IRVINE, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference in New York, NY on Tuesday, May 20, 2025, at 11:30 am ET. Interested parties can access the live audio webcast for this confere ...

Core Insights - Calidi Biotherapeutics Inc. reported its first quarter 2025 operating and financial results, highlighting advancements in its systemic oncolytic targeted immunotherapy platform, Redtail [1][3] Company Developments - The management team has been strengthened with the appointment of Eric Poma, PhD, as CEO and Guy Travis Clifton, MD, as Chief Medical Officer, both bringing extensive biopharmaceutical experience [4][5] - The company selected IL15-superagonist as the first payload for its lead candidate using the Redtail platform, with an Investigational New Drug (IND) filing expected in the second half of 2026 [4] - The FDA cleared the IND application for CLD-201, an allogeneic stem cell-based immunotherapy targeting solid tumors, including breast cancer, head & neck cancer, and soft tissue sarcoma [4][6] Financial Performance - For Q1 2025, Calidi reported a net loss of $5.0 million, or $0.18 per share, an improvement from a net loss of $7.2 million, or $2.03 per share, in Q1 2024 [7][15] - Research and development expenses decreased to $2.4 million in Q1 2025 from $2.7 million in the same period in 2024 [7] - General and administrative expenses also declined to $2.6 million in Q1 2025 from $4.0 million in Q1 2024 [8] Cash Position - As of March 31, 2025, the company had approximately $10.6 million in cash, an increase from $9.6 million as of December 31, 2024 [8][13]

Core Viewpoint - HCW Biologics Inc. has announced a follow-on offering of 671,140 units at a price of $7.45 per unit, aiming to raise approximately $5.0 million for various developmental and corporate purposes [1][3]. Group 1: Offering Details - The offering consists of units that include one share of common stock (or pre-funded warrant) and two warrants, each with an exercise price of $7.45, exercisable immediately and expiring five years from the issuance date [1]. - The closing of the offering is expected around May 15, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to funding preclinical and clinical development, including trials for HCW9302, business development, out-licensing, collaborations, patent portfolio expansion, research and development, and general corporate purposes [3]. Group 3: Existing Warrants Adjustment - The company has negotiated to reduce the exercise price of certain existing warrants from $41.20 to $7.45 per share [4]. Group 4: Company Overview - HCW Biologics Inc. is focused on developing novel immunotherapies targeting chronic inflammation and age-related diseases, with a lead product candidate, HCW9302, developed using the TOBI™ platform [7]. - The company has also created the TRBC platform for constructing immunotherapeutics that target immune responses and cancerous cells, with over 50 molecules developed [7][8].

Additional Phase 1 Data for FT819 Off-the-Shelf CAR T-cell Product Candidate in Moderate-to-Severe Systemic Lupus Erythematosus to be Featured in Oral Presentation at EULAR 2025 Congress in June Regenerative Medicine Advanced Therapy Designation Granted by the FDA for FT819 in Moderate-to-Severe Systemic Lupus Erythematosus Expanding FT819 Phase 1 Study to Include Treatment of Multiple Additional B Cell-mediated Autoimmune Diseases and Ex-US Territories $273 Million in Cash, Cash Equivalents, and Investmen ...

Core Insights - HCW Biologics Inc. has presented studies indicating that its proprietary fusion protein HCW9206 offers a new pathway for generating CAR-T cells with enhanced function and reduced manufacturing costs [2][3] - The research shows that HCW9206 outperforms standard CAR-T production methods, leading to improved persistence and efficacy of CAR-T cells in treating various diseases [2][3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [4][5] - The company has established a GMP master cell bank for HCW9206 and filed a drug master file with the FDA, indicating readiness for commercial partnerships [3][4] Product Development - HCW9206 is designed to deliver synergistic signals from three immune-stimulatory cytokines, enhancing the production of stem cell-like memory T cells (Tscm) which are crucial for effective CAR-T therapies [2][3] - The company has developed additional drug discovery technologies, including the TRBC platform, which allows for the creation of various immunotherapeutic compounds targeting cancer and autoimmune diseases [5]

