HCW Biologics Inc 8-K, filed May 15, 2025
HCW Biologics Inc. (HCWB)
About this 8-K
HCW Biologics Inc filed this 8-K on May 15, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 15, 2025, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended March 31, 2025. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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HCW BIOLOGICS INC. |
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Date: |
May 15, 2025 |
By: |
/s/ Hing C. Wong |
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Hing C. Wong |
Exhibit 99.1
HCW Biologics Reports First Quarter 2025
Business Highlights and Financial Results
Miramar, FL – May 15, 2025 – HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span 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, 2025.
On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform.”
Dr. Wong explained the Company’s financing strategy, stating, “We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade.”
Business Highlights
Business Development Transactions
Financing Transactions
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Clinical Development Results
First Quarter 2025 Financial Results
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Financial Guidance
As of March 31, 2025, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had some early success in completing key elements of our multi-step financing plan, however, we cannot be assured that we will continue to have success with all of the elements of our plan.
About HCW Biologics
HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/
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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: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecule; the initiation of patient enrollment for a clinical trial to evaluate HCW9302; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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 annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025 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
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HCW Biologics Inc.
Unaudited Statements of Operations
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For the Three Months Ended |
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2024 |
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2025 |
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Revenues: |
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Revenues |
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$ |
1,126,712 |
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$ |
5,065 |
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Cost of revenues |
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(511,965 |
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(4,052 |
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Net revenues |
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614,747 |
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1,013 |
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Operating expenses: |
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Research and development |
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2,123,284 |
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1,478,711 |
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General and administrative |
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1,566,092 |
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2,227,597 |
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Legal expenses, net |
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4,419,034 |
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(1,739,493 |
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Total operating expenses |
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8,108,410 |
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1,966,815 |
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Loss from operations |
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(7,493,663 |
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(1,965,802 |
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Interest expense |
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— |
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(255,822 |
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Other income, net |
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25,602 |
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24,749 |
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Net loss |
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$ |
(7,468,061 |
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$ |
(2,196,875 |
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Net loss per share, basic and diluted |
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$ |
(0.20 |
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$ |
(0.05 |
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Weighted average shares outstanding, basic and diluted |
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37,223,588 |
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44,675,656 |
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5
HCW Biologics Inc.
Condensed Balance Sheets
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December 31, |
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March 31, |
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2024 |
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2025 |
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Unaudited |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
4,674,572 |
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$ |
1,107,613 |
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Accounts receivable, net |
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582,201 |
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87,493 |
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Prepaid expenses |
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328,181 |
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256,291 |
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Other current assets |
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113,528 |
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443,311 |
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Total current assets |
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5,698,482 |
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1,894,708 |
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Investments |
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1,599,751 |
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1,599,751 |
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Property, plant and equipment, net |
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22,909,869 |
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22,762,471 |
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Other assets |
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28,476 |
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28,476 |
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Total assets |
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$ |
30,236,578 |
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$ |
26,285,406 |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Liabilities |
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Current liabilities: |
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Accounts payable |
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$ |
22,332,261 |
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$ |
19,734,057 |
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Accrued liabilities and other current liabilities |
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981,940 |
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1,173,695 |
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Short-term debt, net |
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6,314,684 |
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6,234,338 |
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Total current liabilities |
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29,628,885 |
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27,142,090 |
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Debt, net |
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7,377,865 |
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7,705,364 |
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Total liabilities |
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37,006,750 |
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34,847,454 |
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Commitments and contingencies |
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Stockholders’ deficit: |
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Common stock: |
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Common, $0.0001 par value; 250,000,000 shares authorized |
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4,454 |
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4,493 |
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Additional paid-in capital |
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93,781,511 |
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94,186,471 |
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Accumulated deficit |
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(100,556,137 |
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(102,753,012 |
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Total stockholders’ deficit |
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(6,770,172 |
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(8,562,048 |
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Total liabilities and stockholders’ deficit |
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$ |
30,236,578 |
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$ |
26,285,406 |
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6