NEONC TECHNOLOGIES HOLDINGS, INC.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
NTHI$3.49+9.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001829126-26-008512
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001829126-26-012001
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 116 previous paragraphs and 129 current paragraphs.
59 unchanged; 45 reworded; 23 added; 9 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 50 previous and 49 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (23)
Current report
NTHI’s lead product candidate is NEO100, a highly purified form of perillyl alcohol that is administered to patients via intranasal delivery. NEO100 is being evaluated in three sponsor-initiated clinical trials under two active investigational new drug (IND) applications — NEO100-01 in adults with recurrent IDH-mutant astrocytoma, NEO100-02 in meningioma and NEO100-03 in pediatric brain tumors — and has been made available to additional patients through an expanded access (compassionate use) program. NEO100 has received Fast Track designation from the United States Food and Drug Administration (FDA) for the treatment of high-grade glioma. NeOnc is also developing a second product candidate, NEO212, an oral conjugate of temozolomide and NEO100, which is completing its Phase 1 clinical trial.
Current report
We have completed human safety testing of NEO100 in the Phase 1 portion of our NEO100-01 trial, the results of which were published in Neuro-Oncology Advances in 2021; no treatment-related Grade 3 or 4 adverse events were observed and the maximum tolerated dose was not reached at the highest dose tested (1,152 mg/day), which was carried forward into Phase 2a. We have completed patient enrollment in the Phase 2a portion of NEO100-01, which enrolled 24 patients with recurrent IDH1-mutant grade 4 (21 patients) or grade 3 (3 patients) astrocytoma. In the analysis, progression-free survival at six months, the trial’s primary endpoint, was 48.9% as assessed by the RANO 2.0 criteria, exceeding the protocol-defined benchmark of 20%; median overall survival from the start of NEO100 treatment was 26.1 months, with 61.5% of patients alive at 12 months and 54.7% alive at 24 months; and no treatment-related Grade 3 or higher adverse events, treatment-related serious adverse events or discontinuations due to treatment-related adverse events were observed. Five patients remained on NEO100 treatment at the time of the interim database lock, and the trial remains active while those patients continue treatment and survival follow-up. The Phase 2a results have been accepted for presentation as a late-breaking abstract at the Society for Neuro-Oncology 2026 Annual Meeting.
Current report
Based on these data, we intend to seek accelerated approval of NEO100 for the treatment of recurrent IDH-mutant grade 4 astrocytoma, a population for which no therapy is currently approved, on the basis of the NEO100-01 Phase 2a results supported by the Phase 1 and expanded access experience, with clinical benefit to be verified in a randomized confirmatory Phase 3 trial, NEO100-012. In October 2026, we submitted to the FDA meeting requests and briefing packages for two Type B meetings under the NEO100 IND: an End-of-Phase nonclinical and clinical meeting, to obtain the FDA’s feedback on the proposed accelerated approval strategy and on the design of NEO100-012; and a chemistry, manufacturing and controls (CMC) meeting with the FDA’s Office of Pharmaceutical Quality, to obtain feedback on the manufacturing and control strategy to support an NDA. The FDA has not yet confirmed the dates of these meetings.
Current report
NEO100-02 is a Phase 2 trial of intranasal NEO100 in patients with residual, progressive or recurrent meningioma, conducted under the NEO100 IND. The trial is currently active and recruiting.
Current report
NEO100-03 is a Phase 1b trial of intranasal NEO100 in children and young adults with recurrent pediatric-type high-grade glioma — including diffuse midline glioma, H3 K27-altered, and diffuse hemispheric glioma, H3 G34-mutant — and other recurrent malignant pediatric brain tumors, conducted under a separate IND. The trial is open and enrolling at pediatric centers in the United States and, through our Middle East clinical collaboration, in the United Arab Emirates, and two patients have been enrolled and treated to date under expanded use.
Current report
NEO212 is an oral conjugate of temozolomide and NEO100 designed to improve delivery of temozolomide to the brain and to overcome temozolomide resistance. Following the filing and acceptance of an IND, NEO212 has been evaluated in a Phase 1 dose-escalation clinical trial in patients harboring primary and secondary (metastatic) malignant brain cancer types. Phase 1 dose escalation is complete, and we will present the NEO212 Phase 1 data at the Society for Neuro-Oncology 2026 Annual Meeting. We believe the Phase 1 results are very encouraging: no myelosuppression was observed with NEO212, in contrast to the hematologic toxicity that characterizes standard-of-care temozolomide, and two patients had objective responses — one with recurrent glioblastoma and one with a brain metastasis from lung cancer — each of whom has remained on NEO212 treatment for more than 20 months, a duration of treatment that is rare in these patient populations. We have met with the FDA regarding the NEO212 program, and the FDA provided CMC clearance to advance NEO212 into a Phase 2 clinical trial and indicated that the NEO212 program may proceed under the FDA’s accelerated approval pathway. We have since modified the design of the planned Phase 2 trial from a single-arm study to a randomized, controlled trial with three parallel patient cohorts — brain metastases, IDH1-mutant astrocytoma and recurrent IDH1-wildtype glioblastoma — in which patients in each cohort will be randomized to NEO212 or a control arm. We made this change to align the NEO212 program with the FDA’s current expectations for the design of trials intended to support accelerated approval, which favor randomized, controlled trials over single-arm studies, and to provide clarity on the patient populations in which NEO212 is being evaluated. We are scheduled to meet with the FDA on November 23, 2026 for an End-of-Phase 1 Type B meeting to seek feedback on the proposed patient populations, trial design, endpoints and dose selection for the next stage of development, and on whether the proposed trial design could support a potential accelerated approval pathway.
Current report
In June 2025, the Company (through its wholly-owned subsidiary – NuroMENA Holdings Ltd. “NuroMENA”) entered into a heads of terms with a family office in the Middle-East to form an investment and joint venture. The heads of terms was terminated on January 22, 2026 after the family office did not provide evidence of a committed investment by the deadline set by the Company. No investment was made, no NuroMENA shares were issued to the investor, no board seats were allocated to the investor, and the Company has no further obligations under the heads of terms.
Current report
Stock-based compensation expense results from recognizing the grant-date fair value of restricted stock on a straight-line basis over the requisite service period. Expense for awards with performance conditions is recognized when achievement of the performance condition becomes probable.
Current report
Costs related to equity offerings are deferred and charged to additional paid-in capital as securities are sold, and are not amortized (see Note 2).
Current report
Grant income represents allowable costs incurred under the Company’s two NIH STTR grants, including subcontractor costs incurred by USC (see Note 11).
Current report
Change in fair value of derivative liability related to Series A preferred stock reflects the remeasurement of the conversion feature bifurcated from the Series A Convertible Preferred Stock, which was remeasured to $0 and derecognized upon redemption of the Series A Convertible Preferred Stock in September 2026 (see Note 8).
