HCW Biologics Inc 10-Q for FY2026 Q2
HCW Biologics Inc. (HCWB)
About this 10-Q
HCW Biologics Inc filed this 10-Q on August 14, 2026, covering the quarter ended June 30, 2026 (FY2026 Q2).
Headline figures
Quarter ended June 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $121.73K
- Net loss
- $5.22M
- compared with a net loss of $1.93M a year earlier
- Diluted EPS
- -$11.58
- compared with -$40.72 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
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:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| The
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Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| 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.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 12, 2026, the registrant had shares of common stock, $ par value per share, outstanding.
| Page | ||
| PART I. | FINANCIAL INFORMATION | 1 |
| Item 1. | Condensed Financial Statements | 1 |
| Unaudited condensed financial statements as of and for the three and six months ended June 30, 2025 and June 30, 2026: | ||
| Balance sheets | 1 | |
| Statements of operations | 2 | |
| Statements of changes in stockholders’ equity (deficit) | 3 | |
| Statements of cash flows | 5 | |
| Notes to condensed financial statements | 6 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 30 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 48 |
| Item 4. | Controls and Procedures | 48 |
| PART II. | OTHER INFORMATION | 51 |
| Item 1. | Legal Proceedings | 51 |
| Item 1A. | Risk Factors | 53 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 53 |
| Item 3. | Defaults Upon Senior Securities | 54 |
| Item 4. | Mine Safety Disclosures | 54 |
| Item 5. | Other Information | 54 |
| Item 6. | Exhibits | 55 |
| Signatures | 58 | |
| i |
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
HCW Biologics Inc.
Condensed Balance Sheets
| December 31, | June 30, | |||||||
| 2025 | 2026 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Prepaid expenses | ||||||||
| Other current assets | ||||||||
| Total current assets | ||||||||
| Investments | ||||||||
| Property, plant and equipment, net | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities and other current liabilities | ||||||||
| Short-term debt, net | ||||||||
| Deferred revenue | ||||||||
| Total current liabilities | ||||||||
| Contingent liability - related party | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 12) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock: | ||||||||
| Common, $ par value; shares authorized and shares issued at December 31, 2025; shares authorized and shares issued at June 30, 2026 | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to the unaudited condensed financial statements.
| 1 |
HCW Biologics Inc.
Condensed Statements of Operations
(Unaudited)
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross Profit | ( | ) | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Legal expenses (recoveries), net | ( | ) | ( | ) | ||||||||||||
| Indirect tax expense | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating income (loss) | ( | ) | ( | ) | ( | ) | ||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||||||||||
| Change in fair value of investment, net | ||||||||||||||||
| Gain on extinguishment of liability | ||||||||||||||||
| Other income, net | ||||||||||||||||
| Net loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax expense | ( | ) | ||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Equity dividend to investor | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to Common Stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share, basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average shares outstanding, basic and diluted | ||||||||||||||||
See accompanying notes to the unaudited condensed financial statements.
| 2 |
HCW Biologics Inc.
Condensed Statements of Changes in Stockholders’ Equity (Deficit)
For the Three and Six Months Ended June 30, 2025 and 2026
(Unaudited)
| Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||
| Stockholders’ Deficit | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||
| Balance, January 1, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Issuance of Common Stock upon exercise of stock options | ||||||||||||||||||||
| Issuance of Common Stock to Square Gate | ||||||||||||||||||||
| Issuance cost of Common Stock | — | ( | ) | ( | ) | |||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Issuance of Common Stock | ||||||||||||||||||||
| Issuance of pre-funded warrants | — | |||||||||||||||||||
| Issuance of Common Stock warrants | — | |||||||||||||||||||
| Exercise of pre-funded warrants | ||||||||||||||||||||
| Issuance cost of Common Stock | — | ( | ) | ( | ) | |||||||||||||||
| Issuance cost of pre-funded warrants | — | ( | ) | ( | ) | |||||||||||||||
| Issuance cost of Common Stock warrants | — | ( | ) | ( | ) | |||||||||||||||
| Equity dividend to investor | — | ( | ) | ( | ) | |||||||||||||||
| Issuance of Common Stock to extinguish restructured debt | ||||||||||||||||||||
| Issuance of Common Stock warrants to extinguish restructured debt | — | |||||||||||||||||||
| Gain on conversion of debt with related parties, net | — | |||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Adjustment for reverse stock split | ( | ) | ||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
See accompanying notes to the unaudited condensed financial statements.
| 3 |
| Stockholders’ Equity | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, January 1, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Common Stock issued in connection with abeyance shares (1) | ( | ) | ||||||||||||||||||
| Issuance of pre-funded warrants | - | |||||||||||||||||||
| Exercise of pre-funded warrants | ||||||||||||||||||||
| Reclassification of the modified warrant to liability | - | ( | ) | ( | ) | |||||||||||||||
| Issuance of Common Stock warrants | - | |||||||||||||||||||
| Equity dividend to investor | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs of Common Stock warrants | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs of pre-funded warrants | - | ( | ) | ( | ) | |||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||
| Net income | - | |||||||||||||||||||
| Balance, March 31, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of Common Stock | ||||||||||||||||||||
| Issuance of pre-funded warrants | - | |||||||||||||||||||
| Issuance of Common Stock warrants | - | |||||||||||||||||||
| Exercise of pre-funded warrants | ||||||||||||||||||||
| Reclassification of the modified warrant from liability | - | |||||||||||||||||||
| Equity dividend to investor | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs of Common Stock | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs of pre-funded warrants | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs of Common Stock warrants | - | ( | ) | ( | ) | |||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||
| Adjustment for reverse stock split | ( | ) | ||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Net income (loss) | - | ( | ) | ( | ) | |||||||||||||||
| Balance, June 30, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| (1) |
See accompanying notes to the unaudited condensed financial statements.
| 4 |
HCW Biologics Inc.
Condensed Statements of Cash Flows
(Unaudited)
| 2025 | 2026 | |||||||
| Six Months Ended June 30, | ||||||||
| 2025 | 2026 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and accretion | ||||||||
| Stock-based compensation | ||||||||
| Noncash revenue from licensing agreement | ( | ) | ||||||
| Gain on extinguishment of liability | ( | ) | ||||||
| Change in fair value of warrant liability | ||||||||
| Commitment fee | ||||||||
| Change in fair value of investment, net | ( | ) | ||||||
| Loss on conversion of debt with related parties | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ||||||||
| Prepaid expenses and other assets | ( | ) | ||||||
| Accounts payable and other liabilities | ( | ) | ( | ) | ||||
| Deferred revenue | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of property and equipment | ||||||||
| Net cash from investing activities | ||||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of Common Stock | ||||||||
| Proceeds from issuance of Common Stock warrants and pre-funded warrants, net | ||||||||
| Proceeds from issuance of debt | ||||||||
| Issuance costs for Common Stock | ( | ) | ||||||
| Issuance costs for Common Stock warrants and pre-funded warrants | ( | ) | ( | ) | ||||
| Debt repayment | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at the beginning of the period | ||||||||
| Cash and cash equivalents at the end of the period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Noncash investing activities: | ||||||||
| Capital expenditures accrued, but not yet paid | $ | $ | ||||||
| Purchases of property and equipment included in accounts payable and other | $ | $ | ||||||
| Noncash financing activities: | ||||||||
| Extinguishment of restructured debt | $ | $ | ||||||
| Issuance of Common Stock, warrants and other rights upon extinguishment of restructured debt | $ | $ | ||||||
| Gain on extinguishment of debt with related parties | $ | $ | ||||||
| Equity dividend to investor | $ | $ | ||||||
See accompanying notes to the unaudited condensed financial statements.
| 5 |
HCW Biologics Inc.
Notes to Condensed Financial Statements
(Unaudited)
1. Organization and Summary of Significant Accounting Policies
Organization
HCW Biologics Inc. (the “Company”) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation, including autoimmune diseases, cancer, and senescence-associated dysplasia. The Company also has commercial-ready reagents that are based on two of its proprietary immunotherapeutic compounds that are designed to support the production of immunotherapeutics for cancer and infectious diseases. The Company is located in Miramar, Florida and was incorporated in the state of Delaware in April 2018.
Reverse Stock Splits
On
March 31, 2025, at a Special Meeting of the Stockholders, the stockholders of the Company approved a reverse stock split of all outstanding
shares of the Company’s common stock (“Common Stock”), and the Board approved a reverse stock split of the Common Stock
at a final ratio of
On
June 15, 2026, at the Company’s Annual Meeting of Stockholders, the stockholders of the Company approved a reverse stock split
of all outstanding shares of Common Stock, and on June 24, 2026, the Board approved a
All issued and outstanding shares of Common Stock, stock option awards, and per share data included in this Quarterly Report on Form 10-Q have been recast to give retrospective effect to the reverse stock splits for all periods presented. The reverse stock splits did not have any effect on the stated par value of the Company’s Common Stock or the rights and privileges of the holders of shares of Common Stock. Options, warrants and convertible securities outstanding immediately prior to the reverse stock splits were appropriately adjusted to reflect the reverse stock splits.
Liquidity and Going Concern
In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements – Going Concern (“Topic 205-40”), management is required to evaluate whether there are conditions and events, considered in the aggregate that raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the issuance date of the Company’s condensed financial statements. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the condensed financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the condensed financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the condensed financial statements are issued.
As
of June 30, 2026, the Company had not generated any revenue from commercial product sales of its internally developed immunotherapeutic
products. During its development activities, the Company has sustained operating losses, experienced negative operating cash flows and
negative working capital position and expects to continue to incur operating losses for the foreseeable future. Since inception to June
30, 2026, the Company incurred cumulative net losses of $
| 6 |
The accompanying condensed financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain debt or equity financings to continue operations. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. The Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the date of issuance of the Company’s condensed financial statements and that the substantial doubt that existed in its going concern analysis was not alleviated.
Summary of Significant Accounting Policies
Basis of Presentation
Unaudited Interim Financial Information
The accompanying unaudited condensed financial statements as of June 30, 2026 and for the three and six months ended June 30, 2025 and 2026 have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three and six months ended June 30, 2026 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at December 31, 2025 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2025 which appear in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2026 (the “Annual Report”) and in other filings with the SEC.
Segment Reporting
The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing transformative fusion immunotherapeutics for diseases promoted by chronic inflammation, including autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia. The Company’s chief executive officer, who is the chief operating decision maker (“CODM”), reviews financial information on an aggregate basis for allocating and evaluating financial performance. In addition, the Company’s CODM is regularly provided with detailed results of preclinical and clinical data which is considered in his decision for the allocation of resources. See Note 11. Segment Reporting for further details. The single operating segment constitutes all of the Company activity, and the CODM regularly reviews the entity-wide operating results and performance. All long-lived assets are maintained in the United States of America.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Management uses estimates in financial statements to approximate monetary amounts for items that cannot be measured precisely, such as asset valuations, liabilities, and revenue recognition. These estimates are based on subjective judgments, experience, and future assumptions. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from estimates.
| 7 |
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC820, Fair Value Measurement (“Topic 820”) establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
| ● | Level 1: Observable inputs such as quoted prices in active markets; | |
| ● | Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and | |
| ● | Level 3: Unobservable inputs in which there is little or no market data, which require a reporting entity to develop its own assumptions. |
Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values takes into account the market for the Company’s financial assets and liabilities, the associated credit risk, and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. See Note 2. Fair Value of Financial Instruments.
Revenue Recognition
The Company accounts for revenues in accordance with FASB ASC 606, Revenue from Contracts with Customers (“Topic 606”). To determine revenue recognition for arrangements that fall within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer.
At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company’s revenues have been generated exclusively from license agreements, which consist of licenses of intellectual property, research and development cost reimbursements and service fees, upfront signing fees, milestone payments and royalties on future licensee’s product sales. From time to time, the Company may retain manufacturing rights when it enters license agreements, and in this case, the Company and its licensee will enter a separate supply agreement, under which the Company will agree to sell clinical materials needed for research and clinical trials to the licensee, for which the Company will recognize revenue.
License Grants:
For out-licensing arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement.
| 8 |
License related Services:
For license agreements that include service-based performance obligations, the Company evaluates whether these separately identifiable services are distinct performance obligations. The Company considers whether the customer could benefit from the licensed intellectual property with other readily available resources, whether the performance of the service would significantly modify or customize the licensed intellectual property or whether the service is highly interrelated or interdependent with the licensed intellectual property. Revenue attributable to services that are deemed distinct performance obligations are recognized over time as the customer simultaneously receives and consumes the benefits of the Company’s performance. The Company measures progress toward completion using an input method, typically cost-to-cost, which reflects the pattern in which services are delivered. Amounts received in advance for optional future services are recorded as deferred revenue and recognized as revenue when the related services are performed or when the option expires. The transaction price is allocated to the service performance obligations based on their relative standalone selling prices.
Milestone and Contingent Payments:
At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s licensees will generally pay milestones payments subsequent to achievement of the triggering event.
Materials Supply:
The Company provides clinical and research grade materials so that licensees may develop products based on the licensed molecules. The amounts billed are recognized as revenue as the performance obligations are satisfied by the Company, once the Company determines that a contract exists.
Investments
As part of its financing strategy, the Company may enter into licensing or collaboration agreements under which it receives consideration in the form of a minority equity interest in a counterparty, in lieu of or in addition to cash payments. These financial instruments are presented within Investments in the accompanying condensed balance sheets.
When consideration is an equity interest in a private entity whose equity has limited marketability with no readily determinable fair value and for which the Company does not have significant influence over the investee, the Company measures the equity interest using the measurement alternative, at cost less impairment, adjusted for observable price changes in orderly transactions for the identical or similar investment of the same issuer (ASC Topic 321, Investments - Equity Securities or Topic 321), unless the fair value method is otherwise elected. If the Company elects to measure an equity security at fair value, the entity shall measure all identical or similar investments of the same issuer, including future purchases of identical or similar investments of the same issuer, at fair value. The election to measure those securities at fair value shall be irrevocable. Any resulting gains or losses on the securities for which that election is made shall be recorded in earnings at the time of the election and each reporting period thereafter.
| 9 |
In the second quarter of 2025, the Company elected to account for its shares of AlloTera Therapeutics, Inc. (“AlloTera Therapeutics”) formerly Wugen, Inc. (“Wugen”), previously accounted for under the measurement alternative, at fair value determined by using financial valuation techniques and market information available. The Company will remeasure the change in fair value of the AlloTera Therapeutics shares in reporting periods subsequent to the second quarter of 2025 and recognize the change in fair value in earnings. In May 2025, the Company transferred the rights to proceeds of a sale or liquidation of AlloTera Therapeutics shares to certain holders of Secured Notes and Convertible Bridge Notes who agreed to restructure and convert their notes to equity, which gave rise to a contingent liability which is also measured based on the fair value of the relevant number of shares with the change in fair value recognized in earnings beginning in the second quarter of 2025 and each reporting period thereafter. See Note 2. Fair Value of Financial Instruments and Note 4. Debt, Net.
On March 16, 2026, the Company received full payment of the nonrefundable upfront license fee from Beijing Trimmune Biotech Co. Ltd. (“Trimmune”), a private company based in China, which included an in-kind payment of a transferable equity interest in Trimmune. The Company has elected to use the measurement alternative under ASC 321-10-35-2 to account for this investment. The initial fair value was derived by reference to the implied post-financing valuation of Trimmune of RMB 175,000,000 of a contemporaneous Licensee Funding Transaction (“LFT”) with unrelated third party investors (a Level 2 fair value indicator under Topic 820), using the exchange rate on the closing date of the LFT. In subsequent reporting periods, the Company will measure the value of this investment at cost less impairment, adjusted for observable price changes in orderly transactions for the identical or similar investment of the same issuer. See Note 5. License Agreements.
From
time to time, the Company invests excess cash in U.S. Treasury bills and notes, which are classified as trading securities. As of June
30, 2025 and 2026, the Company had
Standby Equity Purchase Agreement
The Company and Square Gate Capital Master Fund, LLC - Series 4 (“Square Gate”) entered a Standby Equity Purchase Agreement (“SEPA”) providing for an equity line of credit with Square Gate on February 20, 2025. This agreement provides a mechanism for submission by the Company and acceptance by Square Gate of Put Notices under the SEPA pursuant to which Square Gate and the Company may agree to and execute one purchase and sale of Put Shares (“Standard Put Shares”). The Standard Put Notice has a pricing mechanism based on a volume-adjusted weighted average trading price over three days following the acceptance of the Standard Put.
On August 14, 2025, the parties entered into a First Amendment to the SEPA (the “First Amendment”) to provide a mechanism for submission by the Company and acceptance by Square Gate of Put Notices under the SEPA pursuant to which Square Gate and the Company may agree to and execute multiple purchases and sales of Put Shares on the same trading day (“Intraday Put Shares”). Under the First Amendment, among other things, the purchase price of the Intraday Put Shares will be the lowest traded price during a specified valuation time period which begins with the acceptance of the Intraday Put and ends when trading volume reaches 1000% of the amount of shares included in the Intraday Put.
