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Outlook Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 18, 2026.

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About this filing

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.

Jun 30, 2026 · Filed Aug 18, 2026

OTLK$0.46+5.2%Stored close · as of Nov 9, 2026

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Notes to Unaudited Interim Consolidated Financial Statements

  1. Organization and Description of Business

Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a biopharmaceutical company focused on developing and commercializing 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 LYTENAVA. The Company submitted a Special Protocol Assessment (“SPA”) for the NORSE EIGHT study in December 2023, and in January 2024 the U.S. Food and Drug Administration (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.

Following receipt of the CRL in December 2025, the Company engaged with the FDA on multiple occasions, including a formal Type A meeting held on March 2, 2026, which led to the submission of a formal dispute resolution meeting request. In April 2026, the meeting with the deciding official was conducted as part of the Company’s ongoing efforts to align with the FDA regarding the regulatory pathway for LYTENAVA™ (bevacizumab-vikg). The meeting also served as a follow-up to the Company’s March 2026 Type A meeting with the Division of Ophthalmology and the Office of Specialty Medicine regarding the December 31, 2025 CRL for the Biologics License Application (“BLA”) for LYTENAVA™ for the treatment of neovascular age-related macular degeneration. On July 24, 2026 the Company announced FDA approval of LYTENAVATMas the only FDA-approved ophthalmic Bevacizumab for the treatment of Wet AMD.

  1. Liquidity

The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $653,540,250 as of June 30, 2026. As of June 30, 2026, the Company had a working capital deficit. Additionally, the Company had $20,311,749 of principal, accrued interest, and exit fees outstanding under an unsecured promissory note issued to Atlas Sciences LLC (“Atlas”) in March 2026 (the “March 2026 Note”), which matures on June 16, 2027. See Note 7 for additional information regarding the March 2026 Note.

As a result of the above factors, 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.

Management does not believe that the existing cash and cash equivalents as of June 30, 2026 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 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 -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.

  1. Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation

The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2026 and its results of operations for the three and nine months ended June 30, 2026 and 2025, cash flows for the nine months ended June 30, 2026 and 2025, and stockholders’ deficit for the three and nine months ended June 30, 2026 and 2025. Operating results for the nine months ended June 30, 2026 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 June 30, 2026, 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 June 30, 2026.

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 June 30, 2026 and September 30, 2025. As of June 30, 2026 and September 30, 2025, inventory consisted of the following:

​​​​​​​
​ · ​ · June 30, 2026 · ​ · September 30, 2025
Raw materials​$2,344,459​$2,350,239
Work-in-process​​2,514,132​​958,539
Finished goods​​184,939​​29,626
Total​$5,043,530​$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 nine months ended June 30, 2026, the Company decreased its returns reserve by $1.1 million. This net decrease includes a $1.2 million increase in return reserves related to sales in the UK and Germany, offset by a $2.4 million reversal

of reserves associated with product that became unsellable due to minimum shelf-life constraints, resulting in a corresponding write-off of accounts receivable. Returns reserves are reviewed on a quarterly basis and may be adjusted based on ongoing assessments of business conditions and distributor-level sales forecasts. Additionally, during the nine months ended June 30, 2026, the Company recognized administrative fees under contractual arrangements with its wholesalers.

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 and nine months ended June 30, 2026 were immaterial.

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. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.

The following table sets forth the computation of basic loss per share and diluted loss per share:

​​​​​​​​​​​​​
​ · ​ · ​ · Three months ended June 30, · ​ · Nine months ended June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Numerator:​​​​​​​​​​​​
Net loss attributable to common stockholders​$(20,319,272)​$(20,152,502)​$(47,830,487)​$(49,132,094)
Denominator:​​​​​​​​​​​​
Weighted average shares outstanding, basic​​136,743,333​​36,956,582​​93,232,060​​30,663,988
Basic net loss per share​$(0.15)​$(0.55)​$(0.51)​$(1.60)
Diluted net loss per share​$(0.15)​$(0.55)​$(0.51)​$(1.60)

The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding for the three and nine months ended June 30, 2026 and 2025, as they would be antidilutive:

​​​​​​​​​​​​​
​ · ​ · ​ · Three months ended June 30, · ​ · Nine months ended June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Performance-based stock options​​30,000​​190,000​​30,000​​190,000
Stock options​​6,203,902​​2,822,893​​6,203,902​​2,822,893
Common stock warrants​​40,353,913​​39,811,227​​40,353,913​​39,811,227
Convertible debt​(i)—​(ii)14,702,063(i)​—​(ii)14,702,063
(i)The balance of the March 2025 Note (as defined in Note 7) underlying these potentially dilutive securities was fully converted during May 2026 as discussed in more detail in Note 7.
(ii)In this period, the potentially dilutive securities related to the March 2025 Note were calculated based on a fixed conversion price of $2.26, which was subject to change as set forth in the March 2025 Note.

