Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 27, 2022 | Mar. 31, 2022 | |
Document And Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Sep. 30, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-37759 | ||
Entity Registrant Name | OUTLOOK THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 38-3982704 | ||
Entity Address, Address Line One | 485 Route 1 South | ||
Entity Address, Address Line Two | Building F, Suite 320 | ||
Entity Address, City or Town | Iselin | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08852 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 228,205,963 | ||
Entity Public Float | $ 221.5 | ||
Entity Central Index Key | 0001649989 | ||
Current Fiscal Year End Date | --09-30 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Firm ID | 185 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Philadelphia, Pennsylvania |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 17,396,812 | $ 14,477,324 |
Prepaid expenses and other current assets | 10,123,634 | 7,030,823 |
Total current assets | 27,520,446 | 21,508,147 |
Property and equipment, net | 163,625 | |
Operating lease right-of-use assets, net | 70,360 | 111,429 |
Equity method investment | 804,930 | 853,660 |
Other assets | 132,015 | 174,590 |
Total assets | 28,527,751 | 22,811,451 |
Current liabilities: | ||
Current portion of long-term debt | 10,915,015 | 904,200 |
Current portion of finance lease liabilities | 11,751 | 26,464 |
Current portion of operating lease liabilities | 26,995 | 42,854 |
Accounts payable | 3,491,485 | 2,196,349 |
Accrued expenses | 3,427,900 | 1,725,721 |
Income taxes payable | 1,856,629 | 1,856,629 |
Total current liabilities | 19,729,775 | 6,752,217 |
Long-term debt | 10,885,854 | |
Finance lease liabilities | 4,267 | 16,018 |
Operating lease liabilities | 26,995 | |
Warrant liability | 57,138 | 522,918 |
Total liabilities | 19,791,180 | 18,204,002 |
Commitments and contingencies (Note 9) | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Stockholders' equity: | ||
Preferred stock, value | ||
Common stock, par value $0.01 per share; 325,000,000 shares authorized; 227,310,572 and 176,461,628 shares issued and outstanding at September 30, 2022 and September 30, 2021, respectively | 2,273,105 | 1,764,616 |
Additional paid-in capital | 415,398,984 | 345,726,087 |
Accumulated deficit | (408,935,518) | (342,883,254) |
Total stockholders' equity | 8,736,571 | 4,607,449 |
Total liabilities, convertible preferred stock and stockholders' equity | 28,527,751 | 22,811,451 |
Series A convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Series A-1 convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Series B convertible preferred stock | ||
Stockholders' equity: | ||
Preferred stock, value |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2022 | Sep. 30, 2021 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 7,300,000 | 7,300,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 325,000,000 | 325,000,000 |
Common stock, shares issued | 227,310,572 | 176,461,628 |
Common stock, shares outstanding | 227,310,572 | 176,461,628 |
Series A convertible preferred stock | ||
Convertible stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock outstanding | 0 | 0 |
Series A-1 convertible preferred stock | ||
Convertible stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 200,000 | 200,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock outstanding | 0 | 0 |
Series B convertible preferred stock | ||
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||
Research and development | $ 42,330,856 | $ 38,958,010 |
General and administrative | 20,739,897 | 12,768,725 |
Loss from operations | (63,070,753) | (51,726,735) |
Loss on equity method investment | 48,730 | 46,340 |
Interest expense, net | 1,487,456 | 936,127 |
Loss on extinguishment of debt | 1,025,402 | |
Change in fair value of unsecured convertible promissory note | 882,903 | |
Change in fair value of warrant liability | (465,780) | 452,146 |
Loss before income taxes | (66,049,464) | (53,161,348) |
Income tax expense | 2,800 | 2,000 |
Net loss | $ (66,052,264) | $ (53,163,348) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (0.31) | $ (0.35) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.31) | $ (0.35) |
Weighted average shares outstanding, basic (in shares) | 212,079,472 | 152,676,145 |
Weighted average shares outstanding, diluted (in shares) | 212,079,472 | 152,676,145 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2020 | $ 1,271,831 | $ 291,274,366 | $ (289,719,906) | $ 2,826,291 |
Balance, beginning (in shares) at Sep. 30, 2020 | 127,183,109 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with exercise of warrants | $ 38,159 | 3,555,221 | 3,593,380 | |
Issuance of common stock in connection with exercise of warrants (in shares) | 3,815,935 | |||
Sale of common stock, net of issuance costs | $ 454,626 | 46,009,213 | 46,463,839 | |
Sale of common stock, net of issuance costs (in shares) | 45,462,584 | |||
Stock-based compensation expense | 4,887,287 | 4,887,287 | ||
Net loss | (53,163,348) | (53,163,348) | ||
Balance at Sep. 30, 2021 | $ 1,764,616 | 345,726,087 | (342,883,254) | 4,607,449 |
Balance, ending (in shares) at Sep. 30, 2021 | 176,461,628 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with exercise of stock options | $ 250 | 17,500 | 17,750 | |
Issuance of common stock in connection with exercise of stock options (in shares) | 25,000 | |||
Issuance of common stock in connection with exercise of warrants | $ 157 | 187,943 | 188,100 | |
Issuance of common stock in connection with exercise of warrants (in shares) | 15,675 | |||
Sale of common stock, net of issuance costs | $ 508,082 | 61,756,650 | 62,264,732 | |
Sale of common stock, net of issuance costs (in shares) | 50,808,269 | |||
Stock-based compensation expense | 7,710,804 | 7,710,804 | ||
Net loss | (66,052,264) | (66,052,264) | ||
Balance at Sep. 30, 2022 | $ 2,273,105 | $ 415,398,984 | $ (408,935,518) | $ 8,736,571 |
Balance, ending (in shares) at Sep. 30, 2022 | 227,310,572 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
OPERATING ACTIVITIES | ||
Net loss | $ (66,052,264) | $ (53,163,348) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 204,694 | 262,140 |
Loss on extinguishment of debt | 1,025,402 | |
Non-cash interest expense | 1,655,340 | 893,886 |
Stock-based compensation | 7,710,804 | 4,887,287 |
Change in fair value of unsecured convertible promissory note | 882,903 | |
Change in fair value of warrant liability | (465,780) | 452,146 |
Gain on settlement of lease termination obligation | (552,340) | |
Loss on equity method investment | 48,730 | 46,340 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (3,092,811) | (1,729,944) |
Other assets | 298,523 | |
Operating lease liability | (42,854) | (150,346) |
Accounts payable | 1,295,136 | (198,469) |
Accrued expenses | 156,141 | (5,299,163) |
Net cash used in operating activities | (56,674,559) | (54,253,288) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of issuance costs | 62,307,307 | 46,301,841 |
Proceeds from debt | 10,000,000 | 10,000,000 |
Payment of debt issuance costs | (8,032) | |
Proceeds from exercise of common stock warrants | 188,100 | 3,593,380 |
Proceeds from exercise of stock options | 17,750 | |
Payments of finance lease obligations | (26,464) | (29,778) |
Repayment of stockholder notes | (3,612,500) | |
Repayment of debt | (12,292,646) | (50,285) |
Payment of financing costs | (600,000) | |
Net cash provided by financing activities | 59,594,047 | 56,194,626 |
Net increase in cash and cash equivalents | 2,919,488 | 1,941,338 |
Cash and cash equivalents at beginning of year | 14,477,324 | 12,535,986 |
Cash and cash equivalents at end of year | 17,396,812 | 14,477,324 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,556,691 | $ 46,239 |
Supplemental schedule of non-cash financing activities: | ||
Deferred offering costs amortization | $ 42,575 |
Organization and Operations
Organization and Operations | 12 Months Ended |
Sep. 30, 2022 | |
Organization and Operations | |
Organization and Operations | 1. Organization and Operations Description of the 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. The Company has been actively monitoring the COVID-19 pandemic and its impact globally. Given the Company’s current infrastructure needs and current strategy, the Company was able to transition to remote working with limited impact on productivity, as shelter-in-place and similar government orders were imposed. All development activities are currently active in support of the Company’s Biologics License Application (“BLA”) registration program for ONS-5010 for wet age-related macular degeneration (“wet AMD”). In fiscal year 2022, the Company submitted the BLA and received confirmation from the U.S. Food and Drug Administration (“FDA”) that the BLA had been accepted for filing with a goal date of August 29, 2023 for a review decision by the FDA. Additionally, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), which has been validated for review with an estimated decision date expected in early 2024. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. Management believes the financial results for the year ended September 30, 2022 were not significantly impacted by COVID-19. |
Liquidity
Liquidity | 12 Months Ended |
Sep. 30, 2022 | |
Liquidity | |
Liquidity | 2. Liquidity The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $408.9 million as of September 30, 2022. As of September 30, 2022, the Company had $11.1 million of principal and accrued interest due under an unsecured promissory note maturing on January 1, 2023 (“the November 2021 note”). As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying 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 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. Subsequent to September 30, 2022, the Company sold 895,391 shares of common stock under its "at-the-market" equity offering program (the "ATM Offering"). The Company received $1.1 million in net proceeds from the ATM Offering. In December 2022, in a registered direct equity offering to certain institutional and accredited investors, including GMS Ventures and Investments, or GMS Ventures, the Company’s largest stockholder, the Company issued 28,460,831 shares of common stock at a purchase price per share of $0.8784 for $24.0 million in net proceeds after payment of placement agent fees and other estimated offering costs. GMS Ventures purchased an aggregate of 14,230,418 shares of common stock in the registered direct equity offering at the offering price per share. 