-Ends- Enquiries: OXB: Sophia Bolhassan, Head of Investor Relations – T: +44 (0) 1865 509 737 / E: ir@oxb.com Oxford, UK – 11 June 2025: OXB (LSE: OXB) ("the Company"), a global quality and innovation-led cell and gene therapy CDMO, provides an update to coincide with its Annual General Meeting being held at 3pm BST today at Windrush Court, Oxford, UK. OXB has demonstrated strong commercial momentum and made good operational and commercial progress in the year 2025 to date, as it continues to provide viral ...

Lantheus (LNTH) FY Conference June 10, 2025 02:40 PM ET Speaker0 Following session is not open to the press. Okay. Speaker1 Good afternoon, everyone. I'm Paul Choi, and I cover the biotechnology sector here at the firm at Goldman Sachs. It's my pleasure to welcome Lampius. Joining me on stage to my immediate left is Brian Markinson, CEO, and Bob Marshall to my far left. What I'll do is turn it over to Brian maybe for some introductory or overview comments and then we'll get into Q and A after that. Speaker0 ...

Financial Data and Key Metrics Changes - The company has approximately $688 million in cash as of Q1, which is expected to last through the first half of 2028, covering existing programs and initial launch activities [77][79]. Business Line Data and Key Metrics Changes - The company is preparing to file a Biologics License Application (BLA) this year, targeting the BCG unresponsive high-risk population, which consists of about 15,000 patients annually [3][37]. - In a trial called BON-three, the company reported a 75.5% complete response rate at any time, with a durable response rate of 65% at one year and 58% at two years [7][8]. Market Data and Key Metrics Changes - In the U.S., there are 85,000 new bladder cancer patients diagnosed each year, with 75% being non-muscle invasive, and 70% of those being in the intermediate and high-risk categories [37]. - The company is addressing a growing number of patients in the BCG exposed category, estimated to be well over 30,000 to 50,000 patients [37]. Company Strategy and Development Direction - The company aims to revolutionize the treatment landscape for non-muscle invasive bladder cancer, focusing on both intermediate and high-risk populations [5]. - The strategy includes simplifying the administration process from a five-step to a two-step process, which is expected to save time and improve patient throughput [23][24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA filing, emphasizing the importance of demonstrating a minimum duration of response of at least twelve months [22]. - The company is optimistic about its unique position in the market due to the ongoing BCG shortage, which allows for faster enrollment in clinical trials [41]. Other Important Information - The company has generated data showing consistent response rates in patients who have had prior chemotherapy, which will be leveraged in discussions with providers [53]. - The company is focused on building relationships with key accounts, particularly in high-volume centers, to prepare for the commercial launch [73][75]. Q&A Session Summary Question: What is the current cash position and runway guidance? - The company has about $688 million in cash, which is expected to last through the first half of 2028, covering all existing programs and commercial preparations [77][79]. Question: What are the key endpoints for the papillary population study? - The benchmark for the papillary population is a recurrence-free survival rate of about 40% at twelve months, with the company aiming to exceed this in their studies [66]. Question: How does the company plan to prepare for a potential approval? - The commercial leadership team is already in place, focusing on building relationships with key accounts and preparing for the launch [73].

An updated edition of the April 16, 2025, article.The global cancer treatment market is transforming rapidly, driven by an increasing demand for more effective, less toxic therapies. As per the American Cancer Society, the United States alone is expected to see 2,041,910 new cancer cases and 618,120 cancer-related deaths in 2025. While advances in early detection and treatment have contributed to a decline in mortality rates for certain cancers, the overall rise in cancer incidence continues to push global ...