Current report
Interest expense was $97,508 and $869,815 for the three months ended September 30, 2026 and 2025, respectively. The decrease of $772,307 was primarily due to the repayment in January 2026 of the convertible promissory notes, which eliminated the accretion of the original issue discount. Interest expense for the three months ended September 30, 2026 related primarily to interest accrued on the OEP litigation settlement and of interest accrued on unremitted income tax withholdings on shares of common stock withheld from recipients upon the vesting of restricted stock. Interest expense for the three months ended September 30, 2025 related primarily to the accretion of the original issue discount on the convertible promissory notes and accrued interest for a litigation matter.
Current report
Loss on Change in Fair Value of Derivative Liability – Equity Line of Credit
Current report
Loss on change in fair value of derivative liability related to sales of common stock through the equity line of credit was $0 and $380,162 for the three months ended September 30, 2026 and 2025, respectively. The loss for the three months ended September 30, 2025 related to the discount at which Mast Hill Fund, LP purchased shares of common stock under the Equity Purchase Agreement, draws under which commenced in July 2025.
Current report
Deemed Dividends
Current report
During the three months ended September 30, 2026, net loss attributable to common stockholders included deemed dividends of $2,655,996 on the redemption of the Series A Convertible Preferred Stock, representing the excess of cash paid over the carrying amount of the Series A Convertible Preferred Stock, and $177,930 from the down round adjustment of the exercise price of the warrants issued in the January 2026 PIPE (see Note 8). The deemed dividends are non-cash, have no effect on net loss or total stockholders’ equity, and increased net loss per share attributable to common stockholders by $0.11.
Current report
Comparison of the nine months ended September 30, 2026 and 2025:
Current report
Research and laboratory expense was substantially unchanged, as the reversal of previously accrued laboratory fees payable to USC during the three months ended September 30, 2026 offset higher research costs, including subcontractor costs incurred by USC under the NIH grants.
Current report
Deemed Dividends
Current report
Net loss attributable to common stockholders for the nine months ended September 30, 2026 included deemed dividends of $2,655,996 on the redemption of the Series A Convertible Preferred Stock and $177,930 from the down round adjustment of the exercise price of the warrants issued in the January 2026 PIPE (see Note 8). The deemed dividends are non-cash and have no effect on net loss or total stockholders’ equity.
Current report
On September 10, 2026, the Company closed a registered direct offering of 2,610,715 shares of common stock, pre-funded warrants to purchase up to 960,715 shares of common stock and warrants to purchase up to 3,571,430 shares of common stock at an exercise price of $4.20 per share, at a combined offering price of $4.20 per share and accompanying warrant, resulting in gross proceeds of approximately $15.0 million and net proceeds of approximately $13.9 million after deducting placement agent fees and other offering costs (see Note 8).
Current report
Registered Direct Offering Warrants
Current report
We consider the accounting for the Registered Direct Warrants and Pre-Funded Warrants issued in the Registered Direct Offering a critical accounting estimate. Management exercised significant judgment in concluding the Registered Direct Warrants are indexed to our own stock and classified in equity under ASC 815-40, including in evaluating the provisions governing settlement upon a fundamental transaction, under which holders may receive consideration based on the Black-Scholes value of the unexercised Registered Direct Warrants. A conclusion that the Registered Direct Warrants require liability classification would result in their remeasurement to fair value at each reporting date, with changes recognized in our results of operations. The net proceeds of the Registered Direct Offering were allocated between the common stock and the Pre-Funded Warrants and RD Warrants on a relative fair value basis. The fair value of the RD Warrants was determined using a binomial lattice model and the Black-Scholes model, which require significant judgment in the selection of key inputs, including expected volatility, risk-free interest rate, the fair value of our common stock and the likelihood of a fundamental transaction during the term of the warrants. Changes in these assumptions would affect the allocation of proceeds among the securities issued within additional paid-in capital but would not affect our results of operations, as the warrants are classified in equity and are not remeasured after issuance.
Removed paragraphs (9)
Previous report
NeOnc’s lead product candidate is NEO100. NEO100 is administered to patients via intranasal delivery. We have completed human safety testing in a Phase 1 clinical trial and have completed patient enrollment in, and the collection of clinical data from, our Phase 2a trial in patients with recurrent malignant glioma (Grade IV IDH1 mutant and Grade III Astrocytoma IDH1 mutant). Based on the data generated to date, we intend to meet with the FDA to discuss the design of a potential Phase 3 clinical trial of NEO100. NeOnc is also developing a second product candidate, NEO212, which has completed preclinical testing and, following the filing and acceptance of an investigational new drug (IND) application with the United States Food and Drug Administration (FDA), has completed its Phase 1 clinical trial in patients harboring primary and secondary malignant brain cancer types. We have met with the FDA regarding the NEO212 program, and the FDA provided chemistry, manufacturing and controls (CMC) clearance to advance NEO212 into a Phase 2 clinical trial and indicated that the NEO212 program may proceed under the FDA’s accelerated approval pathway. We have since modified the design of the planned Phase 2 trial to focus on recurrent IDH1 wildtype glioblastoma multiforme (GBM). Several additional drug candidates are in the pipeline and are undergoing preclinical development.
Previous report
In June 2025, the Company (through its recently formed subsidiary – Nuromena Holdings Ltd. “NuroMena”) entered into a letter of intent to form an investment and joint venture agreement with a Middle-East investor (“Investor”), Quazar Investments. At the formation date, the Company would own 10 million shares of NuroMena and contribute a license to its technology to NuroMena, and the Investor will purchase 2.5 million shares of NuroMena for a subscription price of $400,000 (“Initial Investment”). Following the formation of the entity and closing of the Initial Investment, the Investor shall source one or more future investors to purchase up to $50.0 million at $25/share in common stock of the Company, of which 70% of the proceeds will be maintained by the Company and 30% will be transferred to an operating entity to be formed under NuroMena, to conduct clinical trials in the middle-east markets. As of the date of this filing, the Initial Investment has not yet occurred.
Previous report
Stock based compensation expense result from the recognition of the fair value of restricted stock recorded on a straight-line basis from the date of grant to the date the restricted stock becomes fully vested.
Previous report
Interest expense primarily results from the bridge loan and a short-term loan both from related parties. Borrowings under these loans carry a 50% (or 1 times amounts borrowed) original issue discount (“OID”) on principal. The Company also had interest expense related to the convertible debt entered into in 2025, which contained an OID factor on the original principal amount. The OID to be earned under the loan is recognized ratably over the term of each draw-down under the loan through the maturity date.
Previous report
Amortization on deferred offering costs resulted from the issuance of common stock in connection with a private equity agreement.
