Outlook Therapeutics (OTLK) 10-Q14 Feb 252025 Q1 Quarterly reportFinancial data

Company Profile

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Dec. 31, 2024	Feb. 12, 2025
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Dec. 31, 2024
Document Transition Report	false
Securities Act File Number	001-37759
Entity Registrant Name	OUTLOOK THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	38-3982704
Entity Address, Address Line One	111 S. Wood Avenue, Unit #100
Entity Address, City or Town	Iselin
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08830
City Area Code	609
Local Phone Number	619-3990
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		32,017,179
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q1
Amendment Flag	false

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Current assets:
Cash and cash equivalents	$ 5,702,576	$ 14,927,538
Inventory, Net	3,109,397
Prepaid expenses and other current assets	6,855,401	12,488,498
Total current assets	15,667,374	27,416,036
Operating lease right-of-use assets, net	262,822	274,645
Equity method investment	659,895	693,190
Other assets	415,974	439,283
Total assets	17,006,065	28,823,154
Current liabilities:
Unsecured convertible promissory note	30,744,000	29,440,000
Current portion of operating lease liabilities	52,645	50,907
Accounts payable	12,192,747	7,968,725
Accrued expenses	3,391,232	3,237,468
Income taxes payable	1,856,629	1,856,629
Total current liabilities	48,237,253	42,553,729
Operating lease liabilities	233,113	246,922
Warrant liability	18,826,133	59,099,013
Total liabilities	67,296,499	101,899,664
Commitments and contingencies (Note 8)
Stockholders' deficit:
Preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding
Common stock, par value $0.01 per share; 60,000,000 shares authorized; 24,905,635 and 23,905,635 shares issued and outstanding at December 31, 2024 and September 30, 2024, respectively	249,057	239,057
Additional paid-in capital	475,367,795	469,969,333
Accumulated deficit	(525,907,286)	(543,284,900)
Total stockholders' deficit	(50,290,434)	(73,076,510)
Total liabilities and stockholders' deficit	$ 17,006,065	$ 28,823,154

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parentheticals) - $ / shares	Dec. 31, 2024	Sep. 30, 2024
Consolidated Balance Sheets
Preferred stock, par value per share (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value per share (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	60,000,000	60,000,000
Common stock, shares issued	24,905,635	23,905,635
Common stock, shares outstanding	24,905,635	23,905,635

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	3 Months Ended
Consolidated Statements of Operations - USD ($)	Dec. 31, 2024	Dec. 31, 2023
Operating expenses:
Research and development	$ 9,660,150	$ 4,529,358
General and administrative	11,946,702	5,793,764
Loss from operations	(21,606,852)	(10,323,122)
Loss (income) on equity method investment	33,295	(2,548)
Interest Income, net	(48,881)	(188,677)
Loss from change in fair value of promissory notes	1,304,000	993,000
(Gain) loss from change in fair value of warrant liability	(40,272,880)	53,342
Net income (loss)	$ 17,377,614	$ (11,178,239)
Per share information:
Net income (loss) per share of common stock, basic (in dollars per share)	$ 0.72	$ (0.86)
Net income (loss) per share of common stock, diluted (in dollars per share)	$ 0.72	$ (0.86)
Weighted average shares outstanding, basic (in shares)	24,233,957	13,012,833
Weighted average shares outstanding, diluted (in shares)	24,233,957	13,012,833

Consolidated Statements of Stoc

Consolidated Statements of Stockholders' Equity (Deficit) - USD ($)	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance, beginning at Sep. 30, 2023	$ 130,128	$ 453,350,281	$ (467,918,186)	$ (14,437,777)
Balance, beginning (in shares) at Sep. 30, 2023	13,012,833
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense		1,272,611		1,272,611
Net Income (Loss)	$ 0	0	(11,178,239)	(11,178,239)
Balance, ending at Dec. 31, 2023	$ 130,128	454,622,892	(479,096,425)	(24,343,405)
Balance, ending (in shares) at Dec. 31, 2023	13,012,833
Balance, beginning at Sep. 30, 2024	$ 239,057	469,969,333	(543,284,900)	(73,076,510)
Balance, beginning (in shares) at Sep. 30, 2024	23,905,635
Increase (Decrease) in Stockholders' Equity
Sale of common stock, net of issuance costs	$ 10,000	1,726,042		1,736,042
Sale of common stock, net of issuance costs (in shares)	1,000,000
Stock-based compensation expense		3,672,420		3,672,420
Net Income (Loss)			17,377,614	17,377,614
Balance, ending at Dec. 31, 2024	$ 249,057	$ 475,367,795	$ (525,907,286)	$ (50,290,434)
Balance, ending (in shares) at Dec. 31, 2024	24,905,635

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Dec. 31, 2024	Dec. 31, 2023
OPERATING ACTIVITIES
Net income (loss)	$ 17,377,614	$ (11,178,239)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	28,801	28,195
Stock-based compensation	3,672,420	1,272,611
Loss from change in fair value of promissory notes	1,304,000	993,000
(Gain) loss from change in fair value of warrant liability	(40,272,880)	53,342
Loss (income) on equity method investment	33,295	(2,548)
Changes in operating assets and liabilities:
Inventory	(3,109,397)
Prepaid expenses and other current assets	5,633,097	(2,445,363)
Operating lease liabilities	(12,071)
Accounts payable	4,224,022	(3,094,197)
Accrued expenses	153,764	1,341,030
Net cash used in operating activities	(10,967,335)	(13,032,169)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of issuance costs	1,742,373
Payments of finance lease obligations		(3,183)
Net cash provided by (used in) financing activities	1,742,373	(3,183)
Net decrease in cash and cash equivalents	(9,224,962)	(13,035,352)
Cash and cash equivalents at beginning of period	14,927,538	23,391,982
Cash and cash equivalents at end of period	5,702,576	$ 10,356,630
Supplemental schedule of non-cash financing activities:
Reclassification of deferred offering costs against ATM proceeds	$ 6,331

Organization and Description of

Organization and Description of Business	3 Months Ended
Organization and Description of Business	Dec. 31, 2024
Organization and Description of Business
Organization and Description of Business	1. Organization and Description of Business Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA TM In May 2024 the Company received Marketing Authorization from the European Commission for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (“AMD”) in the European Union (“EU”). Additionally, in July 2024 the Company also received marketing authorization for LYTENAVA™ (bevacizumab gamma) in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK. In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial following discussions with the U.S. Food and Drug Administration (“FDA”) in support of the Company’s Biologics License Application (“BLA”) for ONS-5010/LYTENAVA. In December 2023, the Company submitted a Special Protocol Assessment (“SPA”) to the FDA for this study (NORSE EIGHT) seeking confirmation that, if successful, it will address the FDA’s requirement for a second adequate and well-controlled clinical trial to support its planned resubmission of the ONS-5010/LYTENAVA BLA. In January 2024, the Company received confirmation that the FDA had reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA and that, if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (“CRL”). In addition, through a Type A meeting and additional interactions, the Company has identified the approaches needed to resolve the chemistry, manufacturing and controls (“CMC”) comments in the CRL. In November 2024, the Company reported that ONS-5010/LYTENAVA did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the SPA. In January 2025, the Company reported the complete data and safety results from NORSE EIGHT which demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010/LYTENAVA.