A SEPA is an equity-linked instrument for which an investor has the right, but not the obligation, to purchase shares of the entity’s common stock over a specified period of time. The SEPA creates a purchase put option for the overarching arrangement which was determined to be a derivative. Economically, before the entity has elected to sell shares, a SEPA represents a purchased put option on the entity’s own equity. However, once the entity “draws” on the SEPA, the related number of shares issued constitutes a financial instrument. Thus, a SEPA contains both a purchased put option element and a forward share issuance element. This means that a SEPA generally does not qualify for equity classification. Accordingly, entities must recognize an asset or liability for its SEPA. Such asset or liability must be measured at fair value, with changes in fair value recognized in net (loss) income. Further, individual draws must also be evaluated to determine if they meet criteria for equity classification.
| 10 |
With
regards to the individual draws for a Standard Put under the SEPA, an individual draw would create a separate financial instrument with
settlement criteria that does not meet indexation guidance. While the number of shares is known at inception and therefore not subject
to the overarching share cap, there are two inputs into the settlement amount paid by the Investor which are not inputs into a fixed-for-fixed
option: (1) the maximum amount to be funded under the SEPA of $
Basic net income (loss) per share is calculated by dividing the net income (loss) attributable to Common Stockholders by the daily weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to Common Stockholders by the sum of the daily weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted income or loss per share if the effect of such inclusion is anti-dilutive. The Company’s potentially dilutive securities, which include options granted under the 2019 Equity Incentive Plan (“2019 Plan”) and the 2021 Equity Incentive Plan (“2021 Plan”) as well as the Company’s Common Stock Warrants, have been excluded from the computation of diluted net income (loss) per share as their exercise prices exceeded the average market price of the Company’s Common Stock during the period. Options and warrants are considered dilutive to the income per share calculation when their exercise price is below the average market price of the stock (“in-the-money”).
The Company has issued certain Common Stock Warrants that have a provision for participation in earnings. Under ASC 260, Earnings per Share, undistributed earnings shall be allocated to Common Stock and participating securities utilizing the two-class method. The Company reports distributed and undistributed allocations of earnings on a cumulative period basis in accordance with contractual participation rights using the two-class method.
Restatement of Previously Issued Interim Financial Information
The Company has restated its previously issued unaudited condensed financial statements for the three months ended March 31, 2026 (the “Amendment”) in a Form 10-Q/A filed on August 14, 2026 to correct the misapplication of the two-class method of calculating earnings per share under ASC 260, Earnings Per Share. The Company originally calculated earnings per share without identifying certain outstanding warrants as participating securities in a Quarterly Report on Form 10-Q for the three months ended March 31, 2026 filed on May 14, 2026 (“Original Filing”). The Amendment reflects the identification of these warrants as participating securities and the resulting correction of the calculation of earnings per shares by applying the two-class method.
As of March 31, 2026, after
giving effect to the Reverse Stock Split, the Company had weighted-average shares of Common Stock outstanding and participating
warrants which may be exercised for shares of Common Stock issued. The correct application of the two-class method required that
undistributed earnings are allocated according to shares held or shares that may be held upon exercise, specifically, the Company must
allocate
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued Accounting Standards Update (ASU) No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (ASU 2024-03) which requires public business entities to provide enhanced disaggregation of expenses in financial statements, including detailed disclosures on inventory purchases, employee compensation, depreciation, and amortization. The new guidance is effective for the Company for fiscal periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. The Company is evaluating the impact of the standard on the Company’s financial statements.
In September 2025, the FASB issued ASU 2025-06, Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40): Accounting for and Disclosure of Software Costs to update the accounting for internal use software costs. The guidance requires entities to start capitalizing eligible costs when (1) management has authorized and committed to funding the software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended. The guidance, which applies to all entities, is effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Entities may apply the guidance using a prospective, retrospective or modified transition approach. Early adoption is permitted. The Company is evaluating the impact of the standard on the Company’s financial statements.
In September 2025, the FASB issued ASU 2025-07—Derivatives and Hedging (“Topic 815”) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-based Noncash Consideration from a Customer in a Revenue Contract, to expand the scope of contracts that are excluded from derivative accounting (i.e., measured at fair value through earnings). ASU 2025-07 addresses stakeholders’ concerns about (1) the application of derivative accounting to contracts with features based on the operations or activities of one of the parties to the contract and (2) the diversity in accounting for share-based noncash consideration from a customer that is consideration for the transfer of goods or services. The guidance is effective for annual reporting periods beginning after December 15, 2026, and interim periods within those annual periods. Entities may apply the guidance either on a modified retrospective or prospective basis. Early adoption is permitted. The Company is evaluating the impact of the standard on the Company’s financial statements.
As of December 31, 2026, the Company will cease to be an ‘emerging growth company’ as defined in the Jumpstart Our Business Startups Act of 2012. We expect to remain a non-accelerated filer and smaller reporting company. The Company is currently assessing potential regulatory and operational changes that may be required as a result.
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2. Fair Value of Financial Instruments
The carrying amount of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses, other current assets, U.S. government-backed securities with maturity dates up to one year, accounts payable and accrued liabilities, approximate fair value due to their short-term maturities.
Money market funds included in cash and cash equivalents and U.S. government-backed securities are measured at fair value based on quoted prices in active markets, which are considered Level 1 inputs.
During
the three months ended March 31, 2026, the Company agreed to modify certain outstanding warrants, subject to stockholder approval.
Since there was a contingency in the terms of settlement, the Company recognized a warrant liability as of March 31, 2026. The
warrant liability is measured at fair value using the Black-Scholes option pricing model. The fair value is classified as Level 3
within the fair value hierarchy due to the use of significant unobservable inputs. The change in fair value is recognized in
earnings. On June 15, 2026, at the Company’s Annual Meeting of Stockholders, the stockholders approved the repricing of the
warrants underlying this warrant liability, after which the warrants met all requirements for classification as equity. On that
date, the Company remeasured the warrant liability at fair value and recognized the change in fair value in earnings. In the three
and six months ended June 30, 2026, the Company recognized the change in fair value of the warrant liability of $
The Company’s investment in shares of AlloTera Therapeutics common stock is classified as Level 3 within the fair value hierarchy due to the use of significant unobservable inputs. The fair value is estimated using a combination of valuation techniques, including an adjusted enterprise valuation method and a backsolve method, which incorporates information from recent financing transactions and the Company’s assessment of the underlying enterprise value of AlloTera Therapeutics. Significant unobservable inputs used in these valuations include assumptions related to the enterprise value of AlloTera Therapeutics discounts for lack of marketability, the capital structure of the investee, and the probability and timing of potential liquidity events. The fair value of the AlloTera Therapeutics investment is reassessed each reporting period based on updated assumptions and available market information with the change in fair value recognized in earnings.
A contingent liability arose in May 2025 when the Company agreed to transfer some of the proceeds from the sale or liquidation of shares in AlloTera Therapeutics, if such event occurs, to certain holders of Secured Notes and Convertible Bridge Notes as part of the terms to restructure and convert their debt to equity. The valuation of the contingent liability is based on assumptions that are consistent with those used in valuing the related AlloTera Therapeutics investment, including the expected distribution of proceeds upon a liquidity event. The fair value of the contingent liability is reassessed each reporting period with the change in fair value recognized in earnings. See Note 4. Debt, Net.
There were no material changes in the valuation techniques or significant unobservable inputs used to measure these Level 3 instruments during the six months ended June 30, 2026.
The following table presents the Company’s assets and liabilities which were measured at fair value at December 31, 2025 and June 30, 2026:
Schedule of Fair Value of Financial Instruments
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| December 31, 2025 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Investments | ||||||||||||||||
| Liabilities | ||||||||||||||||
| Contingent liability | ( | ) | ( | ) | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
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| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| June 30, 2026 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Investments | ||||||||||||||||
| Liabilities | ||||||||||||||||
| Contingent liability | ( | ) | ( | ) | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
3. Accrued Liabilities and Other Current Liabilities
As
of December 31, 2025, the Company had a balance of $
As
of June 30, 2026, the Company had a balance of $
4. Debt, Net
Cogent Bank Loan
On
August 15, 2022, the Company entered into the 2022 Loan Agreement with Cogent Bank (the “2022 Loan Agreement”), pursuant
to which it received $
As
of June 30, 2026, the Company had $
As of December 31, 2025 and June 30, 2026, certain subcontractors filed mechanics liens related to unpaid invoices issued in connection with the Company’s construction of its new manufacturing facilities and upgraded research laboratories. The 2022 Loan Agreement contains a provision for a discretionary default in the event that the Company fails to pay sums due in connection with construction of any improvements. As of December 31, 2025 and June 30, 2026, the Company has reported this loan as Short-term debt, net. On October 24, 2025, the Company was notified by Cogent Bank that it exercised its discretion to make a demand that the Company cure the mechanics liens no later than thirty (30) days after receipt of this letter in strict compliance with Section 7.2(3) of the Loan Agreement by: (i) paying and discharging all of the Claims of Lien and causing satisfactions to be recorded in the Public Records of Broward County, Florida for all of the Claims of Lien, and (ii) resolving all litigation against the Borrower and the mortgaged property described in the Mortgage and causing such claims in the Foreclosure Actions to be dismissed and all related notices of lis pendens to be released. On June 26, 2026, B&I Contractors, Inc. (“B&I”) filed a Voluntary Dismissal with Prejudice and a final Satisfaction of Lien removing a lien of $1.1 million against the Company. The Company and Cogent Bank continue to negotiate the terms of a forbearance agreement to provide additional time for the Company to comply with the demands it made in the demand letter.
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Senior Secured Notes
During
the year ended December 31, 2024, the Company received $
As a condition to entering into the Amended and Restated Note Purchase Agreement, the Company, Mercedes M. Sellek, P.A. (“Escrow Agent”), and the Purchasers entered into that certain Escrow Agreement and Amended and Restated Pledge Agreement, dated July 2, 2024, pursuant to which the Company agreed to pledge its equity ownership interest in AlloTera Therapeutics (the “Pledged Collateral”), to be held and released by Escrow Agent according to the terms of the Escrow Agreement, as security for the Secured Notes.
The
Secured Notes bear interest at a rate of
The
Secured Notes have a Mandatory Prepayment provision, according to which the Company is required to prepay the Secured Notes before
the Maturity Date under certain circumstances. In the event of a Mandatory Prepayment, Secured Notes may receive a bonus payment
based on the gross proceeds of the sale of the Pledged Collateral. The agreement also contains default provisions, according to
which, following an event of default, the Company may be required to distribute the Pledged Collateral to the Purchasers on a pro
rata basis based on a $
If
the Secured Notes are repaid on the Maturity Date, holders will receive their pro rata share of a fixed bonus payment of $
The Secured Notes were deemed to be a hybrid instrument, consisting of a debt host with embedded derivatives requiring bifurcation and accounting for separately. The embedded derivatives consist of the Mandatory Redemption, which depends on certain events occurring, and the fixed bonus payable upon the Maturity Date. The fair value of the embedded derivative, which incorporated the likelihood of certain events occurring, was immaterial. Thus, as of December 31, 2025 and June 30, 2026, the Company did not recognize the embedded derivative in the accompanying condensed balance sheets. The Company accounts for the fixed bonus payment to be paid if the Secured Notes are repaid on the Maturity Date by accreting the bonus payment to the full amount due on the Maturity Date, utilizing the effective interest rate method.
On
May 1, 2025, noteholders holding $
For
those Secured Notes which remain outstanding as of December 31, 2025 and June 30, 2026, the Company reported $
For
the three months ended June 30, 2025 and 2026, the Company recognized $
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Troubled Debt Restructuring of Secured Notes
The
Company entered into the Second Amendment to its Amended and Restated Note Purchase Agreement in which certain Secured Note
noteholders and the Company agreed to the terms to effectively extinguish $
The
net carrying amount of the restructured Secured Notes was $
Unsecured Promissory Notes
During
the year ended December 31, 2025, the Company issued a total of $
As
of May 15, 2025, the outstanding principal of the Convertible Bridge Notes were converted. The fair value of consideration
transferred including
shares of Common Stock and rights to proceeds of a portion of the Company’s shares of AlloTera Therapeutics common stock was
$
Contingent Liabilities
In
connection with the Trouble Debt Restructuring and the conversion of the Unsecured Promissory Note discussed above, the converting
noteholders have a right to receive a portion of the proceeds of the sale or liquidation of the Company’ shares of AlloTera
Therapeutics common stock if such an event occurs. The Company retained ownership of all of its AlloTera Therapeutics shares which
is presented in Investments on the accompanying condensed balance sheets. The Company recognized a contingent liability for the
rights transferred to the converting noteholders presented as a contingent liability on the accompanying condensed balance sheets.
As of December 31, 2025 and June 30, 2026, the fair value of the Company’s AlloTera Therapeutics shares was $
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Promissory Note with Personal Guaranty
On
May 8, 2025, the Company issued a promissory note for $
For
the three and six months ended June 30, 2025, the Company recognized accretion of original issue discount of $
5. License Agreements
AlloTera Therapeutics License
On May 21, 2026, the Company elected to exercise its option to terminate the exclusive worldwide license agreement with AlloTera Therapeutics, Inc. (the “AlloTera Therapeutics License”) for ex vivo rights to the Company’s molecules HCW9201 and HCW9206. The termination was made pursuant to Section 1(b) of the 12-month suspension letter agreement the parties entered into on May 29, 2025.
Beijing Trimmune Biotech Co. Ltd. License
On November 17, 2025, the Company and Trimmune entered into an Amended and Restated License, Research and Co-Development Agreement (“Trimmune License”) following the assignment of the original License, Research and Co-Development Agreement, which includes an exclusive license to HCW11-006 for in vivo applications (“WY Biotech License”) from WY Biotech Co., Ltd. to Trimmune. The parties restructured the terms of the original WY Biotech License to include the assignment of rights to Trimmune. In addition to the license for HCW11-006, the parties agreed that for additional consideration, Trimmune has an option to license the exclusive China rights to clinical development and commercialization for in vivo applications of HCW9302, the Company’s clinical-stage molecule currently being evaluated for the treatment of an autoimmune disorder.
On
March 16, 2026, the Company received the full nonrefundable upfront license fee, consisting of $
In
addition, the Company is eligible to receive up to $
Because
the Trimmune License and the equity interest were negotiated as a package with a single commercial objective, the Company combined and
accounted for them as a single arrangement under ASC 606. The equity interest represents non-cash consideration, measured at its fair
value of $
| 16 |
The Company allocated the transaction price to the two performance obligations using a relative standalone selling price basis. The standalone selling price of the Services was estimated using contemporaneous third-party Contract Research Organization (“CRO”) and Contract Manufacturing Organization (“CMO”) contracted pricing. The standalone selling price of the Licensed IP was estimated using the residual approach. The Licensed IP has significant standalone functionality and the Company does not expect to undertake activities that will change that functionality. Accordingly, the license is a right to use the Company’s functional intellectual property, and revenue allocated to the Licensed IP performance obligation was recognized at the point in time control of the Licensed IP transferred to Trimmune. Trimmune simultaneously receives and consumes the benefits of the Services as they are performed; accordingly, revenue allocated to the Services is recognized over time using a cost-to-cost measure of progress. Milestone payments will be recognized when the related constraint is resolved, typically upon achievement of the underlying clinical or regulatory event. Royalties and sales-based sublicensing consideration will be recognized when the underlying sales occur. The Opt-in Right is not a repurchase feature and does not require deferral of revenue at inception. If exercised, the Opt-in Right will be accounted for as a contract modification at that time.
For
the three and six months ended June 30, 2026, the Company recognized $
Transaction Price and Contract Liability as of June 30, 2026
Schedule of Transaction Price and Contract Liability
| Revenue Recognized | ||||||||||||
| Transaction Price | as of June 30, 2026 | Contract Liability | ||||||||||
| Licensed IP | $ | $ | $ | |||||||||
| Prepaid technology transfer costs | ||||||||||||
| Master Cell Bank | ||||||||||||
| $ | $ | $ | ||||||||||
Trimmune is a variable interest entity. Through equity ownership in Trimmune, licensing fees, Opt-In Rights, milestone payments and other potential payments, the Company has variable interests. The investment at risk is limited to the Company’s shares in Trimmune and contractual rights. As of the closing date of the Trimmune License, the Company concluded that it is not the primary beneficiary and should not consolidate the entity. There have been no reconsideration events in the three months ended June 30, 2026 that change the conclusion. The Company has no control over the operating and business activities that most significantly impact the entity’s economic performance. The Company has contractually agreed to cede its voting rights as they relate to operations of the entity. This was accomplished through a voting rights agreement in which all shares are voted by the Chief Executive Officer of Trimmune and an agreement related to voting on the joint steering committee by which the Company agreed that Trimmune will have the tie-breaking vote. As a result, the Company’s role is to act as an advisor and expert for technical advice, but it does not have any power to control the activities of the entity. The Company’s exposure to loss is limited to its investment and rights under the contractual arrangement with Trimmune. Risk of economic loss is borne by Trimmune’s investors, who are not related parties with the Company. The Company is not obligated to participate in future investment rounds in Trimmune, nor does the Company have contractual obligations or guarantees to Trimmune or any of its employees or investors.
| 17 |
6. Sale of Common Stock and Warrants
May 2025 Equity Financing
On
May 13, 2025, the Company entered into a securities purchase agreement with a single institutional investor (the “Investor”)
for the issuance and sale of (i) shares of the Company’s Common Stock and (ii) pre-funded warrants to purchase up to
The
gross proceeds to the Company from the May 2025 Offering were approximately $
Both the Common Stock Warrants and Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital and were recorded at the issuance date. The Common Stock Warrants and Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of shares of Common Stock upon exercise, are indexed to the Company’s Common Stock and meet the equity classification criteria. In addition, the Common Stock Warrants and the Pre-Funded Warrants do not provide any guarantee of value or return.
As
of June 30, 2025, all Pre-Funded Warrants issued in the May 2025 offering had been exercised. The May 2025 Common Warrants exercisable
for up to
Inducement Transaction and Shares held in Abeyance
On
November 19, 2025, the Company entered into a warrant inducement agreement with the Investor (the “Inducement
Agreement”), pursuant to which the Investor agreed to immediately exercise in full all of its outstanding Common Stock
Warrants originally issued on November 20, 2024 (as amended on May 15, 2025) and on May 15, 2025 to purchase
In
consideration for the immediate exercise of the Common Stock Warrants, the Company issued to the Investor, in a private placement pursuant
to Section 4(a)(2) of the Securities Act, new Common Stock Warrants to purchase up to
As of December 31, 2025 and June 30, 2026, there were shares and shares held in abeyance, respectively.
