the December 2022 Note) and 5% for a Minor Trigger Event (as defined in the December 2022 Note). If a Trigger Event is not cured within ten certain exceptions, while the December 2022 Note is outstanding, the Lender will have a consent right on any future variable rate transactions or any debt and a 10% participation right in any future debt or equity financings. On January 22, 2024, the Company entered into an amendment to the December 2022 Note (the “Note Amendment”) with the Lender, which became effective on April 1, 2024 after satisfaction of certain conditions, including various required stockholder approvals and the closing of the private placement on March 18, 2024. The maturity of the December 2022 Note was extended to July 1, 2025. An extension fee of $2,681,847 (calculated as 7.5% of the outstanding balance of the December 2022 Note) was added to the outstanding balance on March 18, 2024. The extension fee was expensed in the quarter ended March 31, 2024 and included in interest expense in the unaudited interim consolidated statement of operations. Under the Note Amendment, the initial conversion price with respect to $15,000,000 in aggregate principal amount of the December 2022 Note was changed to $7.00, the price per share in the private placement that closed on March 18, 2024. Effective April 1, 2024, the December 2022 Note bears interest at the prime rate (as published in the Wall Street Journal) plus 3% (subject to a floor of 9.5%) and the Company has an obligation to repay at least $3,000,000 of the outstanding balance of the December 2022 Note for each calendar quarter beginning with the second calendar quarter of 2024 (subject to adjustment for conversions by the Lender and to payment of an exit fee as set forth in the Note Amendment) and continuing until the December 2022 Note is repaid in full. As of June 30, 2024, the December 2022 Note was classified as current on the unaudited interim consolidated balance sheets as the Lender has the right to convert the December 2022 Note into equity until the entire outstanding balance has been paid off. During the three and nine months ended June 30, 2024, an aggregate of principal and accrued interest totaling $4,750,000 and $7,750,000, respectively, of the December 2022 Note was converted into 678,524 and 1,107,095 shares of the Company’s common stock, respectively. The Company elected to account for the December 2022 Note at fair value (Note 4) and was not required to bifurcate the conversion option as a derivative and as a result the original issue discount of $1,820,000 and debt issuance costs were written off upon election to fair value and accounted for as interest. During the nine months ended June 30, 2023, the Company recognized $2,074,964 of interest expense related to the December 2022 Note, consisting of the original issue discount of $1,820,000 and other third-party debt issuance costs of $254,964 as the Company elected the fair value option. During the nine months ended June 30, 2024, the Company recorded $3,156,964 of interest expense. This interest expense was associated with the fees incurred for extending the debt. During the three months ended June 30, 2024, no interest expense was recognized. November 2021 Note On November 16, 2021, the Company received $10,000,000 in net proceeds from the issuance of the November 2021 Note with a face amount of $10,220,000. Debt issuance costs totaling $820,000 were recorded as debt discount and were deducted from the principal. The debt discount was amortized as a component of interest expense over the term of the underlying debt using the effective interest method. The November 2021 Note bore interest at a rate of 9.5% per annum compounding daily and was set to mature on January 1, 2023. The Company could prepay all or a portion of the November 2021 Note at any time by paying 105% of the outstanding balance elected for pre-payment. As discussed above, the November 2021 Note was cancelled using proceeds from the December 2022 Note issued to the same lender. The total repayment was $11,947,539, which represented 105% of the outstanding balance and included $1,158,609 of interest expense. The transaction has been accounted for as an extinguishment of the November 2021 Note. As a result, the Company recorded a loss on debt extinguishment of $577,659, which included $8,729 of unamortized debt discount, and prepayment fees of $568,930. During the nine months ended June 30, 2023, the Company recognized $454,866 of interest expense related to the November 2021 Note of which $190,775 was related to the amortization of debt discount. During the three months ended June 30, 2023, no interest expense was recognized. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies | |
Commitments and Contingencies | 8. Commitments and Contingencies Litigation On November 3, 2023, a securities class action lawsuit was filed against the Company and certain of its officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by the Company related to the Company’s BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that the Company violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010 as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for ONS-5010, which remained unresolved at the time the Company’s BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve the Company’s BLA, and that the Company’s stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. The parties are in the process of briefing a motion to dismiss. The pending lawsuit and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuit and any other related lawsuits is necessarily uncertain. The Company could be forced to expend significant resources in the defense of the pending lawsuit and any additional lawsuits, and the Company may not prevail. In addition, the Company may incur substantial legal fees and costs in connection with such lawsuits. The Company currently is not able to estimate the possible cost to it from these matters, as the pending lawsuit is currently at an early stage, and the Company cannot be certain how long it may take to resolve the pending lawsuit or the possible amount of any damages that the Company may be required to pay. Such amounts could be material to the Company’s financial statements if it does not prevail in the defense of the pending lawsuit and any other related lawsuits, or even if it does prevail. The Company has not established any reserve for any potential liability relating to the pending lawsuit and any other related lawsuits. It is possible that the Company could, in the future, incur judgments or enter into settlements of claims for monetary damages. Leases Corporate office In March 2021, the Company entered into a three-year term corporate office lease for its former corporate headquarters in Iselin, New Jersey that ended on April 30, 2024. In March 2024, the Company entered into a five-year