What changed in this filing

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Item 1. Financial Statements

2025-11-14 compared with 2025-08-18 · 309 added, 198 removed, 465 unchanged (52% of the section changed)

2 unchanged sentences

Condensed Balance Sheets

September 30,

Current assets:

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250,000,000 shares

authorized and 2,146,601 shares issued at June 30, 2025

authorized and 2,621,607 shares issued at September 30, 2025

Additional paid-in capital

8 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Cost of revenues

7 unchanged sentences

Interest expense

Unrealized gain on investment

Change in fair value of investment and contingent liability, net

Loss on sale of put shares

Other income, net

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Condensed Statements of Changes in Stockholders’ Equity (Deficit)

For the Six Months Ended June 30, 2024 and 2025

For the Nine Months Ended September 30, 2024 and 2025

Stockholders’ Equity (Deficit)

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Balance, June 30, 2024

Issuance of Common Stock upon exercise of stock options

Stock-based compensation

Balance, September 30, 2024

Stockholders’ Deficit

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( 104,680,742

Issuance of common stock under Standby Equity Purchase Agreement (SEPA)

Issuance cost of Common Stock

Stock-based compensation

Adjustment for reverse stock split

Balance, September 30, 2025

( 109,235,078

See accompanying notes to the unaudited condensed interim financial statements.

1 unchanged sentence

Condensed Statements of Cash Flows

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

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Commitment fee

Unrealized gain on investment

Change in fair value of investment and contingent liability, net

Loss on sale of put shares

Loss on conversion of debt with related parties

8 unchanged sentences

Purchases of property and equipment

Net cash (used in) provided by investing activities

Net cash used in investing activities

Cash flows from financing activities:

Proceeds from issuance of Common Stock

Proceeds from issuance of Common Stock under SEPA, net

Proceeds from issuance of pre-funded warrants

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Capital expenditures accrued, but not yet paid

Purchases of property and equipment included in accounts payable and other

Purchases of property and equipment included in accounts payable

Noncash financing activities:

Put shares issued but not priced under SEPA

Extinguishment of restructured debt

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In addition to the Reverse Stock Split, the stockholders approved two other proposals at the Special Meeting:

(1) use of our equity line of credit to raise up to $ 40.0 million through sales of shares of the Company’s Common Stock thereunder and (2) execution of the principal terms for the conversion of up to approximately $ 6.9 million of the outstanding principal of Secured Notes into shares of Common Stock.

(1) use of the Company’s equity line of credit to raise up to $ 40.0 million through sales of shares of the Company’s Common Stock thereunder and (2) execution of the principal terms for the conversion of up to approximately $ 6.9 million of the outstanding principal of Secured Notes into shares of Common Stock.

Debt, net -- Senior Secured Notes.

All authorized, issued, and outstanding shares of common stock, preferred stock, stock option awards, and per share data included in these financial statements have been recast to give retrospective effect to the adjusted authorized shares and Reverse Stock Split for all periods presented.

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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 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 financial statements are issued.

As of June 30, 2025, the Company had not generated any revenue from commercial product sales of its internally developed immunotherapeutic products for the treatment of cancer and other age-related diseases.

As of September 30, 2025, the Company had not generated any revenue from commercial product sales of its internally developed immunotherapeutic products for the treatment of cancer and other age-related diseases.

During its development activities, the Company has sustained operating losses, experienced negative operating cash flows and negative working capital position and it expects to continue to incur operating losses for the foreseeable future.

Since inception to June 30, 2025, the Company incurred cumulative net losses of $ 102.0 million.

Since inception to September 30, 2025, the Company incurred cumulative net losses of $ 106.5 million.

These losses reflect a $ 5.3 million res erve for credit losses and a $ 1.3 million nonoperating losses reported in prior periods.

To date, the Company has funded operations primarily through the sale of stock and warrants, issuance of Secured Notes and other debt, and revenues generated from the Company’s exclusive worldwide licenses and its development supply agreement with Wugen Inc.

(“Wugen”), pursuant to which Wugen licensed limited rights to develop, manufacture, and commercialize cell-based therapy treatments for cancer based on two of our internally-developed, multi-cytokine fusion protein molecules, HCW9201 and HCW9206.

In the quarter ended June 30, 2025, the Company agreed to a request from Wugen to suspend the Wugen License, including Wugen’s clinical trial due diligence obligations and its obligation to pay up to $ 500,000 annually to reimburse the Company for certain R&D expenses.

The suspension will run for a period of one year from the effective date and will end on May 29, 2026.

During the suspension, the Company has the exclusive right to seek alternate licensees and terminate the license in order to enter other business development transactions related to the ex vivo use of the licensed molecules.

In the quarter ended June 30, 2025, WY Biotech Co., Ltd.

(“WY Biotech”) notified the Company that it had completed its due diligence and review of the technical report delivered by the Company and elected to proceed with next steps pursuant to the exclusive worldwide license agreement between WY Biotech and the Company with respect to development and commercialization of one of HCWB’s preclinical product candidates, HCW11-006, for in vivo applications (as amended, the “WY Biotech License”).

As a result, WY Biotech is financially obligated to the Company, as detailed in the WY Biotech License, as amended, including the obligation to pay a $ 7.0 million upfront license fee.

WY Biotech is in the process of finalizing agreements with its contract development and manufacturing organization (“CDMO”) and investors.

Since the Company has no payment history with WY Biotech, it did not recognize the upfront license fee as revenue as we concluded collectability was not probable.

In order to accommodate WY Biotech’s timing in finalizing agreements, the Company and WY Biotech agreed to extend the latest date for payment of the $ 7.0 million license fee to September 30, 2025 .

During the period ended June 30, 2025, the Company extinguished $ 7.7 million of debt through restructuring or conversion of debt.

This was accomplished by restructuring $ 7.4 million of Secured Notes, including accumulated accretion of a fixed bonus payable upon Maturity Date, through the Second Amendment to the Amended and Restated Note Purchase Agreement and converting $ 270,000 of unsecured promissory notes according to the terms of the purchase agreement.

Both transactions include the right to a portion of the proceeds received on the liquidation or sale of the Wugen shares, if such an event occurs.

The Company maintains ownership of the Wugen shares included in these transactions and has recorded a contingent liability to account for the right to receive proceeds upon liquidation or sale of the Wugen shares.

The noteholders for this debt consisted of officers, directors and other significant stockholders.

Due to the related party nature of the converting noteholders, the gain on restructuring and loss on conversion were recorded to additional paid-in capital for the period ended June 30, 2025.

Since inception, the Company has recognized $ 16.2 million of revenues derived from the Wugen License, including upfront license fees in cash and shares of Wugen common stock, payments for vials of materials, and for manufacturing of development supplies for clinical trials.

On May 29, 2025, the Company agreed to a request from Wugen to suspend the Wugen License, including Wugen’s clinical trial due diligence obligations and its obligation to pay up to $ 500,000 annually to reimburse the Company for certain research and development expenses.

The suspension will run for a period of one year from the effective date of the suspension and will end on May 29, 2026.

During the suspension, the Company has the exclusive right to seek alternate licensees and terminate the Wugen license in order to enter other business development transactions related to the ex vivo use of the licensed molecules.

The Company and WY Biotech Co., Ltd.

(“WY Biotech”) are currently finalizing the terms of an amendment to an exclusive worldwide license agreement (“WY Biotech License”) that the parties first entered on November 17, 2024.

The subject of the license is the use of in vivo rights to one of the Company’s preclinical molecules, HCW11-006.

The Company had extended the date for payment of the $ 7.0 million upfront license fee due under the WY Biotech License while WY Biotech worked to finalize agreements with their contract development and manufacturing organization (“CDMO”) and investors.

On September 5, 2025, WY Biotech proposed further revisions and additions to the terms of the WY Biotech License.

Negotiations between the parties to restructure the terms of the WY Biotech License are ongoing.

