1. MIRAMAR, Fla., Jan. 20, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced the publication of a scientific paper, authored by the Company's scientific research team, in the peer-reviewed journal, Molecular Therapy. The paper is entitled, "Immunotherapeutic HCW9218 augments anti-tumor activity of chemotherapy via NK cell mediated reduction of therapy-induced senescent cells." It highlights preclinical data from in vivo animal studies demonstrating the ability of the Company's lead investigational candidate…

    MIRAMAR, Fla., Jan. 20, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced the publication of a scientific paper, authored by the Company's scientific research team, in the peer-reviewed journal, Molecular Therapy. The paper is entitled, "Immunotherapeutic HCW9218 augments anti-tumor activity of chemotherapy via NK cell mediated reduction of therapy-induced senescent cells." It highlights preclinical data from in vivo animal studies demonstrating the ability of the Company's lead investigational candidate, HCW9218, to both enhance the anti-tumor efficacy of chemotherapy drugs and diminish their harmful side effects by reducing therapy-induced senescence (TIS).

    Cellular senescence is an essential mechanism for tumor suppression. However, an increasing body of evidence has shown that chemotherapy and radiation, standard-of-care anti-cancer regimens, cause the accumulation of senescent cells both in tumor and normal tissue. Paradoxically, cellular senescence protects non-dividing cancer cells by limiting the effect of chemotherapeutic drugs and radiation and contributes to chemoresistance, radiation resistance, disease relapse, and systemic side effects. The Company's data presented in this publication shows that HCW9218 activated immune response can significantly reduce cellular senescence induced by current chemotherapy to improve the anti-tumor efficacy and alleviate the unwanted side effects.

    Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, and the corresponding author of this published article, stated, "We believe our preclinical research findings are groundbreaking and among the very first studies that show our immunotherapeutic can enhance the efficacy of chemotherapy. We are also interested in the collateral damage caused by chemotherapy treatment that has such a detrimental impact on health span and quality of life for millions of cancer patients."

    Dr. Wong continued, "We believe the findings reported in this paper could have broad implications in the future of chemotherapy. Multiple studies have revealed that increased cellular senescence in normal tissues can promote tumor progression, creating a link between aging and cancer. We have demonstrated with this data that targeting senescence cells with an immunotherapy could create an exciting clinical opportunity to maximize the anti-tumor efficacy of chemotherapies and minimize their negative side effects on normal tissues. In addition, we found that HCW9218 in combination chemotherapies can further augment the anti-cancer activities of therapeutic and immune-checkpoint antibodies against solid tumors. These encouraging preclinical results further support our decision to advance clinical development of HCW9218 for chemotherapy-refractory pancreatic cancer and other solid tumors."

    HCW9218 is a heterodimeric, bifunctional fusion protein complex engineered using the company's proprietary TOBI™ platform technology. As detailed in the paper published today, data from in vivo animal studies demonstrated that HCW9218 improved the efficacy of the chemotherapy agent docetaxel against B16F10 melanoma, and anti-cancer agents gemcitabine combined with nab-paclitaxel against SW1990 pancreatic tumors by augmenting the metabolic and cytotoxic activities of immune cells and reducing TIS tumor cells that play a role in cancer recurrence, metastasis, and resistance to chemotherapy and radiation.

    As demonstrated in the paper, HCW9218 treatment in animal models reduced the immunosuppressiveness of the tumor microenvironment and enhanced immune-cell infiltration and cytotoxicity in tumors to eliminate TIS cancer cells. Immunodepletion analysis suggested that natural killer (NK) cells activated by HCW9218 played a pivotal role in TIS cancer cell removal. HCW9218 treatment following docetaxel chemotherapy further enhanced the efficacy of tumor antigen-specific and anti-PD-L1 antibodies in B16F10 melanoma tumor-bearing mice. Data also demonstrated that tumor-bearing mice treated with chemotherapy and HCW9218 showed decreased TIS cells and proinflammatory senescence-associated secretory phenotype (SASP) factors in off-target tissues. SASP factors are believed to contribute to chemoresistance, disease relapse, and chemotherapy's negative side effects.