Previous report
In April 2026, the Company’s Board of Directors approved the acceleration of vesting for certain outstanding unvested shares of restricted stock previously granted to employees, directors, and scientific advisory board members, such that 734,356 shares that would otherwise have vested on their original vesting schedules vested immediately on April 30, 2026. The accelerated shares related to awards originally granted on July 12, 2024, June 5, 2025, September 25, 2025, and November 6, 2025. The acceleration was accounted for as a modification under ASC 718-20. Based on the $4.30 closing stock price on April 30, 2026, the Company recognized stock-based compensation expense of $4,781,116 related to the accelerated shares during the three and six months ended June 30, 2026, representing the previously unrecognized compensation cost associated with the original awards that was accelerated into the period.
Previous report
Grant Income
Previous report
Comparison of the six months ended June*** ***30, 2026 and 2025:
Reworded paragraphs (45)
Previous wording
Since inception, our operations have focused on organizing and staffing our Company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales other than for humanitarian usage.
Current wording
Since inception, our operations have focused on organizing and staffing our Company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales. Amounts received for compassionate use of NEO100 are recorded as a reduction of research and development expense.
Previous wording
Since our inception, we have incurred significant operating losses. For the three and six months ended June 30, 2026, the Company incurred a net loss of $14,240,044 and $23,059,976, respectively. We had an accumulated deficit of $135,814,631 as of June 30, 2026, compared to $112,754,655 as of December 31, 2025. We expect to continue to incur operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
Current wording
Since our inception, we have incurred significant operating losses. For the three and nine months ended September 30, 2026, the Company incurred a net loss of $4,440,209 and $27,500,185, respectively. We had an accumulated deficit of $140,254,840 as of September 30, 2026, compared to $112,754,655 as of December 31, 2025. As of September 30, 2026, we had cash and cash equivalents of $6,166,342, which is not sufficient to fund our operations for one year from the issuance date of this Form 10-Q. We expect to continue to incur operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
Previous wording
The Company is actively taking steps to mitigate the substantial doubt about the Company’s ability to continue as a going concern, including pursuing additional financing. If the Company is unable to obtain additional capital and continue as a going concern, it may have to further scale back operations or liquidate its assets and cease operations entirely, and the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in these financial statements. Accordingly, these financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
The Company is actively taking steps to mitigate the substantial doubt about the Company’s ability to continue as a going concern, including pursuing additional financing through its at-the-market offering program and other equity or debt financings (see Note 1). If the Company is unable to obtain additional capital and continue as a going concern, it may have to further scale back operations or liquidate its assets and cease operations entirely, and the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in these financial statements. Accordingly, these financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
Our operating expenses consist of (i) research and development expenses and (ii) legal and professional expenses and (iii) general and administrative expenses.
Current wording
Our operating expenses consist of (i) research and development expenses, (ii) legal and professional expenses, (iii) general and administrative expenses, (iv) stock-based compensation and (v) advisory fees, principally to related parties.
Previous wording
Interest expense primarily relates to the convertible debt entered into in 2025, which contained an original issue discount (“OID”) factor on the original principal amount, which was repaid in January 2026. The Company also had interest expense related to the outstanding litigation settlements.
Current wording
Interest expense primarily relates to the convertible notes issued in 2025, which contained an original issue discount (“OID”) and were repaid in January 2026. The Company also had interest expense related to interest accrued on outstanding litigation settlements and on unremitted restricted stock tax withholding obligations.
Previous wording
Advisory fees principally represent amounts due AFH Holdings, a related party, for their services in recapitalizing the Company.
Current wording
Advisory fees principally represent amounts due AFH Holdings, a related party, for strategic advisory, capital markets and financing services (see Note 4).
Previous wording
Loss on change in fair value of derivative liability related to Series A preferred stock
Current wording
Gain (Loss) on Change in Fair Value of Derivative Liabilities
Previous wording
Gain (loss) on change in fair value of derivative liability relates to the fair value of the discount offered to stockholders who purchased shares under the equity line of credit.
Current wording
Gain (loss) on change in fair value of derivative liability related to the equity line of credit relates to the fair value of the discount offered to Mast Hill on shares purchased under the Equity Purchase Agreement, which terminated on October 22, 2026.
Previous wording
Research and development expenses were $2,649,673 and $677,332 for the three months ended June 30, 2026 and 2025, respectively. A portion of these expenses amounting to approximately $0 and $82,225 for the three months ended June 30, 2026 and 2025, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $1,972,341 was primarily due to:
Current wording
Research and development expenses were $1,307,468 and $715,038 for the three months ended September 30, 2026 and 2025, respectively. A portion of these expenses amounting to approximately $0 and $382 for the three months ended September 30, 2026 and 2025, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $592,430 was primarily due to:
Previous wording
Legal and professional expenses were $1,286,167 and $520,364 for the three months ended June 30, 2026 and 2025, respectively. The increase of $765,803 was primarily attributable to investment banking associated with the Company’s capital raising activities, incremental legal fees associated with the Second Addendum to the Company’s advisory agreement with AFH Holding & Advisory, LLC, the Series A Convertible Preferred Stock issuance, and other corporate and securities matters, and increased audit fees associated with the Company’s expanded reporting requirements as a public company.
Current wording
Legal and professional expenses were $894,752 and $276,378 for the three months ended September 30, 2026 and 2025, respectively. The increase of $618,374 was primarily attributable to investment banking associated with investment banking advisory fees under the Company’s strategic and capital markets advisory engagement, legal fees related to corporate and securities matters, including the Third Addendum to the Company’s advisory agreement with AFH and the redemption of the Series A Convertible Preferred Stock, increased intellectual property legal fees, and increased audit fees associated with the Company’s expanded reporting requirements as a public company.
Previous wording
General and administrative expenses were $895,559 and $984,262 for the three months ended June 30, 2026 and 2025, respectively. The decrease of $88,703 was primarily due to a reduction in D&O insurance premiums, as well as a reduction in advertising, marketing, and travel expenses incurred during the three months ended June 30, 2025 in connection with a marketing campaign and in pursuit of a strategic partnership in the Middle East, for which a letter of intent was executed subsequent to June 30, 2025. This decrease was partially offset by an increase in business development costs during the three months ended June 30, 2026.
Current wording
General and administrative expenses were $636,620 and $902,985 for the three months ended September 30, 2026 and 2025, respectively. The decrease of $266,365 was primarily due to the reversal of previously accrued compensation and lower business development costs during the three months ended September 30, 2026, as well as lower travel expenses compared with the three months ended September 30, 2025, when the Company incurred expenses in pursuit of a strategic partnership in the Middle East. These decreases were partially offset by continued advertising, marketing and investor relations costs.
