Core Viewpoint - Outlook Therapeutics reported a net loss of $20.2 million for the third quarter of fiscal year 2025, with initial revenue from the sales of LYTENAVA™ in Germany and the UK, marking the company's transition into a commercial entity [2][6][16]. Financial Performance - For the fiscal third quarter ended June 30, 2025, the company reported a net loss attributable to common stockholders of $20.2 million, or $0.55 per share, with revenue of $1.5 million from initial sales of LYTENAVA™ [2][3]. - The adjusted net loss for the same period was $15.8 million, or $0.44 per share, compared to an adjusted net loss of $19.2 million, or $0.83 per share, for the third quarter of 2024 [3][4]. - As of June 30, 2025, the company had cash and cash equivalents of $8.9 million [5]. Product and Market Update - LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD), being the first authorized ophthalmic formulation of bevacizumab in the EU and UK [7][13]. - The FDA has set a PDUFA goal date of August 27, 2025, for ONS-5010, which is expected to receive 12 years of regulatory exclusivity if approved [6][11]. - The company has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals [9][10]. Clinical and Regulatory Developments - The resubmission of the Biologics License Application (BLA) for ONS-5010 was based on the efficacy and safety demonstrated in the NORSE EIGHT trial, with the FDA acknowledging the resubmission [11][12]. - The NORSE EIGHT trial evaluated ONS-5010 against ranibizumab, with a primary efficacy endpoint at 8 weeks [12]. Industry Context - Off-label repackaged bevacizumab is widely used in Europe and the U.S. for retinal diseases, with approximately 2.8 million and 2.7 million injections annually, respectively [8]. - ONS-5010/LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [8].

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retinal diseases [3] - The company is developing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Industry Event - Outlook Therapeutics will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, in Long Beach, CA [1] - The presentation will be part of the Innovation Showcase, led by CEO Bob Jahr [1] - The Ophthalmology Innovation Summit aims to showcase novel therapies for unmet needs in ophthalmic diseases and vision disorders, facilitating connections among entrepreneurs, clinical leaders, and investment professionals [2]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [3] - The company has developed ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Leadership Insights - Bob Jahr, the newly appointed CEO, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, sharing his journey and excitement for the future of Outlook Therapeutics [2] - The on-demand video webcast of the conference is available on virtualinvestorco.com and the company's website [2]

NASDAQ: OTLK outlooktherapeutics.com Redefining the Treatment of Retinal Disease Corporate Presentation July 2025 This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Company") based on management's current expectations, which are subject to known and unknown uncertainties and risks. Words such as "expect," "explore," "initiate," "intend," "may," "plan," and "potential," and variations of these words or similar expressions are intended to ide ...

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Summary of Outlook Therapeutics Conference Call Company Overview - **Company**: Outlook Therapeutics - **Ticker**: OTLK (trades on Nasdaq) [4] Recent Achievements - **Product**: Lightnova - **Regulatory Approvals**: Lightnova approved in the EU and UK; received positive recommendation from NICE for use in the UK [5][6] - **Launch**: Launched simultaneously in Germany and the UK in May 2025; first patients dosed in both countries [6] Market Landscape - **Industry**: Treatment of wet Age-related Macular Degeneration (AMD) - **Market Size**: The European market for wet AMD treatments is valued at approximately $3.6 billion annually, with 8 million anti-VEGF injections per year [9] - **Injection Distribution**: Germany accounts for 1.7 million injections, while the UK accounts for 1.3 million [10] Competitive Positioning - **Market Share**: Off-label bevacizumab holds a 33% market share in Europe, with Germany at 50% and the UK at 5% [11][12] - **Cost-Effectiveness**: Lightnova positioned as a cost-effective first-line treatment option for wet AMD [9][12] Pricing Strategy - **UK Pricing**: List price set at £470, the lowest among approved products; patient access scheme in place for competitive net pricing [16][18] - **Germany Pricing**: List price set at €751.61; negotiations for a post-launch price expected in early 2026 [20][19] Commercial Launch Strategy - **Market Access**: Focus on subnational access critical for success; rebate agreements in place covering 50% of the population in Germany, expected to increase to 90% by year-end [26] - **Team Experience**: Strong teams with extensive ophthalmology experience in both Germany and the UK [24] Physician Engagement - **Receptiveness**: Positive feedback from ophthalmologists regarding Lightnova; significant interest in an ophthalmic standard formulation of bevacizumab [13][14] - **Educational Efforts**: Focus on educating physicians about the ophthalmic formulation and clinical data supporting Lightnova [35][36] Future Expansion Plans - **Market Expansion**: Approved in 31 countries; focus on launching in Italy, Spain, France, Ireland, and the Nordics [44][47] - **Potential Partnerships**: Currently focused on maximizing Lightnova's potential independently, but open to partnerships if beneficial [48] FDA Approval Update - **BLA Submission**: BLA submitted to the FDA in February 2025; PDUFA goal date set for August 27, 2025 [50][51] - **Expectations**: Confident in the data provided to the FDA supporting approval for wet AMD treatment [75][76] Financial Outlook - **Liquidity**: Recent capital raised through a CMPO; sufficient funds to support operations through the PDUFA decision [58] - **Profit Margins**: Anticipated healthy profit margins, with a focus on minimizing dilution during financing [63] Conclusion - **Key Milestones**: Upcoming quarterly results expected in August, along with the FDA decision; preparations for further European launches ongoing [84][85]