    HCW Biologics received clearance in October 2021 from the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application for a first-in-human Phase 1b clinical trial to evaluate HCW9218 in patients with advanced pancreatic cancer. The Company is in discussions with several leading National Cancer Institute-designated cancer centers as potential clinical trial sites. Discussions are simultaneously underway with a research facility to sponsor an IND for a second, investigator-initiated trial to evaluate HCW9218 in patients with breast, ovarian, prostate, colorectal and other solid tumors.

    About the TOBI™ platform:

    HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ discovery platform. The TOBI™ platform is a proprietary immunotherapeutic drug design and discovery platform. The Company has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

    About HCW Biologics:

    HCW Biologics is a transformative immunotherapy company that focuses on inflammaging, a state of unresolved inflammatory responses and chronic inflammation. The Company is developing novel immunotherapies designed to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. The Company uses its TOBI™ discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties for the treatment of inflammaging. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The FDA has cleared HCW Biologics to initiate a first-in-human Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. The Company is also advancing IND-enabling studies for HCW9302 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, statements regarding immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities; the balancing of certain activities believed to be the key to developing immunotherapeutic agents that are expected to be safe, well tolerated and efficacious; the development of novel immunotherapies expected to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, and the Company's intention to use TOBI™ technology to develop the next generation of cancer immunotherapeutics, the ability of HCW9218 to augment and enhance the anti-tumor efficacy of chemotherapy drugs and diminish their harmful side effects by reducing or eliminating TIS, the ability of HCW9218 to significantly reduce senescence, the potential clinical opportunity with chemotherapies and therapeutic and immune-checkpoint antibodies, the ability of HCW9218 to drive significant bifunctional antitumor activity and augment the metabolic and cytotoxic activities of immune cells, the ability of HCW9218 to reduce immunosuppressiveness of tumor microenvironment and enhanced immune-cell infiltration and cytotoxicity in tumors. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to the Company's initial public offering filed with the Securities and Exchange Commission on July 21, 2021. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

    Company Contact:



    Rebecca Byam

    CFO

    HCW Biologics Inc.

    Investor Relations Contact:



    Lisa Sher

    Senior Vice President

    Tiberend Strategic Advisors, Inc.

     
    Media Relations Contact:



    Dave Schemelia

    Senior Vice President

    Tiberend Strategic Advisors, Inc.



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  2. MIRAMAR, Fla., Jan. 19, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. ("HCW Biologics" or the "Company") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced that Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, will speak at the Cambridge Healthtech Institute's 24th Annual PepTalk Conference to be held on January 17-19, 2022 (https://www.chi-peptalk.com/protein-expression-production). The conference is taking place virtually and in person at the Hilton San Diego Bayfront in San Diego, California.

    Dr. Wong's presentation entitled, "A Novel Platform to Create…

    MIRAMAR, Fla., Jan. 19, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. ("HCW Biologics" or the "Company") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced that Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, will speak at the Cambridge Healthtech Institute's 24th Annual PepTalk Conference to be held on January 17-19, 2022 (https://www.chi-peptalk.com/protein-expression-production). The conference is taking place virtually and in person at the Hilton San Diego Bayfront in San Diego, California.

    Dr. Wong's presentation entitled, "A Novel Platform to Create Multi-Functional Immunotherapeutics for Cancer," is part of the session for Recombinant Protein Expression and Production: Effective Expression and Production of Unique Bioproducts and takes place on January 19 at 11:15 a.m. PST. His presentation will feature a discussion of the Company's internally developed platform for drug discovery called the TOBI™ (Tissue factOr-Based fusIon) platform. The TOBI™ platform is a scaffold for the creation of novel multi-functional immunotherapeutics that have the potential to rejuvenate the immune system by reducing the accumulation of senescent cells and suppressing the activity of inflammasomes. Using the TOBI™ platform, the Company has developed over 30 molecules that are capable of activating and targeting desired immune responses and blocking unwanted immunosuppressive activities.