Liquidity

Liquidity	3 Months Ended
Liquidity	Dec. 31, 2024
Liquidity
Liquidity	2. Liquidity The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $525,907,286 as of December 31, 2024. As of December 31, 2024, the Company had a working capital deficit including $32,229,130 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued in December 2022 (as amended, the “December 2022 Note”), maturing on July 1, 2025. Refer to Note 7 for further details on the December 2022 Note. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. On January 16, 2025, the Company entered into warrant exercise inducement offer letter agreements with GMS Ventures and Investments (“GMS”), the Company’s largest stockholder, and certain other holders of existing warrants to purchase the Company’s common stock, pursuant to which the holders agreed to exercise their existing warrants (“Existing Warrants”) for an aggregate of 7,074,637 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company issued two new inducement warrants for each Existing Warrant exercised (“Inducement Warrants”), which are exercisable for an aggregate of up to 14,149,274 additional shares of common stock (the “Inducement Warrant Shares”) at an exercise price of $2.26 per share (collectively, the “Warrant Inducement Transaction”). The Company received net proceeds of $15,746,960 after capital markets advisory fees and estimated offering costs, from the Warrant Inducement Transaction. Concurrently with the Warrant Inducement Transaction, the Company entered into a warrant exercise inducement offer letter agreement with Syntone Ventures, LLC (“Syntone”), pursuant to which Syntone agreed to exercise existing warrants (“Existing Syntone Warrants”) for an aggregate of 1,071,429 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company agreed to issue two new inducement warrants for each Existing Syntone Warrant exercised (the "Syntone Inducement Warrants”), which will be exercisable for up to 2,142,858 shares of common stock (the “Syntone Inducement Warrant Shares”) at an exercise price of $2.26 per share (the “Syntone Warrant Inducement Transaction”). The closing of the Syntone Warrant Inducement Transaction is subject to receipt of certain regulatory approvals. The Company expects to generate net proceeds of approximately $2,400,000 after capital markets advisory fees and estimated offering costs. Refer to Note 11 for further details on the Warrant Inducement Transaction and the Syntone Warrant Inducement Transaction. On January 31, 2025, the Company entered into a Securities Purchase Agreement (“SPA”) with Avondale Capital, LLC (“Avondale”), pursuant to which the Company agreed to issue to Avondale an unsecured convertible promissory note for $33,100,000 (the “January 2025 Note”). The Company expects to use the proceeds from the January 2025 Note to repay in full the remaining obligations, including accrued and unpaid interest and the applicable exit fee owed under the December 2022 Note. The December 2022 Note will be cancelled in connection with the issuance of the January 2025 Note. The closing of the transaction (the “Note Closing”) is expected to occur shortly after the Company’s 2025 annual meeting of stockholders, subject to certain closing conditions, including stockholder approval of the issuance of shares of the Company’s common stock in excess of 19.99% of the outstanding common stock upon conversion of the January 2025 Note. Prior to the Note Closing, the Company has agreed not to sell common stock, other than issuances pursuant to the Company’s at-the-market offering, below a per share price of $2.26 and must maintain its Nasdaq listing. The Company has agreed to file a registration statement registering the resale of common stock issuable upon conversion of the January 2025 Note within seven days of the Note Closing. The Company must use commercially reasonable efforts to have the registration statement declared effective within 45 days; otherwise, the outstanding balance on the January 2025 Note will automatically increase by 0.5% monthly until the registration statement is declared effective. The January 2025 Note will bear interest at the prime rate Management does not believe that the existing cash and cash equivalents as of December 31, 2024, together with net proceeds from the sale of shares of common stock in the Warrant Inducement Transaction, are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, additional financing will be needed by the Company to fund its operations in the future and to commercially develop ONS-5010/LYTENAVA and to develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations, including but not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, sale of the development and commercial rights to the Company’s drug product candidates in regions outside of the U.S., the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offering agreements (refer to Note 9 for further details), and revenues from potential future product sales, if any. There can be no assurance that these future funding efforts will be successful. 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	3 Months Ended
	Dec. 31, 2024
Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation and Summary of Significant Accounting Policies	3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2024 and its results of operations for the three months ended December 31, 2024 and 2023, cash flows for the three months ended December 31, 2024 and 2023, and stockholders’ deficit for the three months ended December 31, 2024 and 2023. Operating results for the three months ended December 31, 2024 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2025. The unaudited interim consolidated financial statements presented herein do not contain all of the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 27, 2024. Reverse stock split Effective on March 14, 2024, the Company amended its amended and restated certificate of incorporation to implement a one-for-twenty Inventory The Company values inventory at the lower of cost or net realizable value. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of December 31, 2024. Upon the initiation of production for the first commercial batches of drug product in October 2024, the Company began capitalizing the purchases of saleable inventory of the product from suppliers. As of December 31, 2024, all inventory is classified as work-in-process. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, such as the current macroeconomic environment, including as a result of fluctuations in inflation, and interest rates or ongoing overseas conflict, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Net income (loss) per share Basic net income (loss) per share of common stock is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants, performance-based stock options and units, and stock options using the treasury stock method, which would result in the issuance of incremental shares of common stock. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. All common stock equivalents were considered anti-dilutive for the three months ended December 31, 2024 as they are all out of the money. The following table sets forth the computation of basic loss per share and diluted loss per share: Three months ended December 31, 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Effect of dilutive securities: (Gain) loss from change in fair value of warrant liability — — Loss from change in fair value of promissory notes — — Adjusted net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Denominator: Weighted average shares outstanding, basic 24,233,957 13,012,833 Effect of dilutive securities: Common stock warrants — — Convertible promissory notes — — Dilutive effect of stock options — — Weighted average shares outstanding, diluted 24,233,957 13,012,833 Basic net income (loss) per share $ 0.72 $ (0.86) Diluted net income (loss) per share $ 0.72 $ (0.86) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2024 and 2023, as they would be antidilutive: As of December 31, 2024 2023 Performance-based stock units — 123 Performance-based stock options 190,000 35,000 Stock options 2,816,851 1,299,105 Common stock warrants 14,193,772 (i) 366,427 Convertible debt 1,191,479 (ii) 875,970 (i) Refer to Note 11 for disclosures on the warrant inducement transactions entered into in January 2025. (ii) The calculation for potentially dilutive securities pertaining to convertible debt is as follows: $3,750,000 of outstanding principal and accrued interest as of December 31, 2024, is converted at a rate of $7.00 , and the remaining amount is converted based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7. Recently issued accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses

Fair Value Measurements

Fair Value Measurements	3 Months Ended
Fair Value Measurements	Dec. 31, 2024
Fair Value Measurements
Fair Value Measurements	4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s liabilities that are measured at fair value on a recurring basis: December 31, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 30,744,000 Warrant liability — — 18,826,133 Total $ — $ — $ 49,570,133 September 30, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 29,440,000 Warrant liability — — 59,099,013 Total $ — $ — $ 88,539,013 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 three months ended December 31, 2024: Unsecured Convertible Promissory Note Warrants Balance at October 1, 2024 $ 29,440,000 $ 59,099,013 Change in fair value 1,304,000 (40,272,880) Balance at December 31, 2024 $ 30,744,000 $ 18,826,133 As further described in Note 7, the Company elected the fair value option to account for the December 2022 Note. The fair value of the December 2022 Note is estimated using a binomial lattice model, which evaluates the payouts under hold, convert or call decisions. Significant estimates in the binomial lattice model include the Company’s stock price, volatility, risk-free rate of return, and credit-adjusted discount rate. The fair value of the December 2022 Note was estimated using a binomial lattice model with the following assumptions: December 31, 2024 September 30, 2024 Term (years) 0.5 0.8 Volatility 134.0 % 91.0 % Risk-free rate 4.2 % 4.2 % Dividend yield — % — % Credit-adjusted discount rate 20.5 % 20.4 % Stock price $ 1.89 $ 5.34 The warrants issued in connection with the convertible senior secured notes originally issued pursuant to that certain Note and Warrant Purchase Agreement dated December 22, 2017 and warrants issued in connection with private placements that closed on March 18, 2024 and April 15, 2024, are classified as liabilities on the accompanying unaudited interim consolidated balance sheets. The warrants related to the Note and Warrant Purchase Agreement dated December 22, 2017 are classified as liabilities as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrants issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are classified as liabilities as the Company assessed that they are not indexed to the Company’s own stock and must be classified as liabilities. The above warrant liabilities are revalued each reporting period with the change in fair values recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair values of the warrant liabilities are estimated using the Black-Scholes option pricing model using the following weighted average assumptions: December 31, 2024 September 30, 2024 Risk-free interest rate 4.34 % 3.58 % Remaining contractual term of warrants (years) 4.2 4.5 Expected volatility 135.5 % 125.0 % Annual dividend yield — % — % Stock price $ 1.89 $ 5.34

Equity Method Investment

Equity Method Investment	3 Months Ended
Equity Method Investment	Dec. 31, 2024
Equity Method Investment
Equity Method Investment	5. Equity Method Investment In connection with the execution of a stock purchase agreement with Syntone, the United States-based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Beijing Syntone Biopharma Ltd (“Syntone JV”), that is 80% owned by Syntone PRC and 20% owned by the Company. As the Company can exert significant influence over, but does not control, Syntone JV’s operations through voting rights or representation on Syntone JV’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone JV in April 2021, the Company entered into a royalty-free license with Syntone JV for the development, commercialization and manufacture of ONS-5010/LYTENAVA in the greater China market, which includes Hong Kong, Taiwan and Macau. The Company made the initial investment of $900,000 in June 2020 and is committed to making capital contributions to Syntone JV of approximately $2,100,000, based upon the development plan contemplated in the license agreement. The maximum exposure to a loss as a result of the Company’s involvement in Syntone JV is limited to the initial investment and the future capital contributions totaling approximately $2,100,000.

