0001104659-25-123264 | 10-K | XBRL Viewer

Commitments and Contingencies (Tables)

12 Months Ended

Sep. 30, 2025

The components of lease cost for the years ended September 30, 2025 and 2024 were as follows:


		Year ended September 30,
		2025			2024
Lease cost:
Interest on lease liabilities		$	—		$	116
Total finance lease cost			—			116
Operating lease cost			76,321			57,973
Total lease cost		$	76,321		$	58,089

Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows:


	September 30,
	2025			2024
Operating leases:
Right-of-use asset	$	225,508		$	274,645
Operating lease liabilities		247,698			297,829
Weighted-average remaining lease term (years):
Operating leases		3.6			4.6
Weighted-average discount rate:
Operating leases		9.9%			9.9%

Other information related to leases for the years ended September 30, 2025 and 2024 are as follows:


	Year ended September 30,
	2025			2024
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	—		$	116
Operating cash flows from operating leases		77,315			14,514
Financing cash flows from finance leases		—			4,267
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—		$	294,416

Schedule of operating lease future minimum payments


	Operating leases
2026	$	80,730
2027		81,817
2028		83,680
2029		49,447
Total undiscounted lease payments		295,674
Less: Imputed interest		47,976
Total lease obligations	$	247,698

Income Taxes - Deferred (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Deferred tax assets:
Net operating loss carryforwards	$ 110,272,674	$ 102,906,140
Capitalized research and development costs	13,720,059	15,200,918
Stock-based compensation	6,612,848	6,463,068
Lease liability	52,366	83,720
Research and development credit carryforward	12,370,887	13,748,600
Foreign tax credits	100,000	290,188
Accruals and others	2,799,707	144,079
Gross deferred tax assets	145,928,541	138,836,713
Less: valuation allowance	(145,880,866)	(138,759,510)
Deferred tax assets net of valuation allowance	47,675	77,203
Deferred tax liabilities:
Right-of-use assets	$ (47,675)	$ (77,203)

Income Taxes - Reconciliation (Details)	12 Months Ended
Income Taxes - Reconciliation (Details)	Sep. 30, 2025	Sep. 30, 2024
Reconciliation of income taxes (as a percent)
U.S. federal statutory rate	(21.00%)	(21.00%)
State taxes, net of federal benefit	(0.10%)	(6.20%)
Change in state rate	8.50%
Deferred true-up	0.20%	0.20%
Foreign withholding tax	(2.40%)
Permanent differences	(0.90%)	2.50%
Foreign tax credits	0.30%	1.70%
Research and development credit	2.20%	(2.40%)
Change in valuation allowance	11.10%	25.30%
Other	(0.30%)	(0.10%)
Effective income tax rate	(2.40%)	0.00%

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Share-based Compensation
Capitalized stock-based compensation expense	$ 37,991
Stock-based compensation expense	$ 8,859,896	$ 5,385,124
Employee Stock Option
Share-based Compensation
Risk-free interest rate	3.70%	4.30%
Expected term (years)	5 years 8 months 12 days	6 years
Expected volatility	132.00%	131.40%
Expected dividend yield	0.00%
Unrecognized compensation expense	$ 2,016,949
Unrecognized compensation exercise period	10 months 24 days
Performance-based stock options
Share-based Compensation
Risk-free interest rate		4.30%
Expected term (years)	0 years	10 years
Expected volatility		125.60%
Stock-based compensation expense	$ 0

Consolidated Balance Sheets - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Current assets:
Cash and cash equivalents	$ 8,083,085	$ 14,927,538
Accounts receivable	1,490,931
Inventory	3,338,404
Prepaid expenses and other current assets	4,476,549	12,488,498
Total current assets	17,388,969	27,416,036
Operating lease right-of-use assets, net	225,508	274,645
Equity method investment	552,183	693,190
Other assets	417,523	439,283
Total assets	18,584,183	28,823,154
Current liabilities:
Current portion of unsecured convertible promissory note	29,947,000	29,440,000
Current portion of operating lease liabilities	58,897	50,907
Accounts payable	10,192,388	7,968,725
Accrued expenses	5,314,320	3,237,468
Income taxes payable	302,000	1,856,629
Total current liabilities	45,814,605	42,553,729
Operating lease liabilities	188,801	246,922
Warrant liability	4,768,438	59,099,013
Total liabilities	50,771,844	101,899,664
Commitments and contingencies (Note 9)
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; 260,000,000 shares authorized; 53,887,233 and 23,905,635 shares issued and outstanding at September 30, 2025 and September 30, 2024, respectively	538,873	239,057
Additional paid-in capital	572,983,229	469,969,333
Accumulated deficit	(605,709,763)	(543,284,900)
Total stockholders' deficit	(32,187,661)	(73,076,510)
Total liabilities and stockholders' deficit	$ 18,584,183	$ 28,823,154

Inventory (Details)	Sep. 30, 2025 USD ($)
Inventory
Raw materials	$ 2,350,239
Work-in-process	958,539
Finished goods	29,626
Total	$ 3,338,404

Basis of Presentation and Summary of Significant Accounting Policies (Policies)

12 Months Ended

Sep. 30, 2025

Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation

The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of Outlook Therapeutics Pty Ltd (incorporated in Australia), Outlook Therapeutics NL B.V. (incorporated in the Netherlands), Outlook Therapeutics CH GmbH (incorporated in Switzerland), and Outlook Therapeutics DE GmbH (incorporated in Germany), the Company’s wholly owned subsidiaries (the “Subsidiaries”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiaries to be the United States dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statements of operations as they occur.

Cash and cash equivalents

Cash and cash equivalents include cash-on-hand and demand deposits with financial institutions and other short-term investments with maturities of less than three months when acquired and convertible to known cash amounts. At September 30, 2025 and 2024, the Company’s cash equivalents consist of a money market account.

Equity method investment

The Company accounts for equity investments where it owns a non-controlling interest, but has the ability to exercise significant influence, under the equity method of accounting. Under the equity method of accounting, the original cost of the investment is adjusted for the Company’s share of equity in the earnings or loss of the equity investee and reduced by dividends and distributions of capital received, unless the fair value option is elected, in which case the investment balance is marked to fair value each reporting period and the impact of changes in fair value of the equity investment are reported in earnings. The Company has not elected the fair value option. The Company assesses its investment for other-than-temporary impairment when events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable and recognize an impairment loss to adjust the investment to its then-current fair value.

Use of estimates

The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual

results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary.

Revenue recognition

The Company recognizes revenue from sales of a single product, LYTENAVA (bevacizumab gamma) (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers. LYTENAVA (bevacizumab gamma) became available for commercial sale and shipment to patients in Europe in fiscal year 2025. The Company sells the Product to several customers who are pharmaceutical wholesalers/distributors who in turn sell the Product directly to clinics, hospitals, and pharmacies. Revenue is recognized as the Product is physically delivered to the customers.

Gross product sales are reduced by corresponding Gross-to-Net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Revenues, net” in the accompanying consolidated statements of operations. Revenues, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, rebates and distribution fees may be materially above or below the amount estimated. The variance between actual amounts and estimated amounts may result in prospective adjustments to the reported net product revenue.

Each of the GTN estimate categories are discussed below:

●

Sales returns are estimated by the Company based on the relative risk of return based on expiration date, and other qualitative factors that can impact the volume of future returns, including competitive developments, product discontinuation, or new product introductions. The Company will consider the level of inventory in the distribution channel by monitoring inventories held at the distributor and wholesalers to assess whether historical rates of returns continue to be appropriate.

●

Distribution fees are contractually charged by the wholesalers and are typically credited directly against amounts due to the Company.

●

Price adjustments are contractually charged to the Company by customers and include the Voluntary Scheme for Branded Medicines Pricing, Access and Growth rebate with the UK National Health Service, as well as chargebacks and other discounts.

Accounts Receivable

Accounts receivable

As of September 30, 2025, the Company had no allowance for credit losses. An allowance for credit losses is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected.

Inventory

The Company values inventory at the lower of cost or net realizable value, computed on a weighted average basis. The Company analyzes its inventory levels quarterly for obsolescence and, if required, adjusts inventory to its net realizable value if the cost basis of inventory is in excess of its expected net realizable value, or for quantities in excess of expected demand.

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. The Company expenses prelaunch inventory as research and development expense in the period incurred unless objective and persuasive evidence exists that regulatory approval and subsequent commercialization of a product candidate is probable and where the Company also expects the

future economic benefit from the sales of the product candidate to be realized. There were no costs related to prelaunch inventory included in inventory as of September 30, 2025, and 2024.

Fair value of financial instruments

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

●

Level 1 — Quoted prices in active markets for identical assets or liabilities.

●

Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

●

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.

At September 30, 2025 and 2024, the Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, unsecured convertible promissory note and warrant liabilities. The carrying amount of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximates fair value due to the short-term maturities of these instruments.

Fair Value Option

The Company elected the fair value option to account for both the December 2022 Note, defined in Note 8, and March 2025 Note. Refer to Note 8 for further details on these financial instruments.

Leases

Leases

At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (“Short-Term Leases”). For Short-Term Leases, the Company records the rent expense on a straight-line basis and does not record the leases on the consolidated balance sheet.

After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement and (ii) the right-of-use lease asset based on the re-measured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any

lease incentives received, and any initial direct costs incurred are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term.

Stock-based compensation

The Company measures equity classified stock-based awards based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures of stock option awards as they occur.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 11. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant.

Research and development

Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs.

Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use.

Income taxes

The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Segment reporting

The Company has one reportable segment which consists of the development and commercialization of ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. For additional information regarding the Company’s reportable segments, refer to Note 14 – Segment Information.

Net loss per share

Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net 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.

During the years ended September 30, 2025, and 2024, the Company incurred a net loss. As a result, all potentially dilutive securities were considered anti-dilutive and were excluded from the calculation of diluted Earnings per share (“EPS”). Therefore, basic and diluted EPS are the same for such periods.

The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding for the years ended September 30, 2025, and 2024, as they would be antidilutive:


		Year ended September 30,
		2025			2024
Performance-based stock options			125,500			666,500
Stock options			3,611,362			1,946,646
Common stock warrants			35,989,085			14,207,622
Convertible debt	⁽ⁱ⁾		12,946,011		⁽ⁱⁱ⁾	1,171,100

(i)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $2.26 per share, which is subject to change as described in Note 8. The convertible debt relates to the March 2025 Note.

(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 September 30, 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 8. The convertible debt relates to the December 2022 Note.

Recently issued accounting pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07, which is applicable to entities with a single reportable segment and will primarily require enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning after December 31, 2024, with early adoption permitted. The Company adopted ASU 2023-07 during fiscal year 2025, as the standard became effective for public entities for fiscal years beginning after December 15, 2023. For further details regarding the adoption and its impact, refer to the discussion above within Notes 3 and 14.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 which is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses. ASU 2024-03 requires additional disclosure of specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The requirements will be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.