Previous wording
Stock-based compensation expense, which is a non-cash expense, for the six months ended June 30, 2026 primarily resulted from the acceleration of vesting of certain outstanding restricted stock awards approved by the Board of Directors in April 2026, which resulted in the recognition of previously unrecognized compensation expense associated with those awards, in addition to the ongoing recognition of the grant date fair value of restricted stock over the applicable service periods for awards not subject to the acceleration. Stock-based compensation expense for the six months ended June 30, 2025 included the recognition of expense from the original grant dates of certain restricted stock through the Listing Date that occurred on March 26, 2025, reflecting a cumulative catch-up upon removal of the listing contingency, in addition to amortization of the grant date fair value of those shares of restricted stock over their respective service periods following the Listing Date. Since stock-based compensation is a non-cash item, it does not affect our cash position or our cash used in operating activities.
Current wording
Stock-based compensation expense, which is a non-cash expense, was $267,565 and $5,040,246 for the three months ended September 30, 2026 and 2025, respectively. Expense for the three months ended September 30, 2026 resulted from the ongoing recognition of the grant date fair value of restricted stock over the applicable service periods. Stock-based compensation expense for the three months ended September 30, 2025 reflected the amortization of the grant date fair value of shares of restricted stock over their respective service periods following the Listing Date that occurred on March 26, 2025. The decrease of $4,772,681 reflects the vesting in prior periods of awards granted in connection with the Listing. Since stock-based compensation is a non-cash item, it does not affect our cash position or our cash used in operating activities.
Previous wording
Advisory fee expense, a related party, was $3,586,575 and $0 for the three months ended June 30, 2026 and 2025, respectively. Advisory fee expense for the three months ended June 30, 2026 consisted of fees incurred for advisory services related to our capital financing arrangements pursuant to a letter of intent with AFH (see Note 4). In addition, on June 11, 2026, the Company and AFH entered into a Second Addendum to the Letter of Intent and Advisory Services Agreement, which amends and clarifies the methodology for determining AFH’s annual advisory fee. Under the Second Addendum, AFH is entitled to an annual advisory fee equal to 2.5% of the Company’s fully diluted market capitalization as of December 31 of each fiscal year. As of June 30, 2026, the Company had an outstanding accrued advisory fee – related party balance of approximately $1,600,000 payable to AFH pursuant to the Second Addendum.
Current wording
Advisory fee expense, a related party, was $2,727,945 and $0 for the three months ended September 30, 2026 and 2025, respectively. In September 2026, the Company and AFH entered into a Third Addendum to the Letter of Intent and Advisory Services Agreement, which increased AFH’s annual advisory fee from 2.5% to 4.0% of the Company’s fully diluted market capitalization as of December 31 of each fiscal year, effective January 1, 2025. Advisory fee expense for the three months ended September 30, 2026 consisted of the resulting increase in the 2025 advisory fee from $4,546,575 to $7,274,520 (see Note 4). As of September 30, 2026, the Company had an outstanding accrued advisory fee – related party balance of $2,727,945 payable to AFH.
Previous wording
Interest and income was $334 and $28,725 for the three months ended June 30, 2026 and 2025, respectively. Interest and other income for the three months ended June 30, 2026 and 2025 related primarily to interest earned on our money market account.
Current wording
Interest and other income was $15,412 and $6,815 for the three months ended September 30, 2026 and 2025, respectively. Interest and other income for the three months ended September 30, 2026 and 2025 related primarily to interest earned on our money market account.
Previous wording
Grant income was $482,778 and $0 for the three months ended June 30, 2026 and 2025, respectively. Grant income for the three months ended June 30, 2026 related to the Company’s two Small Business Technology Transfer (“STTR”) grants from the National Institutes of Health (“NIH”), awarded in August 2025 and September 2025, respectively, pursuant to which the Company’s academic research collaborator at USC serves as subcontractor. The Company recognizes grant income related to the whole portion of allowable costs as incurred and reimbursed by the NIH. There was no comparable grant income during the three months ended June 30, 2025, as the grants were not awarded until the second half of 2025.
Current wording
Grant income was $95,044 for the three months ended September 30, 2026. Grant income for the three months ended September 30, 2026 related to the Company’s two Small Business Technology Transfer (“STTR”) grants from the National Institutes of Health (“NIH”), awarded in August 2025 and September 2025, respectively, pursuant to which the Company’s academic research collaborator at USC serves as subcontractor. The Company recognizes grant income for the gross amount of allowable costs incurred, including subcontractor costs incurred by USC (see Note 11). There was no comparable grant income during the three months ended September 30, 2025, as no allowable expenses had been incurred under the grants, which were awarded in August 2025 and September 2025.
Previous wording
Amortization of debt issuance costs was $167,951 and $192,249 for the three months ended June 30, 2026 and 2025, respectively. Amortization of debt issuance costs in both periods primarily reflected the ongoing amortization of debt issuance costs associated with the warrants issued in connection with the line of credit with HCWG.
Current wording
Amortization of debt issuance costs was $167,951 and $438,111 for the three months ended September 30, 2026 and 2025, respectively. Amortization of debt issuance costs in both periods primarily reflected the ongoing amortization of debt issuance costs associated with the warrants issued in connection with the line of credit with HCWG. Amortization for the three months ended September 30, 2025 also included related to the Equity Purchase Agreement with Mast Hill and debt issuance costs associated with the convertible promissory notes.
Previous wording
Other expense was $189,627 and other income was $240,138 for the three months ended June 30, 2026 and 2025, respectively. Other expense for the three months ended June 30, 2026 consisted of penalties and interest accrued in connection with the unremitted income tax withholdings on shares of common stock that were withheld from recipients upon the vesting of shares of restricted stock to satisfy the recipients’ tax obligations. As of June 30, 2026, the Company had not remitted such withholding taxes to the applicable taxing authorities, and accordingly the Company has accrued penalties and interest, which is included within accrued expenses in the condensed consolidated balance sheets.
Current wording
Other expense was $105,651 and $0 for the three months ended September 30, 2026 and 2025, respectively. Other expense for the three months ended September 30, 2026 consisted of penalties accrued in connection with the unremitted income tax withholdings on shares of common stock that were withheld from recipients upon the vesting of shares of restricted stock to satisfy the recipients’ tax obligations. As of September 30, 2026, the Company had not remitted such withholding taxes to the applicable taxing authorities, and accordingly the Company has accrued interest recorded in interest expense, and penalties recorded in other expense. The accrued interest and penalties are included within accrued restricted stock tax withholding obligations in the condensed consolidated balance sheets.
Previous wording
Loss on change in fair value of derivative liability related to Series A Preferred Stock was $61,321 and $0 for the six months ended June 30, 2026 and 2025, respectively. In connection with the issuance of the Company’s Series A Convertible Preferred Stock during the three months ended June 30, 2026, the Company bifurcated an embedded variable-rate conversion feature as a derivative liability, which is remeasured to fair value at each reporting period using a Monte Carlo simulation model, with changes in fair value recognized in the condensed consolidated statements of operations. The loss recognized during the three months ended June 30, 2026 reflects the change in fair value of the derivative liability between the issuance date and June 30, 2026 (see Note 8). There was no comparable activity during the six months ended June 30, 2025, as the Series A Preferred Stock was not issued until the current period.
