ISELIN, N.J., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and CEO of Outlook Therapeutics will participate in a fireside chat at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024. A video webcast of the fir ...

Core Viewpoint - Outlook Therapeutics has received regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab for treating wet AMD, with financial results for Q3 FY 2024 to be reported on August 14, 2024 [1][3]. Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for retinal diseases, including wet AMD [3]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and the UK for wet AMD treatment [3]. - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in Q1 2025 [3]. - In the US, ONS-5010/LYTENAVA™ is currently investigational and undergoing a non-inferiority study for wet AMD treatment, with potential plans to resubmit a BLA application to the FDA if successful [3]. Financial Reporting - The company will host a quarterly conference call and live audio webcast on August 14, 2024, at 8:30 AM ET to discuss operational and financial results [1][2].

Core Viewpoint - Outlook Therapeutics has received regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab for treating wet AMD, with financial results for Q3 FY 2024 to be reported on August 14, 2024 [1][3]. Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for retinal diseases, including wet AMD [3]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and the UK for wet AMD treatment [3]. - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in Q1 2025 [3]. - In the US, ONS-5010/LYTENAVA™ is currently investigational and undergoing a non-inferiority study for wet AMD treatment, with potential plans to resubmit a BLA application to the FDA if successful [3]. Financial Reporting - The company will host a quarterly conference call and live audio webcast on August 14, 2024, at 8:30 AM ET to discuss operational and financial results [1][2].

Company to participate in a fireside chat on Monday, August 5th at 8:00 AM ET ISELIN, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics will participate in a fireside chat at the BTIG Virtual Biotechnology Con ...

Outlook Therapeutics Today Outlook Therapeutics NASDAQ: OTLK has gained attention, with analysts forecasting an upside of over 500% based on the consensus price target. Outlook Therapeutics -0.49 (-6.48%) ▼ Price Target $46.43 It's essential to remember that low-float biopharmaceutical companies often experience volatility due to frequent breaking news and technical factors such as float size and short interest. While the bullish price target is noteworthy, it's crucial to delve deeper into the company's fu ...

ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, today announced that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 12:00 PM ET. A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics web ...

Live video webcast on Tuesday, June 18th at 12:00 PM ET A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics website (outlooktherapeutics.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days. About Outlook Therapeutics, Inc. Investor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247 OTLK@jtcir.com ISELIN, N.J., June 11, 2024 (GLOBE NEWSWI ...

LYTENAVA™ (bevacizumab gamma) becomes first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD European Commission decision applies automatically to all 27 EU Member States and, within 30 days, also to Iceland, Norway and Liechtenstein LYTENAVA™ (bevacizumab gamma) receives ten years of market exclusivity in EU Advancing toward commercial launch of LYTENAVA™ (bevacizumab gamma) in EU expected in calendar Q1 2025 Strategic partnership wit ...

Financial Data and Key Metrics Changes - The company reported a successful capital raise with gross proceeds of up to $172 million, including $65 million in cash and an additional $107 million available upon full cash exercise of warrants [97] - The increase in R&D expenses during the fiscal second quarter was expected as the company began recruiting and initiating clinical trial sites for NORSE EIGHT [24] Business Line Data and Key Metrics Changes - The company is actively engaged with the FDA regarding the BLA resubmission and has reached an agreement on a Special Protocol Assessment for the NORSE EIGHT study [4][22] - Over 30% of patients have been enrolled in the NORSE EIGHT study, with expectations to complete enrollment in the third quarter of this year [22][31] Market Data and Key Metrics Changes - The European market opportunity for ONS-5010 is significant, with approximately 3 million injections per year, similar to the US market [27] - The company anticipates potential approval in the EU this quarter and in the UK by the third quarter of 2024, with initial launches expected in early 2025 [5][20] Company Strategy and Development Direction - The company aims to enhance the standard of care for treating wet AMD by achieving the first approval for an ophthalmic formulation of bevacizumab [96] - The strategy includes working with Cencora to leverage their infrastructure for launching ONS-5010 in Europe while maintaining a customer-facing approach [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming approvals in both the EU and the US, highlighting the importance of the NORSE EIGHT study data for resubmission of the BLA [20][22] - The company believes that the current cash position will support operations through 2025, aligning with anticipated approvals and launches [8][21] Other Important Information - The company is utilizing non-GAAP adjusted results to eliminate noise from non-cash quarterly fair value changes for warrants and convertible notes [8] - The management emphasized the importance of maintaining a strong relationship with the FDA through ongoing discussions and meetings [64][89] Q&A Session Summary Question: What data sets are especially derisking for NORSE EIGHT? - Management highlighted the non-inferiority results from the NORSE TWO trial as a key indicator of potential success for NORSE EIGHT [28] Question: How large is the European market opportunity for ONS-5010 relative to the US? - The European market is similar in size to the US, with about 3 million injections per year, although there is some price compression [27] Question: How many sites are currently enrolling patients? - The company has over 60 sites enrolling patients, with 30% of patients already enrolled [31][35] Question: What is the latest thinking regarding DME and BRVO indications? - The company has pipeline studies planned for DME and BRVO, but the initial focus remains on wet AMD [39] Question: What preparations are being made for the launch in Europe? - The company has inventory ready and is working with contract manufacturers to ensure sufficient supply for both Europe and the US [43][44] Question: Will production need to move to Europe for commercialization? - Initially, there is no need to move production, but the company will evaluate future needs based on market demands [86] Question: What is the timeline for addressing CMC questions with the FDA? - The company expects to handle Type C and D meetings within the second and third quarters of this year [89]

Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update ISELIN, N.J., May 15, 2024 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for the second quarter of fiscal year 2024 and provided a corporate update. As previously announced, ...