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.

  1. Fair Value Measurements

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

●Level 1 – Quoted prices in active markets for identical assets or liabilities.
●Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
●Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

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

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

​​​​​​​​​​
​ · ​ · June 30, 2026
​ · ​ ​ ​ · (Level 1) · ​ ​ ​ · (Level 2) · ​ ​ ​ · (Level 3)
Liabilities​​​​​​​​​
Unsecured promissory note (measured at fair value)​$—​$—​$18,227,000
Warrant liability​​—​​—​​7,758,238
Total​$—​$—​$25,985,238
​​​​​​​​​​
​​September 30, 2025
​​(Level 1)​ ​ ​(Level 2)​ ​ ​(Level 3)
Liabilities​​​​​​​​​
Unsecured convertible promissory note (measured at fair value)​$—​$—​$29,947,000
Warrant liability​​—​​—​​4,768,438
Total​$—​$—​$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 and non-convertible promissory notes for the nine months ended June 30, 2026:

​​​​​​​​​​
​ · ​ · Unsecured · ​ · Unsecured Convertible · ​ · ​ · ​
​ · ​ ​ ​ · Promissory Note · ​ ​ ​ · Promissory Note · ​ ​ ​ · Warrants
Balance at September 30, 2025​$—​$29,947,000​$4,768,438
Issuance of promissory notes​​17,000,000​​—​​—
Principal and accrued interest converted to common stock​​—​​(18,114,784)​​—
Loss from change in fair value​​1,227,000​​4,124,336​​2,989,800
Repayment​​—​​(17,000,000)​​—
Loss on extinguishment of debt​​—​​1,043,448​​—
Balance at June 30, 2026​$18,227,000​$—​$7,758,238

The $4.1 million loss from the change in fair value shown in the table above includes an increase of $3.0 million on the March 2025 Note as a result of a Major Trigger Event (defined in the March 2025 Note) during the 9 months ended June 30, 2026.

Unsecured convertible promissory note

As further described in Note 7, the Company elected the fair value option to account for the unsecured convertible promissory notes. Prior to the conversion of the remaining outstanding principal and accrued interest into shares of the Company’s common stock in May 2026, the fair value was 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.

Immediately prior to the conversion of the remaining outstanding principal and accrued interest into shares of the Company’s common stock in May 2026, the notes were remeasured at fair value based on the closing price of the Company’s common stock on the applicable conversion dates.

The fair values of the unsecured convertible promissory notes were estimated using a binomial lattice model with the following assumptions at September 30, 2025:

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

In May 2026, the remaining outstanding principal and accrued interest under the unsecured convertible promissory notes were converted into shares of the Company’s common stock. Immediately prior to each conversion, the notes were remeasured at fair value based on the number of shares issued upon conversion and the quoted closing price of the Company’s common stock on the applicable conversion date. The closing prices used to determine fair value were $0.40 per share on May 26, 2026 and $0.59 per share on May 27, 2026. Accordingly, the binomial lattice model was not used to estimate the fair value of the notes on the conversion dates. Following the conversions, no amounts remained outstanding under the unsecured convertible promissory notes.

March 2026 Note

As further described in Note 7, the Company elected the fair value option to account for the March 2026 Note. The fair value is estimated using a discounted cash flow model which estimates the fair value of the instrument based on the present value of expected future cash flows, using assumptions that reflect the instrument’s terms and risk characteristics.

Significant estimates in the discounted cash flow model include the term, final redemption value and discount rate.