Accrued Expenses

Accrued Expenses	3 Months Ended
Accrued Expenses	Dec. 31, 2024
Accrued Expenses
Accrued Expenses	6. Accrued Expenses Accrued expenses consist of: December 31, 2024 September 30, 2024 Compensation $ 683,479 $ 1,012,962 Severance and related costs 1,388,397 (i) — Professional fees 979,178 1,798,767 Research and development 63,220 41,373 Other accrued expenses 276,958 384,366 $ 3,391,232 $ 3,237,468 (i) In December 2024, the Chief Executive Officer of the Company resigned, and the Company implemented a workforce reduction to conserve capital. The Chief Executive Officer’s departure constituted a termination and was entitled to 12 months of base salary, a lump sum of 100% of his target bonus for the year, employee benefits for up to 12 months, full vesting of 50% of his unvested equity awards, and reimbursement of expenses owed up to his termination date. At a minimum, all employees affected by the workforce reduction are eligible to receive severance payments and paid COBRA premiums for a specified time period post-termination, subject to execution of a general release of claims against the Company. In connection with the departure of the Chief Executive Officer and the reduction in the workforce, during the three months ended December 31, 2024, the Company recognized $1,428,455 in severance related charges in connection with the workforce reduction, consisting of cash-based expenses related to employee severance and notice period payments, benefits and related costs. In addition, during the three months ended December 31, 2024, the Company recorded a non-cash expense totaling $2,079,083 related to stock-based compensation for accelerated equity awards for the former Chief Executive Officer. During the three months ended December 31, 2024, the Company made cash payments totaling $40,058.

Debt

Debt	3 Months Ended
Debt	Dec. 31, 2024
Debt
Debt	7. Debt Debt consists of: December 31, 2024 September 30, 2024 Unsecured convertible promissory note (measured at fair value) $ 30,744,000 $ 29,440,000 Less: current portion (30,744,000) (29,440,000) Long-term debt $ — $ — December 2022 Note On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued the December 2022 Note with a face amount of $31,820,000 to Streeterville Capital, LLC (the “Lender”), the holder of the Company’s unsecured promissory note issued in November 2021 (the “November 2021 Note”). The December 2022 Note has an original issue discount of $1,820,000. The Company received net proceeds of $18,052,461 upon the closing on December 28, 2022 after deducting the Lender’s transaction costs in connection with the issuance and a full payment of the remaining outstanding principal and accrued interest on the November 2021 Note. In December 2023, the Company extended the maturity of the December 2022 Note from January 1, 2024 to April 1, 2024. The Company incurred a $475,000 extension fee, which was expensed and included in interest expense in the unaudited interim consolidated statement of operations. The December 2022 Note bore interest at 9.5% per annum through April 1, 2024. The December 2022 Note contains customary covenants, including a restriction on the Company’s ability to pledge certain of the Company’s assets, subject to certain exceptions, without the Lender’s consent. Beginning on April 1, 2023, the Lender had the right to convert the December 2022 Note at the Conversion Price (as defined below). The principal amount and conversion price of the December 2022 Note 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 December 2022 Note into shares of common stock at the Conversion Price if certain conditions have been met at the time of conversion, including if at any time after the six-month anniversary of the closing date, the daily volume-weighted average price of the common stock on Nasdaq equals or exceeds $50.00 per share (subject to adjustments for stock splits and stock combinations) for a period of 30 consecutive trading days. Payments may be made by the Company (i) in cash, (ii) in shares of common stock, with the number of shares being equal to the portion of the applicable payment amount divided by the Conversion Price (as defined below), or (iii) a combination of cash and shares of common stock. Any payments made by the Company in cash, including prepayments or repayment at maturity, will be subject to an additional fee of 7.5%. Upon the occurrence of certain events described in the December 2022 Note, including, among others, the Company’s failure to pay amounts due and payable under the December 2022 Note, events of insolvency or bankruptcy, failure to observe covenants contained in the Securities Purchase Agreement and the December 2022 Note, breaches of representations and warranties in the Securities Purchase Agreement, and the occurrence of certain transactions without the Lender’s consent (each such event, a “Trigger Event”), the Lender shall have the right, subject to certain exceptions, to increase the balance of the December 2022 Note by 10% for a Major Trigger Event (as defined in the December 2022 Note) and 5% for a Minor Trigger Event (as defined in the December 2022 Note). If a Trigger Event is not cured within ten “Conversion Price” meant, prior to a Major Trigger Event, $40.00 per share (subject to adjustment for stock splits and stock combinations), and following a Major Trigger Event, the lesser of (i) $40.00 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. If the Conversion Price is below $3.51 per share, the Company will be required to satisfy a conversion notice from the Lender in cash. Subject to certain exceptions, while the December 2022 Note is outstanding, the Lender will have a consent right on any future variable rate transactions or any debt and a 10% participation right in any future debt or equity financings. On January 22, 2024, the Company entered into an amendment to the December 2022 Note (the “Note Amendment”) with the Lender, which became effective on April 1, 2024 after satisfaction of certain conditions, including various required stockholder approvals and the closing of the private placement on March 18, 2024. The maturity of the December 2022 Note was extended to July 1, 2025. An extension fee of $2,681,847 (calculated as 7.5% of the outstanding balance of the December 2022 Note) was added to the outstanding balance on March 18, 2024. The extension fee was expensed in the quarter ended March 31, 2024 and included in interest expense in the unaudited interim consolidated statement of operations. Under the Note Amendment, the initial conversion price with respect to $15,000,000 in aggregate principal amount of the December 2022 Note was changed to $7.00, the price per share in the private placement that closed on March 18, 2024. Effective April 1, 2024, the December 2022 Note bears interest at the prime rate The Company elected to account for the December 2022 Note at fair value (Note 4) and was not required to bifurcate the conversion option as a derivative and as a result the original issue discount of $1,820,000 and debt issuance costs were written off upon election to fair value and accounted for as interest. During the three months ended December 31, 2024 and 2023, no interest expense was recognized.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Dec. 31, 2024
Commitments and Contingencies.
Commitments and Contingencies	8. Commitments and Contingencies Litigation On November 3, 2023, a securities class action lawsuit was filed against the Company and certain of its officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by the Company related to the Company’s BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that the Company violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time the Company’s BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve the Company’s BLA, and that the Company’s stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. On June 25, 2024, the defendants filed a motion to dismiss the amended class action complaint in its entirety. On February 6, 2025, the court entered an order granting the motion to dismiss and dismissing the complaint without prejudice and with leave to amend, and providing for the filing of a further amended complaint and briefing on the defendants’ anticipated motion to dismiss such further amended complaint in the spring of 2025. On October 10, 2024, certain of the company’s officers and directors were named as defendants in a shareholder derivative action filed in the District Court of the District of Delaware. The derivative complaint alleges that defendants breached their fiduciary duties by causing and/or allowing the Company to violate federal securities laws based on the same alleged misstatements as the securities class action. The derivative complaint also alleges defendants violated Section 14(a) of the Exchange Act, as well as claims for contribution, unjust enrichment, and waste of corporate assets. The derivative complaint seeks unspecified damages, corporate governance reforms, restitution, contribution, attorneys’ fees, and other costs. The derivative action is currently stayed, pending the final resolution of the November 3, 2023, securities class action pending in the United States District Court for the District of New Jersey. The pending lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuits and any other related lawsuits is necessarily uncertain. The Company could be forced to expend significant resources in the defense of the pending lawsuits and any additional lawsuits, and the Company may not prevail. In addition, the Company may incur substantial legal fees and costs in connection with such lawsuits. The Company currently is not able to estimate the possible cost to it from these matters, as the pending lawsuits are currently at an early stage, and the Company cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages that the Company may be required to pay. Such amounts could be material to the Company’s financial statements if it does not prevail in the defense of the pending lawsuits and any other related lawsuits, or even if it does prevail. The Company has not established any reserve for any potential liability relating to the pending lawsuits and any other related lawsuits. It is possible that the Company could, in the future, incur judgments or enter into settlements of claims for monetary damages. Leases Corporate office In March 2021, the Company entered into a three-year term corporate office lease for its former corporate headquarters in Iselin, New Jersey that ended on April 30, 2024. In March 2024, the Company entered into a five-year term corporate office lease for its new corporate headquarters in Iselin, New Jersey that commenced on May 1, 2024. The components of lease cost for the three months ended December 31, 2024 and 2023 are as follows: Three months ended December 31, 2024 2023 Lease cost: Interest on lease liabilities $ — $ 104 Total finance lease cost — 104 Operating lease cost 19,080 11,217 Total lease cost $ 19,080 $ 11,321 Amounts reported in the unaudited interim consolidated balance sheets for leases where the Company is the lessee are as follows: December 31, 2024 September 30, 2024 Operating leases: Right-of-use asset $ 262,822 $ 274,645 Operating lease liabilities 285,758 297,829 Weighted-average remaining lease term (years): Operating leases 4.3 4.6 Weighted-average discount rate: Operating leases 9.9% 9.9% Other information related to leases for the three months ended December 31, 2024 and 2023 are as follows: Three months ended December 31, 2024 2023 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ — $ 104 Operating cash flows from operating leases 19,329 — Financing cash flows from finance leases — 3,183 Future minimum lease payments under non-cancelable leases at December 31, 2024 are as follows for the years ending September 30: Operating leases 2025 (remaining nine months) $ 58,762 2026 79,954 2027 81,817 2028 83,680 2029 49,447 Total undiscounted lease payments 353,660 Less: Imputed interest 67,902 Total lease obligations $ 285,758

