Outlook Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Feb 17, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Dec 31, 2025 · Filed Feb 17, 2026
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Notes to Unaudited Interim Consolidated Financial Statements
- Organization and Description of Business
Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVATM, an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Iselin, New Jersey.
In May 2024 the Company received Marketing Authorization from the European Commission for LYTENAVA (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (“AMD”) in the European Union (“EU”). Additionally, in July 2024 the Company also received marketing authorization for LYTENAVA (bevacizumab gamma) in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK. In June 2025, the Company launched LYTENAVA commercially in both Germany and the UK, and commenced commercial sales in those countries.
In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial to support its Biologics License Application (“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 Chemistry, Manufacturing, and Controls (“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 third CRL on December 31, 2025. On February 11, 2026, the Company reported that it had submitted a Type A meeting request with the FDA to discuss the CRL and potential regulatory pathways for ONS-5010/LYTENAVA.
- Liquidity
The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $628,767,898 as of December 31, 2025. As of December 31, 2025, the Company had a working capital deficit. Additionally, the Company has $32,234,985 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued to Avondale Capital, LLC (“Avondale”) in March 2025 (the “March 2025 Note”), maturing on July 1, 2026. Refer to Note 7 for further details on the March 2025 Note.
On December 31, 2025, the Company did not satisfy the required $3,000,000 Quarterly Debt Reduction Obligation (as defined below in Note 7). The failure to make this required payment constituted a Major Trigger Event (as defined below in Note 7) under the March 2025 Note. Subsequent to December 31, 2025, Avondale converted $6,285,000 of principal and accrued interest on the March 2025 Note into 13,510,620 shares of the Company’s common stock. This Major Trigger Event has not resulted in an Event of Default (as defined below in Note 7).
Pursuant to the terms of the March 2025 Note, the occurrence of a Major Trigger Event resulted in (i) an automatic 10% increase to the outstanding balance, effective January 1, 2026, and (ii) an adjustment to the Conversion Price (as defined below). Following the adjustment, the Conversion Price is equal to the lesser of the fixed conversion price of $2.26 or 90% of the lowest closing bid price during thethree trading days immediately preceding the delivery of a conversion notice, provided that the Conversion Price may not be reduced below the contractual floor price of $0.404. See Note 7 – Debt, for more information related to the March 2025 Note.
As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Subsequent to December 31, 2025, the Company sold 5,000,000 shares of common stock under the ATM Agreement (as defined below and described in additional detail in Note 9) and generated $2,425,000 in net proceeds after paying fees to BTIG, LLC (“BTIG”) and other issuance costs of $75,000.
Management does not believe that the existing cash and cash equivalents as of December 31, 2025, together with $2,425,000 in net proceeds from the sale of shares of common stock under the ATM Agreement since December 31, 2025, are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, additional financing will be needed by the Company to fund its operations in the future, 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 U.S., the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offerings (refer to Note 9 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 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.
- Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation
The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2025 and its results of operations for the three months ended December 31, 2025 and 2024, cash flows for the three months ended December 31, 2025 and 2024, and stockholders’ deficit for the three months ended December 31, 2025 and 2024. Operating results for the three months ended December 31, 2025 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2026. The unaudited interim consolidated financial statements presented herein do not contain all of the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 19, 2025.
Accounts Receivable
As of December 31, 2025, the Company hadno 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 regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of December 31, 2025.
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 December 31, 2025, and September 30, 2025. As of December 31, 2025 and September 30, 2025, inventory consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · September 30, 2025 | ||||||
| Raw materials | | $2,350,239 | | $2,350,239 | ||
| Work-in-process | | | 1,107,825 | | | 958,539 |
| Finished goods | | | — | | | 29,626 |
| Total | | $3,458,064 | | $3,338,404 | ||
Use of estimates
The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, such as the current macroeconomic environment, including as a result of fluctuations in inflation and interest rates, tariffs and trade tensions, and geopolitical instability and uncertainty, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.