Current wording
The change in fair value of the derivative liability related to Series A preferred stock was a gain of $1,654,795 and $0 for the three months ended September 30, 2026 and 2025, respectively. In connection with the issuance of the Company’s Series A Convertible Preferred Stock in June 2026, the Company bifurcated an embedded variable-rate conversion feature as a derivative liability, measured at fair value with changes recognized in the condensed consolidated statements of operations. On September 14, 2026, in connection with the redemption of all outstanding shares of Series A Convertible Preferred Stock, the derivative liability was remeasured from $1,654,795 at June 30, 2026 to $0, as the holders’ conversion right could no longer arise, and was derecognized (see Note 8). There was no comparable activity during the three months ended September 30, 2025, as the Series A Preferred Stock was not issued until June 2026.
Previous wording
No revenue was generated for fees for a “right to try” humanitarian program during the six months ended June 30, 2026 and June 30, 2025.
Current wording
No revenue was generated for fees for a “right to try” humanitarian program during the nine months ended September 30, 2026 and September 30, 2025.
Previous wording
Research and development expenses were $3,936,009 and $1,635,564 for the six months ended June 30, 2026 and 2025, respectively. A portion of these expenses amounting to approximately $38,409 and $184,449 for the six months ended June 30, 2026 and 2025, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $2,300,445 was primarily due to:
Current wording
Research and development expenses were $5,243,477 and $2,350,602 for the nine months ended September 30, 2026 and 2025, respectively. A portion of these expenses amounting to approximately $0 and $164,449 for the nine months ended September 30, 2026 and 2025, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $2,892,875 was primarily due to higher clinical trial expense, principally for the NEO100-01 trial and, to a lesser extent, the NEO212-01, NEO100-02 and NEO100-03 pediatric trials, reflecting:
Previous wording
Legal and professional expenses were $2,474,387 and $1,477,909 for the six months ended June 30, 2026 and 2025, respectively. The increase of $996,478 was primarily attributable to investment banking and advisory fees associated with the Company’s capital raising activities. Additionally, the increase reflected incremental legal fees associated with the preparation and filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, its Registration Statement on Form S-3 and related prospectus supplement, the Second Addendum to the Company’s advisory agreement with AFH Holding & Advisory, LLC, the Series A Convertible Preferred Stock issuance, and other corporate and securities matters, as well as increased audit fees associated with the Company’s expanded reporting requirements as a public company.
Current wording
Legal and professional expenses were $3,369,139 and $1,754,287 for the nine months ended September 30, 2026 and 2025, respectively. The increase of $1,614,852 was primarily attributable to investment banking advisory fees under the Company’s strategic and capital markets advisory engagement. Additionally, the increase reflected incremental legal fees associated with the preparation and filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, its Registration Statement on Form S-3 and related prospectus supplement, the Second and Third Addenda to the Company’s advisory agreement with AFH Holding & Advisory, LLC, the Series A Convertible Preferred Stock issuance and redemption, and other corporate and securities matters, as well as increased audit fees associated with the Company’s expanded reporting requirements as a public company. These increases were partially offset by costs incurred in 2025 in connection with the Listing.
Previous wording
General and administrative expenses were $1,384,267 and $1,833,747 for the six months ended June 30, 2026 and 2025, respectively. The decrease of $449,480 was primarily due to a reduction in advertising and marketing expense in connection with the Company’s direct public listing, a reduction in D&O insurance premiums, and a reduction in rent, travel, and other costs incurred during the six months ended June 30, 2025 in connection with a marketing campaign and in pursuit of a strategic partnership in the Middle East. This decrease was partially offset by an increase in business development and travel costs during the six months ended June 30, 2026.
Current wording
General and administrative expenses were $2,020,888 and $2,736,732 for the nine months ended September 30, 2026 and 2025, respectively. The decrease of $715,844 was primarily due to a reduction in advertising and marketing expense in connection with the Company’s direct public listing, a reduction in D&O insurance premiums, and a reduction in rent, travel, and other costs incurred during the nine months ended September 30, 2025 in connection with a marketing campaign and in pursuit of a strategic partnership in the Middle East, as well as the reversal of previously accrued compensation and credits to general business and insurance expenses during the nine months ended September 30, 2026. This decrease was partially offset by an increase in business development and travel costs during the nine months ended September 30, 2026.
Previous wording
Stock-based compensation expense, which is a non-cash expense, for the three months ended June 30, 2026 primarily resulted from the acceleration of vesting of certain outstanding restricted stock awards approved by the Board of Directors in April 2026, which resulted in the recognition of previously unrecognized compensation expense associated with those awards, in addition to the ongoing recognition of the grant date fair value of restricted stock over the applicable service periods for awards not subject to the acceleration. Stock-based compensation expense for the three months ended June 30, 2025 included the recognition of expense from the original grant dates of certain restricted stock through the Listing Date that occurred on March 26, 2025, reflecting a cumulative catch-up upon removal of the listing contingency, in addition to amortization of the grant date fair value of those shares of restricted stock over their respective service periods following the Listing Date. Since stock-based compensation is a non-cash item, it does not affect our cash position or our cash used in operating activities.
Current wording
Stock-based compensation expense, which is a non-cash expense, was $8,651,875 and $25,964,096 for the nine months ended September 30, 2026 and 2025, respectively. Expense for the nine months ended September 30, 2026 primarily resulted from the acceleration of vesting of certain outstanding restricted stock awards approved by the Board of Directors in April 2026, which resulted in the recognition of previously unrecognized compensation expense associated with those awards, in addition to the ongoing recognition of the grant date fair value of restricted stock over the applicable service periods for awards not subject to the acceleration. Stock-based compensation expense for the nine months ended September 30, 2025 included the recognition of expense from the original grant dates of certain restricted stock through the Listing Date that occurred on March 26, 2025, reflecting a cumulative catch-up upon removal of the listing contingency, in addition to amortization of the grant date fair value of those shares of restricted stock over their respective service periods following the Listing Date. Since stock-based compensation is a non-cash item, it does not affect our cash position or our cash used in operating activities.