Debt - Information (Details)				1 Months Ended	12 Months Ended
Debt - Information (Details)	Mar. 13, 2025 USD ($) D $ / shares	Jan. 22, 2024 USD ($)	Dec. 22, 2022 USD ($)	Dec. 31, 2023 USD ($)	Sep. 30, 2025 USD ($)	Sep. 30, 2024 USD ($) shares
Debt
Proceeds from loan					$ 33,100,000
Convertible promissory note converted into common stock					2,525,000	$ 11,250,000
Repayment of debt					36,142,586
December 2022 Note
Debt
Original principal amount			$ 31,820,000
Debt issuance costs		$ 2,681,847	1,820,000	$ 475,000
Proceeds from loan			$ 18,052,461
Extension fee based on balance (as a percent)		7.50%
Interest expense						3,156,847
Convertible promissory note converted into common stock						$ 11,250,000
Shares converted \| shares						1,607,093
March 2025 Note
Debt
Original principal amount	$ 33,100,000
Stock trigger price (in dollars per share) \| $ / shares	$ 3
Additional fee cash payments (as a percent)	7.50%
Increase in debt balance for a Major Trigger Event (as a percent)	10.00%
Increase in debt balance for a Minor Trigger Event (as a percent)	5.00%
Threshold trading days for Trigger Event cure	10 days
Default interest rate (as a percent)	22.00%
Debt conversion rate (in dollars per share) \| $ / shares	$ 2.26
Conversion notice threshold (in dollars per share) \| $ / shares	$ 0.404
Variable rate (as a percent)	3.00%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:PrimeRateMember
Total interest rate (as a percent)	9.50%
Quarterly payment	$ 3,000,000
Interest expense					40,686
Beneficial ownership for holders post conversion (as a percent)	4.99%
Minimum trading volume trigger amount	$ 1,000,000
Preceding trading days \| D	30
Consecutive trading days \| D	30
Exit fee (as a percent)	7.50%
Convertible promissory note converted into common stock					2,525,000
Repayment of debt					3,475,000
interest expense associated with the exit fees					$ 242,442
March 2025 Note \| Major Trigger Event
Debt
Trading day threshold \| D	3
Stock price trigger threshold (as a percent)	90.00%
Debt conversion rate (in dollars per share) \| $ / shares	$ 2.26
March 2025 Note \| If Market Capitalization Falls Below $25000000
Debt
Beneficial ownership for holders post conversion (as a percent)	9.99%
Minimum trading volume trigger amount	$ 25,000,000

Document And Entity Information - USD ($) $ in Millions	12 Months Ended
Document And Entity Information - USD ($) $ in Millions	Sep. 30, 2025	Dec. 16, 2025	Mar. 31, 2025
Document And Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Sep. 30, 2025
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	08852
City Area Code	609
Local Phone Number	619-3990
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 26.9
Entity Common Stock, Shares Outstanding		64,114,399
Documents Incorporated by Reference [Text Block]	Part III of this report incorporates information by reference from the Company's definitive proxy statement, which proxy statement is due to be filed with the Securities and Exchange Commission not later than 120 days after September 30, 2025.
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	FY
Amendment Flag	false
Auditor Firm ID	185
Auditor Name	KPMG LLP
Auditor Location	Philadelphia, Pennsylvania

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive securities (Details) - USD ($)	12 Months Ended
	Sep. 30, 2026	Sep. 30, 2025
Performance-based stock options
Antidilutive securities
Antidilutive securities	125,500	666,500
Employee Stock Option
Antidilutive securities
Antidilutive securities	3,611,362	1,946,646
Common stock warrants
Antidilutive securities
Antidilutive securities	35,989,085	14,207,622
Convertible debt
Antidilutive securities
Antidilutive securities	12,946,011	1,171,100
Debt conversion rate (in dollars per share)		$ 2.26
Convertible debt \| Scenario one
Antidilutive securities
Outstanding principal and accrued interest		$ 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 - Assumptions (Details)	Sep. 30, 2025 $ / shares Y	Sep. 30, 2024 $ / shares Y
Term
Fair value inputs
Debt inputs \| Y	0.8	0.8
Warrant inputs \| Y	3.5	4.5
Volatility
Fair value inputs
Debt inputs	1.18	0.91
Warrant inputs	1.486	1.25
Risk-free rate
Fair value inputs
Debt inputs	0.038	0.042
Warrant inputs	0.0364	0.0358
Dividend yield
Fair value inputs
Debt inputs	0	0
Warrant inputs	0	0
Credit-adjusted discount rate
Fair value inputs
Debt inputs	0.188	0.204
Stock price (in dollars per share)
Fair value inputs
Debt inputs \| $ / shares	1.06	5.34
Warrant inputs \| $ / shares	1.06	5.34

Debt (Tables)

12 Months Ended

Sep. 30, 2025

Debt

Schedule of debt


		September 30, 2025			September 30, 2024
Unsecured convertible promissory note (measured at fair value)		$	29,947,000		$	29,440,000
Less: current portion			(29,947,000)			(29,440,000)
Long-term debt		$	—		$	—

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
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-Name Accounting Standards Codification
-Section 55
-Paragraph 69B
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+ Details

Collaboration Arrangements (Details) - Syntone - USD ($)		1 Months Ended
	May 22, 2020	Jun. 30, 2020
Collaborative arrangements
Ownership (as a percent)	20.00%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000
Syntone PRC
Collaborative arrangements
Ownership (as a percent)	80.00%

Stock-Based Compensation - Option activity (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Employee Stock Option
Number of Shares
Balance, Beginning (in shares)	1,946,646
Granted (in shares)	2,046,599
Forfeited (in shares)	(356,167)
Expired (in shares)	(25,716)
Balance, Ending (in shares)	3,611,362	1,946,646
Vested and exercisable (in shares)	1,579,487
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 19.51
Granted (in dollars per share)	3.69
Forfeited (in dollars per share)	10.46
Expired (in dollars per share)	30.48
Balance, Ending (in dollars per share)	11.36	$ 19.51
Vested and exercisable (in dollars per share)	$ 20.87
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term	7 years 10 months 24 days	7 years 3 months 18 days
Vested and exercisable -Remaining contractual term	6 years 2 months 12 days
Aggregate intrinsic value, Outstanding		$ 53,985
Grant date fair value of options (in dollars per share)	$ 3.3	$ 6.04
Performance-based stock options
Number of Shares
Balance, Beginning (in shares)	666,500
Forfeited (in shares)	(541,000)
Balance, Ending (in shares)	125,500	666,500
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)	12.92	$ 7.94
Vested and exercisable (in dollars per share)	$ 28.8
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term	7 years 7 months 6 days	9 years 3 months 18 days
Vested and exercisable -Remaining contractual term	5 years 3 months 18 days

Inventory

12 Months Ended

Sep. 30, 2025

Inventory

Inventory

5. Inventory

Inventory consists of:


	September 30,
	2025			2024
Raw materials	$	2,350,239		$	—
Work-in-process		958,539			—
Finished goods		29,626			—
Total	$	3,338,404		$	—

Commitments and Contingencies - Minimum lease payments (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Operating leases
2026	$ 80,730
2027	81,817
2028	83,680
2029	49,447
Total undiscounted lease payments	295,674
Less: Imputed interest	47,976
Total lease obligations	$ 247,698	$ 297,829

Income Taxes - Unrecognized benefits (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Unrecognized tax benefits
Balance at beginning of year	$ 1,854,629	$ 1,854,629
Changes based on tax positions related to the current year	(1,554,629)	0
Balance at end of year	$ 300,000	$ 1,854,629

Debt

12 Months Ended

Sep. 30, 2025

Debt

Debt

8. Debt

Debt consists of:


		September 30, 2025			September 30, 2024
Unsecured convertible promissory note (measured at fair value)		$	29,947,000		$	29,440,000
Less: current portion			(29,947,000)			(29,440,000)
Long-term debt		$	—		$	—

December 2022 Note

On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued an unsecured promissory note (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 had 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 consolidated statement of operations for the year ending September 30, 2024.

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 included in interest expense in the consolidated statement of operations for the year ended September 30, 2024.

During the year ended September 30, 2024, an aggregate of principal and accrued interest totaling $11,250,000 of the December 2022 Note was converted into 1,607,093 shares of the Company’s common stock.

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 year ended September 30, 2024, the Company recognized $3,156,847 of interest expense related to extension fees.

On March 13, 2025, the Company used the proceeds from the March 2025 Note to pay off the December 2022 Note.

March 2025 Note

On March 13, 2025, the Company issued the March 2025 Note for $33,100,000 to Avondale Capital, LLC (“Avondale”) pursuant to a Securities Purchase Agreement (“Avondale SPA”) dated January 31, 2025. Certain terms of the March 2025 Note were approved at the Company’s annual meeting of stockholders on March 11, 2025, and the Company used the proceeds from the March 2025 Note to pay off the December 2022 Note.

The March 2025 Note bears interest at the prime rate plus 3% (subject to a floor of 9.5%), is scheduled to mature on July 1, 2026, and is convertible into common stock. The Company must repay at least $3,000,000 (by cash or conversions into common stock) of the outstanding balance on the March 2025 Note each quarter starting in the second calendar quarter of 2025 (subject to adjustments for conversions and to payment of a 7.5% exit fee) (the “Quarterly Debt Reduction Obligations”). Any amount converted by Avondale during a given calendar quarter in excess of the Quarterly Debt Reduction Obligations will be credited toward meeting the Quarterly Debt Reduction Obligations for the next quarter or quarters. During the year ended September 30, 2025, Avondale converted $2,525,000 of principal and accrued interest under the March 2025 Note into shares of common stock. In addition, the Company made cash payments totaling $3,475,000. These transactions were applied toward the Quarterly Debt Reduction Obligations and exit fees for the year ended September 30, 2025.

Avondale has the right to convert all or any portion of the outstanding balance under the March 2025 Note into shares of common stock, calculated by dividing the amount of the March 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 March 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 March 2025 Note stipulates that the Company shall not permit any conversion of the March 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 March 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 Avondale SPA and the March 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 March 2025 Note by 10% in the case of a Major Trigger Event (as defined in the March 2025 Note) and by 5% for a Minor Trigger Event (as defined in the March 2025 Note). Should any Trigger Event persist without resolution for ten trading days following written notification from Avondale, this will constitute an event of default (such event, an “Event of Default”). Upon an event of default, Avondale may accelerate the March 2025 Note, resulting in all amounts becoming immediately due and payable, with interest accruing at a rate of 22% per annum until full payment is made.

Under the terms of the March 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.

