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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MONMOUTH JUNCTION, N.J., Oct. 13, 2020 (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 the initiation and enrollment of the first patients in its planned supplemental open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) (NORSE THREE).

Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., Oct. 07, 2020 (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 Kenyon, President, CEO and CFO of Outlook Therapeutics, will participate at the BIO Investor Forum Digital taking place on October 13-15, 2020.

Outlook Therapeutics to Present at the Virtual BIO Investor Forum Digital

MONMOUTH JUNCTION, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg (LYTENAVA™) for use in retinal indications (known as ONS-5010). Outlook Therapeutics is advancing on multiple fronts, including: progress on its Phase 3 clinical program, manufacturing and regulatory activities, and global strategic partnering negotiations, all leading to the planned commercial launch of ONS-5010 anticipated in 2022. In addition, Outlook Therapeutics recently completed a strategic partnership for commercialization in Greater China and is in discussions with other strategic partners for commercial launches in the United States, Asia and Europe.

Outlook Therapeutics Provides Update on Progress Towards First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration

MONMOUTH JUNCTION, N.J., Sept.  08, 2020  (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 Kenyon, President, CEO and CFO of Outlook Therapeutics, will present at two upcoming investor conferences in September.

Outlook Therapeutics to Present at Two Upcoming Investor Conferences

The share price of Outlook Therapeutics fell sharply due to the anticipated differentiation between LYTENAVA and LUCENTIS.

Outlook Therapeutics: Interpreting The New Phase 3 Trial Results

MONMOUTH JUNCTION, N.J., Aug.  26, 2020  (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 topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) from its NORSE 1 clinical study, the first of two registration clinical trials.  ONS-5010 is the first injectable ophthalmic formulation of bevacizumab-vikg seeking U.S. Food and Drug Administration (FDA) approval for the treatment of wet AMD under a new Biologics License Application (BLA).

Outlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) from NORSE 1

Oncobiologics, Inc. (OTLK) delivered earnings and revenue surprises of -83.33% and -100.00%, respectively, for the quarter ended June 2020.

Oncobiologics, Inc. (OTLK) Reports Q3 Loss, Lags Revenue Estimates

MONMOUTH JUNCTION, N.J., Aug.  14, 2020  (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 its corporate highlights and financial results for its fiscal third quarter ended June 30, 2020.   Outlook Therapeutics also provided a clinical development 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 the Third Quarter of Fiscal Year 2020 and Provides Corporate Update

Oncobiologics, Inc. (OTLK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report.

Oncobiologics, Inc. (OTLK) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

MONMOUTH JUNCTION, N.J., July  17, 2020  (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 the successful closing of its previously announced private placement of 823,045 shares of common stock at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $1.0 million, to Syntone Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group Co. Ltd.  The securities were priced at-the-market under Nasdaq rules.

Outlook Therapeutics Announces Closing of $1.0 Million Private Placement Priced At-The-Market Under Nasdaq Rules

MONMOUTH JUNCTION, N.J., July  07, 2020  (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 the completion of patient enrollment in its NORSE 2 clinical trial for  ONS-5010 / LYTENAVA™  (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in retinal indications.

Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

Outlook Therapeutics (OTLK) saw a big move last session, as its shares jumped 7% on the day, amid huge volumes.

Outlook Therapeutics (OTLK) Catches Eye: Stock Jumps 7%

MONMOUTH JUNCTION, N.J., June  25, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (“the Company”), 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 it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules of 8,407,411 shares of its common stock, at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $10.2 million.

Outlook Therapeutics Announces Closing of $10.2 Million Financing Priced At-The-Market Under Nasdaq Rules

MONMOUTH JUNCTION, N.J., June  17, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a clinical update for  ONS-5010 / LYTENAVA™  (bevacizumab-vikg), the Company’s investigational ophthalmic formulation of bevacizumab.

Outlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

Live moderated video webcast discussion with President, CEO and CFO Lawrence Kenyon, on Wednesday, June 17th at 2:00 PM ET, immediately followed by an interactive Q&A session Live moderated video webcast discussion with President, CEO and CFO Lawrence Kenyon, on Wednesday, June 17th at 2:00 PM ET, immediately followed by an interactive Q&A session

Outlook Therapeutics to Present at the Virtual Investor Fireside Chat Series

MONMOUTH JUNCTION, N.J., June  03, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the successful closing of its previously announced private placement of $16.0 million of common stock at a price of $1.00 per share (representing a 34% premium at signing) to Syntone Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group Co. Ltd.

Outlook Therapeutics Announces Closing of $16.0 Million Private Placement

MONMOUTH JUNCTION, N.J., May  26, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has entered into a Stock Purchase Agreement with Syntone Ventures LLC for a private placement of $16.0 million of common stock at a price of $1.00 per share. In addition, Outlook Therapeutics entered into a joint venture agreement with Syntone Technologies Group Co. Ltd. (“Syntone”) to form a PRC joint venture to develop and commercialize  ONS-5010 / LYTENAVA™  (bevacizumab-vikg) in China pursuant to a license agreement to be entered into between Outlook Therapeutics and the joint venture. Outlook Therapeutics will use $0.9 million of the private placement proceeds to fund its initial capital contribution to the PRC joint venture.

Outlook Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., May  15, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its corporate highlights and financial results for its fiscal second quarter ended March 31, 2020.

Outlook Therapeutics Reports Financial Results for the Second Quarter of Fiscal Year 2020 and Provides Corporate Update

CRANBURY, N.J., April  21, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has bolstered its Board of Directors with the appointments of Prof. Dr. Gerd Auffarth and Mr. Julian Gangolli.

Outlook Therapeutics Bolsters Clinical and Commercial Expertise with Two Key Appointments to Board of Directors

Outlook Therapeutics (OTLK) saw a big move last session, as its shares jumped nearly 8% on the day, amid huge volumes.

Outlook Therapeutics (OTLK) Catches Eye: Stock Jumps 7.6%

CRANBURY, N.J., April  14, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a clinical update on the impact of the COVID-19 pandemic on the status of NORSE 1 and NORSE 2, its ongoing registration clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab.

Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2

CRANBURY, N.J., March  05, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), 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 it has received U.S. Food and Drug Administration (FDA) tentative approval of the Tradename for ONS-5010 as LYTENAVA™ (bevacizumab-vikg). The Tradename is conditionally approved by FDA and will be subject to further review at the time of the Company’s planned filing of a new biologics license application (BLA) with the FDA for LYTENAVA™ (bevacizumab-vikg) in 2021. 

Outlook Therapeutics Announces LYTENAVA™ (bevacizumab-vikg), Anticipated Brand Name for ONS-5010, If Approved

CRANBURY, N.J., Feb.  26, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), 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 it has closed its previously-announced registered direct offering priced at-the-market under Nasdaq rules of 7,598,426 shares of its common stock, at a combined purchase price of $1.016 per share and associated unregistered warrant, for aggregate gross proceeds of approximately $7.72 million. The Company also issued to the investors in the registered direct offering unregistered warrants to purchase up to an aggregate of 3,799,213 shares of its common stock. The warrants have an exercise price of $0.9535 per share of common stock, are exercisable on the date of issuance, and will expire four years following the date of issuance.

Outlook Therapeutics Announces Closing of $10.2 Million Financings Priced At-The-Market

CRANBURY, N.J., Feb.  04, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”),  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 it is scheduled to participate in the BIO CEO & Investor Conference at the New York Marriott Marquis in New York on Feb 10th-11th.

Outlook Therapeutics to Present at the 2020 BIO CEO & Investor Conference

CRANBURY, N.J., Jan.  28, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), 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 it has entered into agreements with BioLexis Pte. Ltd. (“BioLexis”), its largest stockholder, and MTTR, LLC (“MTTR”), its development partner for ONS-5010, to better align the interests of all parties with the Company’s common stockholders and support the continued development of ONS-5010.

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