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 515,755 shares of common stock at an exercise price of $1.05 per share, which warrants have a three-year term. On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued an unsecured convertible promissory note with a face amount of $31.8 million, (the “ Note”), to Streeterville Capital, LLC, or the Lender, the current holder of the Company’s outstanding unsecured promissory note maturing on January 1, 2023. The Note has an original issue discount of $1.8 million. The Company received net proceeds of $17.8 million 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. The Note bears interest at 9.5% per annum and matures on January 1, 2024. The 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 will have the right to convert the Note at the Conversion Price (as defined below). The principal amount and conversion price of the Note are subject to adjustment upon certain triggering events. In addition, the Company has the right to convert all or any portion of the outstanding balance under the 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 $2.50 per share (subject to adjustments for stock splits and stock combinations) for a period of 30 consecutive trading days. Upon the occurrence of certain events described in the Note, including, among others, the Company’s failure to pay amounts due and payable under the Note, events of insolvency or bankruptcy, failure to observe covenants contained in the Securities Purchase Agreement and the 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 Note by 10% for a Major Trigger Event (as defined in the Note) and 5% for a Minor Trigger Event (as defined in the Note). If a Trigger Event is not cured within ten (10) trading days of written notice thereof from the Lender, it will result in an event of default, such event, an Event of Default. Following an Event of Default, the Lender may accelerate the Note such that all amounts thereunder become immediately due and payable, and interest shall accrue at a rate of 22% annually until paid. Under the Note, “Conversion Price” means, prior to a Major Trigger Event, $2.00 per share (subject to adjustment for stock splits and stock combinations), and following a Major Trigger Event, the lesser of (i) $2.00 per share (subject to adjustment for stock splits and stock combinations), and (ii) 90% multiplied by the lowest closing bid price of the Company’s common stock in the three trading days prior to the date on which the conversion notice is delivered. While the Note is outstanding, the Lender will have a consent right on any future variable rate transactions or any debt. Lender will also have a 10% participation right in any future debt or equity financings. Management believes that the Company’s existing cash and cash equivalents as of September 30, 2022 together with the net proceeds of $17.8 million from the December 2022 issuance of the Note, $24.0 million from the December 2022 sale of shares of common stock in the registered direct equity offering, and $1.1 million in net proceeds from the sale of shares of common stock under the ATM Offering since September 30, 2022 are expected to fund its operations into the third calendar quarter of 2023. Additional financing will be needed by the Company to fund its operations in the future and to commercially launch ONS-5010 and develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may also include, but are not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, the issuance of equity securities, the issuance of additional debt, and revenues from potential future product sales, if any. There can be no assurance that these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to successfully begin marketing of its product candidates or complete revenue-generating partnerships with other companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market acceptance of the Company’s proposed future products. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). 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”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statements of operations as they occur. Cash and cash equivalents Cash and cash equivalents include cash-on-hand and demand deposits with financial institutions and other short-term investments with maturities of less than three months when acquired and convertible to known cash amounts. At September 30, 2022 and 2021, the Company’s cash equivalents consist of a money market account. Equity method investment The Company accounts for equity investments where it owns a non-controlling interest, but has the ability to exercise significant influence, under the equity method of accounting. Under the equity method of accounting, the original cost of the investment is adjusted for the Company’s share of equity in the earnings or loss of the equity investee and reduced by dividends and distributions of capital received, unless the fair value option is elected, in which case the investment balance is marked to fair value each reporting period and the impact of changes in fair value of the equity investment are reported in earnings. The Company has not elected the fair value option. The Company assesses its investment for other-than-temporary impairment when events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable and recognize an impairment loss to adjust the investment to its then-current fair value. Use of estimates The preparation of the 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 consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. Fair value of financial instruments 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. At September 30, 2022 and 2021, the Company’s financial instruments included cash, accounts payable, accrued expenses and the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The carrying amount of accounts payable, accrued expenses, and the PPP loan approximates fair value due to the short-term maturities of these instruments. Fair Value Option The Company elected the fair value option to account for its amended unsecured convertible promissory note. Refer to Note 8 for further details on the amended unsecured convertible promissory note. The fair value of the amended unsecured convertible promissory note at issuance and subsequent to issuance was estimated using a discounted cash flow model. Significant estimates in the cash flow model include the discount rate and the probability and timing of redemption. Fair Value of Other Financial Instruments As of September 30, 2022, the carrying value of the unsecured promissory note of $10.9 million approximates fair value due to the short maturity of this instrument. Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the term of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. Leases At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (“Short-Term Leases”). For Short-Term Leases, the Company records the rent expense on a straight-line basis and does not record the leases on the consolidated balance sheet. The Company had no Short-Term Leases as of September 30, 2022. After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement and (ii) the right-of-use lease asset based on the re-measured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any lease incentives received, and any initial direct costs incurred are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term. Stock-based compensation The Company measures equity classified stock-based awards based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures of stock option awards as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 12. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the year ended September 30, 2021, the Company recorded $0.1 million in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program. During the year ended September 30, 2022, there was no eligible spending as part of this incentive program and as result no amount was recorded on the Company’s consolidated statements of operations. Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, performance-based stock options and units, and stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2022 and 2021, as they would be antidilutive: As of September 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 1,000,000 Stock options 20,124,581 16,110,015 Common stock warrants 6,812,794 5,128,829 Recently issued accounting pronouncements There have been no other accounting pronouncements issued but not yet adopted by the Company which are expected to have a material impact on the Company’s consolidated financial position, results of operations or cash flows. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: September 30, 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 57,138 September 30, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 522,918 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability and unsecured convertible promissory note for the years ended September 30, 2022 and 2021: Unsecured Convertible Promissory Note Warrants Balance at October 1, 2020 $ — $ 70,772 Fair value at issuance date 12,051,581 — Change in fair value — 452,146 Balance at September 30, 2021 12,051,581 522,918 Change in fair value 882,903 (465,780) Repayment (12,934,484) — Balance at September 30, 2022 $ — $ 57,138 As further described in Note 8, the Company elected the fair value option to account for its amended unsecured convertible promissory note. The fair value of the amended unsecured convertible promissory note at issuance and subsequent to issuance was estimated using a discounted cash flow model. Significant estimates in the cash flow model include the discount rate and the probability and timing of redemption. The amended unsecured convertible promissory note was repaid in full during the year ended September 30, 2022. The warrants issued in connection with convertible senior secured notes originally issued pursuant to a certain Note and Warrant Purchase Agreement dated December 22, 2017, are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following weighted-average assumptions: September 30, 2022 2021 Risk-free interest rate 4.23 % 0.62 % Remaining contractual term of warrants (years) 2.4 3.4 Expected volatility 92.5 % 124.7 % Annual dividend yield — % — % Fair value of common stock (per share) $ 1.22 $ 2.17 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2022 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment Property and equipment, net, consists of: September 30, 2022 2021 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation (1,067,351) (903,726) $ — $ 163,625 Depreciation expense for the years ended September 30, 2022 and 2021 was $163,625 and $163,624, respectively. |
Equity Method Investment
Equity Method Investment | 12 Months Ended |
Sep. 30, 2022 | |
Equity Method Investment | |
Equity Method Investment | 6. Equity Method Investment In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone Ventures”), the U.S. based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Beijing Syntone Biopharma Ltd (“Syntone 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 expects to be required to make an additional capital contribution to Syntone JV of approximately $2,100,000, which will be made within four years after the establishment date in accordance with the development plan contemplated in the license agreement or on such other terms within such four-year period. The maximum exposure to a loss as a result of the Company’s involvement in Syntone JV is limited to the initial investment and the future capital contributions totaling approximately $2,100,000. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Accrued Expenses | 7 Accrued expenses consists of: September 30, 2022 2021 Compensation $ 1,976,252 $ 753,808 Research and development 744,154 808,780 Interest payable — 12,909 Professional fees 564,423 — Other accrued expenses 143,071 150,224 $ 3,427,900 $ 1,725,721 |
Debt
Debt | 12 Months Ended |
Sep. 30, 2022 | |
Debt | |
Debt | 8. Debt Debt consists of: September 30, 2022 2021 Unsecured convertible promissory note (measured at fair value) $ — $ 10,938,145 Unsecured promissory note 11,114,518 — Paycheck Protection Program term loan — 904,200 Total debt 11,114,518 11,842,345 Less: unamortized loan costs (199,503) (52,291) Total debt, net of unamortized loan costs 10,915,015 11,790,054 Less: current portion (10,915,015) (904,200) Long-term debt $ — $ 10,885,854 Unsecured convertible promissory note On November 5, 2020, the Company received $10,000,000 in net proceeds from the issuance of an unsecured promissory note with a face amount of $10,220,000, which was amended in November 2021 and became convertible. Debt issuance costs totaling $228,032 were recorded as debt discount and were deducted from the principal in the accompanying consolidated balance sheets. The debt discount was amortized as a component of interest expense over the 14-month term of the underlying debt using the effective interest method. The note bore interest at a rate of 7.5% per annum and was due to mature January 1, 2022. On November 16, 2021, the Company entered into a note amendment, which, among other things, (i) extended the maturity date to January 1, 2023, (ii) increased the interest rate from 7.5% per annum to 10% per annum beginning on January 1, 2022, and (iii) provided for the lender’s right to redeem some or all of the outstanding balance of the note for shares of the Company’s common stock beginning July 1, 2022, subject to certain limitations. The amendment was accounted for as an extinguishment of the old promissory note. As a result, the Company recorded a loss on debt extinguishment of $1,025,402, which is the difference between the fair value of the amended promissory note and the net carrying value of the old promissory note, which includes $26,488 of unamortized debt discount and lender fees of $552,633. The amended promissory note included redemption