Common Stock and Stockholders'

Common Stock and Stockholders' Equity	3 Months Ended
Common Stock and Stockholders' Equity	Dec. 31, 2024
Common Stock and Stockholders' Equity
Common Stock and Stockholders' Equity	9. Common Stock and Stockholders’ Equity Preferred Stock On May 13, 2024, the Company filed a Certificate of Elimination to its Certificate of Incorporation, as then amended, with the Secretary of State of the State of Delaware to eliminate from the Certificate of Incorporation all matters set forth in the Certificates of Designation filed with the Secretary of State of the State of Delaware on September 8, 2017 (with respect to its Series A Convertible Preferred Stock and the Series B Convertible Preferred Stock) and July 18, 2018, as amended on March 19, 2020 (with respect to its Series A-1 Convertible Preferred Stock) and returning each of the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series A-1 Convertible Preferred Stock to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series. There were no outstanding shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock or Series A-1 Convertible Preferred Stock as of May 13, 2024. Immediately following the filing of the Certificate of Elimination, the Company filed a Restated Certificate of Incorporation of the Company with the Secretary of State of the State of Delaware, which restates and integrates but does not further amend the Company’s Certificate of Incorporation, as then a mended. The number of authorized shares of preferred stock under the Company’s Certificate of Incorporation is 10,000,000 shares. Common stock On March 7, 2024, following receipt of stockholder approval at the Company’s 2024 annual meeting of stockholders, the number of authorized shares of common stock under the Company’s Certificate of Incorporation was increased from 21,250,000 shares to 60,000,000 shares. BTIG, LLC At-the-Market Offering Agreement On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) as sales agent (as amended, the “BTIG ATM Agreement” or the “BTIG ATM Offering”), under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000,000 from time to time through BTIG. The Company incurred financing costs of $353,688, which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the BTIG ATM Offering. As of December 31, 2024, $325,181 of such deferred costs are included in other assets on the unaudited interim consolidated balance sheets. Under the BTIG ATM Agreement, the Company pays BTIG a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the BTIG ATM Agreement. The offering of common stock pursuant to the BTIG ATM Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the BTIG ATM Agreement or (ii) termination of the BTIG ATM Agreement in accordance with its terms. During the three months ended December 31, 2024, the Company sold 1,000,000 shares of common stock under the BTIG ATM Offering and generated $1,742,373 in net proceeds. During the three months ended December 31, 2024, the Company paid fees to BTIG and other issuance costs of $53,888. No shares of common stock were sold under the BTIG ATM Offering during the three months ended December 31, 2023. Common stock warrants As of December 31, 2024, shares of common stock issuable upon the exercise of outstanding warrants were as follows: Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 24, 2025 8,642 $ 25.40 April 13, 2025 (i) 7,284 $ 240.00 May 31, 2025 (i) 3,121 $ 240.00 June 22, 2025 9,563 $ 30.38 December 28, 2025 25,787 $ 21.00 January 28, 2026 12,576 $ 25.00 February 2, 2026 93,238 $ 25.00 November 23, 2026 104,999 $ 31.25 March 18, 2029 (ii) 12,857,133 $ 7.70 April 15, 2029 (ii) 1,071,429 $ 7.70 14,193,772 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 and are classified as liabilities on the accompanying unaudited interim consolidated balance sheets, as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. (ii) The warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging , guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure in Note 4 for further details on classification and fair value measurements. A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $20.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010/LYTENAVA, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting. Refer to Note 11 for disclosures on the warrant inducement transactions entered into in January 2025.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
Stock-Based Compensation	Dec. 31, 2024
Stock-Based Compensation
Stock-Based Compensation	10. Stock-Based Compensation 2024 Equity Incentive Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provided for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”) awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. In August 2024, the Company’s stockholders approved the amendment and restatement of the 2015 Plan and, in connection with amending and restating the 2015 Plan, the name of the 2015 Plan was updated to the Outlook Therapeutics, Inc. 2024 Equity Incentive Plan (the “2024 Plan”). The 2024 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 2024 Plan is 7,303,677. As of December 31, 2024, there were 4,287,050 shares available for grant under the 2024 Plan. Stock options and RSUs are granted under the Company’s 2024 Plan and generally vest over a period of one The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim consolidated statements of operations for the three December 31, 2024 and 2023: Three months ended December 31, 2024 2023 Research and development $ 110,029 $ 231,416 General and administrative 3,562,391 1,041,195 $ 3,672,420 $ 1,272,611 Stock options As of December 31, 2024, options to purchase common stock of the Company outstanding under the 2024 Plan were as follows: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2024 1,946,646 $ 19.51 Granted 1,179,276 5.22 Forfeited (304,636) 10.25 Expired (4,435) 46.78 Balance at December 31, 2024 2,816,851 $ 14.49 8.2 $ — Vested and exercisable at December 31, 2024 1,375,258 $ 22.83 6.7 $ — The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The weighted average grant date fair value of the options awarded to employees for the three months ended December 31, 2024 and 2023 was $4.67 and $5.20 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: Three months ended December 31, 2024 2023 Risk-free interest rate 3.5 % 4.6 % Expected term (years) 5.5 5.5 Expected volatility 134.0 % 130.6 % Expected dividend yield — — As of December 31, 2024, there was $6,496,794 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 0.8 years. Performance-based stock options The Company granted certain officers of the Company option awards whose vesting is contingent upon meeting company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 10 years. The fair value of each option grant under the performance share option plan was estimated on the date of grant using the same option valuation model used for non-statutory options above. Compensation expense for performance-based stock options is only recognized when management determines it is probable that the awards will vest. A summary of the activity under the performance share option plan as of December 31, 2024 and changes during the three months then ended are presented below. Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2024 666,500 $ 7.94 Granted — — Forfeited (476,500) 6.78 Balance at December 31, 2024 190,000 $ 10.85 8.6 $ — Vested and exercisable at December 31, 2024 35,000 $ 28.80 6.1 $ — The vesting of the performance-based stock options is conditional upon FDA approval of ONS-5010/LYTENAVA. The expense for the performance-based stock options is not recognized until the performance conditions are deemed probable of achievement. The Company did not record any expense related to the performance-based stock options during the three months ended December 31, 2024 as the performance conditions were not deemed probable of being met. As of December 31, 2024, the Company assessed that the performance conditions related to the performance options granted were not probable of achievement. The assessment was based on the relevant facts and circumstances and therefore no compensation costs were recognized.

