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]

Core Insights - Tempest Therapeutics has received approval from the National Medical Products Administration (NMPA) in China to initiate a pivotal trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development - Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist that shows promise in treating cancer by targeting tumor cells and modulating the tumor microenvironment [7] - The planned Phase 3 study will be a global, blinded, 1:1 randomized trial comparing amezalpat plus atezolizumab and bevacizumab against a placebo combination for first-line treatment of HCC [3] - The company has received agreement from both the FDA and EMA on the study design and statistical plan for the Phase 3 trial [3] Hepatocellular Carcinoma (HCC) Insights - HCC is an aggressive cancer with over 900,000 new diagnoses globally each year, and it is projected to become the third leading cause of cancer death by 2030 [4] - The highest incidence and mortality rates of HCC are found in East Asia, with increasing rates in Europe and the US [4] - Chronic liver diseases, including hepatitis B and C, NAFLD, NASH, and cirrhosis, account for 90% of HCC cases [5] Clinical Trial Context - The ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab has shown clinical superiority in overall survival compared to the standard of care [7] - Early-stage HCC patients face a 70-80% recurrence rate post-surgery, which is associated with poorer prognosis [6]

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].

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to sta ...

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 Insights - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO Annual Meeting, demonstrating its potential to convert "cold tumors" into "hot tumors" in advanced colorectal cancer [1][2][10] Clinical Data Summary - IBI363 monotherapy showed a median overall survival (OS) of 16.1 months in patients with advanced colorectal cancer, significantly better than standard treatments which range from 6.4 to 9.3 months [6][10] - In Phase 1 studies, IBI363 combined with bevacizumab resulted in a confirmed objective response rate (cORR) of 15.1% and a disease control rate (DCR) of 61.6% among 73 participants [9] - The combination therapy showed a median progression-free survival (PFS) of 4.7 months, with a notable increase in efficacy for patients without liver metastases, achieving a cORR of 31.3% and a DCR of 81.3% [9] Mechanism of Action - IBI363 operates by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, specifically targeting tumor-specific T cells, which enhances its therapeutic efficacy in treating colorectal cancer [11][12] - Tumor immune cell infiltration analysis indicated that higher levels of CD8+ T cells were associated with improved clinical responses to IBI363, supporting its mechanism of action [8] Future Development - Innovent is conducting further clinical studies in multiple countries to explore IBI363's efficacy across various tumor indications, including immune-resistant and cold tumors [12] - The company has initiated a pivotal trial for IBI363 targeting unresectable locally advanced or metastatic mucosal or acral melanoma [12][13] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 15 products to date [14][15] - The company has received fast track and breakthrough designations from regulatory authorities for IBI363, indicating its potential in treating specific cancer types [13]

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]

Core Insights - Outlook Therapeutics is on track to transition into a commercial-stage company with the planned launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK for wet AMD treatment in Q2 2025 [2][3] - The company anticipates potential FDA approval for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in the US by August 27, 2025, which would provide a much-needed approved ophthalmic formulation of bevacizumab [2][6] Financial Performance - For the fiscal second quarter ended March 31, 2025, the company reported a net loss of $46.4 million, or $1.50 per share, a significant reduction from a net loss of $114.3 million, or $8.01 per share, in the same period last year [10][26] - The adjusted net loss for the same period was $12.5 million, or $0.40 per share, compared to an adjusted net loss of $22.1 million, or $1.55 per share, for the fiscal second quarter of 2024 [10][11] Product Development and Regulatory Updates - LYTENAVA™ (bevacizumab gamma) is the first authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [4][16] - The FDA has acknowledged the resubmission of the Biologics License Application (BLA) for ONS-5010, which is undergoing a Class 2 review with a six-month review period [6][9] Market Strategy and Collaborations - Outlook Therapeutics has entered a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [5][16] - The company is also exploring authorization in additional European countries and Japan, indicating a broader market strategy [5]