​​​​​
​ · ​ · ​ · June 30, 2026
Term (years)​​0.96​
Credit spread​​24.1%
Final redemption value​$122.2​

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:

​​​​​​​​​
​ · ​ ​ ​ · June 30, 2026 · ​ · ​ · September 30, 2025 · ​
Risk-free interest rate​​4.15%​​3.64%
Remaining contractual term of warrants (years)​​2.8​​​3.5​
Expected volatility​​170.1%​​148.6%
Annual dividend yield​​—%​​—%
Stock price​$1.59​​$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 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 an additional capital contribution of approximately $2.1 million in June 2026, consistent with the development plan contemplated in the license agreement. Following the June 2026 contribution, the Company’s total capital contributions to Syntone JV were approximately $3.0 million, andno further capital contribution commitments remained outstanding under the development plan. The Company’s maximum exposure to a loss as a result of the Company’s involvement in Syntone JV is limited to the initial investment and its aggregate capital contributions of approximately $3,000,000.

6. Accrued Expenses

Accrued expenses consist of:

​​​​​​​
​ · ​ ​ ​ · June 30, 2026 · ​ · September 30, 2025
Compensation​$812,537​$1,437,049
Severance and related costs​​243,144(i)​1,590,835
Professional fees​​184,381​​195,623
Research and development​​159,462​​1,188,212
Accrued rebates​​1,659,057​​317,754
Other accrued expenses​​220,158​​584,847
​​$3,278,739​$5,314,320
(i)In 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 their 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.
  1. Debt

Debt consists of:

​​​​​​​
​ · ​ ​ ​ · June 30, 2026 · ​ ​ ​ · September 30, 2025
Unsecured convertible promissory note (measured at fair value)​$—​$29,440,000
Less: current portion​​—​​(29,440,000)
Unsecured promissory note (measured at fair value)​​18,227,000​​—
Less: current portion​​(18,227,000)​​—
Long-term debt​$—​$—

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 bore interest at theprime rate plus 3% (subject to a floor of 9.5%), was originally scheduled to mature on July 1, 2026, but was amended on March 16, 2026 to extend the maturity to December 31, 2026, and was convertible into common stock. On March 16, 2026, the Company repaid $17,000,000 of outstanding principal and accrued interest under the March 2025 Note using proceeds from the issuance of the March 2026 Note. The Company accounted for this pay down as a partial extinguishment under ASC 470. As a result, the Company recognized a $285,600 gain on partial extinguishment in the unaudited condensed consolidated statement of operations during the three and nine months ended June 30, 2026. During the nine months ended June 30, 2026, Avondale converted $16,771,352 of outstanding principal and accrued interest on the March 2025 Note into 39,404,455 shares of the Company’s common stock, fully extinguishing the March 2025 Note. As a result, the Company recognized a $1,329,048 and $1,043,448 loss on extinguishment in the unaudited condensed consolidated statement of operations during the three and nine months ended June 30, 2026, respectively.

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 expensed upon election to fair value and accounted for as interest.

March 2026 Note

On March 16, 2026, the Company entered into a note purchase agreement with Atlas, pursuant to which the Company issued the March 2026 Note, an unsecured promissory note with an original principal balance of $18,360,000 at an original issue discount of $1,360,000, resulting in gross proceeds of $17,000,000. The proceeds were used solely to partially repay $17,000,000 of outstanding principal and accrued interest under the Company’s March 2025 Note.

The March 2026 Note bears interest at theprime rate, as published in The Wall Street Journal, plus 3%, subject to a minimum rate of 9.5%, and matures 15 months from issuance. Interest is calculated on the basis of a 360‑day year and is compounded daily. Beginning on thesix‑month anniversary of issuance, Atlas has the right to redeem up to $3,000,000 of the outstanding balance under the March 2026 Note per calendar quarter. All cash payments made by the Company under the March 2026 Note, including prepayments, redemptions, or repayment at maturity, are subject to a 7.5% exit fee.

The March 2026 Note is unsecured and contains customary representations and warranties, affirmative and negative covenants, and provisions governing Trigger Events, events of default, and remedies. Trigger Events include, among other things, failure to make payments when due, insolvency or bankruptcy‑related events, the occurrence of certain fundamental transactions without Atlas’ consent, covenant breaches, and material misrepresentations. Upon the occurrence of certain Trigger Events, Atlas has the right to increase the outstanding balance of the March 2026 Note, subject to contractual limitations, and if a Trigger Event is not cured within specified time periods, it may result in an event of default. Upon an

event of default, Atlas has the right to accelerate the outstanding balance, apply default interest of up to 22% per annum, and pursue available remedies.