Pursuant to the terms currently being negotiated, the Company will retain its payment-free, milestone-free, and royalty-free option to recapture the development and commercialization in vivo rights of the licensed molecule for the United States, Canada, Central America, and South America (Opt-in Territory) after the conclusion of the Phase 1 clinical trial.

WY Biotech is financially responsible for all costs associated with research and development, manufacturing, clinical development, regulatory approval, and commercialization for the molecule.

The Company will be responsible for costs associated with clinical development, regulatory approval, and commercialization in the Opt-in Territory, if it exercises its opt-in rights.

During the nine months ended September 30, 2025 , the Company extinguished $ 7.7 million of debt through restructuring or conversion of debt.

This was accomplished by restructuring $ 7.4 million of Senior Secured Notes, including accumulated accretion of a fixed bonus payable upon maturity through the Second Amendment to the Amended and Restated Note Purchase Agreement (the “Conversion Agreement”) and converting $ 270,000 of unsecured promissory notes according to the terms of the note purchase agreement.

Both transactions include providing the former noteholders with the right to a portion of the proceeds received on the liquidation or sale of the Company’s Wugen shares.

The Company maintains ownership of the Wugen shares included in these transactions and has recorded a contingent liability to account for the right of the former noteholders to receive a portion of the proceeds upon liquidation or sale of the Wugen shares.

See Note 1 - Organization and Summary of Significant Accounting Policies – Investments for further details on the Company’s investment in Wugen shares.

The former noteholders for this debt consisted of officers, directors and other significant stockholders.

Due to the related party nature of the conversion transaction, the gain on restructuring and loss on conversion were recorded to additional paid-in capital, which is presented as a gain on conversion of debt with related parties, net in the accompanying interim condensed statements of changes in stockholders’ equity (deficit) for the three months ended June 30, 2025, the period in which the conversion occurred.

As of September 30, 2025, the Company’s short-term debt includes $ 382,652 held by Senior Note noteholders who did not elect to convert.

The Maturity Date of the Secured Notes is August 30, 2026 , at which time the Company will rep ay $ 435,500 , inclusive of the fixed bonus due upon the Maturity Date.

The Company also has a short-term debt obligation with a carrying value of $ 189,722 as of September 30, 2025.

This debt has a Maturity Date of February 7, 2026 , at which time the Company will repay $ 225,000 .

On August 15, 2022, the Company entered into a loan and security agreement (the “2022 Loan Agreement”) with Cogent Bank, pursuant to which it received $ 6.5 million in proceeds to purchase a property at which the Company planned to build a facility to manufacture biologics and upgrade its research laboratory facilities.

The loan is secured by a first priority lien on the property.

As of June 30, 2025, certain subcontractors had filed mechanics liens related to unpaid invoices issued in connection with construction of the Company’s new manufacturing facilities and upgraded research laboratories.

As of September 30, 2025, the general contractor and certain subcontractors filed mechanics liens related to unpaid invoices issued in connection with construction of the Company’s 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.

however, as of the reporting date, the lender has not elected to do so.

As of June 30, 2025, the Company has reflected this loan as Short-term debt, net, to reflect that the lender has the right to accelerate the loan under a discretionary default provision.

On January 22, 2025, the Company entered into a forbearance agreement with BE&K Building Group (“BE&K”), its general contractor, to allow the Company until March 31, 2025 to continue efforts to find the financing required to complete the construction and renovation of the property.

As of September 30, 2025 , the Company has reported the $ 6.2 million remaining balance of this loan as Short-term debt, net, to reflect that the lender has the right to accelerate the loan under a discretionary default provision.

As discussed below, on October 24, 2025, the Company was notified by Cogent Bank that it exercised its discretion to make a demand that the Company cure mechanics liens.

In connection with the mechanics liens filed by the general contractor and certain subcontractors which triggered the discretionary acceleration provision under the 2022 Loan Agreement, o n January 22, 2025, the Company entered into a forbearance agreement with BE&K Building Group (“BE&K”), its general contractor, to allow the Company until March 31, 2025 to continue efforts to find the financing required to complete the construction and renovation of the property.

Pursuant to the forbearance agreement, the Company made an initial payment of $ 1.0 million in partial satisfaction of amounts owing to BE&K and its subcontractors.

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On August 8, 2025, B&I Contractors, Inc., one of the defendants in the BE&K Complaint, filed a motion for summary judgment (the “MSJ”) as to the Count I (Foreclosure of Construction Lien).

The Company has responded to the BE&K and Fisk Complaints and cross-claims and intends to file a timely response to the B&I MSJ.

The Company has responded to the BE&K and Fisk Complaints and cross-claims as well as the B&I MSJ.

The parties are engaged in discovery and the court has set the case for trial in early December 2026.

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.

The Company and Cogent Bank are in negotiations to come to terms for a forbearance agreement to provide additional time for the Company to comply with the demands it made in the demand letter.

As of July 13, 2024, the Company and Dr.

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No party was required to make any monetary payments to any other party or person under the Settlement Agreement and each party will bear its own expenses incurred in connection with the matter.

The Arbitration and related Complaint were dismissed on December 24, 2024.

The Arbitration and related Complaint were dismissed with prejudice on or about December 24, 2024.

With the execution of the Settlement Agreement, the Company resolved the attendant uncertainties for the outcome of the Arbitration and additional complexities, and it launched its new financing plan.

In the accompanying condensed balance sheet as of June 30, 2025, the Com pany reported a balance of $ 12.3 million for legal fees incurred but not yet paid that were included within Accounts payable and an accrual of $ 8,000 for accrued legal fees within Accrued liabilities and other current liabilities.

The Company is engaged in discussions with the law firms involved wi th this matter to arrange a reasonable payment plan with respect to those legal fees.

In the six months ended June 30, 2025, the Company received a $ 2.0 million insurance payment, which was paid directly to the law firm who represented Dr.

Wong for his defense during the Arbitration.

The insurance payment is reported within Legal expenses, net in the condensed interim statement of operations for the six months ended June 30, 2025.

With the ability to approach the equity markets post Settlement, the Company raised gross proceeds of $ 11.9 million through the issuance of equity securities in two offerings to the same intuitional investor who was the sole investor in both financings (the “Investor”).

The first financing occurred on November 18, 2024, when the Company raised gross proceeds of $ 6.9 million in a registered direct offering and a concurrent private placement of common stock and warrants.

This offering priced above market under Nasdaq rules and closed on November 20, 2024.

The second financing occurred pursuant to a purchase agreement entered into on May 13, 2025, when the Company raised gross proceeds of $ 5.0 million in a follow-on public offering of common stock and warrants.

This offering priced at the market under Nasdaq rules and closed on May 15, 2025.

Contemporaneously with the May 2025 financing, the Company entered into an agreement with the Investor to set a new exercise price, of $ 7.45 per share, with respect to certain Common Stock Warrants to purchase 167,925 shares of the Company’s Common Stock which were issued in November 2024.

Sale of Common Stock and Warrants .

Prior to the May 2025 financing, the Company obtained bridge financing in the form of a $ 150,000 promissory note, guaranteed by securities held by the Company’s Founder and Chief Executive Officer, and in the form of a $ 270,000 unsecured promissory note which converted to equity on May 15, 2025 according to the provision of the loan documents.

On February 20, 2025 , the Company entered into an Equity Purchase Agreement and a related Registration Rights Agreement with Square Gate Capital Master Fund, LLC - Series 4 (“Square Gate”), pursuant to which 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 $ 20.0 million (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.

In the accompanying condensed balance sheet as of September 30, 2025, the Company reported a balance of $ 12.1 million for legal fees incurred but not yet paid that were included within Accounts payable.

The Company is in discussions with the law firms involved with this matter to establish a reasonable payment plan for the related legal fees.

During the nine months ended September 30, 2025, the Company received an insurance reimbursement of $ 2.0 million, which was paid directly to the law firm who represented Dr.

Wong in connection with his defense in the Arbitration.

