UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40591 HCW Biologics Inc. (Exact name of registrant as specified in its Charter) Securities registered pursuant to Section 12(b) of th ...

Miramar, FL – April 1, 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 fourth quarter and fiscal year ended December 31, 2023. Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, "These are exciting times at ...

Financial Performance - Revenues for the three months ended September 30, 2023, were $853,102, a decrease of 53% from $1.8 million in the same period of 2022[86]. - The net loss for the three months ended September 30, 2023, was $4,938,641, compared to a net loss of $3,914,194 in Q3 2022[85]. - Cash used in operating activities increased from $6.6 million in 2022 to $18.6 million in 2023, reflecting a net loss of $14.3 million in 2023[121][123]. - Cash provided by investing activities decreased from $14.8 million in 2022 to $7.5 million in 2023, with $10.0 million from short-term investments maturing in 2023[124][125]. - Cash provided by financing activities dropped significantly from $6.3 million in 2022 to $716 in 2023, primarily due to the repayment of principal under the 2022 Loan Agreement[126]. - The net increase in cash and cash equivalents turned negative, decreasing from $14.5 million in 2022 to a decrease of $11.1 million in 2023[121]. - As of September 30, 2023, the company had cash and cash equivalents of $11.2 million and a deposit for interest reserve of $5.3 million[131]. - The company believes its cash and cash equivalents will be sufficient to meet capital requirements for at least the next 12 months[119]. Research and Development - In a Phase 1 clinical trial of HCW9218, 50% of patients evaluated showed stable disease lasting over 6 months, with 66% of ovarian cancer patients demonstrating similar results[69]. - HCW9218 significantly reduced blood levels of TGF-β in cancer patients in a dose-dependent manner, promoting NK and T cell proliferation without causing cytokine release syndrome[69]. - The company plans to submit an Investigational New Drug application for HCW9302 in the fourth quarter of 2023, targeting autoimmune diseases[67]. - HCW9218 is designed to enhance the effectiveness of chemotherapy and immune checkpoint inhibitors by addressing exhausted T cells and reducing immunosuppressive factors[64][65]. - The company anticipates completing the Phase 1b portion of the pancreatic cancer study in late 2023 or early 2024, with a human data readout expected in the first half of 2024[92]. - The company expects research and development expenses to increase substantially in the foreseeable future as product candidates continue to be developed[77]. Expenses and Costs - Research and development expenses decreased by $981,352, or 37%, from $2.6 million for the three months ended September 30, 2022, to $1.7 million for the same period in 2023[88]. - Manufacturing and materials expenses decreased by $545,795, or 73%, from $751,945 in Q3 2022 to $206,150 in Q3 2023[89]. - General and administrative expenses increased by $1.9 million, or 107%, from $1.7 million for the three months ended September 30, 2022, to $3.6 million for the same period in 2023[94]. - Clinical trial expenses increased by $51,545, or 18%, from $292,276 in Q3 2022 to $343,821 in Q3 2023[91]. - Total operating expenses for the three months ended September 30, 2023, were $5,252,657, an increase from $4,381,460 in the same period of 2022[85]. - General and administrative expenses increased by $4.4 million, or 83%, from $5.3 million for the nine months ended September 30, 2022, to $9.7 million for the same period in 2023[107]. - Research and development expenses decreased by $868,434, or 14%, from $6.4 million for the nine months ended September 30, 2022, to $5.5 million for the same period in 2023[102]. - Clinical trial expenses increased by $301,124, or 62%, from $486,992 for the nine months ended September 30, 2022, to $788,116 for the same period in 2023[106]. Legal and Regulatory Matters - Legal expenses related to ongoing litigation are expected to continue to incur material costs through the end of 2023 and into 2024[80]. - The company continues to assess the impact of ongoing clinical trials and regulatory reviews on its financial performance[122]. Capital and Financing - The company expects to draw down funds under the 2023 Loan Agreement, with a maximum loan amount of $26.3 million, primarily for the renovation of its new headquarters and repayment of previous borrowings[73]. - The 2023 Loan Agreement allows the company to draw up to $26.3 million, with funds expected to be drawn over the next ten months[116]. - The company intends to raise capital through additional debt or equity financings and is focused on business development transactions[114]. - The company purchased a 36,000 square foot building for approximately $10.1 million, funded partially by a $6.5 million loan[115]. Market and Operational Challenges - The company has been impacted by inflationary pressures and global supply chain disruptions, employing strategies like product redesign and alternate sourcing to navigate these challenges[70]. - The company is exposed to market risk related to interest rate sensitivity and the marketability of its common stock[131]. Intellectual Property - The company was granted two patents in August 2023 related to methods for promoting the activation and proliferation of NK and T cells[73]. - The company has retained manufacturing rights and will provide Wugen with clinical and research grade materials for the development of licensed products[72]. Product Development - HCW9218 has shown potential to convert 'cold' tumors into 'hot' tumors, indicating its utility in combination with standard-of-care anti-cancer therapies[63].