Item 1. Financial Statements
Item
1. Financial Statements.
HCW
Biologics Inc.
Condensed
Balance Sheets
December 31,
June 30,
2025
2026
Unaudited
ASSETS
Current assets:
Cash and cash equivalents
$ 1,952,464
$ 741,324
Accounts receivable, net
32,175
18,451
Prepaid expenses
222,156
282,533
Other current assets
77,564
97,702
Total current assets
2,284,359
1,140,010
Investments
1,326,329
4,854,028
Property, plant and equipment, net
20,880,849
20,745,804
Other assets
28,476
28,476
Total assets
$ 24,520,013
$ 26,768,318
LIABILITIES AND STOCKHOLDERS’ EQUITY
Liabilities
Current liabilities:
Accounts payable
$ 13,143,394
$ 10,609,950
Accrued liabilities and other current liabilities
1,110,104
1,128,592
Short-term debt, net
6,809,215
6,561,361
Deferred revenue
—
348,270
Total current liabilities
21,062,713
18,648,173
Contingent liability - related party
692,531
692,531
Total liabilities
21,755,244
19,340,704
Commitments and contingencies (Note 12)
-
Stockholders’ equity:
Common stock:
Common, $ 0.0001 par value; 250,000,000 shares authorized
and 546,635 shares issued at December 31, 2025; 250,000,000 shares authorized and 1,617,642 shares issued at June 30, 2026
55
161
Additional paid-in capital
111,280,560
117,690,050
Accumulated deficit
( 108,515,846 )
( 110,262,597 )
Total stockholders’ equity
2,764,769
7,427,614
Total liabilities and stockholders’ equity
$ 24,520,013
$ 26,768,318
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
$ 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 )
Equity dividend to investor
( 10,153,799 )
( 10,154,642 )
( 10,153,799 )
( 11,643,114 )
Net loss attributable to Common Stockholders
$ ( 12,081,529 )
$ ( 15,373,873 )
$ ( 14,278,405 )
$ ( 13,389,865 )
Net loss per share, basic and diluted
$ ( 40.72 )
$ ( 11.58 )
$ ( 59.14 )
$ ( 11.98 )
Weighted average shares outstanding, basic and diluted
296,686
1,327,966
241,417
1,117,350
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
185,589
$ 19
$ 93,785,946
$ ( 100,556,137 )
$ ( 6,770,171 )
Issuance of Common Stock upon exercise of stock options
34
—
1,654
—
1,654
Issuance of Common Stock to Square Gate
1,603
1
149,999
—
150,000
Issuance cost of Common Stock
—
—
( 22,297 )
—
( 22,297 )
Stock-based compensation
—
—
275,642
—
275,642
Net loss
—
—
—
( 2,196,875 )
( 2,196,875 )
Balance, March 31, 2025
187,226
$ 20
$ 94,190,944
$ ( 102,753,012 )
$ ( 8,562,047 )
Issuance of Common Stock
32,374
3
1,592,782
—
1,592,785
Issuance of pre-funded warrants
—
—
4,207,718
—
4,207,718
Issuance of Common Stock warrants
—
—
9,650,404
—
9,650,404
Exercise of pre-funded warrants
85,523
9
42
—
51
Issuance cost of Common Stock
—
—
( 70,094 )
—
( 70,094 )
Issuance cost of pre-funded warrants
—
—
( 504,861 )
—
( 504,861 )
Issuance cost of Common Stock warrants
—
—
( 227,646 )
—
( 227,646 )
Equity dividend to investor
—
—
( 10,153,780 )
( 10,153,780 )
Issuance of Common Stock to extinguish restructured debt
42,181
4
1,774,108
—
1,774,112
Issuance of Common Stock warrants to extinguish restructured debt
—
—
544,249
—
544,249
Gain on conversion of debt with related parties, net
—
—
3,346,562
—
3,346,562
Stock-based compensation
—
—
278,307
—
278,307
Adjustment for reverse stock split
10,464
1
( 1 )
—
—
Net loss
—
—
-
( 1,927,730 )
( 1,927,730 )
Balance, June 30, 2025
357,767
$ 37
$ 104,628,734
$ ( 104,680,742 )
$ ( 51,972 )
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
546,635
$ 55
$ 111,280,560
$ ( 108,515,846 )
$ 2,764,769
Common Stock issued in connection with abeyance shares (1)
162,834
16
( 16 )
-
-
Issuance of pre-funded warrants
-
-
1,499,753
-
1,499,753
Exercise of pre-funded warrants
412,882
41
206
-
247
Reclassification of the modified warrant to liability
-
-
( 1,595,778 )
-
( 1,595,778 )
Issuance of Common Stock warrants
-
-
1,488,472
-
1,488,472
Equity dividend to investor
-
-
( 1,488,472 )
-
( 1,488,472 )
Issuance costs of Common Stock warrants
-
-
( 181,198 )
-
( 181,198 )
Issuance costs of pre-funded warrants
-
-
( 207,858 )
-
( 207,858 )
Stock-based compensation
-
-
10,019
-
10,019
Net income
-
-
-
3,472,480
3,472,480
Balance, March 31, 2026
1,122,351
$ 112
$ 110,805,688
$ ( 105,043,366 )
$ 5,762,434
Balance
1,122,351
$ 112
$ 110,805,688
$ ( 105,043,366 )
$ 5,762,434
Issuance of Common Stock
71,174
7
1,101,772
-
1,101,779
Issuance of pre-funded warrants
-
-
6,243,229
-
6,243,229
Issuance of Common Stock warrants
-
-
6,809,392
-
6,809,392
Exercise of pre-funded warrants
403,322
40
202
-
242
Reclassification of the modified warrant from liability
-