The insurance recovery is reported within Legal expenses (recoveries), net in the condensed interim statement of operations for the nine months ended September 30, 2025.

During the nine months ended September 30, 2025, the Company raised gross proceeds of $ 7.0 million through the issuance of equity securities.

These include sale of shares of Common Stock through the Company’s Standby Equity Purchase Agreement (“SEPA”) and issuance of equity securities through a follow-on public offering to one institutional investor (the “Investor”).

The Investor was also the sole investor in the Company’s $ 6.9 million equity offering which closed on November 20, 2024.

On February 20, 2025, the Company entered into an Equity Purchase Agreement, which qualified as a SEPA, and a related Registration Rights Agreement with Square Gate Capital Master Fund, LLC - Series 4 (“Square Gate”), pursuant to which 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 $ 20.0 million (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.

On April 16, 2025, the U.S.

Securities and Exchange Commission (“SEC”) declared a registration statement effective to register 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.

On August 14, 2025, the parties agreed to amend the SEPA to allow for intraday trading.

In the three months ended September 30, 2025, the Company issued 475,000 sh ares of Common Stock through the SEPA for net proceeds of $ 2.2 million, $ 2.0 million of which settled as of September 30, 2025.

Standby Equity Purchase Agreement.

On June 26, 2025, the Company announced that it received formal notice from Nasdaq that the Company was in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”).

On May 13, 2025, the Company received formal notice from Nasdaq that it regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5).

As a result, the Company is in compliance with all applicable criteria for continued listing on the Nasdaq Capital Market tier, and the previously disclosed listing compliance matters have been closed.

The Company was also notified that it will remain subject to a “Panel Monitor,” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through June 23, 2026.

If, during the term of the Panel Monitor, the Company does not continue to remain in compliance with the Equity Rule, the Company will not be provided with the opportunity to submit a compliance plan for review by the Listing Qualifications Staff and must instead request a hearing before the Panel to address the deficiency, with such request staying any further action with respect to the Company’s listing on Nasdaq pending completion of the hearing process.

As of June 30, 2025, the conclusion of a going concern assessment, before consideration of our financing plans, was that there is substantial doubt about the Company’s ability to continue as a going concern.

Future financial transactions planned in the next twelve months consist of business development transactions for out licenses and corporate partnering, as well as the sale of Common Stock through Put Shares to Square Gate under the Equity Purchase Agreement.

The Company considered future elements of its financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient mitigate the substantial doubt in the going concern analysis, in addition to considering continued operating losses and the burden of obligations for expenses incurred in connection with past legal proceedings.

On November 20, 2024, the Company closed a $ 6.9 million registered direct offering and a concurrent private placement of common stock and warrants with an offering priced above market under Nasdaq rules.

On May 15, 2025, the Company closed on a $ 5.0 million in a follow-on public offering with an offering priced at the market under Nasdaq rules.

Sale of Common Stock and Warrants .

An important part of the Company’s future financing plans is the ability to access the public markets for the sale of securities.

This requires that the Company remain in compliance with all Nasdaq Listing Rules, and it is currently deficient in meeting the requirements of Listing Rule 5550(b)(1), or the Equity Rule, related to the minimum requirements to maintain a $ 2.5 million balance in stockholders’ equity.

The Company was recently granted an extension to regain compliance with the Equity Rule until December 31, 2025, as discussed in more detail below.

In the first quarter of 2025, following a hearing before a Nasdaq Hearings Panel (the “Panel”), the Panel granted the Company an extension until June 30, 2025 to regain compliance with all Nasdaq Listing Rules The Company had been deficient in three areas:

Listing Rule 5550(a)(2), or requirements for the minimum bid price;

Listing Rule 5550(a)(4), or requirements for the public float requirement in and the market value of publicly held shares, and the Equity Rule.

On June 26, 2025, the Company announced that it received a formal notice from the Listing Qualifications Staff (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) that the Company was in compliance with the Equity Rule for continued listing on the Nasdaq Capital Market (the “Exchange”).

At that time, the Company was also notified that it will remain subject to a “Panel Monitor,” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through June 23, 2026.

While the Company successfully completed several elements of its compliance plan including the Reverse Stock Split, the restructuring or conversion of $ 7.7 million of debt, putting a Standby Equity Purchase Agreement in place, and completing a $ 5.0 million equity financing by June 30, 2025, as previously reported, the Company’s upfront license fee from WY Biotech did not meet the criteria for revenue recognition for the period ended June 30,2025.

As a result, as of June 30, 2025, the Company did not meet the requirements of the Equity Rule.

The Company filed its Form 10-Q for quarter ended June 30, 2025 on August 18, 2025.

On August 19, 2025, the Company received written notice from the Staff that as of June 30, 2025, the Company was non-compliant with the Equity Rule for continued listing on the Exchange.

The Company made a timely request for a hearing before the Panel and was granted a hearing.

On October 13, 2025, the Panel granted the Company an extension in which to regain compliance with all continued listing rules of the Exchange.

The Panel’s determination follows the Company’s hearing on September 25, 2025, at which the Company presented, and the Panel considered, the Company’s plan to regain compliance with the Equity Rule.

The Panel granted the Company’s request for continued listing on the Exchange, subject to, among other things, the Company demonstrating compliance with the Equity Rule by December 31, 2025, and with all other Exchange continued listing rules by February 16, 2026.

The Company was advised that February 16, 2026, represents the full extent of the Panel’s discretion to grant continued listing while the Company is non-compliant with the Nasdaq Listing Rules.

The Panel also required that the Company provide prompt notification of any significant events that occur during the exception period that may affect the Company’s compliance with Nasdaq requirements.

In addition, the Company must timely file Form 10-Q for the third quarter, and provide notice of the status of certain elements of the Company’s compliance plan.

Any compliance documentation submitted by the Company will be subject to review by the Panel, which may, in its discretion, request additional information before determining that the Company has complied with the terms of the exception.

The Panel has discretion to review its decision to grant an exception period within 45 calendar days after issuance of the written decision.

As of September 30, 2025, the conclusion of a going concern assessment, before consideration of our financing plans, was that there is substantial doubt about the Company’s ability to continue as a going concern.

The Company considered future elements of its financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in the going concern analysis, in addition to considering continued operating losses and the burden of obligations for expenses incurred in connection with past legal proceedings.

Management concluded that there were no mitigating circumstances which alleviated the substantial doubt over its ability to continue as a going concern.

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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 audited financial statements and that the substantial doubt that existed in its going concern analysis was not alleviated.

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 financial statements and that the substantial doubt that existed in its going concern analysis was not alleviated.

Summary of Significant Accounting Policies

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Unaudited Interim Financial Information

The accompanying unaudited condensed interim financial statements as of June 30, 2025 and for the three and six-month periods ended June 30, 2024 and 2025 have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.

The accompanying unaudited condensed interim financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2024 and 2025 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”).

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These unaudited condensed interim 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-month periods ended June 30, 2025 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period.

The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period.

The condensed interim balance sheet at December 31, 2024 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S.

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Segment Reporting for further details.

The single operating segment constitutes all of the Company activity, the chief operating decision maker regularly reviews the entity-wide operating results and performance .

The single operating segment constitutes all of the Company activity, the CODM regularly reviews the entity-wide operating results and performance .

All long-lived assets are maintained in the United States of America.

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There is no effect on reporting results of operations from prior periods.

Legal expenses related to the Arbitration are presented in Legal expenses (recoveries), net in the accompanying condensed statements of operations.

Use of Estimates

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For each in process SOW, amounts are billed in the same quarter the costs are incurred.

For the three months ended June 30, 2024 and June 30, 2025, the Company recogni zed $ 618,854 and $ 6,550 in re venue, respectively, related to sale of development supply materials to the Company’s licensee, Wugen.

In the six months ended June 30, 2024 and June 30, 2025, the Company recognized $ 1.7 million and $ 11,615 in revenue, respectively, related to sale of clinical materials to Wugen.