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 (the “Customers”) 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 administrative 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. |
| ● | Administrative fees are contractually charged by the wholesalers and are typically credited directly against amounts due to the Company. |
| ● | Rebates are contractually charged to the Company by customers, including a Voluntary Scheme for Branded Medicines Pricing, Access and Growth rebate with the National Health System in the UK. |
During the three months ended December 31, 2025, the Company increased its returns reserve by $1,094,000 on product held by its UK distributor due to lower-than-forecasted sell-through. Returns reserves are reviewed quarterly and may be adjusted based on our ongoing assessment of business conditions and distributor-level sales forecasts. Additionally, during the three months ended December 31, 2025, the Company recognized administrative fees assessed under contractual arrangements with its wholesalers, which, together with the increase in the returns reserve, resulted in negative net revenue for the period.
Cost of revenues consists primarily of the cost of inventory sold, which includes direct manufacturing, production and packaging materials for LYTENAVA (bevacizumab gamma) sales. Prior to receiving authorization to sell LYTENAVA (bevacizumab gamma) in Europe, the Company expensed costs associated with manufacturing of LYTENAVA (bevacizumab gamma) as a component of research and development expense. The cost of previously expensed inventory that would have been recognized in cost of revenue for the three months ended December 31, 2025 were immaterial.
Net (loss) income per share
Basic net (loss) income per share of common stock is computed by dividing net (loss) income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net (loss) income per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants, performance-based stock options and units, and stock options using the treasury stock method, which would result in the issuance of incremental shares of common stock. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.
The following table sets forth the computation of basic (loss) income per share and diluted loss per share:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three months ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Numerator: | | | | | | |
| Net (loss) income attributable to common stockholders | | $(23,058,135) | | $17,377,614 | ||
| Denominator: | | | | | | |
| Weighted average shares outstanding, basic | | | 60,205,035 | | | 24,233,957 |
| Basic net (loss) income per share | | $(0.38) | | $0.72 | ||
| Diluted net loss per share | | $(0.38) | | $0.72 | ||
The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding for the three months ended December 31, 2025 and 2024, as they would be antidilutive:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three months ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Performance-based stock options | | | 30,000 | | | 190,000 |
| Stock options | | | 6,640,881 | | | 2,816,851 |
| Common stock warrants | | | 35,534,727 | | | 14,193,772 |
| Convertible debt | | | 13,268,156 | | (ii) | 1,191,479 |
| (i) | The potentially dilutive securities related to the March 2025 Note was calculated based on a fixed conversion price of $2.26, which is subject to change as described in Note 7. |
| (ii) | The calculation for potentially dilutive securities pertaining to December 2022 Note, defined in Note 7 below, was as follows: $3,750,000 of outstanding principal and accrued interest as of December 31, 2024, converted at a rate of $7.00, and the remaining amount converted based on a fixed conversion price of $40.00 per share, which was subject to change. |
Recently issued accounting pronouncements
In December 2023, the FASB issued ASU No. 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of income tax disclosures primarily on the income tax rate reconciliation and income taxes paid. This authoritative guidance will be effective for fiscal years beginning after December 15, 2024, and for interim periods within fiscal years beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the effect of this new standard on the Company's 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.
- Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial
assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
| ● | Level 1 – Quoted prices in active markets for identical assets or liabilities. |
| ● | Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. |
| ● | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.