-
3,371,770
-
3,371,770
Equity dividend to investor
-
-
( 10,154,642 )
-
( 10,154,642 )
Issuance costs of Common Stock
-
-
( 38,031 )
-
( 38,031 )
Issuance costs of pre-funded warrants
-
-
( 215,502 )
-
( 215,502 )
Issuance costs of Common Stock warrants
-
-
( 235,046 )
-
( 235,046 )
Stock-based compensation
-
-
1,220
-
1,220
Adjustment for reverse stock split
20,795
2
( 2 )
-
-
Net loss
-
-
-
( 5,219,231 )
( 5,219,231 )
Net income (loss)
-
-
-
( 5,219,231 )
( 5,219,231 )
Balance, June 30, 2026
1,617,642
$ 161
$ 117,690,050
$ ( 110,262,597 )
$ 7,427,614
Balance
1,617,642
$ 161
$ 117,690,050
$ ( 110,262,597 )
$ 7,427,614
(1) During the three
months ended March 31, 2026, 162,834 shares previously issued on November 20, 2025, and held in abeyance, were issued. As of June 30,
2026, there were no shares held in abeyance.
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
$ ( 4,124,606 )
$ ( 1,746,751 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and accretion
710,926
269,144
Stock-based compensation
553,949
11,239
Noncash revenue from licensing agreement
—
( 3,500,000 )
Gain on extinguishment of liability
—
( 483,383 )
Change in fair value of warrant liability
—
1,775,992
Commitment fee
150,000
—
Change in fair value of investment, net
( 1,748,688 )
—
Loss on conversion of debt with related parties
( 131,134 )
—
Changes in operating assets and liabilities:
Accounts receivable
560,590
13,724
Prepaid expenses and other assets
5,156
( 108,214 )
Accounts payable and other liabilities
( 2,772,352 )
( 2,121,385 )
Deferred revenue
—
348,270
Net cash used in operating activities
( 6,796,159 )
( 5,541,364 )
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
1,475,939
546,861
Proceeds from issuance of Common Stock warrants and pre-funded warrants, net
3,822,894
4,953,139
Proceeds from issuance of debt
150,000
—
Issuance costs for Common Stock
—
( 38,031 )
Issuance costs for Common Stock warrants and pre-funded warrants
( 824,899 )
( 839,604 )
Debt repayment
( 63,385 )
( 292,141 )
Net cash provided by financing activities
4,560,549
4,330,224
Net decrease in cash and cash equivalents
( 2,235,610 )
( 1,211,140 )
Cash and cash equivalents at the beginning of the period
4,674,572
1,952,464
Cash and cash equivalents at the end of the period
$ 2,438,962
$ 741,324
Supplemental disclosure of cash flow information:
Cash paid for interest
$ 404,162
$ 269,354
Noncash investing activities:
Capital expenditures accrued, but not yet paid
$ —
$ —
Purchases of property and equipment included in accounts payable and other
$ 13,000
$ —
Noncash financing activities:
Extinguishment of restructured debt
$ 7,440,462
$ —
Issuance of Common Stock, warrants and other rights upon extinguishment of restructured debt
$ 3,962,766
$ —
Gain on extinguishment of debt with related parties
$ 3,477,696
$ —
Equity dividend to investor
$ 10,153,799
$ 11,643,114
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 one-for-forty ( 1 ::40). This reverse stock split was effective on April 11, 2025, and the Common Stock commenced trading
on a reverse split-adjusted basis when the markets opened on April 11, 2025, under the existing trading symbol “HCWB.”
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 reverse stock split at a final ratio of one-for-six
(1::6), or the Reverse Stock Split , which was effective at 12:01 a.m. Eastern Time on Tuesday, June 30, 2026 (the “Effective Date”).
The Common Stock commenced trading on a Reverse Stock Split-adjusted basis under the Company’s existing trading symbol, “HCWB,”
at market open on Tuesday, June 30, 2026.
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 $ 107.5 million. These factors raise substantial doubt regarding the Company’s
ability to continue as a going concern.
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 no short-term investments.
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 $ 20.0
million, which inherently limits the settlement amount regardless
of the Company’s stock price and (2) the discount which reduces the amount to be paid upon settlement. See Note 7. Standby
Equity Purchase Agreement.
Net
Income (Loss) Per Share
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 904,312 weighted-average shares of Common Stock outstanding and participating
warrants which may be exercised for 524,501 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 63.3 % of undistributed earnings to Common Stockholders and 36.7 % of undistributed earnings to holders of participating securities.