The Company elected to account for the March 2026 Note at fair value (Note 4). Debt issuance costs were written off upon election of the fair value option and recognized as interest expense. The maturity date of the March 2026 Note is June 16, 2027, as such the entire June 30, 2026 balance is classified in current liabilities.

  1. 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 LYTENAVA as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for 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 plaintiffs filed a third amended complaint in February 2026 and a revised third amended complaint in April 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 June 30, 2026, the Company had outstanding contractual commitments of approximately $0.9 million, primarily related to fill-finish manufacturing services for 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 and nine months ended June 30, 2026 and 2025 are as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three months ended June 30, · ​ · Nine months ended June 30,
​​ ​ ​2026​ ​ ​2025​ ​ ​2026​ ​ ​2025
Lease cost:​​​​​​​​
Operating lease cost​19,080​19,080​57,241​57,241
Total lease cost​$19,080​$19,080​$57,241​$57,241

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

​​​​​​​
​ · ​ · June 30, 2026 · ​ ​ ​ · September 30, 2025
Operating leases: · ​ · ​ · ​ · ​
Right-of-use asset​$185,183​$225,508
Operating lease liabilities​204,144​247,698
Weighted-average remaining lease term (years):​​​​
Operating leases​​2.8​​3.8
Weighted-average discount rate:​​​​
Operating leases​​9.9%​​9.9%

Other information related to leases for the nine months ended June 30, 2026 and 2025 are as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Nine months ended June 30,
​​ ​ ​2026​ ​ ​2025
Cash paid for amounts included in the measurement of lease obligations:​​​​
Operating cash flows from operating leases​$59,694​$57,986

Future minimum lease payments under non-cancelable leases at June 30, 2026 are as follows for the years ending September 30:

​​​​​​​
​ · ​ · ​ · ​ · ​ · Operating leases
2026 (remaining three months)​​​​$20,260
2027​​​​​81,817
2028​​​​​83,680
2029​​​​​49,447
Total undiscounted lease payments​​​​​235,204
Less: Imputed interest​​​​31,060
Total lease obligations​​​​$204,144
  1. 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.

H.C. Wainwright At-The-Market Offering Agreement

On May 13, 2026, the Company entered into an At The Market Offering Agreement (the “Sales Agreement” or the “ATM Program”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”), pursuant to which the Company may issue and sell shares of its common stock, from time to time, through H.C. Wainwright as sales agent and/or principal having an aggregate offering price of up to $100,000,000.

Under the Sales Agreement, the Company pays H.C. Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Sales Agreement. The Sales Agreement may be terminated by the Company at any time upon five business days’ prior written notice to H.C. Wainwright, or by H.C. Wainwright at any time.

During the three months ended June 30, 2026, the Company sold 17,005,831 shares of common stock under the ATM Program and generated $14,131,114 in net proceeds after payment of fees to H.C. Wainwright of $492,506.

BTIG, LLC At-the-Market Offering Agreement

On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”), as sales agent (as amended, the “Prior Sales Agreement” or the “Prior ATM Program”), under which the Company could 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. In connection with entering into the Sales Agreement, the Company terminated, effective May 12, 2026, the Prior Sales Agreement. As a result of the termination of the Prior Sales Agreement, the Company will not offer or sell any additional shares of common stock under the Prior ATM Program

The Company incurred financing costs of $353,688 in connection with the execution of the Prior Sales Agreement, which were capitalized and amortized to additional paid in capital on a pro rata basis when the Company sold common stock under the Prior ATM Program. The remaining balance of deferred finaning costs of $259,560 were fully amortized during the three months ended June 30, 2026.

Under the Prior Sales Agreement, the Company paid BTIG a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Prior Sales Agreement.

During the three and nine months ended June 30, 2026, the Company sold 0 and 15,227,166 shares of common stock, respectively, under the Prior ATM Program and generated $0 and $17,356,537, respectively in net proceeds after payment of fees to BTIG of $536,800.

** **Offerings

May 2026 Offering

On May 29, 2026, the Company completed a registered direct offering to GMS Ventures and Investments, the Company’s largest stockholder (“GMS”), priced at-the-market under Nasdaq rules for the purchase and sale of an aggregate of 8,539,709 shares of its common stock at an offering price of $0.5855 per share of common stock for aggregate net proceeds of $4,851,903, after deducting fees of $148,097.

In connection with the offering, on May 28, 2026, the Company entered into a warrant amendment with GMS pursuant to which the Company agreed to amend certain outstanding common stock warrants to purchase up to an aggregate of 15,488,570 shares of common stock previously issued to GMS in January 2025 and May 2025, with a weighted average

exercise price of $1.78 per share, effective upon the closing of the offering, such that the amended warrants have an exercise price per share of $0.5855. The incremental value related to warrant amendment was $807,582, which was recognized as an equity issuance cost. The warrants, which are equity classified otherwise remain unchanged.

April 2026 Offering

On April 23, 2026, the Company completed a registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of an aggregate of 16,129,033 shares of its common stock at an offering price of $0.31 per share (the “April 2026 Offering”). Additionally, in a concurrent private placement, the Company issued unregistered warrants to purchase up to an aggregate of 16,129,033 shares of common stock at an exercise price of $0.31 per share, which are equity classified, subject to customary ownership limitations and antidilution adjustments (the “April 2026 Warrants”). The unregistered warrants became exercisable on July 16, 2026 and will expire on July 21, 2031.

In connection with the April 2026 Offering, the Company entered into a warrant amendment pursuant to which the Company agreed to amend certain outstanding common stock warrants to purchase 2,142,855 shares of common stock previously issued in January 2025 and held by an investor in the Offering with an exercise price of $2.26, effective as of the closing of the Offering, such that the amended warrants (the “Amended Warrants”) (i) have a reduced exercise price of $0.31 per share, (ii) will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the Amended Warrants and (iii) will expire five years from the effective date of such stockholder approval. The incremental value related to the warrant amendment was $158,033, which was recognized as an equity issuance cost. Other than as described herein, the terms of the Amended Warrants remain unchanged.

In connection with the April 2026 Offering, the Company also issued to the placement agent warrants to purchase up to 1,129,032 shares of common stock (the “April 2026 Placement Agent Warrants”) at an exercise price of $0.3875 per share, which became exercisable on July 16, 2026 and expire five years from the commencement of sales in the April 2026 Offering, and paid the placement agent customary fees and reimbursed certain expenses

The aggregate net proceeds to the Company from the offering were approximately $4,113,550, net of issuance costs of $886,450. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, will be approximately $5,000,000. No assurance can be given that any of the unregistered warrants will be exercised for cash.

March 2026 Offering

On March 23, 2026, the Company completed a best‑efforts public offering, for which H.C. Wainwright acted as the exclusive placement agent. The offering closed on March 25, 2026, and the Company issued an aggregate of 20,000,000 shares of common stock together with accompanying warrants to purchase up to 20,000,000 shares of common stock, with each share issued together with a warrant to purchaseone share, at a combined public offering price of $0.25 per share and accompanying warrant, each equity classified. Gross proceeds to the Company were $5,000,000 before deducting placement agent fees and other offering expenses, and net proceeds were approximately $3.9 million after such deductions.

Each warrant has an exercise price of $0.25 per share, was exercisable immediately upon issuance, and expires five years from the date of issuance, subject to customary ownership limitations and antidilution adjustments. In connection with the offering, the Company also issued to the placement agent warrants to purchase up to 1,400,000 shares of common stock at an exercise price of $0.3125 per share, which were exercisable immediately and expire five years from the commencement of sales in the offering, and paid the placement agent customary fees and reimbursed certain expenses.

Common stock warrants

As of June 30, 2026, 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
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​6,917,142​$0.5855
January 17, 2030​2,142,855​$0.31
January 17, 2030​4,138,564​$2.26
May 27, 2030​8,571,428​$0.5855
May 27, 2030​6,700,000​$1.40
March 25, 2031​3,525,000​$0.25
March 25, 2031​1,400,000​$0.3125
​​40,353,913​​​
(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 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 nine months ended June 30, 2026, warrants to purchase an aggregate of 131,601 shares of common stock with a weighted average exercise price of $24.22 expired. No warrants expired during the three months ended June 30, 2026. In addition, during the three and nine months ended June 30, 2026, warrants to purchase an aggregate of 16,475,000 and 16,903,571 shares of common stock, respectively, were exercised, generating net proceeds of $4,118,750 and $5,026,091, respectively, after deducting expenses associated with such exercises. The warrants exercised during the three months ended June 30, 2026 had an exercise price of $0.25 per share, while the warrants exercised during the nine months ended June 30, 2026 had exercise prices ranging from $0.25 to $2.26 per share.