term corporate office lease for its new corporate headquarters in Iselin, New Jersey that commenced on May 1, 2024. Equipment leases As of June 30, 2024, all equipment leases had expired. The Company had equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bore interest between 4.0% and 13.0% per annum. Certain lease agreements contained provisions for future rent increases. Payments due under the lease contracts included minimum payments that the Company was obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense was 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, 2024 and 2023 are as follows: Three months ended June 30, Nine months ended June 30, 2024 2023 2024 2023 Lease cost: Amortization of right-of-use assets $ — $ — $ — $ — Interest on lease liabilities — 304 116 1,193 Total finance lease cost — 304 116 1,193 Operating lease cost 16,459 11,217 38,892 33,650 Total lease cost $ 16,459 $ 11,521 $ 39,008 $ 34,843 Amounts reported in the unaudited interim consolidated balance sheets for leases where the Company is the lessee are as follows: June 30, 2024 September 30, 2023 Operating leases: Right-of-use asset $ 286,462 $ 26,172 Operating lease liabilities 292,196 — Finance leases: Right-of-use asset $ — $ — Financing lease liabilities — 4,267 Weighted-average remaining lease term (years): Operating leases 4.8 0.6 Finance leases — 0.3 Weighted-average discount rate: Operating leases 9.9% 7.5% Finance leases — 13.0% Other information related to leases for the nine months ended June 30, 2024 and 2023 are as follows: Nine months ended June 30, 2024 2023 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 116 $ 1,193 Operating cash flows from operating leases 11,799 27,675 Financing cash flows from finance leases 4,267 8,669 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 294,416 $ — Future minimum lease payments under non-cancelable leases at June 30, 2024 are as follows for years ending September 30: Operating leases 2024 (remaining three months) $ 1,630 2025 78,091 2026 79,954 2027 81,817 2028 83,680 Thereafter 49,447 Total undiscounted lease payments 374,619 Less: Imputed interest 82,423 Total lease obligations $ 292,196 |
Common Stock and Stockholders'
Common Stock and Stockholders' Equity | 9 Months Ended |
Jun. 30, 2024 | |
Common Stock and Stockholders' Equity | |
Common Stock and Stockholders' Equity | 9. Common Stock and Stockholders’ Equity Preferred Stock On May 13, 2024, the Company filed a Certificate of Elimination to its Certificate of Incorporation, as then amended, with the Secretary of State of the State of Delaware to eliminate from the Certificate of Incorporation all matters set forth in the Certificates of Designation filed with the Secretary of State of the State of Delaware on September 8, 2017 (with respect to its Series A Convertible Preferred Stock and the Series B Convertible Preferred Stock) and July 18, 2018, as amended on March 19, 2020 (with respect to its Series A-1 Convertible Preferred Stock) and returning each of the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series A-1 Convertible Preferred Stock to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series. There were no outstanding shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock or Series A-1 Convertible Preferred Stock as of May 13, 2024. Immediately following the filing of the Certificate of Elimination, the Company filed a Restated Certificate of Incorporation of the Company with the Secretary of State of the State of Delaware, which restates and integrates but does not further amend the Company’s Certificate of Incorporation, as then a mended. The number of authorized shares of preferred stock under the Company’s Certificate of Incorporation is 10,000,000 shares. Common stock On March 7, 2024, following receipt of stockholder approval at the Company’s 2024 annual meeting of stockholders, the number of authorized shares of common stock under the Company’s Certificate of Incorporation was increased from 21,250,000 shares to 60,000,000 shares. On March 18, 2024, in a private placement (the “Private Placement”) pursuant to a securities purchase agreement entered in January 2024 with certain institutional and accredited investors, including GMS Ventures and Investments (“GMS Ventures”), the Company’s largest stockholder, the Company issued an aggregate of 8,571,423 shares of common stock and warrants to purchase an aggregate of 12,857,133 shares of common stock at a purchase price per share of $7.00 per share and accompanying warrant to purchase one and one On April 15, 2024, in a private placement with Syntone pursuant to a securities purchase agreement entered into on January 22, 2024 (the “Syntone Private Placement”), the Company issued 714,286 shares of common stock and accompanying warrants to purchase 1,071,429 shares of common stock for $4,835,371 in net proceeds on substantially the same terms as those in the Private Placement. The warrants have an exercise price of $7.70 per share of common stock and will expire on April 15, 2029. The Company evaluated the equity classification for the common stock warrants and considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity As the fair value of the warrants upon issuance was more than the proceeds of the Private Placement and Syntone Private Placement, there are no proceeds allocated to additional paid in capital. The excess fair value of the Private Placement and Syntone Private Placement warrants over the net proceeds was $34,097,568 and $3,392,444, respectively, in the aggregate and was recorded as warrant related expenses in the unaudited interim consolidated statement of operations. In December 2022, in a registered direct equity offering to certain institutional and accredited investors, including GMS Ventures, the Company issued 1,423,041 shares of common stock at a purchase price per share of $17.568 for $23,208,679 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 711,520 shares of common stock in the registered direct equity offering. In connection with the registered direct equity offering, the Company issued to M.S. Howells & Co., the placement agent, warrants to purchase up to an aggregate of 25,787 shares of common stock at an exercise price of $21.00 per share, which warrants have a three-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 with H.C. Wainwright & Co., as sales agent (“Wainwright”) (the “Wainwright ATM Agreement” or the “Wainwright ATM Offering”), under which the Company could issue and sell shares of its common stock having an aggregate offering price of up to $40,000,000 from time to time through Wainwright. The Company incurred financing costs of $197,654, which were capitalized and reclassified to additional paid in capital on a pro rata basis when the Company sold common stock under the Wainwright ATM Offering. Under the Wainwright ATM Agreement, the Company