Prior to the Amendment, the Company reported basic and diluted EPS of $2.19 per share for the three months ended March 31, 2026, an overstatement
of $0.80 per share. In the Amendment, for the three months ended March 31, 2026, the Company reported basic and diluted EPS of $1.39
per share. See Note 9. Net income (loss) per share. Due to the cumulative nature of the two-class method, this error had no impact on
the unaudited condensed financial statements for the three and six months ended June 30, 2026, nor any other reporting period.
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.
11
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 $ 2.4
million and $ 1.8
million, respectively. There was no warrant liability outstanding as of June 30, 2026. See Note 6. Sale of Common Stock and
Warrants.
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
$ 1,607,009
$ —
$ —
$ 1,607,009
Investments
—
—
1,326,329
1,326,329
Liabilities
Contingent liability
—
—
( 692,531 )
( 692,531 )
Total
$ 1,607,009
$ —
$ 633,798
$ 2,240,807
12
Level 1
Level 2
Level 3
Total
June 30, 2026
Level 1
Level 2
Level 3
Total
Assets:
Money market funds
$ 246,046
$ —
$ —
$ 246,046
Investments
—
—
1,326,329
1,326,329
Liabilities
Contingent liability
—
—
( 692,531 )
( 692,531 )
Total
$ 246,046
$ —
$ 633,798
$ 879,844
3.
Accrued Liabilities and Other Current Liabilities
As
of December 31, 2025, the Company had a balance of $ 1.1 million included in Accrued liabilities and other current liabilities in the
accompanying condensed balance sheet, consisting of $ 422,000 for construction expenses, $ 87,000 for accrued interest expense, $ 49,000
for manufacturing expenses, $ 159,000 for legal fees, $ 186,000 for clinical expenses, $ 79,000 for salary expenses and $ 118,000 for other
accrued expenses or current liabilities.
As
of June 30, 2026, the Company had a balance of $ 1.1 million included in Accrued liabilities and other current liabilities in the accompanying
condensed balance sheet, consisting of $ 422,000 for construction expenses, $ 74,000 for manufacturing expenses, $ 74,000 for legal fees,
$ 240,000 for clinical expenses, $ 166,000 for salary expenses and $ 124,000 for other accrued expenses or current liabilities.
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 $ 6.5
million in proceeds to purchase a property where the Company planned to construct a manufacturing facility for biologics and
upgraded research laboratory facilities. The loan is secured by a first priority lien on the property.
As
of June 30, 2026, the Company had $ 6.1 million in principal outstanding under the 2022 Loan Agreement. The interest-only period was one
year followed by 48 months of equal payments of principal and interest beginning on September 15, 2023 based on a 25-year amortization
rate. The unamortized balance is due on August 15, 2027 (the “2022 Loan Agreement Maturity Date”), and bears interest at
a fixed per annum rate equal to 5.75 %. The Company is in compliance with covenants related to current payment of principal, interest,
property taxes and insurance as of June 30, 2026. The Company has the option to prepay the outstanding balance of the loan prior to the
2022 Loan Agreement Maturity Date without penalty.
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.
13
Senior
Secured Notes
During
the year ended December 31, 2024, the Company received $ 6.9 million in funding from the issuance of Secured Notes. Investors included
Dr. Hing C. Wong, Founder and Chief Executive Officer, who invested $ 2.4 million; Rebecca Byam, Chief Financial Officer, who invested
$ 220,000 ; Lee Flowers, Senior Vice President of Business Development, who invested $ 25,000 ; Scott T. Garrett, the Chairman of the Company’s
board of directors, who invested $ 140,000 ; Gary M. Winer, who was serving as a member of the Company’s board of directors at the
time of his investment, who invested $ 60,000 ; Rick S. Greene, a member of the board of directors, who invested $ 25,000 , and other significant
investors. In July and October 2024, the terms of the Secured Notes were amended, including but not limited to a fixed bonus payable
on Maturity, or August 30, 2026 (the “Maturity Date”).
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 9 % per annum, payable quarterly in arrears, and mature on August 30, 2026 (the “Maturity
Date”), on which date the principal balance, accrued but unpaid interest, and other amounts that may be due under the terms of
the Amended and Restated Note Purchase Agreement shall be due and payable. The Senior Notes may be repaid upon a Mandatory Redemption
event or at the end of the term.
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 $ 10.0
million issuance of Secured Notes, in full satisfaction of the indebtedness evidenced by the Secured Notes. The Pledged Collateral
will be held and released according to the terms of the Escrow Agreement, as security for the Secured Notes.
If
the Secured Notes are repaid on the Maturity Date, holders will receive their pro rata share of a fixed bonus payment of $ 3.4 million
in addition to payment of outstanding principal and accrued interest. If a bonus payment is paid, there is no prepayment penalty.
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 $ 6.6
million of the principal of the outstanding Secured Notes elected to convert their outstanding indebtedness to equity and entered the Second Amendment to the Amended and Restated Note Purchase Agreement (the “Conversion Agreement”). On May 7,
2025, the conversion date, the Company extinguished $ 6.6
million of the outstanding principal amount of Secured Notes and $ 860,462
of accumulated accretion of a fixed bonus to be paid on the Maturity Date. For those noteholders who converted to equity, the right
to a fixed bonus payable on the Maturity Date was terminated and the previously accumulated fixed bonus was waived. See section
“Troubled Debt Restructuring of Secured Notes” below.