In the three months ended June 30, 2025, the Company agreed to Wugen’s request to suspend the Wugen License for a period of one year, ending on May 29, 2026.

The Company holds a minority equity interest in Wugen.

Prior to the current reporting period as of June 30, 2025, the Company accounted for the Wugen shares using the measurement alternative whereby the investment is recorded at cost less impairment, adjusted for observable price changes in orderly transactions for an identical or similar investment of the same investee.

No impairment has been recognized.

With support provided by a third-party valuation advisor for the valuation of the shares, during the current reporting period as of June 30, 2025, the Company elected to measure its investment at fair value.

The Company will remeasure the change in fair value of the Wugen shares in subsequent reporting periods and recognize the change in earnings.

As of December 31, 2024 and June 30, 2025, the Company included $ 1.6 million and $ 3.3 million, respectively, for its investment in Wugen in Investments in the accompanying condensed interim balance sheets.

For further discussion of the impact of the fair value measurement for the investment in Wugen, see Note 3.

Debt, net - “Troubled Debt Restructuring” and “Contingent Liability.”

The Company invests excess cash in bills and notes issued by the U.S.

Treasury which are classified as trading securities.

As of December 31, 2024 and June 30, 2025 , the Company had no Short-term investments.

For the three months ended September 30, 2024 and September 30, 2025, the Company recognize d $ 426,423 and $ 15,606 in revenue, respectively, related to sale of development supply materials to the Company’s licensee, Wugen.

In the nine months ended September 30, 2024 and September 30, 2025, the Company recognize d $ 2.2 million and $ 27,222 i n revenue, respectively, related to sale of clinical materials to Wugen.

In the nine months ended September 30, 2025, the Company agreed to Wugen’s request to suspend the Wugen License for a period of one year, ending on May 29, 2026.

Wugen has made the strategic decision to focus its ongoing pivotal clinical trials for its CAR-T clinical program which received regenerative medicine advanced therapy (RMAT) designation by the FDA and priority medicines (PRIME) designation by the European Medicines Agency for the treatment of patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

During this time, Wugen will not be purchasing additional clinical materials for the licensed molecules as its clinical program based on these molecules has been paused however the Company continues to earn revenue from related ancillary services such as storage and insurance.

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 interim 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 has elected to measure 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), 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.

Fair Value of Financial Instruments.

In the period ended June 30, 2025, the Company elected to account for its Wugen shares, previously accounted for under the measurement alternative, at fair value as determined using financial valuation techniques and market information available.

Further, the Company will remeasure the change in fair value of the Wugen shares, and related contingent liability, in subsequent reporting periods and recognize the change in earnings.

The Company invests excess cash in U.S.

Treasury bills and notes, which are classified as trading securities.

As of December 31, 2024 and September 30, 2025, the Company had no short-term investments.

Operating Leases

The Company determines if an arrangement is a lease at inception.

Operating leases are included in Other assets, Accrued liabilities and Other current liabilities, and Other liabilities on its condensed interim balance sheets.

Operating leases are included in Other assets, Accrued liabilitie s and Other current liabilities, and Other liabilities on its condensed interim balance sheets.

Operating lease Right of Use (“ROU”) assets and Operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date.

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For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.

During the current reporting period, the Company refined its methodology for calculating weighted average shares outstanding from a monthly average to a daily average.

This change was implemented to improve the precision of the earnings (loss) per share calculations.

The change does not represent a correction of an error, as both methodologies are permitted under ASC Topic 260, Earnings per Share .

The change in methodology will be applied prospectively.

As the effect of this refinement does not materially impact previously reported results and both approaches are consistent with U.S.

GAAP, prior period net loss per share figures have not been recast.

Standby Equity Purchase Agreement

The Company entered an Equity Purchase Agreement providing for an equity line of credit with an investor on February 20, 2025.

This arrangement is in the nature of a Standby Equity Purchase Agreement (“SEPA”), which is an equity-linked instrument for which an entity has the right, but not the obligation, to sell the entity’s common stock to third-party investors over a specified period.

The total number of shares that the entity may issue to the investor is capped by either an aggregate dollar amount or an aggregate number of shares.

Furthermore, the number of shares that an entity may issue at any particular time during the life of the SEPA is also limited.

The price payable by the investor for each share of common stock purchased from the entity is generally discounted.

In exchange for its access to capital through the SEPA, the entity typically provides up-front consideration to the investor in the form of cash or shares of the entity’s common stock.

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 issuable constitutes a forward contract to issue common stock.

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.

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Such asset or liability must be measured at fair value, with changes in fair value recognized in net (loss) income.

Because SEPAs do not qualify for classification in equity, an entity must expense as incurred the amount by which any consideration provided to the investor at the inception of the arrangement exceeds the fair value of the asset recognized for the SEPA.

An entity should recognize at fair value the common shares issued to the investor upon settlement of a SEPA by using the quoted price of the shares on the date of issuance.

The then-current fair value of the asset or liability for the associated forward share issuance contract must be derecognized in conjunction with the settlement.

The proceeds received from the investor are reflected and any residual amount must be charged (or credited) to earnings.

This accounting is consistent with the guidance in ASC 815 that applies upon the settlement of a derivative instrument.

When an equity-linked instrument classified as an asset or liability is settled, entities should measure the instrument at its current fair value as of the settlement date and include in earnings any previously unrecognized fair value gain or loss.

In summary, upon settlement of a forward issuance contract element of a SEPA, an entity would recognize in earnings the following amounts:

• The gain (loss) for the excess (deficit) of (a) the carrying amount of the asset or liability for the forward issuance contract plus the proceeds received and (b) the fair value of the common shares as of the issuance date.

• Any issuance or transaction costs incurred in conjunction with the issuance of the shares.

Further, individual draws must also be evaluated to determine if they meet criteria for equity classification.

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 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.

With regards to the individual draws for an Intraday Put under the First Amendment to the SEPA, an individual draw would create a separate financial instrument with settlement criteria that does not meet the indexation guidance.

While the number of shares is known at inception and therefore not subject to an overarching share cap, the only inputs into its settlement is the Company’s stock price and trading volume during the pricing period.

Inputs noted above are not all inputs into a fixed-for-fixed option pricing model, thus the individual draw issuances are not eligible for equity classification in accordance with ASC 815-40, and therefore an asset or liability will be recorded and marked to market while the financial instrument is outstanding.

Upon settlement of the financial instruments, the Company should recognize the following amounts in earnings:

• The gain (loss) for the excess (deficit) of (a) the carrying amount of the asset or liability for the financial instrument plus the proceeds received and (b) the fair value of the common shares.

• Any discount, issuance or transaction costs incurred in conjunction with the settlement of the put shares.

Accrued Liabilities and Other Current Liabilities

As of December 31, 2024 , the Company had a balance of $ 981,940 included in Accrued liabilities and other current liabilities in the audited condensed balance sheet, consisting of $ 422,000 for construction expenses, $ 49,000 for manufacturing expenses, $ 155,000 for legal fees, $ 121,000 for clinical expenses, $ 5,000 for bonus expense, $ 202,000 for salary expenses and $ 28,000 for other liabilities.

As of June 30, 2025 , the Company had a balance of $ 1.1 million included in Accrued liabilities and other current liabilities in the accompanying condensed interim balance sheet, consisting of $ 422,000 for construction expenses, $ 87,000 for property taxes, $ 52,000 for manufacturing expenses, $ 193,000 for legal fees, $ 127,000 for clinical expenses, and $ 180,000 for salary expenses.

As of September 30, 2025 , the Company had a balance of $ 1.1 million included in Accrued liabilities and other current liabilities in the accompanying condensed interim balance sheet, consisting of $ 422,000 for construction expenses, $ 120,000 for property taxes, $ 49,000 for manufacturing expenses, $ 138,000 for legal fees, $ 137,000 for clinical expenses, $ 118,000 for salary expenses and $ 116,000 for other accrued expenses or current liabilities.