paid Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Wainwright ATM Agreement. The Company terminated the Wainwright ATM Agreement effective May 15, 2023. As a result, the Company wrote off unamortized deferred costs under the Wainwright ATM Agreement effective as of the termination date. No shares of common stock were sold under the Wainwright ATM Offering during the three months ended June 30, 2023. During the nine months ended June 30, 2023, the Company sold 44,769 shares of common stock under the Wainwright ATM Offering and generated $1,089,105 in net proceeds. During the nine months ended June 30, 2023, the Company paid fees to Wainwright and other issuance costs of $38,799. BTIG, LLC At-the-Market Offering Agreement On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) as sales agent (as amended, the “BTIG ATM Agreement” or the “BTIG ATM Offering”), under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000,000 from time to time through BTIG. The Company incurred financing costs of $353,688, 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 BTIG ATM Offering. As of June 30, 2024, $331,512 of such deferred costs are included in other assets on the unaudited interim consolidated balance sheets. Under the BTIG ATM Agreement, the Company pays BTIG a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the BTIG ATM Agreement. The offering of common stock pursuant to the BTIG ATM Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the BTIG ATM Agreement or (ii) termination of the BTIG ATM Agreement in accordance with its terms. No shares of common stock were sold under the BTIG ATM Offering during the three and nine months ended June 30, 2024. During the three and nine months ended June 30, 2023, the Company sold 101,863 shares of common stock under the BTIG ATM Offering and generated $3,429,104 in net proceeds. During the three and nine months ended June 30, 2023, the Company paid fees to BTIG and other issuance costs of $106,055. Common stock warrants As of June 30, 2024, 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) 13,850 $ 240.00 February 24, 2025 8,642 $ 25.40 April 13, 2025 (i) 7,284 $ 240.00 May 31, 2025 (i) 3,121 $ 240.00 June 22, 2025 9,563 $ 30.38 December 28, 2025 25,787 $ 21.00 January 28, 2026 12,576 $ 25.00 February 2, 2026 93,238 $ 25.00 November 23, 2026 104,999 $ 31.25 March 18, 2029 (ii) 12,857,133 $ 7.70 April 15, 2029 (ii) 1,071,429 $ 7.70 14,207,622 (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 unaudited interim 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. (ii) The warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging , guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure above under the header “—Common stock” for further details. A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $20.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. 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, 2024, there were no PSUs 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 2,503,677. As of June 30, 2024, there were no shares 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 unaudited interim consolidated statements of operations for the three and nine months ended June 30, 2024 and 2023: Three months ended June 30, Nine months ended June 30, 2024 2023 2024 2023 Research and development $ 147,359 $ 280,489 $ 615,735 $ 893,413 General and administrative 1,248,950 1,101,316 3,363,692 3,264,190 $ 1,396,309 $ 1,381,805 $ 3,979,427 $ 4,157,603 Stock options As of June 30, 2024, 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, 2023 1,197,774 $ 28.72 Granted 799,729 6.70 Forfeited (59,212) 26.27 Expired (9,645) 34.50 Balance at June 30, 2024 1,928,646 $ 19.63 7.9 $ 636,830 Exercisable at June 30, 2024 945,096 $ 27.10 6.7 $ 193,438 Vested and expected to vest at June 30, 2024 1,928,646 $ 19.63 7.9 $ 636,830 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, 2024 and 2023 was $6.01 and $18.80 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, 2024 2023 Risk-free interest rate 4.3 % 3.7 % Expected term (years) 6.0 5.9 Expected volatility 131.3 % 111.7 % Expected dividend yield — — As of June 30, 2024, there was $8,818,798 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 1.5 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, 2024 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, 2023 35,000 $ 28.80 Granted 499,336 6.78 Forfeited (1,969) 6.78 $ 4,351 Balance at June 30, 2024 532,367 $ 7.93 9.6 $ 298,420 Exercisable at June 30, 2024 35,000 $ 28.80 6.6 $ — Vested and expected to vest at June 30, 2024 532,367 $ 7.93 9.6 $ 298,420 The vesting of the performance-based stock options is conditional upon FDA approval of ONS-5010. The expense for the performance-based stock options is not recognized until the performance conditions are deemed probable of achievement. The Company did not record any expense related to the performance-based stock options during the three and nine months ended June 30, 2024 as the performance conditions were not deemed probable of being met. The weighted average grant date fair value of the performance stock options awarded during the nine months ended June 30, 2024, was $6.52 per option. As of June 30, 2024, the Company assessed that the performance conditions related to the performance options granted were not probable of achievement. The assessment was based on the relevant facts and circumstances and therefore no compensation costs were recognized. 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, 2024 2023 Risk-free interest rate 4.3 % 3.8 % Expected term (years) 10.0 10.0 Expected volatility 125.6 % 91.3 % Expected dividend yield — — 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, 2024: Weighted Average Number Exercise Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2023 123 $ 999.40 Forfeitures — — Expired (123) 999.40 Balance at June 30, 2024 — $ — — $ — Exercisable at June 30, 2024 — $ — — $ — Vested and expected to vest at June 30, 2024 — $ — — $ — |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Jun. 30, 2024 | |
Related-Party Transactions | |
