HCW Biologics Inc. 8-K Filings

HCW Biologics Inc. (HCWB) reported that on September 9, 2026 it filed Amendment No. 1 to its Preliminary Proxy Statement for an upcoming Special Meeting of Stockholders. After considering stockholder feedback, the board decided not to seek approval of Proposal No. 2 from the original preliminary proxy, which would have asked stockholders to approve an amended performance-based equity plan for eligible officers, directors and employees, and removed that proposal in the amendment. The amendment also changes the date of the Special Meeting, the record date for stockholders entitled to vote, and certain related dates, while making no other substantive changes to the original preliminary proxy.

HCW Biologics Inc. (HCWB) entered into an Exclusive Distribution Agreement with Akron Biotech to commercialize its commercial-ready molecule HCW11-006 as a reagent for cell therapy manufacturing and other ex vivo applications worldwide, excluding China. The agreement has a five-year term from closing, which is subject to satisfactory due diligence and product testing and is expected to close no later than November 30, 2026.

HCW Biologics and Akron plan to enter a Supply Agreement within 60 days after closing. Assuming closing occurs, HCW Biologics will receive $200,000 at closing, $100,000 within 30 days of executing the Supply Agreement, and $100,000 on each of the first and second anniversaries of closing, plus additional quarterly payments for technical support as needed. HCW Biologics also committed to continue supplying HCW11-006 to support existing Akron customers if it terminates the agreement for convenience.

HCW Biologics Inc. reported second-quarter and first-half 2026 results alongside business and clinical updates. Preliminary human data from a Phase 1 alopecia areata study of lead autoimmune candidate HCW9302 showed early signs of efficacy with ≥25% SALT score reductions in all three patients in the second dose cohort, without dose-limiting toxicities or key IL‑2–related side effects.

The company re-acquired ex vivo rights to two commercial-ready molecules from AlloTera Therapeutics and is seeking a partner to commercialize HCW9206 and related molecules as reagents for CAR‑T manufacturing. It is advancing tetravalent T‑cell engager HCW11-018b, having requested a Type B pre‑IND meeting with the FDA, targeting a first clinical trial in the first half of 2027, subject to authorization.

HCW completed $5.6 million of equity financings in May and July 2026 involving common stock, pre-funded warrants and common warrants. Revenue rose to $135,568 for the quarter and $6.7 million for the first half of 2026, driven by a licensing agreement with Trimmune. Net loss was $5.2 million for the quarter and $1.7 million for the first half, with a fair value loss on warrant liabilities partly offset by a gain on extinguishment of a liability. As of June 30, 2026, the company reported substantial doubt about its ability to continue as a going concern without additional funding. Cash and cash equivalents were $741,324, and a one-for-six reverse stock split was effected on June 30, 2026. HCW regained compliance with Nasdaq bid price and equity listing rules, with a potential one-year discretionary panel monitor if conditions are maintained through September 22, 2026.

HCW Biologics Inc. reports that its previously issued unaudited condensed financial statements for the three months ended March 31, 2026 should no longer be relied upon, due to an error in applying the two-class method for earnings per share (EPS). The company plans to file a Form 10-Q/A to restate the affected financial statements and related disclosures and to update any registration statements that include this information before they become effective.

After a reverse stock split effective June 30, 2026, the company had 904,312 weighted-average common shares outstanding and participating warrants exercisable for 524,501 shares as of March 31, 2026. EPS was reported as $2.19 per share on a post-split basis, an overstatement of $0.80 per share, because 100% of undistributed earnings were allocated to common stock instead of approximately 63.3% to common stock and 36.7% to participating securities. Management concluded this was a material misstatement of EPS and identified a material weakness in internal control over financial reporting related to technical accounting review of complex warrant instruments and financing transactions. Remediation steps include enhanced technical accounting procedures and improved coordination with legal counsel and advisors.