The Company elected to account for the March 2025 Note at fair value (Note 4) and was not required to bifurcate the conversion option as a derivative and as a result the debt issuance costs were accounted for as interest upon election to account for the instrument at fair value. During the year ended September 30, 2025, the Company recorded $40,686 of interest expense associated with the debt issuance costs for the March 2025 Note. During the year ended September 30, 2025, the Company recognized $242,442 of interest expense associated with the exit fees on debt repayments for the March 2025 Note.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stock-Based Compensation - Expense (Details) - USD ($)	12 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Share-based Compensation
Stock-based compensation expense	$ 8,859,896	$ 5,385,124
Research and development
Share-based Compensation
Stock-based compensation expense	379,604	800,956
General and administrative
Share-based Compensation
Stock-based compensation expense	$ 8,480,292	$ 4,584,168

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(iv)(03)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 29: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 718
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+ Details

Income Taxes

12 Months Ended

Sep. 30, 2025

Income Taxes

Income Taxes

13. Income Taxes

Income tax benefit for the years ended September 30, 2025 and 2024 consists of the following:


		Year ended September 30,
		2025			2024
State tax		$	2,800		$	2,800
Foreign tax provision			(1,554,629)			—
		$	(1,551,829)		$	2,800

A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows:


	Year ended September 30,
	2025		2024
U.S. federal statutory rate	(21.0)	%	(21.0)	%
State taxes, net of federal benefit	(0.1)		(6.2)
Change in state rate	8.5		—
Deferred true-up	0.2		0.2
Foreign withholding tax	(2.4)		—
Permanent differences	(0.9)		2.5
Foreign tax credits	0.3		1.7
Research and development credit	2.2		(2.4)
Change in valuation allowance	11.1		25.3
Other	(0.3)		(0.1)
Effective income tax rate	(2.4)	%	0.0	%

The tax effects of the temporary differences that gave rise to deferred taxes were as follows:


	September 30,
	2025		2024
Deferred tax assets:
Net operating loss carryforwards	$	110,272,674	$	102,906,140
Capitalized research and development costs		13,720,059		15,200,918
Stock-based compensation		6,612,848		6,463,068
Lease liability		52,366		83,720
Research and development credit carryforward		12,370,887		13,748,600
Foreign tax credits		100,000		290,188
Accruals and others		2,799,707		144,079
Gross deferred tax assets		145,928,541		138,836,713
Less: valuation allowance		(145,880,866)		(138,759,510)
		47,675		77,203
Deferred tax liabilities:
Right-of-use assets		(47,675)		(77,203)
Net deferred tax assets	$	—	$	—

As of September 30, 2025, the Company had approximately $441.0 million and $243.6 million of United States federal and New Jersey NOLs that will begin to expire in 2030 and 2039, respectively. As of September 30, 2025, the Company had federal and state research and development tax credit carryforwards of $11.6 million and $0.8 million, respectively, available to reduce future tax liabilities which will begin to expire in 2032 and 2033, respectively. As of September 30, 2025, the Company has federal foreign tax credit (“FTC”) carryforwards of $0.1 million available to reduce future tax liabilities which began to expire starting in 2023, of which $1.9 million of the FTC carryforward is included in the balance of unrecognized tax benefits. Realization of the deferred tax asset is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax asset does not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax assets as of September 30, 2025 and 2024. The valuation allowance increased by $7.1 million and $19.0 million during the year ended September 30, 2025 and 2024, respectively.

When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties accrued on any unrecognized tax benefits within the provision for income taxes in its consolidated statements of operations.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The legislation includes significant corporate tax reforms, including the permanent reinstatement of the ability to deduct domestic research and development expenditures as incurred beginning in fiscal 2026, replacing the previous requirement to capitalize and amortize such expenditures over five years. The OBBBA also introduces modifications to the international tax framework, including changes to the foreign-derived intangible income (“FDII”) regime. Under the legislation, FDII is renamed foreign-derived deduction-eligible income (“FDDEI”), with the current FDDEI effective tax rate of 13% maintained through fiscal 2026, followed by a permanent adjustment to a 14% rate beginning in fiscal 2027 (compared to 16% under prior law). The legislation contains multiple effective dates, with certain provisions effective in 2025 and others becoming effective in subsequent years. The effects of OBBBA are not expected to have a material impact relative the financials of the Company.

A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:


	Year ended September 30,
	2025		2024
Balance at beginning of year	$	1,854,629	$	1,854,629
Changes based on tax positions related to the current year		(1,554,629)		—
Balance at end of year	$	300,000	$	1,854,629

The Company expects the remaining $300,000 to be recognized as a tax benefit in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2024 remain open for examination by the Internal Revenue Service as well as various states and municipalities.

Due to the change in ownership provisions of the Code, the availability of the Company’s NOL carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred tax assets with an offsetting reduction in the valuation allowance.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 740
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477617/942-740-50-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 740
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478822/944-740-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-13

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/740/tableOfContent

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-14

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-21

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-17

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-2

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

Stockholders' Equity - Common Stock and At-the-Market Offering Agreement (Details) - USD ($)					12 Months Ended
	May 27, 2025	Apr. 15, 2024	Mar. 18, 2024	May 16, 2023	Sep. 30, 2025	Sep. 30, 2024	Mar. 11, 2025	Mar. 10, 2025	Jan. 16, 2025	Mar. 07, 2024	Mar. 06, 2024
Common Stock and Stockholders' Equity
Common stock, shares authorized					260,000,000	260,000,000	260,000,000	60,000,000		60,000,000	21,250,000
Common stock issued (in shares)		714,286	8,571,423
Common stock issuable on exercise of warrants (in shares)		1,071,429	12,857,133		35,989,085
Shares issued price (in dollars per share)			$ 7
Common stock issuable by each warrants (in shares)			1.5
Proceeds from issuance of stock		$ 4,835,371	$ 55,498,311		$ 25,396,398	$ 60,333,681
Exercise price per share		$ 7.7	$ 7.7
Warrants related expenses						$ 37,490,012
GMS Ventures
Common Stock and Stockholders' Equity
Common stock issued (in shares)			2,305,714
Common stock issuable on exercise of warrants (in shares)			3,458,571
Existing Warrants
Common Stock and Stockholders' Equity
Exercise price per share					$ 2.51
Existing Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									7,074,637
Exercise price per share									$ 2.51
Existing Warrants \| Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									1,071,429
Exercise price per share									$ 2.51
Inducement Warrants
Common Stock and Stockholders' Equity
Exercise price per share					$ 2.26
Inducement Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									14,149,274
Exercise price per share									$ 2.26
Inducement Warrants \| Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									2,142,858
Exercise price per share									$ 2.26
Warrants exercise term									5 years
Tranche A Inducement Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									7,074,637
Tranche A Inducement Warrants \| Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)									1,071,429
Underwriter
Common Stock and Stockholders' Equity
Common stock issued (in shares)	9,285,714
Shares issued price (in dollars per share)	$ 1.4
Proceeds from issuance of stock	$ 11,617,407
Underwriter \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issued (in shares)	4,285,714
BTIG ATM
Common Stock and Stockholders' Equity
Common stock issued (in shares)					8,681,852	0
Proceeds from issuance of stock					$ 13,461,540
Aggregate maximum offering price				$ 100,000,000
Amount reclassified on additional paid in capital				$ 353,688
Deferred costs					282,420
Common stock sale commission (as a percent)				3.00%
Payment of fees to sales agent					$ 416,337

Basis of Presentation and Summary of Significant Accounting Policies

12 Months Ended

Sep. 30, 2025

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

Cash and cash equivalents

Equity method investment

Use of estimates

Revenue recognition

Each of the GTN estimate categories are discussed below:

●

Distribution fees are contractually charged by the wholesalers and are typically credited directly against amounts due to the Company.

●

Accounts receivable

Inventory

future economic benefit from the sales of the product candidate to be realized. There were no costs related to prelaunch inventory included in inventory as of September 30, 2025, and 2024.

Fair value of financial instruments

●

Level 1 — Quoted prices in active markets for identical assets or liabilities.

●

Fair Value Option

The Company elected the fair value option to account for both the December 2022 Note, defined in Note 8, and March 2025 Note. Refer to Note 8 for further details on these financial instruments.

Leases

Stock-based compensation

Research and development

Income taxes

Segment reporting

Net loss per share


		Year ended September 30,
		2025			2024
Performance-based stock options			125,500			666,500
Stock options			3,611,362			1,946,646
Common stock warrants			35,989,085			14,207,622
Convertible debt	⁽ⁱ⁾		12,946,011		⁽ⁱⁱ⁾	1,171,100

(i)

(ii)

Recently issued accounting pronouncements

Inventory (Tables)

12 Months Ended

Sep. 30, 2025

Inventory

Schedule of Inventory


	September 30,
	2025			2024
Raw materials	$	2,350,239		$	—
Work-in-process		958,539			—
Finished goods		29,626			—
Total	$	3,338,404		$	—

Equity Method Investment

12 Months Ended

Sep. 30, 2025

Equity Method Investment

Equity Method Investment

6. Equity Method Investment

In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone Ventures”), the 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.

Liquidity

12 Months Ended

Sep. 30, 2025

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 $605,709,763 as of September 30, 2025. As of September 30, 2025, the Company had a working capital deficit. Additionally, the Company had $31,452,334 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued in March 2025 (the “March 2025 Note”), maturing on July 1, 2026. Refer to Note 8 for further details on the March 2025 Note. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

Subsequent to September 30, 2025, the Company sold 10,227,166 shares of common stock under the BTIG ATM Offering and generated $14,931,537 in net proceeds after paying fees to BTIG and other issuance costs of $461,800. Refer to Note 10 for further details on the BTIG ATM Offering.

Management does not believe that the Company’s existing cash and cash equivalents as of September 30, 2025, together with $14,931,537 in net proceeds from the sale of shares of common stock under the BTIG ATM Offering since September 30, 2025, are sufficient to fund the Company’s operations through one year from the Form 10-K filing date. As a result, there is substantial doubt about the Company’s ability to continue as a going concern and additional financing will be needed by the Company to fund its operations in the future, fully commercialize 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 United States the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offerings (refer to Note 10 for further details), and revenues from product sales. There can be no assurance that any of these future funding efforts will be successful. The Company’s consolidated financial statements do not include any adjustments that might be necessary if it is unable to continue as a going concern.

The Company’s future operations are highly dependent on a combination of factors, including: (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to successfully commercialize ONS-5010/LYTENAVA, including executing marketing arrangements or completing 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.

Commitments and Contingencies - Lease cash flow (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Leases
Operating cash flows from finance leases		$ 116
Operating cash flows from operating leases	$ 77,315	14,514
Financing cash flows from finance leases		4,267
Right-of-use assets obtained in exchange for operating lease obligations		$ 294,416

Segment Information (Tables)

12 Months Ended

Sep. 30, 2025

Segment Information

Schedule of significant expense categories


	Year ended September 30,
	2025		2024
Revenues, net	$	1,413,535	$	—
Cost of revenues		1,356,330		—
Gross profit		57,205		—
Operating expenses:
Research and development expenses
ONS-5010/LYTENAVA development		23,286,684		37,355,884
Compensation and related benefits		2,385,606		2,507,635
Stock-based compensation		379,604		800,956
Other research and development		1,128,746		1,098,572
		27,180,640		41,763,047
Selling, general and administrative expenses
Professional fees		6,173,453		9,866,128
Compensation and related benefits		8,177,077		6,301,200
Stock-based compensation		8,480,292		4,584,168
Europe launch expenses		13,377,691		5,010,687
Facilities, fees and other related costs		3,729,718		4,178,005
		39,938,231		29,940,188

Segment loss from operations		(67,061,666)		(71,703,235)
Other segment items ⁽ⁱ⁾		3,084,974		(3,660,679)
Segment loss before income taxes	$	(63,976,692)	$	(75,363,914)

(i)

Other segment items included in segment loss includes loss on equity method investment, interest income, interest expense, loss from change in fair value of promissory notes, warrant related expenses, warrant inducement expenses, and gain from change in fair value of warrant liability.