Previous wording
Advisory fee expense, primarily to a related party, was $4,946,575 and $11,737,806 for the six months ended June 30, 2026 and 2025, respectively. Advisory fee expense for the six months ended June 30, 2026 consisted of fees incurred for advisory services related to our capital financing arrangements pursuant to a letter of intent with AFH (see Note 4). In addition, on June 11, 2026, the Company and AFH entered into a Second Addendum to the Letter of Intent and Advisory Services Agreement, which amends and clarifies the methodology for determining AFH’s annual advisory fee. Under the Second Addendum, effective retroactively to January 1, 2025, AFH is entitled to an annual advisory fee equal to 2.5% of the Company’s fully diluted market capitalization as of December 31 of each fiscal year. As of June 30, 2026, the Company had an outstanding accrued advisory fee – related party balance of approximately $1,600,000 payable to AFH pursuant to the Second Addendum. Advisory fee expense for the six months ended June 30, 2025 was substantially comprised of the $11,328,565 fee earned upon the Listing Date on March 26, 2025 in accordance with the AFH advisory agreement then in effect.
Current wording
Advisory fee expense, primarily to a related party, was $7,674,520 and $11,737,806 for the nine months ended September 30, 2026 and 2025, respectively. Advisory fee expense for the nine months ended September 30, 2026 consisted primarily of the annual advisory fee to AFH (see Note 4). On June 11, 2026, the Company and AFH entered into a Second Addendum to the Letter of Intent and Advisory Services Agreement, which amends and clarifies the methodology for determining AFH’s annual advisory fee. Under the Second Addendum, effective retroactively to January 1, 2025, AFH is entitled to an annual advisory fee equal to 2.5% of the Company’s fully diluted market capitalization as of December 31 of each fiscal year. On September 16, 2026, the Company and AFH entered into a Third Addendum, which increased the annual advisory fee to 4.0% of the Company’s fully diluted market capitalization, effective January 1, 2025, resulting in a 2025 advisory fee of $7,274,520. As of September 30, 2026, the Company had an outstanding accrued advisory fee – related party balance of $2,727,945 payable to AFH for the unpaid portion of the 2025 advisory fee. Advisory fee expense for the nine months ended September 30, 2025 was substantially comprised of the $11,328,565 fee earned upon the Listing Date on March 26, 2025 in accordance with the AFH advisory agreement then in effect.
Previous wording
Interest and income was $5,530 and $80,424 for the six months ended June 30, 2026 and 2025, respectively. Interest and other income for the six months ended June 30, 2026 and 2025 related primarily to interest earned in our money market account.
Current wording
Interest and other income was $20,942 and $327,377 for the nine months ended September 30, 2026 and 2025, respectively. Interest and other income for the nine months ended September 30, 2026 and 2025 related primarily to interest earned in our money market account.
Previous wording
Grant income was $529,901 and $0 for the six months ended June 30, 2026 and 2025, respectively. Grant income for the six months ended June 30, 2026 related to the Company’s two Small Business Technology Transfer (“STTR”) grants from the National Institutes of Health (“NIH”), awarded in August 2025 and September 2025, respectively, pursuant to which the Company’s academic research collaborator at USC serves as subcontractor. The Company recognizes grant income related to the whole portion of allowable costs as incurred and reimbursed by the NIH. There was no comparable grant income during the six months ended June 30, 2025, as the grants were not awarded until the second half of 2025.
Current wording
Grant income was $624,945 for the nine months ended September 30, 2026. Grant income for the nine months ended September 30, 2026 related to the Company’s two Small Business Technology Transfer (“STTR”) grants from the National Institutes of Health (“NIH”), awarded in August 2025 and September 2025, respectively, pursuant to which the Company’s academic research collaborator at USC serves as subcontractor. The Company recognizes grant income for the gross amount of allowable costs incurred, including subcontractor costs incurred by USC (see Note 11). There was no comparable grant income during the nine months ended September 30, 2025, as no allowable expenses had been incurred under the grants, which were awarded in August 2025 and September 2025.
Previous wording
Amortization of debt issuance costs was $360,116 and $360,200 for the six months ended June 30, 2026 and 2025, respectively. Amortization of debt issuance costs in both periods primarily reflected the ongoing amortization of debt issuance costs associated with the warrants issued in connection with the line of credit with HCWG.
Current wording
Amortization of debt issuance costs was $528,067 and $798,311 for the nine months ended September 30, 2026 and 2025, respectively. Amortization of debt issuance costs in both periods primarily reflected the ongoing amortization of debt issuance costs associated with the warrants issued in connection with the line of credit with HCWG. Amortization for the nine months ended September 30, 2025 also included the amortization of deferred offering costs related to the Equity Purchase Agreement with Mast Hill and debt issuance costs associated with the convertible promissory notes.
Previous wording
Interest expense was $234,370 and $48,750 for the three months ended June 30, 2026 and 2025, respectively. The increase of $185,620 was primarily related to interest accrued on the Company’s unremitted restricted stock tax withholding obligations and accrued interest for a litigation matter.
Current wording
Interest expense was $1,314,502 and $1,227,487 for the nine months ended September 30, 2026 and 2025, respectively. The increase of $87,015 was primarily related to the accretion of the original issue discount on the short-term OID loan through its repayment in January 2026 (see Note 6), interest accrued on the Company’s unremitted restricted stock tax withholding obligations, and accrued interest on litigation settlements. Interest expense for the nine months ended September 30, 2025 related primarily to the $300,000 original issue discount on the short-term related party loan, the accretion of the original issue discount on the convertible promissory notes, and accrued interest for a litigation matter.
Previous wording
Other expense was $834,228 and other income was $240,138 for the six months ended June 30, 2026 and 2025, respectively. Other expense for the six months ended June 30, 2026 consisted of penalties and interest accrued in connection with the unremitted income tax withholdings on shares of common stock that were withheld from recipients upon the vesting of restricted stock to satisfy the recipients’ tax obligations. As of June 30, 2026, the Company had not remitted such withholding taxes to the applicable taxing authorities, and accordingly the Company has accrued penalties and interest, which is included within accrued expenses in the condensed consolidated balance sheets.
Current wording
Other expense was $939,879 and $0 for the nine months ended September 30, 2026 and 2025, respectively. Other expense for the nine months ended September 30, 2026 consisted of penalties accrued in connection with the unremitted income tax withholdings on shares of common stock that were withheld from recipients upon the vesting of restricted stock to satisfy the recipients’ tax obligations. As of September 30, 2026, the Company had not remitted such withholding taxes to the applicable taxing authorities, and accordingly the Company has accrued interest recorded in interest expense, and penalties recorded in other income (expense). The accrued interest and penalties are included within accrued restricted stock tax withholding obligations in the condensed consolidated balance sheets.
Previous wording
Loss on change in fair value of derivative liability related to Series A Preferred Stock was $61,321 and $0 for the three months ended June 30, 2026 and 2025, respectively. In connection with the issuance of the Company’s Series A Convertible Preferred Stock during the three months ended June 30, 2026, the Company bifurcated an embedded variable-rate conversion feature as a derivative liability, which is remeasured to fair value at each reporting period using a Monte Carlo simulation model, with changes in fair value recognized in the condensed consolidated statements of operations. The loss recognized during the three months ended June 30, 2026 reflects the change in fair value of the derivative liability between the issuance date and June 30, 2026 (see Note 8). There was no comparable activity during the three months ended June 30, 2025, as the Series A Preferred Stock was not issued until the current period.