Subsequent Events

Subsequent Events	3 Months Ended
Subsequent Events	Dec. 31, 2024
Subsequent Events
Subsequent Events	11. Subsequent Events Warrant Inducement Transaction In connection with the Warrant Inducement Transaction (see Note 2), half of the Inducement Warrants (the “Tranche A Inducement Warrants”), representing warrants to purchase up to 7,074,637 shares of common stock are exercisable immediately and expire on January 17, 2030. The remaining Inducement Warrants (the “Tranche B Inducement Warrants”) will be exercisable upon the effective date of an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock. The Company plans to present a proposal at its 2025 annual meeting of stockholders to authorize a sufficient increase in the number of authorized shares. The Tranche A Inducement Warrants, Tranche B Inducement Warrants and the underlying Inducement Warrant Shares were offered in a private placement and are exempt from Securities Act registration. The Company has committed to filing resale registration statements with the SEC to register the resale of the Inducement Warrant Shares underlying the Tranche A Inducement Warrants and Tranche B Inducement Warrants within specified time frames. GMS, the Company’s largest stockholder affiliated with Yezan Haddadin and Faisal G. Sukhtian, directors of the Company participated in the Warrant Inducement Transaction. In this transaction, GMS exercised Existing Warrants for an aggregate of 3,458,571 shares of common stock at a reduced exercise price of $2.51 per share, generating gross proceeds of $8,681,013 to the Company, in exchange for Inducement Warrants to purchase 6,917,142 shares of common stock. Syntone Warrant Inducement Transaction In connection with the Syntone Warrant Inducement Transaction (see Note 2), half of the Syntone Inducement Warrants (the “Syntone Tranche A Inducement Warrants”) will be immediately exercisable upon receipt of certain regulatory approvals and will expire on the five-year anniversary of the date of issuance. The remaining Syntone Inducement Warrants (the “Syntone Tranche B Inducement Warrants”) will be exercisable upon receipt of certain regulatory approvals and the effective date of an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock. The Company plans to present a proposal at its 2025 annual meeting of stockholders to authorize a sufficient increase in the number of authorized shares. The Syntone Tranche A Inducement Warrants, Syntone Tranche B Inducement Warrants and the underlying Syntone Inducement Warrant Shares were offered in a private placement exempt from Securities Act registration. The Company has committed to filing resale registration statements with the SEC to register the resale of the Syntone Inducement Warrant Shares underlying the Syntone Tranche A Inducement Warrants and Syntone Tranche B Inducement Warrants within specified time frames. Unsecured Convertible Promissory Note Securities Purchase Agreement Commencing on the earlier of (i) six months following the issuance of the January 2025 Note (see Note 2) or (ii) the date on which the registration statement is declared effective (the “Conversion Commencement Date”), Avondale shall have the right to convert all or any portion of the outstanding balance under the January 2025 Note into shares of common stock, calculated by dividing the amount of the January 2025 Note being converted by the Conversion Price (as defined below). Furthermore, the Company retains the right to convert any portion of the outstanding balance under the January 2025 Note into shares of common stock at the Conversion Price, provided certain conditions are met at the time of conversion, including, but not limited to, the condition that the daily volume-weighted average price of the Company’s common stock on Nasdaq equals or exceeds $3.00 per share (subject to adjustments for stock splits and combinations) for a continuous period of 30 trading days, and that the median daily dollar trading volume during the preceding 30 consecutive trading day period meets or exceeds $1,000,000. The Company reserves the right to make payments (i) in cash, (ii) in shares of common stock, calculated as the applicable payment amount divided by the Conversion Price, or (iii) a combination of both cash and shares of common stock. Any cash payments made by the Company, including prepayments or payments made at maturity, will incur an additional fee of 7.5%. The January 2025 Note stipulates that the Company shall not permit any conversion of the January 2025 Note if, following such conversion, Avondale and its affiliates would beneficially own shares of common stock exceeding 4.99% of the total number of outstanding shares as of that date (the “Beneficial Ownership Limitation”). However, this limitation shall increase to 9.99% when the Company’s market capitalization falls below $25,000,000. Avondale may, by written notice to the Company, adjust the Beneficial Ownership Limitation for itself, though any such adjustment will not take effect until the 61st day after such notice is received. In the event that specific occurrences outlined in the January 2025 Note transpire—such as the Company’s failure to fulfill payment obligations, non-compliance with the Quarterly Debt Reduction Obligations, insolvency or bankruptcy events, breaches of covenants in the SPA and the January 2025 Note, and unauthorized transactions without Avondale's consent (collectively referred to as “Trigger Events”)—Avondale reserves the right to increase the balance of the January 2025 Note by 10% in the case of a Major Trigger Event (as defined in the January 2025 Note) and by 5% for a Minor Trigger Event (as defined in the January 2025 Note). Should any Trigger Event persist without resolution for ten Under the terms of the January 2025 Note, the “Conversion Price” is defined as $2.26 per share prior to a Major Trigger Event (subject to adjustments for stock splits and combinations). Following a Major Trigger Event, the Conversion Price will be the lesser of (i) $2.26 per share (subject to adjustments) or (ii) 90% of the lowest closing bid price over the three trading days preceding the conversion notice. Furthermore, if the Conversion Price falls below $0.404 per share (subject to adjustments), the Company will be required to fulfill a conversion notice from Avondale in cash.

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($)	3 Months Ended
Pay vs Performance Disclosure - USD ($)	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ 17,377,614	$ (11,178,239)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Basis of Presentation and Sum_2

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Dec. 31, 2024
Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation	Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2024 and its results of operations for the three months ended December 31, 2024 and 2023, cash flows for the three months ended December 31, 2024 and 2023, and stockholders’ deficit for the three months ended December 31, 2024 and 2023. Operating results for the three months ended December 31, 2024 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2025. The unaudited interim consolidated financial statements presented herein do not contain all of the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 27, 2024.
Reverse stock split	Reverse stock split Effective on March 14, 2024, the Company amended its amended and restated certificate of incorporation to implement a one-for-twenty
Inventory	Inventory The Company values inventory at the lower of cost or net realizable value. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of December 31, 2024. Upon the initiation of production for the first commercial batches of drug product in October 2024, the Company began capitalizing the purchases of saleable inventory of the product from suppliers. As of December 31, 2024, all inventory is classified as work-in-process.
Use of estimates	Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, such as the current macroeconomic environment, including as a result of fluctuations in inflation, and interest rates or ongoing overseas conflict, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.
Net income (loss) per share	Net income (loss) per share Basic net income (loss) per share of common stock is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants, performance-based stock options and units, and stock options using the treasury stock method, which would result in the issuance of incremental shares of common stock. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. All common stock equivalents were considered anti-dilutive for the three months ended December 31, 2024 as they are all out of the money. The following table sets forth the computation of basic loss per share and diluted loss per share: Three months ended December 31, 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Effect of dilutive securities: (Gain) loss from change in fair value of warrant liability — — Loss from change in fair value of promissory notes — — Adjusted net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Denominator: Weighted average shares outstanding, basic 24,233,957 13,012,833 Effect of dilutive securities: Common stock warrants — — Convertible promissory notes — — Dilutive effect of stock options — — Weighted average shares outstanding, diluted 24,233,957 13,012,833 Basic net income (loss) per share $ 0.72 $ (0.86) Diluted net income (loss) per share $ 0.72 $ (0.86) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2024 and 2023, as they would be antidilutive: As of December 31, 2024 2023 Performance-based stock units — 123 Performance-based stock options 190,000 35,000 Stock options 2,816,851 1,299,105 Common stock warrants 14,193,772 (i) 366,427 Convertible debt 1,191,479 (ii) 875,970 (i) Refer to Note 11 for disclosures on the warrant inducement transactions entered into in January 2025. (ii) The calculation for potentially dilutive securities pertaining to convertible debt is as follows: $3,750,000 of outstanding principal and accrued interest as of December 31, 2024, is converted at a rate of $7.00 , and the remaining amount is converted based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.
Recently issued accounting pronouncements	Recently issued accounting pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Dec. 31, 2024
Basis of Presentation and Summary of Significant Accounting Policies
Schedule of computation of basic and diluted earnings per share	Three months ended December 31, 2024 2023 Numerator: Net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Effect of dilutive securities: (Gain) loss from change in fair value of warrant liability — — Loss from change in fair value of promissory notes — — Adjusted net income (loss) attributable to common stockholders $ 17,377,614 $ (11,178,239) Denominator: Weighted average shares outstanding, basic 24,233,957 13,012,833 Effect of dilutive securities: Common stock warrants — — Convertible promissory notes — — Dilutive effect of stock options — — Weighted average shares outstanding, diluted 24,233,957 13,012,833 Basic net income (loss) per share $ 0.72 $ (0.86) Diluted net income (loss) per share $ 0.72 $ (0.86)
Schedule of anti-dilutive securities	As of December 31, 2024 2023 Performance-based stock units — 123 Performance-based stock options 190,000 35,000 Stock options 2,816,851 1,299,105 Common stock warrants 14,193,772 (i) 366,427 Convertible debt 1,191,479 (ii) 875,970 (i) Refer to Note 11 for disclosures on the warrant inducement transactions entered into in January 2025. (ii) The calculation for potentially dilutive securities pertaining to convertible debt is as follows: $3,750,000 of outstanding principal and accrued interest as of December 31, 2024, is converted at a rate of $7.00 , and the remaining amount is converted based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	3 Months Ended
Fair Value Measurements (Tables)	Dec. 31, 2024
Fair value
Schedule of assets and liabilities measured at fair value	December 31, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 30,744,000 Warrant liability — — 18,826,133 Total $ — $ — $ 49,570,133 September 30, 2024 (Level 1) (Level 2) (Level 3) Liabilities Unsecured convertible promissory note $ — $ — $ 29,440,000 Warrant liability — — 59,099,013 Total $ — $ — $ 88,539,013
Schedule of changes in the fair value of Level 3 liabilities	Unsecured Convertible Promissory Note Warrants Balance at October 1, 2024 $ 29,440,000 $ 59,099,013 Change in fair value 1,304,000 (40,272,880) Balance at December 31, 2024 $ 30,744,000 $ 18,826,133
December 2022 Note
Fair value
Schedule of fair value inputs	December 31, 2024 September 30, 2024 Term (years) 0.5 0.8 Volatility 134.0 % 91.0 % Risk-free rate 4.2 % 4.2 % Dividend yield — % — % Credit-adjusted discount rate 20.5 % 20.4 % Stock price $ 1.89 $ 5.34
Common stock warrants
Fair value
Schedule of fair value inputs	December 31, 2024 September 30, 2024 Risk-free interest rate 4.34 % 3.58 % Remaining contractual term of warrants (years) 4.2 4.5 Expected volatility 135.5 % 125.0 % Annual dividend yield — % — % Stock price $ 1.89 $ 5.34

