HCWB HCW Biologics Inc

HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, will have a human data readout at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”) from an ongoing Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors, conducted by the Masonic Cancer Center, University of Minnesota. The poster will be presented by Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota, a Principal Investigator for this study.

Title: Pre-clinical and first-in-human studies of HCW9218, a bifunctional TGF-β antagonist/IL-15 protein complex, in advanced solid tumors Presentation Type: Poster 767Presenter: Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of MinnesotaLocation: Exhibit Halls A and B1 – San Diego Convention CenterDate/Time: Friday, November 3, 2023, 9 a.m.–7 p.m. Pacific time.

The presentation will be available on the Company’s website in the Investors section under Events & Presentations, following the conference.

For conference information, visit https://www.sitcancer.org/2023/home

About the HCW9218 Phase 1 Clinical Trial Sponsored by Masonic Cancer CenterA Phase 1, first-in-human clinical trial initiated in May 2022 and has enrolled patients with advanced solid tumors with progressive disease after prior chemotherapies. The trial is led by University of Minnesota oncologist Melissa Geller, MD, MS, Professor, and Division Director, Gynecologic Oncology, Department of Obstetrics, Gynecology and Women's Health (OBGYN) in the Medical School and the Masonic Cancer Center’s Associate Director for Clinical Research, with collaboration from Jeffrey Miller, MD, Professor of Medicine in the Medical School’s Division of Hematology, Oncology and Transplantation and Deputy Director of the Masonic Cancer Center, and Manish Patel, DO, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation and Director of the Developmental Therapeutics Clinic (Clinicaltrials.gov: NCT05322408).

About Masonic Cancer Center:The Masonic Cancer Center, University of Minnesota, is the Twin Cities’ only Comprehensive Cancer Center, designated ‘Outstanding’ by the National Cancer Institute. As Minnesota’s Cancer Center, they have served the entire state for more than 25 years. Their researchers, educators, and care providers have worked to discover the causes, prevention, detection, and treatment of cancer and cancer-related diseases.

About HCW Biologics:HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBI™ discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Masonic Cancer Center, University of Minnesota, has initiated a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is also enrolling patients in a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication.

Forward-Looking Statements:Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, the ability of HCW9218 to be an effective senescent-cell reducing and senomorphic drug against age-related diseases; the ability of HCW9218 to rejuvenate the immune system, activate and expand NK cells and T cells, and create systemic changes that reduce senescence and SASP factors without compromising the healthspan; statements regarding the ability of HCW9218 to improve the performance of standard-of-care cancer therapies and immune checkpoint inhibitors; statements regarding the potential for HCW9218 to redefine or fundamentally change the approach for treating aging conditions and age-related diseases, or constitute a new class of immunotherapeutics; that trials may not have satisfactory outcomes; that preclinical studies of product candidates may not be predictive of the results of future preclinical studies or trials; the Company’s anti-inflammaging clinical development strategy and the Company’s intellectual property strategy; competition and other risks described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2023, the Company’s latest Quarterly Report on Form 10-Q filed with the SEC on August 11, 2023, and in other filings filed from time to time with the SEC. The forward-looking statements in this presentation represent the Company's view as of the date of this presentation and the Company does not assume any obligation to update any forward-looking statements, except as required by law.

Company Contact:Rebecca ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com