Current wording
The change in fair value of the derivative liability related to Series A preferred stock was a gain of $1,593,474 and $0 for the nine months ended September 30, 2026 and 2025, respectively. In connection with the issuance of the Company’s Series A Convertible Preferred Stock in June 2026, the Company bifurcated an embedded variable-rate conversion feature as a derivative liability, measured at fair value with changes recognized in the condensed consolidated statements of operations. The derivative liability was recognized at its issuance-date fair value and, on September 14, 2026, in connection with the redemption of all outstanding shares of Series A Convertible Preferred Stock, was remeasured to $0, as the holders’ conversion right could no longer arise, and derecognized (see Note 8). There was no comparable activity during the nine months ended September 30, 2025, as the Series A Preferred Stock was not issued until June 2026.
Previous wording
Gain on change in fair value of derivative liability was $2,801 and $0 for the six months ended June 30, 2026 and 2025, respectively. The derivative liability is created from the settlement feature embedded in the Company’s equity line of credit agreement with Mast Hill Fund, LP. Under the agreement, shares of common stock are purchased at a discount due to the five-day settlement period between the commitment date and the issuance date. This discount feature creates a variable settlement mechanism that is required to be accounted for as a derivative liability. The gain represents the change in fair value of this derivative liability from each draw under the agreement through the corresponding settlement date. There were no draws under the equity purchase agreement during the six months ended June 30, 2025, and no related loss was recognized in that period.
Current wording
Gain (loss) on change in fair value of derivative liability was a gain of $2,801 and a loss of $380,162 for the nine months ended September 30, 2026 and 2025, respectively. The derivative liability is created from the settlement feature embedded in the Company’s equity line of credit agreement with Mast Hill Fund, LP. Under the agreement, shares of common stock are purchased at a discount due to the five-day settlement period between the commitment date and the issuance date. This discount feature creates a variable settlement mechanism that is required to be accounted for as a derivative liability. The gain (loss) represents the change in fair value of this derivative liability from each draw under the agreement through the corresponding settlement date. The gain for the nine months ended September 30, 2026 related to draws under the Equity Purchase Agreement during the three months ended March 31, 2026. The loss for the nine months ended September 30, 2025 related to draws under the Equity Purchase Agreement in July 2025 and September 2025.
Previous wording
During the six months ended June 30, 2026, net cash used in operating activities was $11,756,954, consisting primarily of our net loss of $23,059,976, offset by stock-based compensation of $8,384,311, accretion of original issue discount on the convertible promissory notes of $714,600, amortization of debt issuance costs of $360,116, amortization of right of use asset of $38,996, amortization of intangible asset of $18,519, transaction costs expensed on the issuance of Series A Convertible Preferred Stock of $127,478, loss on change in fair value of derivative liability related to Series A Convertible Preferred Stock of $61,321, an increase in accrued expense of $2,261,282, and an increase in accounts payable of $582,222. These were offset by decreases in accrued advisory fee of $100,566, accounts payable – related parties of $197,762, and lease liability of $33,596, an increase in prepaid expenses and other of $824,168, an increase in deferred offering costs of $86,930, and a gain on change in fair value of derivative liability of $2,801.
Current wording
During the nine months ended September 30, 2026, net cash used in operating activities was $16,846,814, consisting primarily of our net loss of $27,500,185, offset by stock-based compensation of $8,651,875, accretion of original issue discount on the convertible promissory notes of $714,601, amortization of debt issuance costs of $528,067, amortization of right of use asset of $57,753, amortization of intangible asset of $25,463, transaction costs expensed on the issuance of Series A Convertible Preferred Stock of $127,478, an increase in accrued expense of $1,886,044, an increase in accounts payable of $1,190,168, and an increase in accrued advisory fee of $970,804. These were offset by a gain on change in fair value of derivative liability related to Series A Convertible Preferred Stock of $1,593,474, decreases in accounts payable and accrued expenses – related parties of $608,437, accrued compensation of $255,108 and lease liability of $51,599, an increase in prepaid expenses and other of $828,334, an increase in deferred offering costs of $161,930, and a gain on change in fair value of derivative liability related to the equity line of credit of $2,801.
Previous wording
During the six months ended June 30, 2025, net cash used in operating activities was $10,964,226, consisting primarily of our net loss of $38,006,186, offset by stock-based compensation of $20,923,850, accretion of original issue discount on the bridge loan – related party of $300,000, amortization of debt issuance costs of $769,441, amortization of right of use asset of $18,153, an increase in accrued advisory fee of $5,882,710, and an increase in accounts payable – related parties of $45,350. These were offset by an increase in prepaid expenses and other of $350,134, a decrease in other assets of $47,177, a decrease in accrued compensation of $479,775, and a decrease in lease liability of $20,458.
Current wording
During the nine months ended September 30, 2025, net cash used in operating activities was $16,772,776, consisting primarily of our net loss of $46,622,106, offset by stock-based compensation of $25,964,096, accretion of original issue discount on the bridge loan – related party of $300,000, accretion of original issue discount on the convertible promissory notes of $820,794, amortization of debt issuance costs of $1,161,311, amortization of right of use asset of $36,461, loss on change in fair value of derivative liability of $380,162, and an increase in accrued advisory fee of $3,675,569. These were offset by a decrease in accounts payable and accrued expenses of $1,657,722, an increase in prepaid expenses and other of $267,160, an increase in other assets of $47,177, a decrease in accrued compensation of $479,775, and a decrease in lease liability of $37,229.
Previous wording
During the six months ended June 30, 2026, cash provided by financing activities was $13,671,645, consisting primarily of proceeds from the issuance of common stock and warrants in connection with our PIPE financing of $15,071,783, proceeds from the issuance of Series A Convertible Preferred Stock of $5,000,000, and proceeds from sales of common stock under the equity purchase agreement of $666,528, offset by the repayment of the OID loan of $6,666,667 and payment of issuance costs related to the Series A Convertible Preferred Stock of $400,000.
Current wording
During the nine months ended September 30, 2026, cash provided by financing activities was $22,954,427, consisting primarily of proceeds from the issuance of common stock and warrants in connection with our PIPE financing of $15,071,783, net proceeds from the Registered Direct Offering of $13,874,916, proceeds from the issuance of Series A Convertible Preferred Stock of $5,000,000, net proceeds from sales of common stock under the ATM Agreement of $1,200,668, and proceeds from sales of common stock under the equity purchase agreement of $663,727, offset by the repayment of the OID loan of $6,666,667, the redemption of the Series A Convertible Preferred Stock for $5,790,000 and payment of issuance costs related to the Series A Convertible Preferred Stock of $400,000.