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
Accrued Expenses (Tables)	Dec. 31, 2024
Accrued Expenses
Schedule of accrued expenses	December 31, 2024 September 30, 2024 Compensation $ 683,479 $ 1,012,962 Severance and related costs 1,388,397 (i) — Professional fees 979,178 1,798,767 Research and development 63,220 41,373 Other accrued expenses 276,958 384,366 $ 3,391,232 $ 3,237,468 (i) In December 2024, the Chief Executive Officer of the Company resigned, and the Company implemented a workforce reduction to conserve capital. The Chief Executive Officer’s departure constituted a termination and was entitled to 12 months of base salary, a lump sum of 100% of his target bonus for the year, employee benefits for up to 12 months, full vesting of 50% of his unvested equity awards, and reimbursement of expenses owed up to his termination date. At a minimum, all employees affected by the workforce reduction are eligible to receive severance payments and paid COBRA premiums for a specified time period post-termination, subject to execution of a general release of claims against the Company. In connection with the departure of the Chief Executive Officer and the reduction in the workforce, during the three months ended December 31, 2024, the Company recognized $1,428,455 in severance related charges in connection with the workforce reduction, consisting of cash-based expenses related to employee severance and notice period payments, benefits and related costs. In addition, during the three months ended December 31, 2024, the Company recorded a non-cash expense totaling $2,079,083 related to stock-based compensation for accelerated equity awards for the former Chief Executive Officer. During the three months ended December 31, 2024, the Company made cash payments totaling $40,058.

Debt (Tables)

Debt (Tables)	3 Months Ended
Debt (Tables)	Dec. 31, 2024
Debt
Schedule of debt	December 31, 2024 September 30, 2024 Unsecured convertible promissory note (measured at fair value) $ 30,744,000 $ 29,440,000 Less: current portion (30,744,000) (29,440,000) Long-term debt $ — $ —

Commitments and Contingencies (

Commitments and Contingencies (Tables)	3 Months Ended
Commitments and Contingencies (Tables)	Dec. 31, 2024
Commitments and Contingencies.
Schedule of lease information	The components of lease cost for the three months ended December 31, 2024 and 2023 are as follows: Three months ended December 31, 2024 2023 Lease cost: Interest on lease liabilities $ — $ 104 Total finance lease cost — 104 Operating lease cost 19,080 11,217 Total lease cost $ 19,080 $ 11,321 Amounts reported in the unaudited interim consolidated balance sheets for leases where the Company is the lessee are as follows: December 31, 2024 September 30, 2024 Operating leases: Right-of-use asset $ 262,822 $ 274,645 Operating lease liabilities 285,758 297,829 Weighted-average remaining lease term (years): Operating leases 4.3 4.6 Weighted-average discount rate: Operating leases 9.9% 9.9% Other information related to leases for the three months ended December 31, 2024 and 2023 are as follows: Three months ended December 31, 2024 2023 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ — $ 104 Operating cash flows from operating leases 19,329 — Financing cash flows from finance leases — 3,183
Schedule of operating lease future minimum payments	Operating leases 2025 (remaining nine months) $ 58,762 2026 79,954 2027 81,817 2028 83,680 2029 49,447 Total undiscounted lease payments 353,660 Less: Imputed interest 67,902 Total lease obligations $ 285,758

Common Stock and Stockholders_2

Common Stock and Stockholders' Equity (Tables)	3 Months Ended
Common Stock and Stockholders' Equity (Tables)	Dec. 31, 2024
Common Stock and Stockholders' Equity
Schedule of warrants outstanding	As of December 31, 2024, shares of common stock issuable upon the exercise of outstanding warrants were as follows: Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 24, 2025 8,642 $ 25.40 April 13, 2025 (i) 7,284 $ 240.00 May 31, 2025 (i) 3,121 $ 240.00 June 22, 2025 9,563 $ 30.38 December 28, 2025 25,787 $ 21.00 January 28, 2026 12,576 $ 25.00 February 2, 2026 93,238 $ 25.00 November 23, 2026 104,999 $ 31.25 March 18, 2029 (ii) 12,857,133 $ 7.70 April 15, 2029 (ii) 1,071,429 $ 7.70 14,193,772 (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 and are classified as liabilities on the accompanying unaudited interim consolidated balance sheets, as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. (ii) The warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging , guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure in Note 4 for further details on classification and fair value measurements. A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $20.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010/LYTENAVA, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting. Refer to Note 11 for disclosures on the warrant inducement transactions entered into in January 2025.

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
Stock-Based Compensation (Tables)	Dec. 31, 2024
Share-based Compensation
Schedule of stock-based compensation expense	Three months ended December 31, 2024 2023 Research and development $ 110,029 $ 231,416 General and administrative 3,562,391 1,041,195 $ 3,672,420 $ 1,272,611
Employee Stock Option
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, 2024 1,946,646 $ 19.51 Granted 1,179,276 5.22 Forfeited (304,636) 10.25 Expired (4,435) 46.78 Balance at December 31, 2024 2,816,851 $ 14.49 8.2 $ — Vested and exercisable at December 31, 2024 1,375,258 $ 22.83 6.7 $ —
Schedule of option assumptions	Three months ended December 31, 2024 2023 Risk-free interest rate 3.5 % 4.6 % Expected term (years) 5.5 5.5 Expected volatility 134.0 % 130.6 % 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, 2024 666,500 $ 7.94 Granted — — Forfeited (476,500) 6.78 Balance at December 31, 2024 190,000 $ 10.85 8.6 $ — Vested and exercisable at December 31, 2024 35,000 $ 28.80 6.1 $ —

Liquidity (Details)

Liquidity (Details)	Jan. 31, 2025 USD ($) D $ / shares	Jan. 16, 2025 USD ($) $ / shares shares	Dec. 31, 2024 USD ($) shares	Sep. 30, 2024 USD ($)
Accumulated deficit			$ (525,907,286)	$ (543,284,900)
Debt, interest, fees			$ 32,229,130
Common stock issuable on exercise of warrants (in shares) \| shares			14,193,772
January 2025 Note \| Subsequent Events
Convertible promissory note	$ 33,100,000
Shares exceeding (as a percent)	19.99%
Minimum share price (in dollars per share) \| $ / shares	$ 2.26
Number of days available for filing of registration statement \| D	7
Number of days for effectiveness of registration statement \| D	45
Monthly increase (as a percent)	0.50%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:PrimeRateMember
Variable rate (as a percent)	3%
Quarterly payment	$ 3,000,000
Exit fee (as a percent)	7.50%
January 2025 Note \| Subsequent Events \| Minimum
Total interest rate (as a percent)	9.50%
GMS Ventures \| Subsequent Events
Net proceeds		$ 15,746,960
Syntone Ventures, LLC \| Subsequent Events
Net proceeds		$ 2,400,000
Existing Warrants \| GMS Ventures \| Subsequent Events
Common stock issuable on exercise of warrants (in shares) \| shares		7,074,637
Exercise price per share (in dollars per share) \| $ / shares		$ 2.51
Existing Warrants \| Syntone Ventures, LLC \| Subsequent Events
Common stock issuable on exercise of warrants (in shares) \| shares		1,071,429
Exercise price per share (in dollars per share) \| $ / shares		$ 2.51
Inducement Warrants \| GMS Ventures \| Subsequent Events
Common stock issuable on exercise of warrants (in shares) \| shares		14,149,274
Exercise price per share (in dollars per share) \| $ / shares		$ 2.26
Inducement Warrants \| Syntone Ventures, LLC \| Subsequent Events
Common stock issuable on exercise of warrants (in shares) \| shares		2,142,858
Exercise price per share (in dollars per share) \| $ / shares		$ 2.26