Related-Party Transactions | 11. 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 Operations 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 Operations 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 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 target options one options Mr. Dagnon transitioned from Chief Operations Officer to Senior Advisor on December 6, 2023, as part of the Company's strategic organizational realignment program. During the three months ended June 30, 2024 and 2023, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate of $60,000 during each period, and $180,000 and $125,552 during the nine months ended June 30, 2024 and 2023, respectively, which includes monthly consulting fees and expense reimbursement. There were no amounts payable to the former MTTR principals at June 30, 2024 and September 30, 2023. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2024 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events Unsecured convertible promissory note conversions In July 2024, an aggregate of principal and accrued interest totaling $1,750,000 of the December 2022 Note was converted into 249,999 shares of the Company’s common stock. For further details on the December 2022 Note, refer to Note 7. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jun. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ 44,409,187 | $ (114,288,943) | $ (11,178,239) | $ (20,675,108) | $ (6,654,286) | $ (18,662,513) | $ (81,057,995) | $ (45,991,907) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2024 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of presentation | Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2024 and its results of operations for the three and nine months ended June 30, 2024 and 2023, cash flows for the nine months ended June 30, 2024 and 2023, and stockholders’ equity for the three and nine months ended June 30, 2024 and 2023. Operating results for the nine months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2024. 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, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 22, 2023. |
Reverse stock split | Reverse stock split Effective on March 14, 2024, the Company amended its amended and restated certificate of incorporation to implement a one-for-twenty |
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, such as the current macroeconomic environment, including as a result of inflation, high interest rates or ongoing overseas conflict, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. |
Net income (loss) per share | Net income (loss) per share Basic net income (loss) per share of common stock is computed by dividing net income (loss) common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants, performance-based stock options and units, and stock options using the treasury stock method, which would result in the issuance of incremental shares of common stock. 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. 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, 2024 2023 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 44,409,187 $ (20,675,108) $ (81,057,995) $ (45,991,907) Effect of dilutive securities: Change in fair value of warrant liability (59,393,374) — — — Change in fair value of promissory notes (7,563,000) — — — Adjusted net loss attributable to common stockholders $ (22,547,187) $ (20,675,108) $ (81,057,995) $ (45,991,907) Denominator: Weighted average shares outstanding, basic 23,227,069 12,844,079 16,822,774 12,343,951 Effect of dilutive securities: Common stock warrants 562,685 — — — Convertible promissory notes 1,686,684 — — — Dilutive effect of stock options — — — — Weighted average shares outstanding, diluted 25,476,438 12,844,079 16,822,774 12,343,951 Basic net income (loss) per share $ 1.91 $ (1.61) $ (4.82) $ (3.73) Diluted net loss per share $ (0.89) $ (1.61) $ (4.82) $ (3.73) 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, 2024 and 2023, as they would be antidilutive: As of June 30, 2024 2023 Performance-based stock units — 123 Performance-based stock options 532,367 95,000 Stock options 1,928,646 1,181,563 Common stock warrants 279,060 366,427 Convertible debt — 835,074 (i) (i) The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7. |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
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, 2024 2023 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 44,409,187 $ (20,675,108) $ (81,057,995) $ (45,991,907) Effect of dilutive securities: Change in fair value of warrant liability (59,393,374) — — — Change in fair value of promissory notes (7,563,000) — — — Adjusted net loss attributable to common stockholders $ (22,547,187) $ (20,675,108) $ (81,057,995) $ (45,991,907) Denominator: Weighted average shares outstanding, basic 23,227,069 12,844,079 16,822,774 12,343,951 Effect of dilutive securities: Common stock warrants 562,685 — — — Convertible promissory notes 1,686,684 — — — Dilutive effect of stock options — — — — Weighted average shares outstanding, diluted 25,476,438 12,844,079 16,822,774 12,343,951 Basic net income (loss) per share $ 1.91 $ (1.61) $ (4.82) $ (3.73) Diluted net loss per share $ (0.89) $ (1.61) $ (4.82) $ (3.73) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of June 30, 2024 2023 Performance-based stock units — 123 Performance-based stock options 532,367 95,000 Stock options 1,928,646 1,181,563 Common stock warrants 279,060 366,427 Convertible debt — 835,074 (i) (i) The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Fair value | |
Schedule of assets and liabilities measured at fair value on a recurring basis | June 30, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 32,432,000 Warrant liability — — 87,950,992 Total $ — $ — $ 120,382,992 September 30, 2023 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 35,551,000 Warrant liability — — 6,219 Total $ — $ — $ 35,557,219 |
Schedule of changes in the fair value of Level 3 liabilities | Unsecured Convertible Promissory Note Warrants Balance at October 1, 2023 $ 35,551,000 $ 6,219 Issued in connection with sale of common stock — 97,730,836 Promissory note maturity extension fee added to outstanding balance 2,681,847 — Principal and accrued interest converted to common stock (7,750,000) — Change in fair value 1,949,153 (9,786,063) Balance at June 30, 2024 $ 32,432,000 $ 87,950,992 |
December 2022 Note | |
Fair value | |
Schedule of fair value inputs | June 30, 2024 September 30, 2023 Term (years) 1.0 0.3 Stock price $ 7.38 $ 4.40 Volatility 163.0 % 71.0 % Risk-free rate 5.1 % 5.5 % Dividend yield — % — % Credit-adjusted discount rate 22.7 % 22.8 % |
Warrant liability | |
Fair value | |
Schedule of fair value inputs | June 30, 2024 September 30, 2023 Risk-free interest rate 4.36 % 5.30 % Remaining contractual term of warrants (years) 4.7 1.4 Expected volatility 130.2 % 158.3 % Annual dividend yield — % — % Fair value of common stock (per share) $ 7.38 $ 4.40 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, 2024 September 30, 2023 Compensation $ 895,177 $ 919,970 Professional fees 1,107,166 165,192 Research and development 399,853 1,234,192 Other accrued expenses 278,718 426,386 $ 2,680,914 $ 2,745,740 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Debt | |
Schedule of debt | June 30, 2024 September 30, 2023 Unsecured convertible promissory note (measured at fair value) $ 32,432,000 $ 35,551,000 Less: current portion (32,432,000) (35,551,000) Long-term debt $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies | |
Schedule of lease information | The components of lease cost for the three and nine months ended June 30, 2024 and 2023 are as follows: Three months ended June 30, Nine months ended June 30, 2024 2023 2024 2023 Lease cost: Amortization of right-of-use assets $ — $ — $ — $ — Interest on lease liabilities — 304 116 1,193 Total finance lease cost — 304 116 1,193 Operating lease cost 16,459 11,217 38,892 33,650 Total lease cost $ 16,459 $ 11,521 $ 39,008 $ 34,843 Amounts reported in the unaudited interim consolidated balance sheets for leases where the Company is the lessee are as follows: June 30, 2024 September 30, 2023 Operating leases: Right-of-use asset $ 286,462 $ 26,172 Operating lease liabilities 292,196 — Finance leases: Right-of-use asset $ — $ — Financing lease liabilities — 4,267 Weighted-average remaining lease term (years): Operating leases 4.8 0.6 Finance leases — 0.3 Weighted-average discount rate: Operating leases 9.9% 7.5% Finance leases — 13.0% Other information related to leases for the nine months ended June 30, 2024 and 2023 are as follows: Nine months ended June 30, 2024 2023 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 116 $ 1,193 Operating cash flows from operating leases 11,799 27,675 Financing cash flows from finance leases 4,267 8,669 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 294,416 $ — |
Schedule of operating lease future minimum payments | Operating leases 2024 (remaining three months) $ 1,630 2025 78,091 2026 79,954 2027 81,817 2028 83,680 Thereafter 49,447 Total undiscounted lease payments 374,619 Less: Imputed interest 82,423 Total lease obligations $ 292,196 |
Common Stock and Stockholders_2
Common Stock and Stockholders' Equity (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Common Stock and Stockholders' Equity | |
Schedule of warrants outstanding | As of June 30, 2024, 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) 13,850 $ 240.00 February 24, 2025 8,642 $ 25.40 April 13, 2025 (i) 7,284 $ 240.00 May 31, 2025 (i) 3,121 $ 240.00 June 22, 2025 9,563 $ 30.38 December 28, 2025 25,787 $ 21.00 January 28, 2026 12,576 $ 25.00 February 2, 2026 93,238 $ 25.00 November 23, 2026 104,999 $ 31.25 March 18, 2029 (ii) 12,857,133 $ 7.70 April 15, 2029 (ii) 1,071,429 $ 7.70 14,207,622 (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 unaudited interim 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. (ii) The warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging , guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure above under the header “—Common stock” for further details. A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $20.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Share-based Compensation | |
Schedule of stock-based compensation expense | Three months ended June 30, Nine months ended June 30, 2024 2023 2024 2023 Research and development $ 147,359 $ 280,489 $ 615,735 $ 893,413 General and administrative 1,248,950 1,101,316 3,363,692 3,264,190 $ 1,396,309 $ 1,381,805 $ 3,979,427 $ 4,157,603 |
Schedule of performance-based stock units activity | Weighted Average Number Exercise Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2023 123 $ 999.40 Forfeitures — — Expired (123) 999.40 Balance at June 30, 2024 — $ — — $ — Exercisable at June 30, 2024 — $ — — $ — Vested and expected to vest at June 30, 2024 — $ — — $ — |
Employee Stock Option [Member] | |
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, 2023 1,197,774 $ 28.72 Granted 799,729 6.70 Forfeited (59,212) 26.27 Expired (9,645) 34.50 Balance at June 30, 2024 1,928,646 $ 19.63 7.9 $ 636,830 Exercisable at June 30, 2024 945,096 $ 27.10 6.7 $ 193,438 Vested and expected to vest at June 30, 2024 1,928,646 $ 19.63 7.9 $ 636,830 |
Schedule of option assumptions | Nine months ended June 30, 2024 2023 Risk-free interest rate 4.3 % 3.7 % Expected term (years) 6.0 5.9 Expected volatility 131.3 % 111.7 % 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, 2023 35,000 $ 28.80 Granted 499,336 6.78 Forfeited (1,969) 6.78 $ 4,351 Balance at June 30, 2024 532,367 $ 7.93 9.6 $ 298,420 Exercisable at June 30, 2024 35,000 $ 28.80 6.6 $ — Vested and expected to vest at June 30, 2024 532,367 $ 7.93 9.6 $ 298,420 |
Schedule of option assumptions | Nine months ended June 30, 2024 2023 Risk-free interest rate 4.3 % 3.8 % Expected term (years) 10.0 10.0 Expected volatility 125.6 % 91.3 % Expected dividend yield — — |
Liquidity (Details)
Liquidity (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Liquidity | ||
Accumulated deficit | $ 548,976,181 | $ 467,918,186 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - EPS (Details) | 3 Months Ended | 9 Months Ended | |||
Mar. 14, 2024 | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | |
Numerator: | |||||
Net income (loss) attributable to common stockholders | $ | $ 44,409,187 | $ (20,675,108) | $ (81,057,995) | $ (45,991,907) | |
Effect of dilutive securities: | |||||
Change in fair value of warrant liability | $ | (59,393,374) | ||||
Change in fair value of promissory notes | $ | (7,563,000) | ||||
Adjusted net loss attributable to common stockholders | $ | $ (22,547,187) | $ (20,675,108) | $ (81,057,995) | $ (45,991,907) | |
Denominator: | |||||
Weighted average shares outstanding, basic (in shares) | shares | 23,227,069 | 12,844,079 | 16,822,774 | 12,343,951 | |
Effect of dilutive securities: | |||||
Common stock warrants | shares | 562,685 | ||||
Convertible promissory notes | shares | 1,686,684 | ||||
Weighted average shares outstanding, diluted (in shares) | shares | 25,476,438 | 12,844,079 | 16,822,774 | 12,343,951 | |
Basic net income (loss) per share (in dollars per share) | $ / shares | $ 1.91 | $ (1.61) | $ (4.82) | $ (3.73) | |
Diluted net loss per share (in dollars per share) | $ / shares | $ (0.89) | $ (1.61) | $ (4.82) | $ (3.73) | |
Conversion ratio | 0.05 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - $ / shares | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Performance-based stock units | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 123 | |
Performance-based stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 532,367 | 95,000 |
Stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 1,928,646 | 1,181,563 |
Common stock warrants | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 279,060 | 366,427 |
Convertible debt | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 835,074 | |
Conversion rate per share | $ 40 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Liabilities | ||
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Warrants and Rights Outstanding | Warrants and Rights Outstanding |
Fair value measurements recurring basis | Level 3 | ||
Liabilities | ||
Unsecured convertible promissory note | $ 32,432,000 | $ 35,551,000 |
Warrant liability | 87,950,992 | 6,219 |
Total | $ 120,382,992 | $ 35,557,219 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in fair value (Details) | 9 Months Ended |
Jun. 30, 2024 USD ($) | |
Unsecured convertible promissory note | |
Liabilities fair value changes | |
Balance, beginning | $ 35,551,000 |