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Sep. 30, 2025	Sep. 30, 2024
OPERATING ACTIVITIES
Net loss	$ (62,424,863)	$ (75,366,714)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization	117,052	113,859
Non-cash interest expense		2,681,847
Stock-based compensation	8,897,887	5,385,124
Loss from change in fair value of promissory notes	6,074,586	2,457,153
Warrant related expenses (Note 10)		37,490,012
Warrant inducement expenses (Note 10)	33,521,874
Gain from change in fair value of warrant liability	(43,015,831)	(38,638,042)
Loss on equity method investment	141,007	100,742
Changes in operating assets and liabilities:
Accounts receivable	(1,490,931)
Inventory	(3,338,404)
Prepaid expenses and other current assets	8,011,949	(4,901,282)
Other assets	(95,247)	(5,900)
Operating lease liabilities	(50,131)	3,413
Accounts payable	1,666,049	1,394,202
Accrued expenses	1,710,195	491,728
Income taxes payable	(1,554,629)
Net cash used in operating activities	(51,829,437)	(68,793,858)
FINANCING ACTIVITIES
Proceeds from the sale of common stock and warrants to purchase common stock, net of issuance costs	25,396,398	60,333,681
Proceeds from exercise of common stock warrants	22,631,172
Proceeds from debt	33,100,000
Payments of finance lease obligations		(4,267)
Repayment of debt	(36,142,586)
Net cash provided by financing activities	44,984,984	60,329,414
Net (decrease) increase in cash and cash equivalents	(6,844,453)	(8,464,444)
Cash and cash equivalents at beginning of year	14,927,538	23,391,982
Cash and cash equivalents at end of year	8,083,085	14,927,538
Supplemental disclosure of cash flow information:
Cash paid for interest		475,000
Supplemental schedule of non-cash financing activities:
Convertible promissory note converted into common stock	2,525,000	11,250,000
Recognition of warrant liability		97,730,836
Fair value of common stock warrants exercised reclassified from warrant liability to equity	13,262,801
Common stock and warrant issuance costs in accounts payable and accrued expenses	924,271
Reclassification of deferred offering costs against ATM proceeds	$ 49,092
Right-of-use asset and lease liability recognized for new operating lease liabilities		$ 294,416

Collaboration Arrangements

12 Months Ended

Sep. 30, 2025

Collaboration Arrangements

Collaboration Arrangements

12. Collaboration Arrangements

Syntone Strategic Partnership and PRC Joint Venture

In connection with a stock purchase agreement entered in May 2020 between the Company and Syntone, the Company and Syntone entered into a joint venture agreement pursuant to which they agreed to form a PRC joint venture that will be 80% owned by Syntone and 20% owned by the Company. Upon formation of the PRC joint venture in April 2021, the Company entered into a royalty-free license with the PRC joint venture for the development, commercialization and manufacture of ONS-5010/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. The Company is committed to making up to $2,100,000 in additional capital contributions to the PRC joint venture, based upon the development plan contemplated in the license agreement or on such other terms.

Stock-Based Compensation - Information (Details) - shares	1 Months Ended	12 Months Ended
	Aug. 31, 2024	Sep. 30, 2025
Share-based Compensation
Share-based stock authorized (in shares)	7,293,901
Share-based stock available for grant (in shares)		4,357,084
Term of award	10 years
Minimum
Share-based Compensation
Vesting period	1 year
Maximum
Share-based Compensation
Vesting period	4 years
Employee Stock Option
Share-based Compensation
Term of award		10 years
Employee Stock Option \| Minimum
Share-based Compensation
Vesting period		1 year
Employee Stock Option \| Maximum
Share-based Compensation
Vesting period		4 years
Performance-based stock options
Share-based Compensation
Term of award		10 years

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Accrued Expenses

12 Months Ended

Sep. 30, 2025

Accrued Expenses

Accrued Expenses

7. Accrued Expenses

Accrued expenses consists of:


		September 30,
		2025			2024
Compensation		$	1,437,049		$	1,012,962
Severance and related costs			1,590,835	⁽ⁱ⁾		—
Professional fees			195,623			1,798,767
Research and development			1,188,212			41,373
Accrued rebates			317,754			—
Other accrued expenses			584,847			384,366
		$	5,314,320		$	3,237,468

(i)

In December 2024 and September 2025, the Company implemented workforce reductions to conserve capital. Both the Chief Executive Officer and Chief Commercial Officer of the Company departed from the Company during the fiscal year and their departures constituted a termination without cause, and accordingly were entitled to 12 months of base salary, a lump sum of 100% of their 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 their termination dates. 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 workforce reductions, during the year ended September 30, 2025, the Company recognized $2,894,191 in severance related charges consisting of cash-based expenses related to employee severance and notice period payments, benefits and related costs. In addition, during the year ended September 30, 2025, the Company recorded a non-cash expense totaling $2,201,373 related to stock-based compensation in connection with the acceleration of equity awards for the former Chief Executive Officer and Chief Commercial Officer. The Company made total cash payments related to severance and related charges of $1,303,356 during the year ended September 30, 2025.

Commitments and Contingencies

12 Months Ended

Sep. 30, 2025

Commitments and Contingencies.

Commitments and Contingencies

9. Commitments and Contingencies

Selexis Commercial License Agreements

In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS-3010, ONS-1045 and ONS-1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense.

The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Company’s affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to

terminate its royalty payment obligation by providing written notice to Selexis and paying Selexis a royalty termination fee.

Each of the Company’s commercial agreements with Selexis will expire upon the expiration of all applicable Selexis patent rights. Either party may terminate the related agreement in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, winding up or similar circumstances. Either party may also terminate the related agreement under designated circumstances if the Selexis Technology infringes third-party intellectual property rights. In addition, the Company has the right to terminate each of the commercial agreements at any time at its convenience; however, with respect to the agreements relating to ONS-3010 and ONS-1045, this right is subject to the licensee’s consent pursuant to a corresponding letter the Company executed in conjunction with the standby agreement entered into between Selexis and Laboratories Liomont, S.A. de C.V. (“Liomont”) in November 2014.

The standby agreement permits Liomont to assume the license under the applicable commercial agreement for Mexico upon specified triggering events involving the Company’s bankruptcy, insolvency or similar circumstances.

Technology License

The Company entered into a technology license agreement with Selexis, under which a milestone payment of $365,195 (converted from Swiss Francs to United States dollars) was due upon achievement of certain commercial and clinical milestones. The milestone payment was accrued for as of September 30, 2025 and payment was made in fiscal year 2026. In addition, the agreement requires the Company to pay a single digit royalty on net sales by the Company utilizing such technology. The Company also has the contractual right to buy out the royalty payments at a future date.

Purchase Commitments

As of September 30, 2025, the Company had outstanding contractual commitments of approximately $955,050, primarily related to fill-finish manufacturing services for ONS-5010/LYTENAVA to be performed by its contract manufacturers.

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. The defendants’ motion to dismiss plaintiffs’ second amended complaint is currently pending before the court.

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 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 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 years ended September 30, 2025 and 2024 were as follows:


		Year ended September 30,
		2025			2024
Lease cost:
Interest on lease liabilities		$	—		$	116
Total finance lease cost			—			116
Operating lease cost			76,321			57,973
Total lease cost		$	76,321		$	58,089

Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows:


	September 30,
	2025			2024
Operating leases:
Right-of-use asset	$	225,508		$	274,645
Operating lease liabilities		247,698			297,829
Weighted-average remaining lease term (years):
Operating leases		3.6			4.6
Weighted-average discount rate:
Operating leases		9.9%			9.9%

Other information related to leases for the years ended September 30, 2025 and 2024 are as follows:


	Year ended September 30,
	2025			2024
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	—		$	116
Operating cash flows from operating leases		77,315			14,514
Financing cash flows from finance leases		—			4,267
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—		$	294,416

Future minimum payments under noncancelable leases at September 30, 2025 are as follows for the years ending September 30:


	Operating leases
2026	$	80,730
2027		81,817
2028		83,680
2029		49,447
Total undiscounted lease payments		295,674
Less: Imputed interest		47,976
Total lease obligations	$	247,698

Employee Benefit Plan

The Company maintains a defined contribution 401(k) plan (the “Plan”) in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company matches 100% of the first 3% of employee contributions. The Company assumes all administrative costs of the Plan. For the years ended September 30, 2025 and 2024, the expense relating to the matching contribution was $165,388 and $177,309, respectively.

Stockholders' Equity (Tables)

12 Months Ended

Sep. 30, 2025

Stockholders' Equity

Schedule of warrants outstanding


		Shares of
		common stock
		issuable upon
		exercise of		Exercise Price
Expiration Date		warrants		Per Share
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	(i)	5,782,496		$	7.70
April 15, 2029	(i) (ii)	1,071,429		$	7.70
January 17, 2030	(iii)	13,627,132		$	2.26
May 27, 2030		15,271,428		$	1.40
		35,989,085

(i)

The warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 and are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815-40 guidance and determined that the warrants did not meet Step 2 of the indexation. As a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure above under the header “—Common stock” for further details.

A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the daily volume weighted average price (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) 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 a duly called meeting.

(ii)

Refer above for disclosures on the Syntone Warrant Inducement Transaction for details on these warrants.

(iii)

These are Inducement Warrants. Refer above for disclosures on the Inducement Warrants

Income Taxes (Details) - USD ($)	12 Months Ended
Income Taxes (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Income Taxes
State tax	$ 2,800	$ 2,800
Foreign tax provision	(1,554,629)
Income tax benefit	$ (1,551,829)	$ 2,800

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References

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+ Details

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Sep. 30, 2025
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

Stock-Based Compensation

12 Months Ended

Sep. 30, 2025

Stock-Based Compensation

Stock-Based Compensation

11. 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, RSU 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 7,293,901. As of September 30, 2025, 4,357,084 shares remained available for grant under the 2024 Plan.

Stock options and RSUs granted under the Company's 2024 Plan generally vest over a period of one to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period.

The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2025 and 2024:


	Year ended September 30,
	2025			2024
Research and development	$	379,604		$	800,956
General and administrative		8,480,292			4,584,168
Total	$	8,859,896		$	5,385,124

During the year ended September 30, 2025, the Company capitalized stock-based compensation of $37,991 as part of inventory costs. This amount relates to stock-based compensation expense for employees directly involved in manufacturing activities.

Stock options

The following table summarizes all of the Company’s stock option activity for the year ended September 30, 2025:


						Weighted
						Average
			Weighted			Remaining
	Number of		Average			Contractual		Aggregate
	Shares		Exercise Price			Term (Years)		Intrinsic Value
Balance at September 30, 2024	1,946,646		$	19.51		7.3		$	53,985
Granted	2,046,599			3.69
Forfeited	(356,167)			10.46
Expired	(25,716)			30.48
Balance at September 30, 2025	3,611,362		$	11.36		7.9		$	—
Vested and exercisable at September 30, 2025	1,579,487		$	20.87		6.2		$	—

The aggregate intrinsic value represents the total amount by which the fair market value of the common stock subject to options exceeds the exercise price of the related options.

The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected volatility is based on the Company’s historical volatility. The expected term calculation is based on the “simplified” method described in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, and SAB No. 110, Share-Based Payment, since the simplified method provides a reasonable estimate in comparison to actual experience. The risk-free interest rate is based on the United States Treasury yield at the date of grant for an instrument

with a maturity that is commensurate with the expected term of the stock options. The dividend yield is zero since the Company has never paid cash dividends on its common stock and has no present intention to pay cash dividends. Options granted under the 2024 Plan generally vest over one to four years and have a term of 10 years.

The weighted average grant date fair value of the options awarded to employees and directors for the years ended September 30, 2025 and 2024 was $3.30 and $6.04 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Year ended September 30,
	2025		2024
Risk-free interest rate	3.7	%	4.3	%
Expected term (years)	5.7		6.0
Expected volatility	132.0	%	131.4	%
Expected dividend yield	—		—

As of September 30, 2025, there was $2,016,949 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 0.9 years.

Performance-based stock options

The Company granted certain officers of the Company option awards where vesting was contingent upon meeting certain company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 10 years.

The fair value of each option grant under the performance share option plan was estimated on the date of grant using the same option valuation model used for non-statutory options above. Compensation expense for performance-based stock options is only recognized when management determines it is probable that the awards will vest.