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Inducement Transaction and Shares held in Abeyance
On
November 19, 2025, the Company entered into a warrant inducement agreement with the Investor (the “November 2025 Inducement
Transaction”), pursuant to which the Investor agreed to immediately exercise in full all of its outstanding Common Stock
Warrants originally issued on November 20, 2024 (as amended on May 15, 2025) and on May 15, 2025 to purchase
In
consideration for the immediate exercise of the Common Stock Warrants, the Company issued to the Investor, in a private placement pursuant
to Section 4(a)(2) of the Securities Act, new Common Stock Warrants to purchase up to
As of December 31, 2025 and June 30, 2026, there were shares and shares held in abeyance, respectively.
February 2026 Sale of Common Stock and Warrants
On
February 17, 2026, the Company entered into a securities purchase agreement (“February 2026 SPA”) with the Investor, pursuant
to which the Company issued
The
combined purchase price for each Unit consisting of one Pre-Funded Warrant that may be exercised for one share of Common Stock and
an accompanying Common Stock Warrant to purchase one share of Common Stock was $.
The Common Stock Warrants have an exercise price of $
On
February 17, 2026, the Company also entered into a privately negotiated agreement with the Investor, which holds certain existing outstanding
warrants to purchase up to
Stockholder approval was required for the warrants issued or modified in the February 2026 transaction in order to comply with Nasdaq Stock Market Rules. Nasdaq Stock Rule 5635(d) is referred to as the “Nasdaq 20% Rule.” In order to comply with the Nasdaq 20% Rule, the Company must seek stockholder approval to permit the potential issuance of more than 19.99% of outstanding Common Stock upon exercise of the Common Warrants in accordance with their terms. To meet the Nasdaq 20% Rule, the Company required stockholder approval under the listing rules of Nasdaq to remove the Exchange Cap provisions in the February 2026 SPA to permit the potential issuance of more than 20% of its outstanding Common Stock in accordance with the terms of the SPA.
The
gross proceeds to the Company from the February 2026 Offering were approximately $
The Investor may not exercise any portion of the Common Stock Warrants to the extent it would beneficially own more than the limits defined in the respective Warrant Purchase Agreement. The exercise price and number of shares of Common Stock issuable upon the exercise of the Common Stock Warrants are subject to adjustment in the event of any stock dividends and distributions, stock splits, stock combinations or stock reclassifications, as described in the respective warrant agreements. Under certain circumstances, the warrants may be exercised on a “cashless” basis.
| 19 |
The
fair value of the Common Stock Warrants issued in this transaction was estimated at $
On
March 16, 2026, the Investor exercised all of its Pre-Funded Warrants issued from the February 2026 offering, and the Company issued
February 2026 Offering and Warrant Classification
The
February 2026 Common Stock Warrants that may be exercised to purchase up to
Upon modification of the November 2025 Common Stock Warrants on February 17, 2026, these warrants were reclassified from equity to a warrant liability due to a contingency in the settlement terms, and were therefore reclassified as a warrant liability. As a result, the Company recognized a warrant liability, which was measured at fair value as of March 31, 2026. Upon stockholder approval of the new strike price of $ per share on June 15, 2026, the contingent strike price adjustment was resolved, all requirements for equity classification were met and the November 2025 Common Stock Warrants were reclassified to permanent equity. See Note 2. Fair Value of Financial Instruments.
May 2026 Sale of Common Stock and Warrants
On
May 21, 2026, the Company completed a private placement with existing accredited investors, including the Investors in which it entered
into a Securities Purchase Agreement (the “May 2026 SPA”), pursuant to which the Company agreed to issue and sell an aggregate
of units, with each unit consisting of (i) one share of the Company’s common stock, par value $ per share (the “Common
Stock” or “Shares”), at a purchase price of $ per Share, or, in lieu thereof, one pre-funded warrant, and (ii)
one warrant to purchase one share of Common Stock (the “Common Stock Warrants”) at a purchase price of $ per Common Warrant.
The units were sold at a purchase price of $ per unit, and the Shares or Pre-Funded Warrants and Common Warrants comprising the units
are immediately separable and were issued separately.
| 20 |
Pursuant
to the May 2026 SPA, the Company issued and sold an aggregate of Shares, Pre-Funded Warrants, and Common Warrants to purchase
an aggregate of up to
In connection with the May 2026 SPA, the Company also entered into a Registration Rights Agreement with the Investors (the “Registration Rights Agreement”), pursuant to which the Company agreed to provide certain registration rights with respect to the resale of the Shares and the Warrant Shares. On June 18, 2026, the SEC declared effective a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in this private placement.
The Common Warrants may not be exercised to the extent that, after giving effect to such exercise, the holder would beneficially own more than 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise.
On June 22, 2026, the holder exercised all Pre-Funded Warrants issued in the May 2026 offering, and the Company issued shares of Common Stock.
Participating Warrants
Certain warrants issued by the Company are participating warrants. Under U.S. GAAP, participating warrants are instruments that grant the holder the right to receive non-forfeitable dividends or dividend equivalents on an equal basis with common stockholders before exercise. Because they are considered “participating securities,” the Company utilizes the two-class method to calculate and report basic and diluted Earnings Per Share (EPS). See Note 9. Net Loss per Share.
As
of June 30, 2025, outstanding participating warrants included: November 2024 Common Stock Warrants to purchase up to
As
of June 30, 2026, outstanding participating warrants included: November 2025 Common Stock Warrants to purchase up to
7. Standby Equity Purchase Agreement
On
On August 14, 2025, the Company and the Square Gate entered into a First Amendment to the Equity Purchase Agreement to provide a mechanism for submission by the Company and acceptance by the Square Gate of Put Notices under the Equity Purchase Agreement pursuant to which the Square Gate and the Company may agree to and execute multiple purchases and sales of Put Shares on the same trading day. Under the First Amendment, among other things, the purchase price of the intraday Put Shares will be the lowest traded price during a specified shortened valuation time period.
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As of June 30, 2025, the Company concluded that the Equity Purchase Agreement for Standard Put Shares does not qualify for equity classification. On the effective date, the Company concluded that the fair value of the Equity Purchase Agreement at inception was zero and no asset or liability was recorded. As a result, fees paid to Square Gate in excess of the fair value of the Equity Purchase Agreement were expensed as incurred. Any issuance costs or other transaction costs attributable to a freestanding equity-linked financial instrument that is classified as an asset or liability should be recognized in earnings in the period incurred
The
Commitment Fee was paid in-kind with an equivalent value of shares of the Company’s Common Stock. On March 12, 2025, the Company
issued shares of the Company’s Common Stock to Square Gate in payment of the Commitment Fee. At the Special Meeting of Stockholders
held on March 31, 2025, stockholders approved the Company’s use of the Equity Purchase Agreement. Pursuant to the Registration
Agreement, the Company filed a registration statement to register the underlying shares. On April 16, 2025, the SEC declared a registration
statement effective to register the Commitment Shares and shares required to sell up to $
For
the six months ended June 30, 2025, the Company expensed the $
8. Preferred Stock
As of December 31, 2025 and June 30, 2026, the Company had shares of preferred stock authorized and shares of preferred stock issued.
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Summary of Basic and Diluted Net Loss Per Common Share
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Equity dividend to investor | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to Common Stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator: | ||||||||||||||||
| Weighted-average common shares outstanding, basic and diluted | ||||||||||||||||
| Net loss per share, basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
The following table summarizes the outstanding warrants provision to participate in distribution of earnings. For the three and six months ended June 30, 2025 and 2026, these securities were excluded in the calculation for distribution of net loss:
Summary of Outstanding Warrants Provision to Participate in Distribution of Earnings
| June 30, | ||||||||
| 2025 | 2026 | |||||||
| November 2024 warrants | ||||||||
| May 2025 warrants | ||||||||
| Warrants from Debt Conversion | ||||||||
| November 2025 warrants | ||||||||
| Potentially participating warrants | ||||||||
Summary of Outstanding Potentially Dilutive Securities
| June 30, | ||||||||
| 2025 | 2026 | |||||||
| Common stock options | ||||||||
| Common stock warrants | ||||||||
| Potentially dilutive securities | ||||||||
10. Income Taxes
The Company accounts for income taxes under ASC 740, Income Taxes. The income tax provision for interim periods is determined using an estimated annual effective tax rate, adjusted for discrete items, if any, recognized in the period in which they occur.
For
the six months ended June 30, 2025 and 2026, the Company recorded an income tax provision of $
and $
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The following are income taxes paid by jurisdiction:
Schedule of Income Tax Paid
| 2025 | 2026 | |||||||
Six Months Ended June 30, | ||||||||
| 2025 | 2026 | |||||||
| Income Tax Payments - U.S. Federal | $ | $ | ||||||
| Income Tax Payments - U.S. States | ||||||||
| China - Income tax payments, net of refunds | ||||||||
| Total income taxes paid | $ | $ | ||||||
11. Segment Reporting
HCW
Biologics Inc. has
The
accounting policies of the life science segment are the same as those described in the summary of significant accounting policies.
The Company has not generated any product revenue from commercial product sales of internally-developed immunotherapeutic products for the treatment of diseases, as no products have been approved for commercial sale as of June 30, 2026. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances molecules through all stages of development and clinical trials and, ultimately, seek approval for commercial sale.
As such, the CODM uses cash forecast models in deciding how to invest into the life science segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance in conjunction with monitoring the results of R&D experiments for preclinical compounds and clinical trial data for clinical-stage compounds. The assessment of results of preclinical and clinical studies is critical to the allocation of resources by the CODM.
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The tables below summarize the significant expense categories regularly reviewed by the CODM for the three and six months ended June 30, 2025 and 2026:
Summary of Significant Expense Categories
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross Profit | ( | ) | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | ||||||||||||||||
| Salaries, benefits and related expenses | ||||||||||||||||
| Manufacturing and materials | ||||||||||||||||
| Preclinical expenses | ||||||||||||||||
| Clinical trials | ||||||||||||||||
| Overhead allocations | ||||||||||||||||
| Total research and development expenses | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Salaries, benefits and related expenses | ||||||||||||||||
| Professional services(a) | ||||||||||||||||
| Facilities and office expenses | ||||||||||||||||
| Depreciation expenses | ||||||||||||||||
| Rent and occupancy expenses | ||||||||||||||||
| Insurance | ||||||||||||||||
| Taxes | ||||||||||||||||
| Other expenses | ||||||||||||||||
| Total general and administrative expenses | ||||||||||||||||
| Other segment items(b) | ( | ) | ( | ) | ||||||||||||
| Total operating expenses | ||||||||||||||||
| Net segment loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| (a) | |
| (b) |
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Arbitration legal fees (recoveries), net | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||
| Accretion of fixed bonus upon maturity of Secured Notes | ||||||||||||||||
| Interest expense | ||||||||||||||||
| Indirect tax expense | ||||||||||||||||
| Change in fair value of investment, net | ( | ) | ( | ) | ||||||||||||
| Gain on extinguishment of liability | ( | ) | ( | ) | ||||||||||||
| Change in fair value of warrant liability | ||||||||||||||||
| Other income, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other segment items | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||
12. Commitments and Contingencies
Operating Leases
The
Company has operating leases for approximately
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For
the three months ended June 30, 2025 and 2026, rent expense recognized by the Company was $
Contractual Commitments
The
Company has commitments with R&D outsourcing and development companies to supply us with clinical grade materials or other development
services. As of June 30, 2026, it is under contract for future obligations of $
Legal Matters
Legal Proceedings
From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. In addition, the Company enters into agreements that may include indemnification provisions, pursuant to which the Company agrees to indemnify, hold harmless and defend the indemnified parties for losses suffered or incurred by the indemnified party. When the Company believes that the outcome of such a matter will result in a liability that is probable to be incurred and result in a potential loss, or range of loss, that can be reasonably estimated, the Company will accrue a liability and make the appropriate disclosure in the footnotes to the condensed financial statements.
Arbitration, Settlement and General Release
As of July 13, 2024, the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, entered into a confidential Settlement Agreement with Altor BioScience, LLC (“Altor”), NantCell, Inc. (“NantCell”), and ImmunityBio, Inc. (the parent of Altor and NantCell, together with Altor and NantCell, “ImmunityBio”), to resolve the previously disclosed Arbitration. The Arbitration and related Complaint were dismissed with prejudice as of December 31, 2024.
In
January 2025, the Company received a $
After
this settlement, as of December 31, 2025 and June 30, 2026, the Company recognized a liability of $
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Legal Matters related to Real Estate
During the year ended December 31, 2025, certain subcontractors had filed mechanics liens related to unpaid invoices issued in connection with the construction and renovation of a property owned by the Company. On April 17, 2025, the Company received a summons and a copy of a complaint filed by BE&K in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “BE&K Complaint”). Other Defendants named in the BE&K Complaint who are subcontractors elected to file counterclaims and cross-claims as part of their responses to the BE&K Complaint. To our knowledge as of the date hereof, Cogent Bank, also named as a Defendant in the BE&K Complaint, has not elected to take legal action at this time. The cases have been consolidated. The court has set the BE&K matter for a five-day jury trial in December 2026. There will also be a pretrial conference on November 20, 2026.
On
June 26, 2026, as part of a settlement with B&I Contractors, Inc. (“B&I”), we received notice that B&I had filed
a voluntary dismissal with prejudice of its crossclaims against us in the matter BE&K Building Group, LLC v. HCW Biologics Inc.,
et al. pending in the Circuit Court of the Seventeenth Judicial Circuit in and for Broward County, Florida. The matter arose from
a mechanics’ lien filed by B&I in connection with allegedly unpaid invoices relating to renovation work at our facility located
at 3300 Corporate Way, Miramar, Florida, which is being renovated for future office and laboratory use. In connection with the settlement,
B&I filed a final satisfaction of lien releasing a lien in the amount of approximately $
On
October 24, 2025, the Company was notified by Cogent Bank that it exercised its discretion to make a demand that the Company cure the
Defaults no later than thirty (30) days after receipt of this letter in strict compliance with Section 7.2(3) of the Loan Agreement by:
(i) paying and discharging all of the Claims of Lien and causing satisfactions to be recorded in the Public Records of Broward County,
Florida for all of the Claims of Lien, and (ii) resolving all litigation against the Borrower and the mortgaged property described in
the Mortgage and causing such claims in the Foreclosure Actions to be dismissed and all related notices of lis pendens to be released.
The Company and Cogent Bank are negotiating terms for a forbearance agreement to provide additional time for the Company to comply with
the demands Cogent Bank made in their demand letter. As of June 30, 2026, the balance due under the Loan Agreement is $
Other Matters
On
May 26, 2026, we paid in full all amounts due under a settlement agreement with EirGenix, Inc. (“EirGenix”), our contract
development and manufacturing organization, relating to manufacturing costs. Pursuant to the settlement agreement entered into on December
9, 2025, EirGenix agreed to accept $
On June 26, 2025, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company is in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”). On June 29, 2026, the Company received written notice from the Nasdaq Listing Staff that the Nasdaq Hearings Panel found that the Company had regained compliance with the Bid Price Rule, subject to certain restrictions.
On
July 29, 2026, the SEC temporarily stayed the effectiveness of its July 22, 2026 order approving the Nasdaq’s proposed rule change
to adopt a new $
New
Nasdaq Rules 5450(a)(3) (Nasdaq Global Select and Global Market) and 5550(a)(6) (Nasdaq Capital Market) would have required listed companies
to maintain a Market Value of Listed Securities (MVLS) of at least $5 million (MVLS is the consolidated closing bid price multiplied
by the total shares outstanding of the listed class). If a company failed the $5 million MVLS Requirement for 30 consecutive business
days, it would receive an immediate Staff Delisting Determination, with no compliance plan or cure period available. A company may appeal
the Staff Delisting Determination, however, timely Nasdaq Hearings Panel (the “Panel”) appeal would not stay the suspension
from trading for an MVLS-based delisting determination. It means that the securities would trade on the over-the-counter market (“OTC”)
while the appeal is pending.
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Inflationary Cost Environment, Banking Crisis, Supply Chain Disruption and the Macroeconomic Environment
The Company’s operations have been affected by many headwinds, including inflationary pressures, tariffs, rising interest rates, ongoing global supply chain disruptions resulting from increased geopolitical tensions such as the war in the Middle East, the conflict between Russia and Ukraine, China-Taiwan relations, financial market volatility and currency movements. The Company has been impacted by inflation, and may continue to be so, when securing materials needed for our operations, the costs for recruiting and retaining employees and other employee-related costs. Management employs a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines. Future developments in these and other areas present material uncertainty and risk with respect to the Company’s clinical trials, IND-enabling activities, as well as the Company’s financial condition and results of operations. The extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable.
13. Subsequent Events
Subsequent events have been evaluated through the date the financial statements were filed. In addition to the required recognition or disclosure disclosed in the footnotes herein, there were also the following subsequent events after the reporting date:
| ● | On July 29, 2026, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (each, an investor, and collectively, the “Investors”), pursuant to which the Company agreed to issue and sell an aggregate of units (the “Units”), with each Unit consisting of (i) one share of the Company’s Common Stock, or, in lieu thereof, one pre-funded warrant to purchase one share of Common Stock (the “Pre-Funded Warrants”), and (ii) the right to receive one common stock purchase warrant (the “Common Warrants”) to purchase one share of Common Stock upon, and subject to, stockholder approval of the issuance of the Common Warrants. The Units were sold at a purchase price of $ per Unit consisting of one share of Common Stock and the right to receive one Common Warrant and $ per Unit consisting of one Pre-Funded Warrant and the right to receive one Common Warrant. The Common Stock (or Pre-Funded Warrants) and Common Warrants comprising the Units are immediately separable and will be issued separately, the Common Warrants to be issued only upon, and subject to, stockholder approval thereof, which the Company is obligated to seek pursuant to the terms of the Purchase Agreement. |
Pursuant
to the Purchase Agreement, the Company agreed to issue and sell Units that include an aggregate of shares of Common Stock and
Pre-Funded Warrants for aggregate gross proceeds of approximately $
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The
Pre-Funded Warrants have an exercise price of $
The
Investors are entitled to receive Common Warrants exercisable for an aggregate of up to
In connection with the Purchase Agreement, Hing C. Wong, Ph.D., the Company’s Founder and Chief Executive Officer, Scott Garrett, a member and the Chairman of the Company’s Board of Directors, and Lee Flowers, the Company’s Senior Vice President of Business Development, participated in the private placement on the same terms and conditions as the other Investor.
