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].

Core Viewpoint - Outlook Therapeutics, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aimed at enhancing the standard of care for bevacizumab in treating retina diseases [1][2] Group 1: Offering Details - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2] - BTIG, LLC is serving as the sole book-running manager for the offering [2] Group 2: Regulatory and Product Information - The securities are being offered under a shelf registration statement declared effective by the SEC on April 5, 2024 [3] - Outlook Therapeutics is focused on the development of ONS-5010/LYTENAVA™ (bevacizumab-vikg), which is the first ophthalmic formulation of bevacizumab approved for wet age-related macular degeneration in the EU and UK [5] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the second quarter of 2025, while the product is still investigational in the U.S. [5]

Financial Performance - For the fiscal second quarter ended March 31, 2025, Outlook Therapeutics reported a net loss of $46.4 million, or $1.50 per share, compared to a net loss of $114.3 million, or $8.01 per share, for the same period last year[11]. - The adjusted net loss for the fiscal second quarter was $12.5 million, or $0.40 per share, down from an adjusted net loss of $22.1 million, or $1.55 per share, in the fiscal second quarter of 2024[11]. - For the three months ended March 31, 2025, the net loss attributable to common stockholders was $46.358 million, compared to a net loss of $114.289 million for the same period in 2024, representing a 59.3% improvement[26]. - The adjusted net loss attributable to common stockholders (non-GAAP) for the three months ended March 31, 2025, was $12.450 million, compared to $22.057 million in 2024, a reduction of 43.5%[26]. - The company reported a loss from operations of $12.391 million for the three months ended March 31, 2025, compared to a loss of $18.940 million in the same period of 2024, a 34.5% decrease[26]. - The loss before income taxes for the six months ended March 31, 2025, was $28.977 million, a significant improvement from $125.464 million in the same period of 2024, representing a 77.0% reduction[26]. Cash and Assets - As of March 31, 2025, Outlook Therapeutics had cash and cash equivalents of $7.6 million[13]. - Cash and cash equivalents decreased to $7.556 million as of March 31, 2025, from $14.928 million in 2024, a decline of 49.3%[24]. - Total assets decreased to $19.075 million as of March 31, 2025, from $28.823 million in 2024, a decline of 33.7%[24]. - The total stockholders' deficit decreased to $32.463 million as of March 31, 2025, from $73.077 million in 2024, reflecting a 55.6% improvement[24]. Product Development and Regulatory Approvals - The FDA has set a PDUFA goal date of August 27, 2025, for the approval of ONS-5010 (bevacizumab-vikg) for the treatment of wet AMD[8]. - LYTENAVA™ is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the U.S. for retinal diseases[6]. - The BLA resubmission for ONS-5010 was based on data from the NORSE EIGHT trial, which demonstrated efficacy and safety for the treatment of wet AMD[9]. - If approved, ONS-5010/LYTENAVA™ will receive 12 years of regulatory exclusivity in the United States[8]. - The company may seek authorization for LYTENAVA™ in other European countries, Japan, and additional markets[7]. Strategic Collaborations and Launch Plans - The company is on track for the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following marketing authorizations granted in May 2024 and July 2024[3][4]. - Outlook Therapeutics has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals[7]. Research and Development Expenses - Research and development expenses for the six months ended March 31, 2025, were $14.067 million, down from $18.038 million in the same period of 2024, indicating a 22.0% decrease[26]. - The company incurred warrant inducement expenses of $33.857 million for the three months ended March 31, 2025, compared to no such expenses in the same period of 2024[26].