HCW Biologics Inc. entered into a private placement Securities Purchase Agreement with accredited investors for 618,682 units, expected to generate aggregate gross proceeds of approximately $1.6 million before expenses. Each unit consists of one share of common stock or one Pre-Funded Warrant plus the right to receive one Common Warrant, with Common Warrant issuance subject to stockholder approval under Nasdaq Listing Rule 5635(d).

The placement will include 218,682 shares of common stock and 400,000 Pre-Funded Warrants. Units with common stock are priced at $2.585 per unit, and units with a Pre-Funded Warrant at $2.5849 per unit. Pre-Funded Warrants are exercisable immediately at $0.0001 per share and remain outstanding until fully exercised, subject to a 9.99% beneficial ownership cap. Following stockholder approval, investors will receive Common Warrants to purchase up to 618,682 shares at $2.585 per share, exercisable immediately and expiring 5.5 years after issuance, with a 4.99% ownership limitation.

The financing, in which the CEO, board chairman and a senior executive are participating on the same terms, relies on Section 4(a)(2) and Rule 506(b) of Regulation D. HCW Biologics plans to file a resale registration statement on Form S-1 within 15 trading days of closing and seek effectiveness within 60 days. Net proceeds are intended to support clinical trials for HCW9302, IND-enabling studies for HCW11-018b and HCW11-040, and general corporate purposes.

HCW Biologics Inc. reports that, in the three months ending June 30, 2026, it will record the settlement and extinguishment of $2.8 million of disputed accounts payable. This primarily reflects a legal resolution and a manufacturing payables settlement.

B&I Contractors filed a Voluntary Dismissal with Prejudice of its crossclaims in litigation involving HCW Biologics and submitted a final Satisfaction of Lien, removing a mechanics’ lien of $1.1 million on the Company’s Miramar, Florida property. Separately, HCW Biologics finalized a settlement with contract manufacturer EirGenix, Inc., reducing amounts owed from $1.7 million to $1.2 million, and paying that amount in full via two installments of $620,000 each by May 26, 2026, fully satisfying those obligations.

HCW Biologics Inc. reported that a Nasdaq Hearings Panel determined the company has regained compliance with Nasdaq Listing Rule 5550(a)(2), the minimum bid price or “Bid Price Rule,” under the terms of a prior Panel decision. The company is now considered compliant with all Nasdaq continued listing standards.

The decision subjects HCW Biologics to a mandatory monitoring period through June 17, 2027, during which any new bid-price deficiency could lead directly to a delisting determination without additional cure periods. To support long-term compliance, the company will implement a one-for-six reverse stock split on June 30, 2026.

HCW Biologics Inc. is implementing a 1-for-6 reverse stock split of its common stock to help maintain compliance with Nasdaq’s minimum bid price rule and conditions set by a Nasdaq Hearings Panel. The split becomes effective at 12:01 a.m. Eastern time on June 30, 2026, with trading on a split-adjusted basis that day under the symbol HCWB.

The company’s outstanding common shares will be reduced from 9,581,079 as of June 25, 2026 to approximately 1,596,849, while authorized common shares remain at 250,000,000 and par value stays $0.0001. Fractional shares will be rounded up to the nearest whole share, so no cash will be paid for fractions and no stockholder’s overall percentage ownership is expected to change except for minor rounding effects.

All outstanding options and warrants and shares available under equity plans will be proportionately adjusted, and exercise prices will be multiplied by six. The new CUSIP number for the common stock will be 40423R303. The move follows a Nasdaq Panel decision letter requiring the stock to trade above $1.00 for a defined period and warning that any future bid-price noncompliance before September 22, 2026 could lead to automatic delisting.

HCW Biologics Inc. reported positive preliminary human data from the first two dose cohorts of its dose-escalating Phase 1 trial of HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. All three participants in the second cohort, who received a single 3 micrograms/kg subcutaneous dose, showed at least a 25% reduction in Severity of Alopecia Tool scores at four and/or nine weeks.