For
those Secured Notes which remain outstanding as of December 31, 2025 and June 30, 2026, the Company reported $ 397,065 and $ 425,891 ,
respectively, for the outstanding principal and accumulated accretion of a fixed bonus payment due upon Maturity Date as a current liability
in Short-term debt, net in the accompanying condensed balance sheets.
For
the three months ended June 30, 2025 and 2026, the Company recognized $ 102,248 and $ 14,413 , respectively, as an expense for accretion
of the fixed bonus payment due in the event the Secured Notes are repaid on the Maturity Date, presented within General and administrative
expenses in the accompanying condensed statements of operations. For the six months ended June 30, 2025 and 2026, the Company recognized
$ 375,308 and $ 28,826 , respectively, for this expense.
14
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 $ 7.4
million of debt through the issuance of 42,181
shares of Common Stock, warrants to purchase 21,090
shares of Common Stock, and rights to receive a pro rata share of 49.11 %
of the proceeds or shares from the Company’s investment in AlloTera Therapeutics. The transaction was accounted for under ASC
Subtopic 470-50, Debt Modifications and Extinguishments, and ASC Subtopic 470-60, Troubled Debt Restructurings by Debtors as a
troubled debt extinguishment, as the Company was experiencing financial difficulty and it was granted a concession by Secured Note
noteholders whereby the fair value of consideration transferred was less than the carrying amount of the Secured Notes.
The
net carrying amount of the restructured Secured Notes was $ 7.4 million, including principal of $ 6.6 million and accumulated accretion
of a fixed bonus payable upon Maturity Date of $ 860,462 . The fair value of consideration transferred including Common Stock, warrants
to purchase Common Stock, and rights to proceeds of a portion of the Company’s shares of AlloTera Therapeutics common stock was
$ 4.0 million, with the difference of $ 3.5 million being recognized as a troubled debt restructuring gain. Due to the related party nature
of the converting noteholders, the gain was recorded to additional paid-in capital and is reflected in the beginning balance as of January
1, 2026 for the period ended June 30, 2026, in the accompanying condensed statements of stockholders’ equity (deficit).
Unsecured
Promissory Notes
During
the year ended December 31, 2025, the Company issued a total of $ 270,000 principal amount of unsecured convertible promissory notes that
mature on May 5, 2026 with paid in kind interest accruing thereon, payable quarterly in arrears at 10 % per annum (the “Convertible
Bridge Notes”). In accordance with their terms, following the completion of a qualified offering, the Convertible Bridge Notes
were converted into shares of our Common Stock at the final offering price in an offering that closed on May 15, 2025. In addition, holders
of the Convertible Bridge Notes have the right to receive a portion of the proceeds of the Company’s shares of AlloTera Therapeutics
common stock, if and when such shares are ever sold, determined by the number of the AlloTera Therapeutics shares equal to 0.25 multiplied
by the original principal amount, in dollars, of the Convertible Bridge Notes. Investors included: $ 60,000 invested by Hing C. Wong,
the Company’s Founder and CEO; $ 100,000 invested by Scott T. Garrett, the Chairman of the Company’s board of directors; and
$ 10,000 invested by Gary M. Winer, who was serving as a member of the Company’s board of directors at the time of his investment.
As
of May 15, 2025, the outstanding principal of the Convertible Bridge Notes were converted. The fair value of consideration
transferred including 6,041
shares of Common Stock and rights to proceeds of a portion of the Company’s shares of AlloTera Therapeutics common stock was
$ 401,134 ,
with the difference of $ 131,135
being recognized as a loss on conversion. Due to the related party nature of the converting noteholders, the loss was recorded to
additional paid-in capital and is reflected in the beginning balance as of January 1, 2026 for the period ended June 30, 2026, in
the accompanying condensed statements of stockholders’ equity (deficit).
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 $ 1.3
million and the fair value for the Contingent liability was $ 692,531
in the accompanying condensed balance sheets. See Note 2. Fair Value of Financial Instruments.
15
Promissory
Note with Personal Guaranty
On
May 8, 2025, the Company issued a promissory note for $ 150,000 , secured by a personal guaranty and pledge given by the Company’s
Founder and CEO, Dr. Hing C. Wong in accordance with the provisions of that certain Guaranty and Pledge Agreement of even date herewith
between the Company and the holder. The promissory note was issued with an original issue discount of $ 75,000 . On the Maturity Date of
February 7, 2026, the Company was obligated to repay $ 225,000 . The Company repaid the promissory note in full on February 6, 2026.
For
the three and six months ended June 30, 2025, the Company recognized accretion of original issue discount of $ 14,722 and for the six
months ended June 30, 2026 the Company recognized accretion of original issue discount of $ 10,278 , in Interest expense in the accompanying
condensed statement of operations. As of December 31, 2025, the Company reported a balance of $ 214,722 for the promissory note in Short-term
debt, net in the accompanying condensed balance sheet.
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 $ 3.5 million in gross cash proceeds, or
$ 2.9 million net of foreign 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.