In connection with the Purchase Agreement, the Company also entered into a Registration Rights Agreement with the Investors (the “Registration Rights Agreement”), pursuant to which the Company agreed to provide certain registration rights with respect to the resale of the shares of Common Stock issued in the offering, the shares issuable upon exercise of the Pre-Funded Warrants and the shares issuable upon exercise of the Common Warrants. The Company agreed to file an initial registration statement within 15 trading days following the closing of the offering and to use commercially reasonable efforts to cause such registration statement to be declared effective by the SEC within 60 days following the closing.
| ● | On
July 29, 2026, the SEC temporarily stayed the effectiveness of its July 22, 2026 order approving
the Nasdaq’s proposed rule change to adopt a new $ |
| 29 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with (i) our unaudited condensed interim financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) our audited financial statements and related notes and the discussion under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for the fiscal year ended December 31, 2025 included in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2026 (the “Annual Report”). Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to the “Company,” “HCW Biologics,” “HCWB,” “we,” “us” and “our” refer to HCW Biologics Inc.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success of our clinical trials, plans and objectives of management for future operations, adequacy of our cash resources and working capital, future economic conditions or performance, and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part II, Item 1A -”Risk Factors,” in this Quarterly Report on Form 10-Q and in other filings we make with the SEC from time to time. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. These forward-looking statements speak only as of the date hereof. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Overview
HCW Biologics Inc. (“HCW Biologics” or the “Company”) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation. We have created novel compounds that represent a new class of drugs that we believe have the potential to fundamentally change the treatment of autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia. In addition, we have begun commercialization of certain commercial-ready proprietary compounds for use as reagents to support the production of immunotherapeutics for the treatment of infectious diseases and cancer.
By leveraging our extensive immunology expertise, we have developed fusion immunotherapeutics representing a new class of drug that we believe has the potential to fundamentally change the treatments for autoimmune diseases, cancer, senescence-associated dysplasia, and many other diseases promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity.
HCW Biologics has an experienced team led by Dr. Hing C. Wong, our Founder and CEO, who discovered and developed the immunotherapeutic Anktiva® (also known as ALT-803, an IL-15 receptor agonist) through pivotal trials. This blockbuster immunotherapeutic treatment for cancer was sold to ImmunityBio, Inc. in 2017 in a $1.0 billion acquisition. In April 2024, Anktiva® was approved by the U.S. Food and Drug Administration for its first indication, the treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer in combination with BCG.
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Business Highlights
Reverse Stock Split
The Company completed a one-for-six reverse stock split on June 30, 2026 (the “Reverse Stock Split”). All share amounts and price per share amounts discussed herein reflect the Reverse Stock Split.
Financing
May 2026 Sale of Common Stock, Pre-Funded Warrants and Common Stock Warrants
On May 21, 2026, the Company completed a $4.0 million private placement with a group of existing stockholders, in which the Company sold 474,496 units, each of which consisted of one share of Common Stock, or a Pre-Funded Warrant in lieu thereof, and a Common Stock Warrant to purchase one share of Common Stock. Net proceeds to the Company after placement agent commissions and offering costs were $3.5 million. On June 18, 2026, the SEC declared effective a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in this private placement. Investors included a single institutional investor and certain of our directors and executive officers. Scott Garrett, Chairman of our board of directors, purchased $250,000 of securities, Hing C. Wong, our Founder and Chief Executive Officer, purchased $160,000 of securities, and Rebecca Byam, our Chief Financial Officer, purchased $20,000 of securities. Such purchases were made on the same terms and conditions as those offered to other investors. On June 22, 2026, the holder exercised all Pre-Funded Warrants issued in this transaction to purchase 403,322 shares of Common Stock for $0.0001 per share.
July 2026 Sale of Units Comprised of Common Stock, Pre-Funded Warrants and Rights to Receive Common Stock Warrants
Subsequent to June 30, 2026, on July 29, 2026, the Company completed a private placement with certain accredited investors in which the Company sold 618,682 units, each unit consisting of one share of Common Stock, or a Pre-Funded Warrant in lieu thereof, and (ii) the right to receive one Common Stock Warrant upon, and subject to, stockholder approval of the issuance of such Common Stock Warrants, which approval the Company is obligated to seek pursuant to the terms of the purchase agreement. Gross proceeds of the offering were approximately $1.6 million before deducting offering expenses. Hing C. Wong, Ph.D., our Founder and Chief Executive Officer, Scott Garrett, Chairman of our board of directors, and Lee Flowers, our Senior Vice President of Business Development, participated in the private placement on the same terms and conditions as the other investor.
Preparing for Business Development Transaction for Commercial-Ready Reagents
Two of our internally-developed, multi-cytokine fusion protein molecules, HCW9201 and HCW9206, were licensed to AlloTera Therapeutics in 2020. During 2025, AlloTera Therapeutics was refocusing its clinical development programs, and the Company agreed to a suspension of the AlloTera Therapeutics License. On May 21, 2026, the Company elected to terminate the AlloTera Therapeutics License according to the terms provided in the suspension agreement.
We are positioning HCW9206 and HCW9201 as commercial-ready reagents for use in supporting the manufacture of cell-based immunotherapeutics to treat cancer and infectious diseases. The extensive research done in collaboration with the Albert Einstein College of Medicine showed that HCW9206 and similar molecules developed by the Company appear to support more efficient production of CAR-T cells that keep fighting disease longer. We intend to enter into a commercialization partnership with a biopharmaceutical manufacturing company in the second half of 2026.
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Since inception in December 2020, the Company has recognized $16.2 million in revenue derived from the AlloTera Therapeutics License, including upfront license fees in cash and shares of AlloTera Therapeutics common stock, purchases of the Company’s inventory of certain molecules needed for manufacturing, and purchases of materials for its clinical trials. In addition, the Company received over $1.8 million in reimbursements for its R&D expenses. The upfront license fee is nonrefundable, and as such, the Company retains ownership of the 2.2 million shares of AlloTera Therapeutics common stock.
Settlement of Accounts Payable Obligations
The Company continues to strengthen its balance sheet through repayment and restructuring of obligations. In the three months ended June 30, 2026, the Company settled $2.8 million of overdue accounts payable, including $1.1 million owed to B&I Contractors, Inc. (“B&I”) and $1.7 million owed to Eirgenix. Settlement terms fully resolved all amounts claimed to be owed by the Company to these vendors. In the three months ended June 30, 2026, the Company paid Eirgenix $620,000 and paid B&I $512,655. In the six months ended June 30, 2026, the Company paid Eirgenix $1,240,000 and paid B&I $865,655.
Nasdaq Compliance
On June 26, 2025, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company is in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”). On June 29, 2026, the Company received written notice from the Nasdaq Listing Staff that the Nasdaq Hearings Panel found that the Company had regained compliance with the Bid Price Rule, subject to certain restrictions. The Company will be subject to a Mandatory Panel Monitor until June 17, 2027. See Part II, Item 1, “Legal Proceedings – Other Matters.”
Clinical Development
Preliminary Human Data Readout for Phase 1 Clinical Study Evaluating HCW9302 as Monotherapy in Alopecia Areata
On June 16, 2026, the Company disclosed a preliminary human data readout for the Phase 1 clinical study evaluating HCW9302 in patients with alopecia areata. The Company believes that based on the human data readout and extensive preclinical studies, HCW9302 is potentially a best-in-class IL-2 based treatment for autoimmune diseases by expanding and activating regulatory T cells. Preliminary results indicate that HCW9302 is well tolerated, with no dose-limiting toxicities or significant known IL-2-treatment-related adverse effects, including no reported incidence of capillary leak syndrome, cytokine release syndrome, or increase in blood eosinophil counts.
The readout was for two dose cohorts in a dose-escalating study. All patients, including the first dose cohort at one (1) microgram/kg body weight and the second dose cohort at three (3) micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. In the second dose cohort, all three participants showed preliminary indications of improvement in their Severity of Alopecia Tool (“SALT”) scores. These three participants, all with mild alopecia, showed a ≥25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. Treatment of patients in the third dose cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing.
There were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment emergent adverse events were mild in severity and self-limiting and resolved without medical intervention. The most common side effect was temporary injection-site reaction.
Dosing of the third dose cohort is underway at eight (8) micrograms/kg body weight. The Company has not reported any dose limiting toxicities in the patients treated to date. Patient enrollment continues to be strong, and the Company has added a third clinical site to the study. The full Phase 1 human data readout for the HCW9302 study remains on track to be released in the fourth quarter of 2026. Primary endpoints are safety and a recommended Phase 1 dose. Working with collaborators, the Company is conducting ancillary studies to supplement this data.
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Milestone for HCW11-018b, Leading Product Candidate in Company’s Tetravalent T-Cell Engager Program
The Company requested a Type B (pre-IND application) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager (“TCE”) constructed with the Company’s proprietary TRBC drug development platform. The Company would like to reach agreement with FDA on requirements for a clinical study before we submit an IND application to evaluate HCW11-018b in cancer. This clinical trial is on track to initiate in the first half of 2027, provided we secured FDA authorization.
HCW11-018b is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity in solid tumors, particularly in gynecologic and pancreatic cancers.
The Company believes that our robust, streamlined, and cost-efficient manufacturing process will produce high-quality cGMP material to support clinical development. Our manufacturing process for HCW11-018b is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. This monoclonal antibody will be manufactured under GMP standards using a top-tier CDMO.
TCEs have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but they continue to face significant challenges, including limited antigen selection, poor efficacy in solid tumors, tolerability and safety concerns, and complex manufacturing processes. Extensive preclinical studies of HCW11-018b —including assessments of in vitro and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window — suggest that HCW11-018b may be able to overcome the limitations of earlier-generation TCEs.
Trends and Uncertainties
Inflationary Cost Environment, Geopolitical Risks and Other Macroeconomic Factors
The Company’s operations have been affected by many headwinds, including inflationary pressures, tariffs, rising interest rates, ongoing global supply chain disruptions resulting from increased geopolitical tensions such as the war in the Middle East, the conflict between Russia and Ukraine, China-Taiwan relations, financial market volatility and currency movements. The Company has been impacted by inflation, and may continue to be so, when securing materials needed for our operations, the costs for recruiting and retaining employees and other employee-related costs. Management employs a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines. Future developments in these and other areas present material uncertainty and risk with respect to the Company’s clinical trials, IND-enabling activities, as well as the Company’s financial condition and results of operations. The extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable.
Components of our Results of Operation
Revenues
We have no products approved for commercial sale and have not generated any revenue from commercial product sales of internally-developed immunotherapeutic products for the treatment of autoimmune disorders, cancer and senescence-associated dysplasia. Since inception, our sole source of revenue is from license and clinical development supply agreements.
AlloTera Therapeutics License
The Company entered the AlloTera Therapeutics License at the end of 2020, and we entered a development supply agreement with them to provide it with clinical development materials needed for research and clinical development in the first quarter of 2021. On May 29, 2025, the Company agreed to a one-year suspension of the AlloTera Therapeutics License, while they assessed the strategic direction of their clinical development programs. On May 21, 2026, the Company elected to terminate the AlloTera Therapeutics License according to the terms of the suspension agreement. The Company has launched a commercial-ready program to commercialize the two molecules formerly licensed to AlloTera Therapeutics as reagents to support the manufacturing process of cell-based immunotherapies for cancer and infectious diseases.
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The Company will continue to hold the upfront, nonrefundable license fee from AlloTera Therapeutics, including the in-kind payment of 2.2 million shares of their common stock.
Trimmune License
On November 17, 2025, the Company and Beijing Trimmune Biotech Co., Ltd. (“Trimmune”) entered into an Amended and Restated License, Research and Co-Development Agreement (“Trimmune License”) following the assignment of the original License, Research and Co-Development Agreement, which includes an exclusive license to HCW11-006 for in vivo applications (“WY Biotech License”) from WY Biotech Co., Ltd. to Trimmune. The parties restructured the terms of the original WY Biotech License to include the assignment of rights to Trimmune and an option to license HCW9302 for in vivo applications in China or Asia. The Company retained its Opt-In Rights for the Americas market, which we may exercise after Trimmune completes its first Phase 1 clinical study.
On March 16, 2026, the Company received the full nonrefundable upfront license fee, consisting of $3.5 million in gross cash proceeds, or $2.9 million net of taxes, and a transferable minority equity ownership interest in Trimmune with a fair value of $3.5 million, whereupon the transaction was deemed closed and the contract was binding. The Company elected to use the measurement alternative under ASC 321-10-35-2 to account for the investment in Trimmune shares — cost less impairment, with adjustment for observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
In addition to the upfront license fee and Opt-In Rights, the Company is eligible to receive additional development milestone payments and double-digit royalties on future product sales. Further, in the event Trimmune elects to exercise its option to license HCW9302 in China or Asia, the Company will receive additional consideration. None of these elements met the threshold for recognition under Topic 606 as of June 30, 2026.
Operating Expenses
Our operating expenses are reported as research and development expenses and general and administrative expenses.
Research and Development
Our research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:
| ● | Employee-related expenses, including salaries, benefits, and stock-based compensation expense; |
| ● | Expenses related to manufacturing and materials, consisting primarily of expenses incurred in connection with CMOs, which produce cGMP materials for clinical trials on our behalf; |
| ● | Expenses associated with preclinical activities, including research and development and other IND-enabling activities; |
| ● | Expenses incurred in connection with clinical trials; and |
| ● | Other expenses, such as facilities-related expenses, direct depreciation costs for capitalized scientific equipment, and allocation for overhead. |
We expense research and development costs as they are incurred. Costs for contract manufacturing are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the agreement, and the pattern of payments for goods and services will change depending on the material. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and expensed as the related goods are delivered or the services are performed.
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We expect research and development expenses to increase substantially for the foreseeable future as we continue the development of our product candidates. We cannot reasonably determine the nature, timing, and costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. Product candidates in later stages of development generally have higher development costs than those in earlier stages. See “Risk Factors — Risks Related to the Development and Clinical Testing of Our Product Candidates,” in our Annual Report for a discussion of some of the risks and uncertainties associated with the development and commercialization of our product candidates. Any changes in the outcome of any of these risks and uncertainties with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.
General and Administrative
General and administrative expenses consist primarily of employee-related expenses for executive, legal, finance, accounting, human resources and other administrative personnel, as well as professional fees (including legal, audit and tax services), insurance costs, facilities expenses, and other public company compliance costs.
We expect general and administrative expenses incurred in the normal course of business for other purposes, such as costs for recruitment and retention of personnel, service fees for consultants, advisors and accountants, as well as costs to comply with government regulations, corporate governance, internal control over financial reporting, insurance and other requirements for a public company, to continue to increase for the foreseeable future as we build our clinical programs.
Legal Expenses (Recoveries), Net
The Company was involved in an Arbitration and related Complaint that were dismissed with prejudice as of December 31, 2024. See Part II, Item 1, “Legal Proceedings – Arbitration, Settlement and General Release.” In the Settlement Agreement, the Company retained exclusive rights to HCW9302 and certain other molecules. The Company anticipates that it will continue to incur legal expenses for patent filings and other matters to protect our intellectual property rights and remain in compliance with the terms of the Settlement Agreement.
Indirect Tax Expense and Income Tax Expense
When Trimmune paid the full nonrefundable upfront license fee on March 16, 2026, the Chinese government withheld income taxes of $330,186, which the Company recognized as an expense in the six months ended June 30, 2026 in the accompany condensed statements of operations.
Interest Expense
Interest expense includes interest paid on debt. This includes interest due on the Cogent Bank loan, Secured Notes issued by the Company and accretion of original issue discount and accretion of debt issuance costs.
On August 15, 2022, we entered into a loan and security agreement with Cogent Bank to partially fund our purchase of the property we acquired on that same date (the “2022 Loan”). We borrowed $6.5 million under this agreement. Amounts outstanding on the term loan accrue interest at a rate per annum equal to 5.75%. We were obligated to make interest-only payments on this loan from September 2022 through August 2023 and principal and interest payments in 48 equal monthly installments, based on a 25-year maturity schedule, commencing September 15, 2023.
During the three months ended June 30, 2025, certain noteholders agreed to restructure $6.6 million of the principal amount of Secured Notes issued by the Company, including the accumulated accretion of a fixed bonus payable on Maturity Date, and convert to equity. Noteholders who purchased notes for $325,000 did not elect to convert their Secured Notes. The Secured Notes bear interest at an annual rate of 9%, payable quarterly in arrears. They are also entitled to a fixed bonus, payable on the Maturity Date of August 31, 2026, which is accreted on a straight-line basis.
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On May 8, 2025, the Company issued a $150,000 promissory note with a personal guarantee from the Company’s Founder and Chief Executive Officer, which has an original issue discount of $75,000 which is accreted on a straight-line basis from the date of issuance to the Maturity Date of February 7, 2026 (the “Secured Promissory Note”). The Company repaid $225,000 on February 6, 2026.