Previous wording
During the six months ended June 30, 2025, cash provided by financing activities was $11,024,372 consisting primarily of proceeds from the sale of common stock of $11,324,372 and proceeds from related party loans of $300,000, offset by repayment of related party loans of $600,000.
Current wording
During the nine months ended September 30, 2025, cash provided by financing activities was $18,221,108 consisting primarily of proceeds from the sale of common stock of $11,324,372, proceeds from the issuance of convertible promissory notes of $4,000,000, proceeds from sales of common stock under the equity purchase agreement of $3,196,736, and proceeds from related party loans of $300,000, offset by repayment of related party loans of $600,000.
Previous wording
Since our inception, we have funded our operations through the sale and issuance of common stock and debt financings from related and third parties. Our historical sources of liquidity, including the issuances of common stock under our private placements, sales under the Equity Purchase Agreement with Mast Hill Fund, LP, the line of credit with HCWG, and our convertible debt financings, are described in the “Liquidity and Capital Resources” section of our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to these arrangements during the six months ended June 30, 2026 except as described below.
Current wording
Since our inception, we have funded our operations through the sale and issuance of common stock and debt financings from related and third parties. Our historical sources of liquidity, including the issuances of common stock under our private placements, sales under the Equity Purchase Agreement with Mast Hill Fund, LP, the line of credit with HCWG, and our convertible debt financings, are described in the “Liquidity and Capital Resources” section of our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to these arrangements during the nine months ended September 30, 2026 except as described below.
Previous wording
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Since our inception, we have not generated any revenue from product sales or any other sources, except humanitarian use, and we have incurred significant operating losses. We have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As reflected in the accompanying condensed consolidated financial statements, we have incurred recurring net losses since our inception. For the six months ended June 30, 2026, we incurred a net loss of $23,059,976, and we had an accumulated deficit of $135,814,631 at June 30, 2026. At June 30, 2026, we had cash totaling $1,973,420. These factors raise substantial doubt about our ability to continue as a going concern for at least one year from the date of issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies, such as executing additional licensing contracts. The condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Current wording
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Since our inception, we have not generated any revenue from product sales or any other sources, except humanitarian use, and we have incurred significant operating losses. We have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As reflected in the accompanying condensed consolidated financial statements, we have incurred recurring net losses since our inception. For the nine months ended September 30, 2026, we incurred a net loss of $27,500,185, and we had an accumulated deficit of $140,254,840 at September 30, 2026. At September 30, 2026, we had cash and cash equivalents totaling $6,166,342. These factors raise substantial doubt about our ability to continue as a going concern for at least one year from the date of issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies. The condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Previous wording
In January 2026, the Company entered into the first of a series of related Securities Purchase Agreements providing for the issuance, in one or more closings, of up to an aggregate of 2,222,222 shares of common stock and warrants to purchase up to 2,222,222 shares of common stock at an exercise price of $9.00 per share, for aggregate gross proceeds of up to approximately $16,000,000. During the six months ended June 30, 2026, we completed closings under three Securities Purchase Agreements for an aggregate of 2,093,305 shares of common stock and warrants to purchase 2,093,305 shares of common stock, resulting in gross proceeds of $15,071,783. The offering of securities under the PIPE Financing terminated on April 30, 2026.
Current wording
In January 2026, the Company entered into the first of a series of related Securities Purchase Agreements providing for the issuance, in one or more closings, of up to an aggregate of 2,222,222 shares of common stock and warrants to purchase up to 2,222,222 shares of common stock at an exercise price of $9.00 per share, for aggregate gross proceeds of up to approximately $16,000,000. During the nine months ended September 30, 2026, we completed closings under four Securities Purchase Agreements for an aggregate of 2,093,305 shares of common stock and warrants to purchase 2,093,305 shares of common stock, resulting in gross proceeds of $15,071,783. The offering of securities under the PIPE Financing terminated on April 30, 2026. During the three months ended September 30, 2026, sales of common stock under the ATM Agreement and the Registered Direct Offering triggered the down-round provision in these warrants, reducing their exercise price to $8.01 per share (see Note 8).
Previous wording
In June 2026, the Company entered into a Securities Purchase Agreement providing for the issuance of shares of Series A Convertible Preferred Stock for aggregate gross proceeds of $5,000,000. During the six months ended June 30, 2026, the Company completed the closing under the Securities Purchase Agreement, resulting in gross proceeds of $5,000,000 and net proceeds of approximately $4,600,000, after deducting issuance costs of $400,000. See Note 8 to the condensed consolidated financial statements for additional information regarding the terms of the Series A Convertible Preferred Stock.
Current wording
In June 2026, the Company entered into a Securities Purchase Agreement providing for the issuance of shares of Series A Convertible Preferred Stock for aggregate gross proceeds of $5,000,000. During the nine months ended September 30, 2026, the Company completed the closing under the Securities Purchase Agreement, resulting in gross proceeds of $5,000,000 and net proceeds of approximately $4,600,000, after deducting issuance costs of $400,000. On September 14, 2026, the Company redeemed all outstanding shares of Series A Convertible Preferred Stock for $5,790,000 in cash. See Note 8 to the condensed consolidated financial statements for additional information regarding the terms of the Series A Convertible Preferred Stock.
Previous wording
While the proceeds from the PIPE Financing and the Series A Convertible Preferred Stock financing have provided additional liquidity during the six months ended June 30, 2026, management does not believe these proceeds, together with the Company’s other available resources, are sufficient to fund operations for at least twelve months from the date of issuance of these financial statements, and substantial doubt about the Company’s ability to continue as a going concern therefore remains, as discussed above.
Current wording
While the proceeds from the PIPE Financing, the Registered Direct Offering, and sales under the ATM Agreement have provided additional liquidity during the nine months ended September 30, 2026, management does not believe these proceeds, together with the Company’s other available resources, are sufficient to fund operations for at least twelve months from the date of issuance of these financial statements, and substantial doubt about the Company’s ability to continue as a going concern therefore remains, as discussed above.
Showing the first 40 of 45 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Change in fair value of derivative liability related to Series A preferred stock
Current report — wording carried from elsewhere
Change in fair value of derivative liability related to Series A preferred stock
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Interest expense was $1,216,994 and $357,672 for the six months ended June 30, 2026 and 2025, respectively. The increase of $859,322 was primarily related to the short-term OID loan (see Note 6), interest accrued on the Company’s unremitted restricted stock tax withholding obligations, and accrued interest for a litigation matter.
Previous report — wording carried elsewhere
Loss on change in fair value of derivative liability related to Series A preferred stock
Previous report — wording carried elsewhere
Gain on Change in Fair Value of Derivative Liability