options whereby beginning on July 1, 2022, the holder had the option to redeem up to $2,000,000 of outstanding principal and accrued and unpaid interest per calendar month for shares of the Company’s common stock at a redemption price equal to 75% of the lowest closing bid price in the three trading days immediately preceding the date the holder delivers written notice. The Company elected to account for the amended promissory note at fair value (Note 4) and was not required to bifurcate the redemption options as derivatives. The Company prepaid the note in full on June 30, 2022 by paying 105% of the outstanding balance. The total payment was $12,934,484, which included interest of $1,546,038. Unsecured promissory note On November 16, 2021, the Company received $10,000,000 in net proceeds from the issuance of an unsecured promissory note with a face amount of $10,220,000. Debt issuance costs totaling $820,000 were recorded as debt discount and are deducted from the principal in the accompanying consolidated balance sheets. The debt discount is amortized as a component of interest expense over the term of the underlying debt using the effective interest method. The note bears interest at a rate of 9.5% per annum compounding daily and matures January 1, 2023. The Company may prepay all or a portion of the note at any time by paying 105% of the outstanding balance elected for pre-payment. During the years ended September 30, 2022 and 2021, the Company recognized $1,655,340 and $893,886, respectively, of interest expense related to the unsecured promissory notes, of which $646,299 and $175,741, respectively, are related to the amortization of debt discount. Paycheck Protection Program term loan On May 4, 2020, the Company received $904,200 in proceeds from a loan granted pursuant to the PPP of the CARES Act. The PPP term loan was evidenced by a promissory note containing the terms and conditions for repayment of the PPP term loan. The PPP term loan provided for an initial six-month deferral of payments and any amount owed on the loan had a two-year maturity (May 2022), with an interest rate of 1% per annum. Commencing October 15, 2021, the Company began to pay the lender equal monthly payments of principal and interest as required to fully amortize any principal amount outstanding on the PPP term loan as of October 15, 2021 by May 2, 2022. The loan was fully repaid on May 2, 2022. Interest expense on the PPP loan for the years ended September 30, 2022 and 2021 was $2,718 and $9,219, respectively. Future maturities of indebtedness at September 30, 2022 are as follows for the years ending September 30: 2023 $ 11,114,518 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. Commitments and Contingencies Selexis Commercial License Agreements In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS-3010, ONS-1045 and ONS-1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense. The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Company’s affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to terminate its royalty payment obligation by providing written notice to Selexis and paying Selexis a royalty termination fee. Each of the Company’s commercial agreements with Selexis will expire upon the expiration of all applicable Selexis patent rights. Either party may terminate the related agreement in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, winding up or similar circumstances. Either party may also terminate the related agreement under designated circumstances if the Selexis Technology infringes third-party intellectual property rights. In addition, the Company has the right to terminate each of the commercial agreements at any time at its convenience; however, with respect to the agreements relating to ONS-3010 and ONS-1045, this right is subject to the licensee’s consent pursuant to a corresponding letter the Company executed in conjunction with the standby agreement entered into between Selexis and Laboratories Liomont, S.A. de C.V. (“Liomont”) in November 2014. The standby agreement permits Liomont to assume the license under the applicable commercial agreement for Mexico upon specified triggering events involving the Company’s bankruptcy, insolvency or similar circumstances. Technology license The Company entered into a technology license agreement with Selexis that will require milestone payments of $355,737 (based on an exchange rate on September 30, 2022 for converting Swiss Francs to U.S. dollars) to the licensor by the Company upon achievement of certain clinical milestones and pay a single digit royalty on net sales by the Company utilizing such technology. The Company also has the contractual right to buy out the royalty payments at a future date. Litigation On July 20, 2020, Liomont, filed a complaint against the Company in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under the June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045 claiming $3,000,000 in damages. On March 30, 2021, the Company entered into a confidential settlement agreement with Liomont, and the complaint was dismissed on April 11, 2021. The Company agreed to make an initial settlement payment of $625,000 that was paid in April 2021; and an additional payment of $750,000, which was paid in April 2022. There are no remaining future financial obligations. Leases Corporate office In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and as of September 30, 2021, did not have remaining future obligations. In March 2021, the Company entered into a new three-year term corporate office lease in Iselin, New Jersey which commenced on April 23, 2021. Equipment leases The Company has equipment leases with terms between 12 and 36 months and has recorded those leases as finance leases. The equipment leases bear interest between 4.0% and 13.0% per annum. Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include minimum payments that the Company is obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense is recorded as research and development or general and administrative based on the use of the leased asset. The components of lease cost for the years ended September 30, 2022 and 2021 were as follows: Year ended September 30, 2022 2021 Lease cost: Amortization of right-of-use assets $ — $ — Interest on lease liabilities 3,141 5,093 Total finance lease cost 3,141 5,093 Operating lease cost 44,867 106,879 Total lease cost $ 48,008 $ 111,972 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows: September 30, 2022 2021 Operating leases: Right-of-use asset $ 70,360 $ 111,429 Operating lease liabilities 26,995 69,849 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 16,018 42,482 Weighted-average remaining lease term (years): Operating leases 1.6 2.6 Finance leases 1.3 1.7 Weighted-average discount rate: Operating leases 7.5% 7.5% Finance leases 13.0% 9.5% Other information related to leases for the years ended September 30, 2022 and 2021 are as follows: Year ended September 30, 2022 2021 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 3,141 $ 5,093 Operating cash flows from operating leases 46,652 158,708 Financing cash flows from finance leases 26,464 29,778 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 128,473 Future minimum payments under noncancelable leases at September 30, 2022 are as follows for the years ending September 30: Operating leases Finance leases 2023 $ 27,675 $ 13,149 2024 — 4,383 Total undiscounted lease payments 27,675 17,532 Less: Imputed interest 680 1,514 Total lease obligations $ 26,995 $ 16,018 Employee Benefit Plan The Company maintains a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company matches 100% of the first 3% of employee contributions. The Company assumes all administrative costs of the Plan. For the years ended September 30, 2022 and 2021, the expense relating to the matching contribution was $83,266 and $40,305, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity Common stock In February 2021, the Company issued in an underwritten public offering an aggregate of 38,593,767 shares of common stock at a purchase price per share of $1.00 for $35.5 million in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures purchased an aggregate of 8,360,000 shares of common stock in the public offering at the public offering price per share. In a separate concurrent private placement, the Company issued 3,000,000 shares of common stock to Syntone Ventures at a purchase price of $1.00 per share for aggregate gross proceeds of $3.0 million. Following partial exercise of the underwriters’ overallotment option subsequent to the initial closing, and pursuant to the Investor Rights Agreement dated as of September 11, 2017 and as amended, by and among the Company, BioLexis and GMS Ventures, the Company sold an additional 1,013,627 shares of common stock to GMS Ventures in a private placement for aggregate gross proceeds to the Company of $1.0 million at the public offering price per share of $1.00. In connection with the underwritten public offering (including the partial exercise of the overallotment option) the Company issued the underwriter warrants to purchase up to an aggregate of 2,116,364 shares of common stock at an exercise price of $1.25 per share, which warrants have a 5-year term. On March 24, 2021, following receipt of stockholder approval at the Company’s 2021 annual meeting of stockholders, the number of authorized shares of common stock was increased from 200,000,000 shares to 325,000,000 shares. In November 2021, the Company issued 46,000,000 shares of common stock in an underwritten public offering at a purchase price per share of $1.25 for $54.0 million in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures, the Company’s largest stockholder and strategic partner, purchased an aggregate of 16,000,000 shares of common stock in the public offering at the public offering price per share. In connection with the underwritten public offering, the Company issued the underwriter warrants to purchase up to an aggregate of 2,100,000 shares of common stock at an exercise price of $1.5625 per share, which warrants have a five-year term. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through September 30, 2022. H.C. Wainwright & Co. At-the-Market Offering Agreement On March 26, 2021, the Company entered into an At-the-Market Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., as sales agent (“Wainwright” or the “Agent”), under which the Company may issue and sell shares of its common stock from time to time through Wainwright as sales agent. The Company filed a prospectus supplement, dated March 26, 2021, with the Securities and Exchange Commission pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to up to $40.0 million from time to time through Wainwright. The Company incurred financing costs of $197,654 which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of September 30, 2022, $119,422 of such deferred costs are included in other assets on the consolidated balance sheets. Under the Agreement, the Company pays Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Agreement. The offering of common stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms. During the year ended September 30, 2022, the Company sold 4,808,269 shares of common stock under the ATM Offering and generated $8.6 million in gross proceeds. The Company paid fees to the sales agent of $0.3 million. During the year ended September 30, 2021, the Company sold 2,855,190 shares of common stock under the ATM Offering and generated $7.2 million in gross proceeds. The Company paid fees to the sales agent of $0.2 million. Common stock warrants As of September 30, 2022, the Company had the following warrants outstanding to acquire shares of its common stock: Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share December 22, 2024 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 172,864 $ 1.27 February 26, 2024 1,747,047 $ 0.9535 June 22, 2025 191,268 $ 1.51875 January 28, 2026 2,116,364 $ 1.25 November 23, 2026 2,100,000 $ 1.5625 6,812,794 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 and are classified as liabilities on the accompanying consolidated balance sheets, as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. During the year ended September 30, 2022, warrants to purchase an aggregate of 400,360 shares of common stock with a weighted average exercise price of $12.00 expired; and warrants to purchase an aggregate of 15,675 shares of common stock with a weighted average exercise price of $12.00 were exercised for cash. During the year ended September 30, 2021, warrants to purchase an aggregate of 3,642,138 shares of common stock with a weighted averaged exercise price of $0.9866 were exercised for aggregate gross proceeds to the Company of $3,593,380. In addition, warrants to purchase an aggregate of 397,251 shares of common stock with a weighted averaged exercise price of $1.51875 were exercised on a cashless basis and the Company issued 173,797 shares of common stock in connection with these cashless exercises. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Sep. 30, 2022 | |