The following table presents the Company’s liabilities that are measured at fair value on a recurring basis:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2025 | |||||||||
| · · (Level 1) · · (Level 2) · · (Level 3) | |||||||||
| Liabilities | | | | | | | | | |
| Unsecured convertible promissory note | | $— | | $— | | $36,660,000 | |||
| Warrant liability | | | — | | | — | | | 7,560,251 |
| Total | | $— | | $— | | $44,220,251 | |||
| | | | | | | | | | |
| | | 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 | |||
The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability and unsecured convertible promissory notes for the three months ended December 31, 2025:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Unsecured Convertible · · · | ||||||
| · · Promissory Notes · · Warrants | ||||||
| Balance at October 1, 2025 | | $29,947,000 | | $4,768,438 | ||
| Principal and accrued interest converted to common stock | | | (30,736) | | | — |
| Loss from change in fair value | | | 6,743,736 | | | 2,791,813 |
| Balance at December 31, 2025 | | $36,660,000 | | $7,560,251 | ||
Unsecured convertible promissory notes
As further described in Note 7, the Company elected the fair value option to account for the unsecured convertible promissory notes. The fair value 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 were estimated using a binomial lattice model with the following assumptions:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · December 31, 2025 · · · September 30, 2025 · | ||||||||
| Term (years) | | | 0.5 | | | | 0.8 | |
| Volatility | | | 172.0% | | | 118.0% | ||
| Risk-free rate | | | 3.6% | | | 3.8% | ||
| Dividend yield | | | —% | | | —% | ||
| Credit-adjusted discount rate | | | 19.9% | | | 18.8% | ||
| Stock price | | $1.58 | | | $1.06 | | ||
Common stock warrants
The warrants issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 (the “Private Placement Warrants”) were classified as liabilities on the accompanying unaudited interim consolidated balance sheets as the Company assessed that they are not indexed to the Company’s own stock.
The above warrant liabilities are revalued each reporting period with the change in fair values recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair values of the warrant liabilities are estimated using the Black-Scholes option pricing model using the following weighted average assumptions:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · December 31, 2025 · · · September 30, 2025 · | ||||||||
| Risk-free interest rate | | | 3.57% | | | 3.64% | ||
| Remaining contractual term of warrants (years) | | | 3.2 | | | | 3.5 | |
| Expected volatility | | | 153.5% | | | 148.6% | ||
| Annual dividend yield | | | —% | | | —% | ||
| Stock price | | $1.58 | | | $1.06 | | ||
5. Equity Method Investment
In connection with the execution of a stock purchase agreement with Syntone Ventures, LLC (“Syntone”), the United States-based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Beijing Syntone Biopharma Ltd (“Syntone JV”), that is 80% owned by Syntone PRC and 20% owned by the Company. As the Company can exert significant influence over, but does not control, Syntone JV’s operations through voting rights or representation on Syntone JV’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone JV in April 2021, the Company entered into a royalty-free license with Syntone JV for the development, commercialization and manufacture of ONS-5010/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 $3,000,000.
6. Accrued Expenses
Accrued expenses consist of:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · September 30, 2025 | ||||||
| Compensation | | $1,554,514 | | $1,437,049 | ||
| Severance and related costs | | | 855,132(i) | | 1,590,835 | |
| Professional fees | | | 458,394 | | | 195,623 |
| Research and development | | | 1,047,662 | | | 1,188,212 |
| Accrued rebates | | | 439,269 | | | 317,754 |
| Other accrued expenses | | | 359,055 | | | 584,847 |
| | | $4,714,026 | | $5,314,320 | ||
| (i) | In December 2024 and September 2025, the Company implemented workforce reductions to conserve capital. Both the Company’s Chief Executive Officer and Chief Commercial Officer departed from the Company during the fiscal year ended September 30, 2025, and their departures each constituted terminations without cause. Accordingly, each was 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 were 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. |
During the three months ended December 31, 2024, the Company recognized $1,428,455 in severance related charges in connection with the workforce reduction, consisting of cash-based expenses related to employee severance and notice period payments, benefits and related costs. In addition, during the three months ended December 31, 2024, the Company recorded a non-cash expense totaling $2,079,083 related to stock-based compensation for accelerated equity awards for the former Chief Executive Officer. During the three months ended December 31, 2025 and 2024, the Company made total cash payments related to severance and related charges of $735,703 and $40,058, respectively.