The treatment was well tolerated with no dose-limiting toxicities, and no reported capillary leak, cytokine release syndrome, or increased blood eosinophil counts; adverse events were mild, self-limiting, and mainly injection-site reactions. The study is designed to treat up to 30 patients and aims to define a recommended Phase 2 dose by year-end 2026, after which the company may pursue multi-dose studies in alopecia areata and other autoimmune and inflammatory dermatologic indications.

HCW Biologics Inc. reported the results of its 2026 Annual Meeting of Stockholders. Stockholders voted on five proposals, including the election of two directors. Lisa M. Giles received 1,127,580 votes for and 230,984 withheld, with 1,189,957 broker non-votes. Rick S. Greene received 1,128,039 votes for and 230,525 withheld, with the same broker non-votes. Four additional proposals each received more votes for than against, with for votes ranging from about 1.08 million to 2.54 million, indicating generally supportive voting outcomes.

HCW Biologics Inc. received a decision from a Nasdaq Hearings Panel granting more time to regain compliance with Nasdaq’s minimum bid price requirement. The company had previously fallen below the $1 per share minimum bid price under Nasdaq Listing Rule 5550(a)(2) after already completing a 1-for-40 reverse stock split on April 11, 2025.

The Panel is allowing the company to remain listed if it achieves a bid price of at least $1 per share for twenty consecutive trading days on or before July 29, 2026. The Panel indicated that if the company again becomes deficient with the bid price rule before September 22, 2026, it will be immediately delisted.

If HCW Biologics satisfies the conditions and regains compliance, the Panel intends to place the company under a Discretionary Panel Monitor for an additional one-year period, adding ongoing oversight of its listing status.

HCW Biologics Inc. terminated its exclusive worldwide license with Wugen Inc. for ex vivo rights to its HCW9206 and HCW9201 molecules and regained full ex vivo rights to both reagents. The company acquired these rights for no cost and retained the upfront license consideration, including 2.2 million shares of Wugen common stock.

HCW Biologics believes recent peer-reviewed data suggest HCW9206 may help manufacture more persistent, functional CAR-T cells and memory-like NK cells, potentially lowering production costs. The company plans to commercialize these reagents through partnerships with CAR-T and NK-cell therapy developers and manufacturers.

HCW Biologics Inc. entered into a private placement financing, selling 2,846,975 units at $1.405 per unit for aggregate gross proceeds of approximately $4.0 million. Each unit includes one share of common stock (or a pre-funded warrant) and one common warrant to buy an additional share.

At closing, the company issued 427,046 shares, 2,419,929 pre-funded warrants, and common warrants to purchase up to 2,846,975 shares of common stock. The common warrants have a $1.28 exercise price and a five-and-a-half-year term, while pre-funded warrants are exercisable at $0.0001 per share and have no expiration.

The company plans to use net proceeds to continue clinical trials for HCW9302, advance IND-enabling studies for T-cell engager HCW11-018b and immune checkpoint inhibitor HCW11-040, as well as for general corporate purposes and repayment of certain debts and settlements. Investor ownership is capped through 9.99% and 4.99% beneficial ownership limitations on warrant exercises.

HCW Biologics reported first quarter 2026 results showing a sharp swing to profitability driven by a new licensing deal. Revenue for the three months ended March 31, 2026 rose to $6.54 million from $5,065 a year earlier, largely from an exclusive worldwide license for HCW11-006 with Trimmune that generated a $3.5 million cash fee and a $3.5 million equity interest. Net income for the quarter improved to $3.47 million from a loss of $2.20 million, while net income attributable to common stockholders was $1.98 million, or $0.37 per share. Despite the stronger quarter, the company states there is “substantial doubt” about its ability to continue as a going concern over the next 12 months without additional funding, and it is appealing a Nasdaq decision to delist its shares for failing to meet the $1.00 minimum bid price requirement.

HCW Biologics Inc. reported that its April 27, 2026 Special Meeting of Stockholders was adjourned without any business because there was no quorum. The two proposals scheduled for that meeting will instead be voted on at the virtual Annual Meeting on June 15, 2026, with an April 22, 2026 record date.