Change in Fair Value of Investment and Contingent Liability
The Company received 2.2 million shares of AlloTera Therapeutics as an in-kind payment for a nonrefundable license fee in December 2020. In the second quarter of 2025, the Company elected to account for its shares of AlloTera Therapeutics, previously accounted for under the measurement alternative, at fair value determined using financial valuation techniques and market information available. In May 2025, the Company entered two transactions to restructure and convert debt. The terms of conversion gave the converting Secured Noteholders and holders of Convertible Bridge Notes the right to a portion of the proceeds upon the sale or liquidation of the Company’s AlloTera Therapeutics shares, if such an event occurs, giving rise to a contingent liability. The Company derives the fair value of the contingent liability according to the fair value measured for underlying the AlloTera shares. The Company remeasures the change in fair value of the AlloTera shares and related contingent liability in earnings.
Gain on Extinguishment of Liability
From time to time, the Company restructures liabilities and debt obligations to strengthen our balance sheet. When the Company settles the obligation for less than the recorded carrying value, we recognize a gain on debt extinguishment or extinguishment of a liability in earnings during the period in which it is settled.
Change in Fair Value of Warrant Liability
As a result of the modification of existing warrants that may be exercised to purchase up to 503,402 shares of Common Stock to lower the strike price from $14.46 to $3.633 per share, the Company classified these warrants as a warrant liability and recognized it at fair value on the date of the modification as of March 31, 2026. On June 15, 2026, the Company’s stockholders approved the repricing of these warrants at the Annual Meeting of Stockholders. The Company recognized the change in fair value of the warrant liability through the period ended June 15, 2026. With the resolution of the contingency for settlement, these warrants were reclassified to equity as of June 15, 2026.
Other Income, Net
Other income, net consists of interest earned on our cash, cash equivalents, unrealized gains and losses related to our investments in U.S. government-backed securities, and other income and expenses related to non-operating activities.
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Results of Operations
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenues | $ | 6,550 | $ | 135,568 | $ | 11,615 | $ | 6,678,569 | ||||||||
| Cost of revenues | (5,240 | ) | (229,455 | ) | (9,292 | ) | (240,526 | ) | ||||||||
| Gross Profit | 1,310 | (93,887 | ) | 2,323 | 6,438,043 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,226,824 | 1,203,352 | 2,705,536 | 2,461,300 | ||||||||||||
| General and administrative | 2,096,021 | 1,870,375 | 4,302,301 | 3,703,652 | ||||||||||||
| Legal expenses (recoveries), net | 142,542 | (1,325 | ) | (1,596,951 | ) | 5,525 | ||||||||||
| Indirect tax expense | - | - | - | 198,146 | ||||||||||||
| Total operating expenses | 3,465,387 | 3,072,402 | 5,410,886 | 6,368,623 | ||||||||||||
| Operating income (loss) | (3,464,077 | ) | (3,166,289 | ) | (5,408,563 | ) | 69,420 | |||||||||
| Interest expense | (228,714 | ) | (100,541 | ) | (505,853 | ) | (209,815 | ) | ||||||||
| Change in fair value of warrant liability | - | (2,443,335 | ) | - | (1,775,992 | ) | ||||||||||
| Change in fair value of investment, net | 1,748,688 | - | 1,748,688 | - | ||||||||||||
| Gain on extinguishment of liability | - | 483,383 | - | 483,383 | ||||||||||||
| Other income, net | 16,373 | 7,551 | 41,122 | 16,439 | ||||||||||||
| Net loss before income taxes | (1,927,730 | ) | (5,219,231 | ) | (4,124,606 | ) | (1,416,565 | ) | ||||||||
| Income tax expense | - | - | - | (330,186 | ) | |||||||||||
| Net loss | $ | (1,927,730 | ) | $ | (5,219,231 | ) | $ | (4,124,606 | ) | $ | (1,746,751 | ) | ||||
Comparison of the Three Months ended June 30, 2025 and June 30, 2026
Revenues
For the three months ended June 30, 2025, there was $6,550 of revenue the Company derived from ancillary services such as drug storage and insurance related to the winddown of the AlloTera Therapeutics License during the one-year suspension period that began on May 29, 2025.
For the three months ended June 30, 2026, there was $135,568 of revenue related to the completion of some of the services required under the Service Performance Obligation for the Trimmune License, primarily for supporting Trimmune with building a master cell bank. For remaining services under the Service Performance Obligation as of June 30, 2026, the Company recognized a contractual liability of $348,270 in deferred revenue in the accompanying condensed balance sheet.
Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended June 30, 2025 and June 30, 2026:
| Three Months Ended June 30, | ||||||||||||||||
| 2025 | 2026 | $ Change | % Change | |||||||||||||
| Salaries, benefits and related expenses | $ | 778,440 | $ | 761,312 | $ | (17,128 | ) | (2 | )% | |||||||
| Manufacturing and materials | 33,986 | 27,073 | (6,913 | ) | (20 | )% | ||||||||||
| Preclinical expenses | 146,948 | 158,917 | 11,969 | 8 | % | |||||||||||
| Clinical trials | 110,935 | 101,246 | (9,689 | ) | (9 | )% | ||||||||||
| Other expenses | 156,515 | 154,804 | (1,711 | ) | (1 | )% | ||||||||||
| Total research and development expenses | $ | 1,226,824 | $ | 1,203,352 | $ | (23,472 | ) | (2 | )% | |||||||
Research and development expenses decreased by $23,472, or 2%, from $1.2 million for the three months ended June 30, 2025 to $1.2 million for the three months ended June 30, 2026. The decrease was primarily due to decreases in salaries, benefits and related taxes and clinical trial expenses.
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Salaries, benefits, and related expenses decreased by $17,128, or 2%, from $778,440 for the three months ended June 30, 2025 to $761,312 for the three months ended June 30, 2026. This decrease was primarily attributable to decreases of $24,900 in salaries, benefits and related taxes and $15,448 in expense for stock-based compensation, partially offset by an increase of $23,220 in costs associated with employee benefits.
Manufacturing and materials expense decreased by $6,913, or 20%, from $33,986 for the three months ended June 30, 2025 to $27,073 for the three months ended June 30, 2026. In the three months ended June 30, 2025, the Company had produced and vialed the product necessary for the clinical trials for HCW9302. In the three months ended June 30, 2026, the Company focused on internal development and preparation for the creation of master cell banks to generate its TRBC-based lead product candidates.
Expenses associated with preclinical activities increased by $11,969, or 8%, from $146,948 for the three months ended June 30, 2025 to $158,917 for the three months ended June 30, 2026. In the three months ended June 30, 2025, the Company incurred costs to complete development of intellectual property required for the technology being licensed to Trimmune. In the three months ended June 30, 2026, the Company focused on IND-enabling activities required to prepare HCW11-018b, the Company’s tetravalent T-cell engager, for a Phase 1 clinical trial in cancer. The Company will continue to incur preclinical expenses for IND-enabling studies for HCW11-018b as well as HCW11-040, the second-generation immune checkpoint inhibitor in the coming year. The Company intends to file an IND-application to seek authorization to evaluate HCW11-018b in a Phase 1 clinical study in patients with cancer in the first half of 2027, and an IND-application to seek authorization to evaluate HCW11-040 in bronchopulmonary dysplasia, a chronic lung disease primarily affecting premature infants, in the second half of 2027.
Expenses associated with clinical activities decreased by $9,689, or 9%, from $110,935 for the three months ended June 30, 2025 to $101,246 for the three months ended June 30, 2026. The decrease was primarily attributable to decreases of $51,301 for consulting and outsourced R&D services and $10,961 for IRB fees and clinical site start-up expenses, partially offset by increases of $47,767 in patient fees and $4,806 for software licenses and data management. We anticipate that clinical expenses will increase in the coming year due to the continuation of clinical trials to evaluate HCW9302 in autoimmune indications and the initiation of a Phase 1 clinical study to evaluate HCW11-018b in cancer.
Other expenses, which include overhead allocations, decreased by $1,711, or 1%, from $156,515 for the three months ended June 30, 2025 to $154,804 for the three months ended June 30, 2026. This decrease is primarily attributable to a $7,617 decrease in the allocation of depreciation for scientific equipment, partially offset by an increase of $5,908 in rent, utilities and other office expenses.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2025 and June 30, 2026:
| Three Months Ended June 30, | ||||||||||||||||
| 2025 | 2026 | $ Change | % Change | |||||||||||||
| Salaries, benefits and related expenses | $ | 765,539 | $ | 523,466 | $ | (242,073 | ) | (32 | )% | |||||||
| Professional services | 496,641 | 504,837 | 8,196 | 2 | % | |||||||||||
| Facilities and office expenses | 111,740 | 103,883 | (7,857 | ) | (7 | )% | ||||||||||
| Accretion of fixed bonus upon maturity of Secured Notes | 102,248 | 14,413 | (87,835 | ) | NM | |||||||||||
| Depreciation | 59,160 | 49,994 | (9,166 | ) | (15 | )% | ||||||||||
| Rent and occupancy expense | 62,528 | 45,887 | (16,641 | ) | (27 | )% | ||||||||||
| Other expenses | 498,165 | 627,895 | 129,730 | 26 | % | |||||||||||
| Total general and administrative expenses | $ | 2,096,021 | $ | 1,870,375 | $ | (225,646 | ) | (11 | )% | |||||||
NM = Not meaningful
General and administrative expenses decreased $225,646, or 11%, from $2.1 million for the three months ended June 30, 2025 to $1.9 million for the three months ended June 30, 2026. The decrease is primarily attributable to decreases in compensation expense for stock-based compensation and accretion of fixed bonus upon maturity of Secured Notes, offset by an increase of expenses for financing related activities.
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Salaries, benefits and related expenses decreased by $242,073, or 32%, from $765,539 for the three months ended June 30, 2025 to $523,466 for the three months ended June 30, 2026. The decrease is primarily attributable to decreases of $261,638 in compensation expense for stock-based compensation and $10,000 in compensation for the Board of Directors, partially offset by an increase of $16,495 in employee benefits. In the second quarter of 2025, Gary M. Winer resigned from the Board of Directors in the second quarter of 2025, and the seat remains vacant.
Professional services increased by $8,196, or 2%, from $496,641 for the three months ended June 30, 2025 to $504,837 for the three months ended June 30, 2026. The increase is primarily attributable to an increase of $63,862 in professional fees related to corporate legal fees, audit fees, tax advisory fees and technical accounting advisory fees, partially offset by a decrease of $58,209 related to patent filings and other legal activity performed for our intellectual property portfolio.
Facilities and office expenses decreased by $7,857, or 7%, from $111,740 for the three months ended June 30, 2025 to $103,883 for the three months ended June 30, 2026. The decrease is primarily due to a decrease of $7,182 for fees paid for licenses, software and IT services.
Throughout 2024, the Company issued $6.9 million of Secured Notes. The terms of the Secured Notes were amended on July 2, 2024 to include a fixed bonus payment in the event that the Secured Notes were repaid on their Maturity Date of August 30, 2026. On May 7, 2025, $6.6 million of the principal of the Secured Notes and the balance of their accumulated accretion for the fixed bonus payment due on the Maturity Date converted to equity. As of June 30, 2026, the Company continues to hold $325,000 of principal of the Senior Notes. In the three months ended June 30, 2025 and 2026, the Company recognized $102,248 and $14,413, respectively, for the expense for accretion of the fixed bonus payable upon Maturity Date.
Other expenses increased by $129,730, or 26%, from $498,165 for the three months ended June 30, 2025 to $627,895 for the three months ended June 30, 2026. The increase is primarily attributable to increases of $147,121 in costs associated with financing activities, $49,702 in taxes and $14,623 in travel-related expenses, partially offset by a decrease of $79,518 in insurance premiums.
Legal Expenses (Recoveries), Net
In the three months ended June 30, 2025 and 2026, the Company recognized $142,542 net expenses and $1,325 net recovery, respectively.
Interest Expense
In the three months ended June 30, 2025 and 2026, the Company recognized interest expense of $228,714 and $100,541, respectively, including the following items which were reported within Interest expense on the condensed statements of operations:
| ● | For the three months ended June 30, 2025 and 2026, $92,569 and $90,657 in cash for interest, respectively, related to the 2022 Loan, which were recognized as an expense in both periods. | |
| ● | For the three months ended June 30, 2025 and 2026, $67,324 and $7,292 in interest expense, respectively, related to the Secured Notes. | |
| ● | For the three months ended June 30, 2025 and 2026, $14,722 and nil, respectively, in accretion expense for original issue discount of the Secured Promissory Note which was repaid on February 6, 2026. | |
| ● | For the three months ended June 30, 2025 and 2026, $2,592 of amortization of debt issuance costs related to the 2022 Loan in each period. | |
| ● | For the three months ended June 30, 2025, the Company recognized $51,507 in other costs. |
Change in Fair Value of Investment and Contingent Liability
There was a net change in the fair value of the Company’s investment in AlloTera Therapeutics shares of common stock and the related contingent liability of $1.8 million in the three months ended June 30, 2025. There was no change in fair value for the shares or the contingent liability in the three months ended June 30, 2026.
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Gain on Extinguishment of Liability
In the three months ended June 30, 2026, the Company paid $1.2 million in cash to settle a $1.7 million obligation owed to Eirgenix, a CDMO, resulting in a gain on extinguishment of debt of $483,383.
Change in Fair Value of Warrant Liability
In the three months ended June 30, 2026, the Company recognized a change in fair value of $2.4 million. On June 15, 2026, the underlying warrants were reclassified to permanent equity.
Other Income, Net
Other income, net had a de minimis decrease from $16,373 for the three months ended June 30, 2025 to $7,551 for the three months ended June 30, 2026.
Comparison of the Six Months ended June 30, 2025 and June 30, 2026
Revenues
For the six months ended June 30,2025, $11,615 of revenue was recognized in the condensed statements of operations for ancillary services such as drug storage and insurance provided during the winddown of the AlloTera Therapeutics License. The one-year suspension period began on May 29, 2025.
For the six months ended June 30, 2026, $6.7 million of revenue was recognized in the condensed statements of operation which was mainly attributable to the closing of the Trimmune License transaction and transfer of Licensed IP. In addition, there was $135,568 of revenue recognized upon the completion of some of services required under the Service Performance Obligation, primarily for supporting Trimmune in building a master cell bank. The Company recognized $348,270 of deferred revenue for the contract liability for the remaining services required under the Service Performance Obligation as of June 30, 2026.
Research and Development Expenses
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and June 30, 2026:
| Six Months Ended June 30, | ||||||||||||||||
| 2025 | 2026 | $ Change | % Change | |||||||||||||
| Salaries, benefits and related expenses | $ | 1,479,546 | $ | 1,539,698 | $ | 60,152 | 4 | % | ||||||||
| Manufacturing and materials | 296,783 | 17,114 | (279,669 | ) | (94 | )% | ||||||||||
| Preclinical expenses | 324,060 | 376,483 | 52,423 | 16 | % | |||||||||||
| Clinical trials | 298,755 | 228,777 | (69,978 | ) | (23 | )% | ||||||||||
| Other expenses | 306,392 | 299,228 | (7,164 | ) | (2 | )% | ||||||||||
| Total research and development expenses | $ | 2,705,536 | $ | 2,461,300 | $ | (244,236 | ) | (9 | )% | |||||||
Research and development expenses decreased by $244,236, or 9%, from $2.7 million for the six months ended June 30, 2025 to $2.5 million for the six months ended June 30, 2026. This decrease was primarily attributable to a decrease in expenses related to manufacturing and materials and clinical trials, partially offset by increases in salaries, benefits and related expenses.
Salaries, benefits, and related expenses increased by $60,152, or 4%, from $1.5 million for the six months ended June 30, 2025 to $1.5 million for the six months ended June 30, 2026. This increase is primarily attributable to increases of $62,500 for salaries and payroll taxes and $31,804 for employee benefits, partially offset by a decrease of $24,316 for compensation expense related to stock-based compensation.
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Manufacturing and materials expense decreased by $279,669, or 94%, from $296,783 for the six months ended June 30, 2025 to $17,114 for the six months ended June 30, 2026. In the six months ended June 30, 2025, activities were related to completing the manufacturing of the high producing cell-line of HCW9101, used in the manufacturing process for some of our immunotherapeutics. In the six months ended June 30, 2026, costs were incurred for ancillary services such as storage and insurance.
Expenses associated with preclinical activities increased by $52,423, or 16%, from $324,060 for the six months ended June 30, 2025 to $376,483 for the six months ended June 30, 2026. In the six months ended June 30, 2025, expenses were incurred primarily in connection with further testing and research with collaborators for HCW9302. In the six months ended June 30, 2026, activities were primarily related to the Company’s IND-enabling studies for HCW11-018b, in preparation for an IND application to obtain authorization from the FDA to evaluate HCW11-018b in patients with cancer.
Expenses associated with clinical activities decreased by $69,978, or 23%, from $298,755 for the six months ended June 30, 2025 to $228,777 for the six months ended June 30, 2026, primarily due to a decrease of $135,832 in fees for consultation, R&D collaborations and professional fees, partially offset by increases of $56,415 for patient fees and $14,014 for software licenses and data management. In the six months ended June 30, 2025, activities were focused on additional studies with collaborators and start up fees related to opening clinical sites in preparation for the initiation of the Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disease. In the six months ended June 30 2026, the Company completed the first two cohorts of a dose-escalating trial and provided a preliminary readout of human data from the clinical trial. The Company had two active clinical sites as of June 30, 2026, and will soon be opening a third clinical site in the third quarter of 2026.
