Core Insights - HUTCHMED will present new and updated data from several studies at the upcoming ESMO Asia Congress 2025 and ASH Annual Meeting, showcasing its commitment to advancing cancer therapies [1][2][3] Group 1: Upcoming Presentations - A first-in-human study of HMPL-A83, an anti-CD47 monoclonal antibody, will be presented, focusing on advanced solid tumors [2] - The phase II results of the FRUSICA-2 study, evaluating the combination of fruquintinib and sintilimab for renal cell carcinoma, will also be shared [2] - Surufatinib's phase II results in combination with camrelizumab and chemotherapy for metastatic pancreatic cancer will be reported [2] Group 2: Specific Study Details - HMPL-A83 presentation details include a mini oral session on December 7, 2025, led by Ye Guo [2] - Fruquintinib's results will be presented by Shanshan Wang on December 5, 2025, in a proffered paper session [2] - Surufatinib's study will be displayed as a poster by Shukui Qin [2] Group 3: Additional Studies - Several investigator-initiated studies will also be presented, including combinations of fruquintinib with other treatments for metastatic colorectal cancer [3] - The final analysis of the ESLIM-01 study on sovleplenib for chronic primary immune thrombocytopenia will be presented at the ASH Annual Meeting [3] Group 4: Product Information - Fruquintinib is a selective oral inhibitor of VEGFRs, co-developed by HUTCHMED and Eli Lilly, marketed as ELUNATE in China [4] - HMPL-A83 is a humanized anti-CD47 monoclonal antibody that disrupts cancer cells' immune evasion [5] - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, marketed as ORPATHYS [6] - Surufatinib is an oral angio-immuno kinase inhibitor marketed as SULANDA in China [7] - Sovleplenib is a selective small molecule inhibitor targeting Syk, with potential applications in B-cell lymphomas [8]

MIRAMAR, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend health span by targeting the link between chronic inflammation and disease, today announced it has entered into a warrant inducement agreement with an investor (“Investor”) for the immediate exercise of certain outstanding warrants that the Company issued on November 20, 2 ...

Core Viewpoint - HCW Biologics Inc. reported its financial results for Q3 2025, highlighting advancements in its clinical programs, particularly the upcoming Phase 1 study for HCW9302 targeting autoimmune diseases, and the need for additional funding to ensure continued operations [1][12]. Business Highlights - The company plans to dose the first patient in a Phase 1 clinical study for HCW9302 in Q4 2025, which is aimed at treating autoimmune diseases and inflammatory conditions [2]. - HCW9302 is a novel IL-2 fusion molecule designed to enhance Treg cell activity, which is crucial for controlling inflammation in autoimmune diseases [2]. - The company is actively seeking a commercial partner for its T-cell engager (TCE) compounds, which aim to improve cancer treatment by targeting tumor antigens while reducing immunosuppression in the tumor microenvironment [3]. Financial Results - Revenues for Q3 2025 were $15,606, a significant decrease from $426,423 in Q3 2024. For the nine months ended September 30, 2025, revenues totaled $27,222 compared to $2.2 million in the same period of 2024 [7]. - R&D expenses increased by 18% in Q3 2025 to $1.4 million, while for the nine months, they decreased by 23% to $4.1 million due to prior year manufacturing costs [8]. - G&A expenses rose by 15% in Q3 2025 to $1.9 million, and for the nine months, they increased by 29% to $6.2 million, primarily due to higher salaries and professional fees [9]. - The net loss for Q3 2025 was $4.6 million, compared to $3.9 million in Q3 2024. For the nine months, the net loss was $8.7 million, significantly lower than $26.7 million in the same period of 2024 [11]. Financial Guidance - The company expressed substantial doubt regarding its ability to continue as a going concern for at least 12 months without additional funding [12]. - As of September 30, 2025, the company is not in compliance with Nasdaq's Equity Rule, which requires a minimum stockholders' equity of $2.5 million [13]. - A Nasdaq Hearings Panel granted the company continued listing on the exchange, contingent upon compliance with the Equity Rule by December 31, 2025 [14].

Core Insights - HUTCHMED has completed patient enrollment for the SAFFRON Phase III study, which investigates the combination of ORPATHYS and TAGRISSO for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][3][16] - The combination therapy is a promising chemotherapy-free, all-oral treatment option that has already received approval in China based on previous trial results [2][15] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases [18] - The company has successfully brought drug candidates from discovery to market, with its first three medicines approved in China and one also approved globally [18] Study Details - The SAFFRON study is a global, open-label, randomized trial involving 338 patients across 29 countries, aiming to assess the efficacy and safety of ORPATHYS in combination with TAGRISSO compared to traditional chemotherapy [3][4][16] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS) and objective response rate (ORR) [3][4] Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients exhibiting EGFR mutations [5][6] - The combination of ORPATHYS and TAGRISSO addresses resistance mechanisms in patients who have progressed on EGFR TKI therapy, with a notable percentage of these patients presenting with MET aberrations [14][15] Product Information - ORPATHYS (savolitinib) is a selective MET TKI approved in China for specific NSCLC patients, while TAGRISSO (osimertinib) is a third-generation EGFR TKI with proven efficacy in NSCLC [7][10][11] - The combination therapy has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SAFFRON [14][15]