The company is asking stockholders to approve warrants issued to Armistice Capital Master Fund Ltd. to purchase up to 5,497,702 shares of common stock at $0.6055 per share. Armistice has invested $17.4 million in HCW Biologics. The company is required to seek stockholder approval every 60 days until it is obtained, which means it will continue to incur costs for additional voting efforts.

HCW Biologics Inc. plans to enter two consulting agreements that will begin only if a planned public offering on Form S-1 closes. The company expects both agreements to start on or about May 1, 2026 after the financing close.

HCW Biologics agreed to engage I.R. Agency LLC as a marketing consultant for future marketing efforts, with fees of $2.5 million to be paid from the public offering proceeds. It also agreed to engage Bowery Consulting Group as a financial consultant for six months, with a $500,000 fee, also payable from the same offering proceeds.

HCW Biologics Inc. is changing its corporate rules to make it easier to conduct shareholder meetings. On April 15, 2026, the board approved a Bylaw amendment that, effective April 28, 2026, lowers the quorum needed to do business at stockholder meetings.

Going forward, holders of 33 1/3% of the voting power, present in person or by proxy, will be enough to constitute a quorum. Previously, the Bylaws required a majority of the voting power of outstanding shares entitled to vote to be present for business to proceed.

HCW Biologics Inc. reported fourth quarter and full-year 2025 results showing very limited revenue and ongoing losses alongside financing and listing pressures. Revenue was $27,010 for the quarter and $54,232 for 2025, down sharply from $2.6 million in 2024, mainly due to changes in a licensing arrangement.

The company cut operating expenses to $13.2 million in 2025 from $30.4 million in 2024, helped by a $5.5 million gain tied to resolving prior legal fees. Net loss improved to $7.96 million in 2025 from $30.0 million in 2024, but cash fell to $1.95 million as of December 31, 2025.

Management states that substantial doubt exists about the company’s ability to continue as a going concern for at least 12 months without new funding. HCW also received a new Nasdaq notice on March 26, 2026 for failing to maintain the $1 minimum bid price after a prior reverse stock split and plans to appeal. On the business side, the company initiated a Phase 1 trial of its lead autoimmune candidate HCW9302 in alopecia areata and received a $3.5 million upfront fee for licensing preclinical molecule HCW11-006, plus a minority equity stake and potential milestones and royalties.

HCW Biologics Inc. entered a material license agreement for its fusion immunotherapy candidate HCW11-006, securing an upfront license fee valued at $7.0 million. This consists of a $3.5 million cash payment and a $3.5 million in-kind payment via a transferable equity interest in its licensee, Beijing Trimmune Biotech.

Trimmune will lead development and commercialization of HCW11-006, with a Phase 1 clinical study in China expected in the first half of 2027 and will bear all trial costs. HCW Biologics remains eligible for development milestone payments, double-digit royalties on future product sales, and a share of proceeds from future transactions involving HCW11-006.

The company also negotiated a payment-, milestone-, and royalty-free option to recapture rights to HCW11-006 for in vivo use in the United States, Canada, Central America and South America after completion of the Phase 1 study in China, and granted Trimmune an option to license regional China rights to its clinical-stage molecule HCW9302.

HCW Biologics Inc. reports that a Nasdaq Hearings Panel determined on February 26, 2026 that the company has regained compliance with all continued listing rules of The Nasdaq Capital Market. This follows an earlier Panel decision that gave HCW Biologics until December 31, 2025 to meet the Equity Rule 5550(b)(1) and until February 16, 2026 to satisfy all other listing standards.

The company will remain under a one-year Mandatory Panel Monitor starting January 7, 2026. If it again falls out of compliance with the Equity Rule during this period, Nasdaq staff must issue a delist determination without providing any cure or additional compliance period, though the company could request a new hearing. Management highlighted that maintaining compliance supports ongoing access to public capital markets to fund its clinical-stage immunotherapy programs.