The following table summarizes all of the Company’s performance-based stock option activity for the year ended September 30, 2025.


						Weighted
						Average
			Weighted			Remaining
	Number of		Average			Contractual		Aggregate
	Shares		Exercise Price			Term (Years)		Intrinsic Value
Balance at September 30, 2024	666,500		$	7.94		9.3		$	—
Granted	—			—
Forfeited	(541,000)			6.78
Balance at September 30, 2025	125,500		$	12.92		7.6		$	—
Vested and exercisable at September 30, 2025	35,000		$	28.80		5.3		$	—

During the year ended September 30, 2025, no expense was recognized because the performance conditions were not considered probable of achievement. The assessment was based on the relevant facts and circumstances and therefore no compensation costs were recognized. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Year ended September 30,
	2025		2024
Risk-free interest rate	—	%	4.3	%
Expected term (years)	—		10.0
Expected volatility	—	%	125.6	%
Expected dividend yield	—		—

Accrued Expenses (Tables)

12 Months Ended

Sep. 30, 2025

Accrued Expenses

Schedule of accrued expenses


		September 30,
		2025			2024
Compensation		$	1,437,049		$	1,012,962
Severance and related costs			1,590,835	⁽ⁱ⁾		—
Professional fees			195,623			1,798,767
Research and development			1,188,212			41,373
Accrued rebates			317,754			—
Other accrued expenses			584,847			384,366
		$	5,314,320		$	3,237,468

(i)

Stockholders' Equity - Assumptions (Details)	Sep. 30, 2025 USD ($) $ / shares Y	Sep. 30, 2024 $ / shares Y
Risk-free rate
Fair value inputs
Warrant inputs	0.0364	0.0358
Term
Fair value inputs
Warrant inputs \| Y	3.5	4.5
Volatility
Fair value inputs
Warrant inputs	1.486	1.25
Dividend yield
Fair value inputs
Warrant inputs	0	0
Stock price (in dollars per share)
Fair value inputs
Warrant inputs	1.06	5.34
Inducement Warrants
Fair value inputs
Warrant fair value (in dollars per share)	$ 1.96
Inducement Warrants \| Risk-free rate
Fair value inputs
Warrant inputs	0.0439
Inducement Warrants \| Term
Fair value inputs
Warrant inputs \| Y	5
Inducement Warrants \| Volatility
Fair value inputs
Warrant inputs	1.302
Inducement Warrants \| Dividend yield
Fair value inputs
Warrant inputs	0
Inducement Warrants \| Stock price (in dollars per share)
Fair value inputs
Warrant inputs	2.23
Existing Warrants \| Prior To Modification
Fair value inputs
Warrant fair value (in dollars per share)	$ 1.64
Existing Warrants \| At The Modification
Fair value inputs
Warrant fair value (in dollars per share)	$ 1.88
Existing Warrants \| Risk-free rate
Fair value inputs
Warrant inputs	0.0434
Existing Warrants \| Term
Fair value inputs
Warrant inputs \| $	4.2
Existing Warrants \| Volatility
Fair value inputs
Warrant inputs	1.36
Existing Warrants \| Dividend yield
Fair value inputs
Warrant inputs	0
Existing Warrants \| Stock price (in dollars per share)
Fair value inputs
Warrant inputs	2.23

Stockholders' Equity - Underwritten Public Offering (Details) - USD ($)				12 Months Ended
	May 27, 2025	Apr. 15, 2024	Mar. 18, 2024	Sep. 30, 2025	Sep. 30, 2024
Class of Stock [Line Items]
Aggregate of common stock		714,286	8,571,423
Warrants to purchase aggregate		1,071,429	12,857,133	35,989,085
Purchase price			$ 7
Proceeds from issuance of stock		$ 4,835,371	$ 55,498,311	$ 25,396,398	$ 60,333,681
Common stock shares			1.5
Exercise price		$ 7.7	$ 7.7
GMS Ventures
Class of Stock [Line Items]
Aggregate of common stock			2,305,714
Warrants to purchase aggregate			3,458,571
May 27, 2030
Class of Stock [Line Items]
Warrants to purchase aggregate				15,271,428
Exercise price				$ 1.4
Underwriter
Class of Stock [Line Items]
Aggregate of common stock	9,285,714
Purchase price	$ 1.4
Proceeds from issuance of stock	$ 11,617,407
Underwriter \| GMS Ventures
Class of Stock [Line Items]
Aggregate of common stock	4,285,714
Underwriter \| May 27, 2030
Class of Stock [Line Items]
Warrants to purchase aggregate	18,571,428
Common stock shares	2
Exercise price	$ 1.4
Underwriter \| May 27, 2030 \| GMS Ventures
Class of Stock [Line Items]
Warrants to purchase aggregate	8,571,428

Accrued Expenses (Details) - USD ($)	12 Months Ended
Accrued Expenses (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Accrued Expenses
Compensation	$ 1,437,049	$ 1,012,962
Severance and related costs	1,590,835
Professional fees	195,623	1,798,767
Research and development	1,188,212	41,373
Accrued rebates	317,754
Other accrued expenses	584,847	384,366
Total accrued expenses	5,314,320	$ 3,237,468
Severance related expense	2,894,191
Accelerated equity awards expense	2,201,373
Restructuring severance payment	$ 1,303,356

Commitments and Contingencies - Lease cost (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Mar. 31, 2024	Mar. 31, 2021
Commitments and Contingencies.
Operating lease term			5 years	3 years
Lease cost
Interest on lease liabilities		$ 116
Total finance lease cost		116
Operating lease cost	$ 76,321	57,973
Total lease cost	$ 76,321	$ 58,089

Commitments and Contingencies - Employee Benefit (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Commitments and Contingencies.
Maximum employee annual contributions (as a percent)	100.00%
Maximum employer annual contributions (as a percent)	100.00%
Maximum employer match (as a percent)	3.00%
Expense related to matching contribution	$ 165,388	$ 177,309

Fair Value Measurements - Fair value changes (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Liabilities fair value changes
Fair value of common stock warrants exercised reclassified from warrant liability to equity	$ 13,262,801
Unsecured convertible promissory notes
Liabilities fair value changes
Balance, beginning	29,440,000	$ 35,551,000
Fair value of unsecured convertible promissory note issued	33,100,000
Promissory note maturity extension fee added to outstanding balance		2,681,847
Principal and accrued interest converted to common stock	(2,525,000)	(11,250,000)
Loss (gain) from change in fair value	$ 6,074,586	$ 2,457,153
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Change In Fair Value Of Redemption Feature	Change In Fair Value Of Redemption Feature
Repayment	$ (36,142,586)
Balance, ending	29,947,000	$ 29,440,000
Common stock warrants
Liabilities fair value changes
Balance, beginning	59,099,013	6,219
Fair value of unsecured convertible promissory note issued		97,730,836
Loss (gain) from change in fair value	(43,015,831)	(38,638,042)
Loss from change in fair value from warrant inducement	1,948,057
Reclassification of fair value of common stock warrants exercised to equity	(13,262,801)
Balance, ending	$ 4,768,438	$ 59,099,013

Consolidated Balance Sheets (Parentheticals) - $ / shares	Sep. 30, 2025	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	260,000,000	260,000,000
Common stock, shares issued	53,887,233	23,905,635
Common stock, shares outstanding	53,887,233	23,905,635

Fair Value Measurements

12 Months Ended

Sep. 30, 2025

Fair Value Measurements

Fair Value Measurements

4. Fair Value Measurements

The following table presents the Company’s liabilities that are measured at fair value on a recurring basis:


		September 30, 2025
		(Level 1)			(Level 2)			(Level 3)
Liabilities
Unsecured convertible promissory note		$	—		$	—		$	29,947,000
Warrant liability			—			—			4,768,438
Total		$	—		$	—		$	34,715,438

		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 the unsecured convertible promissory notes for the years ended September 30, 2025 and 2024:


	Unsecured Convertible
	Promissory Notes		Warrants
Balance at October 1, 2023	$	35,551,000	$	6,219
Issued in connection with sale of common stock		—		97,730,836
Promissory note maturity extension fee added to outstanding balance		2,681,847		—
Principal and accrued interest converted to common stock		(11,250,000)		—
Loss (gain) from change in fair value		2,457,153		(38,638,042)
Balance at September 30, 2024		29,440,000		59,099,013
Fair value of unsecured convertible promissory note issued		33,100,000		—
Principal and accrued interest converted to common stock		(2,525,000)		—
Loss (gain) from change in fair value		6,074,586		(43,015,831)
Loss from change in fair value from warrant inducement		—		1,948,057
Reclassification of fair value of common stock warrants exercised to equity		—		(13,262,801)
Repayment		(36,142,586)		—
Balance at September 30, 2025	$	29,947,000	$	4,768,438

Unsecured convertible promissory notes

As further described in Note 8, the Company elected the fair value option to account for the unsecured convertible promissory notes. The fair value of these instruments 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 values of the unsecured convertible promissory notes as of September 30, 2025 and 2024 were estimated using a binomial lattice model with the following assumptions:


	September 30,
	2025			2024
Term (years)		0.8			0.8
Volatility		118.0	%		91.0	%
Risk-free rate		3.8	%		4.2	%
Dividend yield		—	%		—	%
Credit-adjusted discount rate		18.8	%		20.4	%
Stock price	$	1.06		$	5.34

Common stock warrants

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. These warrants expired during the fiscal year ended September 30, 2025. 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. During the year ended September 30, 2025, the Company reclassified the warrant liability balance of $13,262,801 into additional paid in capital upon the exercise of certain of the private placement warrants. Refer to Note 10 for further details on warrants exercised pursuant to the warrant inducement transaction.

