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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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Date of Report (Date of earliest event reported): June 05, 2025 |
HCW Biologics Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-40591 |
82-5024477 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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2929 N. Commerce Parkway |
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Miramar, Florida |
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33025 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 954 842-2024 |
(Former Name or Former Address, if Changed Since Last Report)
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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share |
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HCWB |
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The Nasdaq Stock Market LLC |
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 8.01 Other Events.
Nasdaq Continued Listing Requirements As previously disclosed, HCW Biologics Inc. (the “Company” or “HCW Biologics”) was notified by the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that it was not in compliance with Nasdaq Listing Rules for The Nasdaq Global Market tier, as set forth in Listing Rules 5450(a)(1), 5450(b)(2)(A) and 5450(b)(2&3)(C), the minimum bid price (“Bid Price”), the market value of publicly held securities (“MVPHS”) and the market value of listed securities (“MVLS”) rules, respectively. As a result of the extension and a clarifying amendment that the Company received on April 8, 2025, the Panel granted the Company’s request for continued listing on the Exchange on The Nasdaq Capital Market, provided that the Company demonstrates compliance with the Bid Price Rule by April 28, 2025, and all other Exchange continued listing rules by June 16, 2025. By letter dated May 13, 2025, Nasdaq notified the Company that it had evidenced compliance with the Bid Price Rule and the MVPHS Rule requirements for continued listing on The Nasdaq Capital Market. On May 7, 2025, the Company completed the conversion of $6.6 million of its outstanding principal of certain secured notes into shares of the Company’s common stock, warrants to purchase additional shares of the Company’s common stock, and a portion of the Company’s shares of Wugen common stock (the “Senior Note Conversion”). On May 15, 2025, the Company closed an equity financing with gross proceeds of $5.0 million (the “Offering”). On May 29, 2025, WY Biotech Co., Ltd. (“WY Biotech”) sent the Company notification that it completed its due diligence related to HCW Biologics’ report on the characterization of the licensed molecule which the Company delivered on May 13, 2025. This was the Company’s sole deliverable to complete its performance obligation under the terms of the worldwide exclusive license agreement, as amended, between the Company and WY Biotech (the “WY Agreement”). In addition, WY Biotech confirmed its commitment to proceed with the development and commercialization of the licensed molecule, HCW11-006. As a result, the WY Agreement is now fully binding and HCW Biologics has earned the $7.0 million upfront license fee under the terms of the WY Agreement. As a result of the transactions described above, the Company believes that, as of the date of the filing of this Current Report on Form 8-K, the Company has in excess of $2.5 million in stockholders’ equity. for continued listing on The Nasdaq Capital Market (an alternative standard to the MVLS Rule). As of the date of this Current Report on Form 8-K, the Company believes it is currently in full compliance with all continued listing requirements for the Nasdaq Capital Markets. The Company awaits Nasdaq’s formal confirmation that it has evidenced compliance with all applicable criteria for continued listing on The Nasdaq Capital Market and will provide an update upon receipt of such determination. Supplemental Information On April 1, 2025, the Company filed a Form 8-K in which it disclosed the results of its Special Meeting of Stockholders (the “Special Meeting”), at which the stockholders approved three proposals, including (1) a reverse stock split, (2) use of up to $40.0 million in an equity lines of credit, and (3) the principal terms for the conversion of at least $6.6 million of Secured Notes. On April 11, 2025, a 1-for-40 reverse stock split was effective. On April 16, 2025, a registration statement registering the underlying shares of the equity line of credit was declared effective by the SEC. On May 7, 2025, the holders of $6.6 million of the outstanding principal of the Secured Notes converted their holdings under the principal terms for conversion approved by the Company’s stockholders. On May 13, 2025, the Company issued a press release announcing the pricing of the Offering. On May 15, 2025, the Company filed a Form 8-K disclosing the closing of the Offering. On May 30, 2025, the Company and Wugen, Inc. signed an agreement suspending the Wugen License Agreement for 12 months, providing relief to Wugen from its obligations related to clinical due diligence and the funding of $250,000 per year for product development support. On June 4, 2025, the Company issued a press release announcing the formal acceptance of the technical report by WY Biotech and recognition of $7.0 million in revenue for the upfront license fee. A copy of each such press release is attached as Exhibit 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference herein.
Cautionary Note Regarding Forward-looking Statements
This Current Report on Form 8-K contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this Current Report on Form 8-K, including statements that express the Company’s intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about the Company’s business, industry and other conditions affecting its financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties, including those risks and uncertainties described in the filings the Company makes with the SEC. Any forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this Current Report on Form 8-K, except as required by applicable law. Investors should evaluate any statements made by the Company in light of these important factors.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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 hereunto duly authorized.
