ISELIN, N.J., May 15, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported financial results for the second quarter of fiscal year 2025 and provided a corporate update. "Outlook Therapeutics remains on track in 2025 to transform into a commercial-stage company with the planned upcoming commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the United Kingdom for ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37759 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (State ...

LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported financial results for the second quarter of fiscal year 2025 and p ...

Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (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 that the U ...

ISELIN, N.J., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (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 it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophtha ...

On-demand video webcast now available here ISELIN, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (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 it participated in the Virtual Investor "Top 5 for ‘25” On-Demand Conference. As part of the event, Law ...

or (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2024 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37759 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (Sta ...

Financial Performance - Outlook Therapeutics reported a net income of $17.4 million, or $0.72 per share, for the fiscal first quarter ended December 31, 2024, compared to a net loss of $11.2 million, or $0.86 per share, for the same period last year[11]. - The adjusted net loss for the fiscal first quarter was $21.6 million, or $0.89 per share, compared to an adjusted net loss of $10.1 million, or $0.78 per share, for the fiscal first quarter of 2024[11]. - For the three months ended December 31, 2024, total operating expenses were $21,607,000, compared to $10,323,000 for the same period in 2023, representing a 109.5% increase[23]. - The net income for the three months ended December 31, 2024, was $17,378,000, compared to a net loss of $11,178,000 for the same period in 2023[23]. - The basic and diluted net income per share for the three months ended December 31, 2024, was $0.72, compared to a loss of $0.86 per share for the same period in 2023[23]. - Adjusted net loss attributable to common stockholders for the three months ended December 31, 2024, was $(21,591,000), compared to $(10,132,000) for the same period in 2023[27]. - The weighted average shares outstanding, basic and diluted, increased to 24,234,000 for the three months ended December 31, 2024, from 13,013,000 for the same period in 2023[27]. Cash and Assets - Cash and cash equivalents decreased to $5,703,000 as of December 31, 2024, from $14,928,000 as of September 30, 2024[25]. - Total assets decreased to $17,006,000 as of December 31, 2024, from $28,823,000 as of September 30, 2024[25]. - Current liabilities increased to $48,237,000 as of December 31, 2024, compared to $42,554,000 as of September 30, 2024[25]. - The total stockholders' deficit improved to $(50,290,000) as of December 31, 2024, from $(73,077,000) as of September 30, 2024[25]. Product Development and Market Opportunity - The company plans to launch LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following marketing authorizations received in May and July 2024[3][4]. - Over 2.5 million off-label injections of repackaged bevacizumab are administered annually in Europe, with approximately 1.6 million in Germany alone, indicating a significant market opportunity for LYTENAVA™[6]. - The resubmission of the ONS-5010 Biologics License Application (BLA) is on track for Q1 CY2025, with potential US FDA approval anticipated in Q3 CY2025[5][8]. - In the NORSE EIGHT clinical trial, ONS-5010 demonstrated a mean improvement of 5.5 letters in best corrected visual acuity (BCVA) at week 12, indicating positive efficacy[10]. - The complete data set from the NORSE EIGHT trial showed a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes, comparable to -127.3 microns for the ranibizumab group[10]. - Outlook Therapeutics aims to provide an approved ophthalmic formulation of bevacizumab, enhancing treatment options for wet AMD patients[2]. - The company anticipates potential commercial launch of LYTENAVA™ in Germany and the UK, with expected revenue generation timing still to be determined[20]. Strategic Collaborations - Outlook Therapeutics received $17.8 million in gross proceeds from a warrant exercise inducement in January 2025, enhancing its cash position[14]. - The company has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals[7].

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025 ISELIN, N.J., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic for ...

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of retinal diseases, including wet age-related macular degeneration (wet AMD) [5] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive regulatory approval in the European Union and the United Kingdom for treating wet AMD, with a commercial launch expected in the first half of 2025 [5] Leadership Changes - Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately, succeeding Randy Thurman, who will continue as Lead Independent Director [1][2] - Sukhtian expressed gratitude for Thurman's leadership, highlighting his role in guiding the company from a preclinical stage to preparing for product launch [2] Strategic Focus - The company is preparing for the launch of LYTENAVA™ in the EU and UK while also focusing on completing a timely FDA resubmission in the United States [2] - The successful resubmission could lead to LYTENAVA™ being the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5] Leadership Background - Faisal G. Sukhtian has been a member of the Board since 2017 and has extensive experience in operations, strategy development, and mergers and acquisitions in the biopharma sector [3] - Prior to GMS Holdings, Sukhtian worked in investment banking at J.P. Morgan, focusing on M&A, debt, and equity transactions [4]