Cogent Bank Loan

On August 15, 2022, the Company entered the 2022 Loan Agreement with Cogent Bank, 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.

On August 15, 2022, the Company entered 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 building.

As of June 30, 2025, the Compa ny had $ 6.3 million in principal outstanding under the 2022 Loan Agreement.

As of September 30, 2025, the Compa ny had $ 6.2 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 “Maturity Date”), and bears interest at a fixed per annum rate equal to 5.75 %.

Upon the Maturity Date, a final payment of unamortized principal will be due.

The Company is in compliance with covenants related to current payment of principal and interest as of June 30, 2025.

The Company has the option to prepay the outstanding balance of the loan prior to the Maturity Date without penalty.

As of December 31, 2024 and June 30, 2025, 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 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 %.

Upon the 2022 Loan Agreement Maturity Date, a final payment of unamortized principal will be due.

The Company is in compliance with covenants related to current payment of principal and interest as of September 30, 2025.

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, 2024 and September 30, 2025, 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.

however, as of the reporting date, the lender has not elected to do so.

As of December 31, 2024 and June 30, 2025, the Company has reflected this loan as Short-term debt, net, to reflect that the lender has the right to accelerate the loan under a discretionary default provision.

As of December 31, 2024 and September 30, 2025, the Company has reported this loan as Short-term debt, net.

The Company and Cogent Bank are in negotiations to come to terms for a forbearance agreement to provide additional time for the Company to comply with the demands it made in the demand letter.

Commitment and Contingencies -- Other Matters.

Senior Secured Notes

As of June 30, 2025, there was $ 325,000 of outstanding principal amount of Secured Notes reported in Debt, net in the accompanying condensed interim balance sheet.

As of June 30, 2025, the Company restructured $ 6.6 million outstanding principal of Secured Notes by conversion to equity.

On May 1, 2025, those noteholders who elected to convert their outstanding principal to equity entered the Second Amendment to the Amended and Restated Note Purchase Agreement (the “Conversion Agreement”).

On May 7, 2025, $ 6.6 million of outstanding principal amount of Secured Notes were extinguished upon conversion.

See discussion in section “Troubled Debt Restructuring of Secured Notes” below.

Those noteholders who elected not to convert had no change in terms, except for the termination of their conversion feature.

Under the terms of the agreement, the Secured Notes continue to bear interest at a rate of 9 % per annum, payable quarterly in arrears.

The Secured Notes will mature on August 30, 2026 (the “Maturity Date”), on which date the principal balance, accrued but unpaid interest and other amounts owed under the terms of the agreement shall be due and payable.

The Company pledged its equity ownership interest in Wugen, which was equivalent to a 5.6 % ownership stake in that company as of June 30, 2025 (“Pledged Collateral”).

As of September 30, 2024, the Company received $ 6.5 million in funding from the issuance of Secured Notes, which is included within Debt, Net on the accompanying condensed interim balance sheet.

Investors included Dr.

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 ;

Garrett, the Chairman of the Company’s board of directors, who invested $ 140,000 ;

Winer, a former member of our board of directors, who invested $ 60,000 ;

Greene, a member of the board of directors, who invested $ 25,000 , and other significant investors.

As of September 30, 2025 , there was $ 325,000 of outstanding principal amount of Secured Notes reported in Short-term Debt, net in the accompanying condensed interim balance sheet.

As of September 30, 2025 , the Company restructured $ 6.6 million outstanding principal of Secured Notes by conversion to equity.

On May 1, 2025, those noteholders who elected to convert their outstanding indebtedness to equity entered the Second Amendment to the Amended and Restated Note Purchase Agreement (the “Conversion Agreement”).

On May 7, 2025, $ 6.6 million of outstanding principal amount of Secured Notes and the Company’s obligation to pay these noteholders a fixed bonus on the Maturity Date were extinguished upon conversion.

The Company pledged its equity ownership interest in Wugen which was 2.2 million shares of Wugen common stock as of September 30, 2025 (“Pledged Collateral”).

The Pledged Collateral will be held and released according to the terms of the Escrow Agreement, as security for the Secured Notes.

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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 and unpaid interest.

If a bonus payment is paid, then there is no prepayment penalty.

In the three and six months ended June 30, 2025, the Company recognized $ 102,248 and $ 375,308 , 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 Depreciation in the accompanying condensed interim statements of operations.

On May 7, 2025, upon conversion of $ 6.6 million of outstanding principal of Secured Notes, accretion of the fixed bonus was terminated for these Secured Notes and the accumulated accretion balance of $ 860,462 was derecognized.

See discussion in section “Troubled Debt Restructuring of Secured Notes” below.

For those Secured Notes which remain outstanding, as of June 30, 2025, the Company reported $ 367,151 for the outstanding principal and accumulated accretion of a fixed bonus payment due upon maturity as a noncurrent liability in Debt, net in the accompanying condensed interim balance sheet.

If a bonus payment is paid, there is no prepayment penalty.

In the three and nine months ended September 30, 2025, the Company recognize d $ 15,502 and $ 390,810 , 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 interim statements of operations.

In the nine months ended September 30, 2025, the accumulated accretion balance of $ 860,462 , related to the $ 6.6 million of Secured Notes that were restructured and converted, was derecognized.

For those noteholders who converted to equity, the right to a fixed bonus payable on the Maturity Date was terminated and previously accumulated fixed bonus was waived.

See section “Troubled Debt Restructuring of Secured Notes” below.

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 September 30, 2025, the Company did not recognize the embedded derivative in the accompanying condensed financial statements.

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.

For those Secured Notes which remain outstanding, as of September 30, 2025 , the Company reported $ 382,652 for the outstanding principal and accumulated accretion of a fixed bonus payment due upon maturity as a current liability in Short-term debt, net in the accompanying condensed interim balance sheet.

Troubled Debt Restructuring of Senior Secured Notes

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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 Wugen 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 for the period ended June 30, 2025.

Due to the related party nature of the converting noteholders, the gain was recorded to additional paid-in capital as of September 30, 2025.

Unsecured Promissory Notes

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The fair value of consideration transferred including 36,242 shares of Common Stock and rights to proceeds of a portion of the Company’s shares of Wugen common stock was $ 401,134 , with the difference of $ 131,134 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 for the period ended June 30, 2025.

Due to the related party nature of the converting noteholders, the loss was recorded to additional paid-in capital in the accompanying condensed interim financial statements as of and for the period ended September 30, 2025.

Promissory Note with Personal Guarantee

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There is no current interest due on the promissory note with personal guarantee.

In the three and six months ended June 30, 2025, the Company recognized accretion of original issue discount of $ 0 and $ 14,722 , respectively, in Interest expense in the accompanying condensed interim statements of operations.

As of September 30, 2025, the Company reported a balance of $ 189,722 in the accompanying condensed balance sheet.

In the three and nine months ended September 30, 2025 , the Company recognized accretion of original issue discount of $ 25,000 and $ 39,722 , respectively, in Interest expense in the accompanying condensed interim statements of operations.

Contingent Liabilities

The Company extinguished $ 6.9 million of debt through conversion or restructuring of outstanding principal to shares of the Company’s Common Stock, warrants to purchase the Company’s Common Stock and the right to receive proceeds of a liquidation or sale of a portion of the Company’s Wugen shares.

The Company retained ownership of the Wugen shares allocated to the converted noteholders and recorded a contingent liability for the right to receive proceeds upon liquidation or sale, if such event occurs.

As of June 30, 2025, the Company elected to measure its investment in Wugen at fair value.

Similar to the underlying asset, the Company recognized the contingent liability at fair value and will recognize changes in fair value in subsequent reporting periods in earnings.

As of June 30, 2025, the Company included $ 1.7 million for this contingent liability in the accompanying condensed interim balance sheets.

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 proceeds of a portion of the Company’ shares of Wugen common stock in the event of a liquidation or sale of these shares.

The Company retained ownership of all of its Wugen shares which is presented in Investments on the accompanying condensed interim balance sheets.