- Debt
Debt consists of:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · September 30, 2025 | ||||||
| Unsecured convertible promissory note (measured at fair value) | | $36,660,000 | | $29,947,000 | ||
| Less: current portion | | | (36,660,000) | | | (29,947,000) |
| Long-term debt | | $— | | $— | ||
March 2025 Note
On March 13, 2025, the Company issued the March 2025 Note for $33,100,000 to Avondale pursuant to a Securities Purchase Agreement (“Purchase Agreement”) 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.The net proceeds from the March 2025 Note were used to repay the Company’s unsecured convertible promissory note issued on December 22, 2022 (the “December 2022 Note”).
The March 2025 Note bears interest at theprime 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 three months ended December 31, 2025, Avondale converted $30,736 of accrued interest on the March 2025 Note into 13,600 shares of the Company’s common stock.
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. 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 Purchase Agreement 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 forten 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 thethree 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.
On December 31, 2025, the Company did not meet the required $3,000,000 Quarterly Debt Reduction Obligation. The failure to make this required payment constituted a Major Trigger Event under the March 2025 Note. This Major Trigger Event has not resulted in an Event of Default.
Pursuant to the terms of the March 2025 Note, the occurrence of a Major Trigger Event resulted in (i) an automatic 10% increase to the outstanding balance, effective January 1, 2026, and (ii) an adjustment to the Conversion Price. Following the adjustment, the Conversion Price is equal to the lesser of the fixed conversion price of $2.26 or 90% of the lowest closing bid price during thethree trading days immediately preceding the delivery of a conversion notice, provided that the Conversion Price may not be reduced below the contractual floor price of $0.404.
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 of were written off upon election to fair value and accounted for as interest.
- Commitments and Contingencies
Litigation
On November 3, 2023, a securities class action lawsuit was filed against the Company and certain of its officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by the Company related to the Company’s BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that the Company violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time the Company’s BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve the Company’s BLA, and that the Company’s stock price dropped when such information was disclosed. The plaintiffs in the class action seek damages and interest, and an award of reasonable costs, including attorneys’ fees. On December 23, 2025, the court dismissed the plaintiffs’ second amended complaint in part with prejudice and in part with leave to amend. The deadline for the plaintiffs to file a third amended complaint is February 27, 2026.
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.
Purchase Commitments
As of December 31, 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.
Leases
Corporate office
In March 2021, the Company entered into athree-year term corporate office lease for its former corporate headquarters in Iselin, New Jersey that ended on April 30, 2024.
In March 2024, the Company entered into afive-year term corporate office lease for its new corporate headquarters in Iselin, New Jersey that commenced on May 1, 2024.
The components of lease cost for the three months ended December 31, 2025 and 2024 are as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Three months ended December 31, | ||||
| | | 2025 | | 2024 |
| Lease cost: | | | | |
| Operating lease cost | | 19,080 | | 19,080 |
| Total lease cost | | $19,080 | | $19,080 |
Amounts reported in the unaudited interim consolidated balance sheets for leases where the Company is the lessee are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · September 30, 2025 | ||||||
| Operating leases: · · · · | ||||||
| Right-of-use asset | | $212,413 | | $225,508 | ||
| Operating lease liabilities | | 233,113 | | 247,698 | ||
| Weighted-average remaining lease term (years): | | | | | ||
| Operating leases | | | 3.3 | | | 3.6 |
| Weighted-average discount rate: | | | | | ||
| Operating leases | | | 9.9% | | | 9.9% |
Other information related to leases for the three months ended December 31, 2025 and 2024 are as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Three months ended December 31, | ||||
| | | 2025 | | 2024 |
| Cash paid for amounts included in the measurement of lease obligations: | | | | |
| Operating cash flows from operating leases | | $19,484 | | $19,329 |
Future minimum lease payments under non-cancelable leases at December 31, 2025 are as follows for the years ending September 30:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · · · Operating leases | ||||||
| 2026 (remaining nine months) | | | | | $60,159 | |
| 2027 | | | | | | 81,817 |
| 2028 | | | | | | 83,680 |
| 2029 | | | | | | 49,447 |
| Total undiscounted lease payments | | | | | | 275,103 |
| Less: Imputed interest | | | | | 41,990 | |
| Total lease obligations | | | | | $233,113 | |
- Common Stock and Stockholders’ Equity
Preferred Stock
The number of authorized shares of preferred stock under the Company’s Certificate of Incorporation is 10,000,000 shares.
