ISELIN, N.J., March 25, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the closing of its previously announced public offering of 20,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 20,000,000 shares of common stock. Each share of common stock and accompanying common warrant were sold together at a combi ...

ISELIN, N.J., March 24, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the pricing of its previously announced public offering of 20,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 20,000,000 shares of common stock. Each share of common stock and accompanying common warrant are being sold together at a ...

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ISELIN, N.J., March 23, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has commenced a best-efforts public offering of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions and there can be no assurance as to wheth ...

Core Insights - Outlook Therapeutics, Inc. announced an amendment to its existing convertible note with Avondale Capital, LLC, extending the maturity date to December 31, 2026, with no other changes to the terms [2] - The company issued a new non-convertible, unsecured note with Atlas Sciences, LLC, amounting to $18.4 million, expecting to receive $17 million in net proceeds after original issue discount [3] - Proceeds from the new note will be utilized to pay down a portion of the existing note, leaving approximately $10.8 million of principal and interest remaining [3] - The new note carries an interest rate of Prime Rate plus 3%, with a minimum interest rate of 9.5% per annum, and matures on June 16, 2027 [4] Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [5] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD, with commercial launch initiated in Germany, Austria, and the UK [5] - In the U.S., ONS-5010/LYTENAVA™ is currently investigational and, if approved, would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [6]

Core Viewpoint - Outlook Therapeutics, Inc. is focused on enhancing the standard of care for bevacizumab in treating retina diseases and is actively engaging with the FDA to address issues raised in the Complete Response Letter for its Biologics License Application for ONS-5010/LYTENAVA™ [1][3] Regulatory Update - A Type A meeting with the FDA was held to clarify the outstanding issues regarding the evidence of effectiveness and to discuss potential regulatory pathways for approval [2] - The company aims to align with the FDA on confirmatory evidence supporting its application and to identify the most efficient pathway toward potential approval [3] Clinical Trial Results - ONS-5010/LYTENAVA™ showed clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO Phase 3 trial, meeting its primary and key secondary endpoints [4] - The NORSE EIGHT trial and other submitted information provided confirmatory evidence of efficacy and safety, supporting the successful NORSE TWO trial [4] Product Potential - If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab, backed by standardized manufacturing and robust pharmacovigilance [5] - The product candidate is supported by a fully domestic, end-to-end U.S. manufacturing supply chain [5] Product Description - ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the U.S. for treating wet AMD and has received Marketing Authorization in the EU and UK [6] - In the U.S., ONS-5010/LYTENAVA™ is currently investigational and, if approved, would be the first ophthalmic formulation of bevacizumab for retinal indications [10] Mechanism of Action - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds to all isoforms of human VEGF, neutralizing its biological activity and reducing endothelial cell proliferation and vascular leakage in the retina [8]

Core Viewpoint - Outlook Therapeutics, Inc. has entered into an exclusive commercial distribution agreement with Mediconsult AG for the sale and distribution of LYTENAVA™ (bevacizumab gamma) in Switzerland, aiming to enhance access to this treatment for retinal diseases in the European market [1][2][3] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to improve the standard of care for retinal diseases [10] - Mediconsult AG is a leading full-service partner for ophthalmic professionals in Switzerland, with over 35 years of experience in the ophthalmology market [9] Agreement Details - Mediconsult will have exclusive rights to market, import, distribute, and commercialize LYTENAVA™ in Switzerland, while also handling regulatory activities including seeking and maintaining Marketing Authorization [2][3] - Outlook Therapeutics will retain responsibility for manufacturing, product supply, and intellectual property maintenance [2] Market Potential - Switzerland is identified as an important European market for LYTENAVA™, with the product expected to launch in 2027, pending receipt of Marketing Authorization [4][8] - The partnership is part of a broader strategy to expand access to LYTENAVA™ across Europe while maintaining control over manufacturing and product quality [3] Product Information - LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet age-related macular degeneration (AMD) [5] - It has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for treating wet AMD [5][10]