Basis of Presentation and Sum_4

Basis of Presentation and Summary of Significant Accounting Policies - EPS (Details)		3 Months Ended
	Mar. 14, 2024	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares
Numerator:
Net income (loss) attributable to common stockholders \| $		$ 17,377,614	$ (11,178,239)
Effect of dilutive securities:
Adjusted net income (loss) attributable to common stockholders \| $		$ 17,377,614	$ (11,178,239)
Denominator:
Weighted average shares outstanding, basic (in shares) \| shares		24,233,957	13,012,833
Effect of dilutive securities:
Weighted average shares outstanding, diluted (in shares) \| shares		24,233,957	13,012,833
Basic net income (loss) per share (in dollars per share) \| $ / shares		$ 0.72	$ (0.86)
Diluted net income (loss) per share (in dollars per share) \| $ / shares		$ 0.72	$ (0.86)
Stock split ratio	0.05

Basis of Presentation and Sum_5

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive securities (Details) - USD ($)	3 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Performance-based stock units
Antidilutive securities
Antidilutive securities		123
Performance-based stock options
Antidilutive securities
Antidilutive securities	190,000	35,000
Employee Stock Option
Antidilutive securities
Antidilutive securities	2,816,851	1,299,105
Common stock warrants
Antidilutive securities
Antidilutive securities	14,193,772	366,427
Convertible debt
Antidilutive securities
Antidilutive securities	1,191,479	875,970
Convertible debt \| Scenario one
Antidilutive securities
Original principal amount	$ 3,750,000
Debt conversion rate (in dollars per share)	$ 7
Convertible debt \| Scenario two
Antidilutive securities
Debt conversion rate (in dollars per share)	$ 40

Fair Value Measurements (Detail

Fair Value Measurements (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Liabilities
Derivative Liability, Statement of Financial Position [Extensible Enumeration]	Warrants and Rights Outstanding	Warrants and Rights Outstanding
Recurring \| Level 3
Liabilities
Unsecured convertible promissory note	$ 30,744,000	$ 29,440,000
Warrant liability	18,826,133	59,099,013
Total	$ 49,570,133	$ 88,539,013

Fair Value Measurements - Fair

Fair Value Measurements - Fair value changes (Details)	3 Months Ended
Fair Value Measurements - Fair value changes (Details)	Dec. 31, 2024 USD ($)
Unsecured convertible promissory note
Liabilities fair value changes
Balance, beginning	$ 29,440,000
Change in fair value	$ 1,304,000
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Change In Fair Value Of Redemption Feature
Balance, ending	$ 30,744,000
Common stock warrants
Liabilities fair value changes
Balance, beginning	59,099,013
Change in fair value	$ (40,272,880)
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Fair Value Adjustment of Warrants
Balance, ending	$ 18,826,133

Fair Value Measurements - Assum

Fair Value Measurements - Assumptions (Details)	Dec. 31, 2024 Y $ / shares	Sep. 30, 2024 Y $ / shares
Term
Fair value inputs
Debt inputs \| Y	0.5	0.8
Warrant inputs \| Y	4.2	4.5
Volatility
Fair value inputs
Debt inputs	1.34	0.91
Warrant inputs	1.355	1.25
Risk-free rate
Fair value inputs
Debt inputs	0.042	0.042
Warrant inputs	0.0434	0.0358
Dividend yield
Fair value inputs
Debt inputs	0	0
Warrant inputs	0	0
Credit-adjusted discount rate
Fair value inputs
Debt inputs	0.205	0.204
Stock price (in dollars per share)
Fair value inputs
Debt inputs \| $ / shares	1.89	5.34
Warrant inputs \| $ / shares	1.89	5.34

Equity Method Investment - Synt

Equity Method Investment - Syntone (Details) - Syntone - USD ($)		1 Months Ended
	May 22, 2020	Jun. 30, 2020
Investments
Ownership (as a percent)	20%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000
Syntone PRC
Investments
Ownership (as a percent)	80%

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	3 Months Ended
Accrued Expenses (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Accrued Expenses
Compensation	$ 683,479	$ 1,012,962
Severance and related costs	1,388,397
Professional fees	979,178	1,798,767
Research and development	63,220	41,373
Other accrued expenses	276,958	384,366
Total accrued expenses	3,391,232	$ 3,237,468
Severance related expense	1,428,455
Accelerated equity awards expense	2,079,083
Restructuring severance payment	$ 40,058

Debt - Summary (Details)

Debt - Summary (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Debt
Less: current portion	$ (30,744,000)	$ (29,440,000)
Unsecured convertible promissory note
Debt
Total debt	$ 30,744,000	$ 29,440,000

Debt - Information (Details)

Debt - Information (Details) - December 2022 Note			1 Months Ended	3 Months Ended
Debt - Information (Details) - December 2022 Note	Jan. 22, 2024 USD ($) $ / shares	Dec. 22, 2022 USD ($) D $ / shares	Dec. 31, 2023 USD ($)	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)
Debt
Original principal amount	$ 15,000,000	$ 31,820,000
Debt issuance costs	$ 2,681,847	1,820,000	$ 475,000
Proceeds from loan		$ 18,052,461
Interest rate (as a percent)		9.50%
Trading day threshold \| D		30
Additional fee cash payments (as a percent)		7.50%
Increase in debt balance for a Major Trigger Event (as a percent)		10%
Increase in debt balance for a Minor Trigger Event (as a percent)		5%
Threshold trading days for Trigger Event cure		10 days
Default interest rate (as a percent)		22%
Debt conversion rate (in dollars per share) \| $ / shares	$ 7	$ 50
Conversion notice threshold (in dollars per share) \| $ / shares		$ 3.51
Participation right in future financing (as a percent)		10%
Extension fee based on balance (as a percent)	7.50%
Variable rate (as a percent)	3%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:PrimeRateMember
Quarterly payment	$ 3,000,000
Interest expense				$ 0	$ 0
Major Trigger Event
Debt
Trading day threshold \| D		3
Stock price trigger threshold (as a percent)		90%
Debt conversion rate (in dollars per share) \| $ / shares		$ 40
Minimum
Debt
Total interest rate (as a percent)	9.50%

Commitments and Contingencies -

Commitments and Contingencies - Lease cost (Details) - USD ($)	3 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Mar. 31, 2024	Mar. 31, 2021
Commitments and Contingencies.
Operating lease term			5 years	3 years
Lease cost
Interest on lease liabilities		$ 104
Total finance lease cost		104
Operating lease cost	$ 19,080	11,217
Total lease cost	$ 19,080	$ 11,321

Commitments and Contingencies_2

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Leases
Operating leases, Right-of-use asset	$ 262,822	$ 274,645
Operating lease liabilities	$ 285,758	$ 297,829
Operating leases, Weighted-average remaining lease term	4 years 3 months 18 days	4 years 7 months 6 days
Operating leases, Weighted-average discount rate (as a percent)	9.90%	9.90%

Commitments and Contingencies_3

Commitments and Contingencies - Lease cash flow (Details) - USD ($)	3 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Leases
Operating cash flows from finance leases		$ 104
Operating cash flows from operating leases	$ 19,329
Financing cash flows from finance leases		$ 3,183

Commitments and Contingencies_4

Commitments and Contingencies - Minimum lease payments (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Operating leases
2025 (remaining nine months)	$ 58,762
2026	79,954
2027	81,817
2028	83,680
2029	49,447
Total undiscounted lease payments	353,660
Less: Imputed interest	67,902
Total lease obligations	$ 285,758	$ 297,829