HCW Biologics Inc. entered into a follow-on public offering of 2,477,292 units at $0.6055 per unit, raising approximately $1.5 million in gross proceeds. Each unit includes one share of common stock or a pre-funded warrant plus one common stock warrant.

The common stock warrants carry a $0.6055 exercise price, become exercisable only after stockholder approval under Nasdaq rules, and expire five years after that approval. Pre-funded warrants are exercisable immediately at $0.0001 per share and remain outstanding until fully exercised.

The company also agreed, subject to stockholder approval, to reduce the exercise price of existing warrants to purchase up to 3,020,410 shares from $2.41 to $0.6055 per share. Net proceeds are intended for preclinical and clinical development, including trials for lead candidate HCW9302, and for general corporate purposes.

HCW Biologics Inc. entered into an exclusive worldwide license agreement with WY Biotech’s newly formed joint venture, Beijing Trimmune Biotech, for certain in vivo applications of its preclinical molecule HCW11-006. Trimmune will develop and commercialize the molecule and fund the first Phase 1 trial in China for solid tumors.

HCW Biologics is receiving a $3.5 million upfront cash license fee, paid in two installments, plus a minority co‑founder equity stake in Trimmune currently valued at about $3.5 million. The company may also receive development milestone payments, double‑digit royalties on future product sales, and a share of proceeds from future transactions involving HCW11-006.

HCW Biologics retains a payment‑free, milestone‑free, and royalty‑free option to recapture rights to HCW11-006 for in vivo applications in the Americas after the Phase 1 trial in China. If exercised, HCW Biologics and Trimmune would co‑develop the drug with each party funding costs in its territory, while coordinating clinical and business development efforts.

HCW Biologics Inc. entered into an inducement agreement with a single institutional investor on November 19, 2025. The company reduced the exercise price of the investor’s existing November 2024 and May 2025 warrants from $7.45 per share to $2.66 per share, and the investor immediately exercised these warrants to purchase 1,510,205 shares of common stock. This generated approximately $4.0 million in gross proceeds for the company before fees and expenses.

In exchange for the exercise of the existing warrants, HCW Biologics issued new common stock purchase warrants to the investor for up to 3,020,410 shares at an exercise price of $2.41 per share, which are immediately exercisable and expire five and one-half years after their November 20, 2025 issuance. The company agreed to file a registration statement within 30 days to cover the resale of shares issuable upon exercise of the new warrants and engaged Maxim Group LLC as financial advisor, paying a 6.0% cash fee on the gross proceeds from the warrant exercise and up to $15,000 in reimbursable expenses.

HCW Biologics Inc. entered into an Amended and Restated License, Research and Co-Development Agreement with Beijing Trimmune Biotech covering the HCW11-006 molecule for in vivo applications. The deal restructures an earlier license so Trimmune pays a $7.0 million upfront fee, split into $3.5 million in cash at closing and $3.5 million in transferable equity in Trimmune valued from its current equity financing round. The agreement also gives Trimmune an option to license HCW9302 for in vivo use in China or Asia and sets a 90-day window from signing to close the transaction.

HCW Biologics keeps a payment-free, milestone-free, and royalty-free option to recapture rights to develop and commercialize HCW11-006 for in vivo applications in the United States, Canada, Central America, and South America after Phase 1 clinical trials. Trimmune will be financially responsible for research, development, manufacturing, clinical work, regulatory approvals, and commercialization in its territory. If the closing does not occur within 90 days of execution, all intellectual property and rights to HCW11-006 revert to HCW Biologics.

HCW Biologics Inc. reported that the first patient has been dosed in its company-sponsored, multi-center Phase 1 clinical trial of lead product candidate HCW9302 in patients with an autoimmune disorder. This marks an early clinical step for HCW9302 as the company moves from planning into active patient treatment under a formal trial setting. The update was shared through a press release dated November 18, 2025, which is furnished as an exhibit for informational purposes and not deemed filed for liability purposes under the securities laws.

