Core Article Summary - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma) as a treatment option for wet age-related macular degeneration (wet AMD) [1][3] - LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK, with 10 years of market exclusivity [3][4] - Outlook Therapeutics, the developer of LYTENAVA™, has achieved regulatory approval in the EU and UK for this treatment [2][4] Product Details - LYTENAVA™ (bevacizumab gamma) is an ophthalmic formulation of bevacizumab specifically designed for treating wet AMD [4][6] - The product works by binding to vascular endothelial growth factor (VEGF), preventing its interaction with receptors on endothelial cells, thereby reducing cell proliferation and new blood vessel formation in the retina [6] - In the US, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is currently under investigation in a non-inferiority study for wet AMD treatment [5][7] Company Strategy - Outlook Therapeutics is focused on the development and commercialization of LYTENAVA™ for retina diseases, particularly wet AMD [7] - The company plans to commercially launch LYTENAVA™ in the EU and UK in the first half of 2025 [7] - In the US, if the ongoing study is successful, Outlook Therapeutics may resubmit a Biologics License Application (BLA) to the FDA [7] Regulatory Status - LYTENAVA™ has received Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [4][7] - The product is currently investigational in the US, with potential to become the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [5][7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 Delaware 38-3982704 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Exchange Commission not la ...

Product Development and Approvals - LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU and UK, with the first commercial launch anticipated in H1 CY25[2] - The company plans to resubmit the BLA for ONS-5010 in Q1 CY2025, with final efficacy data from NORSE EIGHT expected in January 2025[6][9] - Initial commercial launches of LYTENAVA™ in Europe are planned to commence in H1 CY2025[6] - Potential US FDA approval of ONS-5010 is anticipated in H2 CY2025[6] Financial Performance - Outlook Therapeutics had cash and cash equivalents of $14.9 million as of September 30, 2024[10] - The company reported a net loss of $75.4 million, or $4.06 per basic and diluted share, for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million, or $4.72 per basic and diluted share, for the prior fiscal year[18] - Research and development expenses increased to $41.8 million in FY2024 from $26.5 million in FY2023[23] - General and administrative expenses increased to $29.9 million in FY2024 from $26.7 million in FY2023[23] - Total assets decreased to $28.8 million as of September 30, 2024, from $32.3 million as of September 30, 2023[24] - Total stockholders' deficit increased to $73.1 million as of September 30, 2024, from $14.4 million as of September 30, 2023[24]

LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK); First commercial launch anticipated in H1 CY25Received NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD ISELIN, N.J., Dec. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year ...

Core Viewpoint - Outlook Therapeutics is focusing on the commercial launch of LYTENAVA™ (bevacizumab gamma) for wet age-related macular degeneration (wet AMD) in the EU and UK, while also preparing to resubmit its Biologics License Application (BLA) for ONS-5010 in the U.S. following a strategic review to streamline operations and reduce costs [1][2]. Company Initiatives - The management team has implemented initiatives to streamline the organization, reduce operating expenses, and preserve capital, aiming to maximize efforts for the commercial launch of LYTENAVA™ [1][2]. - A 23% reduction in workforce has been announced, which is expected to save approximately $1.4 million annually, excluding the costs associated with the workforce reduction [2]. Regulatory Approvals - LYTENAVA™ has received Marketing Authorization from the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, making it the first authorized ophthalmic formulation of bevacizumab for treating wet AMD [2][5]. - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ as a treatment option for wet AMD [2]. Clinical Trials and Future Plans - The company plans to resubmit its BLA for ONS-5010 in the first quarter of 2025, pending the full efficacy and safety results from the NORSE EIGHT clinical trial expected in January 2025 [2][6]. - Preliminary data from the NORSE EIGHT trial indicated an improvement in vision and a favorable safety profile for ONS-5010, despite not meeting the pre-specified non-inferiority endpoint [2][6]. Product Overview - ONS-5010/LYTENAVA™ is a recombinant humanized monoclonal antibody designed to treat wet AMD by neutralizing vascular endothelial growth factor (VEGF) [4][5]. - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [6].

ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effecti ...

NEW YORK, Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Outlook and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On November 27, ...

Core Viewpoint - Outlook Therapeutics' ONS-5010 (Lytenava) failed to meet the non-inferiority endpoint in the NORSE EIGHT clinical study for treating wet age-related macular degeneration (AMD), leading to a significant drop in share price by 65.2% [2][5] Company Summary - The NORSE EIGHT study involved newly diagnosed wet AMD patients receiving either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) through intravitreal injections, with the primary endpoint being the mean change in best-corrected visual acuity from baseline to week eight [3] - Despite the failure to meet the primary endpoint, ONS-5010 showed vision improvement, biological activity, and a favorable safety profile, with ocular adverse event rates comparable to Lucentis [4] - Further analysis of the study data is ongoing, with full results expected in January 2025, and the company plans to resubmit the biologics license application (BLA) for ONS-5010 in Q1 2025 [5] Regulatory and Market Context - In August 2023, Outlook Therapeutics received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010, citing concerns related to chemistry, manufacturing, and controls [7][8] - The company has addressed the issues raised by the FDA and received regulatory approval for ONS-5010 in the EU and the U.K. for treating wet AMD, with plans to launch in 2025 [10][11] - ONS-5010 is positioned as a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use [11]

Outlook Therapeutics Inc. OTLK revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.Also Read: Why Is Eye Disease-Focused Outlook Therapeutic ...

Final efficacy data expected in January 2025Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced preliminary topline results of NORSE EIGHT, ...