In
addition, the Company is eligible to receive up to $ 16.0 million in development and regulatory milestone payments, royalties on future
product sales, and a share of proceeds from certain future transactions involving the licensed molecule. Trimmune is responsible for
all research, development, manufacturing, regulatory, and commercialization costs in its territory, including the Phase 1 clinical trial
in China. Following completion of that trial, the Company has a payment-free, milestone-free, and royalty-free option (the “Opt-in
Right”) to recapture development and commercialization rights to HCW11-006 in the United States, Canada, Central America, and South
America (the “Opt-in Territory”). If the Company exercises its Opt-in Right, it will be responsible for the costs of clinical
development in its territory.
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 $ 3.5 million at contract inception. The corresponding equity investment is accounted for under the measurement alternative in
ASC 321. The Company identified two distinct performance obligations: (i) the delivery of licensed intellectual property— comprising
the licensed patent rights, licensed know-how, a related license to HCW9109, and a technology transfer (collectively, the “Licensed
IP”); and (ii) post-transfer development services consisting of an improved cell line and a master cell bank (collectively, the
“Services”). The transaction price at inception was $6,650,000, reflecting the $7.0 million in upfront consideration, less
$350,000 that was carved out as a contract liability related to prepaid optional post-transfer services . Development and regulatory milestone
payments, royalties, and sales-based sublicensing consideration are fully constrained at inception and excluded from the transaction
price. Non-sales-based sublicensing consideration remains constrained until the related uncertainty is resolved.
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 $ 121,730 and $ 6.7 million of revenue, respectively, under the Trimmune
License. For the three months ended June 30, 2026, revenues were comprised of $ 121,730 of Services revenue. For the six months ended
June 30, 2026, revenues were comprised of $ 6.3 million allocated to the Licensed IP recognized at closing and $ 351,730 of Services revenue
earned through the reporting period. As of June 30, 2026, the contract liability of $ 348,270 reported in the accompanying condensed consolidated
balance sheet represents $ 40,000 of remaining Services consideration and the $ 308,270 prepayment associated with the optional post-transfer
services. The carrying value of the Company’s equity interest in Trimmune was $ 3.5 million as of June 30, 2026, which is included
in investments in the accompanying condensed balance sheet. See Note 1. Organization and Significant Accounting Policies – Investments.
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
$ 6,300,000
$ 6,300,000
$ -
Prepaid technology transfer costs
500,000
191,730
308,270
Master Cell Bank
200,000
160,000
40,000
$ 7,000,000
$ 6,651,730
$ 348,270
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) 26,334 shares of the Company’s Common Stock and (ii) pre-funded warrants to purchase up to 85,524
shares of Common Stock (the “Pre-Funded Warrants”) in a follow-on public offering (the “May 2025 Offering”),
pursuant to a registration statement filed under Rule 424(b)(4) (File No. 333-287136), which was declared effective by the SEC on May
15, 2025. The Company also issued warrants to purchase up to an aggregate of 223,714 shares of Common Stock (“Common Stock Warrants”).
The
gross proceeds to the Company from the May 2025 Offering were approximately $ 5.0 million before deducting the placement agent’s
fees and other offering expenses of $ 802,602 payable by the Company. The May 2025 Offering closed on May 15, 2025. In this financing,
the Company issued shares of Common Stock or Pre-Funded Warrants that may be exercised to purchase Common Stock in lieu thereof, and
warrants that may be exercised to purchase Common Stock. In a contemporaneous private agreement entered into with the Investor, the Company
agreed to reprice warrants to purchase up to 27,988 shares of Common Stock that were issued to the Investor in a financing that closed
on November 20, 2024. The Company estimated the fair value of the securities issued, using the Black Scholes valuation model to estimate
the fair value of the warrants, and determined the fair value of securities issued was $ 15.2 million. As this was a transaction with
an existing stockholder, the Company recognized a $ 10.2 million deemed equity dividend to the Investor which was recorded in additional-paid-in
capital for the period ended June 30, 2025.
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 223,714 shares of Common Stock, together with the November 2024 Common Warrants (as repriced in connection with the May 2025
offering) exercisable for up to 27,988 shares of Common Stock, were subsequently exercised in the November 2025 inducement transaction
discussed below.
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 251,702
shares of Common Stock, resulting in aggregate gross proceeds to the Company of approximately $ 4.0
million before fees and expenses. At closing, the Company issued 49,834
shares and held 201,868
shares in abeyance, until such time as the Investor requested issuance.
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 503,402 shares of Common Stock at an exercise price
of $ 14.46 per share. In a private transaction entered into contemporaneously with the February 2026 Sale of Common Stock and Warrants
discussed below, the Company agreed to an amendment to reduce the exercise price of these Common Stock Warrants to $ 3.633 per share,
which was approved by the Company’s stockholders on June 15, 2026 at the Annual Meeting of Stockholders.
As
of December 31, 2025 and June 30, 2026, there were 162,834 shares and no shares held in abeyance, respectively.
18
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 251,702
shares of Common Stock, resulting in aggregate gross proceeds to the Company of approximately $ 4.0
million before fees and expenses. At closing, the Company issued 49,834
shares and held 201,868
shares in abeyance, until such time as the Investor requested issuance.