HCW Biologics Inc. reported that a Nasdaq Hearings Panel granted an extension to regain compliance with continued listing requirements. The company must demonstrate compliance with the Nasdaq Equity Rule (Listing Rule 5550(b)(1)) by December 31, 2025, and with all other Nasdaq continued listing rules by February 16, 2026, which the Panel stated is the full extent of its discretion.

The company is required to promptly notify the Panel of any significant events affecting compliance, timely file its Form 10-Q for the third quarter, and provide status updates on elements of its compliance plan. The Panel may review its decision within 45 calendar days after issuing the written decision and may request additional information before confirming compliance.

HCW Biologics Inc. reports that partner WY Biotech Co., Ltd. may miss the amended deadline to pay a $7.0 million upfront license fee under their worldwide exclusive license agreement. The payment date had already been extended to on or before September 30, 2025, and HCW had delayed recognizing this upfront payment as revenue.

WY Biotech has not yet finalized agreements with its contract development and manufacturing organization and investors, which affects the timing of the upfront fee. Both parties are now negotiating potential further revisions and additions to the license agreement, so the future structure and timing of payments under this collaboration remain subject to change.

HCW Biologics Inc. reported that Nasdaq has notified the company it is not in compliance with Nasdaq Listing Rule 5550(b)(1), known as the equity requirement for continued listing on the Nasdaq Capital Market, based on its status as of June 30, 2025. Nasdaq has informed the company that its securities are scheduled to be suspended from trading on August 28, 2025 unless it requests a hearing by August 26, 2025. The company plans to timely request a hearing before a Nasdaq Hearings Panel, which would pause any trading suspension while the hearing process is completed. HCW Biologics notes there is no assurance the Panel will grant continued listing or that it will be able to regain and demonstrate compliance within any period set by the Panel.

HCW Biologics Inc. filed an amended Form 8-K/A to correct a clerical error about the timing of a press release. The amendment explains that the press release announcing financial results was issued on August 18, 2025 instead of August 14, 2025, as originally indicated.

The company states that no other disclosures from the original report are being updated and that the amendment should be read together with the original filing and later SEC filings. The press release for the quarter ended June 30, 2025 is furnished as Exhibit 99.1, not deemed “filed” under the Exchange Act.

HCW Biologics Inc. filed a current report to furnish a press release announcing its financial results for the quarter ended June 30, 2025. The company issued this press release on August 14, 2025, and attached it as Exhibit 99.1. The information in this report, including the exhibit, is designated as furnished rather than filed under securities law, which limits certain legal liabilities and incorporation into other registration statements.

HCW Biologics (Nasdaq: HCWB) filed an 8-K announcing it has regained full compliance with Nasdaq Capital Market rules, including Listing Rule 5550(b)(1) on minimum shareholders’ equity. Earlier, on May 13, 2025, Nasdaq confirmed compliance with the bid-price, public-float and market-value requirements.

All prior delisting proceedings are now closed. However, HCWB will remain under a “Panel Monitor” until June 23, 2026. Any breach of the Equity Rule during this one-year period would trigger an immediate hearing without the usual compliance-plan option. No financial results were disclosed.

HCW Biologics held its 2025 Annual Meeting of Stockholders on June 17, 2025, marked by technical difficulties with their service provider Broadridge Financial Solutions that affected virtual attendance. Despite these issues, the meeting achieved a quorum through in-person and proxy attendance.

Key developments include:

• Director Resignation: Gary M. Winer resigned from the Board of Directors immediately after the meeting. His resignation was not due to any disagreements with company operations or policies
• Director Election Results: Scott T. Garrett was successfully elected as Class I director with 534,541 votes in favor, while Gary M. Winer received significantly less support with only 133,365 votes in favor
• Auditor Appointment: Stockholders ratified Crowe LLP as the independent registered public accounting firm with overwhelming support (693,874 votes in favor)

To address the technical issues, the company will provide stockholders access to meeting replay until June 2026 and accept questions through July 31, 2025, via email at info@hcwbiologics.com.