Verekitug Phase 2 CRSwNP Top-line Results September 2, 2025 © 2025 Upstream Bio, Inc. No Image Disclaimer This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "continue," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "predict ...

Core Insights - LanzaTech has developed a revolutionary technology that expands feedstock options for the Hydroprocessed Esters and Fatty Acids (HEFA) pathway for Sustainable Aviation Fuel (SAF), while also providing a sustainable alternative to palm oil [1][8] - The collaboration with the Fraunhofer Institute and Mibelle Group has led to the creation of a palm oil substitute that meets the functional requirements of the cosmetics industry, addressing sustainability and supply chain challenges [2][4] - The innovative dual fermentation technology converts waste CO2 into alcohol and subsequently into a palm oil-like fat, with production scaling efforts currently underway [6] Industry Context - The global reliance on palm oil has resulted in significant environmental issues, including deforestation and CO2 emissions, highlighting the need for sustainable alternatives [5] - LanzaTech's technology is positioned to play a crucial role in the decarbonization of the aviation sector by providing advanced feedstock for SAF production [7][9] - The versatility of LanzaTech's technology allows for the transformation of ethanol into synthetic oils, which can serve as alternatives to conventional HEFA feedstocks, thereby enhancing the sustainability of aviation fuels [8][9]

Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]

Core Viewpoint - Emergent BioSolutions Inc. has received a $30 million contract modification from BARDA to supply the CYFENDUS anthrax vaccine, with deliveries expected to start this year and conclude by March 2026 [1][2]. Group 1: Contract Details - The new contract modification is part of an ongoing collaboration with the U.S. government to ensure the availability of medical countermeasures against anthrax [2]. - This follows a previous contract modification of $50 million announced in December 2024 for the same vaccine [3]. Group 2: Product Information - CYFENDUS is indicated for post-exposure prophylaxis of anthrax disease in individuals aged 18 to 65 when administered with recommended antibacterial drugs [4]. - The vaccine was approved by the U.S. FDA in July 2023 for post-exposure use [2]. Group 3: Safety and Efficacy - The efficacy of CYFENDUS for post-exposure prophylaxis is based on studies in animal models of inhalational anthrax [4]. - Important safety information includes contraindications for individuals with a history of severe allergic reactions to the vaccine or its components [5].

Open-label study in as few as 16 tumor hyperinsulinism (HI) patients Study initiated and enrolling patients in the U.S. and Europe Topline data expected in the second half of 2026 REDWOOD CITY, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that the Company has gained alignment with FDA on a significantly streamlined clinical development path ...

Core Insights - Royalty Pharma plc will provide up to $300 million in funding to Zenas BioPharma, in exchange for a royalty on sales of obexelimab, targeting autoimmune diseases such as IgG4-RD [1][2][3] Company Overview - Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation in the biopharmaceutical industry, collaborating with various innovators [8] - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing transformative therapies for autoimmune diseases, with obexelimab as its lead product candidate [9] Product Development - Obexelimab is an investigational bifunctional monoclonal antibody designed to inhibit B cell function, currently in Phase 3 development for IgG4-RD and Phase 2 for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The funding will support the development of obexelimab and a potential commercial launch for IgG4-RD in the first half of 2027, pending FDA approval [2][3][6] Financial Terms - The agreement includes an upfront payment of $75 million, with three additional payments of $75 million each contingent on specific milestones related to clinical trials and FDA approvals [3][6] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3]

Core Insights - Zenas BioPharma and Royalty Pharma have entered into a partnership where Royalty Pharma will provide up to $300 million in funding for the development and potential commercialization of obexelimab, a treatment for IgG4-Related Disease [1][2][3] Funding and Financial Terms - The agreement includes an initial payment of $75 million, with three additional payments of $75 million each contingent upon specific milestones: success in the Phase 3 INDIGO trial, FDA approval for IgG4-RD, and FDA approval for Systemic Lupus Erythematosus [3] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3] Product Development and Clinical Trials - Obexelimab is currently in Phase 3 development for IgG4-RD and Phase 2 development for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The topline results from the pivotal Phase 3 trial for IgG4-RD are expected around the end of 2025, with a potential commercial launch in the first half of 2027, pending FDA approval [2][6] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function by binding to CD19 and FcγRIIb, which are present across B cell lineage, without depleting them [5][8] Company Background - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases, with obexelimab as its lead product candidate [8] - Royalty Pharma is a leading funder of innovation in the biopharmaceutical industry, known for acquiring royalties and co-funding late-stage clinical trials [9]

REHOVOT, Israel, Sept. 2, 2025 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetic medicine company developing disruptive technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen), today announced its participation in the annual meeting of The International Society of Biofabrication: the International Conference on Biofabrication 2025, to be held September 14–17, 2025, at the Palace of Culture and Science in Warsaw, Poland.CollPlant ...

Core Insights - Editas Medicine has nominated EDIT-401 as its lead in vivo development candidate, marking a significant milestone in its vision for programmable gene editing [2][3] - EDIT-401 is designed to treat hyperlipidemia by directly editing the LDLR gene, aiming for a substantial reduction in LDL cholesterol levels [3][5] - The company has a strong cash position, with $178.5 million in cash and equivalents, expected to fund operations into the second quarter of 2027 [9] Product Overview - EDIT-401 is an experimental gene editing medicine that targets the LDLR gene to increase LDLR protein expression, potentially offering a one-time treatment for lifelong benefits [3][7] - Preclinical studies in non-human primates have shown a ~90% mean reduction in LDL-C levels, compared to 40-60% reductions seen with standard therapies [7] - The targeted approach of EDIT-401 aims to address the significant unmet need in the hyperlipidemia patient population, which exceeds 70 million in the U.S. [4][7] Market Potential - Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death globally, with U.S. healthcare expenditures projected to exceed $300 billion by 2035 [4] - The company anticipates a sizeable market potential for EDIT-401, supported by favorable healthcare economics and a business model aligned with typical biopharma margins [7] Upcoming Milestones - Editas plans to submit an investigational new drug (IND) application for EDIT-401 by mid-2026, with the goal of achieving human proof-of-concept data by the end of 2026 [8] - The company expects to identify an additional target cell type or tissue by the end of 2025 [8]

Core Insights - Ascletis Pharma Inc. is set to present data from its Phase Ib clinical study of the oral GLP-1 receptor agonist ASC30 at the 61st EASD Annual Meeting in Vienna, Austria [1][2] - The company is on track to report topline data from a Phase IIa clinical study of ASC30 in participants with obesity or overweight by the fourth quarter of 2025 [1] Group 1: Clinical Study and Presentation - The 28-day multiple ascending dose study of ASC30 demonstrated superior weight loss in participants with obesity [2] - The short oral discussion will take place on September 16, 2025, from 12:00 to 13:00 CEST, with presentation number 827 [2] Group 2: Product Information - ASC30 is a new chemical entity (NCE) with unique properties allowing for both oral tablet and subcutaneous injection administration, protected by U.S. and global patents until 2044 [3] Group 3: Company Overview - Ascletis Pharma Inc. focuses on developing and commercializing therapeutics for metabolic diseases, utilizing its proprietary AI-assisted drug discovery platform [5] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [5]