Core Insights - Bolt Biotherapeutics is hosting a KOL conference call and webcast on May 12, 2025, featuring Dr. Ecaterina Dumbrava discussing the Phase 1 clinical study results of BDC-3042 [1][2] - The management team will also provide updates on BDC-4182 clinical development and first quarter 2025 financial results, followed by a live Q&A session [2] Company Overview - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer treatment [4] - The company's pipeline includes BDC-3042, a first-in-class agonist antibody targeting dectin-2, and BDC-4182, a next-generation Immune-Stimulating Antibody Conjugate (ISAC) targeting claudin 18.2 [4] - BDC-3042 is currently in a Phase 1 dose escalation trial involving patients with seven different solid tumor types, while BDC-4182 is expected to initiate clinical trials in Q2 2025 [4]

Core Insights - BioNTech reported a net loss of €415.8 million for Q1 2025, compared to a net loss of €315.1 million in Q1 2024, indicating a significant increase in losses year-over-year [3][7][10] - Revenues for Q1 2025 were €182.8 million, a decrease from €187.6 million in the same period last year, primarily driven by COVID-19 vaccine collaboration [3][10] - The company maintains a strong financial position with €15.9 billion in cash, cash equivalents, and security investments as of March 31, 2025 [8][9] Financial Review - Revenues for Q1 2025: €182.8 million, down from €187.6 million in Q1 2024 [3] - Net loss for Q1 2025: €415.8 million, compared to €315.1 million in Q1 2024 [7] - Basic and diluted loss per share: €1.73 for Q1 2025, up from €1.31 in Q1 2024 [9] - Cost of sales increased to €83.8 million in Q1 2025 from €59.1 million in Q1 2024 [4] - R&D expenses rose to €525.6 million in Q1 2025 from €507.5 million in Q1 2024, driven by late-stage clinical studies [5] - SG&A expenses decreased to €120.6 million in Q1 2025 from €132.6 million in Q1 2024 [6] Corporate Strategy and Outlook - BioNTech is focusing on advancing its oncology pipeline, particularly the bispecific antibody candidate BNT327 and mRNA cancer immunotherapies [8][17] - The company confirmed its financial guidance for 2025, expecting revenues between €1,700 million and €2,200 million, with a similar revenue phasing to 2024 [10][11] - Planned R&D expenses for 2025 are estimated between €2,600 million and €2,800 million, with SG&A expenses projected at €650 million to €750 million [11] Clinical Development Updates - BioNTech presented multiple clinical updates for its oncology pipeline, including promising data for BNT327 in combination with antibody-drug conjugates [8][19] - Preliminary data from ongoing trials indicate anti-tumor activity and manageable safety profiles for BNT327 in various cancer indications [18][19] - The company is preparing for the 2025/2026 season variant-adapted COVID-19 vaccine [8][26] Management Changes - Ramón Zapata-Gomez has been appointed as the new CFO effective July 1, 2025, succeeding Jens Holstein [26]

WESTLAKE VILLAGE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Thomas Zindrick, President, CEO and Chairman of the Board, and Matt Pulisic, CFO, will discuss clinical-stage programs and upcoming milestones in a fireside chat at the Citizens Life Sciences Conference taking place May 7-8, 2025, in New York. The conversation with Biotech Equity Research Managing Director, Silvan Tuerkcan, PhD, is scheduled to be ...

Core Insights - Fate Therapeutics is advancing its iPSC-derived CAR T-cell therapy products aimed at providing conditioning chemotherapy-free treatments for autoimmune diseases and cancer [1][2][7] - The company will present five sets of clinical and preclinical data at the ASGCT Annual Meeting, highlighting the potential of its innovative therapies [1][3] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on developing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases [7] - The company utilizes a proprietary iPSC product platform that combines multiplexed-engineering and single-cell selection to create clonal master iPSC lines, which are essential for manufacturing engineered cell products [5][6] Product Development - The company will deliver an oral presentation on its Phase 1 clinical trial of FT522, a CD19-targeted CAR NK cell product candidate, which aims to eliminate the need for conditioning chemotherapy [2][3] - Preclinical data will also be presented on various iPSC-derived CAR T-cell products targeting autoimmune diseases, hematological malignancies, and solid tumors [2][4] Presentation Details - The oral presentation on FT522 is scheduled for May 17, 2025, at the ASGCT Annual Meeting [3] - Multiple poster presentations will occur on May 13 and May 14, 2025, showcasing various aspects of the company's iPSC-derived therapies [4][3]

NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today announced that it will present new clinical and preclinical data from its pipeline of gamma-delta T cell therapies at several upcoming scientific conferences. "The breadth of data we're presenting at upcoming medical conferences reflects the scientific rigor and clinical potential of IN8bio's gamma-de ...