Preferred Stock. | |
Preferred Stock | 11. Preferred Stock The Company’s board of directors has the authority, without further action by its stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series and to fix the number, rights, preferences, privileges and restrictions thereof. The Company’s board of directors has previously designated 1,000,000 shares as “Series A Convertible Preferred Stock,” 200,000 shares as “Series A-1 Convertible Preferred Stock” and 1,500,000 shares as “Series B Convertible Preferred Stock.” At September 30, 2022 and 2021, there were no shares of preferred stock issued and outstanding. Series A Convertible Preferred Stock The Series A Convertible preferred stock, or Series A Convertible, accrued dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A Convertible. The Series A Convertible was also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of common stock or other securities. The initial conversion rate was subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the common stock. Series A-1 Convertible Preferred Stock The Series A-1 Convertible preferred stock, or the Series A-1, accrued dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A-1. The Series A-1 was also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of Common Stock or other securities. The holders of the Series A-1 had the right to vote on matters submitted to a vote of the Company’s stockholders on an as-converted basis, voting with the Company’s other stockholders as a single class. In addition, without the prior written consent of a majority of the outstanding shares of Series A-1, the Company would not take certain actions, including amending its certificate of incorporation or bylaws, or issuing securities ranking pari passu or senior to the Series A-1. Series B Convertible Preferred Stock The Series B Convertible preferred stock, or Series B Convertible, were non-voting, did not accrue dividends nor did the shares of Series B Convertible had any specific rights or preferences, and had a par value of $0.01 per share and were convertible into 2,112,676 shares of common stock. The Series B Convertible were not convertible into common stock if the holder thereof would beneficially own more than 9.99% of the common stock, or, if during the first six-month period following the closing of the exchange, 7.50%, but automatically converted into common stock in part from time to time if the holder beneficially owned below a certain beneficial ownership threshold of the common stock. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 12. 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 September 30, 2022, PSUs representing 2,470 shares of the Company’s common stock were outstanding under the 2011 Plan. In light of the December 2015 adoption of the 2015 Equity Incentive Plan, (the “2015 Plan”) no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Plan. The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Company’s 2015 Plan is 34,565,837. As of September 30, 2022, 13,546,604 shares remained available for grant under the 2015 Plan. Stock options and RSUs granted under the Company's 2015 Plan generally vest over a period of one The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2022 and 2021: Year ended September 30, 2022 2021 Research and development $ 2,691,330 $ 953,328 General and administrative 5,019,474 3,933,959 $ 7,710,804 $ 4,887,287 Stock options The following table summarizes all of the Company’s stock option activity for the years ended September 30, 2021 and 2022: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2020 3,762,143 $ 2.01 Granted 12,461,645 1.29 Forfeited or expired (113,773) 0.76 Balance at September 30, 2021 16,110,015 1.46 Granted 4,039,566 1.60 Exercised (25,000) 0.71 $ 38,960 Balance at September 30, 2022 20,124,581 $ 1.49 8.3 $ 4,521,960 Exercisable 8,353,802 $ 1.53 7.9 $ 2,067,210 Vested and expected to vest at September 30, 2022 20,124,581 $ 1.49 8.3 $ 4,521,960 The aggregate intrinsic value represents the total amount by which the fair market value of the common stock subject to options exceeds the exercise price of the related options. The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected volatility is based on a weighted average of the Company’s historical volatility and the volatilities of similar entities within the Company’s industry which are commensurate with the expected term assumption. The expected term calculation is based on the “simplified” method described in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment Share-Based Payment one The weighted average grant date fair value of the options awarded to employees and directors for the years ended September 30, 2022 and 2021 was $1.23 and $0.98 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: Year ended September 30, 2022 2021 Risk-free interest rate 1.77 % 0.58 % Expected term (years) 6.0 6.0 Expected volatility 95.3 % 94.5 % Expected dividend yield — — As of September 30, 2022, there was $11,016,572 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.7 years. Performance-based stock options The Company granted certain officers of the Company option awards where vesting was contingent upon meeting certain 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. The following table summarizes all of the Company’s performance-based stock option activity for the years ended September 30, 2021 and 2022. Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2020 — $ — Granted 1,000,000 2.42 Balance at September 30, 2021 1,000,000 2.42 Granted 1,900,000 1.44 Forfeited or expired (2,200,000) 1.89 Balance at September 30, 2022 700,000 $ 1.44 9.2 $ — Exercisable 700,000 $ 1.44 9.2 $ — Vested and expected to vest at September 30, 2022 700,000 $ 1.44 9.2 $ — The weighted average grant date fair value of the performance stock options awarded for the years ended September 30, 2022 and 2021 was $1.03 and $1.76 per option, respectively. During the year ended September 30, 2022, an aggregate of 700,000 performance-based stock options vested as a result of achieving one of the set performance conditions related to the Company’s BLA submission that resulted in the Company recognizing stock-based compensation expense of $718,950 during the year ended September 30, 2022. During the year ended September 30, 2022, an aggregate of 2,200,000 performance-based stock options were forfeited because certain performance conditions were not achieved. During the year ended September 30, 2021, no expense was recognized because the performance conditions were not considered probable of achievement. As of September 30, 2022, there were no remaining performance conditions. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Year ended September 30, 2022 2021 Risk-free interest rate 1.26 % 0.88 % Expected term (years) 5.2 5.4 Expected volatility 91.5 % 93.1 % Expected dividend yield — — Performance-based stock units The Company has issued PSUs, which generally have a ten-year life from the date of grant. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. The following table summarizes the activity related to PSUs during the years ended September 30, 2021 and 2022: Weighted Average Number Base Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2020 2,470 $ 49.97 Forfeitures — — Balance at September 30, 2021 2,470 $ 49.97 Forfeitures — — Balance at September 30, 2022 2,470 $ 49.97 2.0 $ — Vested and exercisable at September 30, 2022 2,470 $ 49.97 2.0 $ — Vested and expected to vest at September 30, 2022 2,470 $ 49.97 2.0 $ — Restricted stock In January 2020, in connection with the consulting agreements entered into by the Company and four principals of MTTR, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 14 for further details on the consulting agreements and terminated strategic partnership agreement. The shares may not be sold until the earlier of (i) six months following FDA approval of ONS-5010, (ii) the date the Company publicly announces not to pursue development of ONS-5010, (iii) a change in control or (iv) January 2025. In addition, the Company has the right to repurchase the shares for $0.01 per share if the consultant terminates his agreement other than for good reason or the Company terminates the agreement for cause. The repurchase right lapses, in tiered percentages, based upon the completion of enrollment of the Company’s NORSE TWO clinical trial of ONS-5010 by certain dates. The repurchase right may also lapse as to 50% or 100% of the shares if the Company enters into certain agreements pertaining to ONS-5010 that meet certain value thresholds or the Company’s share price meets certain predefined targets. The repurchase right also lapses as to 100% of the shares upon the earliest to occur of (i) filing of the BLA for ONS-5010, (ii) termination of the agreement by the consultant for good reason or by the Company other than for cause, (iii) in the event of disability, or (iv) upon a change in control. The grant date fair value of the restricted shares was $0.54 per share and equal to the closing stock price of the Company’s common stock at the time of grant. Compensation expense is recognized over the shorter of the explicit service period or derived service period which was determined to be 4.8 years at the time of grant. Compensation expense may be accelerated when certain performance conditions become probable and the corresponding purchase right has lapsed. During the years ended September 30, 2022 and 2021, the Company recognized compensation expense related to the restricted stock of $2,003,946 and $607,060, respectively. As of September 30, 2022, there was no unrecognized compensation expense related to the restricted stock. |
Collaboration Arrangements
Collaboration Arrangements | 12 Months Ended |
Sep. 30, 2022 | |
Collaboration Arrangements | |
Collaboration Arrangements | 13. Collaboration Arrangements Syntone Strategic Partnership and PRC Joint Venture In connection with a stock purchase agreement entered in May 2020 between the Company and Syntone, the Company and Syntone entered into a joint venture agreement pursuant to which they agreed to form a PRC joint venture that will be 80% owned by Syntone and 20% owned by the Company. Upon formation of the PRC joint venture in April 2021, the Company entered into a royalty-free license with the PRC joint venture for the development, commercialization and manufacture of ONS-5010 in the greater China market, which includes Hong Kong, Taiwan and Macau. The Company made the initial investment of $900,000 in June 2020. The Company expects to be required to make an additional capital contribution to the PRC joint venture of approximately $2.1 million, which will be made within four years after the establishment date in accordance with the development plan contemplated in the license agreement or on such other terms within such four-year |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Sep. 30, 2022 | |
Related-Party Transactions | |