The Company recognized a contingent liability for the rights transferred to the converting noteholders presented in Contingent liability - related party on the accompanying interim condensed balance sheets.

As of September 30, 2025 , the carrying value of the Company’s Wugen shares was $ 1.3 million, and carrying value for the Contingent liability - related party was $ 692,531 in the accompanying condensed interim balance sheets.

Fair Value of Financial Instruments.

Sale of Common Stock and Warrants

Sale of Shares of Common Stock through SEPA

In the three months and nine months ended September 30, 2025, the Company submitted Put Shares to Square Gate which were accepted and resulted in the sale of 475,000 shares of Common Stock.

Standby Equity Purchase Agreement.

May 2025 Equity Financing

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The gross proceeds to the Company from the 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 Offering closed on May 15, 2025.

In this financing, the Company issued shares of Common Stock of 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 167,925 shares of Common Stock that were issued to the Investor in a financing that closed on November 20, 2024 to an exercise price of $ 7.45 per share.

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.

The fair value of the securities issued in this transaction was $ 15.2 million.

This included a fair value of $ 1.3 million for the shares of Common Stock issued based on the number of shares issued times the closing price on May 15, 2025, or $ 8.20 per share.

In addition, the fair value of the warrants issued in this transaction was estimated at $ 13.9 million using the Black-Scholes option pricing model with assumptions including a term of 5 - 10 years, volatility of 120.6 % and a risk-free rate of 4.07 % - 4.45 % As this was a transaction with an existing stockholder, the difference between the gross proceeds and the fair value of securities issued, or $ 10.2 million, was deemed to be an equity dividend to the Investor which was recorded in additional-paid-in capital as of September 30, 2025.

The Investor may not exercise any portion of the Common Stock Warrants or Pre-Funded Warrants to the extent it would beneficially own more than the limits defined in the respective Warrant Purchase Agreement.

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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, the Investor exercised all of the Pre-Funded Warrants by delivering a notice of exercise to the Company and paying the exercise price.

As a result, as of June 30, 2025, the Company issued 513,140 shares of registered Common Stock to the Investor.

As of June 30, 2025, no ne of the Common Stock Warrants issued on May 15, 2025 had been exercised.

As of September 30, 2025 , the Investor exercised all of the Pre-Funded Warrants by delivering a notice of exercise to the Company and paying the exercise price.

As a result, the Company issued 513,140 shares of registered Common Stock to the Investor as of September 30, 2025.

As of September 30, 2025 , no ne of the Common Stock Warrants issued on May 15, 2025 had been exercised.

November 2024 Equity Financing

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The Registered Offering was made by means of a prospectus supplement filed with the SEC on November 20, 2024 that forms a part of such registration statement.

In a concurrent private placement (the “Private Placement” and together with the Registered Offering, the Company also issued unregistered warrants to purchase up to an aggregate of 167,925 shares of Common Stock (“Common Stock Warrants”) for $ 41.20 per share.

Share amounts and exercise price per share have been adjusted for the reverse stock split the Company effected on April 11, 2025.

The Common Stock Warrants have an exercise price of $ 7.45 per share, are exercisable immediately, and expire on the five-year anniversary of the date of issuance.

The Company sold the Common Stock and Pre-Funded Warrants with an accompanying Common Stock Warrant to purchase one share of Common Stock, and the Common Stock and Pre-Funded Warrants were immediately separated from the Common Stock Warrants and issued separately.

The combined purchase price for each Share and accompanying Common Stock Warrant was $ 41.20 per unit and the combined purchase price for each Pre-Funded Warrant and accompanying Common Stock Warrant was $ 41.1999 per unit.

The Common Stock Warrants have an exercise price of $ 41.20 per share, are exercisable immediately, and expire on the five-year anniversary of the date of issuance.

The Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are exercisable immediately, and will not expire until exercised in full.

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The Company issued 63,925 registered shares of Common Stock to the Investor on November 21, 2024.

On April 16, 2025, the 167,925 shares of Common Stock underlying the Common Stock Warrants issued on November 20, 2024 were registered in a registration statement filed pursuant to Rule 424(b)(3) (File No.

On April 16, 2025, the 167,925 shares of Common Stock underlying the Common Stock Warrants issued to the Investor on November 20, 2024 were registered in a registration statement filed pursuant to Rule 424(b)(3) (File No.

On May 15, 2025, the Company entered into a privately negotiated agreement with the Investor for its Common Stock Warrants to reduce the exercise price of such warrants from $ 41.20 per share to $ 7.45 per share.

The Company considered the change in fair value of this modification of the warrant as a deemed dividend to the Investor related to the equity offering that closed in May 2025 with the Investor.

As of June 30, 2025, no ne of the Common Stock Warrants issued on November 20, 2024 and repriced on May 15, 2025 had been exercised.

As of September 30, 2025 , none of the Common Stock Warrants issued on November 20, 2025 had been exercised.

Preferred Stock

As of December 31, 2024 and June 30, 2025 , the Company had 10,000,000 shares of preferred stock authorized and no shares of preferred stock issued.

As of December 31, 2024 and September 30, 2025 , the Company had 10,000,000 shares of preferred stock authorized and no shares of preferred stock issued.

Net Loss Per Share

The following table summarizes the computation of the basic and diluted net loss per share:

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Equity dividend to investor

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The following table summarizes the outstanding potentially dilutive securities.

At June 30, 2024 and 2025, these securities were excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

At September 30, 2024 and 2025, these securities were excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

September 30,

Common stock options

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Potentially dilutive securities

During the current reporting period, the Company refined its methodology for calculating weighted average shares outstanding from a monthly average to a daily average.

This change was implemented to improve the precision of the earnings (loss) per share calculations.

The change does not represent a correction of an error, as both methodologies are permitted under ASC Topic 260, Earnings per Share .

The change in methodology will be applied prospectively.

As the effect of this refinement does not materially impact previously reported results and both approaches are consistent with U.S.

GAAP, prior period net loss per share figures have not been recast.

Standby Equity Purchase Agreement

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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.

During the Commitment Period, the Company will have the right, but not the obligation, to direct Square Gate to make a purchase of the Put Shares by delivering written notice (a “Put Notice”) to Square Gate on any trading day (the “Put Date”) to purchase a number of Put Shares pursuant to a formula set forth in the Equity Purchase Agreement.

The number of Put Shares that the Company can issue to Square Gate from time to time under the Equity Purchase Agreement may not exceed 4.99 % of the number of shares of our common stock outstanding immediately after giving effect to the issuance of shares issuable pursuant to a Put Notice.

The per share purchase price for the Put Shares that we elect to sell to Square Gate in a Put Notice pursuant to the Equity Purchase Agreement will be equal to 98 % of the lowest daily VWAP during the Valuation Period (as defined in the Equity Purchase Agreement), in the case of a Valuation Period ending on the date that is at the end of the third trading day immediately following the applicable Put Date.

The Company also agreed to a $ 150,000 commitment fee (the “Commitment Fee”), which shall be in the form of shares of Common Stock to be issued to Square Gate in accordance with the terms of the Equity Purchase Agreement.

The Equity Purchase Agreement and Registration Rights Agreement contain customary representations, warranties and agreements by the Company and customary conditions to Square Gate’s obligation to purchase the Put Shares.

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Any proceeds that the Company receives from sales of shares of our common stock to Square Gate under the Equity Purchase Agreement will be used to advance our clinical development programs and expand our discovery, research and preclinical activities in the near term and in the future.

On March 12, 2025, the Company issued 9,616 shares of the Company’s Common Stock (subject to adjustment for the Reverse Stock Split) to Square Gate in payment of the Commitment Fee (“Commitment Shares”).

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Securities and Exchange Commission (“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 Company concluded that the Equity Purchase Agreement does not qualify for equity classification.

As of September 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.

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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 expensed as of March 31, 2025.

The issuance costs were expensed as of June 30, 2025.

