Drug Development and Clinical Trials - HCW Biologics reported a focus on developing novel immunotherapies targeting age-related diseases linked to chronic inflammation, with a significant emphasis on the TOBI™ drug discovery platform[61]. - The company has manufactured quantities of four TOBI-based molecules in a cGMP manufacturing setting, indicating readiness for clinical applications[65]. - HCW9218 is a clinical-stage bifunctional molecule aimed at reducing senescent cells and their proinflammatory factors, with a Phase 2 study planned for ovarian cancer[66]. - The company has exclusive rights to develop HCW9218 for age-related diseases other than cancer, leveraging findings from Phase 1 studies completed in early 2024[67]. - HCW9302 is under FDA review for an IND application, targeting autoimmune indications, with plans to explore its utility in neurodegenerative diseases[71][72]. - The company has initiated IND-enabling activities for HCW9206, which is designed to stimulate T cell proliferation and enhance immune responses against tumors[73]. - HCW9201 is currently being evaluated in a Phase 1 clinical trial for Acute Myeloid Leukemia, with potential for further indications[74]. - A new drug discovery platform utilizing a novel protein scaffold has been developed, expanding treatment possibilities beyond the TOBI™ platform[75]. Financial Performance and Revenue - Revenues for the three months ended September 30, 2024, were $426,423, a decrease of 50% from $853,102 in the same period of 2023[101]. - Revenues for the nine months ended September 30, 2024, were $2,171,988, an increase from $1,517,792 for the same period in 2023[100]. - The principal source of revenue has been from the Wugen License and Master Services Agreement, which includes nonrefundable upfront payments and royalties[86]. - The company has not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products as of September 30, 2024[133]. Expenses and Losses - Operating expenses are primarily composed of research and development expenses and general and administrative expenses[88]. - Research and development expenses are expected to increase substantially as the Company continues to develop its product candidates[90]. - General and administrative expenses increased by $129,216, or 9%, from $1,509,936 for the three months ended September 30, 2023, to $1,639,152 for the same period in 2024[109]. - Net loss for the three months ended September 30, 2024, was $3,902,288, compared to a net loss of $14,313,746 for the same period in 2023[100]. - Total operating expenses for the three months ended September 30, 2024, were $3,775,520, compared to $15,256,684 for the same period in 2023[100]. - Legal expenses increased from $4.6 million for the nine months ended September 30, 2023, to $15.8 million for the nine months ended September 30, 2024[129]. Funding and Financial Strategy - The company signed an out-license agreement with Wugen, Inc., receiving a 5.6% ownership interest, which supports its financing strategy for clinical development[78]. - The Company has launched a new financing plan, issuing $6.9 million in Secured Notes and is authorized to issue up to $10.0 million[81]. - The Company raised $9.4 million in financing in 2024, including a $2.5 million private placement of common stock and $6.5 million from the issuance of Secured Notes[134]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $8.9 million, significantly higher than the previous year's $716[144]. - The Company continues to seek financing to complete the construction of its new headquarters, which is currently facing mechanics liens from subcontractors[134]. Operational Challenges - As of September 30, 2024, substantial doubt exists regarding the Company's ability to continue as a going concern for at least 12 months without additional funding[82]. - The Company is facing headwinds from inflation, rising interest rates, and supply chain disruptions impacting operations and costs[83]. - The Company anticipates further cost reductions or restructuring after reassessing its clinical development strategy[134]. - As of September 30, 2024, the company had $1.0 million in cash and cash equivalents, raising substantial doubt about its ability to operate for the next 12 months[133].

Exhibit 99.1 HCW Biologics Reports Third Quarter 2024 Financial Results and Business Highlights Miramar, FL– November 14, 2024 – 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, today reported financial results and recent business highlights for its third quarter ended September 30, 2024. Dr. H ...

MIRAMAR, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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, today reported financial results and recent business highlights for its third quarter ended September 30, 2024.  Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 20 ...

This release has made a correction to a release issued under the same headline on August 14, 2024, by HCW Biologics, Inc. (NASDAQ: HCWB), to show the amount included in the condensed interim balance sheet for Cash and cash equivalents as of December 31, 2023 as $3,595,101, not $95,101 as previously stated. The full text of the corrected release is as follows: MIRAMAR, Fla., Aug. 23, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceuti ...

F UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each classTrading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share HCWB The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ...

Exhibit 99.1 HCW Biologics Reports Second Quarter 2024 Financial Results and Business Highlights Miramar, FL– August 14, 2024 – 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, today reported financial results and recent business highlights for its second quarter ended June 30, 2024. Dr. Hing C ...

MIRAMAR, Fla., Aug. 14, 2024 (GLOBE NEWSWIRE) -- 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, today reported financial results and recent business highlights for its second quarter ended June 30, 2024. Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, "We reached a critical milest ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2929 N. Commerce Parkway Miramar, Florida 33025 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (954) 842–2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCH ...

Exhibit 99.1 HCW Biologics Reports First Quarter 2024 Financial Results and Business Highlights Financial Guidance Miramar, FL – May 15, 2024 – 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, today reported financial results and recent business highlights for its first quarter ended March 31, ...

He added, "With the recommended Phase 2 dose established in our early studies, we plan to expand into age- related indications in skin diseases and conditions associated with senescence. These studies will be designed as investigative studies, and we anticipate that it will be quicker to see human data read outs from this type of indication than would be possible in a cancer study. We are interested to see the aesthetic effects with the deep wrinkles and senile lentigo, perhaps as secondary endpoints." MIRA ...