Core Insights - The combination of fruquintinib and sintilimab shows significant improvements in progression-free survival (PFS) for patients with advanced renal cell carcinoma after first-line therapy failure [1][3][5] Study Overview - The FRUSICA-2 trial is a randomized, open-label study comparing fruquintinib and sintilimab combination therapy against axitinib or everolimus monotherapy for second-line treatment of advanced renal cell carcinoma, involving 234 patients [2] - The median follow-up for the final PFS analysis was 16.6 months, with a cutoff date of February 17, 2025 [2] Efficacy Results - The median PFS was 22.2 months for the fruquintinib and sintilimab group compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio of 0.373 (p<0.0001) [3] - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy (Odds Ratio 4.622, p<0.0001) [3] - The median duration of response (DoR) was 23.7 months for the combination compared to 11.3 months for the monotherapy [3] - Efficacy benefits were consistent across all prognostic risk groups as defined by the International mRCC Database Consortium (IMDC) criteria [3] Safety Profile - The safety profile of the fruquintinib and sintilimab combination was tolerable, with treatment-emergent adverse events (TEAEs) of grade 3 or above occurring in 71.4% of patients in the combination group compared to 58.8% in the axitinib/everolimus group [4] Regulatory Developments - A New Drug Application (NDA) for the combination therapy has been accepted for review by the China National Medical Products Administration (NMPA) [5] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with around 74,000 cases in China, where renal cell carcinoma accounts for about 90% of kidney tumors [6]

Core Insights - HCW Biologics congratulates Wugen on its $115 million equity financing led by Fidelity Management & Research Company, indicating strong institutional support for Wugen's development of CAR-T cell therapies [1][3] - HCW Biologics holds a minority equity interest in Wugen, which has generated $16.2 million in revenue from a license agreement since its inception [2] Company Overview: HCW Biologics - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing immunotherapies targeting chronic inflammation and age-related diseases [3] - The company’s lead product candidate, HCW9302, is developed using the TOBI™ platform, and it has also created the TRBC platform for constructing various immunotherapeutics [3] - HCW Biologics has over 50 molecules in development using the TRBC platform, with ongoing preclinical evaluations [3] Company Overview: Wugen - Wugen is a pivotal-stage biotechnology company specializing in off-the-shelf cell therapies derived from healthy donor cells, aimed at treating hematologic malignancies [4] - The company utilizes a proprietary CAR-T platform to address unmet medical needs and has optimized its US-based manufacturing for scalability and rapid deployment [4]

Company Overview - Oncotelic Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products aimed at addressing high unmet needs in cancer and rare pediatric diseases [4][3] - The company is led by Dr. Vuong Trieu, who has a strong background in intellectual property with approximately 500 patent applications and 75 granted patents [3][4] Innovation and Technology - Oncotelic is leveraging advanced technologies such as AI, nanomedicine, and innovative clinical approaches to transform biotechnology and improve treatment options for cancer and rare diseases [3][4] - The company has a robust pipeline of therapeutic candidates that are in late-stage development, which is designed to address significant medical needs [4] Strategic Positioning - Oncotelic Therapeutics holds a 45% stake in GMP Bio, a joint venture that is developing its own pipeline of drug candidates, thereby enhancing Oncotelic's strategic position in oncology and rare disease therapeutics [4] - The company benefits from a strong intellectual property portfolio, which is critical for its competitive advantage in the biopharmaceutical industry [3][4]

Core Viewpoint - HCW Biologics Inc. has regained compliance with Nasdaq's listing requirements, ensuring its continued presence on the Nasdaq Capital Market [1][2]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [3]. - The company aims to improve healthspan and quality of life by addressing age-related and senescence-associated diseases through its proprietary drug platforms [3]. Compliance Details - On June 24, 2025, HCW Biologics received formal notice from Nasdaq confirming compliance with the minimum stockholders' equity requirement [2]. - The company had previously regained compliance with other Nasdaq requirements, including bid price, public float, and market value of publicly held shares [2]. Product Development - The lead product candidate, HCW9302, was developed using the TOBI™ platform, while the TRBC platform allows for the creation of various immunotherapeutic compounds [3]. - The TRBC platform has produced over 50 molecules, with ongoing preclinical evaluations for selected candidates based on early promising data [3].

Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [3] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [3] Upcoming Event - Management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference in New York on May 20, 2025, at 11:30 am ET [1] - Interested parties can access the live audio webcast from the Investor Relations section of the company's website, with a replay available for approximately 90 days post-event [2]

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].