Promissory note maturity extension fee added to outstanding balance | 2,681,847 |
Principal and accrued interest converted to common stock | (7,750,000) |
Change in fair value | $ 1,949,153 |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Change In Fair Value Of Redemption Feature |
Balance, ending | $ 32,432,000 |
Warrant liability | |
Liabilities fair value changes | |
Balance, beginning | 6,219 |
Issued in connection with sale of common stock | 97,730,836 |
Change in fair value | $ (9,786,063) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Fair Value Adjustment of Warrants |
Balance, ending | $ 87,950,992 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions (Details) | Jun. 30, 2024 $ / shares Y | Sep. 30, 2023 $ / shares Y |
Expected Term | ||
Fair value inputs | ||
Debt inputs | Y | 1 | 0.3 |
Warrant inputs | Y | 4.7 | 1.4 |
Stock price (per share) | ||
Fair value inputs | ||
Debt inputs | $ / shares | 7.38 | 4.40 |
Warrant inputs | $ / shares | 7.38 | 4.40 |
Expected volatility | ||
Fair value inputs | ||
Debt inputs | 1.630 | 0.710 |
Warrant inputs | 1.302 | 1.583 |
Risk-free interest rate | ||
Fair value inputs | ||
Debt inputs | 0.051 | 0.055 |
Warrant inputs | 0.0436 | 0.0530 |
Annual dividend yield | ||
Fair value inputs | ||
Debt inputs | 0 | 0 |
Warrant inputs | 0 | 0 |
Discount rate | ||
Fair value inputs | ||
Debt inputs | 0.227 | 0.228 |
Equity Method Investment - Synt
Equity Method Investment - Syntone (Details) - Syntone - USD ($) | 1 Months Ended | |
May 22, 2020 | Jun. 30, 2020 | |
Investments | ||
Ownership percentage | 20% | |
Investment in joint venture | $ 900,000 | |
Expected future investment | $ 2,100,000 | |
Syntone PRC | ||
Investments | ||
Ownership percentage | 80% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Accrued Expenses | ||
Compensation | $ 895,177 | $ 919,970 |
Professional fees | 1,107,166 | 165,192 |
Research and development | 399,853 | 1,234,192 |
Other accrued expenses | 278,718 | 426,386 |
Accrued expenses, total | $ 2,680,914 | $ 2,745,740 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Debt | ||
Less: current portion | $ (32,432,000) | $ (35,551,000) |
Unsecured convertible promissory note | ||
Debt | ||
Total debt | $ 32,432,000 | $ 35,551,000 |
Debt - Information (Details)
Debt - Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jan. 22, 2024 USD ($) $ / shares | Dec. 22, 2022 USD ($) D $ / shares | Nov. 16, 2021 USD ($) | Dec. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | |
Debt | ||||||||
Proceeds from loan | $ 30,000,000 | |||||||
Carrying value of notes exchanged | $ 7,750,000 | |||||||
Interest paid | 1,158,609 | |||||||
Loss on extinguishment of debt | (577,659) | |||||||
Interest expense | $ 303 | 3,156,964 | 2,531,022 | |||||
Payment of lender fees | 823,894 | |||||||
December 2022 Note | ||||||||
Debt | ||||||||
Original principal amount | $ 31,820,000 | |||||||
Debt issuance costs | 1,820,000 | $ 475,000 | ||||||
Proceeds from loan | $ 18,052,461 | |||||||
Interest rate (as a percent) | 9.50% | |||||||
Conversion rate per share | $ / shares | $ 7 | $ 50 | ||||||
Trading day threshold | D | 30 | |||||||
Percentage of additional fee on payments in cash | 7.50% | |||||||
Percentage of increase in debt balance by lender for a Major Trigger Event | 10% | |||||||
Percentage of increase in debt balance by lender for a Minor Trigger Event | 5% | |||||||
Threshold trading days of written notice from Lender for cure of Trigger Event | 10 days | |||||||
Interest rate for the immediately due and payable amounts | 22% | |||||||
Conversion price required to satisfy conversion notice from the lender in cash | $ / shares | $ 3.51 | |||||||
Percentage of participation right to Lender in future debt or equity financing | 10% | |||||||
Extension fees | $ 2,681,847 | |||||||
Extension fee as percentage of the outstanding balance | 7.50% | |||||||
Aggregate principal amount on which initial conversion price is reduced | $ 15,000,000 | |||||||
Quarterly payment | $ 3,000,000 | |||||||
Carrying value of notes exchanged | $ 4,750,000 | $ 7,750,000 | ||||||
Shares converted | shares | 678,524 | 1,107,095 | ||||||
Interest expense | $ 0 | $ 3,156,964 | 2,074,964 | |||||
Payment of lender fees | 254,964 | |||||||
December 2022 Note | Prime rate | ||||||||
Debt | ||||||||
Spread on variable rate | 3% | |||||||
Floor interest rate | 9.50% | |||||||
December 2022 Note | Major Trigger Event | ||||||||
Debt | ||||||||
Conversion rate per share | $ / shares | $ 40 | |||||||
Threshold percentage of stock price trigger | 90% | |||||||
Trading day threshold | D | 3 | |||||||
November 2021 Note | ||||||||
Debt | ||||||||
Original principal amount | $ 10,220,000 | |||||||
Proceeds from loan | 10,000,000 | |||||||
Unamortized discount | $ 820,000 | |||||||
Interest rate (as a percent) | 9.50% | |||||||
Redemption price (as a percent) | 105% | 105% | ||||||
Repayments of unsecured debt | $ 11,947,539 | |||||||
Interest paid | 1,158,609 | |||||||
Loss on extinguishment of debt | (577,659) | |||||||
Amortization of debt issuance costs | 8,729 | 190,775 | ||||||
Prepayment fee | $ 568,930 | |||||||
Interest expense | $ 0 | $ 454,866 |
Commitments and Contingencies -
Commitments and Contingencies - Lease cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2024 | Mar. 31, 2021 | |
Leases | ||||||
Operating lease term for lease not yet commenced | 5 years | |||||
Finance lease term | 3 years | |||||
Remaining future minimum lease payments for operating leases | $ 374,619 | $ 374,619 | ||||
Lease cost | ||||||
Interest on lease liabilities | $ 304 | 116 | $ 1,193 | |||
Total finance lease cost | 304 | 116 | 1,193 | |||
Operating lease cost | 16,459 | 11,217 | 38,892 | 33,650 | ||
Total lease cost | $ 16,459 | $ 11,521 | $ 39,008 | $ 34,843 | ||
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_2
Commitments and Contingencies - Lease balance sheet (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Leases | ||
Operating leases, Right-of-use asset | $ 286,462 | $ 26,172 |
Operating lease liabilities | $ 292,196 | |
Financing lease liabilities | $ 4,267 | |
Operating leases, Weighted-average remaining lease term | 4 years 9 months 18 days | 7 months 6 days |
Finance leases, Weighted-average remaining lease term | 3 months 18 days | |
Operating leases, Weighted-average discount rate (as a percent) | 9.90% | 7.50% |
Finance leases, Weighted-average discount rate (as a percent) | 13% |
Commitments and Contingencies_3
Commitments and Contingencies - Lease cash flow (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Leases | ||
Operating cash flows from finance leases | $ 116 | $ 1,193 |
Operating cash flows from operating leases | 11,799 | 27,675 |
Financing cash flows from finance leases | 4,267 | $ 8,669 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 294,416 |
Commitments and Contingencies_4