Common Stock and Stockholders_3

Common Stock and Stockholders' Equity - Preferred Stock (Details) - shares	Dec. 31, 2024	Sep. 30, 2024	May 13, 2024
Class of Stock [Line Items]
Preferred stock, shares outstanding	0	0
Preferred stock, shares authorized	10,000,000	10,000,000	10,000,000
Series A convertible preferred stock
Class of Stock [Line Items]
Preferred stock, shares outstanding			0
Series B convertible preferred stock
Class of Stock [Line Items]
Preferred stock, shares outstanding			0
Series A-1 convertible preferred stock
Class of Stock [Line Items]
Preferred stock, shares outstanding			0

Common Stock and Stockholders_4

Common Stock and Stockholders' Equity - Common Stock (Details) - USD ($)		3 Months Ended
	May 16, 2023	Dec. 31, 2024	Dec. 31, 2023	Sep. 30, 2024	Mar. 07, 2024	Mar. 06, 2024
Common Stock and Stockholders' Equity
Common stock, shares authorized		60,000,000		60,000,000	60,000,000	21,250,000
Common stock issuable on exercise of warrants (in shares)		14,193,772
Proceeds from issuance of stock		$ 1,742,373
BTIG ATM
Common Stock and Stockholders' Equity
Common stock issued (in shares)		1,000,000	0
Proceeds from issuance of stock		$ 1,742,373
Aggregate maximum offering price	$ 100,000,000
Amount reclassified on additional paid in capital	$ 353,688
Payment of fees to sales agent		53,888
Deferred costs		$ 325,181
Common stock sale commission (as a percent)		3%

Common Stock and Stockholders_5

Common Stock and Stockholders' Equity - Warrants (Details)	3 Months Ended
Common Stock and Stockholders' Equity - Warrants (Details)	Dec. 31, 2024 $ / shares shares
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	14,193,772
February 24, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	8,642
Exercise price per share (in dollars per share) \| $ / shares	$ 25.4
April 13, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	7,284
Exercise price per share (in dollars per share) \| $ / shares	$ 240
May 31, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	3,121
Exercise price per share (in dollars per share) \| $ / shares	$ 240
June 22, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	9,563
Exercise price per share (in dollars per share) \| $ / shares	$ 30.38
December 28, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	25,787
Exercise price per share (in dollars per share) \| $ / shares	$ 21
January 28, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	12,576
Exercise price per share (in dollars per share) \| $ / shares	$ 25
February 2, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	93,238
Exercise price per share (in dollars per share) \| $ / shares	$ 25
November 23, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	104,999
Exercise price per share (in dollars per share) \| $ / shares	$ 31.25
March 18, 2029
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	12,857,133
Exercise price per share (in dollars per share) \| $ / shares	$ 7.7
Beneficial ownership exercise restriction, one (as a percent)	4.99%
Beneficial ownership exercise restriction, two (as a percent)	9.99%
Beneficial ownership exercise restriction, three (as a percent)	19.99%
Warrant holders exercise under certain conditions (as a percent)	20%
April 15, 2029
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	1,071,429
Exercise price per share (in dollars per share) \| $ / shares	$ 7.7

Stock-Based Compensation - Info

Stock-Based Compensation - Information (Details) - shares	3 Months Ended
Stock-Based Compensation - Information (Details) - shares	Dec. 31, 2024	Aug. 31, 2024
Performance-based stock options
Share-based Compensation
Term of award	10 years
2024 Equity Incentive Plan
Share-based Compensation
Share-based stock authorized (in shares)		7,303,677
Share-based stock available for grant (in shares)	4,287,050
Term of award	10 years
2024 Equity Incentive Plan \| Minimum
Share-based Compensation
Vesting period	1 year
2024 Equity Incentive Plan \| Maximum
Share-based Compensation
Vesting period	4 years

Stock-Based Compensation - Expe

Stock-Based Compensation - Expense (Details) - USD ($)	3 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Dec. 31, 2024	Dec. 31, 2023
Share-based Compensation
Stock-based compensation expense	$ 3,672,420	$ 1,272,611
Research and development
Share-based Compensation
Stock-based compensation expense	110,029	231,416
General and administrative
Share-based Compensation
Stock-based compensation expense	$ 3,562,391	$ 1,041,195

Stock-Based Compensation - Opti

Stock-Based Compensation - Option activity (Details) - $ / shares	3 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Employee Stock Option
Number of Shares
Balance, Beginning (in shares)	1,946,646
Granted (in shares)	1,179,276
Forfeited (in shares)	(304,636)
Expired (in shares)	(4,435)
Balance, Ending (in shares)	2,816,851
Vested and exercisable (in shares)	1,375,258
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 19.51
Granted (in dollars per share)	5.22
Forfeited (in dollars per share)	10.25
Expired (in dollars per share)	46.78
Balance, Ending (in dollars per share)	14.49
Vested and exercisable (in dollars per share)	$ 22.83
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term	8 years 2 months 12 days
Vested and exercisable -Remaining contractual term	6 years 8 months 12 days
Grant date fair value of options (in dollars per share)	$ 4.67	$ 5.2
Performance-based stock options
Number of Shares
Balance, Beginning (in shares)	666,500
Forfeited (in shares)	(476,500)
Balance, Ending (in shares)	190,000
Vested and exercisable (in shares)	35,000
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 7.94
Forfeited (in dollars per share)	6.78
Balance, Ending (in dollars per share)	10.85
Vested and exercisable (in dollars per share)	$ 28.8
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term	8 years 7 months 6 days
Vested and exercisable -Remaining contractual term	6 years 1 month 6 days

Stock-Based Compensation - Op_2

Stock-Based Compensation - Option Assumptions (Details) - Employee Stock Option - USD ($)	3 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-based Compensation
Risk-free interest rate	3.50%	4.60%
Expected term (years)	5 years 6 months	5 years 6 months
Expected volatility	134%	130.60%
Expected dividend yield	0%	0%
Unrecognized compensation expense	$ 6,496,794
Unrecognized compensation exercise period	9 months 18 days

Subsequent Events - Warrant Ind

Subsequent Events - Warrant Inducement Transaction (Details) - USD ($)	Jan. 16, 2025	Dec. 31, 2024
Subsequent Events
Common stock issuable on exercise of warrants (in shares)		14,193,772
Subsequent Events \| Existing Warrants \| GMS Ventures
Subsequent Events
Common stock issuable on exercise of warrants (in shares)	7,074,637
Issuance of common stock in connection with exercise of warrants (in shares)	3,458,571
Exercise price per share (in dollars per share)	$ 2.51
Proceeds from exercise of warrants	$ 8,681,013
Subsequent Events \| Existing Warrants \| Syntone Ventures, LLC
Subsequent Events
Common stock issuable on exercise of warrants (in shares)	1,071,429
Exercise price per share (in dollars per share)	$ 2.51
Subsequent Events \| Inducement Warrants \| GMS Ventures
Subsequent Events
Common stock issuable on exercise of warrants (in shares)	14,149,274
Exercise price per share (in dollars per share)	$ 2.26
Subsequent Events \| Inducement Warrants \| Syntone Ventures, LLC
Subsequent Events
Common stock issuable on exercise of warrants (in shares)	2,142,858
Exercise price per share (in dollars per share)	$ 2.26
Warrants exercise term	5 years
Subsequent Events \| Tranche A Inducement Warrants \| GMS Ventures
Subsequent Events
Common stock issuable on exercise of warrants (in shares)	7,074,637
Issuance of common stock in connection with exercise of warrants (in shares)	6,917,142

Subsequent Events - Unsecured C

Subsequent Events - Unsecured Convertible Promissory (Details) - Subsequent Events - January 2025 Note	Jan. 31, 2025 USD ($) D $ / shares
Subsequent Events
Stock trigger price (in dollars per share)	$ 3
Consecutive trading days \| D	30
Preceding trading days \| D	30
Minimum trading volume trigger amount \| $	$ 1,000,000
Additional fee cash payments (as a percent)	7.50%
Beneficial ownership for holders post conversion (as a percent)	4.99%
Increase in debt balance for a Major Trigger Event (as a percent)	10%
Increase in debt balance for a Minor Trigger Event (as a percent)	5%
Threshold trading days for Trigger Event cure	10 days
Default interest rate (as a percent)	22%
Debt conversion rate (in dollars per share)	$ 2.26
Conversion notice threshold (in dollars per share)	$ 0.404
If Market Capitalization Falls Below $25000000
Subsequent Events
Minimum trading volume trigger amount \| $	$ 25,000,000
Beneficial ownership for holders post conversion (as a percent)	9.99%
Major Trigger Event
Subsequent Events
Debt conversion rate (in dollars per share)	$ 2.26
Stock price trigger threshold (as a percent)	90%
Trading day threshold \| D	3