Related-Party Transactions | 14. Related-Party Transactions MTTR - Strategic Partnership Agreement (ONS-5010) In February 2018, the Company entered into a strategic partnership agreement with MTTR to advise on regulatory, clinical and commercial strategy and assist in obtaining approval of ONS-5010, the Company's bevacizumab therapeutic product candidate for ophthalmic indications. In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operating Officer, and Mr. Jeff Evanson as Chief Commercial Officer. Both Mr. Dagnon and Mr. Evanson initially provided services to the Company pursuant to the February 2018 strategic partnership agreement with MTTR, as amended. Mr. Dagnon and Mr. Evanson were both principals in MTTR. The Company did not pay Mr. Dagnon or Mr. Evanson any direct compensation as consultants or as employees during the period from October 1, 2019 through March 19, 2020. Both Mr. Dagnon and Mr. Evanson were compensated directly by MTTR for services provided to the Company as the Company's Chief Operating Officer and Chief Commercial Officer, respectively, pursuant to the strategic partnership agreement until such agreement, as amended, was terminated effective March 19, 2020. The Company began compensating Mr. Dagnon and Mr. Evanson directly as consultants effective March 19, 2020 pursuant to their respective consulting agreements with the Company, which became effective March 19, 2020 following stockholder approval of the share issuances contemplated therein. Mr. Dagnon and Mr. Evanson have also agreed to provide consulting services to an affiliate of BioLexis pursuant to a separate arrangement. On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson), an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000, upon effectiveness of the agreement. Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement, and the consulting agreements, became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 12 for the accounting of the restricted stock issued and compensation expense recognized. MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $526,435 and $1,089,408 during the years ended September 30, 2022 and 2021, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 12). As of September 30, 2022 and 2021, the amounts payable to former MTTR principals as consultants of $18,333 and $89,762, respectively, were included in accounts payable in the accompanying consolidated balance sheets. On December 21, 2021, the Company entered into employment agreements with each of Mr. Dagnon and Mr. Evanson, which superseded and replaced their prior consulting agreements. Pursuant to their new employment agreements, each of Mr. Dagnon and Mr. Evanson will receive a base salary cash bonus grant vest on the first anniversary of the grant and the remainder of which will vest in monthly installments over the succeeding three years, subject to their continued service through each vesting date. In addition, each of Mr. Dagnon and Mr. Evanson received a performance grant |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | 15. Income Taxes Income tax benefit for the years ended September 30, 2022 and 2021 consists of the following: Year ended September 30, 2022 2021 State tax $ 2,800 $ 2,000 The Company did not sell any New Jersey State net operating losses (“NOLs”) or unused research and development tax credits during the years ended September 30, 2022 and 2021. A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year ended September 30, 2022 2021 U.S. federal statutory rate (21.0) % (21.0) % State taxes, net of federal benefit (7.1) (7.0) Net operating loss — 1.9 Permanent differences — 0.4 Research and development credit (3.5) (3.7) Change in valuation allowance 32.1 30.7 Other (0.5) (1.3) Effective income tax rate (0.0) % (0.0) % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 83,971,779 $ 67,778,970 Stock-based compensation 4,331,889 2,168,228 Lease liability 7,588 31,577 Research and development credit carryforward 11,166,153 8,842,001 Foreign tax credits 2,357,309 2,357,309 Accruals and others 815,310 348,605 Gross deferred tax assets 102,650,028 81,526,690 Less: valuation allowance (102,630,250) (81,449,372) 19,778 77,318 Deferred tax liabilities: Property and equipment — (45,995) Right-of-use assets (19,778) (31,323) Net deferred tax assets $ — $ — As of September 30, 2022, the Company has approximately $339.9 million and $175.7 million of U.S. federal and New Jersey NOLs that will begin to expire in 2030 and 2039, respectively. As of September 30, 2022, the Company has federal and state research and development tax credit carryforwards of $10.4 million and $0.8 million, respectively, available to reduce future tax liabilities which will begin to expire in 2032 and 2033, respectively. As of September 30, 2022, the Company has federal foreign tax credit (“FTC”) carryforwards of $2.4 million available to reduce future tax liabilities which will begin to expire starting in 2023, of which $1.9 million of the FTC carryforward is included in the balance of unrecognized tax benefits. Realization of the deferred tax asset is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax asset does not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax assets as of September 30, 2022 and 2021. The valuation allowance increased by $21.2 million and $16.3 million during the year ended September 30, 2022 and 2021, respectively. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties accrued on any unrecognized tax benefits within the provision for income taxes in its consolidated statements of operations. The 2017 Tax Cuts and Jobs Act (the "Act"), which was signed into law on December 22, 2017, has resulted in significant changes to the U.S. corporate income tax system. These changes include a federal statutory rate reduction from 34% to 21%, the elimination or reduction of certain domestic deductions and credits and limitations on the deductibility of interest expense and executive compensation. For the fiscal year ending September 30, 2018, the federal tax rate is 24.3%; for the fiscal year ending September 30, 2019, the federal tax rate is 21.0%. The Act also transitions international taxation from a worldwide system to a modified territorial system and includes base erosion prevention measures on non-U.S. earnings, which has the effect of subjecting certain earnings of the Company's foreign subsidiaries to U.S. taxation as global intangible low-taxed income. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year ended September 30, 2022 2021 Balance at beginning of year $ 1,856,629 $ 1,856,629 Changes based on tax positions related to the current year — — Balance at end of year $ 1,856,629 $ 1,856,629 The Company does not anticipate material change in the unrecognized tax benefits in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2021 remain open for examination by the Internal Revenue Service as well as various states and municipalities. Due to the change in ownership provisions of the Code, the availability of the Company’s NOL carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred tax assets with an offsetting reduction in the valuation allowance. On August 16, 2022, President Biden signed the Inflation Reduction Act (“the IRA”). The IRA contains a number of tax related provisions including a 15% minimum corporate income tax on certain large corporations as well as an exercise tax on stock repurchases, both provisions are effective for tax years beginning after December 31, 2022. The Company is in the process of evaluating the IRA, but does not expect it to have a material impact on the Company's consolidated financial statements. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of presentation | Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). 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”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statements of operations as they occur. |
Cash and cash equivalents | Cash and cash equivalents Cash and cash equivalents include cash-on-hand and demand deposits with financial institutions and other short-term investments with maturities of less than three months when acquired and convertible to known cash amounts. At September 30, 2022 and 2021, the Company’s cash equivalents consist of a money market account. |
Equity method investment | Equity method investment The Company accounts for equity investments where it owns a non-controlling interest, but has the ability to exercise significant influence, under the equity method of accounting. Under the equity method of accounting, the original cost of the investment is adjusted for the Company’s share of equity in the earnings or loss of the equity investee and reduced by dividends and distributions of capital received, unless the fair value option is elected, in which case the investment balance is marked to fair value each reporting period and the impact of changes in fair value of the equity investment are reported in earnings. The Company has not elected the fair value option. The Company assesses its investment for other-than-temporary impairment when events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable and recognize an impairment loss to adjust the investment to its then-current fair value. |
Use of estimates | Use of estimates The preparation of the 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 consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. |
Fair value option | Fair value of financial instruments 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. At September 30, 2022 and 2021, the Company’s financial instruments included cash, accounts payable, accrued expenses and the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The carrying amount of accounts payable, accrued expenses, and the PPP loan approximates fair value due to the short-term maturities of these instruments. Fair Value Option The Company elected the fair value option to account for its amended unsecured convertible promissory note. Refer to Note 8 for further details on the amended unsecured convertible promissory note. The fair value of the amended unsecured convertible promissory note at issuance and subsequent to issuance was estimated using a discounted cash flow model. Significant estimates in the cash flow model include the discount rate and the probability and timing of redemption. Fair Value of Other Financial Instruments As of September 30, 2022, the carrying value of the unsecured promissory note of $10.9 million approximates fair value due to the short maturity of this instrument. |
Property and equipment | Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the term of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. |
Long-lived assets | Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. |
Leases | Leases At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (“Short-Term Leases”). For Short-Term Leases, the Company records the rent expense on a straight-line basis and does not record the leases on the consolidated balance sheet. The Company had no Short-Term Leases as of September 30, 2022. After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement and (ii) the right-of-use lease asset based on the re-measured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any lease incentives received, and any initial direct costs incurred are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term. |
Stock-based compensation | Stock-based compensation The Company measures equity classified stock-based awards based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures of stock option awards as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 12. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. |
Research and development | Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the year ended September 30, 2021, the Company recorded $0.1 million in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program. During the year ended September 30, 2022, there was no eligible spending as part of this incentive program and as result no amount was recorded on the Company’s consolidated statements of operations. |
Income taxes | Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. |
Net loss per share | Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, performance-based stock options and units, and stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2022 and 2021, as they would be antidilutive: As of September 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 1,000,000 Stock options 20,124,581 16,110,015 Common stock warrants 6,812,794 5,128,829 |