Commitments and Contingencies - Minimum lease payments (Details) | Jun. 30, 2024 USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
2024 (remaining three months) | $ 1,630 |
2025 | 78,091 |
2026 | 79,954 |
2027 | 81,817 |
2028 | 83,680 |
Thereafter | 49,447 |
Total undiscounted lease payments | 374,619 |
Less: Imputed interest | 82,423 |
Total lease obligations | $ 292,196 |
Common Stock and Stockholders_3
Common Stock and Stockholders' Equity - Preferred Stock (Details) - shares | Jun. 30, 2024 | May 13, 2024 | Sep. 30, 2023 |
Class of Stock [Line Items] | |||
Preferred stock shares outstanding | 0 | 0 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 |
Series A convertible preferred stock | |||
Class of Stock [Line Items] | |||
Preferred stock shares outstanding | 0 | ||
Series B convertible preferred stock | |||
Class of Stock [Line Items] | |||
Preferred stock shares outstanding | 0 | ||
Series A-1 convertible preferred stock | |||
Class of Stock [Line Items] | |||
Preferred stock shares outstanding | 0 |
Common Stock and Stockholders_4
Common Stock and Stockholders' Equity - Common Stock (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Apr. 15, 2024 | Mar. 18, 2024 | May 16, 2023 | Mar. 26, 2021 | Dec. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 07, 2024 | Mar. 06, 2024 | Sep. 30, 2023 | |
Common Stock and Stockholders' Equity | ||||||||||||
Common stock, shares authorized | 60,000,000 | 60,000,000 | 60,000,000 | 21,250,000 | 60,000,000 | |||||||
Common stock issuable on exercise of warrants (in shares) | 14,207,622 | 14,207,622 | ||||||||||
Proceeds from issuance of stock | $ 60,448,635 | $ 27,596,910 | ||||||||||
Warrants related expenses | $ 3,392,444 | $ 37,490,012 | ||||||||||
Private placement | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 8,571,423 | |||||||||||
Common stock issuable on exercise of warrants (in shares) | 12,857,133 | |||||||||||
Shares issued price (in dollars per share) | $ 7 | |||||||||||
Common stock issuable by each warrants (in shares) | 1.5 | |||||||||||
Proceeds from issuance of stock | $ 55,498,311 | |||||||||||
Warrants related expenses | $ 34,097,568 | |||||||||||
Private placement | GMS Ventures & Investments | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 2,305,714 | |||||||||||
Common stock issuable on exercise of warrants (in shares) | 3,458,571 | |||||||||||
Exercise price per share | $ 7.70 | |||||||||||
Syntone Private Placement | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 714,286 | |||||||||||
Common stock issuable on exercise of warrants (in shares) | 1,071,429 | |||||||||||
Proceeds from issuance of stock | $ 4,835,371 | |||||||||||
Exercise price per share | $ 7.70 | |||||||||||
Warrants related expenses | $ 3,392,444 | |||||||||||
Direct registered offering | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 1,423,041 | |||||||||||
Shares issued price (in dollars per share) | $ 17.568 | |||||||||||
Proceeds from issuance of stock | $ 23,208,679 | |||||||||||
Direct registered offering | GMS Ventures & Investments | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 711,520 | |||||||||||
Underwriter | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issuable on exercise of warrants (in shares) | 25,787 | |||||||||||
Exercise price per share | $ 21 | |||||||||||
Warrants exercise term | 3 years | |||||||||||
Wainwright ATM offering | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 0 | 44,769 | ||||||||||
Proceeds from issuance of stock | $ 1,089,105 | |||||||||||
Aggregate maximum offering price | $ 40,000,000 | |||||||||||
Amount reclassified on additional paid in capital | $ 197,654 | |||||||||||
Payment of fees to sales agent | $ 38,799 | |||||||||||
Common stock sale commission (as a percent) | 3% | |||||||||||
BTIG ATM | ||||||||||||
Common Stock and Stockholders' Equity | ||||||||||||
Common stock issued (in shares) | 0 | 101,863 | 0 | 101,863 | ||||||||
Proceeds from issuance of stock | $ 3,429,104 | $ 3,429,104 | ||||||||||
Aggregate maximum offering price | $ 100,000,000 | |||||||||||
Amount reclassified on additional paid in capital | $ 353,688 | |||||||||||
Payment of fees to sales agent | $ 106,055 | $ 106,055 | ||||||||||
Deferred costs | $ 331,512 | $ 331,512 | ||||||||||
Common stock sale commission (as a percent) | 3% |
Common Stock and Stockholders_5
Common Stock and Stockholders' Equity - Warrants (Details) | 9 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 14,207,622 |
December 22, 2024 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 13,850 |
Exercise price per share | $ / shares | $ 240 |
February 24, 2025 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 8,642 |
Exercise price per share | $ / shares | $ 25.40 |
April 13, 2025 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 7,284 |
Exercise price per share | $ / shares | $ 240 |
May 31, 2025 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 3,121 |
Exercise price per share | $ / shares | $ 240 |
June 22, 2025 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 9,563 |
Exercise price per share | $ / shares | $ 30.38 |
December 28, 2025 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 25,787 |
Exercise price per share | $ / shares | $ 21 |
February 2, 2026 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 93,238 |
Exercise price per share | $ / shares | $ 25 |
January 28, 2026 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 12,576 |
Exercise price per share | $ / shares | $ 25 |
November 23, 2026 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 104,999 |
Exercise price per share | $ / shares | $ 31.25 |
March 18, 2029 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 12,857,133 |
Exercise price per share | $ / shares | $ 7.70 |
Beneficial ownership exercise restriction, one (as a percent) | 4.99% |
Beneficial ownership exercise restriction, two (as a percent) | 9.99% |
Beneficial ownership exercise restriction, three (as a percent) | 19.99% |
Warrant holders exercise under certain conditions (as a percent) | 20% |
April 15, 2029 | |
Common Stock and Stockholders' Equity | |
Common stock issuable on exercise of warrants (in shares) | 1,071,429 |
Exercise price per share | $ / shares | $ 7.70 |
Stock-Based Compensation - Info
Stock-Based Compensation - Information (Details) | 9 Months Ended |
Jun. 30, 2024 shares | |
Performance-based stock units | |
Share-based Compensation | |
Term of award | 10 years |
2011 Equity Incentive Plan | Performance-based stock units | |
Share-based Compensation | |
Awards outstanding | 0 |
2015 Equity Incentive Plan | |
Share-based Compensation | |
Aggregate number of common stock authorized for issuance | 2,503,677 |
Number of shares available for grant | 0 |
Term of award | 10 years |
2015 Equity Incentive Plan | Minimum | |
Share-based Compensation | |
Vesting period | 1 year |
2015 Equity Incentive Plan | 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, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation | ||||