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 503,404 shares of Common Stock at an exercise price
of $ 14.46 per share. In a private transaction entered into contemporaneously with the February 2026 Sale of Common Stock and Warrants
discussed below, the Company agreed to an amendment to reduce the exercise price of these Common Stock Warrants to $ 3.633 per share,
which was approved by the Company’s stockholders on June 15, 2026 at the Annual Meeting of Stockholders.
As
of December 31, 2025 and June 30, 2026, there were 162,834 shares and no 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 412,882 units (the “Units”) consisting of (i) 412,882 pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to 412,882 shares of Common Stock, and (ii) up to 412,882 Common Stock purchase warrants (the “Common
Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) to purchase up to 412,882 shares of Common Stock.
The issuance of the Common Warrants was subject to stockholder approval, which was obtained at the Company’s Annual Meeting of
Stockholders held on June 15, 2026. The securities were offered pursuant to a registration statement on Form S-1, as amended (File No.
333-293396), which was declared effective by the Securities and Exchange Commission on February 17, 2026.
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 $ 3.6329 .
The Common Stock Warrants have an exercise price of $ 3.633
per share and expire on the 5 five-year anniversary of receipt of stockholder approval. The Pre-Funded Warrants have an exercise
price of $ 0.0001 ,
are exercisable immediately and will not expire until exercised in full.
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 503,402 shares of Common Stock (the “Existing Warrants”), which were issued in the November 2025
Inducement Transaction, and agreed to reprice these warrants from $ 14.46 to $ 3.633 , which was approved by the Company’s stockholders
on June 15, 2026 at the Annual Meeting of Stockholders.
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 $ 1.5
million before deducting the placement agent’s fees and other offering expenses of $ 389,056
payable by the Company. The offering closed on February 19, 2026.
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 $ 1.3 million using the Black-Scholes option pricing
model with assumptions including a term of 5 years, volatility of 131.8 % and a risk-free rate of 3.57 %. The change in fair value of the
Existing Warrants which were amended to lower the exercise price from $ 14.46 to $ 3.633 per share was estimated at $ 193,910 using the
Black Scholes pricing model with the assumptions including a term of 5.26 years, volatility of 131.8 % and a risk-free rate of 3.57 %.
As this was a transaction with an existing stockholder, the difference between the gross proceeds of $ 1.5 million and the fair value
of securities issued and the modification of the warrant, or $ 3.0 million, was deemed to be an equity dividend to the Investor, which
was recorded in additional-paid-in capital as of June 30, 2026.
On
March 16, 2026, the Investor exercised all of its Pre-Funded Warrants issued from the February 2026 offering, and the Company issued
412,882 shares of Common Stock. As of June 30, 2026, there were no Pre-Funded Warrants outstanding that were purchased in the February
2026 transaction.
February
2026 Offering and Warrant Classification
The
February 2026 Common Stock Warrants that may be exercised to purchase up to 412,882 shares of Common Stock issued on February 17, 2026
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 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 Warrants and the Pre-Funded Warrants do not provide
any guarantee of value or return.
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 $ 3.633 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 474,496 units, with each unit consisting of (i) one share of the Company’s common stock, par value $ 0.0001 per share (the “Common
Stock” or “Shares”), at a purchase price of $ 7.68 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 $ 0.75 per Common Warrant.
The units were sold at a purchase price of $ 8.43 per unit, and the Shares or Pre-Funded Warrants and Common Warrants comprising the units
are immediately separable and were issued separately. In lieu of Shares that would otherwise result in a purchaser’s beneficial
ownership exceeding 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of such
Shares, certain purchasers elected to receive pre-funded warrants (the “Pre-Funded Warrants”) at a purchase price of $7.6799
per Pre-Funded Warrant (equal to the per Share purchase price less $0.0001). Each Pre-Funded Warrant is exercisable immediately upon
issuance for one share of Common Stock at an exercise price of $ 0.0001 per share and will remain exercisable until exercised in full.
Each Common Stock Warrant is exercisable immediately upon issuance for one share of Common Stock at an exercise price of $ 7.68 per share
and will expire on the five and one-half year anniversary of the original issuance date. The shares of Common Stock issuable upon exercise
of the Pre-Funded Warrants and the Common Stock Warrants are referred to herein as the “Warrant Shares.”
20
Pursuant
to the May 2026 SPA, the Company issued and sold an aggregate of 71,174 Shares, 403,322 Pre-Funded Warrants, and Common Warrants to purchase
an aggregate of up to 474,496 shares of Common Stock for aggregate gross proceeds of approximately $ 4.0 million at the closing, before
deducting fees payable to the placement agent and other offering expenses payable by the Company. The Investors included officers, directors
and significant stockholders. 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.
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 403,322 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 27,988 shares of
Common Stock, May 2025 Common Stock Warrants to purchase up to 223,714 shares of Common Stock, and Conversion Common Stock Warrants issued
to the Noteholders who converted Secured Notes to equity to purchase up to 21,099 shares of Common Stock.
As
of June 30, 2026, outstanding participating warrants included: November 2025 Common Stock Warrants to purchase up to 503,402 shares of
Common Stock and Conversion Common Stock Warrants to purchase up to 21,099 shares of Common Stock.