Recently issued accounting pronouncements | Recently issued accounting pronouncements There have been no other accounting pronouncements issued but not yet adopted by the Company which are expected to have a material impact on the Company’s consolidated financial position, results of operations or cash flows. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of September 30, 2022 2021 Performance-based stock units 2,470 2,470 Performance-based stock options 700,000 1,000,000 Stock options 20,124,581 16,110,015 Common stock warrants 6,812,794 5,128,829 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 57,138 September 30, 2021 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 522,918 |
Schedule of changes in the fair value of Level 3 valuation for the warrant liability | Unsecured Convertible Promissory Note Warrants Balance at October 1, 2020 $ — $ 70,772 Fair value at issuance date 12,051,581 — Change in fair value — 452,146 Balance at September 30, 2021 12,051,581 522,918 Change in fair value 882,903 (465,780) Repayment (12,934,484) — Balance at September 30, 2022 $ — $ 57,138 |
Schedule of fair value of the warrant liability | September 30, 2022 2021 Risk-free interest rate 4.23 % 0.62 % Remaining contractual term of warrants (years) 2.4 3.4 Expected volatility 92.5 % 124.7 % Annual dividend yield — % — % Fair value of common stock (per share) $ 1.22 $ 2.17 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Property and Equipment | |
Schedule of property and equipment | September 30, 2022 2021 Laboratory equipment $ 1,067,351 $ 1,067,351 Less: accumulated depreciation (1,067,351) (903,726) $ — $ 163,625 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, 2022 2021 Compensation $ 1,976,252 $ 753,808 Research and development 744,154 808,780 Interest payable — 12,909 Professional fees 564,423 — Other accrued expenses 143,071 150,224 $ 3,427,900 $ 1,725,721 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Debt | |
Schedule of debt | September 30, 2022 2021 Unsecured convertible promissory note (measured at fair value) $ — $ 10,938,145 Unsecured promissory note 11,114,518 — Paycheck Protection Program term loan — 904,200 Total debt 11,114,518 11,842,345 Less: unamortized loan costs (199,503) (52,291) Total debt, net of unamortized loan costs 10,915,015 11,790,054 Less: current portion (10,915,015) (904,200) Long-term debt $ — $ 10,885,854 |
Schedule of future maturities of other indebtedness | 2023 $ 11,114,518 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies. | |
Schedule of lease information | The components of lease cost for the years ended September 30, 2022 and 2021 were as follows: Year ended September 30, 2022 2021 Lease cost: Amortization of right-of-use assets $ — $ — Interest on lease liabilities 3,141 5,093 Total finance lease cost 3,141 5,093 Operating lease cost 44,867 106,879 Total lease cost $ 48,008 $ 111,972 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows: September 30, 2022 2021 Operating leases: Right-of-use asset $ 70,360 $ 111,429 Operating lease liabilities 26,995 69,849 Finance leases: Right-of-use asset $ — $ — Financing lease liabilities 16,018 42,482 Weighted-average remaining lease term (years): Operating leases 1.6 2.6 Finance leases 1.3 1.7 Weighted-average discount rate: Operating leases 7.5% 7.5% Finance leases 13.0% 9.5% Other information related to leases for the years ended September 30, 2022 and 2021 are as follows: Year ended September 30, 2022 2021 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 3,141 $ 5,093 Operating cash flows from operating leases 46,652 158,708 Financing cash flows from finance leases 26,464 29,778 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 128,473 |
Schedule of operating lease future minimum payments | Future minimum payments under noncancelable leases at September 30, 2022 are as follows for the years ending September 30: Operating leases Finance leases 2023 $ 27,675 $ 13,149 2024 — 4,383 Total undiscounted lease payments 27,675 17,532 Less: Imputed interest 680 1,514 Total lease obligations $ 26,995 $ 16,018 |
Schedule of finance lease future minimum payments | Operating leases Finance leases 2023 $ 27,675 $ 13,149 2024 — 4,383 Total undiscounted lease payments 27,675 17,532 Less: Imputed interest 680 1,514 Total lease obligations $ 26,995 $ 16,018 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Schedule of warrants outstanding | Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share December 22, 2024 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 172,864 $ 1.27 February 26, 2024 1,747,047 $ 0.9535 June 22, 2025 191,268 $ 1.51875 January 28, 2026 2,116,364 $ 1.25 November 23, 2026 2,100,000 $ 1.5625 6,812,794 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 and are classified as liabilities on the accompanying consolidated balance sheets, as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Share-based Compensation | |
Schedule of stock-based compensation expense | Year ended September 30, 2022 2021 Research and development $ 2,691,330 $ 953,328 General and administrative 5,019,474 3,933,959 $ 7,710,804 $ 4,887,287 |
Schedule of performance-based stock units activity | Weighted Average Number Base Remaining of Price Contractual Aggregate PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2020 2,470 $ 49.97 Forfeitures — — Balance at September 30, 2021 2,470 $ 49.97 Forfeitures — — Balance at September 30, 2022 2,470 $ 49.97 2.0 $ — Vested and exercisable at September 30, 2022 2,470 $ 49.97 2.0 $ — Vested and expected to vest at September 30, 2022 2,470 $ 49.97 2.0 $ — |
Stock options | |
Share-based Compensation | |
Schedule of stock option activity | Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2020 3,762,143 $ 2.01 Granted 12,461,645 1.29 Forfeited or expired (113,773) 0.76 Balance at September 30, 2021 16,110,015 1.46 Granted 4,039,566 1.60 Exercised (25,000) 0.71 $ 38,960 Balance at September 30, 2022 20,124,581 $ 1.49 8.3 $ 4,521,960 Exercisable 8,353,802 $ 1.53 7.9 $ 2,067,210 Vested and expected to vest at September 30, 2022 20,124,581 $ 1.49 8.3 $ 4,521,960 |
Schedule of option assumptions | Year ended September 30, 2022 2021 Risk-free interest rate 1.77 % 0.58 % Expected term (years) 6.0 6.0 Expected volatility 95.3 % 94.5 % 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, 2020 — $ — Granted 1,000,000 2.42 Balance at September 30, 2021 1,000,000 2.42 Granted 1,900,000 1.44 Forfeited or expired (2,200,000) 1.89 Balance at September 30, 2022 700,000 $ 1.44 9.2 $ — Exercisable 700,000 $ 1.44 9.2 $ — Vested and expected to vest at September 30, 2022 700,000 $ 1.44 9.2 $ — |
Schedule of option assumptions | Year ended September 30, 2022 2021 Risk-free interest rate 1.26 % 0.88 % Expected term (years) 5.2 5.4 Expected volatility 91.5 % 93.1 % Expected dividend yield — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Schedule of Income tax expense | Year ended September 30, 2022 2021 State tax $ 2,800 $ 2,000 |
Schedule of tax expense reconciliation | Year ended September 30, 2022 2021 U.S. federal statutory rate (21.0) % (21.0) % State taxes, net of federal benefit (7.1) (7.0) Net operating loss — 1.9 Permanent differences — 0.4 Research and development credit (3.5) (3.7) Change in valuation allowance 32.1 30.7 Other (0.5) (1.3) Effective income tax rate (0.0) % (0.0) % |
Schedule of deferred taxes | September 30, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 83,971,779 $ 67,778,970 Stock-based compensation 4,331,889 2,168,228 Lease liability 7,588 31,577 Research and development credit carryforward 11,166,153 8,842,001 Foreign tax credits 2,357,309 2,357,309 Accruals and others 815,310 348,605 Gross deferred tax assets 102,650,028 81,526,690 Less: valuation allowance (102,630,250) (81,449,372) 19,778 77,318 Deferred tax liabilities: Property and equipment — (45,995) Right-of-use assets (19,778) (31,323) Net deferred tax assets $ — $ — |
Schedule of reconciliation of unrecognized tax benefits | Year ended September 30, 2022 2021 Balance at beginning of year $ 1,856,629 $ 1,856,629 Changes based on tax positions related to the current year — — Balance at end of year $ 1,856,629 $ 1,856,629 |
Liquidity (Details)
Liquidity (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||
Dec. 22, 2022 | Sep. 11, 2017 | Dec. 31, 2022 | Nov. 30, 2021 | Feb. 28, 2021 | Nov. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Liquidity | ||||||||
Accumulated deficit | $ 408,935,518 | $ 342,883,254 | ||||||
Total debt | 11,114,518 | 11,842,345 | ||||||
Proceeds from issuance of stock | $ 62,307,307 | 46,301,841 | ||||||
Shares of common stock issuable upon exercise of warrants | 6,812,794 | |||||||
Unamortized discount | $ 199,503 | 52,291 | ||||||
Proceeds from debt | $ 10,000,000 | $ 10,000,000 | ||||||
2022 Note | ||||||||
Liquidity | ||||||||
Original principal amount | $ 31,800,000 | |||||||
Unamortized discount | $ 1,800,000 | |||||||
Interest rate (as a percent) | 9.50% | |||||||
Net proceeds (repayments) debt | $ 17,800,000 | |||||||
Net proceeds from debt | $ 17,800,000 | |||||||
ATM Offering | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 895,391 | 4,808,269 | 2,855,190 | |||||
Proceeds from issuance of stock | $ 1,100,000 | $ 8,600,000 | $ 7,200,000 | |||||
Direct registered offering | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 28,460,831 | |||||||
Shares issued price (in dollars per share) | $ 0.8784 | |||||||
Proceeds from issuance of stock | $ 24,000,000 | |||||||
Direct registered offering | GMS Ventures & Investments | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 14,230,418 | |||||||
Direct registered offering | M.S. Howells & Co | ||||||||
Liquidity | ||||||||
Shares of common stock issuable upon exercise of warrants | 515,755 | |||||||
Exercise price per share | $ 1.05 | |||||||
Warrants exercise term | 3 years | |||||||
Private Placement | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 3,000,000 | |||||||
Shares issued price (in dollars per share) | $ 1 | |||||||
Proceeds from issuance of stock | $ 3,000,000 | |||||||
Private Placement | GMS Ventures & Investments | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 1,013,627 | |||||||
Shares issued price (in dollars per share) | $ 1 | |||||||
Proceeds from issuance of stock | $ 1,000,000 | |||||||
Underwritten Public Offering | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 46,000,000 | 38,593,767 | ||||||
Shares issued price (in dollars per share) | $ 1.25 | $ 1 | ||||||
Proceeds from issuance of stock | $ 54,000,000 | $ 35,500,000 | ||||||
Shares of common stock issuable upon exercise of warrants | 2,100,000 | 2,116,364 | ||||||
Exercise price per share | $ 1.5625 | $ 1.25 | ||||||
Warrants exercise term | 5 years | 5 years | ||||||
Underwritten Public Offering | GMS Ventures & Investments | ||||||||
Liquidity | ||||||||
Sale of common stock, net of issuance costs (in shares) | 16,000,000 | 8,360,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Info (Details) - USD ($) $ in Millions | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
New accounting pronouncements | ||
GST receivable | $ 0 | $ 0.1 |
Minimum | ||
New accounting pronouncements | ||
Estimated useful lives | 3 years | |
Maximum | ||
New accounting pronouncements | ||
Estimated useful lives | 10 years | |
Unsecured promissory note (2021) | ||
New accounting pronouncements | ||
Debt fair value | $ 10.9 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Performance-based stock units | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 2,470 | 2,470 |
Performance-based stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 700,000 | 1,000,000 |
Stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 20,124,581 | 16,110,015 |
Common stock warrants | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation of earnings per share | 6,812,794 | 5,128,829 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair value measurements recurring basis - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Liabilities | ||
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Warrants and Rights Outstanding | Warrants and Rights Outstanding |
Level 3 | ||
Liabilities | ||
Warrant liability | $ 57,138 | $ 522,918 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in fair value (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Fair Value Adjustment of Warrants, Change In Fair Value Of Redemption Feature | Fair Value Adjustment of Warrants, Change In Fair Value Of Redemption Feature |