Core Insights - Outlook Therapeutics, Inc. is participating in a Virtual Investor Lunch Break Event on June 25, 2025, at 12:00 PM ET [1] - Key executives will discuss the company's commercial strategy, upcoming milestones, and current activities during the event [2] - A live video webcast will be available on the company's website, with a replay accessible for 90 days [3] Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD [4] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK [4] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [5] - If approved, it would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5]

Core Viewpoint - Outlook Therapeutics has received acceptance from the Scottish Medicines Consortium (SMC) for LYTENAVA™ (bevacizumab gamma) to be used in NHS Scotland for treating wet age-related macular degeneration (wet AMD), marking a significant milestone for the company and enhancing treatment options for patients in Scotland [1][2]. Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to improve the standard of care for retinal diseases [7]. - LYTENAVA™ is the first licensed ophthalmic formulation of bevacizumab for treating wet AMD in the UK, with an initial 10 years of market exclusivity from the date of marketing authorization [1][4]. Clinical Development - The SMC recommendation was based on results from the company's clinical program for ONS-5010/LYTENAVA™, which includes three completed registration clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE [2]. - The product is currently commercially available in the UK for wet AMD treatment [2]. Strategic Collaborations - Outlook Therapeutics has formed a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [3]. Regulatory Status - LYTENAVA™ has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for treating wet AMD [4]. - In the United States, ONS-5010/LYTENAVA™ is still investigational, with a Biologics License Application (BLA) resubmitted to the FDA [8].

Core Viewpoint - Outlook Therapeutics has launched LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in Germany and the UK, marking a significant milestone as it is the first and only authorized ophthalmic formulation of bevacizumab for this condition in the European Union and UK [1][5][9] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ to enhance the standard of care for retinal diseases [8] - The company has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for LYTENAVA™ [5][8] Product Launch and Market Strategy - The commercial launch of LYTENAVA™ in Germany and the UK is supported by a strategic collaboration with Cencora to facilitate market access and distribution [4] - The company aims to ensure success in these markets and is preparing for additional launches across Europe later in 2025 and throughout 2026 [2] Market Context - Off-label repackaged bevacizumab is widely used in Europe and the US, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [3] - LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, and a Biologics License Application (BLA) has been resubmitted to the FDA [6][8] - In certain EU member states, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold [6]

Core Viewpoint - Outlook Therapeutics, Inc. has announced a public offering of 9,285,714 shares of common stock at a price of $1.40 per share, along with warrants to purchase an additional 18,571,428 shares, aiming to raise approximately $13.0 million in gross proceeds [1][2]. Group 1: Offering Details - The public offering includes common stock sold in combination with warrants, where each share sold comes with a warrant to purchase two additional shares at an exercise price of $1.40 [1]. - The offering is expected to close on May 27, 2025, pending customary closing conditions [1]. - BTIG, LLC is acting as the sole book-running manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2]. Group 3: Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg), aimed at enhancing the standard of care for retinal diseases [5]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for treating wet age-related macular degeneration (wet AMD) [5]. - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and the UK in the second quarter of 2025, while the product remains investigational in the United States [5].