Core Viewpoint - Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic product for the treatment of wet age-related macular degeneration (wet AMD), to the FDA, following regulatory approval in the EU and UK for its ophthalmic formulation of bevacizumab [1][8] Group 1: Regulatory Developments - The BLA resubmission is based on the efficacy and safety data from the NORSE EIGHT study and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA [2] - A decision from the FDA regarding the BLA is expected within six months [2] Group 2: Clinical Trial Insights - NORSE EIGHT was a randomized, controlled, parallel-group, masked, non-inferiority study involving 400 newly diagnosed wet AMD subjects [3] - In the NORSE EIGHT study, ONS-5010 showed a mean improvement of 4.2 letters in best corrected visual acuity (BCVA) at week 8, which did not meet the pre-specified non-inferiority endpoint [3] - The 12-week analysis indicated that ONS-5010 demonstrated a mean improvement in BCVA of 3.3 to 5.5 letters, compared to a mean improvement of 4.5 to 6.5 letters in the ranibizumab arm [4] Group 3: Product Information - ONS-5010, branded as LYTENAVA™, is an ophthalmic formulation of bevacizumab for treating wet AMD and has received marketing authorization in the EU and UK [5][8] - In the U.S., ONS-5010 is still investigational and, if approved, would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [8]

Core Viewpoint - Outlook Therapeutics has received regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) [2][4] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for retinal diseases, including wet AMD [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for wet AMD treatment [4] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the second quarter of 2025 [4] Clinical Development - In the United States, ONS-5010 / LYTENAVA™ is currently investigational and is undergoing a non-inferiority study for wet AMD treatment [4] - Successful results from the study may allow the company to resubmit a Biologics License Application (BLA) to the FDA [4] - If approved, ONS-5010 / LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications in the U.S. [4] Investor Engagement - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CFO and Interim CEO presented key reasons for investor interest in Outlook Therapeutics [3]