Summary of Ultragenyx Pharmaceutical (RARE) FY Conference Call Company Overview - Ultragenyx Pharmaceutical is at a significant inflection point, achieving revenues between $640 million to $670 million from four products: Crysvita, Nepsevi, Zolcivi, and Evkesa [2][4] - The company is experiencing a global commercial growth rate of approximately 20% annually [2] - Six late-stage programs are in development, with three expected to be filed within the year [4] Pipeline and Product Development - Key late-stage programs include: - Gene therapy for MPS IIIA, currently under review [2] - Gene therapy for GSD I, expected to be filed soon [2] - Osteogenesis Imperfecta (OI) program with high confidence in its transformative potential [5][6] - Angelman syndrome program (ASPIRE study) is on track to complete enrollment by the end of the year [49] - The company aims to become profitable by 2027, leveraging its existing products and new launches [4][68] Clinical Trials and Expectations - The OI program (cetrusumab) shows promising data from phase two trials, with a 67% reduction in fractures [6][19] - A significant threshold for commercial success is expected to be a fracture reduction of over 40%, with hopes for results above 50% [20][21] - The COSMIC trial aims to demonstrate the superiority of cetrusumab over bisphosphonates, which is crucial for market positioning [29][33] Market Strategy and Commercialization - The company plans to focus on key opinion leaders and centers with a high patient volume for initial launches [46] - A field force of 40 to 50 personnel is expected to support the launch, with an emphasis on home infusion models [42][48] - The commercial launch is anticipated to be easier due to a concentrated patient population in clinics [25] Gene Therapy Opportunities - The MPS IIIA program targets a severe disease with a small patient population but high urgency for treatment [59][60] - GSD I has a larger patient population, estimated at 1,500 to 8,000 in the US, with a significant need for treatment [63] - The company believes that urgency and the severity of conditions will drive adoption of gene therapies [66] Financial Outlook - The company reiterated its 2025 revenue guidance, projecting a 14% to 20% year-over-year growth, primarily driven by existing products [67][68] - Approximately 85% of revenue is expected to come from current products, with new launches contributing a smaller portion initially [68][69] Additional Insights - The company emphasizes the importance of patient quality of life and how treatments improve their daily activities, which will be a key driver for adoption [22][24] - Secondary endpoints in clinical trials are considered important for understanding the broader impact of treatments on patients [26][28] This summary encapsulates the key points discussed during the Ultragenyx Pharmaceutical FY Conference Call, highlighting the company's current status, pipeline developments, market strategies, and financial outlook.

CAMBRIDGE, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced a reverse stock split of its issued and outstanding shares of common stock, par value $0.005 per share (the “Common Stock”), at a ratio of 1-for-15, effective June 12, 2025 at 12:01 a.m. Eastern Time. The Company’s Common Stock is expected to begin trading on a split-adjusted basis when the market opens on Ju ...

Insmed (INSM) Update / Briefing June 10, 2025 08:00 AM ET Speaker0 Thank you for standing by, and welcome to the Insmed Phase 2b PAH Top Line Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer Thank you. I'd now like to turn the call over to Brian Dunn, Head of Investor Relations. You may begin. Speaker1 Thank you, Rob. Good day, everyone, and welcome to today's conference call to discuss the top line ...

Dr. Oren Hershkovitz, CEO, and Einat Galamidi, MD, CMO, will attend the conference and be available for meetings with stakeholders and members of the scientific community. Ness-Ziona, Israel, June 10, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present a poster at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology, taking place June ...

–The Study Met Primary and All Secondary Efficacy Endpoints– –TPIP Was Well Tolerated in the Study, with 75% of Patients Titrating to the Highest Dose– –Insmed to Immediately Engage with FDA to Inform Phase 3 Trial Design with Studies Expected to Begin Before End of 2025 for PH-ILD and in Early 2026 for PAH– –Insmed to Host Investor Call at 8:00 AM ET on Tuesday, June 10, 2025– BRIDGEWATER, N.J., June 10, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical compan ...

Company Overview - Gyre Therapeutics is a biopharmaceutical company focused on advancing fibrosis-first therapies across various organ systems affected by chronic diseases [1][6] - The company is headquartered in San Diego, CA, and is primarily engaged in the development and commercialization of Hydronidone for liver fibrosis, including metabolic dysfunction-associated steatohepatitis (MASH) [6] Clinical Development - Gyre has successfully dosed the first volunteer in a Phase 1 clinical trial for F230, a novel endothelin A receptor antagonist aimed at treating pulmonary arterial hypertension (PAH) [1][4] - The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of F230 in healthy volunteers [4] - F230 is a fully synthetic small molecule that selectively blocks the ETA receptor, intended to reduce pulmonary vascular remodeling and lower pulmonary pressure, which are critical factors in PAH progression [3] Market Potential - Gyre's entry into the PAH field is significant due to the condition's rarity, progressive nature, and high mortality rate, with limited treatment options available [2] - The PAH market in China was valued at $370 million in 2023 and is projected to grow to $480 million by 2031, highlighting the commercial potential for Gyre's F230 [2] Pipeline and Future Plans - F230 joins Gyre's pipeline alongside its lead candidate Hydronidone (F351), which has met the primary endpoint in a pivotal Phase 3 trial for chronic hepatitis B (CHB)-induced liver fibrosis [5] - A New Drug Application (NDA) submission for F351 to China's National Medical Products Administration (NMPA) is planned for the third quarter of 2025 [5] - Gyre is also planning a pre-IND meeting with the U.S. Food and Drug Administration for an expected Phase 2 trial in MASH fibrosis [5]