Outlook Therapeutics Inc

Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.

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Outlook Therapeutics progresses well with ONS-5010, eyes global expansion

Outlook Therapeutics is well-positioned for potential approvals in Europe and the US in 2024 and 2025.
Strong financial backing and progress in key studies indicate a positive trajectory.
Challenges include addressing FDA queries and ensuring smart approval processes.
Opportunities lie in leveraging existing infrastructure, pricing discussions, and FDA agreements.

Outlook Therapeutics advances clinical trials and secures EU market entry

Outlook Therapeutics made significant progress with marketing authorization and clinical trial advancements.
Financial stability improved with reduced convertible notes and ample cash reserves.
Challenges lie in managing expenses, addressing analyst inquiries, and preparing for commercial launch.

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Live fireside chat with CEO, Russ Trenary, on November 12th at 2:30 PM ET Live fireside chat with CEO, Russ Trenary, on November 12th at 2:30 PM ET

Outlook Therapeutics® to Present at the Guggenheim Healthcare Innovation Conference

NEW YORK, Oct. 11, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Outlook Therapeutics, Inc. (NASDAQ: OTLK) on behalf of long-term stockholders following a class action complaint that was filed against Outlook on November 3, 2023 with a Class Period from December 29, 2022 to August 29, 2023. Our investigation concerns whether the board of directors of Outlook have breached their fiduciary duties to the company.

OUTLOOK ALERT: Bragar Eagel & Squire, P.C. is Investigating Outlook Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Live video webcast with Russell Trenary, President and CEO of Outlook Therapeutics on Thursday, September 19th at 4:00 PM ET Live video webcast with Russell Trenary, President and CEO of Outlook Therapeutics on Thursday, September 19th at 4:00 PM ET

Outlook Therapeutics® to Participate in the Virtual Investor Closing Bell Series

Webcast replay of fireside chat now available

Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series

ISELIN, N.J., Sept. 04, 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 the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required before expected resubmission of the Outlook Therapeutics' Biologics License Application (BLA) for ONS-5010.

Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial

ISELIN, N.J., Sept. 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 the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY.

Outlook Therapeutics® to Present at the H.C. Wainwright 26th Annual Global Investment Conference

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Outlook Therapeutics faces liquidity issues and delays in FDA approval for its Wet AMD therapy, leading to a downgrade from Strong Buy to Buy. The potential blockbuster market for LYTENAVA in treating Wet AMD is significant, but FDA hurdles and financial constraints pose risks. Despite high upside potential, investors face the risk of losing their entire stake due to Outlook's financial and regulatory challenges.

Outlook Therapeutics: Poised To Jump With Wet AMD Treatment If It Can Overcome FDA Hurdles

Outlook Therapeutics, Inc. Q3 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Jenene Thomas - JTC Team, LLC, Investor Relations Russell Trenary - President and Chief Executive Officer Lawrence Kenyon - Chief Financial Officer Conference Call Participants Julian Harrison - BTIG Will Hidell - Brookline Capital Markets Tim Chiang - Capital One Douglas Tsao - HC Wainwright Daniil Gataulin - Chardan Capital Markets Operator Greetings. And welcome to the Outlook Therapeutics Corporate Third Quarter Fiscal Year 2024 Update Conference Call and Webcast.

Outlook Therapeutics, Inc. (OTLK) Q3 2024 Earnings Call Transcript

ISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for the third quarter of fiscal year 2024 and provided a corporate update. As previously announced, Outlook Therapeutics will host its quarterly conference call and live audio webcast, today, Wednesday, August 14, 2024, at 8:30 AM ET (details below).

Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update

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 4 th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024.

Outlook Therapeutics® to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference

ISELIN, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that it will report its financial results for third quarter fiscal year 2024 on Wednesday, August 14, 2024. Outlook Therapeutics management will host its quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day.

Outlook Therapeutics® to Report Financial Results for Third Quarter Fiscal Year 2024 on August 14, 2024 and Host Quarterly Conference Call and Webcast

Company to participate in a fireside chat on Monday, August 5 th at 8:00 AM ET

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024

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ISELIN, N.J., July 08, 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 the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.

Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

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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 fundamentals and recent developments to understand what analysts might be seeing or missing.

Outlook Therapeutics: Analysts Forecast Over 500% Stock Upside

Outlook Therapeutics received a Complete Response Letter from the FDA in August 2023, causing a 74% drop in share price. Following a Type A meeting with the FDA in November 2023, Outlook agreed to conduct an additional clinical trial for ONS-5010. Its recent Special Protocol Assessment with the FDA sets it up for filing a BLA if the trial is successful in Q4, 2024.

Outlook Therapeutics: Worth A Good Strong Look After CRL

Outlook Therapeutics is resubmitting a BLA for ONS-5010 by 2024, with top-line data expected in Q4, 2024. ONS-5010 received European Commission Marketing Authorization for treating wet AMD in May 2024, and it is preparing for a commercial launch in early 2025. The anti-VEGF retina market is estimated at $15.9 billion globally, with substantial market opportunities in the US, EU, and UK.

Outlook Therapeutics: Speculative Buy With High Stakes In The Anti-VEGF Market

Live webcast on Thursday, June 13th at 4:00 PM ET FRENCHTOWN, NJ / ACCESSWIRE / June 12, 2024 / JTC Team ("JTC"), a fully integrated corporate communications and investor relations firm, today announced that 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, will participate in the Virtual Investor Closing Bell Series on Thursday, June 13, 2024 at 4:00 PM ET. As part of the event, Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, will provide a corporate overview and business outlook.

Outlook Therapeutics(R) (NASDAQ: OTLK) to Participate Virtual Investor Closing Bell Series

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.

Outlook Therapeutics® to Present at the Virtual Investor Pitch Conference

Watch the "What This Means" video here Outlook CEO, Russ Trenary underscores that LYTENAVA™ (bevacizumab gamma) has become the first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD FRENCHTOWN, NJ / ACCESSWIRE / June 6, 2024 / JTC Team ("JTC"), a fully integrated corporate communications and investor relations firm, today released a Virtual Investor "What This Means" segment featuring 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. As part of this "What This Means" segment, Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, discusses the Company's recently received European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD.

Outlook Therapeutics(R) (NASDAQ:OTLK) Participates in Virtual Investor "What This Means" Segment Hosted by JTC Team

ISELIN, N.J., May 28, 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 the European Commission has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU.

Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Outlook Therapeutics, Inc. (NASDAQ:OTLK ) Q2 2024 Earnings Conference Call May 16, 2024 8:30 AM ET Company Participants Jenene Thomas - IR, JTC Team, LLC Russell Trenary - President & CEO Lawrence Kenyon - Chief Financial Officer Conference Call Participants Julian Harrison - BTIG Eddie Hickman - Guggenheim Securities Douglas Tsao - HC Wainwright Timothy Chiang - Capital One Kemp Dolliver - Brookline Capital Markets Ed Woo - Ascendiant Capital Markets Daniil Gataulin - Chardan Operator Hello, and welcome to the Outlook Therapeutics Inaugural Quarterly Update Conference Call and Webcast. As a brief reminder all participants are currently in a listen-only mode.

Outlook Therapeutics, Inc. (OTLK) Q2 2024 Earnings Call Transcript

ISELIN, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- 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, the Company will host its inaugural quarterly conference call and live audio webcast, on Thursday, May 16, 2024, at 8:30 AM ET (details below).

Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update

ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- 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 in the US and Europe, today announced the submission of its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) seeking authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).

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