Outlook Therapeutics, Inc. 8-K Filings

Outlook Therapeutics, Inc. entered into an Underwriting Agreement with Piper Sandler & Co. and BTIG, LLC for a public offering of 55,555,556 shares of common stock together with accompanying warrants to purchase up to an aggregate of 55,555,556 shares, at a combined public offering price of $0.99 per share and accompanying warrant. The company granted underwriters a 30‑day option to purchase up to 8,333,333 additional shares and/or warrants; the underwriters exercised this option for the additional warrants. Estimated gross proceeds are approximately $55.0 million before underwriting discounts, commissions and expenses and assuming no warrant exercises.

Each warrant is immediately exercisable at $1.10 per share and expires five years from issuance, subject to ownership limits of 4.99%, 9.99% or 19.99% of outstanding common stock. GMS Ventures and Investments, the largest stockholder, and senior executives, including the CEO and CFO, participated in the offering by purchasing common stock and accompanying warrants.

Outlook Therapeutics reported third-quarter fiscal 2026 results and highlighted recent FDA approval of LYTENAVA, described as the only FDA-approved ophthalmic bevacizumab for wet age-related macular degeneration. The company is preparing a targeted U.S. commercial launch by the end of calendar 2026, including payer engagement, pricing and reimbursement strategy, and scaling commercial supply. Management believes LYTENAVA could potentially exceed $500 million in annual U.S. sales by 2030 and is also expanding commercialization in Germany, Austria and the UK, with additional European launches planned.

For the quarter ended June 30, 2026, net loss attributable to common stockholders was $20.3 million, or $0.15 per share, compared with a net loss of $20.2 million, or $0.55 per share, a year earlier. Adjusted net loss improved to $10.9 million versus $15.8 million in the prior-year quarter, mainly excluding fair value changes in promissory notes and warrant liabilities and loss on extinguishment of debt. Revenue declined to $9 thousand from $1.5 million, and gross profit turned from a $1.1 million profit to a slight loss. As of June 30, 2026, the company held $11.2 million in cash and cash equivalents, total assets of $26.2 million, current liabilities of $28.7 million, and a stockholders’ deficit of $10.4 million.

Outlook Therapeutics, Inc. reported that, based on preliminary estimates, it had $11.2 million of cash and cash equivalents as of June 30, 2026; this figure is unaudited and may change after normal closing and review processes. The company disclosed that its only product, LYTENAVA™ (bevacizumab‑vikg), received U.S. FDA approval on July 24, 2026 for the treatment of neovascular (wet) age‑related macular degeneration in adults, complementing existing approvals in the EU and UK.

Detailed amended and restated risk factors highlight that Outlook has a history of significant losses, generating only $1.4 million in LYTENAVA revenue in fiscal 2025, and that there is substantial doubt about its ability to continue as a going concern without substantial additional capital. As of March 31, 2026, cash was $7.7 million, supplemented by $4.2 million in April 2026 and $4.9 million in May 2026 equity financings, and encumbered by a $19.8 million unsecured note to Atlas Sciences LLC carrying at least 9.5% interest, a 7.5% exit fee on cash payments, and quarterly redemption rights beginning September 2026. The company also notified H.C. Wainwright that it terminated the current prospectus supplement for its at‑the‑market equity program, so further sales under that facility will require a new supplement, while the underlying Sales Agreement remains in effect.

Outlook Therapeutics, Inc. received U.S. FDA approval for LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab, for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). LYTENAVA is described as the first and only FDA-approved ophthalmic bevacizumab for wet AMD in the United States.

The company anticipates that this approval will provide 12 years of Reference Product Exclusivity under the BPCIA. It highlights the U.S. anti-VEGF retina market as approximately $8.5 billion annually and is executing a commercial launch aimed at broad reimbursement, physician support, and patient access, with availability for eligible U.S. patients expected before year-end.

LYTENAVA already holds centralized Marketing Authorization in the EU and authorization in the UK for wet AMD, with commercial launches commenced in Germany, Austria, and the UK. Safety information notes risks typical of intravitreal VEGF inhibitors, including endophthalmitis, retinal detachment, intraocular pressure increases, and a potential risk of arterial thromboembolic events, with common adverse reactions including conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%).

Outlook Therapeutics, Inc. approved new equity and cash incentives for its chief executive and chief financial officers tied to potential FDA approval of ONS-5010 (bevacizumab-vikg). The awards recognize their efforts during 2025 and 2026 advancing the Biologics License Application through FDA review and appeal processes.

The chief executive officer received options to purchase 100,000 shares and the chief financial officer 210,078 shares under the 2024 Equity Incentive Plan, all at an exercise price of $1.4304 per share, vesting on July 21, 2027 subject to continued service. They also received cash bonus opportunities of $420,000 and $200,000, respectively, which will be earned and payable only if, on or before July 31, 2026, the FDA approves ONS-5010 and issues a favorable decision on the Biologics License Application and each executive remains in service through payment.

Outlook Therapeutics, Inc. held a special meeting of stockholders on July 16, 2026. Stockholders approved the potential issuance of common shares underlying warrants issued in connection with an April 2026 registered direct offering, including up to 16,129,033 shares from Private Placement Warrants and up to 2,258,064 shares from Placement Agent Warrants, as well as 2,142,854 shares underlying amended previously issued warrants.

Stockholders also approved amending the Restated Certificate of Incorporation to increase authorized common stock from 260,000,000 to 600,000,000 shares. In addition, they approved an amendment authorizing the board to implement a reverse stock split, with a corresponding proportional reduction in authorized shares, at a ratio between 1-for-10 and 1-for-50.

For the meeting, 62,303,960 shares, representing approximately 51.5% of the 120,863,252 shares outstanding as of the record date, were present or represented by proxy.

Outlook Therapeutics, Inc. reports that it has regained compliance with Nasdaq’s minimum bid price requirement for continued listing on the Nasdaq Capital Market. The company received notice that its common stock closed at or above $1.00 per share for ten consecutive business days between June 11, 2026 and June 25, 2026, satisfying Nasdaq Listing Rule 5550(a)(2). This closes a prior delisting determination that had been triggered when the stock traded below $1.00 for 30 consecutive business days.

Outlook Therapeutics reported that the U.S. FDA has acknowledged receipt of its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for wet age-related macular degeneration. The FDA classified the resubmission as a Class 1 review, triggering a 60-day review period and setting a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2026.

The company describes ONS-5010/LYTENAVA as an ophthalmic formulation of bevacizumab that is already covered by centralized Marketing Authorization in the EU and authorization by the UK MHRA for wet AMD, with commercial launch commenced in Germany, Austria, and the UK. In the United States, the product remains investigational and subject to the outcome of this BLA review.

Outlook Therapeutics, Inc. filed an 8-K and issued a press release announcing that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat neovascular age-related macular degeneration.

The company previously successfully appealed a December 2026 Complete Response Letter, after which the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established and that no additional trials are required. The decision directed FDA staff to work with Outlook Therapeutics to finalize product labeling.

The resubmission is classified as a Class 1 resubmission, with a PDUFA date and FDA decision expected within 60 days of FDA’s receipt. ONS-5010/LYTENAVA™ already holds centralized Marketing Authorization in the EU and UK for wet AMD, and commercial launch has begun in Germany, Austria, and the UK.

Outlook Therapeutics, Inc. completed a registered direct offering of 8,539,709 shares of its common stock, $0.01 par value per share, to GMS Ventures and Investments. The shares were issued under an existing shelf registration statement on Form S-3 (File No. 333-278340).

The transaction was executed pursuant to a securities purchase agreement dated May 28, 2026, and used the company’s base prospectus and a prospectus supplement. Legal opinions and related consents from Cooley LLP were filed as exhibits in connection with this equity financing.

Outlook Therapeutics, Inc. agreed to a registered direct offering with GMS Ventures and Investments for 8,539,709 shares of common stock at $0.5855 per share, for expected gross proceeds of approximately $5.0 million before expenses. The transaction is expected to close on or about May 29, 2026, with proceeds intended for working capital and general corporate purposes.

In connection with this financing, the company entered into a warrant amendment with the same investor to reduce the exercise price of outstanding warrants to purchase up to 15,488,570 shares of common stock from a weighted average of $1.78 to $0.5855 per share, effective upon closing. Both the purchase agreement and warrant amendment include customary terms, conditions, and indemnification provisions and are tied to an existing effective Form S-3 registration statement and related prospectus supplement.

Outlook Therapeutics announced that the U.S. FDA has granted its appeal after a Formal Dispute Resolution process over the December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat neovascular age-related macular degeneration.

The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™ in this indication and directed internal offices to work with the company on final labeling. Outlook Therapeutics expects to resubmit the BLA in June 2026 as a Class 1 resubmission, with a PDUFA decision anticipated within 60 days of FDA receipt.

Outlook Therapeutics reported a second fiscal quarter 2026 net loss attributable to common stockholders of $4.5 million, or $0.05 per share, a sharp improvement from a $46.4 million loss, or $1.50 per share, a year earlier largely due to non‑cash fair value movements and prior warrant inducement expenses.

On a non‑GAAP basis, adjusted net loss widened to $14.1 million, or $0.16 per share, from $12.4 million, or $0.40 per share. Revenues were modest at $128,000 and were offset by fixed distribution costs, while European LYTENAVA unit sales declined about 10% versus the prior quarter but have begun to trend upward early in the current quarter.

The company continued its European rollout of LYTENAVA, signed a Swiss distribution agreement with Mediconsult AG, and launched a real‑world evidence study in Germany. It expects an FDA dispute‑resolution decision on ONS‑5010/LYTENAVA in May 2026. Cash and cash equivalents were $7.7 million as of March 31, 2026, excluding $4.2 million of net proceeds from an April 2026 offering.

Outlook Therapeutics, Inc. entered into a new At The Market Offering Agreement with H.C. Wainwright, allowing the company to sell up to $100,000,000 of common stock from time to time under its effective Form S-3 shelf registration. H.C. Wainwright will act as sales agent and/or principal and earn a 3% commission on gross proceeds.

In connection with this new agreement, Outlook Therapeutics terminated its prior $100,000,000 at-the-market program with BTIG and will no longer sell shares under that facility. The company also reported preliminary, unaudited cash and cash equivalents of approximately $7.7 million as of March 31, 2026, excluding $4.5 million of net proceeds from an April 2026 registered direct equity offering.

Outlook Therapeutics, Inc. entered into a registered direct offering and concurrent private placement, issuing 16,129,033 shares of common stock and matching common warrants at a combined price of $0.31 per share and warrant, for gross proceeds of about $5.0 million before fees.

The warrants carry a $0.31 exercise price, become exercisable after stockholder approval and an increase in authorized shares, and have a five‑year term from the later of that date and the effectiveness of a resale registration statement. The company also issued placement agent warrants and agreed to standard cash fees, and separately amended 2,142,854 existing warrants to reduce their exercise price to $0.31 and extend their life to five years after future stockholder approval. Net proceeds are planned primarily for working capital and general corporate purposes.

Outlook Therapeutics filed an 8-K after completing a Federal Dispute Resolution meeting with the FDA’s Office of New Drugs regarding ONS-5010/LYTENAVA, its investigational bevacizumab formulation for wet age-related macular degeneration in the United States. The company expects a formal FDA decision from this dispute process in May 2026 and plans to update the market after receiving the agency’s response.

LYTENAVA already holds centralized Marketing Authorization in the European Union and separate authorization in the UK for wet AMD, and commercial launch has begun in Germany and the UK. In the United States, the product remains investigational following a December 30, 2025 Complete Response Letter on its biologics license application.

Outlook Therapeutics filed a report describing a key regulatory step for its retina drug candidate ONS-5010/LYTENAVA™ (bevacizumab‑vikg) in the United States. After receiving a Complete Response Letter from the FDA on December 30, 2025 for its Biologics License Application in neovascular age‑related macular degeneration, the company submitted a formal dispute resolution request. The FDA has accepted this request and granted a meeting with the deciding official in April 2026, giving the company an opportunity to argue that Phase 3 NORSE TWO and additional NORSE EIGHT data sufficiently support approval. The company notes that no safety concerns have been raised by the FDA and highlights that LYTENAVA already holds Marketing Authorizations in the EU and UK for wet AMD, where commercial launch has begun.

Outlook Therapeutics completed a best-efforts public offering of common stock and warrants. The company sold 20,000,000 shares of common stock with accompanying warrants to purchase up to 20,000,000 shares at a combined public price of $0.25 per share-and-warrant.

Gross proceeds were approximately $5.0 million, with net proceeds of about $4.0 million after placement agent fees and expenses. The investor warrants are exercisable immediately at $0.25 per share and expire five years from issuance, subject to 4.99% or 9.99% beneficial ownership caps.

H.C. Wainwright & Co. received cash fees and 1,400,000 placement agent warrants exercisable at $0.3125 per share, also for five years. The company agreed to certain lock-up and no variable-rate issuance covenants, and used an existing Form S-3 shelf registration and prospectus supplement for this transaction.

Outlook Therapeutics entered a Note Purchase Agreement with Atlas Sciences, issuing an unsecured promissory note with an original principal balance of $18,360,000. The note was sold at a discount for $17,000,000, which must be used solely to repay $17,000,000 of an existing convertible note held by Avondale Capital.

The new note bears interest at the prime rate plus 3%, with a floor of 9.5%, matures 15 months after closing, includes a 7.5% exit fee on cash payments, and allows Atlas to redeem up to $3,000,000 per quarter starting six months after closing. After repayment, about $10.8 million remains outstanding on the Avondale note, whose maturity was extended to December 31, 2026.

In updated risk factors, the company reports cash and cash equivalents of $8.7 million as of December 31, 2025 plus $2.4 million from at-the-market sales, and states there is substantial doubt about its ability to continue as a going concern without substantial additional capital. It also highlights repeated FDA Complete Response Letters for ONS-5010/LYTENAVA and its heavy dependence on this single product.

Outlook Therapeutics, Inc. announced that its Board of Directors accepted the resignation of Dr. Julia Haller from the Board, effective March 11, 2026. She had served as a Class director and was a member of the Nominating and Corporate Governance Committee.

The Board resolved to reduce its size to nine directors upon her resignation. According to the company, Dr. Haller’s decision was not the result of any dispute or disagreement regarding the company’s operations, policies, or practices, and the Board expressed appreciation for her service.

Outlook Therapeutics, Inc. reported results of its Annual Meeting of Stockholders held on March 10, 2026. Of 73,509,455 common shares outstanding as of the record date, 37,271,431 shares, or approximately 50.70%, were present or represented by proxy, establishing a quorum.

Stockholders elected Class I directors Yezan Haddadin, Faisal G. Sukhtian and Kurt J. Hilzinger to the Board, each to serve until the 2029 Annual Meeting of Stockholders or until a successor is duly elected and qualified. This maintains continuity on the company’s Board of Directors.

Stockholders also ratified the Audit Committee’s selection of KPMG LLP as independent registered public accounting firm for the fiscal year ending September 30, 2026, with strong support. In addition, stockholders approved, on a non-binding advisory basis, the compensation of the company’s named executive officers.

Outlook Therapeutics reported that it has held a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for its Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg), an investigational treatment for wet age-related macular degeneration (wet AMD) in the United States.

The discussion focused on the FDA’s remaining concern about “substantial evidence of effectiveness” and on possible regulatory paths forward. The company plans to continue dialog with the FDA and is reviewing regulatory options to advance the program toward potential U.S. approval.

Outlook highlighted that ONS-5010 achieved clinically meaningful, statistically significant visual acuity gains in the NORSE TWO Phase 3 trial and that NORSE EIGHT and other data provide confirmatory efficacy and safety evidence, with no safety concerns identified by the FDA. The product already has Marketing Authorizations in the EU and UK and has been launched in Germany, Austria, and the UK for wet AMD, while remaining investigational in the U.S.

Outlook Therapeutics, Inc. received a notice from Nasdaq that its common stock has closed below $1.00 per share for the last 30 consecutive business days, failing to meet the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The company’s stock remains listed on the Nasdaq Capital Market for now.

Outlook Therapeutics has 180 calendar days, until August 17, 2026, to regain compliance by having its closing bid price at or above $1.00 per share for at least ten consecutive business days. If it still does not comply, it may qualify for an additional 180-day period if it meets other initial listing standards and notifies Nasdaq that it intends to cure the deficiency, potentially through a reverse stock split.

If the company cannot regain compliance and is not granted or does not succeed in an extension, its common stock could be delisted from the Nasdaq Capital Market. Outlook Therapeutics states that it intends to actively monitor its share price and evaluate options to resolve the deficiency.

Outlook Therapeutics reported a GAAP net loss attributable to common stockholders of $23.1 million, or $0.38 per share, for the first fiscal quarter ended December 31, 2025, compared with GAAP net income of $17.4 million, or $0.72 per share, a year earlier. On a non-GAAP basis, which excludes fair value changes in promissory notes and warrants, the company’s adjusted net loss narrowed to $13.5 million, or $0.22 per share, from an adjusted net loss of $21.6 million, or $0.89 per share, in the prior-year quarter.

Revenue was reduced by a higher returns reserve tied to short-dated LYTENAVA shipments in the UK, but European unit sales of LYTENAVA more than doubled versus the previous three months. As of December 31, 2025, cash and cash equivalents were $8.7 million against current liabilities of $49.1 million, with total stockholders’ deficit of $38.5 million. The company is expanding LYTENAVA launches across Europe and has requested a Type A meeting with the FDA following a December 30, 2025 Complete Response Letter for its U.S. ONS‑5010 biologics application.

Outlook Therapeutics filed an 8-K after submitting a Type A meeting request to the FDA in response to a Complete Response Letter for its Biologics License Application for ONS-5010/LYTENAVA, an ophthalmic bevacizumab candidate for wet age-related macular degeneration.

The FDA’s letter cited a single deficiency, stating there was a lack of substantial evidence of effectiveness and recommending additional confirmatory evidence. The company disagrees, pointing to its NORSE TWO Phase 3 trial, which met its primary and key secondary visual acuity endpoints, and to supportive clinical, mechanistic, and natural history data.

Outlook Therapeutics also highlights NORSE EIGHT, a second Phase 3 study that did not meet its primary endpoint at 8 weeks but showed a positive trajectory and pharmacodynamic evidence through 12 weeks, as well as a favorable safety profile. While ONS-5010 remains investigational in the U.S., the same product, branded as LYTENAVA (bevacizumab gamma), already has marketing authorization and commercial launch for wet AMD in the EU and UK.

Outlook Therapeutics reported a key regulatory update for ONS-5010 (bevacizumab-vikg). The U.S. Food and Drug Administration acknowledged receipt of the company’s resubmitted Biologics License Application and designated it a Class 1 review, which provides a two-month review period from the date of resubmission.

The FDA established a PDUFA goal date of December 31, 2025. This sets a clear timeline for the agency’s action on the resubmission and marks formal acceptance into the expedited review track associated with a Class 1 review.

Outlook Therapeutics filed an 8-K stating it has resubmitted the Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration. The company also furnished a related press release as Exhibit 99.1 dated November 3, 2025.

The filing identifies the earliest event as November 3, 2025 and confirms the company’s Nasdaq listing under the symbol OTLK. The report was signed by Lawrence A. Kenyon, Chief Financial Officer.

Outlook Therapeutics, Inc. reported that it has completed a requested Type A meeting with the U.S. Food and Drug Administration regarding the complete response letter dated August 27, 2025 for its biologics license application resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet age-related macular degeneration. Based on this discussion and the FDA’s feedback, the company now expects to resubmit its BLA before the end of calendar year 2025. These details were disclosed through a press release dated September 29, 2025 that is filed as an exhibit.

Outlook Therapeutics, Inc. reported that Chief Commercial Officer Jeff Evanson stepped down from his role effective September 5, 2025. His departure is treated as a termination of employment without “cause” under his executive employment agreement and other company plans. Subject to his signing and not revoking a separation agreement that includes a release of claims against the company, he will receive severance benefits consistent with the terms provided for a termination without cause. The company states that a description of these severance benefits is contained in its Definitive Proxy Statement filed on February 10, 2025, which is incorporated by reference.

Outlook Therapeutics, Inc. reported that the U.S. Food and Drug Administration issued a complete response letter to its biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab being developed to treat wet age-related macular degeneration (wet AMD). A complete response letter means the FDA has finished its review but has decided that the application cannot be approved in its current form. The company disclosed this development through a press release, which is included as an exhibit to the report.

Outlook Therapeutics, Inc. furnished a press release announcing its financial results for the third fiscal quarter ended June 30, 2025. The company released these results through a press release dated August 14, 2025, which is attached as Exhibit 99.1. The disclosure is furnished rather than filed, meaning it is not automatically incorporated into other securities law filings unless specifically referenced.