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:


	September 30,
	2025			2024
Risk-free interest rate		3.64	%		3.58	%
Remaining contractual term of warrants (years)		3.5			4.5
Expected volatility		148.6	%		125.0	%
Annual dividend yield		—	%		—	%
Stock price	$	1.06		$	5.34

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
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-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 3: http://www.xbrl.org/2003/role/exampleRef
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-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

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+ Details

Stock-Based Compensation (Tables)

12 Months Ended

Sep. 30, 2025

Share-based Compensation

Schedule of stock-based compensation expense


	Year ended September 30,
	2025			2024
Research and development	$	379,604		$	800,956
General and administrative		8,480,292			4,584,168
Total	$	8,859,896		$	5,385,124

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 September 30, 2024	1,946,646		$	19.51		7.3		$	53,985
Granted	2,046,599			3.69
Forfeited	(356,167)			10.46
Expired	(25,716)			30.48
Balance at September 30, 2025	3,611,362		$	11.36		7.9		$	—
Vested and exercisable at September 30, 2025	1,579,487		$	20.87		6.2		$	—

Schedule of option assumptions


	Year ended September 30,
	2025		2024
Risk-free interest rate	3.7	%	4.3	%
Expected term (years)	5.7		6.0
Expected volatility	132.0	%	131.4	%
Expected dividend yield	—		—

Performance-based stock options

Share-based Compensation

Schedule of stock option activity


						Weighted
						Average
			Weighted			Remaining
	Number of		Average			Contractual		Aggregate
	Shares		Exercise Price			Term (Years)		Intrinsic Value
Balance at September 30, 2024	666,500		$	7.94		9.3		$	—
Granted	—			—
Forfeited	(541,000)			6.78
Balance at September 30, 2025	125,500		$	12.92		7.6		$	—
Vested and exercisable at September 30, 2025	35,000		$	28.80		5.3		$	—

Schedule of option assumptions


	Year ended September 30,
	2025		2024
Risk-free interest rate	—	%	4.3	%
Expected term (years)	—		10.0
Expected volatility	—	%	125.6	%
Expected dividend yield	—		—

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Consolidated Statements of Stockholders' 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
Sale of common stock, net of issuance costs	$ 92,857			92,857
Sale of common stock, net of issuance costs (in shares)	9,285,709
Issuance of common stock in connection with conversion of convertible promissory note	$ 16,072	11,233,928		11,250,000
Issuance of common stock in connection with conversion of convertible promissory note (in shares)	1,607,093
Stock-based compensation expense		5,385,124		5,385,124
Net loss			(75,366,714)	(75,366,714)
Balance, ending at Sep. 30, 2024	$ 239,057	469,969,333	(543,284,900)	$ (73,076,510)
Balance, ending (in shares) at Sep. 30, 2024	23,905,635			23,905,635
Increase (Decrease) in Stockholders' Equity
Sale of common stock, net of issuance costs	$ 179,676	24,850,179		$ 25,029,855
Sale of common stock, net of issuance costs (in shares)	17,967,567
Issuance of common stock and common stock warrants in connection with exercise of common stock warrants	$ 108,967	66,752,003		66,860,970
Issuance of common stock and common stock warrants in connection with exercise of common stock warrants (in shares)	10,896,779
Issuance of common stock in connection with conversion of convertible promissory note	$ 11,173	2,513,827		2,525,000
Issuance of common stock in connection with conversion of convertible promissory note (in shares)	1,117,252
Stock-based compensation expense		8,897,887		8,897,887
Net loss			(62,424,863)	(62,424,863)
Balance, ending at Sep. 30, 2025	$ 538,873	$ 572,983,229	$ (605,709,763)	$ (32,187,661)
Balance, ending (in shares) at Sep. 30, 2025	53,887,233			53,887,233

Fair Value Measurements (Details) - Recurring - Level 3 - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Liabilities
Unsecured convertible promissory note	$ 29,947,000	$ 29,440,000
Warrant liability	$ 4,768,438	$ 59,099,013
Derivative Liability, Statement of Financial Position [Extensible Enumeration]	Warrants and Rights Outstanding	Warrants and Rights Outstanding
Total	$ 34,715,438	$ 88,539,013

- Definition

Fair value portion of borrowing which can be exchanged for a specified number of another security at the option of the issuer or the holder, for example, but not limited to, the entity's common stock.

+ References

+ Details

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
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-Name Accounting Standards Codification
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+ Details

Segment Information

12 Months Ended

Sep. 30, 2025

Segment Information

Segment Information

14. Segment Information

Operating segments are components of an enterprise for which discrete financial information is available and reviewed by the chief operating decision maker (“CODM”) to allocate resources and assess performance. The Company has one reportable segment, which consists of the development and commercialization of ONS-5010/LYTENAVA™, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Company’s CODM is its Chief Executive Officer, who evaluates and manages the business on a consolidated basis for purposes of resource allocation and performance assessment.

The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies. To date, the Company has generated insignificant product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The CODM uses budget versus forecasted expense and cash forecast models in making decisions. Such models are reviewed to assess the entity-wide operating results and performance, including how long cash is expected to be sufficient. The measure of segment assets is reported on the consolidated balance sheet as total assets.

The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended September 30, 2025 and 2024:


	Year ended September 30,
	2025		2024
Revenues, net	$	1,413,535	$	—
Cost of revenues		1,356,330		—
Gross profit		57,205		—
Operating expenses:
Research and development expenses
ONS-5010/LYTENAVA development		23,286,684		37,355,884
Compensation and related benefits		2,385,606		2,507,635
Stock-based compensation		379,604		800,956
Other research and development		1,128,746		1,098,572
		27,180,640		41,763,047
Selling, general and administrative expenses
Professional fees		6,173,453		9,866,128
Compensation and related benefits		8,177,077		6,301,200
Stock-based compensation		8,480,292		4,584,168
Europe launch expenses		13,377,691		5,010,687
Facilities, fees and other related costs		3,729,718		4,178,005
		39,938,231		29,940,188

Segment loss from operations		(67,061,666)		(71,703,235)
Other segment items ⁽ⁱ⁾		3,084,974		(3,660,679)
Segment loss before income taxes	$	(63,976,692)	$	(75,363,914)

(i)

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

Liquidity (Details) - USD ($)				12 Months Ended
Liquidity (Details) - USD ($)	Oct. 01, 2025	Apr. 15, 2024	Mar. 18, 2024	Sep. 30, 2025	Sep. 30, 2024
Liquidity
Accumulated deficit				$ (605,709,763)	$ (543,284,900)
Debt, interest, fees				31,452,334
Sale of common stock, net of issuance costs (in shares)		714,286	8,571,423
Proceeds from issuance of stock		$ 4,835,371	$ 55,498,311	$ 25,396,398	$ 60,333,681
Subsequent Events
Liquidity
Sale of common stock, net of issuance costs (in shares)	10,227,166
Proceeds from issuance of stock	$ 14,931,537
Payment of fees to sales agent	$ 461,800

- Definition

Fair value portion of debt instrument payable, including, but not limited to, notes payable and loans payable.

+ References

+ Details

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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-Name Accounting Standards Codification
-Section 50
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-URI https://asc.fasb.org/1943274/2147482900/835-30-50-1

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Leases
Operating leases, Right-of-use asset	$ 225,508	$ 274,645
Operating lease liabilities	$ 247,698	$ 297,829
Operating leases, Weighted-average remaining lease term	3 years 7 months 6 days	4 years 7 months 6 days
Operating leases, Weighted-average discount rate (as a percent)	9.90%	9.90%

Basis of Presentation and Summary of Significant Accounting Policies (Details)	12 Months Ended
	Sep. 30, 2025 USD ($) segment
Basis of Presentation and Summary of Significant Accounting Policies
Accounts receivable, allowance for credit loss, current \| $	$ 0
Number of reportable segment \| segment	1

Debt - Summary (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Debt
Less: current portion	$ (29,947,000)	$ (29,440,000)
Unsecured promissory notes-aggregate
Debt
Total debt	$ 29,947,000	$ 29,440,000

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

Fair Value Measurements (Tables)

12 Months Ended

Sep. 30, 2025

Fair value

Schedule of assets and liabilities measured at fair value


		September 30, 2025
		(Level 1)			(Level 2)			(Level 3)
Liabilities
Unsecured convertible promissory note		$	—		$	—		$	29,947,000
Warrant liability			—			—			4,768,438
Total		$	—		$	—		$	34,715,438

		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 Notes		Warrants
Balance at October 1, 2023	$	35,551,000	$	6,219
Issued in connection with sale of common stock		—		97,730,836
Promissory note maturity extension fee added to outstanding balance		2,681,847		—
Principal and accrued interest converted to common stock		(11,250,000)		—
Loss (gain) from change in fair value		2,457,153		(38,638,042)
Balance at September 30, 2024		29,440,000		59,099,013
Fair value of unsecured convertible promissory note issued		33,100,000		—
Principal and accrued interest converted to common stock		(2,525,000)		—
Loss (gain) from change in fair value		6,074,586		(43,015,831)
Loss from change in fair value from warrant inducement		—		1,948,057
Reclassification of fair value of common stock warrants exercised to equity		—		(13,262,801)
Repayment		(36,142,586)		—
Balance at September 30, 2025	$	29,947,000	$	4,768,438

Unsecured convertible promissory notes

Fair value

Schedule of fair value inputs


	September 30,
	2025			2024
Term (years)		0.8			0.8
Volatility		118.0	%		91.0	%
Risk-free rate		3.8	%		4.2	%
Dividend yield		—	%		—	%
Credit-adjusted discount rate		18.8	%		20.4	%
Stock price	$	1.06		$	5.34

Common stock warrants

Fair value

Schedule of fair value inputs


	September 30,
	2025			2024
Risk-free interest rate		3.64	%		3.58	%
Remaining contractual term of warrants (years)		3.5			4.5
Expected volatility		148.6	%		125.0	%
Annual dividend yield		—	%		—	%
Stock price	$	1.06		$	5.34

Consolidated Statements of Operations - USD ($)	12 Months Ended
Consolidated Statements of Operations - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Consolidated Statements of Operations
Revenues, net	$ 1,413,535
Cost of revenues	1,356,330
Gross profit	57,205
Operating expenses:
Research and development	27,180,640	$ 41,763,047
Selling, general and administrative	39,938,231	29,940,188
Loss from operations	(67,061,666)	(71,703,235)
Loss on equity method investment	141,007	100,742
Interest income	(89,738)	(906,150)
Interest expense	283,128	3,156,964
Loss from change in fair value of promissory notes	6,074,586	2,457,153
Warrant related expenses (Note 10)		37,490,012
Warrant inducement expenses (Note 10)	33,521,874
Gain from change in fair value of warrant liability	(43,015,831)	(38,638,042)
Loss before income taxes	(63,976,692)	(75,363,914)
Income tax (benefit) expense	(1,551,829)	2,800
Net loss	$ (62,424,863)	$ (75,366,714)
Per share information:
Net loss per share of common stock, basic (in dollars per share)	$ (1.79)	$ (4.06)
Net loss per share of common stock, diluted (in dollars per share)	$ (1.79)	$ (4.06)
Weighted average shares outstanding, basic (in shares)	34,796,120	18,548,813
Weighted average shares outstanding, diluted (in shares)	34,796,120	18,548,813

Stockholders' Equity - Common Stock Warrants (Details) - USD ($)	12 Months Ended
	Sep. 30, 2025	Apr. 15, 2024	Mar. 18, 2024
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	35,989,085	1,071,429	12,857,133
Exercise price per share (in dollars per share)		$ 7.7	$ 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)	20.00%
Aggregate of common stock expired	42,460
Weighted average exercise price expired	$ 149.11
Aggregate net proceeds	$ 22,024,352
Existing Warrants
Common Stock and Stockholders' Equity
Exercise price per share (in dollars per share)	$ 2.51
Purchase of aggregate common stock	7,074,637
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)	$ 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)	$ 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)	$ 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)	$ 31.25
March 18, 2029
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	5,782,496
Exercise price per share (in dollars per share)	$ 7.7
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)	$ 7.7
January 17, 2030
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	13,627,132
Exercise price per share (in dollars per share)	$ 2.26
May 27, 2030
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	15,271,428
Exercise price per share (in dollars per share)	$ 1.4
Purchase of aggregate common stock	3,300,000
Aggregate net proceeds	$ 4,327,940
Inducement Warrants
Common Stock and Stockholders' Equity
Exercise price per share (in dollars per share)	$ 2.26
Purchase of aggregate common stock	522,142
Aggregate net proceeds	$ 1,105,444

Income Taxes (Tables)

12 Months Ended

Sep. 30, 2025

Income Taxes

Schedule of Income tax expense


		Year ended September 30,
		2025			2024
State tax		$	2,800		$	2,800
Foreign tax provision			(1,554,629)			—
		$	(1,551,829)		$	2,800