When the Company wishes to draw on the Equity Purchase Agreement, the Company submits a put order to Square Gate on Day 0, issues the shares on Day 1, and the pricing of the transaction is determined from Day 1 – 3 trading days, with the price to be paid by Square Gate fixed by using the minimum trading price in one of the three trading days after the put order is accepted.

Square Gate is required to pay for the Put Shares under the terms of the Equity Purchase Agreement by Day 5.

When there is a lag between the pricing of the shares and the issuance of the shares, the Company will account for the sale as a forward contract and the issuance as a settlement of the forward contract.

The fair value of the Equity Purchase Agreement is zero since inception.

In the three months ended June 30, 2025, the Company expensed $ 48,608 of issuance costs incurred during the period, which are reported within General and administrative expenses in the accompanying condensed interim statements of operations.

In the six months ended June 30, 2025, the Company expensed the $ 150,000 Commitment Fee which was incurred in the period ended March 31, 2025 and $ 148,608 of issuance costs which were incurred in the period ended June 30, 2025.

No draws were made under the Equity Purchase Agreement as of June 30, 2025.

Subsequent to June 30, 2025, the Company made draws on the Equity Purchase Agreement and the Equity Purchase Agreement was amended by mutual agreement to allow for intraday trading.

Subsequent Events.

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 in the nine months ended September 30, 2025.

In the nine months ended September 30, 2025 , the Company expensed the $ 150,000 Commitment Fee which was incurred in the period ended March 31, 2025 and $ 74,887 of issuance costs incurred in the period ended June 30, 2025.

The Standby Equity Purchase Agreement (“SEPA”) provide two mechanisms for submission by the Company and acceptance by the investor of Put Notices under the SEPA pursuant to which the investor and the Company may agree to and execute s single purchase and sale of Put Shares (“Standard Put Shares”) or multiple purchases and sales of Put Shares on the same trading day (“Intraday Put Shares”).

Standard Put Shares

For a Standard Put, the Company submits a put order to Square Gate on Day 0.

After Square Gate accepts the Standard Put on Day 0, the Company issues the shares on Day 1.

The amount that Square Gate will pay for the shares is determined in a pricing period that occurs from Day 1 – 3 trading days.

The price to be paid by Square Gate is determined using the minimum volume-weighted trading price in one of the three trading days after the put order is accepted, less fixed discount.

Under the terms of the SEPA, Square Gate is required to transfer proceeds to the Company for the Put Shares by Day 5.

The Company accounts a Standard Put as a financial instrument with a gain or loss recognized in earnings upon settlement.

The discount and cost of issuance for each put will be recognized in earnings upon settlement.

Intraday Put Shares

On August 14, 2025, the Company and the investor 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”).

The Intraday Put Shares have a pricing period that is based on trading volume and a price that is lowest traded price during the pricing period.

When there is a lag between the issuance of the shares and the pricing of the shares, the Company accounts for an Intraday Put as a financial instrument with a gain or loss recognized in earnings upon the settlement.

The discount and cost of issuance for each put will be recognized in earnings upon settlement.

Put Shares Accepted by Square Gate

In the three and nine months ended September 30, 2025 , the Company issued 475,000 shares of Common Stock through issuance of shares under the SEPA which resulted in net proceeds of $ 2.2 million, $ 2.0 million of which settled as of September 30, 2025.

Loss on the sale of put shares was $ 182,146 and was presented in Loss on sale of put shares in the accompanying condensed interim statements of operations for the three and nine months ended September 30, 2025.

Fair Value of Financial Instruments

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government-backed securities are measured at fair value based on quoted prices in active markets, which are considered Level 1 inputs.

The investments and contingent liability included in the balance sheet are measured at fair value based on the adjusted enterprise value method, which is considered Level 3 inputs.

N o transfers between levels occurred during the periods presented.

The following table presents the Company’s assets and liabilities which were measured at fair value at December 31, 2024 and June 30, 2025:

The Company measures its investment in shares of Wugen common stock and related contingent liability at fair value based on a combination of valuation techniques, consisting of the adjusted enterprise valuation method and the backsolve method, which are considered Level 3 inputs.

No transfers between levels occurred during the periods presented.

The following table presents the Company’s assets and liabilities which were measured at fair value at December 31, 2024 and September 30, 2025:

December 31, 2024

Money market funds

June 30, 2025

September 30, 2025

Money market funds

Contingent Liability

For the three and six months ended June 30, 2025, The Company computes its quarterly income tax expense/(benefit) by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter.

The Company did not have a provision for income taxes (current or deferred tax expense) as of December 31, 2024 and June 30, 2025.

The Company holds a minority equity interest in Wugen as a result of an in-kind payment for a nonrefundable, upfront licensing fee paid in shares of Wugen common stock.

Wugen is a private company, and there is limited marketability for the shares of common stock.

The Wugen shares are subject to industry-standard restrictions for investments in venture-backed companies, such as restrictions on transferability in private sales and agreement to a lock-up period in the event of an initial public offering.

Rights of common stockholders are subordinate to preferred stockholders, who control the Board of Directors.

In the second quarter of 2025, the Company restructured or converted $ 7.7 million of debt, and part of the terms of restructuring or conversion included rights to receive a portion of the proceeds of the sale or liquidation of the Company’s shares of Wugen common stock, if such an event occurs.

The Company elected to account for the Wugen investment and related contingent liability at fair value beginning in the second quarter of 2025.

As a result, t he Company will remeasure the change in fair value of the Wugen shares and related contingent liability in each reporting periods and recognize the change in earnings.

Based on available market information and valuation techniques, the fair value of the Wugen investment declined from $ 3.3 million as of June 30, 2025 to $ 1.3 million as of September 30, 2025.

Similarly, the fair value of the related contingent liability for the rights to proceeds from the sale or liquidation of Wugen shares declined from $ 1.7 million as of June 30, 2025 to $ 692,531 as of September 30, 2025.

T he Company recognized an unrealized loss of $ 966,284 in the three months ended September 30, 2025 and an unrealized net gain of $ 782,404 in the nine months ended September 30, 2025 presented within Change in fair value of investment and contingent liability, net in the accompanying condensed interim statements of operations.

For the three and nine months ended September 30, 2025, the Company computes its quarterly income tax expense/(benefit) by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter.

The Company did no t have a provision for income taxes (current or deferred tax expense) as of December 31, 2024 and September 30, 2025.

The Company will continue to maintain a 100% valuation allowance on total deferred tax assets.

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As a result, the Company’s effective tax rate will remain at 0.00% because no items either estimated or discrete items would impact the tax provision.

Subsequent Events for information on the recent One Big Beautiful Bill Act and the potential impacts thereof.

On July 4, 2025 the One Big Beautiful Bill Act was enacted into law in the United States.

This legislation includes various tax provisions that may affect U.S.

corporate taxpayers, including changes to the deductibility of interest expense, the treatment of research and development costs, and depreciation of certain property, among other items.

The adoption of this standard did not have a significant impact on the Company’s financial statements nor is it expected to have a material impact on future periods.

Segment Reporting

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The measure of segment assets is reported on the 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, 2025.

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.

Such cash forecast models are reviewed to assess the entity-wide operating results and performance in conjunction with monitoring the results of research and development activities, including experiments for preclinical compounds and clinical trial data for clinical-stage compounds.

The assessment of results of preclinical and clinical studies are critical to the allocation of resources by the CODM.

There were no material changes to the measures for segment revenue, profit or loss, and other metrics since March 31, 2025.

The tables below summarize the significant expense categories regularly reviewed by the CODM for the three and six months ended June 30, 2024 and June 30, 2025:

There were no material changes to the measures for segment revenue, profit or loss, and other metrics since June 30, 2025.

The tables below summarize the significant expense categories regularly reviewed by the CODM for the three and nine months ended September 30, 2024 and 2025:

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Cost of revenues

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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.