Product Launch and Market Overview - The company launched LYTENAVA (bevacizumab gamma) in Germany and the UK in June 2025, with plans for further expansion into other EU countries and potential U.S. approval [105]. - The total anti-VEGF retina market in Europe is estimated at approximately $3.6 billion, with around 1.52 million treated patients and 8.3 million total anti-VEGF units [106]. - The U.S. anti-VEGF retina market is estimated at $8.5 billion, with 55% of physicians preferring off-label repackaged bevacizumab as the first-line product [107]. - The global market for anti-VEGF retina is estimated to be approximately $16 billion [108]. - The company recognizes revenue from sales of LYTENAVA, which became available for commercial sale in the UK and Germany in June 2025 [121]. Financial Performance - The company reported a net loss of $23.1 million for the three months ended December 31, 2025, compared to a net income of $17.4 million for the same period in 2024 [115]. - For the three months ended December 31, 2025, the company reported net revenue of negative $1.2 million, primarily due to a $1.1 million increase in the returns reserve related to estimated product returns from the UK distributor [144]. - The company incurred a loss from operations of $13.5 million for the three months ended December 31, 2025, an improvement of $8.1 million compared to the loss of $21.6 million in the same period of 2024 [143]. - The company has not generated significant revenue from product sales and continues to incur net losses and negative cash flows from operations [152]. - As of December 31, 2025, the company reported a net cash used in operating activities of $14.9 million, primarily due to a net loss of $23.1 million [168]. Expenses and Cost Management - Research and development expenses for the three months ended December 31, 2025 totaled $3.6 million, a decrease of $6.0 million compared to the same period in 2024, mainly due to reduced expenses for the ONS-5010/LYTENAVA development [146][147]. - Selling, general and administrative expenses for the three months ended December 31, 2025 were $8.6 million, down $3.3 million from the prior year, attributed to decreased compensation and professional fees, partially offset by increased launch expenses for LYTENAVA in Europe [148]. - The total research and development expenses for the three months ended December 31, 2025 included $2.6 million specifically for ONS-5010/LYTENAVA development [146]. Going Concern and Financial Obligations - There is substantial doubt about the company's ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for the next year [120]. - As of December 31, 2025, the company did not meet the required $3.0 million Quarterly Debt Reduction Obligation, resulting in a Major Trigger Event [116]. - A Major Trigger Event occurred due to the failure to meet a $3.0 million Quarterly Debt Reduction Obligation, resulting in a 10% increase to the outstanding balance of the March 2025 Note [160]. - The company plans to finance future operations through a combination of licensing arrangements, debt issuance, and equity sales, but faces potential dilution of ownership for existing shareholders [166]. Future Outlook and Strategic Plans - The company anticipates ongoing increases in general and administrative expenses as it expands its commercial presence and prepares for potential launches in additional territories [130]. - The company anticipates incurring additional losses until significant sales of ONS-5010/LYTENAVA or any other product candidates are generated, necessitating additional financing for future operations [153]. - The company plans to work with the FDA to discern a regulatory pathway for ONS-5010 and prepare for its potential launch, while expecting to incur net losses and negative cash flow from operations for the foreseeable future [163]. Stock and Financing Activities - The company sold 5,000,000 shares of common stock under the ATM Agreement, generating $2.4 million in net proceeds [118]. - The company generated approximately $14.9 million in net proceeds from the sale of 10,227,166 shares of common stock under the ATM Offering during the three months ended December 31, 2025 [156]. - The March 2025 Note issued for $33.1 million is convertible into common stock and bears interest at the prime rate plus 3%, with a minimum interest rate of 9.5% [173]. - The Conversion Price for the March 2025 Note is set at $2.26 per share prior to a Major Trigger Event, with adjustments for stock splits and combinations [179]. - Following the Major Trigger Event, the outstanding balance of the March 2025 Note automatically increased by 10% effective January 1, 2026 [181]. - The adjusted Conversion Price after the Major Trigger Event is the lesser of $2.26 or 90% of the lowest closing bid price over the three trading days preceding the conversion notice, with a floor price of $0.404 [181]. Accounting and Reporting - The Critical Accounting Policies and Significant Judgments and Estimates have not materially changed from the previous fiscal year ended September 30, 2025 [182]. - As a "Smaller Reporting Company," the company is not required to disclose certain market risk information [183].

分组1 - Oncobiologics, Inc. reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.17, representing an earnings surprise of -26.95% [1] - The company posted revenues of -$1.21 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 131.38%, compared to zero revenues a year ago [2] - Oncobiologics shares have declined approximately 69% since the beginning of the year, contrasting with the S&P 500's decline of only 0.1% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $4.97 million, and for the current fiscal year, it is -$0.65 on revenues of $21.13 million [7] - The Medical - Biomedical and Genetics industry, to which Oncobiologics belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]