Stock-based compensation expense | $ 1,396,309 | $ 1,381,805 | $ 3,979,427 | $ 4,157,603 |
Research and development | ||||
Share-based Compensation | ||||
Stock-based compensation expense | 147,359 | 280,489 | 615,735 | 893,413 |
General and administrative | ||||
Share-based Compensation | ||||
Stock-based compensation expense | $ 1,248,950 | $ 1,101,316 | $ 3,363,692 | $ 3,264,190 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Weighted Average Remaining Contractual Term (Years) | ||||
Stock-based compensation expense | $ 1,396,309 | $ 1,381,805 | $ 3,979,427 | $ 4,157,603 |
Employee Stock Option [Member] | ||||
Number of Shares | ||||
Balance, Beginning (in shares) | 1,197,774 | |||
Granted (in shares) | 799,729 | |||
Forfeited (in shares) | (59,212) | |||
Expired (in shares) | 9,645 | |||
Balance, Ending (in shares) | 1,928,646 | 1,928,646 | ||
Exercisable (in shares) | 945,096 | 945,096 | ||
Vested and expected to vest (in shares) | 1,928,646 | 1,928,646 | ||
Weighted Average Exercise Price | ||||
Balance, Beginning (in dollars per share) | $ 28.72 | |||
Granted (in dollars per share) | 6.70 | |||
Forfeited (in dollars per share) | 26.27 | |||
Expired (in dollars per share) | 34.50 | |||
Balance, Ending (in dollars per share) | $ 19.63 | 19.63 | ||
Exercisable (in dollars per share) | 27.10 | 27.10 | ||
Vested and expected to vest (in dollars per share) | $ 19.63 | $ 19.63 | ||
Weighted Average Remaining Contractual Term (Years) | ||||
Balance-Remaining contractual term | 7 years 10 months 24 days | |||
Vested and exercisable -Remaining contractual term | 6 years 8 months 12 days | |||
Vested and expected to vest-Remaining contractual term | 7 years 10 months 24 days | |||
Aggregate intrinsic value, Outstanding | $ 636,830 | $ 636,830 | ||
Aggregate intrinsic value, Vested and exercisable | 193,438 | 193,438 | ||
Aggregate intrinsic value, Vested and expected to vest | $ 636,830 | $ 636,830 | ||
Grant date fair value of options (in dollars per share) | $ 6.01 | $ 18.80 | ||
Performance-based stock options | ||||
Number of Shares | ||||
Balance, Beginning (in shares) | 35,000 | |||
Granted (in shares) | 499,336 | |||
Forfeited (in shares) | (1,969) | |||
Balance, Ending (in shares) | 532,367 | 532,367 | ||
Vested and exercisable (in shares) | 35,000 | 35,000 | ||
Vested and expected to vest (in shares) | 532,367 | 532,367 | ||
Weighted Average Exercise Price | ||||
Balance, Beginning (in dollars per share) | $ 28.80 | |||
Granted (in dollars per share) | 6.78 | |||
Forfeited (in dollars per share) | 6.78 | |||
Balance, Ending (in dollars per share) | $ 7.93 | 7.93 | ||
Vested and exercisable (in dollars per share) | 28.80 | 28.80 | ||
Vested and expected to vest (in dollars per share) | $ 7.93 | $ 7.93 | ||
Weighted Average Remaining Contractual Term (Years) | ||||
Balance-Remaining contractual term | 9 years 7 months 6 days | |||
Vested and exercisable -Remaining contractual term | 6 years 7 months 6 days | |||
Vested and expected to vest-Remaining contractual term | 9 years 7 months 6 days | |||
Aggregate intrinsic value, forfeited | $ 4,351 | |||
Aggregate intrinsic value, Outstanding | $ 298,420 | 298,420 | ||
Aggregate intrinsic value, Vested and expected to vest | $ 298,420 | $ 298,420 | ||
Term of award | 10 years | |||
Grant date fair value of options (in dollars per share) | $ 6.52 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Assumptions (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Employee Stock Option [Member] | ||
Share-based Compensation | ||
Risk-free interest rate | 4.30% | 3.70% |
Expected term (years) | 6 years | 5 years 10 months 24 days |
Expected volatility | 131.30% | 111.70% |
Expected dividend yield | 0% | 0% |
Unrecognized compensation expense | $ 8,818,798 | |
Unrecognized compensation exercise period | 1 year 6 months | |
Performance-based stock options | ||
Share-based Compensation | ||
Risk-free interest rate | 4.30% | 3.80% |
Expected term (years) | 10 years | 10 years |
Expected volatility | 125.60% | 91.30% |
Expected dividend yield | 0% | 0% |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-options (Details) - Performance-based stock units | 9 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Share-based Compensation | |
Term of award | 10 years |
Number of PSUs | |
Balance, Beginning | shares | 123 |
Expired | shares | (123) |
Weighted Average Base Price Per Unit | |
Balance, Beginning | $ / shares | $ 999.40 |
Expired | $ / shares | $ 999.40 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Dec. 21, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
Related party | ||||||
Research and development | $ 11,201,754 | $ 11,101,504 | $ 29,240,046 | $ 21,508,876 | ||
Accounts payable | 5,552,484 | 5,552,484 | $ 6,574,523 | |||
General and administrative | 8,360,933 | 7,039,901 | 19,585,738 | 19,158,487 | ||
Accrued expenses | 2,680,914 | $ 2,680,914 | 2,745,740 | |||
Employee Stock Option [Member] | ||||||
Related party | ||||||
Number of options granted | 799,729 | |||||
Performance-based stock options | ||||||
Related party | ||||||
Number of options granted | 499,336 | |||||
Related Party | Employee Stock Option [Member] | ||||||
Related party | ||||||
Vesting (as a percent) | 25% | |||||
Vesting period | 3 years | |||||
Related Party | Performance-based stock options | ||||||
Related party | ||||||
Number of stock options vested | 200,000 | |||||
Related Party | MTTR | ||||||
Related party | ||||||
Research and development | 60,000 | $ 60,000 | $ 180,000 | $ 125,552 | ||
Accounts payable | $ 0 | $ 0 | $ 0 | |||
Related Party | Terry Dagnon | ||||||
Related party | ||||||
Base salary | $ 450,000 | |||||
Percentage of cash bonus | 50% | |||||
Related Party | Terry Dagnon | Employee Stock Option [Member] | ||||||
Related party | ||||||
Number of options granted | 800,000 | |||||
Related Party | Terry Dagnon | Performance-based stock options | ||||||
Related party | ||||||
Number of options granted | 200,000 | |||||
Related Party | Jeff Evanson | ||||||
Related party | ||||||
Base salary | $ 450,000 | |||||
Percentage of cash bonus | 50% | |||||
Related Party | Jeff Evanson | Employee Stock Option [Member] | ||||||
Related party | ||||||
Number of options granted | 800,000 | |||||
Related Party | Jeff Evanson | Performance-based stock options | ||||||
Related party | ||||||
Number of options granted | 200,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Jul. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | |
Subsequent Events | |||
Carrying value of notes exchanged | $ 7,750,000 | ||
December 2022 Note | |||
Subsequent Events | |||
Carrying value of notes exchanged | $ 4,750,000 | $ 7,750,000 | |
Shares converted | 678,524 | 1,107,095 | |
Subsequent Events | December 2022 Note | |||
Subsequent Events | |||
Carrying value of notes exchanged | $ 1,750,000 | ||
Shares converted | 249,999 |