7.
Standby Equity Purchase Agreement
On
February 20, 2025 , the Company entered into an Equity Purchase Agreement (the “Equity Purchase Agreement”) with Square Gate
Capital Master Fund, LLC - Series 4 (“Square Gate”), which the Company deemed to be a Standby Equity Purchase Agreement (“SEPA”).
Under the Equity Purchase Agreement, the Company will have the right, but not the obligation, to sell to Square Gate, and Square Gate
will have the obligation to purchase from the Company, up to $ 20,000,000 (the “Maximum Commitment Amount”) worth of the Company’s
shares of Common Stock, at the Company’s sole discretion, over the next 36 months (the “Put Shares”), subject to certain
conditions precedent and other limitations. Square Gate has covenanted not to cause or engage in any short sales or hedging transactions
with respect to the shares of the Company’s Common Stock. The Maxim Group LLC acted as the Company’s exclusive Placement
Agent in connection with this transaction.
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.
21
Unless
earlier terminated, the Equity Purchase Agreement will remain in effect until the earlier of February 18, 2028 (i.e., the expiry of the
36-month period commencing on the date of the Equity Purchase Agreement) or the date on which Square Gate has purchased the Maximum Commitment
Amount (the “Commitment Period”). The Company has the right to terminate the Equity Purchase Agreement at any time, subject
to certain provisions as set forth in the Equity Purchase Agreement. Square Gate has the right to terminate the Equity Purchase Agreement
under certain provisions as set forth in the Equity Purchase Agreement, including the continued listing of the Company’s Common
Stock on an Eligible Market.
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 1,603 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 $ 40.0 million of the Company’s shares to
Square Gate, according to provisions of the Equity Purchase Agreement. The Commitment Fee and issuance costs for the registration statement
to register the underlying shares of Common Stock issued under the Equity Purchase Agreement were expensed.
For
the six months ended June 30, 2025, the Company expensed the $ 150,000 Commitment Fee in the accompanying condensed statement of operations.
During the three and six months ended June 30, 2025 and 2026, the Company did not put any shares to Square Gate under the SEPA.
8.
Preferred Stock
As
of December 31, 2025 and June 30, 2026, the Company had 10,000,000 shares of preferred stock authorized and no shares of preferred stock
issued.
22
9.
Net Loss Per Share
The
following table summarizes the computation of the basic and diluted net loss per share:
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
$ ( 1,927,730 )
$ ( 5,219,231 )
$ ( 4,124,606 )
$ ( 1,746,751 )
Equity dividend to investor
( 10,153,799 )
( 10,154,642 )
( 10,153,799 )
( 11,643,114 )
Net loss attributable to Common Stockholders
$ ( 12,081,529 )
$ ( 15,373,873 )
$ ( 14,278,405 )
$ ( 13,389,865 )
Denominator:
Weighted-average common shares outstanding, basic and diluted
296,686
1,327,966
241,417
1,117,350
Net loss per share, basic and diluted
$ ( 40.72 )
$ ( 11.58 )
$ ( 59.14 )
$ ( 11.98 )
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
27,988
—
May 2025 warrants
223,714
—
Warrants from Debt Conversion
21,099
21,099
November 2025 warrants
—
503,402
Potentially participating warrants
272,801
524,501
The
following table summarizes the outstanding potentially dilutive securities. For the three and six months ended June 30, 2025 and 2026,
these securities were excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:
Summary of Outstanding Potentially Dilutive Securities
June 30,
2025
2026
Common stock options
7,391
7,342
Common stock warrants
272,801
1,411,879
Potentially dilutive securities
280,192
1,419,221
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 $ 0
and $ 330,186
on pre-tax losses of $ 4.1
million and $ 1.4
million for effective tax rates of ( 23.28 )% and 0 %,
respectively. The effective tax rate differed from the statutory rate primarily because the Company recorded foreign withholding tax
expense on China licensing revenue while receiving no corresponding U.S. tax benefit due to its full valuation allowance.
23
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
—
330,186
Total income taxes paid
$ —
$ 330,186
11.
Segment Reporting
HCW
Biologics Inc. has one reportable segment: life science. The life science segment consists of operations focused on discovering and developing
novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and diseases. The Company’s
CODM is the chief executive officer.
The
accounting policies of the life science segment are the same as those described in the summary of significant accounting policies. The
CODM assesses performance for the life science segment based on net segment income (loss). The measure of segment assets is reported
on the condensed balance sheet as total assets.
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.