Product Development and Market Approval - ONS-5010/LYTENAVA is the first ophthalmic formulation of bevacizumab approved in the EU and UK for wet AMD, with plans to launch in the US in Q2 2025[110]. - The FDA issued a Complete Response Letter for the BLA of ONS-5010/LYTENAVA on August 29, 2023, citing CMC issues and the need for an additional clinical trial[115]. - The NORSE EIGHT trial, involving 400 subjects, did not meet the pre-specified non-inferiority endpoint at week 8, but showed improvement in vision and a favorable safety profile[119]. - The mean improvement in best corrected visual acuity (BCVA) was +4.2 letters for ONS-5010/LYTENAVA and +6.3 letters for ranibizumab at week 8[119]. - The FDA's PDUFA goal date for a decision on the resubmitted BLA is August 27, 2025, with potential for 12 years of regulatory exclusivity if approved[116]. - The company has agreements with the FDA on SPAs for three additional registration clinical trials for ONS-5010/LYTENAVA[121]. Financial Performance and Losses - The company reported a net loss of $46.4 million for the three months ended March 31, 2025, compared to a net loss of $114.3 million for the same period in 2024, reflecting a decrease of $67.9 million[146]. - The company anticipates incurring additional losses until significant sales of ONS-5010/LYTENAVA or other product candidates can be generated[125]. - The company has substantial doubt about its ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for the next year[127]. - Net loss for the six months ended March 31, 2025 was $28.98 million, a significant improvement compared to a net loss of $125.47 million for the same period in 2024, reflecting a change of $96.49 million[155]. - The company has incurred net losses and negative cash flows from operations, funding its activities with $584.0 million in net proceeds from equity and debt securities[163]. Research and Development Expenses - Research and development expenses decreased by $9.1 million to $4.4 million for the three months ended March 31, 2025, primarily due to a reduction in expenses related to the ONS-5010/LYTENAVA development[147]. - Research and development expenses for the six months ended March 31, 2025 decreased by $4.0 million to $14.1 million compared to $18.0 million for the same period in 2024, primarily due to a $3.3 million decrease in ONS-5010/LYTENAVA development expenses[156]. General and Administrative Expenses - General and administrative expenses increased by $2.6 million to $8.0 million for the three months ended March 31, 2025, driven by prelaunch expenses for ONS-5010/LYTENAVA in Europe[148]. - General and administrative expenses increased by $8.7 million to $19.9 million for the six months ended March 31, 2025, driven by $4.7 million in prelaunch expenses for ONS-5010/LYTENAVA in Europe[157]. Financing and Capital Management - The company has funded operations with $584.0 million in net proceeds from equity and debt securities and $29.0 million from collaboration and licensing agreements as of March 31, 2025[125]. - The company anticipates needing additional financing to fund operations and fully commercialize ONS-5010/LYTENAVA, exploring various strategic opportunities for funding[164]. - The company sold 1,926,742 shares of common stock under the At-the-Market Offering, generating approximately $3.2 million in net proceeds during the six months ended March 31, 2025[166]. - On March 13, 2025, the company issued an unsecured convertible promissory note for $33.1 million to pay off the December 2022 Note[170]. - The company recognized warrant inducement charges associated with warrants exercised, resulting in net proceeds of $15.9 million from the Warrant Inducement Transaction[171]. - The company plans to finance future operations through licensing arrangements, equity issuance, and potential product sales, with risks of dilution and unfavorable terms[178]. Market Overview - The total anti-VEGF retina market in Europe is estimated at approximately $3.6 billion, with around 1.52 million treated patients and 8.3 million total anti-VEGF units[111]. - The US anti-VEGF retina market is estimated at $8.5 billion, with 55% of off-label repackaged bevacizumab injections used as first-line agents[112]. - The global market for anti-VEGF retina is approximately $16 billion[113]. Economic Factors - Macroeconomic factors, including inflation and interest rates, may adversely affect the rollout of LYTENAVA in key markets[122]. Cash Flow and Operating Activities - Net cash used in operating activities for the six months ended March 31, 2025, was $27.6 million, primarily due to a net loss of $29.0 million[180]. - Net cash provided by financing activities during the same period was $20.2 million, driven by proceeds from the issuance of the March 2025 Note and warrant exercises[182]. Warrant and Liability Management - The loss from change in fair value of warrant liability was $42.3 million for the six months ended March 31, 2025, compared to a gain of $49.7 million for the same period in 2024, reflecting a change of $92.0 million[155]. - Syntone agreed to exercise existing warrants for 1,071,429 shares at a reduced price of $2.51, with potential net proceeds of approximately $2.4 million pending regulatory approval[172]. - The conversion price for the March 2025 Note is set at $2.26 per share, subject to adjustments based on market conditions[190].