Schedule of tax expense reconciliation


	Year ended September 30,
	2025		2024
U.S. federal statutory rate	(21.0)	%	(21.0)	%
State taxes, net of federal benefit	(0.1)		(6.2)
Change in state rate	8.5		—
Deferred true-up	0.2		0.2
Foreign withholding tax	(2.4)		—
Permanent differences	(0.9)		2.5
Foreign tax credits	0.3		1.7
Research and development credit	2.2		(2.4)
Change in valuation allowance	11.1		25.3
Other	(0.3)		(0.1)
Effective income tax rate	(2.4)	%	0.0	%

Schedule of deferred taxes


	September 30,
	2025		2024
Deferred tax assets:
Net operating loss carryforwards	$	110,272,674	$	102,906,140
Capitalized research and development costs		13,720,059		15,200,918
Stock-based compensation		6,612,848		6,463,068
Lease liability		52,366		83,720
Research and development credit carryforward		12,370,887		13,748,600
Foreign tax credits		100,000		290,188
Accruals and others		2,799,707		144,079
Gross deferred tax assets		145,928,541		138,836,713
Less: valuation allowance		(145,880,866)		(138,759,510)
		47,675		77,203
Deferred tax liabilities:
Right-of-use assets		(47,675)		(77,203)
Net deferred tax assets	$	—	$	—

Schedule of reconciliation of unrecognized tax benefits


	Year ended September 30,
	2025		2024
Balance at beginning of year	$	1,854,629	$	1,854,629
Changes based on tax positions related to the current year		(1,554,629)		—
Balance at end of year	$	300,000	$	1,854,629

Pay vs Performance Disclosure - USD ($)	12 Months Ended
Pay vs Performance Disclosure - USD ($)	Sep. 30, 2025	Sep. 30, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (62,424,863)	$ (75,366,714)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
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Reference 36: http://www.xbrl.org/2003/role/disclosureRef
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Reference 37: http://www.xbrl.org/2003/role/disclosureRef
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Reference 38: http://www.xbrl.org/2003/role/disclosureRef
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Reference 39: http://www.xbrl.org/2003/role/disclosureRef
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Reference 40: http://www.xbrl.org/2003/role/disclosureRef
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Reference 41: http://www.xbrl.org/2003/role/disclosureRef
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Reference 43: http://www.xbrl.org/2003/role/disclosureRef
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Reference 46: http://www.xbrl.org/2003/role/disclosureRef
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Reference 47: http://www.xbrl.org/2003/role/disclosureRef
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Reference 48: http://www.xbrl.org/2003/role/disclosureRef
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Reference 49: http://fasb.org/us-gaap/role/ref/legacyRef
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2025
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

Stockholders' Equity

12 Months Ended

Sep. 30, 2025

Stockholders' Equity

Stockholders' Equity

10. Stockholders’ Equity

Common stock

On March 7, 2024, following receipt of stockholder approval at the Company’s 2024 annual meeting of stockholders, the number of authorized shares of common stock under the Company’s Certificate of Incorporation was increased from 21,250,000 shares to 60,000,000 shares.

On March 11, 2025, following receipt of stockholder approval at the Company’s 2025 annual meeting of stockholders, the number of authorized shares of common stock under the Company’s Certificate of Incorporation was increased from 60,000,000 shares to 260,000,000 shares.

On March 18, 2024, in a private placement (the “Private Placement”) pursuant to a securities purchase agreement entered in January 2024 with certain institutional and accredited investors, including GMS Ventures and Investments (“GMS Ventures”), the Company’s largest stockholder, the Company issued an aggregate of 8,571,423 shares of common stock and warrants to purchase an aggregate of 12,857,133 shares of common stock at a purchase price per share of $7.00 per share (the “Private Placement Warrants”) and accompanying warrant to purchase one and one-half shares of common stock for $55,498,311 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 2,305,714 shares of common stock and warrants to purchase an aggregate of 3,458,571 shares of common stock in the Private Placement. The Warrants have an exercise price of $7.70 per share of common stock and will expire on March 18, 2029.

On April 15, 2024, in a private placement with Syntone pursuant to a securities purchase agreement entered into in January 2024 (the “Syntone Private Placement”), the Company issued 714,286 shares of common stock and accompanying warrants to purchase 1,071,429 shares of common stock for $4,835,371 in net proceeds on substantially the same terms as those in the Private Placement. The warrants have an exercise price of $7.70 per share of common stock and will expire on April 15, 2029.

On January 16, 2025, the Company executed warrant inducement agreements with GMS Ventures and certain other holders of Private Placement Warrants to exercise warrants for 7,074,637 shares of common stock. Concurrently, the Company entered into a warrant inducement transaction with Syntone to exercise warrants for 1,071,429 shares of common stock issued under the Syntone Warrant Inducement Transaction, defined below. For further details on the warrant inducement

agreements, refer to the sections on the Warrant Inducement Transaction and the Syntone Warrant Inducement Transaction below.

The Company evaluated the equity classification for the common stock warrants and considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity (“ASC 815-40”). The Company determined that the warrants did not meet the “fixed for fixed” settlement provision set forth in Step 2 of the indexation guidance and as a result they are not indexed to the Company’s own stock and must be classified as liabilities. The warrants were measured at fair value at issuance and recorded as a liability and will be remeasured to fair value at each subsequent reporting date, with changes in fair value recorded in current earnings. The net proceeds from the Private Placement were allocated first to the warrants at fair value, with the residual amount recorded as common stock at par value. The Company will continue to classify such warrants as liabilities until they are exercised, expire, or are no longer required to be classified as liabilities.

The fair value of the warrants at issuance exceeded the proceeds received from both the Private Placement and the Syntone Private Placement; therefore, no proceeds were allocated to additional paid-in capital. For the year ended September 30, 2024, the aggregate excess of the warrant fair value over the related proceeds was $37,490,012, which was recognized as warrant-related expenses in the consolidated statements of operations.

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 (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 September 30, 2025, $282,420 of such deferred costs are included in other assets on the 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 year ended September 30, 2024, no shares of common stock were sold under the BTIG ATM Offering. During the year ended September 30, 2025, the Company sold 8,681,852 shares of common stock under the BTIG ATM Offering and generated $13,461,540 in net proceeds after paying fees to BTIG and other issuance costs of $416,337.

Warrant Inducement Transaction

On January 16, 2025, the Company entered into warrant exercise inducement offer letter agreements with GMS Ventures and certain other holders of Private Placement Warrants, 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 $16,590,968 after capital markets advisory fees and offering costs, from the Warrant Inducement Transaction. On the modification date, the Company remeasured the warrants at the reduced exercise price and recognized a $1,692,779 inducement charge in the consolidated statements of operations for the year ended September 30, 2025. Upon the exercise of these liability classified warrants, the Company reclassed the warrant liability balance of $13,262,801 into additional paid in capital.

In connection with the Warrant Inducement Transaction, half of the Inducement Warrants (the “Tranche A Inducement Warrants”), representing warrants to purchase up to 7,074,637 shares of common stock were exercisable immediately and expire on January 17, 2030. The remaining Inducement Warrants (the “Tranche B Inducement Warrants”) became 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 Tranche A and B Inducement Warrants are considered equity-classified

warrants. Given that the Tranche A and Tranche B Inducement Warrants were issued concurrently with the exercise of the Existing Warrants, the Company recorded an inducement charge in the consolidated statements of operations in the amount of $27,421,002 for the year ended September 30, 2025.

Syntone Warrant Inducement Transaction

Concurrently with the Warrant Inducement Transaction, the Company entered into a warrant exercise inducement offer letter agreement with 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. On the modification date, the Company remeasured the warrants at the reduced exercise price and recognized a $255,278 inducement charge in the consolidated statements of operations for the year ended September 30, 2025. As of the date of this filing, Syntone has not received regulatory approval and, thus, the Company has not yet received the proceeds from the exercise of the Existing Syntone Warrants. There can be no assurance that Syntone will receive the requisite regulatory approval in the near term or at all, and the Company may never receive the proceeds from the exercise of the Existing Syntone Warrants, or issue, or receive proceeds from the exercise of, the Syntone Inducement Warrants. In connection with the Syntone Warrant Inducement Transaction, 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. As of the date of this filing, the Syntone Tranche A and Tranche B Inducement Warrants have not been issued. Given that the Company agreed to issue Syntone Tranche A and Tranche B Inducement Warrants in exchange for Syntone’s agreement to exercise existing warrants at a reduced exercise price, the Company recorded an inducement charge in the consolidated statements of operations in the amount of $4,152,815 for the year ended September 30, 2025.

The fair value per share of the Existing Warrants and Existing Syntone Warrants was determined using the Black-Scholes option pricing model. Prior to the modification of the warrant exercise price, the fair value per share was $1.64, based on a risk-free interest rate of 4.34%, a remaining contractual term of 4.2 years, expected volatility of 136.0%, a dividend yield of 0%, and a stock price of $2.23. On the modification date, the fair value per share was $1.88, calculated using the same assumptions.

The fair value per share of the Tranche A Inducement Warrants, Tranche B Inducement Warrants, Syntone Tranche A and B Inducement Warrants of $1.96 was estimated using the Black-Scholes option pricing model using the following weighted average assumptions: a risk-free interest rate of 4.39%, a contractual term of 5 years, an expected volatility of 130.2%, an anticipated annual dividend yield of 0%, and a stock price of $2.23.

Underwritten Public Offering

On May 27, 2025, the Company completed an underwritten public offering (the “Public Offering”) of 9,285,714 shares of common stock and warrants to purchase an aggregate of 18,571,428 shares of common stock pursuant to an underwriting agreement dated May 22, 2025, between the Company and BTIG. The combined price for each share of common stock and accompanying warrant to purchase two shares of common stock was $1.40. The Company received aggregate net proceeds of $11,617,407, after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 4,285,714 shares of common stock and warrants to purchase an aggregate of 8,571,428 shares of common stock in the Public Offering. The warrants have an exercise price of $1.40 per share of common stock and will expire on May 27, 2030.

Common stock warrants

As of September 30, 2025, the Company had the following warrants outstanding to acquire shares of its common stock:


		Shares of
		common stock
		issuable upon
		exercise of		Exercise Price
Expiration Date		warrants		Per Share
December 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	(i)	5,782,496		$	7.70
April 15, 2029	(i) (ii)	1,071,429		$	7.70
January 17, 2030	(iii)	13,627,132		$	2.26
May 27, 2030		15,271,428		$	1.40
		35,989,085

(i)

(ii)

Refer above for disclosures on the Syntone Warrant Inducement Transaction for details on these warrants.

(iii)

These are Inducement Warrants. Refer above for disclosures on the Inducement Warrants

During the year ended September 30, 2025, warrants to purchase an aggregate of 42,460 shares of common stock with a weighted average exercise price of $149.11 expired. In addition, warrants to purchase an aggregate of 7,074,637 shares of common stock with an exercise price of $2.51 related to the Warrant Inducement Transaction, warrants to purchase an aggregate of 3,300,000 shares of common stock with an exercise price of $1.40 generating net proceeds of $4,327,940, and warrants to purchase an aggregate of 522,142 shares of common stock with an exercise price of $2.26 were exercised generating net proceeds of $1,105,444. The Company generated aggregate net proceeds of $22,024,352 from common stock warrants exercised the year ended September 30, 2025 after deducting expenses associated with with such exercises.

- Definition

The entire disclosure for equity.