Regulatory Approvals and Clinical Trials - The company received marketing authorization for ONS-5010/LYTENAVA for the treatment of wet AMD from the European Commission on May 27, 2024, valid throughout the EEA, providing eight years of data exclusivity and ten years of market exclusivity[102]. - The company plans to launch ONS-5010/LYTENAVA in Germany and the UK in Q2 2025, following approvals in the EU and UK[102]. - The FDA issued a Complete Response Letter on August 29, 2023, indicating that the BLA for ONS-5010/LYTENAVA could not be approved due to CMC issues and the need for an additional clinical trial[106]. - The NORSE EIGHT trial, involving approximately 400 subjects, did not meet the pre-specified non-inferiority endpoint at week 8, with a mean difference of -2.257 BCVA letters compared to ranibizumab[109]. - At week 12, the NORSE EIGHT trial showed a mean improvement of 5.5 letters in the ONS-5010/LYTENAVA arm and 6.5 letters in the ranibizumab arm, indicating potential for approval[111]. - The company plans to resubmit the BLA for ONS-5010/LYTENAVA in Q1 2025, expecting 12 years of regulatory exclusivity in the US if approved[111]. - The company has agreements with the FDA on three Special Protocol Assessments for additional registration clinical trials for ONS-5010/LYTENAVA[113]. - The company aims to mitigate risks associated with off-label use of unapproved bevacizumab with the approval of ONS-5010/LYTENAVA in the US[114]. Financial Performance and Funding - The company reported a net income of $17.4 million for the three months ended December 31, 2024, but incurred a net loss of $11.2 million for the same period in 2023[119]. - As of December 31, 2024, the company has funded operations with $532.6 million from equity and debt securities sales, and $29.0 million from collaboration and licensing agreements[119]. - There is substantial doubt about the company's ability to continue as a going concern due to insufficient cash and cash equivalents to fund operations for the next year[120]. - The company has federal and state NOL carryforwards of $406.7 million and $242.5 million, respectively, which will begin to expire in 2030 and 2039[142]. - The company has not generated any revenue from product sales and anticipates incurring additional losses until significant sales can be achieved[119]. - The company anticipates needing additional financing to support operations and the commercial development of ONS-5010/LYTENAVA, with potential strategies including licensing arrangements and equity issuance[153]. - The company sold 1,000,000 shares under the BTIG ATM Offering, generating approximately $1.7 million in net proceeds during the three months ended December 31, 2024[155]. - The company entered into a Warrant Inducement Transaction, receiving net proceeds of $15.7 million from the exercise of existing warrants[158]. - The company expects to incur net losses and negative cash flow for the foreseeable future, heavily dependent on successful financing and regulatory approvals[163]. - As of December 31, 2024, the company does not believe that existing cash and cash equivalents, along with net proceeds from the Warrant Inducement Transaction, are sufficient to fund operations for the next year[166]. - The company may need to modify clinical trial plans, reduce workforce, or seek bankruptcy protection if adequate financing is not obtained[168]. Expenses and Cash Flow - Research and development expenses increased by $5.1 million to $9.66 million for the three months ended December 31, 2024, compared to $4.53 million in 2023, primarily due to expenses related to the NORSE EIGHT clinical trial for ONS-5010/LYTENAVA[146]. - General and administrative expenses rose by $6.2 million to $11.95 million for the three months ended December 31, 2024, compared to $5.79 million in 2023, driven by $2.5 million in prelaunch expenses for Europe and a $3.3 million increase in compensation costs[147]. - The company has incurred net losses and negative cash flows since inception, funding operations with $532.6 million from equity and debt securities[152]. - For the three months ended December 31, 2024, the company reported a net cash used in operating activities of $10.97 million, compared to $13.03 million for the same period in 2023, reflecting a decrease of approximately 15.6%[169][171]. - The net cash provided by financing activities for the three months ended December 31, 2024, was $1.74 million, primarily from the sale of common stock under the BTIG ATM Offering[172]. Debt and Financial Obligations - The December 2022 Note has a face value of $31.8 million, with an original issue discount of $1.8 million, and its maturity was extended to April 1, 2024[174]. - The January 2025 Note, amounting to $33.1 million, is intended to fully settle the December 2022 Note and is expected to close after the 2025 annual meeting of stockholders[177]. - The January 2025 Note will bear interest at the prime rate plus 3%, with a minimum repayment obligation of $3 million each quarter starting in Q2 2025[178].

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 ...

Outlook Therapeutics (OTLK) Update / Briefing February 03, 2025 07:00 PM ET Company Participants Jennifer Kissner - Senior VP, Clinical & Regulatory AffairsJenene Thomas - CEO Jennifer Kissner The 12 week trial demonstrated that we had visual acuity improvements in both study arms across each study visits and improving greater in each at each visit. Jenene Thomas Welcome back for another Virtual Investor What This Means segment featuring Outlook Therapeutics. My name is Janine Thomas, and I am CEO of JTCIR, ...

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]

Live webcast on Wednesday, January 29th at 2:00 PM ETISELIN, N.J., Jan. 22, 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) 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 Lawrence A. Kenyon, Executive Vice President, CFO and Interim CEO of O ...

ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeksBLA resubmission on track for calendar Q1 2025Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic ...

Core Insights - Outlook Therapeutics, Inc. has received regulatory approval for LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in the EU and UK [2][4] - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ as a treatment option for wet AMD, marking it as the first authorized ophthalmic formulation of bevacizumab for this condition [3][4] - LYTENAVA™ is expected to have an initial market exclusivity of 10 years in the EU and UK [3] Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ for retinal diseases, including wet AMD [7] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the first half of 2025 [7] - In the United States, ONS-5010/LYTENAVA™ is currently investigational and undergoing a non-inferiority study for wet AMD [5][7] Product Details - LYTENAVA™ is a recombinant humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), reducing endothelial cell proliferation and vascular leakage in the retina [6] - The product has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK [4][7]