    Dr. Wong stated, "The TOBI™ platform is a novel approach to construct multi-functional fusion proteins and fusion protein complexes, all components are human-derived, using a novel tissue factor (TF) scaffold. The extracellular domain of human TF was selected as it has a rigid elongated structure comprised mainly of ß-sheets with its N- and C-termini located at distal ends of the polypeptide, permitting genetic fusions of other protein domains without anticipated steric interference. This TF domain does not interact with the cell membrane phospholipid bilayer and, as a result, does not exhibit procoagulant activity. It is expressed at high levels by most cell types and is not expected to be immunogenic in humans."

    Dr. Wong added, "Consistent with these properties, we found that genetic fusion to the TF domain promoted increased production of difficult-to-express proteins, such as IL-15. Additionally, the TF fusion proteins could be readily purified by affinity chromatography using an anti-TF antibodies and low pH elution conditions, like those used in Protein A-based affinity purification of therapeutic antibodies."

    Dr. Wong's presentation will include a discussion of data and conclusions contained in recent papers authored by the Company's scientists that have been published in peer-reviewed journals. The presentation will highlight information contained in a pivotal paper published in Molecular Therapy related to preclinical data from in vivo studies demonstrating the potential of the Company's lead investigational candidate, HCW9218, in eliminating therapy-induced senescence and the unwanted side effects of chemotherapy. This ground-breaking finding revealed the underlying mechanism that HCW9218 enhanced the anti-tumor activities and lessened the side effects of chemotherapies. In addition, Dr. Wong's presentation will include a discussion of another paper published in Molecular Therapy related to preclinical data from in vivo studies demonstrating that HCW9218 exhibited favorable pharmacokinetics and pharmacodynamics as a novel immunostimulant with the ability to simultaneously lessen immunosuppression. Finally, the presentation will discuss some of the information in a paper published in Cancer Immunology Research that looked at HCW Biologics' TOBI™ discovery platform.

    About TOBI™

    HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ discovery platform. TOBI™ is a proprietary immunotherapeutic drug design and discovery platform. HCW has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

    About HCW Biologics:

    HCW Biologics is a transformative immunotherapy company that focuses on inflammaging, a state of unresolved inflammatory responses and chronic inflammation. The Company is developing novel immunotherapies designed to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. The Company uses its TOBI™ discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties for the treatment of inflammaging. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The FDA has cleared HCW Biologics to initiate a first-in-human Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. The Company is also advancing IND-enabling studies for HCW9302 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, statements regarding immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities; the balancing of certain activities believed to be the key to developing immunotherapeutic agents that are expected to be safe, well tolerated and efficacious; the Company's intention to use TOBI™ technology to develop the next generation of cancer immunotherapeutics; development of molecules that are capable of activating and targeting desired immune responses and blocking unwanted immunosuppressive activities; development of immunotherapeutics that have the potential to rejuvenate the immune system by reducing the accumulation of senescent cells and suppressing the activity of inflammasomes; the TF domain of the TOBI platform is expressed at high levels by most cell types and is not expected to be immunogenic in humans; claims regarding TF fusion protein production and purification; potential of HCW9218 in eliminating therapy-induced senescence and the unwanted off-target and side effects of chemotherapy; potential of HCW9218 as a novel immunostimulant with the ability to simultaneously lessen immunosuppression in patients with cancer; and development of immunotherapies designed to improve health by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to the Company's initial public offering filed with the Securities and Exchange Commission on July 21, 2021. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

    Company Contact:



    Rebecca Byam

    CFO

    HCW Biologics Inc.

     
    Investor Relations Contact:



    Lisa Sher

    Senior Vice President

    Tiberend Strategic Advisors, Inc.

     
    Media Relations Contact:



    Dave Schemelia

    Senior Vice President

    Tiberend Strategic Advisors, Inc.

     


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  3. MIRAMAR, Fla., Jan. 06, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company") (NASDAQ:HCWB), a 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, announced today that members of the HCW Biologics management team will participate in the H.C. Wainwright BioConnect Conference. The event is taking place January 10 – 13, 2022.

    The Company will provide a corporate overview, including an update on its pipeline and the company's plans to initiate multiple clinical trials for cancer in the first half of 2022. Presenters will include: Hing C. Wong, Ph.D., Founder and CEO; Peter Rhode, Ph.D., CSO…

    MIRAMAR, Fla., Jan. 06, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company") (NASDAQ:HCWB), a 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, announced today that members of the HCW Biologics management team will participate in the H.C. Wainwright BioConnect Conference. The event is taking place January 10 – 13, 2022.

    The Company will provide a corporate overview, including an update on its pipeline and the company's plans to initiate multiple clinical trials for cancer in the first half of 2022. Presenters will include: Hing C. Wong, Ph.D., Founder and CEO; Peter Rhode, Ph.D., CSO and VP of Clinical Operations; Rebecca Byam, CFO; and Nicole Valdivieso, Director of Legal Affairs. The presentation will be available on the HCW Biologics investor relations website beginning on Monday, January 10, 2022.

    About HCW Biologics:

    HCW Biologics is a transformative immunotherapy company that focuses on inflammaging, a state of unresolved inflammatory responses and chronic inflammation. The Company is developing novel immunotherapies designed to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. The Company uses its TOBI™ discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties for the treatment of inflammaging. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The FDA has cleared HCW Biologics to initiate a first-in-human Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. The Company is also advancing IND-enabling studies for HCW9302 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, statements regarding immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities; the balancing of certain activities believed to be the key to developing immunotherapeutic agents that are expected to be safe, well tolerated and efficacious; the development of novel immunotherapies expected to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, the Company's intention to use TOBI™ technology to develop the next generation of cancer immunotherapeutics, and the Company's expectation to initiate multiple clinical trials for cancer in the first half of 2022.. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to the Company's initial public offering filed with the Securities and Exchange Commission on July 21, 2021. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

    Company Contact:



    Rebecca Byam

    CFO

    HCW Biologics Inc.

    Investor Relations Contact:



    Maureen McEnroe, CFA

    Executive Vice President

    Tiberend Strategic Advisors, Inc.

    Media Relations Contact:



    Dave Schemelia

    Senior Vice President

    Tiberend Strategic Advisors, Inc.



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  4. MIRAMAR, Fla., Dec. 13, 2021 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, announced today Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, was named the 2021 Weaver H. Gaines Entrepreneur of the Year by BioFlorida. Presented annually at the BioFlorida Conference, the award recognizes an individual who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. This marks the second time Dr. Wong has received the award; the first being in 2017…

    MIRAMAR, Fla., Dec. 13, 2021 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ:HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, announced today Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, was named the 2021 Weaver H. Gaines Entrepreneur of the Year by BioFlorida. Presented annually at the BioFlorida Conference, the award recognizes an individual who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. This marks the second time Dr. Wong has received the award; the first being in 2017.

    The award was presented at the BioFlorida Conference, which took place from December 8-10, 2021, in Orlando, Florida. BioFlorida represents 6,700 establishments and research organizations in the biopharmaceuticals, medical technology, health IT and bio-agriculture sectors. The Weaver H. Gaines Entrepreneur of the Year Award is named in honor of Weaver Gaines, one of the founding directors of BioFlorida.

    "We are pleased to once again present Dr. Wong with the Entrepreneur of the Year award for his contributions to the Florida life sciences industry and his ongoing passion and commitment to developing transformative immunotherapies to lengthen the quality of life for those with cancer and other age-related diseases," said Nancy K. Bryan, President and CEO of BioFlorida.

    Founded in 2018, HCW Biologics is developing novel immunotherapies that target changes in the human immune system that occur as part of the natural aging process and believed to play a key role in causing cancer, diabetes, cardiovascular disease, neurodegenerative conditions and other age-related disorders. The Company's research and clinical development revolves around molecules created using the TOBI™ platform, a proprietary technology developed by HCW Biologics to engineer multi-functional fusion protein molecules and protein complexes with the ability to stimulate and target desired immune responses and inhibit unwanted inflammation.

    Under Dr. Wong's leadership, HCW Biologics completed an initial public offering in July 2021, and recently received clearance from the U.S. Food and Drug Administration (FDA) to advance its lead product candidate, HCW9218, into a first-in-human Phase 1b clinical trial for advanced pancreatic cancer. The Company expects to begin the trial in the first half of 2022.

    "I am humbled by this honor and to be among the outstanding individuals who are past recipients of this award," stated Dr. Wong. "This accolade is not mine alone but represents the hard work and commitment of the team at HCW Biologics, our research partners and the loyalty and commitment of our investors to a shared vision of harnessing groundbreaking research into the workings of the human immune system to find new immunotherapies for cancer and other age-related diseases. I would like to thank the BioFlorida organization, its members, and its board of directors for the significant contribution that they have made to the growth and success of the biotechnology industry across the state of Florida."

    As previously announced, Dr. Wong participated in a panel discussion at the BioFlorida Conference, titled, "New Strategies in the Fight Against Cancer." Joining Dr. Wong on the panel was Douglas W. Calder, President of Vycellix; Robert Igarashi, Ph.D., Vice President of Discovery and Pre-Clinical Development at Kiadis Pharma; and Margo Shoup, M.D., President of the Orlando Health Cancer Institute and Vice President of Orlando Health.

    About Dr. Hing C. Wong

    Dr. Hing C. Wong has served as CEO and a board member of HCW Biologics since founding the Company in April 2018. His 35-year career in the life sciences industry has included leadership roles spanning early-stage startups to globally established companies. Previously, he founded and served as the CEO of Altor BioScience Corporation ("Altor") and Sunol Molecular Corporation. Dr. Wong served as CEO of NantCell following the company's acquisition of Altor in 2017. Prior to striking out on his own as an entrepreneur, he held senior positions at Baxter Healthcare and Cetus Corporation. Dr. Wong received a Ph.D. in Microbiology and Immunology from the University of Massachusetts, Amherst and completed his postdoctoral training at the University of Washington. He is the major or lead author of over 100 research articles in high-impact peer-review scientific journals and the sole or co-inventor of numerous awarded worldwide patents. He is also the grant recipient of over $25 million from research institutes including the National Institutes of Health.

    About the TOBI™ platform:

    HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ discovery platform. The TOBI™ platform is a proprietary immunotherapeutic drug design and discovery platform. The Company has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

    About HCW Biologics:

    HCW Biologics is a transformative immunotherapy company that focuses on inflammaging, a state of unresolved inflammatory responses and chronic inflammation. The Company is developing novel immunotherapies designed to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. The Company uses its TOBI™ discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties for the treatment of inflammaging. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The FDA has cleared HCW Biologics to initiate a first-in-human Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. The Company is also advancing IND-enabling studies for HCW9302 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, statements regarding immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities; the balancing of certain activities believed to be the key to developing immunotherapeutic agents that are expected to be safe, well tolerated and efficacious; the development of novel immunotherapies expected to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, and the Company's intention to use TOBI™ technology to develop the next generation of cancer immunotherapeutics, expectations to initiate a Phase 1b clinical trial to evaluate HCW9218 in chemotherapy-refractory pancreatic cancer in the first half of 2022. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to the Company's initial public offering filed with the Securities and Exchange Commission on July 21, 2021. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

    Company Contact:



    Rebecca Byam

    CFO

    HCW Biologics Inc.

    Investor Relations Contact:



    Maureen McEnroe, CFA

    Executive Vice President

    Tiberend Strategic Advisors, Inc.

    Media Relations Contact:



    Dave Schemelia

    Senior Vice President

    Tiberend Strategic Advisors, Inc.



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  5. MIRAMAR, Fla., Nov. 12, 2021 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ:HCWB), an innovative biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today reported recent business highlights and financial results for its third quarter ended September 30, 2021.

    "The third quarter of 2021 and recent weeks were an important period for HCW Biologics and our strategy to build a pipeline of first-in-class immunotherapeutic treatments for age-related diseases," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "The third quarter provided bookends to…

    MIRAMAR, Fla., Nov. 12, 2021 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ:HCWB), an innovative biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today reported recent business highlights and financial results for its third quarter ended September 30, 2021.

    "The third quarter of 2021 and recent weeks were an important period for HCW Biologics and our strategy to build a pipeline of first-in-class immunotherapeutic treatments for age-related diseases," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "The third quarter provided bookends to what has been a busy time for the Company. In July, we closed our initial public offering and subsequently listed our common stock on Nasdaq. The Company has never been on stronger financial footing, and we believe we now have capital resources sufficient to fund our operations into 2023. During the third quarter, we filed our first IND to evaluate our lead bifunctional molecule, HCW9218, in a pancreatic cancer trial.   We completed the regulatory review shortly after the end of the third quarter, and we announced FDA clearance for the Phase 1b clinical trial on October 28, 2021."

    Business Highlights:

    • On July 22, 2021, HCW Biologics closed on its IPO, raising $56 million in gross proceeds. The net proceeds of the offering and the Company's existing cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements into 2023.



    • HCW Biologics was added to S&P Total Market Index (TMI) on September 20, 2021.



    • The Company expanded its Board of Directors with the addition of two new independent directors in October 2021, Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. She held senior leadership positions in strategic planning, operations, and commercial planning. In addition, she brings a wealth of corporate governance experience, having served as a board member for several public companies. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, including senior leadership positions with AbbVie and Abbott. He brings valuable insights and experience for operations as well as support and advice for strategic transactions.



    • On October 28, 2021, HCW Biologics announced that it received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for a Phase 1b first-in-human clinical trial to evaluate HCW9218 in patients with advanced pancreatic cancer. The Company is in discussions with several leading National Cancer Institute-designated cancer centers as potential clinical trial sites. Discussions are simultaneously underway with a research facility to sponsor an IND for a second, investigator-initiated trial to evaluate HCW9218 in patients with solid tumors (breast, ovarian, prostate, and colorectal cancers).



    • HCW Biologics continues IND-enabling studies involving HCW9302, its second lead investigational drug candidate. The Company expects to complete FDA-required preclinical studies in mice by the end of 2021 and non-clinical toxicology studies in non-human primates in the second half of 2022. HCW9302 is an IL-2-based immunotherapeutic designed to stimulate regulatory T (Treg) cells to suppress the activity of inflammasome-bearing cells and inflammatory factors.   HCW Biologics intends to evaluate HCW9302 in autoimmune diseases.



    • The HCW Biologics' founder and CEO, Dr. Hing C. Wong, has accepted invitations to present at two noted industry events. Dr. Wong will present at the BioFlorida Annual Conference taking place on December 8-10, 2021, in Orlando, Florida, where he will participate in the featured session, "New Strategies in the Fight Against Cancer." Dr. Wong will also lead a presentation during the Cambridge Healthtech Institute's 24th Annual PepTalk taking place on January 17-19, 2022, in San Diego, California. His presentation, entitled "A Novel Platform to Create Multi-functional Immunotherapies for Cancer," will focus on the TOBI™ discovery platform and HCW9218.



    • The Company continues to expand its intellectual property portfolio through filing provisional U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. As of September 30, 2021, HCW Biologics is the owner of record of 60 pending patent applications worldwide, including 11 pending U.S. utility patent applications, two pending provisional U.S. patent applications, seven pending PCT applications, 36 pending non-U.S. national phase patent applications, and four pending Hong Kong patent applications. The Company also owns five U.S. trademark applications related to its corporate name and logo, and the TOBITM platform.

    Third Quarter Financial Results:

    • Cash and cash equivalents: On September 30, 2021, the Company's cash balance was $15.1 million, short-term investments were $25.0 million and long-term investments were $10.0 million. The net proceeds from the IPO were $49.0 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from existing or new out-licensing agreements.



    • Research and development (R&D) expenses: R&D expenses were $2.7 million for the three-month period ended September 30, 2021, as compared to $2.1 million for the three-month period ended September 30, 2020. Higher costs in the third quarter of 2021 were primarily the result of higher manufacturing and IND-enabling activity costs. During the nine-month period ended September 30, 2021, R&D expenses were $6.7 million versus $5.8 million during the nine-month period ended September 30, 2020. The 14% increase in expense was driven primarily by an increase in IND-enabling and preclinical activities.



    • General and administrative expenses (G&A): G&A expenses were $1.4 million for the three-month period ended September 30, 2021, as compared to $0.6 million for the three-month period ended September 30, 2020. This reflects an increase in compensation expense including salaries, performance-based bonuses and board compensation, and an increase in certain operating expenses including higher insurance costs, professional fees, and legal services expenses. For the nine-month period ended September 30, 2021, G&A expenses were $3.6 million versus $2.0 million for the same period ended September 30, 2020. The 75% increase was primarily driven by an increase in expenses for salaries, performance-based bonuses, employee benefits, professional fees, and other expenses.



    • Net loss: Net loss was $4.1 million for the three-months ended September 30, 2021, compared to $2.7 million for the three-months ended September 30, 2020. For the nine-months ended September 30, 2021, net loss was $9.7 million, compared to $7.9 million for the same period in the prior year.

    About the TOBI™ platform:

    HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ discovery platform. The TOBI™ platform is a proprietary immunotherapeutic drug design and discovery platform. The Company has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

    About HCW Biologics:

    HCW Biologics is a transformative immunotherapy company that focuses on inflammaging, a state of unresolved inflammatory responses and chronic inflammation. The Company is developing novel immunotherapies designed to improve health span by disrupting the link between chronic, low-grade inflammation and age-related diseases such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases and autoimmune diseases. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties for the treatment of inflammaging. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The FDA has cleared HCW Biologics to initiate a first-in-human Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. 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, statements regarding immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities; the balancing of certain activities believed to be the key to developing immunotherapeutic agents that are expected to be safe, well tolerated and efficacious; the Company's intention to use TOBI™ technology to develop the next generation of cancer immunotherapeutics; expectations to submit a second IND to the FDA sponsored by a research facility in connection with an investigator-initiated trial to evaluate HCW9218 in solid tumors; sufficient capital resources through 2023; potential clinical trial sites at NCI Cancer Centers; the timing of preclinical and toxicology studies in HCW9302; and the Company's intellectual property applications which are subject to approval. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to the Company's initial public offering filed with the Securities and Exchange Commission (the "SEC") on July 21, 2021 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

    Company Contact:



    Rebecca Byam

    CFO

    HCW Biologics Inc.

    rebeccabyam@hcwbiologics.com
    Investor Relations Contact:



    Maureen McEnroe, CFA

    Executive Vice President

    Tiberend Strategic Advisors, Inc.

    Media Relations Contact:



    Dave Schemelia

    Senior Vice President

    Tiberend Strategic Advisors, Inc.



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