Common stock
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 increased from 60,000,000 shares to 260,000,000 shares.
BTIG, LLC At-the-Market Offering Agreement
On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG as sales agent (as amended, the “ATM Agreement” or the “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 in connection with the execution of the ATM Agreement, which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of December 31, 2025, the remaining balance under the ATM Agreement was $64,460,655 and $227,987 of unamortized deferred costs are included in other assets on the unaudited interim consolidated balance sheets.
Under the 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 ATM Agreement. The offering of common stock pursuant to the ATM Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the ATM Agreement or (ii) termination of the ATM Agreement in accordance with its terms.
During the three months ended December 31, 2025, the Company sold 10,227,166 shares of common stock under the ATM Offering and generated $14,931,537 in net proceeds after payment of fees to BTIG and other issuance costs of $ $461,800. During the three months ended December 31, 2024, the Company sold 1,000,000 shares of common stock under the ATM Offering and generated $1,742,373 in net proceeds after payment of fees to BTIG and other issuance costs of $53,888.
Common stock warrants
As of December 31, 2025, shares of common stock issuable upon the exercise of outstanding warrants were as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · Shares of · · | |||||
| · · common stock · · | |||||
| · · issuable upon · · | |||||
| · · exercise of · · Exercise Price | |||||
| Expiration Date · · warrants · · Per Share | |||||
| 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) | 1,071,429 | | $7.70 | |
| January 17, 2030 | | 13,198,561 | | $2.26 | |
| May 27, 2030 | | 15,271,428 | | $1.40 | |
| | | 35,534,727 | | | |
| (i) | The Private Placement Warrants were issued in connection with private placements that closed on March 18, 2024 and April 15, 2024 are exercisable only for cash, except in limited circumstances, at any time after the |
date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging, guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer to the disclosure in Note 4 for further details on classification and fair value measurements.
A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%,9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $20.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010/LYTENAVA, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting.
During the three months ended December 31, 2025, warrants to purchase an aggregate of 25,787 shares of common stock with a weighted average exercise price of $21.00 expired. In addition, warrants to purchase an aggregate of 428,571 shares of common stock with an exercise price of $2.26 were exercised generating net proceeds of $907,341 after deducting expenses associated with such exercises.
- Stock-Based Compensation
2024 Equity Incentive Plan
In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provided for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”) awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. In August 2024, the Company’s stockholders approved the amendment and restatement of the 2015 Plan, at which time, 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 December 31, 2025, there were 1,573,065 shares available for grant under the 2024 Plan.
Stock options and RSUs are granted under the Company’s 2024 Plan and generally vest over a period ofone tofour 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 RSU over its vesting period.
The Company recorded stock-based compensation expense in the following expense categories of its unaudited interim consolidated statements of operations for the three months ended December 31, 2025 and 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three months ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Research and development | | $97,818 | | $110,029 | ||
| General and administrative | | | 783,332 | | | 3,562,391 |
| Total | | $881,150 | | $3,672,420 | ||
Stock options
As of December 31, 2025, options to purchase common stock of the Company outstanding under the 2024 Plan were as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | Weighted | | | |
| | | | | | | | Average | | | |
| · · · · Weighted · · Remaining · · · | ||||||||||
| · · Number of · · Average · · Contractual · · Aggregate | ||||||||||
| · · Shares · · Exercise Price · · Term (Years) · · Intrinsic Value | ||||||||||
| Balance at September 30, 2025 | | 3,611,362 | | $11.36 | | 7.9 | | $— | ||
| Granted | | 3,103,887 | | | 1.15 | | | | | |
| Expired | | (74,368) | | | 22.70 | | | | | |
| Balance at December 31, 2025 | | 6,640,881 | | $6.46 | | 8.7 | | $1,486,439 | ||
| Vested and exercisable at December 31, 2025 | | 2,721,153 | | $13.69 | | 7.4 | | $61,687 | ||
The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options.