Other expenses, which include overhead allocations, decreased by $7,164, or 2%, from $306,392 for the six months ended June 30, 2025 to $299,228 for the six months ended June 30, 2026. The decrease in other expenses is primarily attributable to the decrease of $19,889 in the allocation of depreciation.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and June 30, 2026:
| Six Months Ended June 30, | ||||||||||||||||
| 2025 | 2026 | $ Change | % Change | |||||||||||||
| Salaries, benefits and related expenses | $ | 1,554,026 | $ | 1,046,820 | $ | (507,206 | ) | (33 | )% | |||||||
| Professional services | 951,008 | 989,975 | 38,967 | 4 | % | |||||||||||
| Facilities and office expenses | 206,068 | 216,796 | 10,728 | 5 | % | |||||||||||
| Accretion of fixed bonus upon maturity of Secured Notes | 375,308 | 28,826 | (346,482 | ) | NM | |||||||||||
| Depreciation | 120,398 | 103,870 | (16,528 | ) | (14 | )% | ||||||||||
| Rent expense | 112,278 | 87,049 | (25,229 | ) | (22 | )% | ||||||||||
| Other expenses | 983,215 | 1,230,316 | 247,101 | 25 | % | |||||||||||
| Total general and administrative expenses | $ | 4,302,301 | $ | 3,703,652 | $ | (598,649 | ) | (14 | )% | |||||||
NM = Not meaningful
General and administrative expenses related to the ordinary course of business decreased by $598,649, or 14%, from $4.3 million for the six months ended June 30, 2025 to $3.7 million for the six months ended June 30, 2026. The decrease in other expenses is primarily attributable to decreases in salaries and benefits and accretion of the fixed bonus payable on maturity of Secured Notes, partially offset by increases in indirect (VAT) taxes and expenses incurred in connection with financing activities.
Salaries, benefits and related expenses decreased by $507,206, or 33%, from $1.5 million for the six months ended June 30, 2025 to $1.0 million for the six months ended June 30, 2026. The decrease is primarily attributable to a $518,395 decrease in the compensation expense related to stock-based compensation.
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Professional services increased by $38,967, or 4%, from $951,008 for the six months ended June 30, 2025 to $989,975 for the six months ended June 30, 2026. The increase is primarily attributable to a $104,280 increase in fees paid for corporate legal fees, audit services, technical accounting advice, tax services, as well as the costs related to maintaining compliance with SEC and Nasdaq listing requirements, partially offset by a decrease of $65,451 in legal fees related to patents and legal activities performed in connection with our intellectual property portfolio.
Facilities and office expenses increased by $10,728, or 5%, from $206,068 for the six months ended June 30, 2025 to $216,796 for the six months ended June 30, 2026. The increase is primarily due to increases of $14,716 in repairs, maintenance and general office expenses and $9,978 in IT services, partially offset by a decrease of $15,324 in software licenses and other data management services.
In the six months ended June 30, 2025, the Company recognized an expense of $375,308 for accretion of the fixed bonus payment. On May 7, 2025, $6.6 million of the principal of the Secured Notes and the balance of the accumulated fixed bonus payable on the Maturity Date were restructured and converted to equity. Upon conversion, accretion of the fixed bonus payable on the Maturity Date ceased as the right to a fixed bonus was forfeited upon conversion to equity. The Company continues to hold a principal balance of $325,000 of Secured Notes. In the six months ended June 30, 2026, the Company recognized an expense of $28,826 for the accretion of the fixed bonus payable on the Maturity Date for the remaining Secured Notes that were not restructured.
Other expenses increased by $247,101, or 25%, from $983,215 for the six months ended June 30, 2025 to $1.2 million for the six months ended June 30, 2026. The increase is primarily attributable to increases of $204,166 related to expenses for financing costs, $191,798 for annual franchise taxes and $32,301 for travel-related expenses, partially offset by decreases of $175,343 for insurance premiums.
Legal Expenses (Recoveries), Net
For the six months ended June 30, 2025, the Company reported a contra expense of $1.6 million for legal expenses (recoveries), net, reflecting a $2.0 million insurance recovery and legal fees of $397,470. For the six months ended June 30, 2026, the Company reported an expense of $5,525 for legal expenses (recoveries), net.
Interest Expense
In the six months ended June 30, 2025 and 2026, the Company recognized interest expense of $505,853 and $209,815, respectively, including the following items which were reported within Interest expense on the condensed statements of operations:
| ● | For the six months ended June 30, 2025 and 2026, $183,604 and $179,849 in cash for interest, respectively, related to the 2022 Loan, which were recognized as an expense in both periods. | |
| ● | For the six months ended June 30, 2025 and 2026, $220,558 and $14,505 in interest expense, respectively, related to the Secured Notes. | |
| ● | For the six months ended June 30, 2025 and 2026, $14,722 and $10,278 in accretion expense for original issue discount of the Secured Promissory Note which was repaid on February 6, 2026. | |
| ● | For the six months ended June 30, 2025 and 2026, $5,183 for amortization of debt issuance costs related to | |
| ● | the 2022 Loan in each period. | |
| ● | For the six months ended June 30, 2025, the Company recognized $8,961 for amortization of debt issuance costs related to the Secured Notes. | |
| ● | For the six months ended June 30, 2025 and 2026, the Company recognized $72,825 in other costs. |
Change in Fair Value of Investment and Contingent Liability
There was a net change in the fair value of investment in AlloTera shares and the related contingent liability of $1.8 million in the six months ended June 30, 2025. There was no change in fair value in the six months ended June 30, 2026.
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Gain on Extinguishment of Liability
In the six months ended June 30, 2026, the Company paid $1.2 million in cash to settle a $1.7 million obligation owed to Eirgenix, a CDMO, resulting in a gain on extinguishment of debt of $483,383.
Change in Fair Value of Warrant Liability
In the six months ended June 30, 2026, the Company recognized a change in fair value of a warrant liability of $1.8 million. On June 15, 2026, the underlying warrants were reclassified to permanent equity.
Other Income, Net
The change in Other income, net was de minimis, from $41,122 for the six months ended June 30, 2025 and $16,439 for the six months ended June 30, 2026.
Liquidity and Capital Resources
Sources of Liquidity
As of June 30, 2026, the Company had a cash and cash equivalents of $741,324. The Company has not generated any revenue from commercial product sales of its internally developed immunotherapeutic products. During its development activities, the Company has sustained operating losses, experienced negative operating cash flows and negative working capital position and expects to continue to incur operating losses for the foreseeable future. Since inception to June 30, 2026, the Company incurred cumulative net losses of $107.5 million.
From inception to June 30, 2026, the Company has funded operations primarily through the sale of equity securities; issuance of Senior Notes; revenues generated from the Company’s exclusive worldwide licenses to develop and commercialize certain internally-developed molecules, and sale clinical materials for research and clinical studies for our licensees. On March 16 2026, the Trimmune License transaction closed upon receipt of the full upfront license fee. For the three and six months ended June 30, 2026, the Company recognized revenues of $135,568 and $6.7 million, respectively. The upfront, nonrefundable license fee included a transferable minority equity interest in Trimmune. Since Trimmune is a private company, there is limited ability to liquidate these shares at this time. On May 21, 2026, the Company elected to terminate its exclusive worldwide license with AlloTera Therapeutics. With these reacquired rights, the Company is launching the formerly licensed molecules as commercial-ready reagents to use to support more cost-effective and efficient manufacturing for cell-based immunotherapies for cancer and infectious diseases. Our strategy is to commercialize the reagents in partnership with a biopharmaceutical manufacturing company in a business development transaction, such as a joint venture or license. The Company will retain the 2.2 million shares of AlloTera Therapeutics received as an in-kind payment for a portion of the nonrefundable upfront license fee. AlloTera Therapeutics is a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers.
In the three months ended June 30, 2026, the Company completed a $4.0 million offering, which provided $3.5 million in net proceeds after commission and offering costs we are responsible for. Investors who participated in this round were existing stockholders, including officers and directors of the Company. Scott Garrett, Chairman of our board of directors, purchased $250,000 of securities, Hing C. Wong, our Founder and Chief Executive Officer, purchased $160,000 of securities, and Rebecca Byam, our Chief Financial Officer, purchased $20,000 of securities. Such purchases were made on the same terms and conditions as those offered to other investors.
On December 30, 2025, the Company entered a settlement agreement with Cooley related to legal fees incurred in connection with the defense of Dr. Wong. As a result of that agreement, the Company, Dr. Wong and Cooley agreed to settle a $7.5 million obligation for $2.0 million in cash and contingent payments up to $5.5 million upon achievement of certain triggering events, all of which were deemed to be remote as of December 31, 2025. In accordance with the terms of the settlement agreement, $500,000 was paid on December 31, 2025. Based on an amendment to the settlement agreement, the Company paid $750,000 on March 20, 2026, and will pay the remaining $750,000 upon the earlier of the completion of a financing for at least $4.0 million in gross proceeds or August 31, 2026. After this settlement, as of June 30, 2026, the Company has a liability of $5.4 million for remaining amounts owed for legal fees related to the Arbitration which continue to remain outstanding.
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During the year ended December 31, 2025, certain subcontractors had filed mechanics liens related to unpaid invoices issued in connection with the construction and renovation of a property owned by the Company. On April 17, 2025, the Company received a summons and a copy of a complaint filed by BE&K in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “BE&K Complaint”). Other Defendants named in the BE&K Complaint who are subcontractors elected to file counterclaims and cross-claims as part of their responses to the BE&K Complaint. To our knowledge as of the date hereof, Cogent Bank, also named as a Defendant in the BE&K Complaint, has not elected to take legal action at this time. In addition, on April 28, 2025, the Company received a summons and a copy of a complaint filed by Fisk Electric Company (which is a defendant in the BE&K Complaint) in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “Fisk Complaint”) against the Company, BE&K, and the other defendants in the BE&K Complaint. The cases have been consolidated. The Company owes BE&K and other lien holders $2.2 million as of June 30, 2026 that was included within Accounts Payable in the accompanying condensed balance sheets. The court has set the BE&K matter for a five-day jury trial in December 2026. There will also be a pretrial conference on November 20, 2026. The Company intends to settle these claims prior to the pre-trial hearing.
On June 26, 2026, as part of a settlement with B&I Contractors, Inc. (“B&I”), we received notice that B&I had filed a voluntary dismissal with prejudice of its crossclaims against us in the matter BE&K Building Group, LLC v. HCW Biologics Inc., et al. pending in the Circuit Court of the Seventeenth Judicial Circuit in and for Broward County, Florida. The matter arose from a mechanics’ lien filed by B&I in connection with allegedly unpaid invoices relating to renovation work at our facility located at 3300 Corporate Way, Miramar, Florida, which is being renovated for future office and laboratory use. In connection with the settlement, B&I filed a final satisfaction of lien releasing a lien in the amount of approximately $1.1 million. The dismissal and satisfaction of lien completed the parties’ settlement and fully resolved all amounts claimed to be owed by us to B&I. There was no gain or loss on the settlement with B&I.
On October 24, 2025, the Company was notified by Cogent Bank that it exercised its discretion to make a demand that the Company cure the defaults no later than thirty (30) days after receipt of this letter in strict compliance with Section 7.2(3) of the Loan Agreement by: (i) paying and discharging all of the Claims of Lien and causing satisfactions to be recorded in the Public Records of Broward County, Florida for all of the Claims of Lien, and (ii) resolving all litigation against the Borrower and the mortgaged property described in the Mortgage and causing such claims in the Foreclosure Actions to be dismissed and all related notices of lis pendens to be released. The Company and Cogent Bank are negotiating terms for a forbearance agreement to provide additional time for the Company to comply with the demands Cogent Bank made in their demand letter. As of June 30, 2026, the balance due under the Loan Agreement was $6.1 million.
On May 26, 2026, we paid in full all amounts due under a settlement agreement with EirGenix, Inc. (“EirGenix”), our contract development and manufacturing organization, relating to manufacturing costs. Pursuant to the settlement agreement entered into on December 9, 2025, EirGenix agreed to accept $1.24 million in full satisfaction of approximately $1.7 million of outstanding amounts, provided payment was made by an agreed deadline. We paid $620,000 on March 3, 2026 and the remaining $620,000 on May 26, 2026. As a result, all obligations under the settlement agreement were satisfied and the related unpaid invoices and disputed credits were fully resolved. There was a gain on extinguishment of a liability of $483,383 recognized in the three and six months ended June 30, 2026 related to the settlement with Eirgenix.
The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. The Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the date of issuance of the Company’s condensed financial statements, without additional funding or financial support. After considering management’s plan for financing and funds raised that are probable to occur within one year, as well as that the Company expects to continue to incur losses from operations for the foreseeable future, management concluded that the substantial doubt that existed in its going concern analysis as of June 30, 2026 was not alleviated.
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Because of the numerous risks and uncertainties associated with the clinical development and commercialization of immunotherapeutics, we are unable to estimate the exact amount of capital requirements to pursue these activities. Our funding requirements will depend on many factors, including, but not limited to:
| ● | timing, progress, costs, and results of our ongoing preclinical studies and clinical trials of our immunotherapeutic products; |
| ● | costs, timing, and outcome of regulatory review of our product candidates; |
| ● | number of trials required for regulatory approval; |
| ● | whether we enter into any cooperative, collaboration or co-development agreements and the terms of such agreements; |
| ● | whether we raise additional funding through bank loan facilities, other debt arrangements, out-licensing or joint ventures, cooperative agreements or strategic collaborations; |
| ● | effect of competing technology and market developments; |
| ● | cost of maintaining, expanding, and enforcing our intellectual property rights; |
| ● | impact of future arbitration, litigation, regulatory inquiries, or investigations, as well as costs to indemnify
our officers and directors against third-party claims related to our patents and other intellectual property: |
| ● | cost and timing of buildout of the Company’s property for upgraded research and development facilities, including risks of cost overruns and delays, and ability to obtain additional financing, if needed; |
| ● | impact of legal actions taken by BE&K and other lien holders related to foreclosure and other claims; and |
| ● | costs and timing of future commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive regulatory approval. |
A change in the outcome of any of these or other factors with respect to the clinical development and commercialization of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures.
Comparison of the Cash Flows for the Six Months Ended June 30, 2025 and June 30, 2026
The following table summarizes our cash flows for the six months ended June 30, 2025 and June 30, 2026:
| Six Months Ended June 30, | ||||||||
| 2025 | 2026 | |||||||
| Cash used in operating activities | $ | (6,796,159 | ) | $ | (5,541,364 | ) | ||
| Cash used in investing activities | — | — | ||||||
| Cash provided by financing activities | 4,560,549 | 4,330,224 | ||||||
| Net decrease in cash and cash equivalents | $ | (2,235,610 | ) | $ | (1,211,140 | ) | ||
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Operating Activities
Net cash used in operating activities was $6.8 million for the six months ended June 30, 2025 and $5.4 million for the six months June 30, 2026.
Cash used by operating activities for the six months ended June 30, 2025 consisted primarily of net loss for the period of $4.1 million, a $1.7 million adjustment for unrealized gain on investment, a $560,590 decrease in Accounts receivable, a $2.8 million decrease in Accounts payable, and a $131,134 loss on conversion with a related party, partially offset by non-cash adjustments of $710,926 for depreciation and accretion expenses, $553,949 for compensation expenses related to stock-based compensation, and a $150,000 Commitment Fee paid in the Company’s Common Stock. Cash provided by operations includes a $2.0 million insurance reimbursement for legal fees incurred on behalf of Dr. Hing Wong, the Company’s Founder and Chief Executive Officer, for his defense costs associated with the Arbitration, in prior periods, which was paid directly to the law firm involved. See Part II, Item 1, “Legal Proceedings – Arbitration, Settlement and General Release.”
Cash used in operating activities for the six months ended June 30, 2026 consisted primarily of a net loss for the period of $1.7 million, noncash revenue in the form of an in-kind payment of a transferable minority equity interest in Trimmune recognized at the fair value of $3.5 million, $2.0 million of cash used to decrease Accounts payable and other liabilities, a gain on extinguishment of a liability of $483,383 and a $108,214 increase in prepaid expenses and other assets. The uses were partially offset by an increase of $348,270 in Deferred revenue related to contract liabilities under the Trimmune License and noncash adjustments, including a $1.8 million change in fair value of warrant liability, $269,144 for Depreciation and accretion and $11,239 for stock-based compensation.
Investing Activities
There was no cash used in or provided by investing activities for the six months ended June 30, 2025 and June 30, 2026, respectively.
Financing Activities
During the six months ended June 30, 2025, $4.6 million of cash provided by financing activities consisted of the following:
| ● | $1.5 million of gross proceeds for the issuance of shares of the Company’s Common Stock. | |
| ● | $5.0 million in gross proceeds for the issuance of Pre-Funded Warrants and Common Stock Warrants. | |
| ● | $150,000 in gross proceeds upon the issuance of a promissory note secured by a personal guarantee by the Company’s Founder and Chief Executive Officer. | |
| ● | $824,899 used for issuance costs. | |
| ● | $63,385 used to repay debt. |
During the six months ended June 30, 2026, $4.3 million of cash provided by financing activities consisted of the following:
| ● | $546,861 of proceeds for the issuance of shares of the Company’s Common Stock. | |
| ● | $5.0 million in gross proceeds for the issuance of Pre-Funded Warrants which may be exercised to purchase shares of the Company’s Common Stock. | |
| ● | $877,635 used for payment of issuance costs. | |
| ● | $292,141 used to repay debt. |
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In the six months ended June 30, 2025, there were significant noncash transactions. The Company restructured $7.4 million of Secured Notes and accumulated accretion for a fixed bonus payable upon Maturity Date, in exchange for shares of Common Stock, warrants to exercise for Common Stock, and the right to receive proceeds upon the liquidation or sale of a portion of the Company’s shares of AlloTera Therapeutics common stock. Because this was a transaction with related parties, the gain from restructuring was recorded to additional paid-in capital for the period ended June 30, 2025. Also during this period, the Company closed on a $5.0 million financing in which it issued shares of the Company’s Common Stock, warrants to exercise to purchase shares of the Company’s Common Stock and repriced previously issued warrants with an existing stockholder of the Company. The Company estimated fair value of the securities issued and repriced warrants was $15.2 million. The difference between the gross proceeds and fair value was recognized as an equity dividend to investor, as this transaction was with an existing stockholder of the Company. The Company recorded a $10.2 million dividend to additional paid-in capital for the period ended June 30, 2025.