24
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
$ 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 expenses
Salaries, benefits and related expenses
778,440
761,312
1,479,546
1,539,698
Manufacturing and materials
33,986
27,073
296,783
17,114
Preclinical expenses
146,948
158,917
324,060
376,483
Clinical trials
110,935
101,246
298,755
228,777
Overhead allocations
156,515
154,804
306,392
299,228
Total research and development expenses
1,226,824
1,203,352
2,705,536
2,461,300
General and administrative
Salaries, benefits and related expenses
765,539
523,466
1,554,026
1,046,820
Professional services (a)
496,641
504,837
951,008
989,975
Facilities and office expenses
111,740
103,883
206,068
216,796
Depreciation expenses
59,160
49,994
120,398
103,870
Rent and occupancy expenses
62,528
45,887
112,278
87,049
Insurance
270,598
191,080
560,866
385,523
Taxes
61,576
111,278
94,168
285,966
Other expenses
165,991
325,537
328,181
558,827
Total general and administrative expenses
1,993,773
1,855,962
3,926,993
3,674,826
Other segment items (b)
( 1,291,557 )
2,066,030
( 2,505,600 )
1,718,482
Total operating expenses
1,929,040
5,125,344
4,126,929
7,854,608
Net segment loss
$ ( 1,927,730 )
$ ( 5,219,231 )
$ ( 4,124,606 )
$ ( 1,416,565 )
(a)
Professional
services consist primarily of audit and accounting advisory services, tax advisory services, corporate legal services and other services
related to SEC compliance, and legal fees related to patent filings.
(b)
Other
segment items include the following unusual or nonrecurring item that comprise other segment items for the three and six months ended
June 30, 2025 and 2026:
2025
2026
2025
2026
Three Months Ended
June 30,
Six Months Ended
June 30,
2025
2026
2025
2026
Arbitration legal fees (recoveries), net
$ 142,542
$ ( 1,325 )
$ ( 1,596,951 )
$ 5,525
Accretion of fixed bonus upon maturity of Secured Notes
102,248
14,413
375,308
28,826
Interest expense
228,714
100,541
505,853
209,815
Indirect tax expense
—
—
—
198,146
Change in fair value of investment, net
( 1,748,688 )
—
( 1,748,688 )
—
Gain on extinguishment of liability
—
( 483,383 )
—
( 483,383 )
Change in fair value of warrant liability
—
2,443,335
—
1,775,992
Other income, net
( 16,373 )
( 7,551 )
( 41,122 )
( 16,439 )
Other segment items
$ ( 1,291,557 )
$ 2,066,030
$ ( 2,505,600 )
$ 1,718,482
12.
Commitments and Contingencies
Operating
Leases
The
Company has operating leases for approximately 12,250
square feet of space located in Miramar, Florida. On January 27, 2025, the Company entered into a 1 one-year
lease for the same location which commenced on March 1, 2025 and terminated on February
28, 2026 . On February
2, 2026 , the Company entered into a one-year lease for the same location which commenced on March 1, 2026 and terminates on
February 28, 2027. FASB ASC 842, Leases, provides for an exception for short-term leases in ASC 842-20-25-2, whereby a lessee may
elect to recognize lease payments in profit or loss on a straight-line basis over the lease term and forego the requirement to
recognize a ROU asset and lease liability. The Company elected to account for its short-term operating leases on a straight-line basis over the lease
term and did not recognize a ROU asset or lease liability, as allowed for under the exception in ASC842-20-25-2. The Company has no obligations under financing
leases.
25
For
the three months ended June 30, 2025 and 2026, rent expense recognized by the Company was $ 52,619 and $ 55,715 , respectively, of which
$ 27,557 and $ 29,178 , respectively, are included in research and development in the accompanying condensed statements of operations. For
the six months ended June 30, 2025 and 2026, rent expense recognized by the Company was $ 103,175 and $ 109,365 , respectively, of which
$ 54,033 and $ 57,275 , respectively, are included in research and development in the accompanying condensed statements of operations.
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 $ 266,880 it expects to pay during the year ending December
31, 2026.
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 $ 2.0 million insurance reimbursement which was paid directly to Cooley LLP (“Cooley”),
the law firm that represented Dr. Wong in his defense in the Arbitration. 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 and June 30, 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.
After
this settlement, as of December 31, 2025 and June 30, 2026, the Company recognized 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 in the accompanying condensed
balance sheets.
26
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 $ 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 is $ 6.1 million.
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. As a result, the Company recognized $ 483,383 as a Gain on extinguishment of a liability for
the three and six months ended June 30, 2026 in the accompany condensed statements of operations.
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 $ 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.
27
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 618,682 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 $ 2.585 per Unit consisting of
one share of Common Stock and the right to receive one Common Warrant and $ 2.5849 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 218,682 shares of Common Stock and
400,000 Pre-Funded Warrants for aggregate gross proceeds of approximately $ 1.6 million before deducting offering expenses payable by
the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including
continuing clinical development activities.
28
The
Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are exercisable immediately and will remain exercisable until exercised
in full. The Pre-Funded Warrants may not be exercised to the extent that, after giving effect to such exercise, the holder would beneficially
own more than 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise.
The
Investors are entitled to receive Common Warrants exercisable for an aggregate of up to 618,682 shares of Common Stock. Under the terms
of the Purchase Agreement, issuance of the Common Warrants is subject to stockholder approval required under Nasdaq Listing Rule 5635(d).
Following receipt of such stockholder approval, the Company will issue the Common Warrants to the Investors. The Common Warrants will
have an exercise price of $ 2.585 per share, be exercisable immediately upon issuance and expire on the date that is five and one-half
( 5.5 ) years from the date of issuance. The Common Warrants will contain a beneficial ownership limitation of 4.99%, subject to adjustment
by the holder in accordance with their terms.
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 $ 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.
29
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.