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited interim financial statements for June 30, 2023, show total assets decreased to **$39.5 million**, net loss widened to **$9.4 million**, and cash used in operations increased to **$13.0 million** Condensed Balance Sheet Summary (Unaudited) | Metric | Dec 31, 2022 | June 30, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,326,356 | $7,449,010 | | Total current assets | $34,070,919 | $19,799,166 | | Total assets | $46,809,155 | $39,483,244 | | Total current liabilities | $2,956,481 | $4,537,898 | | Total liabilities | $9,380,649 | $10,897,602 | | Total stockholders' equity | $37,428,506 | $28,585,642 | Condensed Statements of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net revenues | $166,800 | $120,405 | $1,956,269 | $132,938 | | Research and development | $1,969,882 | $1,616,666 | $3,759,558 | $3,872,479 | | General and administrative | $1,707,995 | $3,014,260 | $3,588,597 | $6,131,550 | | Net loss | $(3,510,561) | $(4,304,420) | $(5,567,768) | $(9,375,106) | | Net loss per share | $(0.10) | $(0.12) | $(0.16) | $(0.26) | Condensed Statements of Cash Flows Summary (Unaudited) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,281,998) | $(13,030,059) | | Net cash provided by (used in) investing activities | $7,963,379 | $(1,856,900) | | Net cash provided by financing activities | $8,273 | $9,613 | | Net changes in cash and cash equivalents | $3,689,654 | $(14,877,346) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes revenue decline to Wugen's clinical plan changes, with operating expenses rising due to **467% higher professional services** from legal fees, while a **$26.3 million credit line** supports new headquarters - The company is a clinical-stage biopharmaceutical firm focused on immunotherapies for age-related diseases by targeting chronic inflammation ('inflammaging'), with lead candidates HCW9218 (Phase 1/1b trials for solid tumors) and HCW9302 (preclinical, for autoimmune diseases)[63](index=63&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - Recent developments include dosing the first patient in the expansion phase of the HCW9218 UMN study, securing a **$26.3 million line of credit** for its new headquarters, and being granted a U.S. patent for HCW9218's methods of use in treating various cancers[67](index=67&type=chunk) Comparison of R&D Expenses (Three Months Ended June 30) | Category | 2022 | 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Manufacturing and materials | $304,329 | $100,387 | $(203,942) | (67)% | | Preclinical expenses | $599,520 | $323,695 | $(275,825) | (46)% | | Clinical trials | $83,939 | $197,936 | $113,997 | 136% | | **Total R&D expenses** | **$1,969,882** | **$1,616,666** | **$(353,216)** | **(18)%** | Comparison of G&A Expenses (Three Months Ended June 30) | Category | 2022 | 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Professional services | $287,199 | $1,628,214 | $1,341,015 | 467% | | **Total G&A expenses** | **$1,707,995** | **$3,014,260** | **$1,306,265** | **76%** | - The significant increase in professional services costs is primarily due to incurring **$1.2 million in legal fees** during Q2 2023 related to the Altor/NantCell legal matter[94](index=94&type=chunk) - The company's liquidity as of June 30, 2023, consisted of **$7.4 million in cash**, a **$5.3 million interest reserve deposit**, and **$10.0 million in short-term U.S. government-backed securities**, with a new **$26.3 million credit line** secured in April 2023 to fund its new headquarters[107](index=107&type=chunk)[109](index=109&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks include interest rate sensitivity on cash and investments, alongside marketability risk from its illiquid Wugen common stock investment - As of June 30, 2023, the company held **$7.4 million in cash and cash equivalents**, a **$5.3 million interest reserve deposit**, and **$10.0 million in short-term U.S. government-backed securities**[123](index=123&type=chunk) - Primary market risk exposures are interest rate sensitivity and the limited liquidity of its common stock investment in Wugen, which is not publicly traded[123](index=123&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[125](index=125&type=chunk) - No changes occurred during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[126](index=126&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in an arbitration with Altor/NantCell regarding alleged trade secret misappropriation, with potential losses currently unestimable - Altor/NantCell initiated legal proceedings against the company and its CEO, Dr. Hing C. Wong, alleging claims including misappropriation of trade secrets and breach of contract[128](index=128&type=chunk) - The lawsuit against the company was dismissed from federal court and the matter is now proceeding in arbitration before JAMS, consolidated with the action against the CEO[128](index=128&type=chunk) - The company states it is not possible to reasonably estimate the potential loss or range of loss, and no accrual has been recorded[128](index=128&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from the company's 2022 Annual Report on Form 10-K - The company reports no material changes to the risk factors disclosed in its 2022 Form 10-K filed on March 28, 2023[129](index=129&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred, and the planned use of IPO proceeds remains materially unchanged - There were no unregistered sales of equity securities in the reported period[130](index=130&type=chunk) - The planned use of proceeds from the company's IPO has not materially changed from what was described in the final prospectus[132](index=132&type=chunk) [Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable - Not Applicable[133](index=133&type=chunk) [Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable - Not Applicable[134](index=134&type=chunk) [Other Information](index=28&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, amended, or terminated Rule 10b5-1 trading arrangements during the second quarter of 2023 - No directors or officers reported the adoption, amendment, or termination of a Rule 10b5-1 trading arrangement during the second quarter of 2023[135](index=135&type=chunk) [Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including the Development Line of Credit Agreement and CEO/CFO certifications - The exhibits filed with this report include the Development Line of Credit Agreement with Prime Capital Ventures, CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906, and Inline XBRL data[137](index=137&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 82-5024477 | | --- | --- | | ( Sta ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40591 HCW Biologics Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorporation or orga ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 ( State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 ( State or other jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (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.) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPO ...

Novel Immunotherapeutics for Cancer and Other Age-Related Diseases MAXIM GROUP 2022 VIRTUAL GROWTH CONFERENCE MARCH 2022 1 Forward Looking Statements Certain information contained in this presentation and statements made orally during this presentation include forward-looking statements that involve substantial risks and uncertainties. All statements included in this presentation, other than statements of historical facts, are forward-looking statements. Forward-looking statements include, without limitatio ...