In the six months ended June 30, 2026, the Company closed on two financing transactions for $5.5 million in which it issued shares of the Company Common Stock, warrants to exercise to purchase shares of the Company’s Common Stock to investors, including officers, directors and significant existing stockholders of the Company, and repriced previously issued warrants with an existing stockholder of the Company. The Company estimated fair value of the securities issued and repriced warrants was $17.1 million. The difference between the gross proceeds and fair value was recognized as an equity dividend to investors, as both transactions were with an existing stockholder of the Company. The Company recorded a $11.6 million dividend to investors within additional paid-in capital for the period ended June 30, 2026.
Critical Accounting Policies, Significant Judgements and Use of Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed interim financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgements and estimates.
Revenue Recognition
We recognize revenue under the guidance of Topic 606. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of Topic 606, we perform the following five steps: (i) identification of the contract(s) with the customer, (ii) identification of the promised goods or services in the contract and determination of whether the promised goods or services are performance obligations, (iii) measurement of the transaction price, (iv) allocation of the transaction price to the performance obligations, and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to our customer. See Note 1 to our condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for more information.
Earnings per Share
The Company computes basic and diluted earnings per share using the two-class method because certain warrants the Company issued are a participating security that contractually participates with the Company’s Common Stock in any cash dividend or other distribution declared on the Common Stock on an as-converted basis (the “Participating Warrants”). These warrants do not have a contractual obligation to share in the Company’s losses.
Under the two-class method, net income is allocated between Common Stockholders and the holders of the Participating Warrants based on their respective participation rights, and is computed using the more dilutive of (i) the two-class method with dilutive common share equivalents included in the denominator, with a corresponding reallocation of undistributed earnings, or (ii) the if-converted method, which adds preferred-as-converted shares to both the numerator (adding back preferred dividends) and the denominator. For periods in which the Company reports a net loss, no portion of the loss is allocated to the Participating Warrants. The Company reports distributed and undistributed allocations of earnings on a cumulative period basis in accordance with contractual participation rights. As of June 30, 2026, there were participating warrants outstanding that may be exercised to purchase up to 524,501 shares of Common Stock.
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Basic loss per share is computed by dividing net loss attributable to Common Stockholders by the weighted-average number of common shares outstanding during the period. Diluted loss per share gives effect to all potentially dilutive common shares outstanding during the period, including employee stock options and Common Stock Warrants, using the treasury stock method. Potentially dilutive securities, including warrants that may be exercised to purchase up to 1,411,870 shares of Common Stock and options that may be exercised to purchase up to 7,342 shares of Common Stock, are excluded from the diluted loss per share computation when their effect would be anti-dilutive.
Other than the above, there have been no material changes to our critical accounting policies and estimates from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies, Significant Judgements and Use of Estimates” in our Annual Report.
Recent Accounting Pronouncements
As of December 31, 2026, the Company will cease to be an ‘emerging growth company’ as defined in the Jumpstart Our Business Startups Act of 2012. We expect to remain a nonaccelerated filer and smaller reporting company. The Company is currently assessing potential regulatory and operational changes that may be required as a result.
See also Note 1 to our Annual Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As of June 30, 2026, we had cash and cash equivalents of $741,324 including cash, cash equivalents and market investments. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. We are exposed to market risk related to the marketability of investments in private companies, consisting of our AlloTera Therapeutics common stock and our Trimmune shares, reported within Investments in the accompanying condensed balance sheet. Until such time as these shares become publicly traded, we will have limited ability to liquidate these securities.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of June 30, 2026, our management, with participation of our principal executive officer and principal financial officer, performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a – 15(e) under the Exchange Act). In prior reporting periods, two material weaknesses in internal controls over financial reporting (described below) were identified and have not yet been remediated. Our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of June 30, 2026.
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
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Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) under the Exchange Act). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and our principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States.
Previously Reported Material Weaknesses
As previously disclosed, a material weakness was identified related to management’s assessment of long-lived assets for impairment. This material weakness resulted in an adjustment of $1.5 million to the Company’s audited financial statements for the year ended December 31, 2025. Additionally, this material weakness could result in misstatements of long-lived assets (property, plant and equipment) or disclosures that would result in a material misstatement to the annual or condensed financial statements that would not be prevented or detected.
As previously disclosed, Management identified a material weakness in the level of precision of the Company’s review control over the application of technical accounting evaluation related to complex warrant instruments and financing transactions.
The material weakness resulted in the following accounting outcomes: (1) the previously identified misclassification of certain warrants as equity rather than liabilities under ASC 815-40, Derivatives and Hedging, and (2) the subsequently identified failure to recognize certain warrants as participating securities under ASC 260, Earnings Per Share, resulting in the incorrect application of the two-class method.
The ASC 260 error resulted in a material misstatement of net income attributable to common stockholders and basic earnings per share for the three months ended March 31, 2026 and the restatement of the Company’s previously issued unaudited condensed financial statements for that period. The error did not affect total net income, revenues, operating expenses, cash flows, assets, liabilities or stockholders’ equity.
Because of these material weaknesses identified in previous reporting periods but not yet remediated, management concluded that the Company did not maintain effective internal control over financial reporting as of June 30, 2026.
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Remediation Plans for Material Weaknesses in Internal Controls over Financial Reporting
We are committed to establishing and maintaining a strong internal control environment. In response to the identified material weakness as described above, the Company’s Board of Directors and its Audit Committee are conducting an internal investigation to determine the root cause of the material weaknesses, with advice from outside advisors. Upon conclusion of this investigation, they will work with management to evaluate internal controls over financial reporting based on criteria set forth in “Internal Control – Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Remediation plans will include obtaining a current appraisal at least once a year in preparation for the Annual Report, and more often if the market appears to be weakening or other triggers for an indication of impairment have occurred. Management intends to establish procedures to ensure proper monitoring of indicators of impairment such as a significant market price decrease, adverse changes in physical condition/usage, legal factors, or current-period operating losses, for each reporting period. For complex transactions, management resolved to allow for more time and resources to determine proper accounting and disclosure of these transactions. Management intends to enhance the precision of the Company’s technical accounting review control by establishing formal consultation and escalation criteria for complex warrant and financing arrangements, including required legal interpretation where contractual provisions may affect the accounting conclusion. Require documented evaluation of all relevant contractual terms and evidence that identified accounting and legal considerations were fully resolved before the accounting treatment is finalized.
Inherent Limitations of Internal Controls
While we strive to create a stronger control environment, we recognize that it is impossible for our internal controls over financial reporting to prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. While we are committed to continuously improve and strengthen our control environment, over time, our internal controls over financial reporting may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Projections of any evaluation of effectiveness to future periods are subject to the risk that internal controls over financial reporting may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act during the three months ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. Such proceedings can be costly, time consuming, and unpredictable. Therefore, no assurance can be given on the outcome of any proceeding or the potential impact on our results of operations or financial condition.
The legal matters included in our Annual Report continue to apply to us and describe risks and uncertainties that could cause actual results to differ materially from the results expressed or implied by the forward-looking statements contained in this Quarterly Report. Additional facts not presently known to us or that we currently deem immaterial may also impair our business, financial condition and results of operations.
Arbitration, Settlement and General Release
On July 18, 2024, we announced that, as of July 13, 2024, we and Dr. Hing C. Wong, our Founder and Chief Executive Officer, entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”) with Altor BioScience, LLC (“Altor”), NantCell, Inc. (“NantCell”), and ImmunityBio, Inc. (the parent of Altor and NantCell, together with Altor and NantCell, “ImmunityBio”), to resolve the previously disclosed Arbitration. The Arbitration and related Complaint were dismissed with prejudice on or about December 24, 2024. The Company retains ownership and control of the TOBITM platform and TOBI-based molecules, with no restrictions under the Settlement Agreement on our ability to use the TOBITM platform for protein-fusion molecules for non-oncology indications. We have rights to pursue oncology indications, in particular using HCW9302, HCW9206 and HCW9201. Further, the Company retains ownership of the AlloTera Therapeutics license and shares of AlloTera Therapeutics common stock transferred to the Company as the upfront licensing fee from AlloTera Therapeutics for granting the AlloTera Therapeutics license. For our molecule, HCW9218, we maintain the exclusive rights for clinical development and use of HCW9218 in the treatment of all non-oncological diseases. We retain ownership of our lead molecule, HCW9302, which expands Treg cells and is designed to treat autoimmune diseases and other proinflammatory diseases, including cancer, and the ownership of HCW9206, a preclinical molecule which we are developing as a commercial-ready reagent for use in the manufacture of cell-based immunotherapeutics. The Company agreed to provide ImmunityBio with a right of first refusal to enter a licensing agreement for oncology indications for HCW9206. We have no restrictions on the development of HCW9206 for our own clinical development activities, including oncology indications. Under the terms of the Settlement Agreement, ImmunityBio will own the cell line and supply for HCW9218, and the parties agreed that within six months from the date of the Settlement Agreement they will enter into a supply agreement providing the Company with a continuing supply of HCW9218 molecules. The Company also retains in vivo rights to HCW9201, a combination of IL-12, IL-15, and IL-18 in a single protein complex which is designed to stimulate activation and proliferation signals in human NK cells. The Company retains ownership of the cell lines for HCW9302, HCW9206 and HCW9201, and thus will retain independent control over manufacturing and supply for these compounds.
The Company entered into the Settlement Agreement to avoid the costs, disruption and distraction of further litigation. On December 30, 2025, the Company entered a settlement agreement with Cooley LLP (“Cooley”) related to the remaining balance of $7.5 million still outstanding for the payment of legal fees incurred in connection the defense of Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer. As a result of that agreement, the Company, Dr. Wong and Cooley agreed to settle a $7.5 million obligation for $2.0 million in cash and contingent payments up to $5.5 million upon achievement of certain triggering events, all of which were deemed to be remote as of March 31, 2026. In accordance with the terms of the settlement agreement, $500,000 was paid on December 31, 2025. Based on amendments to the settlement agreement, the Company paid $750,000 on March 20, 2026, and will pay the remaining $750,000 upon the earlier of the completion of a financing for at least $4.0 million in gross proceeds or August 31, 2026. As of December 31, 2025 and June 30, 2026, the Company reported a liability of $6.2 million and $5.4 million, respectively, for remaining amounts owed for legal fees related to the Arbitration which continue to remain outstanding.
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Legal Matters related to Real Estate
On April 17, 2025, the Company received a summons and a copy of a complaint filed by BE&K in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “BE&K Complaint”) alleging lien foreclosure and breach of contract. Other Defendants named in the BE&K Complaint who are subcontractors elected to filed counterclaims and cross-claims in response thereto. To our knowledge as of the date hereof, Cogent Bank, also named as a Defendant in the BE&K Complaint, has not elected to take legal action at this time. In addition, on April 28, 2025, the Company received a summons and a copy of a complaint filed by Fisk Electric Company (which is a defendant in the BE&K Litigation) in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “Fisk Complaint”) against the Company, BE&K, and the other defendants in the BE&K Complaint. In addition, on April 28, 2025, the Company received a summons and a copy of a complaint filed by Fisk Electric Company (which is a defendant in the BE&K Complaint) in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “Fisk Complaint”) against the Company, BE&K, and the other defendants in the BE&K Complaint. The cases have been consolidated. The remaining parties are engaged in discovery. The court has set the BE&K matter for a five-day jury trial in December 2026. There will also be a pretrial conference on November 20, 2026. As of June 30, 2026, a balance of $2.2 million remains for amounts owed to BE&K and other lien holders.
On June 26, 2026, as part of a settlement with B&I Contractors, Inc. (“B&I”), we received notice that B&I had filed a voluntary dismissal with prejudice of its crossclaims against us in the matter BE&K Building Group, LLC v. HCW Biologics Inc., et al. pending in the Circuit Court of the Seventeenth Judicial Circuit in and for Broward County, Florida. The matter arose from a mechanics’ lien filed by B&I in connection with allegedly unpaid invoices relating to renovation work at our facility located at 3300 Corporate Way, Miramar, Florida, which is being renovated for future office and laboratory use. In connection with the settlement, B&I filed a final satisfaction of lien releasing a lien in the amount of approximately $1.1 million. The dismissal and satisfaction of lien completed the parties’ settlement and fully resolved all amounts claimed to be owed by us to B&I. There was no gain or loss on the settlement with B&I.
On October 24, 2025, the Company was notified by Cogent Bank that it exercised its discretion to make a demand that the Company cure the Defaults no later than thirty (30) days after receipt of this letter in strict compliance with Section 7.2(3) of the Loan Agreement by: (i) paying and discharging all of the Claims of Lien and causing satisfactions to be recorded in the Public Records of Broward County, Florida for all of the Claims of Lien, and (ii) resolving all litigation against the Borrower and the mortgaged property described in the Mortgage and causing such claims in the Foreclosure Actions to be dismissed and all related notices of lis pendens to be released. The Company and Cogent Bank have had negotiations attempting to come to terms on a forbearance agreement to provide additional time for the Company to comply with the demands Cogent Bank made in the demand letter.
Other Matters
On May 26, 2026, we paid in full all amounts due under a settlement agreement with EirGenix, Inc. (“EirGenix”), our contract development and manufacturing organization, relating to manufacturing costs. Pursuant to the settlement agreement entered into on December 9, 2025, EirGenix agreed to accept $1.2 million in full satisfaction of approximately $1.7 million of outstanding amounts, provided payment was made by an agreed deadline. As a result, all obligations under the settlement agreement were satisfied and the related unpaid invoices and disputed credits were fully resolved.
On June 26, 2025, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company is in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”).
On June 29, 2026, HCW Biologics Inc. (the “Company”) received written notice form the Listing Qualifications Staff (the “Staff”) of the Nasdaq Capital Market Nasdaq Stock Market LLC (“Nasdaq”) that the Nasdaq Hearings Panel (the “Panel”) found that the Company regained compliance with Listing Rule 5550(a)(2), the “Bid Price Rule,” per the terms set forth in the Panel’s decision letter dated May 29, 2026, as amended. As indicated in the Panel’s decision letter, as amended, if the Company satisfies the remaining terms of the decision through September 22, 2026, the Panel also intends to impose a Discretionary Panel Monitor on the Company pursuant to Listing Rule 5815(d)(4)(A) for a one-year period from that date.
In application of Listing Rule 5815(d)(4)(B), the Company will be subject to a Mandatory Panel Monitor until June 17, 2027. If, within that one-year monitoring period, Staff finds the Company again out of compliance with the Bid Price Rule, which was the subject of the exception, then notwithstanding Rule 5810(c)(2) the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, Staff will issue a Delist Determination Letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C). The Company’s securities may be at that time delisted from Nasdaq.
On July 29, 2026, the SEC temporarily stayed the effectiveness of its July 22, 2026 order approving the Nasdaq’s proposed rule change to adopt a new $5 million Market Value of Listed Securities continued listing requirement (the “$5 Million MVLS Requirement”). The SEC received, pursuant to Rule 430 of the Commission’s Rules of Practice, 17 CFR 201.430, notices of intention to petition for review of the delegated action. In accordance with Rule 431(e), the July 22, 2026, order is stayed until the Commission orders otherwise.
New Nasdaq Rules 5450(a)(3) (Nasdaq Global Select and Global Market) and 5550(a)(6) (Nasdaq Capital Market) would have required listed companies to maintain a Market Value of Listed Securities (MVLS) of at least $5 million (MVLS is the consolidated closing bid price multiplied by the total shares outstanding of the listed class). If a company failed the $5 million MVLS Requirement for 30 consecutive business days, it would receive an immediate Staff Delisting Determination, with no compliance plan or cure period available. A company may appeal the Staff Delisting Determination, however, timely Nasdaq Hearings Panel (the “Panel”) appeal would not stay the suspension from trading for an MVLS-based delisting determination. It means that the securities would trade on the over-the-counter market (“OTC”) while the appeal is pending. After an appeals hearing, the Panel may, in its discretion, grant an exception of up to 180 days from the Staff Delisting Determination if it determines that the company has presented a credible plan to regain compliance and, within that period, the company must demonstrate compliance with all applicable Nasdaq initial listing requirements, not merely the $5 million MVLS standard, which are materially more stringent than the continued listing standards, e.g., initial listing on the Nasdaq Capital Market requires Market Value of Unrestricted Publicly Held Shares of at least $15 million, versus the $5 million MVLS needed to maintain listing.
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Item 1A. Risk Factors.
There have been no material changes to the risk factors previously disclosed by us in our Annual Report. The risk factors included our Annual Report continue to apply to us and describe risks and uncertainties that could cause actual results to differ materially from the results expressed or implied by the forward-looking statements contained in this Quarterly Report. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Sale of Unregistered Shares of Common Stock
During the past three years, we sold the following securities without registration under the Securities Act:
On February 20, 2024, the Company completed a private placement of 7,441 shares of Common Stock to certain officers and directors for aggregate gross proceeds of approximately $2.5 million. The shares were sold at a purchase price of $336.00 per share. The Board of Directors and the Audit Committee reviewed the transaction pursuant to the Company’s Related Party Transactions Policy and determined that the transaction complied with the policy.
On November 18, 2024, the Company entered into a securities purchase agreement with Armistice Capital Master Fund Ltd. (“Armistice”). In a concurrent private placement completed on November 20, 2024, the Company issued unregistered warrants to purchase up to 27,988 shares of Common Stock (the “Armistice Warrants”). On April 16, 2025, the SEC declared effective a registration statement on Form S-1 (File No. 333-286409) covering the resale of the shares underlying the Armistice Warrants.
On March 12, 2025, in connection with an equity purchase agreement entered into with Square Gate Capital Master Fund, LLC – Series 4, the Company issued 9,616 shares of Common Stock as a commitment fee.
