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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Investors are excited about the potential of the drugmaker's experimental wet AMD treatment.

Why Outlook Therapeutics Stock Surged Today

H.C. Wainwright raised the price target on Outlook Therapeutics Inc (NASDAQ:OTLK) to $6 from $5 and reiterated a Buy rating. The Company announced "exceptionally strong" data that showed Lytenava's statistically significant superiority over Lucentis, analyst Douglas Tsao tells investors in a research note.

HC Wainwright Raises Price Target On Outlook Therapeutics After Wet AMD Trial Data

OTLK stock is on the move today. The company is coming forth with promising data on its treatment of a damaging eye disease.

OTLK Stock: The Huge Trial News Lifting Outlook Therapeutics

The stock price of Outlook Therapeutics Inc (NASDAQ: OTLK) increased by over 30% pre-market. This is why it happened.

OTLK Stock Price Increases Over 30% Pre-Market: Why It Happened

Outlook Therapeutics Inc (NASDAQ: OTLK) stock is trading higher in premarket session in reaction to positive top-line results from Phase 3 NORSE TWO trial evaluating ONS-5010 / LYTENAVA (bevacizumab) for neovascular age-related macular degeneration (wet AMD).  The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best-corrected visual acuity (BCVA) at 11 months.

Outlook Therapeutics Stock Surges Positive ONS-5010 Data In Wet AMD Patients

ISELIN, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced positive clinical and highly statistically significant top-line results from its pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab) for treatment of neovascular age-related macular degeneration (wet AMD). Outlook Therapeutics will host a conference call and webcast today, August 3, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.

Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

ISELIN, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of C. Russell Trenary III as President, Chief Executive Officer and a member of the Board of Directors. Lawrence A. Kenyon, who has served as Outlook Therapeutics' President, CEO and CFO since June 2018, will continue serving as CFO and as a member of the Board of Directors.

Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer

ISELIN, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that as part of the annual reconstitution of the Russell stock indexes, Outlook Therapeutics has been selected to be added to the Russell 2000® Index effective June 25, 2021, after the close of the U.S. equity markets.

Outlook Therapeutics Announces Inclusion in the Russell 2000® Index

ISELIN, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported today that it has administered the final dose to the last patient enrolled in its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (wet AMD). Topline data are expected to be reported for NORSE TWO in the third calendar quarter of 2021.

Outlook Therapeutics Reports Completion of Patient Dosing in the ONS-5010 Pivotal Phase 3 NORSE TWO Trial

ISELIN, N.J., May 27, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, hosted a virtual Clinical Day on May 20, 2021 to provide an update on the clinical progress of ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (wet AMD). If approved, ONS-5010 will be the first and only ophthalmic formulation of bevacizumab approved to treat retinal conditions.

Virtual Clinical Day Recap: Outlook Therapeutics Joined by Drs. Mark Humayun and Firas Rahhal to Discuss Need for FDA-Approved Ophthalmic Bevacizumab and Status of ONS-5010

ISELIN, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2021. Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications. “Outlook Therapeutics continues to advance ONS-5010 towards a BLA filing for wet AMD. Having reported promising results from two of the three clinical trials for our planned BLA, we are now in the home stretch and focused on the topline data readout next quarter from NORSE TWO, our pivotal Phase 3 study,” commented Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “Additionally, with the funds raised in February, we are well positioned to complete NORSE TWO and prepare the BLA. We are excited about the upcoming clinical milestones and look forward to providing future updates as we continue to advance ONS-5010.”

Outlook Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Corporate Update

Live video webcast with Outlook Therapeutics' management team and key opinion leaders on Thursday, May 20th from 11:00 AM – 1:00 PM ET Live video webcast with Outlook Therapeutics' management team and key opinion leaders on Thursday, May 20th from 11:00 AM – 1:00 PM ET

Outlook Therapeutics to Host Virtual Clinical Day on May 20, 2021

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There is something uniquely exciting about being the first company to bring a much-needed product to market. Outlook Therapeutics Inc (NASDAQ:OTLK) is hoping to become the first and only company to commercialize a US Food & Drug Administration (FDA) approved ophthalmic formulation of bevacizumab, otherwise known as the cancer drug Avastin, for use in a damaging retinal condition known as wet age-related macular degeneration, or wet AMD.

Outlook Therapeutics is bringing a treatment for retinal disease to the market at the right time

MONMOUTH JUNCTION, N.J., March 31, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) to treat retinal diseases.

Outlook Therapeutics Reports Positive Safety Profile from NORSE THREE Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., March 04, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics, will participate in a fireside chat at the virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

Outlook Therapeutics to Present at the H.C. Wainwright Global Life Sciences Conference

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MONMOUTH JUNCTION, N.J., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics, will participate in the Cantor Fitzgerald “Eyeing Key Events and Programs in the Ophthalmology Space in 2021” virtual panel being held on Friday, February 19, 2021 from 10:30 AM – 12:00 PM ET.

Outlook Therapeutics to Participate in Cantor Fitzgerald's Virtual Panel Discussion: Eyeing Key Events and Programs in the Ophthalmology Space in 2021

MONMOUTH JUNCTION, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2020. Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.

Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2021 and Provides Corporate Update

Topline results from open-label safety study (NORSE THREE) on target for Q2 2021 Topline results from open-label safety study (NORSE THREE) on target for Q2 2021

Outlook Therapeutics Reports Final Visit for Last Patient in Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

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Overallotment option on recent public offering partially exercised by underwriter

Outlook Therapeutics' Recent Financing Secures Funding to Support ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Through Planned BLA Submission

MONMOUTH JUNCTION, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the closing of its previously announced underwritten public offering of 35,000,000 shares of common stock of the Company at a price to the public of $1.00 per share. As previously announced, the company has granted the underwriter a 30-day option to purchase up to 5,250,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions.

Outlook Therapeutics Announces Closing of $35.0 Million Bought Deal

MONMOUTH JUNCTION, N.J., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 35,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.00 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 2, 2021, subject to satisfaction of customary closing conditions.

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