Unsecured promissory note (2020) | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning | $ 12,051,581 | |
Fair value at issuance date | $ 12,051,581 | |
Change in fair value | 882,903 | |
Repayment | (12,934,484) | |
Balance, ending | 12,051,581 | |
Warrant liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning | 522,918 | 70,772 |
Change in fair value | (465,780) | 452,146 |
Balance, ending | $ 57,138 | $ 522,918 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions (Details) | Sep. 30, 2022 Y $ / shares | Sep. 30, 2021 $ / shares Y |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 4.23 | 0.62 |
Remaining contractual term of warrants (years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | Y | 2.4 | 3.4 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 92.5 | 124.7 |
Fair value of common stock (per share) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | $ / shares | 1.22 | 2.17 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Property and Equipment | ||
Laboratory equipment | $ 1,067,351 | $ 1,067,351 |
Less: accumulated depreciation | (1,067,351) | (903,726) |
Property and equipment, net | 163,625 | |
Depreciation expense | $ 163,625 | $ 163,624 |
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 | |
Contract period | 4 years | |
Syntone PRC | ||
Investments | ||
Ownership percentage | 80% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Accrued Expenses | ||
Compensation | $ 1,976,252 | $ 753,808 |
Research and development | 744,154 | 808,780 |
Interest payable | 12,909 | |
Professional fees | 564,423 | |
Other accrued expenses | 143,071 | 150,224 |
Accrued expenses, total | $ 3,427,900 | $ 1,725,721 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Sep. 30, 2022 | Nov. 16, 2021 | Sep. 30, 2021 | Nov. 05, 2020 |
Debt Instrument [Line Items] | ||||
Total debt | $ 11,114,518 | $ 11,842,345 | ||
Less: unamortized loan costs | (199,503) | (52,291) | ||
Total debt, net of unamortized loan costs | 10,915,015 | 11,790,054 | ||
Less: current portion | (10,915,015) | (904,200) | ||
Long-term debt | 10,885,854 | |||
Unsecured promissory note (2020) | ||||
Debt Instrument [Line Items] | ||||
Total debt | 11,100,000 | 10,938,145 | ||
Less: unamortized loan costs | $ (26,488) | $ (228,032) | ||
Unsecured promissory note (2021) | ||||
Debt Instrument [Line Items] | ||||
Total debt | $ 11,114,518 | |||
Less: unamortized loan costs | $ (820,000) | |||
Paycheck Protection Program | ||||
Debt Instrument [Line Items] | ||||
Total debt | $ 904,200 |
Debt - Information (Details)
Debt - Information (Details) - USD ($) | 12 Months Ended | |||||
Jun. 30, 2022 | Nov. 16, 2021 | Nov. 05, 2020 | May 04, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | ||||||
Proceeds from loan | $ 10,000,000 | $ 10,000,000 | ||||
Unamortized discount | 199,503 | 52,291 | ||||
Gain (loss) on extinguishment of debt | (1,025,402) | |||||
Payment of lender fees | 600,000 | |||||
Debt outstanding | 10,915,015 | 11,790,054 | ||||
Unsecured promissory note (2020) | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from loan | $ 10,000,000 | |||||
Original principal amount | 10,220,000 | |||||
Unamortized discount | $ 26,488 | $ 228,032 | ||||
Debt Instrument, term | 14 months | |||||
Interest rate (as a percent) | 10% | 7.50% | ||||
Gain (loss) on extinguishment of debt | $ (1,025,402) | |||||
Payment of lender fees | $ 552,633 | |||||
Redemption price (as a percent) | 105% | 75% | ||||
Trading day threshold | 3 | |||||
Repayments of unsecured debt | $ 12,934,484 | |||||
Interest expense | $ 1,546,038 | |||||
Unsecured promissory note (2020) | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Carrying value of notes exchanged | $ 2,000,000 | |||||
Unsecured promissory note (2021) | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from loan | 10,000,000 | |||||
Original principal amount | 10,220,000 | |||||
Unamortized discount | $ 820,000 | |||||
Interest rate (as a percent) | 9.50% | |||||
Redemption price (as a percent) | 105% | |||||
Interest expense | 1,655,340 | 893,886 | ||||
Amortization of debt issuance costs | 646,299 | 175,741 | ||||
Paycheck Protection Program | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from loan | $ 904,200 | |||||
Debt Instrument, term | 2 years | |||||
Interest rate (as a percent) | 1% | |||||
Interest expense | $ 2,718 | $ 9,219 |
Debt - Maturities (Details)
Debt - Maturities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Debt | ||
2023 | $ 11,114,518 | |
Total debt | $ 11,114,518 | $ 11,842,345 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | |||
Jul. 20, 2020 | Apr. 30, 2022 | Apr. 30, 2021 | Sep. 30, 2022 | |
Other Commitments [Line Items] | ||||
Loss contingency damages due to third party | $ 3,000,000 | |||
Settlement payment | $ 750,000 | $ 625,000 | ||
Settlement payable | $ 0 | |||
Selexis | ||||
Other Commitments [Line Items] | ||||
Remaining future financial obligations | $ 355,737 |
Commitments and Contingencies -
Commitments and Contingencies - Lease cost (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | |
Leases | |||
Operating lease term | 3 years | ||
Lease cost | |||
Interest on lease liabilities | $ 3,141 | $ 5,093 | |
Total finance lease cost | 3,141 | 5,093 | |
Operating lease cost | 44,867 | 106,879 | |
Total lease cost | $ 48,008 | $ 111,972 | |
Minimum | |||
Leases | |||
Finance lease term | 12 months | ||
Finance lease interest (as a percent) | 4% | ||
Maximum | |||
Leases | |||
Finance lease term | 36 months | ||
Finance lease interest (as a percent) | 13% |
Commitments and Contingencies_3
Commitments and Contingencies - Lease balance sheet (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Leases | ||
Operating leases, Right-of-use asset | $ 70,360 | $ 111,429 |
Operating lease liabilities | 26,995 | 69,849 |
Financing lease liabilities | $ 16,018 | $ 42,482 |
Operating leases, Weighted-average remaining lease term | 1 year 7 months 6 days | 2 years 7 months 6 days |
Finance leases, Weighted-average remaining lease term | 1 year 3 months 18 days | 1 year 8 months 12 days |
Operating leases, Weighted-average discount rate (as a percent) | 7.50% | 7.50% |
Finance leases, Weighted-average discount rate (as a percent) | 13% | 9.50% |
Commitments and Contingencies_4
Commitments and Contingencies - Lease cash flow (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Leases | ||
Operating cash flows from finance leases | $ 3,141 | $ 5,093 |
Operating cash flows from operating leases | 46,652 | 158,708 |
Financing cash flows from finance leases | $ 26,464 | 29,778 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 128,473 |
Commitments and Contingencies_5
Commitments and Contingencies - Lease minimum payments (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Operating leases | ||
2023 | $ 27,675 | |
Total undiscounted lease payments | 27,675 | |
Less: Imputed interest | 680 | |
Total lease obligations | 26,995 | $ 69,849 |
Finance leases | ||
2023 | 13,149 | |
2024 | 4,383 | |
Total undiscounted lease payments | 17,532 | |
Less: Imputed interest | 1,514 | |
Total lease obligations | $ 16,018 | $ 42,482 |
Commitments and Contingencies_6
Commitments and Contingencies - Employee Benefit (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies. | ||
Maximum employee annual contributions (as a percent) | 100% | |
Maximum employer annual contributions (as a percent) | 100% | |
Maximum employer match (as a percent) | 3% | |
Expense related to matching contribution | $ 83,266 | $ 40,305 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||||
Mar. 26, 2021 | Sep. 11, 2017 | Dec. 31, 2022 | Nov. 30, 2021 | Feb. 28, 2021 | Nov. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Mar. 24, 2021 | Mar. 23, 2021 | |
Stockholders' Equity | ||||||||||
Shares of common stock issuable upon exercise of warrants | 6,812,794 | |||||||||
Proceeds from issuance of stock | $ 62,307,307 | $ 46,301,841 | ||||||||
Common stock, shares authorized | 325,000,000 | 325,000,000 | 325,000,000 | 200,000,000 | ||||||
Common stock warrants | ||||||||||
Stockholders' Equity | ||||||||||
Shares of common stock issuable upon exercise of warrants | 3,642,138 | |||||||||
Proceeds from issuance of stock | $ 3,593,380 | |||||||||
Exercise price per share | $ 0.9866 | |||||||||
Underwritten Public Offering | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 46,000,000 | 38,593,767 | ||||||||
Shares of common stock issuable upon exercise of warrants | 2,100,000 | 2,116,364 | ||||||||
Shares issued price (in dollars per share) | $ 1.25 | $ 1 | ||||||||
Proceeds from issuance of stock | $ 54,000,000 | $ 35,500,000 | ||||||||
Exercise price per share | $ 1.5625 | $ 1.25 | ||||||||
Warrants exercise term | 5 years | 5 years | ||||||||
Underwritten Public Offering | GMS Ventures & Investments | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 16,000,000 | 8,360,000 | ||||||||
Private Placement | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 3,000,000 | |||||||||
Shares issued price (in dollars per share) | $ 1 | |||||||||
Proceeds from issuance of stock | $ 3,000,000 | |||||||||
Private Placement | GMS Ventures & Investments | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 1,013,627 | |||||||||
Shares issued price (in dollars per share) | $ 1 | |||||||||
Proceeds from issuance of stock | $ 1,000,000 | |||||||||
Direct registered offering | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 28,460,831 | |||||||||
Shares issued price (in dollars per share) | $ 0.8784 | |||||||||
Proceeds from issuance of stock | $ 24,000,000 | |||||||||
Direct registered offering | GMS Ventures & Investments | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 14,230,418 | |||||||||
Direct registered offering | M.S. Howells & Co | ||||||||||
Stockholders' Equity | ||||||||||
Shares of common stock issuable upon exercise of warrants | 515,755 | |||||||||
Exercise price per share | $ 1.05 | |||||||||
Warrants exercise term | 3 years | |||||||||
ATM Offering | ||||||||||
Stockholders' Equity | ||||||||||
Number of share issued | 895,391 | 4,808,269 | 2,855,190 | |||||||
Proceeds from issuance of stock | $ 1,100,000 | $ 8,600,000 | $ 7,200,000 | |||||||
Aggregate offering price | $ 40,000,000 | |||||||||
Amount reclassified on additional paid in capital | $ 197,654 | |||||||||
Deferred costs | 119,422 | |||||||||
Percentage of commission on sale of common stock | 3% | |||||||||
Payment of fees to sales agent | $ 300,000 | $ 200,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 6,812,794 | |
Proceeds from issuance of stock | $ 62,307,307 | $ 46,301,841 |
Common stock warrants | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 3,642,138 | |
Exercise price per share | $ 0.9866 | |
Proceeds from issuance of stock | $ 3,593,380 | |
Cashless warrant | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 397,251 | |
Exercise price per share | $ 1.51875 | |
Number of share issued | 173,797 | |
February 18, 2022 | ||
Warrants | ||
Exercise price per share | $ 12 | |
Warrant expired (in shares) | 400,360 | |
Warrants expired (in dollars per share) | $ 12 | |
Issuance of common stock in connection with exercise of warrants (in shares) | 15,675 | |
December 22, 2024 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 277,128 | |
Exercise price per share | $ 12 | |
April 13, 2025 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 145,686 | |
Exercise price per share | $ 12 | |
May 31, 2025 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 62,437 | |
Exercise price per share | $ 12 | |
February 24, 2025 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 172,864 | |
Exercise price per share | $ 1.27 | |
February 26, 2024 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 1,747,047 | |
Exercise price per share | $ 0.9535 | |
June 22, 2025 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 191,268 | |
Exercise price per share | $ 1.51875 | |
January 28, 2026 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 2,116,364 | |
Exercise price per share | $ 1.25 | |
November 23, 2026 | ||
Warrants | ||
Shares of common stock issuable upon exercise of warrants | 2,100,000 | |
Exercise price per share | $ 1.5625 |
Preferred Stock (Details)
Preferred Stock (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock | ||