On May 7, 2025, pursuant to the terms of an amendment to certain outstanding Secured Notes approved by stockholders on March 31, 2025, the Company issued 42,181 shares of Common Stock and warrants to purchase an additional 21,090 shares of Common Stock in connection with the conversion of approximately $6.6 million principal amount of Secured Notes and related amounts.
On November 19, 2025, the Company entered into a warrant inducement transaction with Armistice, pursuant to which Armistice exercised existing warrants to purchase 251,702 shares of Common Stock, resulting in aggregate gross proceeds to the Company of approximately $4.0 million. In consideration for such exercise, the Company issued new unregistered warrants to purchase up to 503,402 shares of Common Stock at an exercise price of $14.46 per share. On January 29, 2026, the SEC declared effective a registration statement on Form S-1 (File No. 333-292652) covering the resale of the shares underlying such warrants.
On November 19, 2025, the Company entered into a warrant inducement agreement with Armistice pursuant to which Armistice exercised existing warrants to purchase 251,702 shares of Common Stock at a reduced exercise price, resulting in gross proceeds to the Company of approximately $4.0 million. In consideration for such exercise, the Company issued new unregistered warrants to purchase up to 503,402 shares of Common Stock at an exercise price of $14.46 per share. On January 29, 2026, the SEC declared effective a registration statement on Form S-1 (File No. 333-292652) covering the resale of the shares underlying such warrants.
On May 21, 2026, the Company completed a private placement of an aggregate of 474,496 units to a group of existing investors, including certain directors, officers and significant stockholders, for aggregate gross proceeds of approximately $4.0 million. Each unit consisted of one share of Common Stock (or a pre-funded warrant in lieu thereof) and one warrant to purchase one share of Common Stock. On June 18, 2026, the SEC declared effective a registration statement on Form S-1 (File No. 333-296577) covering the resale of the securities issued in the private placement.
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On July 29, 2026, the Company completed a private placement with certain accredited investors in which the Company sold 618,682 units, each unit consisting of one share of Common Stock, or a Pre-Funded Warrant in lieu thereof, and (ii) the right to receive one Common Stock Warrant upon, and subject to, stockholder approval of the issuance of such Common Stock Warrants, which approval the Company is obligated to seek pursuant to the terms of the purchase agreement. Gross proceeds of the offering were approximately $1.6 million before deducting offering expenses. The Company entered into a Registration Rights Agreement pursuant to which it agreed to file a registration statement covering the resale of the shares of Common Stock issued in the private placement, the shares issuable upon exercise of the Pre-Funded Warrants and the shares issuable upon exercise of the Common Stock Warrants. Hing C. Wong, Ph.D., our Founder and Chief Executive Officer, Scott Garrett, Chairman of our board of directors, and Lee Flowers, our Senior Vice President of Business Development, participated in the private placement on the same terms and conditions as the other investor.
The foregoing issuances were made in reliance upon exemptions from registration under Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder, as applicable.
Issuer Repurchases of Equity Securities
None.
Item 3. Defaults Upon Senior Securities.
Not Applicable.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
Insider Adoption or Termination of Trading Arrangements
During
the fiscal quarter ended June 30, 2026, none of our directors or officers informed us of the
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Item 6. Exhibits.
The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
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* This certification is deemed not filed for purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
+ Indicates a management contract or compensatory plan or arrangement.
†† Certain information in this document has been excluded pursuant to Item 601(b)(10) of Regulation S-K. Such excluded information is not material and is the type of information the Registrant treats as private and confidential. The Registrant agrees to furnish supplementally such information to the SEC upon request.
# Certain information in this document has been excluded pursuant to Item 601(a)(5) or (a)(6) of Regulation S-K. The Registrant agrees to furnish supplementally such information to the SEC upon request.
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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.
| HCW Biologics Inc. | ||
| Date: August 14, 2026 | By: | /s/ Hing C. Wong |
| Hing C. Wong | ||
| Founder and Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: August 14, 2026 | By: | /s/ Rebecca Byam |
| Rebecca Byam | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
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Exhibit 10.07
FORM OF LOCK-UP AGREEMENT
May 21, 2026
HCW Biologics Inc.
2929 N. Commerce Parkway
Miramar, FL 33025
Re: Placement Agency Agreement, dated as of May 21, 2026 (the “Placement Agency Agreement”), between HCW Biologics Inc. (the “Company”) and E.F. Hutton & Co. (the “Placement Agent”).
Ladies and Gentlemen:
Defined terms not otherwise defined in this letter agreement (the “Letter Agreement”) shall have the meanings set forth in the Placement Agency Agreement. In satisfaction of a condition of the Company’s obligations under the Placement Agreement, the undersigned irrevocably agrees with the Company that, from the date hereof until one hundred eighty (180) days after the Closing Period (such period, the “Restriction Period”), the undersigned will not offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of (or enter into any transaction which is designed to, or might reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the undersigned or any Affiliate of the undersigned to the extent such Affiliate transaction would be required to be reported by the undersigned during the Restriction Period with the Securities and Exchange Commission in accordance with Section 13 or Section 16 of the Exchange Act), directly or indirectly, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with respect to, any shares of Common Stock of the Company or securities convertible, exchangeable or exercisable into, shares of Common Stock of the Company beneficially owned, held or hereafter acquired by the undersigned (the “Securities”), other than Securities acquired in the Offering, or make any demand for or exercise any right or cause to be filed a registration, including any amendments thereto, with respect to the registration of any shares of Common Stock or Common Stock Equivalents or publicly disclose the intention to do any of the foregoing. Beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act. The undersigned acknowledges that the Company shall provide written notice to the transfer agent of the Company to inform them of the Restriction Period, which written notice shall include notification by email. In order to enforce this covenant, the Company shall impose irrevocable stop-transfer instructions preventing the transfer agent of the Company from effecting any actions in violation of this Letter Agreement.
The Placement Agent shall serve as the sole lock-up release agent for the Restriction Period. No release of any obligation under this Letter Agreement shall be effective without the prior written consent of the Placement Agent.
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Notwithstanding the foregoing, and subject to the conditions below, the undersigned may transfer the Securities provided that (1) the Company receives a signed lock-up letter agreement (in the form of this Letter Agreement) for the balance of the Restriction Period from each donee, trustee, distributee, or transferee, as the case may be, prior to such transfer (2) any such transfer shall not involve a disposition for value, (3) such transfer is not required to be reported with the Securities and Exchange Commission in accordance with the Exchange Act and no report of such transfer shall be made voluntarily during the Restricted Period, and (4) neither the undersigned nor any donee, trustee, distributee or transferee, as the case may be, otherwise voluntarily effects any public filing or report regarding such transfers during the Restricted Period, with respect to transfer:
| (i) | as a bona fide gift or gifts; | |
| (ii) | to any immediate family member or to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned (for purposes of this Letter Agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin); | |
| (iii) | to any corporation, partnership, limited liability company, or other business entity all of the equity holders of which consist of the undersigned and/or the immediate family of the undersigned; | |
| (iv) | if the undersigned is a corporation, partnership, limited liability company, trust or other business entity (a) to another corporation, partnership, limited liability company, trust or other business entity that is an Affiliate of the undersigned or (b) in the form of a distribution to limited partners, limited liability company members or stockholders of the undersigned; | |
| (v) | if the undersigned is a trust, to the beneficiary of such trust; | |
| (vi) | by operation of law, such as pursuant to a qualified domestic order, divorce settlement, divorce decree, separation agreement or other court order; | |
| (vii) | to a charity or educational institution; | |
| (viii) | by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate family of the undersigned; or | |
| (ix) | sales of Common Stock made pursuant to and in accordance with a trading plan pursuant to Rule 10b5-1 under the Exchange Act existing on the date hereof. |
In addition, notwithstanding the foregoing, this Letter Agreement shall not restrict (i) the delivery of shares of Common Stock to the undersigned upon exercise of any options or settlement of restricted stock units or other equity awards granted under any employee benefit plan of the Company, or the exercise of warrants; provided in each case that any shares of Common Stock or Securities acquired in connection with any such exercise or settlement will be subject to the restrictions set forth in this Letter Agreement, (ii) the withholding of shares of Common Stock to cover the payment of the exercise prices or the payment of taxes associated with the exercise or settlement of equity set forth in (i) above, or (iii) the issuance to the undersigned of awards by the Company under its equity incentive plans or the issuance of warrants.
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Furthermore, the undersigned may enter into any new plan established in compliance with Rule 10b5-1 of the Exchange Act; provided that (i) such plan may only be established if no public announcement or filing with the Securities and Exchange Commission, or other applicable regulatory authority, is made in connection with the establishment of such plan during the Restriction Period and (ii) no sale of shares of Common Stock are made pursuant to such plan during the Restriction Period.
The undersigned acknowledges that the execution, delivery and performance of this Letter Agreement is a material inducement to the Placement Agent to complete the transactions contemplated by the Placement Agency Agreement and the Company shall be entitled to specific performance of the undersigned’s obligations hereunder. The undersigned hereby represents that the undersigned has the power and authority to execute, deliver and perform this Letter Agreement, that the undersigned has received adequate consideration therefor and that the undersigned will indirectly benefit from the closing of the transactions contemplated by the Placement Agency Agreement.
The undersigned understands that, if the Agreement does not become effective, or if the Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Common Stock to be sold thereunder, the undersigned shall be released from all obligations under this Letter Agreement.
This Letter Agreement may not be amended or otherwise modified in any respect without the written consent of each of the Company and the undersigned. This Letter Agreement shall be construed and enforced in accordance with the laws of the State of New York without regard to the principles of conflict of laws. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. The undersigned agrees and understands that this Letter Agreement does not intend to create any relationship between the undersigned and the Placement Agent and that the Placement Agent is not entitled to cast any votes on the matters herein contemplated and that no issuance or sale of the Securities is created or intended by virtue of this Letter Agreement.
This Letter Agreement shall be binding on successors and assigns of the undersigned with respect to the Securities and any such successor or assign shall enter into a similar agreement for the benefit of the Placement Agent.
*** SIGNATURE PAGE FOLLOWS***
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[SIGNATURE PAGE TO THE LOCK-UP AGREEMENT]
This Letter Agreement may be executed in two or more counterparts, all of which when taken together may be considered one and the same agreement.
| Signature | |
| Print Name | |
| Position in Company | |
| Address for Notice: | |
By signing below, the Company agrees to enforce the restrictions on transfer set forth in this Letter Agreement.
| HCW Biologics Inc. | ||
| By: | ||
| Name: | Hing C. Wong, Ph.D. | |
| Title: | Chief Executive Officer | |
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Exhibit 10.11
FORM OF LOCK-UP AGREEMENT
July 29, 2026
HCW Biologics Inc.
2929 N. Commerce Parkway
Miramar, FL 33025
Re: Securities Purchase Agreement, dated as of July 129, 2026 (the “Securities Purchase Agreement”), between HCW Biologics Inc. (the “Company”) and Purchasers (the “Purchasers”).
Ladies and Gentlemen:
Defined terms not otherwise defined in this letter agreement (the “Letter Agreement”) shall have the meanings set forth in the Securities Purchase Agreement. In satisfaction of a condition of the Company’s obligations under the Securities Purchase Agreement, the undersigned irrevocably agrees with the Company that, from the date hereof until one hundred eighty (180) days after the Closing Period (such period, the “Restriction Period”), the undersigned will not offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of (or enter into any transaction which is designed to, or might reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the undersigned or any Affiliate of the undersigned to the extent such Affiliate transaction would be required to be reported by the undersigned during the Restriction Period with the Securities and Exchange Commission in accordance with Section 13 or Section 16 of the Exchange Act), directly or indirectly, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with respect to, any shares of Common Stock of the Company or securities convertible, exchangeable or exercisable into, shares of Common Stock of the Company beneficially owned, held or hereafter acquired by the undersigned (the “Securities”), other than Securities acquired in the Offering, or make any demand for or exercise any right or cause to be filed a registration, including any amendments thereto, with respect to the registration of any shares of Common Stock or Common Stock Equivalents or publicly disclose the intention to do any of the foregoing. Beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act. The undersigned acknowledges that the Company shall provide written notice to the transfer agent of the Company to inform them of the Restriction Period, which written notice shall include notification by email. In order to enforce this covenant, the Company shall impose irrevocable stop-transfer instructions preventing the transfer agent of the Company from effecting any actions in violation of this Letter Agreement.
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Notwithstanding the foregoing, and subject to the conditions below, the undersigned may transfer the Securities provided that (1) the Company receives a signed lock-up letter agreement (in the form of this Letter Agreement) for the balance of the Restriction Period from each donee, trustee, distributee, or transferee, as the case may be, prior to such transfer (2) any such transfer shall not involve a disposition for value, (3) such transfer is not required to be reported with the Securities and Exchange Commission in accordance with the Exchange Act and no report of such transfer shall be made voluntarily during the Restricted Period, and (4) neither the undersigned nor any donee, trustee, distributee or transferee, as the case may be, otherwise voluntarily effects any public filing or report regarding such transfers during the Restricted Period, with respect to transfer:
| (i) | as a bona fide gift or gifts; | |
| (ii) | to any immediate family member or to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned (for purposes of this Letter Agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin); | |
| (iii) | to any corporation, partnership, limited liability company, or other business entity all of the equity holders of which consist of the undersigned and/or the immediate family of the undersigned; | |
| (iv) | if the undersigned is a corporation, partnership, limited liability company, trust or other business entity (a) to another corporation, partnership, limited liability company, trust or other business entity that is an Affiliate of the undersigned or (b) in the form of a distribution to limited partners, limited liability company members or stockholders of the undersigned; | |
| (v) | if the undersigned is a trust, to the beneficiary of such trust; | |
| (vi) | by operation of law, such as pursuant to a qualified domestic order, divorce settlement, divorce decree, separation agreement or other court order; | |
| (vii) | to a charity or educational institution; | |
| (viii) | by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate family of the undersigned; or | |
| (ix) | sales of Common Stock made pursuant to and in accordance with a trading plan pursuant to Rule 10b5-1 under the Exchange Act existing on the date hereof. |
In addition, notwithstanding the foregoing, this Letter Agreement shall not restrict (i) the delivery of shares of Common Stock to the undersigned upon exercise of any options or settlement of restricted stock units or other equity awards granted under any employee benefit plan of the Company, or the exercise of warrants; provided in each case that any shares of Common Stock or Securities acquired in connection with any such exercise or settlement will be subject to the restrictions set forth in this Letter Agreement, (ii) the withholding of shares of Common Stock to cover the payment of the exercise prices or the payment of taxes associated with the exercise or settlement of equity set forth in (i) above, or (iii) the issuance to the undersigned of awards by the Company under its equity incentive plans or the issuance of warrants.
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Furthermore, the undersigned may enter into any new plan established in compliance with Rule 10b5-1 of the Exchange Act; provided that (i) such plan may only be established if no public announcement or filing with the Securities and Exchange Commission, or other applicable regulatory authority, is made in connection with the establishment of such plan during the Restriction Period and (ii) no sale of shares of Common Stock are made pursuant to such plan during the Restriction Period.
The undersigned acknowledges that the execution, delivery and performance of this Letter Agreement is a material inducement to the Purchasers to complete the transactions contemplated by the Securities Purchase Agreement and the Company shall be entitled to specific performance of the undersigned’s obligations hereunder. The undersigned hereby represents that the undersigned has the power and authority to execute, deliver and perform this Letter Agreement, that the undersigned has received adequate consideration therefor and that the undersigned will indirectly benefit from the closing of the transactions contemplated by the Securities Purchase Agreement.
The undersigned understands that, if the Agreement does not become effective, or if the Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Common Stock to be sold thereunder, the undersigned shall be released from all obligations under this Letter Agreement.
This Letter Agreement may not be amended or otherwise modified in any respect without the written consent of each of the Company and the undersigned. This Letter Agreement shall be construed and enforced in accordance with the laws of the State of New York without regard to the principles of conflict of laws. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. The undersigned agrees and understands that this Letter Agreement does not intend to create any relationship between the undersigned and the Purchasers and that no issuance or sale of the Securities is created or intended by virtue of this Letter Agreement.
This Letter Agreement shall be binding on successors and assigns of the undersigned with respect to the Securities and any such successor or assign shall enter into a similar agreement for the benefit of the Purchasers.
*** SIGNATURE PAGE FOLLOWS***
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[SIGNATURE PAGE TO THE LOCK-UP AGREEMENT]
This Letter Agreement may be executed in two or more counterparts, all of which when taken together may be considered one and the same agreement.
| Signature | |
| Print Name | |
| Position in Company | |
| Address for Notice: | |
By signing below, the Company agrees to enforce the restrictions on transfer set forth in this Letter Agreement.
| HCW Biologics Inc. | ||
| By: | ||
| Name: | Hing C. Wong, Ph.D. | |
| Title: | Chief Executive Officer | |
| 4 |
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Hing C. Wong, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of HCW Biologics Inc. for the quarter ended June 30, 2026; | |
|
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| /s/ Hing C. Wong | |
| Hing C. Wong | |
Founder and Chief Executive Officer (Principal Executive Officer) |
Date: August 14, 2026
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Rebecca Byam, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of HCW Biologics Inc. for the quarter ended June 30, 2026; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| /s/ Rebecca Byam | |
| Rebecca Byam | |
Chief Financial Officer (Principal Financial Officer) |
Date: August 14, 2026
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of HCW Biologics Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2026 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| By: | /s/ Hing C. Wong | |
| Hing C. Wong | ||
Founder and Chief Executive Officer (Principle Executive Officer) |
| Date: August 14, 2026 |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of HCW Biologics Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2026 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| By: | /s/ Rebecca Byam | |
| Rebecca Byam | ||
Chief Financial Officer (Principal Financial Officer) |
Date: August 14, 2026