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HCW BIOLOGICS INC. |
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Date: |
June 5, 2025 |
By: |
/s/ Hing C. Wong |
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Founder and Chief Executive Officer |
EX-99.1
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hcwb-ex99_1.htm
EX-99.1
EX-99.1
Exhibit 99.1
HCW Biologics Announces Pricing of $5.0 Million Follow-On Offering Priced At-The-Market Under NASDAQ Rules
MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company”), (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 announced the pricing of its follow-on offering of an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit consists of one share of common stock (or pre-funded warrant in lieu thereof) and two warrants, each to purchase one share of common stock. The warrants will have an exercise price of $7.45 per share, will be exercisable immediately upon issuance, and will expire on the five-year anniversary of the original issuance date. The shares of common stock (or pre-funded warrants) and the warrants comprising the units are immediately separable and will be issued separately in this offering. The closing of the offering is expected to occur on or about May 15, 2025, subject to the satisfaction of customary closing conditions.
Maxim Group LLC is acting as the sole placement agent for the offering.
The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5.0 million. The Company intends to use the net proceeds from this offering for funding preclinical and clinical development, including the clinical trials for HCW9302, business development and identifying compounds for out-licensing, collaborations, patent portfolio expansion, research and development, and general corporate purposes.
In addition, the Company has entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 167,925 shares of common stock (the “Existing Warrants”) to reduce the exercise price of such Existing Warrants from $41.20 per share to $7.45 per share.
The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-287136), which was declared effective by the Securities and Exchange Commission (the “SEC”) on May 13, 2025. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at www.sec.gov and may also be obtained by contacting Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention:
Prospectus Department, or by telephone at (212) 895-3745 or by email at syndicate@maximgrp.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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.
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 statements on the closing of the offering and the satisfaction of closing conditions and use of proceeds in the offering, the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; the capabilities of the Company’s new platform and the effectiveness of new fusion proteins developed using the new platform.
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
EX-99.2
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hcwb-ex99_2.htm
EX-99.2
EX-99.2
Exhibit 99.2
HCW Biologics Completes Deliverable and Solidifies License Agreement with WY Biotech
HCW Biologics earned upfront payment and will recognize revenue of $7.0 million in Q2 2025
MIRAMAR, Fla., June 4, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, and WY Biotech Co., Ltd., a China-based company specializing in the early-stage development of recombinant protein drugs and gene/cell therapies, announced today that WY Biotech has completed its due diligence related to HCWB’s technology transfer report, including the characterization of the cell line, delivered on May 13, 2025. In addition, WY Biotech confirmed its commitment to proceed with the development and commercialization of the licensed molecule, HCW11-006, for in vivo therapeutic applications. The Agreement is now fully binding and HCW Biologics has earned the $7.0 million upfront license fee under the terms of the Agreement, as amended.
In addition to the $7.0 million upfront payment, HCWB is eligible to receive additional significant development milestone payments and double-digit royalties on future product sales. Furthermore, HCWB will share a substantial portion of the proceeds from a future transaction(s) involving the molecule, if such a transaction occurs. HCWB also has a payment-free, milestone-free, and royalty-free option to recapture the development and commercialization rights of this molecule for the United States, Canada, Central America, and South America (Opt-in Territory) after the conclusion of the Phase 1 clinical trial. WY Biotech is financially responsible for all costs associated with research and development, manufacturing, clinical development, regulatory approval, and commercialization for the molecule. HCWB will be responsible for costs associated with clinical development, regulatory approval, and commercialization in the Opt-in Territory, if HCWB exercises its opt-in rights. Both companies will work cooperatively in the development stage with a global focus for clinical development and partnering.
Dr. Hing C. Wong, Founder and Chief Executive Officer of HCW Biologics, stated, “We have a strategic focus to establish commercialization partnerships for our novel protein and antibody therapies with innovative leaders in the immunotherapy field. HCW11-006, the product candidate subject to the license with WY Biotech, combines several different immune functional domains on HCW Biologics’ TRBC drug discovery and development platform as part of a group of compounds characterized as Multi-Functional Immune Cell Stimulators. Preclinical studies demonstrated that HCW11-006 is highly effective at inducing anti-tumor CD8+ T cell and NK cell responses without triggering unwanted side effects in relevant solid tumor animal models.”
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 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 a versatile scaffold that 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 HCW11-040. 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/
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 potential for a future transaction and sharing proceeds therefrom; the ability for HCWB to recapture and commercialize rights in certain territories; the ability of HCW11-006 to induce anti-tumor CD8+ T cell and NK cell responses; . 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, the latest Form 10-Q filed with the SEC on May 15, 2025 and in other filings filed from time to time with the SEC.
Company Contact:
Lee Flowers
Senior Vice President, Business Development
HCW Biologics Inc.
LeeFlowers@HCWBiologics.com