Other segment items include the following unusual or nonrecurring item that comprise other segment items for the three and six months ended June 30, 2024 and 2025:

Other segment items include the following unusual or nonrecurring item that comprise other segment items for the three and nine months ended September 30, 2024 and 2025:

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Arbitration legal fees (recoveries), net

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Interest expense

Unrealized gain on investment

Change in fair value of investment and contingent liability, net

Nonoperating loss

Loss on sale of put shares

Other income, net

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The Company has no obligations under financing leases.

For the three months ended June 30, 2024 and 2025 , rent expense recognized by the Company was $ 49,524 and $ 52,619 respectively, of which $ 25,936 and $ 27,557 , respectively, are included in research and development in the accompanying condensed interim statements of operations.

For the six months ended June 30, 2024 and 2025, rent expense recognized by the Company was $ 96,907 and $ 103,175 respectively, of which $ 48,389 and $ 54,033 , respectively are included in research and development in the accompanying condensed interim statements of operations.

For the three months ended September 30, 2024 and 2025 , rent expense recognized by the Company was $ 49,524 and $ 52,619 respectively, of which $ 25,936 and $ 27,557 , respectively, are included in research and development in the accompanying condensed interim statements of operations.

For the nine months ended September 30, 2024 and 2025, rent expense recognized by the Company was $ 146,431 and $ 155,794 respectively, of which $ 75,325 and $ 81,590 , respectively are included in research and development in the accompanying unaudited condensed interim statements of operations.

Contractual Commitments

The Company has commitments with a third-party manufacturing organization to supply us with clinical grade materials.

As of June 30, 2025, it is under contract for obligatio ns of $ 34,200 it expects to pay during the year ending December 31, 2025.

On January 22, 2025, the Company entered into a forbearance agreement with BE&K to allow the Company until March 31, 2025 to continue efforts to find the financing required to complete the construction and renovation of the building.

Pursuant to the forbearance agreement, the Company made an initial payment of $ 1.0 million in partial satisfaction of amounts owing to BE&K and its subcontractors.

Upon the expiration of the forbearance agreement, BE&K took additional legal actions.

See Legal - Other Matters below.

The Company has continued to pursue financing alternatives to provide the funding needed to come current in past amounts due and complete the construction and renovation of the property.

The Company has commitments with R&D outsourcing and development companies to supply us with clinical grade materials or other development services.

As of September 30, 2025, it is under contract for future obligatio ns of $ 245,900 it expects to pay during the year ending December 31, 2025.

Company Victim to Fraudulent Criminal Scheme

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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 financial statements.

Arbitration, Settlement and General Release

On December 23, 2022, Altor BioScience, LLC and NantCell, Inc.

(collectively “ImmunityBio”) initiated an arbitration against Dr.

On December 23, 2022, ImmunityBio initiated an arbitration against Dr.

Wong, the Company’s Founder and Chief Executive Officer, in California alleging breach of contract and fiduciary duty, among other claims.

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– “Legal Proceedings,” as of July 13, 2024, the Company and Dr.

Wong, the Company’s Founder and Chief Executive Officer, entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”) with Altor BioScience, LLC (“Altor”), NantCell, Inc.

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.

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No party is required to make any monetary payments to any other party or person under the Settlement Agreement and each party will bear its own expenses incurred in connection with the matter.

The Arbitration and the Complaint were dismissed as of December 31, 2024.

The Arbitration and related Complaint were dismissed with prejudice on or about December 24, 2024.

Other Matters

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On August 8, 2025, B&I Contractors, Inc., one of the defendants in the BE&K Complaint, filed a motion for summary judgment (the “MSJ”) as to the Count I (Foreclosure of Construction Lien).

The Company has responded to the BE&K and Fisk Complaints and cross-claims and intends to file a timely response to the B&I MSJ.

Inflationary Cost Environment, Banking Crisis, Supply Chain Disruption and the Macroeconomic Environment

The Company has responded to the BE&K and Fisk Complaints and cross-claims as well as the B&I MSJ.

The parties are engaged in discovery and the court has set the case for trial in early December 2026.

The Company and Cogent Bank are in negotiations to come to terms for a forbearance agreement to provide additional time for the Company to comply with the demands it made in the demand letter.

Inflationary Cost Environment, Banking Crisis, Supply Chain Disruption and the Macroeconomic Environment including Government Shutdown

The Company’s operations have been affected by many headwinds, including inflationary pressures, including those brought about by tariffs and other economic policies, high 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 as well as U.S.

trade policies, financial market volatility and currency movements.

The Company has been impacted by inflation, and may continue to be so, when procuring materials required for the buildout of our new manufacturing and laboratory facilities, 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, buildout of the new manufacturing and laboratory facilities, 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 unpredicta ble.

These headwinds, specifically the supply chain disruptions, have adversely impacted our ability to procure certain services and materials, which in some cases impacts the cost and timing of clinical trials and IND-enabling activities.

In addition, we have been impacted by inflation when procuring materials required for the buildout of our new manufacturing and laboratory facilities, the costs for recruiting and retaining employees and other employee-related costs.

Further, rising interest rates would also increase borrowing costs to the extent that the Company takes on any additional debt.

The Company uses a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines.

The Company has used equity financing as a key element of its financing strategy, which relies on registration statements that must be declared effective by the SEC.

On October 1, 2025 at 12:01 a.m.

EDT, the federal government of the United States began a shutdown as a result of the failure by the U.S.

Senate to pass appropriations legislation for the 2026 fiscal year, which began that day.

During the shutdown, the SEC has only limited operations.

As a result of the shutdown, the Company will have limited access to public markets through public offerings of our stock, which could negatively impact the Company’s operations and ability to carry on clinical development programs.

However, the extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable.

Subsequent Events

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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 4, 2025, following the end of the second quarter, the One Big Beautiful Bill Act was enacted into law in the United States.

This legislation includes various tax provisions that may affect U.S.

corporate taxpayers, including changes to the deductibility of interest expense, the treatment of research and development costs, and depreciation of certain property, among other items.

The Company is currently assessing the potential impact of this new legislation on its annual income tax expense, deferred tax assets and liabilities, valuation allowances, and projected cash flows.

Based on its preliminary analysis, the Company does not expect the legislation to have a material effect on its financial statements.

On July 22, 2025, the Company submitted a Put Notice to Square Gate for 5,000 shares to be sold under the terms of the Equity Purchase Agreement, which was settled on July 25, 2025 for $ 19,803 , net of transaction fees.

On August 8, 2025, B&I Contractors, Inc., one of the defendants in the BE&K Complaint, filed a motion for summary judgment (the “MSJ”) as to the Count I (Foreclosure of Construction Lien).

On August 14, 2025, the Company entered into the First Amendment to the Equity Purchase Agreement between HCW Biologics Inc., and Square Gate Capital Master Fund, LLC – Series 4, a series limited liability company organized in the State of Delaware (the “Square Gate”).

The amended agreement provides an alternative process for the issuance of put notices to Square Gate, allowing intraday trading.

On August 15, 2025, the Company filed a “Notification of Late Filing” to allow the Company to extend the deadline for filing its Quarterly Report on Form 10-Q.

After the reporting date of September 30, 2025, the Company issued an additional 80,000 shares of Common Stock under the Standby Equity Purchase Agreement for net proceeds of $ 281,531 .

As of September 30, 2025, the Company was deficient in meeting the requirements of Listing Rule 5550(b)(1), or the Equity Rule, related to the minimum requirements to maintain a $ 2.5 million balance in stockholders’ equity.

The Company was recently granted an extension to regain compliance with the Equity Rule until December 31, 2025.

On October 13, 2025, the Panel granted the Company an extension in which to regain compliance with all continued listing rules of the Exchange.

On October 13, 2025, the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida has set the BE&K Complaint for a five-day jury trial during the December 1-18, 2026 jury trial week.

There will be a pretrial conference on November 20, 2026.

The Company and Cogent Bank are in negotiations to come to terms for a forbearance agreement to provide additional time for the Company to comply with the demands it made in the demand letter.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements