{"success":true,"data":{"pressRelease":{"id":"133993","rtpr_id":"nGNXPHYLl","ticker":"HCWB","exchange":"NASDAQ","all_tickers":["HCWB"],"title":"HCW Biologics Strengthens U.S. Patent Estate for Its Lead Clinical-Stage Immunotherapeutic HCW9302 as Alopecia Areata Treatment","author":"Globe Newswire","published_at":"2026-09-02T13:00:00.925Z","article_body":"HCW9302 is a best-in-class IL-2-based immunotherapeutic for treatment of\nautoimmune diseases through expanding and activating regulatory T cells\n\nPatent allowance received for use of HCW9302 as treatment for alopecia areata\n\nPhase 1 dose-escalating clinical study evaluating HCW9302 as monotherapy in\npatients with alopecia areata on track for completion in Q4 2026, continues to\nbe well tolerated with no dose-limiting toxicities\n\nPreliminary readout of first two dose cohorts is encouraging -- patients\ndiagnosed with alopecia areata show positive response after single dose of\nmonotherapy at 3 micrograms/kg dose level\n\nMIRAMAR, Fla., Sept. 02, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the\n“Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based\nclinical-stage biopharmaceutical company focused on developing novel fusion\nimmunotherapeutics to treat autoimmune diseases, cancer, and\nsenescence-associated dysplasia, announced receipt of a Notice of Allowance\nfrom the U.S. Patent and Trademark Office (“USPTO”) for claims directed to\nuse of HCW9302 to treat alopecia areata (U.S. Patent Application Publication\nNo. US2026/0139043).\n\nTogether with four other recently issued patents (U.S. Patent No. 11,401,326,\nU.S. Patent No. 11,987,619, U.S. Patent No.12,018,071, U.S. Patent No.\n12,516,112) with claims for broad compositions, nucleic acids encoding for\nHCW9302 and the vectors comprising these, and method of treating other\nautoimmune diseases, the underlying U.S. patent estate has been further\nstrengthened for the protection of the Company’s intellectual property\nrelated to further development and potential commercialization of HCW9302, a\nbest-in-class IL-2-based immunotherapeutic for the treatment of autoimmune\ndiseases. The Company continues to extend protection of its broad rights for\ntreatments for all indications with respect to HCW9302 built on the foundation\nof its worldwide, perpetual, fully paid-up, royalty-free, exclusive license\nrights for this compound.    \n\nDr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated,\n“Our lead clinical product candidate HCW9302 exhibits a strong IL-2Rα bias,\na unique and novel mechanism of action, while preferentially expanding and\nstimulating T(reg) cells to reduce pro-inflammatory and autoimmune responses\nin relevant animal models, including alopecia areata, atherosclerosis, and\natopic dermatitis. This strong IL-2Rα bias differentiates HCW9302 from native\nrecombinant IL-2 and other IL-2-based muteins and PEG conjugates, which\ntypically exhibit reduced binding activity to IL-2Rα components. In addition,\nHCW9302 is comprised of all human-derived components and can be produced with\na cost-effective, streamlined process similar to therapeutic monoclonal\nantibodies. Ongoing clinical activity for alopecia areata patients continues\nto be encouraging. With exceptionally strong intellectual property protection\nin place, we are vigorously pursuing alopecia areata as our lead indication of\nHCW9302. We are on track to provide the full Phase 1 readout of the current\ntrial in Q4 2026 (ClinicalTrials.gov ID: NCT07049328\n(https://www.globenewswire.com/Tracker?data=l95eBaMDU8tqDwgHajPReFWK-TucgyQ23Hic4srLgkwU4PqAQUJJIqsntgu1mWRMTxmJTR2TlUe6qLcHUkCBQD4FXgxzdqitd1C7B9U4WgmxlAwmoUPRg88ERZpohwUVA3r1z0fswspKc63fIJa4Sg==)).”    \n\nAbout HCW Biologics:\n\nHCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage\nbiopharmaceutical company developing transformative fusion immunotherapeutics\nto treat diseases promoted by chronic inflammation, including autoimmune\ndiseases, cancer, and senescence-associated dysplasia. HCW Biologics is the\nleader in creation of multi-valent immunotherapeutics with a unique\nprotein-based scaffold, without the antibody Fc domain. The Company’s\nimmunotherapeutics represent a new class of drugs that it believes have the\npotential to fundamentally change the treatment of proinflammatory and\nsenescence-associated diseases and conditions that are promoted by chronic\ninflammation —and in doing so, improve patients’ quality of life and\npossibly extend longevity. A key aspect of the Company’s clinical\ndevelopment and financing strategy is to focus on its business development\nprograms, including its commercial-ready reagents to be used in the production\nof immunotherapeutics for cancer and infectious diseases. To date, the Company\nhas entered into two licensing agreements in which it has licensed exclusive,\nworldwide rights for some of its proprietary molecules. See the Company\nPipeline at https://hcwbiologics.com/pipeline/\n\nForward Looking Statements:\n\nStatements in this press release contain “forward-looking statements” that\nare subject to substantial risks and uncertainties. These statements are made\nunder the “safe harbor” provisions of the U.S. Private Securities\nLitigation Reform Act of 1995. Forward-looking statements contained in this\npress release may be identified by the use of words such as “anticipate,”\n“expect,” “believe,” “will,” “may,” “should,”\n“estimate,” “project,” “outlook,” “forecast” or other similar\nwords and include, that a patent and/or specific alopecia treatment allowed\nclaims will issue from U.S. Patent Application Publication No. US2026/0139043;\nthe safety, ability and efficacy of HCW9302 to treat autoimmune diseases and\nother inflammatory diseases, including the efficacy of HCW9302 in the\ntreatment of alopecia areata from preliminary clinical safety data; the\nability of HCW9302 to advance to Phase 2 clinical trials; the ability of\nHCW9302 to treat other autoimmune or neurodegenerative conditions; the ability\nof HCW9302 to expand and stimulate T(reg) cells to reduce pro-inflammatory\nand autoimmune responses in relevant animal models; the completion of the full\nPhase 1 readout of the trial in Q4 2026. Further, certain forward-looking\nstatements are based on assumptions as to future events that may not prove to\nbe accurate. Factors that could cause actual results to differ include, but\nare not limited to, the risks and uncertainties that are described in the\nsection titled “Risk Factors” in the annual report on Form 10-K filed with\nthe United States Securities and Exchange Commission (the “SEC”) on March\n31, 2026, the quarterly report on Form 10-Q filed with the SEC on August 14,\n2026, and in other filings filed from time to time with the SEC.\n\nCompany Contact:\nDr. Peter Rhode\nChief Scientific Officer and Vice President of Clinical Operations\nHCW Biologics Inc.\nPeterRhode@HCWBiologics.com\n\nThis press release was published by a CLEAR® Verified individual.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5689edc3-6997-43a0-a20c-b34dc5f99b0f)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXPHYLl","title":"HCW Biologics Strengthens U.S. Patent Estate for Its Lead Clinical-Stage Immunotherapeutic HCW9302 as Alopecia Areata Treatment","author":"Globe Newswire","ticker":"HCWB","created":"2026-09-02T13:00:00.925Z","tickers":["HCWB"],"exchange":"NASDAQ","article_body":"HCW9302 is a best-in-class IL-2-based immunotherapeutic for treatment of\nautoimmune diseases through expanding and activating regulatory T cells\n\nPatent allowance received for use of HCW9302 as treatment for alopecia areata\n\nPhase 1 dose-escalating clinical study evaluating HCW9302 as monotherapy in\npatients with alopecia areata on track for completion in Q4 2026, continues to\nbe well tolerated with no dose-limiting toxicities\n\nPreliminary readout of first two dose cohorts is encouraging -- patients\ndiagnosed with alopecia areata show positive response after single dose of\nmonotherapy at 3 micrograms/kg dose level\n\nMIRAMAR, Fla., Sept. 02, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the\n“Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based\nclinical-stage biopharmaceutical company focused on developing novel fusion\nimmunotherapeutics to treat autoimmune diseases, cancer, and\nsenescence-associated dysplasia, announced receipt of a Notice of Allowance\nfrom the U.S. Patent and Trademark Office (“USPTO”) for claims directed to\nuse of HCW9302 to treat alopecia areata (U.S. Patent Application Publication\nNo. US2026/0139043).\n\nTogether with four other recently issued patents (U.S. Patent No. 11,401,326,\nU.S. Patent No. 11,987,619, U.S. Patent No.12,018,071, U.S. Patent No.\n12,516,112) with claims for broad compositions, nucleic acids encoding for\nHCW9302 and the vectors comprising these, and method of treating other\nautoimmune diseases, the underlying U.S. patent estate has been further\nstrengthened for the protection of the Company’s intellectual property\nrelated to further development and potential commercialization of HCW9302, a\nbest-in-class IL-2-based immunotherapeutic for the treatment of autoimmune\ndiseases. The Company continues to extend protection of its broad rights for\ntreatments for all indications with respect to HCW9302 built on the foundation\nof its worldwide, perpetual, fully paid-up, royalty-free, exclusive license\nrights for this compound.    \n\nDr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated,\n“Our lead clinical product candidate HCW9302 exhibits a strong IL-2Rα bias,\na unique and novel mechanism of action, while preferentially expanding and\nstimulating T(reg) cells to reduce pro-inflammatory and autoimmune responses\nin relevant animal models, including alopecia areata, atherosclerosis, and\natopic dermatitis. This strong IL-2Rα bias differentiates HCW9302 from native\nrecombinant IL-2 and other IL-2-based muteins and PEG conjugates, which\ntypically exhibit reduced binding activity to IL-2Rα components. In addition,\nHCW9302 is comprised of all human-derived components and can be produced with\na cost-effective, streamlined process similar to therapeutic monoclonal\nantibodies. Ongoing clinical activity for alopecia areata patients continues\nto be encouraging. With exceptionally strong intellectual property protection\nin place, we are vigorously pursuing alopecia areata as our lead indication of\nHCW9302. We are on track to provide the full Phase 1 readout of the current\ntrial in Q4 2026 (ClinicalTrials.gov ID: NCT07049328\n(https://www.globenewswire.com/Tracker?data=l95eBaMDU8tqDwgHajPReFWK-TucgyQ23Hic4srLgkwU4PqAQUJJIqsntgu1mWRMTxmJTR2TlUe6qLcHUkCBQD4FXgxzdqitd1C7B9U4WgmxlAwmoUPRg88ERZpohwUVA3r1z0fswspKc63fIJa4Sg==)).”    \n\nAbout HCW Biologics:\n\nHCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage\nbiopharmaceutical company developing transformative fusion immunotherapeutics\nto treat diseases promoted by chronic inflammation, including autoimmune\ndiseases, cancer, and senescence-associated dysplasia. HCW Biologics is the\nleader in creation of multi-valent immunotherapeutics with a unique\nprotein-based scaffold, without the antibody Fc domain. The Company’s\nimmunotherapeutics represent a new class of drugs that it believes have the\npotential to fundamentally change the treatment of proinflammatory and\nsenescence-associated diseases and conditions that are promoted by chronic\ninflammation —and in doing so, improve patients’ quality of life and\npossibly extend longevity. A key aspect of the Company’s clinical\ndevelopment and financing strategy is to focus on its business development\nprograms, including its commercial-ready reagents to be used in the production\nof immunotherapeutics for cancer and infectious diseases. To date, the Company\nhas entered into two licensing agreements in which it has licensed exclusive,\nworldwide rights for some of its proprietary molecules. See the Company\nPipeline at https://hcwbiologics.com/pipeline/\n\nForward Looking Statements:\n\nStatements in this press release contain “forward-looking statements” that\nare subject to substantial risks and uncertainties. These statements are made\nunder the “safe harbor” provisions of the U.S. Private Securities\nLitigation Reform Act of 1995. Forward-looking statements contained in this\npress release may be identified by the use of words such as “anticipate,”\n“expect,” “believe,” “will,” “may,” “should,”\n“estimate,” “project,” “outlook,” “forecast” or other similar\nwords and include, that a patent and/or specific alopecia treatment allowed\nclaims will issue from U.S. Patent Application Publication No. US2026/0139043;\nthe safety, ability and efficacy of HCW9302 to treat autoimmune diseases and\nother inflammatory diseases, including the efficacy of HCW9302 in the\ntreatment of alopecia areata from preliminary clinical safety data; the\nability of HCW9302 to advance to Phase 2 clinical trials; the ability of\nHCW9302 to treat other autoimmune or neurodegenerative conditions; the ability\nof HCW9302 to expand and stimulate T(reg) cells to reduce pro-inflammatory\nand autoimmune responses in relevant animal models; the completion of the full\nPhase 1 readout of the trial in Q4 2026. Further, certain forward-looking\nstatements are based on assumptions as to future events that may not prove to\nbe accurate. Factors that could cause actual results to differ include, but\nare not limited to, the risks and uncertainties that are described in the\nsection titled “Risk Factors” in the annual report on Form 10-K filed with\nthe United States Securities and Exchange Commission (the “SEC”) on March\n31, 2026, the quarterly report on Form 10-Q filed with the SEC on August 14,\n2026, and in other filings filed from time to time with the SEC.\n\nCompany Contact:\nDr. Peter Rhode\nChief Scientific Officer and Vice President of Clinical Operations\nHCW Biologics Inc.\nPeterRhode@HCWBiologics.com\n\nThis press release was published by a CLEAR® Verified individual.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5689edc3-6997-43a0-a20c-b34dc5f99b0f)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-02T13:00:00.976159161Z","server_sent_at_ms":1788354000976},"received_at":"2026-09-02T13:00:01.061Z","source_url":"https://www.globenewswire.com/news-release/2026/09/02/3355195/0/en/hcw-biologics-strengthens-u-s-patent-estate-for-its-lead-clinical-stage-immunotherapeutic-hcw9302-as-alopecia-areata-treatment.html"},"analysis":{"id":"122888","press_release_id":"133993","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Preliminary readout limited to first two dose cohorts; patient numbers and response durability not disclosed","Notice of Allowance precedes formal issuance — allowed claims must still issue as a granted patent","Pre-revenue clinical-stage company; development and financing risks flagged in forward-looking statements"],"eventType":"operations_update","narrative":"HCW Biologics received a Notice of Allowance from the USPTO for claims directed to use of HCW9302, its lead IL-2-based immunotherapeutic, as a treatment for alopecia areata.\n\nThe Phase 1 dose-escalation study of HCW9302 monotherapy in alopecia areata patients remains on track for completion in Q4 2026 and has continued to be well tolerated, with no dose-limiting toxicities reported.\n\nPreliminary results from the first two dose cohorts are encouraging: diagnosed patients showed a positive response after a single dose of monotherapy at the 3 micrograms/kg dose level.\n\nTogether with four recently issued U.S. patents, the allowance strengthens the IP estate behind the company's push to make alopecia areata the lead indication for HCW9302, with the full Phase 1 readout (NCT07049328) expected in Q4 2026.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Lead-asset IP lock-in plus early positive Phase 1 signal in alopecia areata — the real catalyst is the full Phase 1 readout due Q4 2026."},"keyFigures":{"drugName":"HCW9302","phaseOfTrial":"Phase 1","customDimensions":{"dose_level":"3 micrograms/kg","safety_note":"continues to be well tolerated with no dose-limiting toxicities","clinicaltrials_gov_id":"NCT07049328","patent_publication_no":"US2026/0139043","phase1_completion_target":"Q4 2026","recently_issued_us_patents":["11,401,326","11,987,619","12,018,071","12,516,112"]}},"quotedText":"Ongoing clinical activity for alopecia areata patients continues\nto be encouraging. With exceptionally strong intellectual property protection\nin place, we are vigorously pursuing alopecia areata as our lead indication of\nHCW9302.","namedEntities":{"people":[{"name":"Dr. Hing C. Wong","role":"Founder and Chief Executive Officer"},{"name":"Dr. Peter Rhode","role":"Chief Scientific Officer and Vice President of Clinical Operations"}],"products":["HCW9302"],"companies":[{"name":"HCW Biologics Inc.","ticker":"HCWB","relationship":"filer"},{"name":"U.S. Patent and Trademark Office (USPTO)","relationship":"patent authority"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"USPTO patent allowance for the lead asset's lead indication, paired with encouraging preliminary Phase 1 data (positive response after single dose, no dose-limiting toxicities). Meaningful for a clinical-stage micro-cap, but data is preliminary (first two dose cohorts only) and the patent has not yet formally issued."},"tickerRelevance":{"others":[],"primary":"HCWB"},"globalImportance":16,"audienceRelevance":12,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"micro-cap","dataMaturity":"preliminary, two dose cohorts only","eventGravity":"patent allowance plus preliminary Phase 1 data","sectorWeight":"clinical-stage biotech","issuerAuthored":true,"householdBrandBoost":0,"retailFavoriteBoost":0}},"event_type":"operations_update","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"HCW Biologics received a Notice of Allowance from the USPTO for claims directed to use of HCW9302, its lead IL-2-based immunotherapeutic, as a treatment for alopecia areata.\n\nThe Phase 1 dose-escalation study of HCW9302 monotherapy in alopecia areata patients remains on track for completion in Q4 2026 and has continued to be well tolerated, with no dose-limiting toxicities reported.\n\nPreliminary results from the first two dose cohorts are encouraging: diagnosed patients showed a positive response after a single dose of monotherapy at the 3 micrograms/kg dose level.\n\nTogether with four recently issued U.S. patents, the allowance strengthens the IP estate behind the company's push to make alopecia areata the lead indication for HCW9302, with the full Phase 1 readout (NCT07049328) expected in Q4 2026.","key_figures":{"drugName":"HCW9302","phaseOfTrial":"Phase 1","customDimensions":{"dose_level":"3 micrograms/kg","safety_note":"continues to be well tolerated with no dose-limiting toxicities","clinicaltrials_gov_id":"NCT07049328","patent_publication_no":"US2026/0139043","phase1_completion_target":"Q4 2026","recently_issued_us_patents":["11,401,326","11,987,619","12,018,071","12,516,112"]}},"named_entities":{"people":[{"name":"Dr. Hing C. Wong","role":"Founder and Chief Executive Officer"},{"name":"Dr. Peter Rhode","role":"Chief Scientific Officer and Vice President of Clinical Operations"}],"products":["HCW9302"],"companies":[{"name":"HCW Biologics Inc.","ticker":"HCWB","relationship":"filer"},{"name":"U.S. Patent and Trademark Office (USPTO)","relationship":"patent authority"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-02T16:11:45.985Z","global_importance":16,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","dataMaturity":"preliminary, two dose cohorts only","eventGravity":"patent allowance plus preliminary Phase 1 data","sectorWeight":"clinical-stage biotech","issuerAuthored":true,"householdBrandBoost":0,"retailFavoriteBoost":0}},"durationMs":247199,"modelName":"glm-4.7"}}