Preferred stock, shares authorized | 7,300,000 | 7,300,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Maximum | ||
Stock | ||
Preferred stock, shares authorized | 10,000,000 | |
Series A convertible preferred stock | ||
Stock | ||
Convertible preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock dividend rate (as a percent) | 10% | |
Series A-1 convertible preferred stock | ||
Stock | ||
Convertible preferred stock, shares authorized | 200,000 | 200,000 |
Preferred stock dividend rate (as a percent) | 10% | |
Series B convertible preferred stock | ||
Stock | ||
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Number of common stock shares the preferred stock could be converted to | 2,112,676 | |
Series B convertible preferred stock | Beneficial Holder | ||
Stock | ||
Maximum ownership in order to convert to common stock (as a percentage) | 9.99% | |
Series B convertible preferred stock | Beneficial Holder During First Six-Months | ||
Stock | ||
Maximum ownership in order to convert to common stock (as a percentage) | 7.50% |
Stock-Based Compensation - Info
Stock-Based Compensation - Information (Details) | 12 Months Ended |
Sep. 30, 2022 shares | |
Performance-based stock units | |
Share-based Compensation | |
Term of award | 10 years |
Performance-based stock options | |
Share-based Compensation | |
Term of award | 10 years |
2011 Equity Incentive Plan | Performance-based stock units | |
Share-based Compensation | |
Awards outstanding | 2,470 |
2015 Equity Incentive Plan | |
Share-based Compensation | |
Aggregate number of common stock authorized for issuance | 34,565,837 |
Number of shares available for grant | 13,546,604 |
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 ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 7,710,804 | $ 4,887,287 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 2,691,330 | 953,328 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 5,019,474 | $ 3,933,959 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Other option information | ||
Stock-based compensation expense | $ 7,710,804 | $ 4,887,287 |
Stock options | ||
Number of Shares | ||
Balance, Beginning (in shares) | 16,110,015 | 3,762,143 |
Granted (in shares) | 4,039,566 | 12,461,645 |
Exercised (in shares) | (25,000) | |
Forfeited or expired (in shares) | (113,773) | |
Balance, Ending (in shares) | 20,124,581 | 16,110,015 |
Exercisable (in shares) | 8,353,802 | |
Vested and expected to vest (in shares) | 20,124,581 | |
Weighted Average Exercise Price | ||
Balance, Beginning (in dollars per share) | $ 1.46 | $ 2.01 |
Granted (in dollars per share) | 1.60 | 1.29 |
Exercised (in dollars per share) | 0.71 | |
Forfeited or expired (in dollars per share) | 0.76 | |
Balance, Ending (in dollars per share) | 1.49 | 1.46 |
Exercisable (in dollars per share) | 1.53 | |
Vested and expected to vest (in dollars per share) | $ 1.49 | |
Other option information | ||
Balance-Remaining contractual term | 8 years 3 months 18 days | |
Exercisable-Remaining contractual term | 7 years 10 months 24 days | |
Vested and expected to vest-Remaining contractual term | 8 years 3 months 18 days | |
Aggregate intrinsic value, Exercised | $ 38,960 | |
Aggregate intrinsic value, Exercisable | 2,067,210 | |
Aggregate intrinsic value, Vested and expected to vest | $ 4,521,960 | |
Term of award | 10 years | |
Grant date fair value of options (in dollars per share) | $ 1.23 | $ 0.98 |
Stock options | Minimum | ||
Other option information | ||
Vesting period | 1 year | |
Stock options | Maximum | ||
Other option information | ||
Vesting period | 4 years | |
Performance-based stock options | ||
Number of Shares | ||
Balance, Beginning (in shares) | 1,000,000 | |
Granted (in shares) | 1,900,000 | 1,000,000 |
Forfeited or expired (in shares) | (2,200,000) | |
Balance, Ending (in shares) | 700,000 | 1,000,000 |
Exercisable (in shares) | 700,000 | |
Vested and expected to vest (in shares) | 700,000 | |
Weighted Average Exercise Price | ||
Balance, Beginning (in dollars per share) | $ 2.42 | |
Granted (in dollars per share) | 1.44 | $ 2.42 |
Forfeited or expired (in dollars per share) | 1.89 | |
Balance, Ending (in dollars per share) | 1.44 | 2.42 |
Exercisable (in dollars per share) | 1.44 | |
Vested and expected to vest (in dollars per share) | $ 1.44 | |
Other option information | ||
Balance-Remaining contractual term | 9 years 2 months 12 days | |
Exercisable-Remaining contractual term | 9 years 2 months 12 days | |
Vested and expected to vest-Remaining contractual term | 9 years 2 months 12 days | |
Term of award | 10 years | |
Grant date fair value of options (in dollars per share) | $ 1.03 | $ 1.76 |
Stock-based compensation expense | $ 718,950 | |
Number of stock options vested | 700,000 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Assumptions (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock options | ||
Share-based Compensation | ||
Risk-free interest rate | 1.77% | 0.58% |
Expected term (years) | 6 years | 6 years |
Expected volatility | 95.30% | 94.50% |
Expected dividend yield | 0% | |
Unrecognized compensation expense | $ 11,016,572 | |
Unrecognized compensation exercise period | 2 years 8 months 12 days | |
Performance-based stock options | ||
Share-based Compensation | ||
Risk-free interest rate | 1.26% | 0.88% |
Expected term (years) | 5 years 2 months 12 days | 5 years 4 months 24 days |
Expected volatility | 91.50% | 93.10% |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-options (Details) - Performance-based stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation | ||
Term of award | 10 years | |
Number of PSUs | ||
Balance, Beginning | 2,470 | 2,470 |
Forfeitures | 0 | 0 |
Balance, Ending | 2,470 | 2,470 |
Vested and exercisable | 2,470 | |
Vested and expected to vest | 2,470 | |
Weighted Average Base Price Per Unit | ||
Balance, Beginning | $ 49.97 | $ 49.97 |
Forfeitures | 0 | 0 |
Balance, Ending | 49.97 | $ 49.97 |
Vested and exercisable | 49.97 | |
Vested and expected to vest | $ 49.97 | |
Weighted average remaining contractual term, Outstanding | 2 years | |
Weighted average remaining contractual term, Vested and exercisable | 2 years | |
Weighted average remaining contractual term, Vested and expected to vest | 2 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted stock (Details) | 1 Months Ended | 12 Months Ended | ||
Jan. 27, 2020 item shares | Jan. 31, 2020 item $ / shares shares | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ | $ 7,710,804 | $ 4,887,287 | ||
MTTR, LLC ("MTTR") | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of principals | item | 4 | |||
Shares issued during period | shares | 7,244,739 | |||
Restricted Stock | MTTR, LLC ("MTTR") | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of principals | item | 4 | |||
Shares issued during period | shares | 7,244,739 | |||
Share repurchase price | $ / shares | $ 0.01 | |||
Grant date fair value of share | $ / shares | $ 0.54 | |||
Explicit service period | 4 years 9 months 18 days | |||
Stock-based compensation expense | $ | $ 2,003,946 | $ 607,060 | ||
Restricted Stock | MTTR, LLC ("MTTR") | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Repurchase right lapses on shares (as a percent) | 50% | |||
Restricted Stock | MTTR, LLC ("MTTR") | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Repurchase right lapses on shares (as a percent) | 100% |
Collaboration Arrangements (Det
Collaboration Arrangements (Details) - Syntone - USD ($) | 1 Months Ended | |
May 22, 2020 | Jun. 30, 2020 | |
Collaborative arrangements | ||
Ownership percentage | 20% | |
Investment in joint venture | $ 900,000 | |
Expected future investment | $ 2,100,000 | |
Contract period | 4 years | |
Syntone PRC | ||
Collaborative arrangements | ||
Ownership percentage | 80% |
Related-Party Transactions (Det
Related-Party Transactions (Details) | 12 Months Ended | |||
Dec. 21, 2021 USD ($) shares | Jan. 27, 2020 USD ($) item individual shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) shares | |
Related Party Transaction [Line Items] | ||||
Number Of Executive Officers | individual | 2 | |||
Performance-based stock options | ||||
Related Party Transaction [Line Items] | ||||
Number of shares granted | 1,900,000 | 1,000,000 | ||
Number of stock options vested | 700,000 | |||
MTTR, LLC ("MTTR") | ||||
Related Party Transaction [Line Items] | ||||
Number of principals | item | 4 | |||
Shares issued during period | 7,244,739 | |||
Contract termination settlement fee | $ | $ 110,000 | |||
Related party expense | $ | $ 526,435 | $ 1,089,408 | ||
Due to related party, current | $ | $ 18,333 | $ 89,762 | ||
Employment agreement | Performance-based stock options | ||||
Related Party Transaction [Line Items] | ||||
Number of stock options vested | 200,000 | |||
Employment agreement | Terry Dagnon | ||||
Related Party Transaction [Line Items] | ||||
Base salary | $ | $ 450,000 | |||
Percentage of cash bonus | 50% | |||
Employment agreement | Terry Dagnon | Stock option | ||||
Related Party Transaction [Line Items] | ||||
Number of shares granted | 800,000 | |||
Employment agreement | Terry Dagnon | Performance-based stock options | ||||
Related Party Transaction [Line Items] | ||||
Number of shares granted | 200,000 | |||
Employment agreement | Jeff Evanson | ||||
Related Party Transaction [Line Items] | ||||
Base salary | $ | $ 450,000 | |||
Percentage of cash bonus | 50% | |||
Employment agreement | Jeff Evanson | Stock option | ||||
Related Party Transaction [Line Items] | ||||
Number of shares granted | 800,000 | |||
Employment agreement | Jeff Evanson | Performance-based stock options | ||||
Related Party Transaction [Line Items] | ||||
Number of shares granted | 200,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Income Taxes | ||
State tax | $ 2,800 | $ 2,000 |
Income Taxes - Reconciliation t
Income Taxes - Reconciliation tax expense (Details) | 1 Months Ended | 12 Months Ended | ||||
Jan. 01, 2018 | Dec. 31, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Taxes | ||||||
U.S. federal statutory rate | (21.00%) | (34.00%) | (21.00%) | (21.00%) | (21.00%) | (24.30%) |
State taxes, net of federal benefit | (7.10%) | (7.00%) | ||||
Net operating loss | 1.90% | |||||
Permanent differences | 0.40% | |||||
Research and development credit | (3.50%) | (3.70%) | ||||
Change in valuation allowance | 32.10% | 30.70% | ||||
Other | (0.50%) | (1.30%) | ||||
Effective income tax rate | 0% | 0% |
Income Taxes - Deferred (Detail
Income Taxes - Deferred (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 83,971,779 | $ 67,778,970 |
Stock-based compensation | 4,331,889 | 2,168,228 |
Lease liability | 7,588 | 31,577 |
Research and development credit carryforward | 11,166,153 | 8,842,001 |
Foreign tax credits | 2,357,309 | 2,357,309 |
Accruals and others | 815,310 | 348,605 |
Gross deferred tax assets | 102,650,028 | 81,526,690 |
Less: valuation allowance | (102,630,250) | (81,449,372) |
Deferred tax assets net of valuation allowance | 19,778 | 77,318 |
Deferred tax liabilities: | ||
Property and equipment | (45,995) | |
Right-of-use assets | $ (19,778) | $ (31,323) |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Jan. 01, 2018 | Dec. 31, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2020 | |
Operating Loss Carryforwards [Line Items] | |||||||
Increase (decrease) in valuation allowance | $ 21,200,000 | $ 16,300,000 | |||||
Unrecognized tax benefits | $ 1,856,629 | $ 1,856,629 | $ 1,856,629 | ||||
U.S. federal statutory rate | (21.00%) | (34.00%) | (21.00%) | (21.00%) | (21.00%) | (24.30%) | |
Federal | |||||||
Operating Loss Carryforwards [Line Items] | |||||||
NOL carryforwards | $ 339,900,000 | ||||||
Tax credit carryforward | 10,400,000 | ||||||
State | |||||||
Operating Loss Carryforwards [Line Items] | |||||||
NOL carryforwards | 175,700,000 | ||||||
Tax credit carryforward | 800,000 | ||||||
Foreign | |||||||
Operating Loss Carryforwards [Line Items] | |||||||
Tax credit carryforward | 2,400,000 | ||||||
Unrecognized tax benefits | $ 1,900,000 |
Income Taxes - Unrecognized tax
Income Taxes - Unrecognized tax benefits (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 1,856,629 | $ 1,856,629 |
Changes based on tax positions related to the current year | 0 | 0 |
Balance at end of year | $ 1,856,629 | $ 1,856,629 |