.

  1. 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 June 30, 2026, there were 1,858,785 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 and nine months ended June 30, 2026 and 2025:

​​​​​​​​​​​​​
​ · ​ · Three months ended June 30, · ​ · Nine months ended June 30,
​ · ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Research and development​$63,266​$91,636​$254,202​$289,889
General and administrative​​728,405​​1,579,176​​2,176,102​​6,757,008
Total​$791,671​$1,670,812​$2,430,304​$7,046,897

Stock options

As of June 30, 2026, 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​$11.36​7.6​$—
Granted​3,298,887​​1.18​​​​​
Forfeited​(480,720)​​1.34​​​​​
Expired​(225,627)​​11.18​​​​​
Balance at June 30, 2026​6,203,902​$6.73​8.2​$—
Vested and exercisable at June 30, 2026​2,803,983​$13.17​7.0​$—

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. As of June 30 the intrinsic value was $0.

The weighted average grant date fair value of the options awarded to employees for the nine months ended June 30, 2026 and 2025 was $1.05 and $4.60 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:

​​​​​​
​ · ​ · Nine months ended June 30, · ​
​​2026​ ​ ​2025​
Risk-free interest rate​ ​ ​3.8%3.6%
Expected term (years)​5.6​5.5​
Expected volatility​132.1%134.1%
Expected dividend yield​—​—​

As of June 30, 2026, there was $2,473,849 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 0.6 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 June 30, 2026 and changes during the nine months then ended are presented below.

​​​​​​​​​​​
​​​​​​​Weighted​​​
​​​​​​​Average​​​
​ · ​ · ​ · ​ · Weighted · ​ · Remaining · ​ · ​ · ​
​ · ​ · Number of · ​ · Average · ​ · Contractual · ​ · Aggregate
​ · ​ ​ ​ · Shares · ​ ​ ​ · Exercise Price · ​ ​ ​ · Term (Years) · ​ ​ ​ · Intrinsic Value
Balance at September 30, 2025​125,500​$12.92​7.6​$—
Forfeited​(90,500)​​6.78​​​​​
Expired​(5,000)​​28.80​​​​​
Balance at June 30, 2026​30,000​$28.80​5.5​$—
Vested and exercisable at June 30, 2026​30,000​$28.80​5.5​$—

The vesting of the performance-based stock options is conditional upon FDA approval of 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 and nine months ended June 30, 2026 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 and nine months ended June 30, 2025. The Company received approval of LYTENAVATM during July 2026. The Company will assess performance conditions in light of the July 2026 FDA approval.

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 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 and nine months ended June 30, 2026 and 2025:

​​​​​​​
​ · ​ · Three months ended June 30,
​ · ​ · 2026 · ​ · 2025
Revenues, net​$8,700​$1,505,322
Cost of revenues​​16,965​​439,815
Gross profit​​(8,265)​​1,065,507
Operating expenses:​​​​​​
Research and development expenses​​​​​​
ONS-5010/LYTENAVA development​​2,187,470​​5,847,020
Compensation and related benefits​​567,189​​906,195
Stock-based compensation​​63,266​​91,636
Other research and development​​433,174​​289,855
​​​3,251,099​​7,134,706
Selling, general and administrative expenses​​​​​​
Professional fees​​1,173,827​​1,315,395
Compensation and related benefits​​1,520,593​​1,943,321
Stock-based compensation​​728,405​​1,579,176
Europe commercial expenses​​3,042,474​​3,867,013
Facilities, fees and other related costs​​1,085,546​​974,576
​​​7,550,845​​9,679,481
​​​​​​​
Segment loss from operations​​(10,810,209)​​(15,748,680)
Other segment items (i)​​(9,509,063)​​(4,403,822)
Segment loss before income taxes​$(20,319,272)​$(20,152,502)
​​​​​​​
​ · ​ · Nine months ended June 30,
​ · ​ · 2026 · ​ · 2025
​​​​​​​
Revenues, net​$(1,071,694)​$1,505,322
Cost of revenues​​195,918​​439,815
Gross profit​​(1,267,612)​​1,065,507
Operating expenses:​​​​​​
Research and development expenses​​​​​​
ONS-5010/LYTENAVA development​​8,317,752​​18,282,667
Compensation and related benefits​​1,725,206​​1,831,860
Stock-based compensation​​254,202​​289,889
Other research and development​​1,088,811​​797,459
​​​11,385,971​​21,201,875
Selling, general and administrative expenses​​​​​​
Professional fees​​4,667,134​​5,120,664
Compensation and related benefits​​4,101,809​​5,806,232
Stock-based compensation​​2,176,102​​6,757,008
Europe commercial expenses​​11,919,248​​9,177,513
Facilities, fees and other related costs​​2,803,272​​2,749,275
​​​25,667,565​​29,610,692
​​​​​​​
Segment loss from operations​​(38,321,148)​​(49,747,060)
Other segment items (i)​​(9,509,339)​​617,766
Segment loss before income taxes​$(47,830,487)​$(49,129,294)

Other segment items included in segment loss include 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.

12. Subsequent Events

August 2026 Follow-On Offering

On August 12, 2026, the Company entered into an underwriting agreement with Piper Sandler & Co. and BTIG, LLC, as representatives of the several underwriters named therein, relating to the public offering (the “August 2026 Offering”) by the Company of (i)55,555,556 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 55,555,556 shares of common stock (the “August 2026 Warrants”) at a combined public offering price of $0.99 per share of common stock and accompanying August 2026 Warrant. The shares of common stock and August 2026 Warrants are immediately separable and were issued separately. Each August 2026 Warrant has an initial exercise price per share of $1.10, subject to certain customary adjustments for recapitalizations, stock splits and similar actions. The August 2026 Warrants are immediately exercisable and expire five years from the date of issuance. The August 2026 Offering closed on August 14, 2026.

The Company also granted the underwriters an option for a period of 30 days to purchase up to 8,333,333 additional shares of common stock and/or August 2026 Warrants to purchase up to 8,333,333 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. On August 12, 2026, the underwriters exercised such option with respect to August 2026 Warrants to purchase up to 8,333,333 additional shares of common stock.

The estimated aggregate net proceeds to the Company from the August 2026 Offering were approximately $51.1 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and excluding any exercise of the underwriter's option to purchase additional securities and assuming no exercise of the accompanying August 2026 Warrants. The Company intends use the net proceeds from this offering, together with its cash and cash equivalents, to fund the commercial launch of LYTENAVA in the United States as well as for working capital and general corporate purposes.

GMS, the Company’s largest stockholder, purchased an aggregate of 2,525,252 shares of common stock and accompanying August 2026 Warrants in the August 2026 Offering at the public offering price per share of common stock and accompanying August 2026 Warrant. Robert Jahr, the Company’s Chief Executive Officer, and Lawrence A. Kenyon, the Company’s Chief Financial Officer, purchased an aggregate of 151,515 and 101,010 shares of common stock and accompanying August 2026 Warrants in the August 2026 Offering, respectively, at the public offering price per share of common stock and accompanying August 2026 Warrant.

ATM Program Suspension

On August 12, 2026, the Company delivered written notice to H.C. Wainwright that the Company has terminated its prospectus supplement, dated May 13, 2026, relating to the Sales Agreement. The Company will not make any sales of common stock pursuant to the Sales Agreement unless and until a new prospectus supplement is filed with the SEC; however, the Sales Agreement remains in full force and effect.

Authorized Share Increase

On July 16, 2026, at a special meeting of the Company’s stockholders (the “2026 Special Meeting”) the Company’s stockholders approved an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 260,000,000 shares to 600,000,000 shares. The Company filed the Certificate of Amendment with the Secretary of State of the State of Delaware on July 16, 2026, and the amendment became effective on that date.

Warrant Approval

On July 16, 2026, the April 2026 Warrants and the April 2026 Placement Agent Warrants became exercisable upon stockholder approval of the required proposals at the 2026 Special Meeting. The April 2026 Warrants expire on July 21, 2031 and the April 2026 Placement Agent Warrants expire on April 22, 2031.

FDA Approval

On July 24, 2026, the FDA approved the Company’s biologics license application for LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD. LYTENAVA is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States. Following the approval, the Company commenced activities to support the commercial launch of LYTENAVA in the United States.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.