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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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).

Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD

ISELIN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it will report its financial results for second quarter fiscal year 2024 on Thursday, May 16, 2024. Outlook Therapeutics management will host its inaugural 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 Second Quarter Fiscal Year 2024 on May 16, 2024 and Host Inaugural Quarterly Conference Call and Webcast

ISELIN, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the 2024 Retina World Congress being held May 9-12, 2024 in Fort Lauderdale, FL.

Outlook Therapeutics® to Present at the Retina World Congress 2024

ISELIN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the OIS Retina Innovation Showcase being held May 4, 2024 in Seattle, WA.

Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase

ISELIN, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement with Syntone Ventures, LLC, an existing stockholder, for upfront gross proceeds of approximately $5.0 million from the issuance and sale of shares of the Company's common stock and accompanying warrants, before deducting offering expenses. In addition, Outlook Therapeutics has the potential to receive additional gross proceeds of up to $8 million upon the full cash exercise of the warrants issued in the private placement, before deducting offering expenses.

Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million

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The positive CHMP opinion could mean possible European Approval; European Commission expected to decide upon approval for this in the next few months. Phase 3 NORSE EIGHT study underway using ONS-5010 for the treatment of patients with Wet-AMD; Data expected to be released in Q4 of 2024. Pending the primary endpoint of BCVA in NORSE EIGHT being met with statistical significance, BLA filing of ONS-5010 for Wet-AMD expected in 2024.

Outlook Therapeutics: De-Risked Regulatory Tracks Are Lining Up For Possible ONS-5010 Approval

ISELIN, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the EU. Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

Oncobiologics (OTLK) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About Oncobiologics (OTLK) Rating Upgrade to Buy

ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company's common stock and accompanying warrants, before deducting placement agent fees and offering expenses. Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.

Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million

ISELIN, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a 1-for-20 reverse stock split of its outstanding shares of common stock will be effective on March 14, 2024.

Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split

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ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.

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

ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients.

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Outlook (OTLK) stock rises after aligning with the FDA regarding the protocols of a non-inferiority study of ONS-5010 for AMD. The study is set to become the basis for BLA resubmission by 2024-end.

Outlook (OTLK) Surges 31% on Regulatory Update for AMD Study

ISELIN, N.J., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has received written agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

NEW YORK , Jan. 2, 2024 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook Therapeutics, Inc. (NASDAQ: OTLK) between December 29, 2022 and August 29, 2023, both dates inclusive (the "Class Period"), of the important January 2, 2024 lead plaintiff deadline. SO WHAT: If you purchased Outlook securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

OTLK FINAL DEADLINE: ROSEN, NATIONAL INVESTOR COUNSEL, Encourages Outlook Therapeutics, Inc. Investors to Secure Counsel Before Important January 2 Deadline in Securities Class Action - OTLK

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