The weighted average grant date fair value of the options awarded to employees for the three months ended December 31, 2025 and 2024 was $1.02 and $4.67 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:
| | | | | | |
|---|---|---|---|---|---|
| · · Three months ended December 31, · | |||||
| | | 2025 | | 2024 | |
| Risk-free interest rate | | 3.7% | 3.5% | ||
| Expected term (years) | | 5.5 | | 5.5 | |
| Expected volatility | | 132.0% | 134.0% | ||
| Expected dividend yield | | — | | — | |
As of December 31, 2025, there was $4,311,636 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 1.0 year.
Performance-based stock options
The Company granted certain officers of the Company option awards whose vesting is contingent upon meeting company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 10 years.
The fair value of each option grant under the performance share option plan was estimated on the date of grant using the same option valuation model used for non-statutory options above. Compensation expense for performance-based stock options is only recognized when management determines it is probable that the awards will vest.
A summary of the activity under the performance share option plan as of December 31, 2025 and changes during the three months then ended are presented below.
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | Weighted | | | |
| | | | | | | | Average | | | |
| · · · · Weighted · · Remaining · · · | ||||||||||
| · · Number of · · Average · · Contractual · · Aggregate | ||||||||||
| · · Shares · · Exercise Price · · Term (Years) · · Intrinsic Value | ||||||||||
| Balance at September 30, 2025 | | 125,500 | | $12.92 | | 7.6 | | $— | ||
| Forfeited | | (90,500) | | | 6.78 | | | | | |
| Expired | | (5,000) | | | 28.80 | | | | | |
| Balance at December 31, 2025 | | 30,000 | | $28.80 | | 6.0 | | $— | ||
| Vested and exercisable at December 31, 2025 | | 30,000 | | $28.80 | | 6.0 | | $— | ||
The vesting of the performance-based stock options is conditional upon FDA approval of ONS-5010/LYTENAVA. The expense for the performance-based stock options is not recognized until the performance conditions are deemed probable of achievement. The Company did not record any expense related to the performance-based stock options during the three months ended December 31, 2025 as the performance conditions were not deemed probable of being met. The Company did not record any expense related to the performance-based stock options during the three months ended December 31, 2024. As of December 31, 2025, the Company assessed that the performance conditions related to the performance options granted were not probable of achievement. The assessment was based on the relevant facts and circumstances and thereforeno compensation costs were recognized.
11. 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 hasone 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 three months ended December 31, 2025 and 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three months ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Revenues, net | | $(1,207,833) | | $— | ||
| Cost of revenues | | | 29,626 | | | — |
| Gross profit | | | (1,237,459) | | | — |
| Operating expenses: | | | | | | |
| Research and development expenses | | | | | | |
| ONS-5010/LYTENAVA development | | | 2,594,912 | | | 8,725,849 |
| Compensation and related benefits | | | 614,534 | | | 569,127 |
| Stock-based compensation | | | 97,818 | | | 110,029 |
| Other research and development | | | 327,088 | | | 255,145 |
| | | | 3,634,352 | | | 9,660,150 |
| Selling, general and administrative expenses | | | | | | |
| Professional fees | | | 1,247,517 | | | 2,321,458 |
| Compensation and related benefits | | | 914,465 | | | 2,780,189 |
| Stock-based compensation | | | 783,332 | | | 3,562,391 |
| Europe launch expenses | | | 4,800,734 | | | 2,466,342 |
| Facilities, fees and other related costs | | | 866,093 | | | 816,322 |
| | | | 8,612,141 | | | 11,946,702 |
| | | | | | | |
| Segment loss from operations | | | (13,483,952) | | | (21,606,852) |
| Other segment items (i) | | | (9,574,183) | | | 38,984,466 |
| Segment loss before income taxes | | $(23,058,135) | | $17,377,614 | ||
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.