+ References

+ Details

Stockholders' Equity - Warrant Inducement (Details)		12 Months Ended
Stockholders' Equity - Warrant Inducement (Details)	Jan. 16, 2025 USD ($) item $ / shares shares	Sep. 30, 2025 USD ($) $ / shares shares	Apr. 15, 2024 $ / shares shares	Mar. 18, 2024 $ / shares shares
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)		35,989,085	1,071,429	12,857,133
Exercise price per share (in dollars per share) \| $ / shares			$ 7.7	$ 7.7
Warrant inducement expenses \| $		$ 33,521,874
Fair value of common stock warrants exercised reclassified from warrant liability to equity \| $		13,262,801
GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)				3,458,571
Net proceeds \| $	$ 16,590,968
Warrant inducement expenses \| $	1,692,779	27,421,002
Fair value of common stock warrants exercised reclassified from warrant liability to equity \| $	$ 13,262,801
Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Number of warrants issued \| item	2
Warrant inducement expenses \| $	$ 255,278	$ 4,152,815
Existing Warrants
Common Stock and Stockholders' Equity
Exercise price per share (in dollars per share) \| $ / shares		$ 2.51
Existing Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	7,074,637
Exercise price per share (in dollars per share) \| $ / shares	$ 2.51
Existing Warrants \| Syntone Ventures, LLC
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	$ 2.51
Inducement Warrants
Common Stock and Stockholders' Equity
Exercise price per share (in dollars per share) \| $ / shares		$ 2.26
Inducement Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	14,149,274
Exercise price per share (in dollars per share) \| $ / shares	$ 2.26
Inducement Warrants \| Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	2,142,858
Exercise price per share (in dollars per share) \| $ / shares	$ 2.26
Number of warrants issued \| item	2
Warrants exercise term	5 years
Tranche A Inducement Warrants \| GMS Ventures
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	7,074,637
Tranche A Inducement Warrants \| Syntone Ventures, LLC
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	1,071,429

Commitments and Contingencies (Details)	Sep. 30, 2025 USD ($)
Selexis
Commitments
Milestone payment	$ 365,195
Fill-finish manufacturing
Commitments
Remaining future financial obligations	$ 955,050

Basis of Presentation and Summary of Significant Accounting Policies (Tables)

12 Months Ended

Sep. 30, 2025

Basis of Presentation and Summary of Significant Accounting Policies

Schedule of anti-dilutive securities


		Year ended September 30,
		2025			2024
Performance-based stock options			125,500			666,500
Stock options			3,611,362			1,946,646
Common stock warrants			35,989,085			14,207,622
Convertible debt	⁽ⁱ⁾		12,946,011		⁽ⁱⁱ⁾	1,171,100

(i)

(ii)

Income Taxes - Carryforwards (Details) - USD ($)	12 Months Ended
Income Taxes - Carryforwards (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2023
Carryforwards
Increase (decrease) in valuation allowance	$ 7,100,000	$ 19,000,000
Unrecognized tax benefits	300,000	$ 1,854,629	$ 1,854,629
Federal
Carryforwards
NOL carryforwards	441,000,000
Tax credit carryforward	11,600,000
State
Carryforwards
NOL carryforwards	243,600,000
Tax credit carryforward	800,000
Foreign
Carryforwards
Tax credit carryforward	100,000
Unrecognized tax benefits	$ 1,900,000

Equity Method Investment - Syntone (Details) - Syntone - USD ($)		1 Months Ended
	May 22, 2020	Jun. 30, 2020
Investments
Ownership (as a percent)	20.00%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000
Syntone PRC
Investments
Ownership (as a percent)	80.00%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Organization and Operations

12 Months Ended

Sep. 30, 2025

Organization and Operations

Organization and Operations

1. Organization and Operations

Description of the Business

Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-gamma), an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Iselin, New Jersey.

In May 2024, the Company received Marketing Authorization from the European Commission for ONS-5010/LYTENAVA, 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 ONS-5010/LYTENAVA in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). ONS-5010/LYTENAVA 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 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial to support its BLA for ONS-5010/LYTENAVA. The Company submitted a Special Protocol Assessment (“SPA”) for the NORSE EIGHT study in December 2023, and in January 2024 the FDA agreed that the protocol, if successful, would satisfy the requirement for a second adequate and well-controlled trial. The company also identified approaches to address the CMC comments in the Complete Response Letter (“CRL”). In November 2024, the Company announced that NORSE EIGHT did not meet the pre-specified non-inferiority endpoint; however, results demonstrated improvements in vision, evidence of biologic activity, and a favorable safety profile, which were further supported by the full week 12 data set. The Company resubmitted the BLA in February 2025. On August 27, 2025, the FDA issued a second CRL citing a single deficiency related to substantial evidence of effectiveness and recommended submission of confirmatory efficacy data, while reaffirming that the NORSE TWO trial met its primary endpoint. Following a Type A meeting in September 2025, the Company resubmitted the BLA on November 3, 2025, and received a Prescription Drug User Fee Act. (“PDUFA”) goal date of December 31, 2025.

Segment Information (Details)	12 Months Ended
Segment Information (Details)	Sep. 30, 2025 USD ($) segment	Sep. 30, 2024 USD ($)
Segment Information
Number of reportable segment \| segment	1
Segment loss before income taxes
Revenues, net	$ 1,413,535
Cost of revenues	1,356,330
Gross profit	57,205
Research and development expenses
Research and Development Expense, Total	27,180,640	$ 41,763,047
Selling, general and administrative expenses
Total selling, general and administrative expenses	39,938,231	29,940,188
Loss from operations	$ (67,061,666)	$ (71,703,235)
Segment Reporting, Other Segment Item, Composition, Description	Other segment items included in segment loss includes loss on equity method investment, interest income, interest expense, loss from change in fair value of promissory notes, warrant related expenses, warrant inducement expenses, and gain from change in fair value of warrant liability.	Other segment items included in segment loss includes loss on equity method investment, interest income, interest expense, loss from change in fair value of promissory notes, warrant related expenses, warrant inducement expenses, and gain from change in fair value of warrant liability.
Loss before income taxes	$ (63,976,692)	$ (75,363,914)
Development and commercialization of ONS-5010/LYTENAVA
Segment loss before income taxes
Revenues, net	1,413,535
Cost of revenues	1,356,330
Gross profit	57,205
Research and development expenses
ONS-5010/LYTENAVA development	23,286,684	37,355,884
Compensation and related benefits	2,385,606	2,507,635
Stock-based compensation	379,604	800,956
Other research and development	1,128,746	1,098,572
Research and Development Expense, Total	27,180,640	41,763,047
Selling, general and administrative expenses
Professional fees	6,173,453	9,866,128
Compensation and related benefits	8,177,077	6,301,200
Stock-based compensation	8,480,292	4,584,168
Europe launch expenses	13,377,691	5,010,687
Facilities, fees and other related costs	3,729,718	4,178,005
Total selling, general and administrative expenses	39,938,231	29,940,188
Loss from operations	(67,061,666)	(71,703,235)
Other segment items	3,084,974	(3,660,679)
Loss before income taxes	$ (63,976,692)	$ (75,363,914)

Cybersecurity Risk Management and Strategy Disclosure	12 Months Ended
Cybersecurity Risk Management and Strategy Disclosure	Sep. 30, 2025
Cybersecurity Risk Management, Strategy, and Governance [Line Items]
Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block]	We depend on the functioning, availability and security of our information systems, including financial, data processing, communications and operating systems. Several information systems, such as software applications and cloud platforms, are provided by third parties. Our cybersecurirty risk framework is designed to allow us to identify, assess and manage the cybersecurity risks we face in relation to, our systems and the information we process. As part of our framework, we maintain certain processes defined to assess, identify and manage risks. For example, we have an incident management and response process under which we communicate the details of certain threats and incidents to management and the board as may be appropriate; use manual and automated processes that are designed to monitor relevant information systems for vulnerabilities, threats and incidents; manage and take certain actions designed to address incidents that may occur; and take actions designed to remediate certain vulnerabilities identified in relevant enviornements. We employ an array of data security technologies, processes, and methods across our infrastructure designed to protect our systems and sensitive information from unauthorized access. We work with information technology consultants who provide advice and expertise on monitoring evolving industry practices. Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. For example, certain management executives, including our Executive VP and Chief Financial Officer evaluates material risks from cybersecurity threats in connection with our overall business objectives and reports such evaluations to the audit committee of the board of directors as appropriate, which then evaluates our overall enterprise risks. In addition to the third parties above, we use additional third-party service providers to perform a variety of functions throughout our business, such as enterprise and employee management platforms, labs, contract research organizations, contract manufacturing organizations, and supply chain resources. Depending on the nature of the services provided, the sensitivity of the information systems and data at issue, and the identity of the provider, we take steps designed to address cybersecurity risks that such service providers may present to us, such as conducting diligence into such service providers’ cybersecurity practices and risk profiles.
Cybersecurity Risk Management Processes Integrated [Flag]	true
Cybersecurity Risk Management Processes Integrated [Text Block]	As part of our framework, we maintain certain processes defined to assess, identify and manage risks. For example, we have an incident management and response process under which we communicate the details of certain threats and incidents to management and the board as may be appropriate; use manual and automated processes that are designed to monitor relevant information systems for vulnerabilities, threats and incidents; manage and take certain actions designed to address incidents that may occur; and take actions designed to remediate certain vulnerabilities identified in relevant enviornements. We employ an array of data security technologies, processes, and methods across our infrastructure designed to protect our systems and sensitive information from unauthorized access. We work with information technology consultants who provide advice and expertise on monitoring evolving industry practices. Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. For example, certain management executives, including our Executive VP and Chief Financial Officer evaluates material risks from cybersecurity threats in connection with our overall business objectives and reports such evaluations to the audit committee of the board of directors as appropriate, which then evaluates our overall enterprise risks.
Cybersecurity Risk Management Third Party Engaged [Flag]	true
Cybersecurity Risk Third Party Oversight and Identification Processes [Flag]	true
Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag]	false
Cybersecurity Risk Board of Directors Oversight [Text Block]	Our Board of Directors, with the assistance of the Audit Committee, has oversight for the cybersecurity risks facing us and for our processes designed to identify, prioritize, assess, manage, and mitigate those risks.
Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block]	Audit Committee
Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block]	certain management executives, including our Executive VP and Chief Financial Officer evaluates material risks from cybersecurity threats in connection with our overall business objectives and reports such evaluations to the audit committee of the board of directors as appropriate, which then evaluates our overall enterprise risks.
Cybersecurity Risk Role of Management [Text Block]	Our Director of Information Technology, under the supervision of our Executive VP and Chief Financial Officer, manages and monitors our cybersecurity risk (including that presented by our information technology service providers). Our Director of Information Technology is responsible for informing our Executive VP and Chief Financial Officer of relevant cybersecurity risks including, as relevant, the prevent, detection, mitigation and remediation of cybersecurity incidents.
Cybersecurity Risk Management Positions or Committees Responsible [Flag]	true
Cybersecurity Risk Management Positions or Committees Responsible [Text Block]	Executive VP and Chief Financial Officer
Cybersecurity Risk Management Expertise of Management Responsible [Text Block]	Our cybersecurity risk assessment and management processes are implemented and maintained by certain management, including our Director of Information Technology, who has more than two decades of information technology and information technology leadership experience.Our Executive VP and Chief Financial Officer has over two decades of management experience, including oversight over information technology and cybersecurity matters.
Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block]	we have an incident management and response process under which we communicate the details of certain threats and incidents to management and the board as may be appropriateOur Director of Information Technology is responsible for informing our Executive VP and Chief Financial Officer of relevant cybersecurity risks including, as relevant, the prevent, detection, mitigation and remediation of cybersecurity incidents.
Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag]	true