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Item 2. Management’s Discussion and Analysis

2026-05-15 compared with 2025-11-14 · 114 added, 229 removed, 137 unchanged (71% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q.

In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.

Our actual results may differ materially from these forward-looking statements as a result of certain factors.

For a complete discussion of such risk factors, see the section entitled “Risk Factors”.

Capitalized terms used herein, but not otherwise defined, shall have the meaning ascribed to those terms in the “Part I - Financial Information,” including the related notes to the consolidated financial statements contained therein.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q, as well as our audited consolidated financial statements and related notes thereto and the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “Form 10-K”) filed with the Securities and Exchange Commission on March 31, 2026.

In addition to historical financial information, this discussion and analysis contains forward-looking statements that involve risks, assumptions, and uncertainties, including statements of our plans, objectives, expectations, intentions, forecasts, and projections.

Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors, including those set forth under Part I, Item 1A “Risk Factors” of the Form 10-K, which you should read carefully to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.

Our Company (f/k/a NAS-ONC, Inc.) was formed in 2008, devoted to developing new drugs with new delivery modes.

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We do not have any products approved for sale and have not generated any revenue from product sales other than for humanitarian usage.

On October 11, 2024, the Company entered into an agreement with a broker dealer to serve as placement agent and provide broker services in connection with the proposed sale of common stock up to $10,000,000.

Under this agreement, through December 31, 2024, the Company closed on commitments from investors to purchase 625,000 shares of common stock of the Company at $16 per share for total commitments of $10,000,000, which were to be held in escrow until the Company’s registration statement was declared effective.

During the three months ended March 31, 2025, prior to the Company having an effective registration statement, the Company closed on an additional commitment to purchase 102,750 shares of common stock of the Company at $16.00 per share, for total commitments of $1,644,000.

On March 10, 2025, the Company’s registration statement was declared effective at which time the $11,644,000 in escrow was released to the Company.

On March 26, the Company was listed (“Listing”) on the NASDAQ global markets.

Investment and Joint Venture

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.

Since its inception, we have

incurred significant operating losses.

Our net loss was $8,615,920 and $2,184,500, for the three months ended September 30, 2025

and 2024, respectively, and $46,622,106 and $9,645,482 for the nine months ended September 30, 2025 and 2024, respectively.

an accumulated deficit of $97,230,551 at September 30, 2025.

We expect to continue to incur significant and increasing expenses and

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

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.

Asset Acquisition

In October 2025, the Company paid $500,000 to McMaster University pursuant to a Patent Purchase Agreement, and U.S.

11,788,057 B2 (the “Patent”) was formally assigned effective October 8, 2025.

The Patent covers proprietary technologies combining 3D bioprinting, artificial intelligence, and quantum modeling that are designed to enable the creation of patient-derived three-dimensional brain tumor models for high-throughput preclinical drug screening.

Since our inception, we have incurred significant operating losses.

Our net loss was $8,819,932 and $32,326,016 for the three months ended March 31, 2026 and 2025, respectively.

We had an accumulated deficit of $121,574,587 as of March 31, 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.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

In addition, if we obtain regulatory approval for our product candidates and do not enter a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.

We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all.

Our failure to raise capital or enter into such agreements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition.

The report of our independent registered public accounting firm on our financial statements as of and for the year ended December 31, 2024 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern.

See Note 1 to our financial statements for additional information on our assessment.

We have concluded that there is 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.

Components of Results of Operations

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In addition, if we obtain regulatory approval for any of our product candidates and do not enter a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.

Share Based Compensation

Share based compensation expense result from the recognition of the fair value of restricted stock units (RSU) recorded on a straight-line basis from the date of grant to the date the RSU becomes fully vested.

Stock Based Compensation

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.

Interest Expense

1 unchanged sentence

Borrowings under these loans carry a 50% (or 1 times amounts borrowed) original issue discount (“OID”) on principal.

The OID to be earned under the bridge loan is recognized ratably over the term of each draw-down under the loan through the maturity date.

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.

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.

Advisory fees

Advisory fees principally represent amounts due AFH Holdings, a related party, for their services in recapitalizing the Company.

Amortization on debt issuance costs resulted from the grant of warrants for a line of credit commitment.

1 unchanged sentence

Amortization on deferred offering costs resulted from the issuance of common stock in connection with a private equity agreement.

on Change in Fair Value of Derivative Liability

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.

Comparison of the three and nine months

ended September 30, 2025 and 2024:

Gain (Loss) on Change in Fair Value of Derivative Liability

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.

Comparison of the three months ended March 31, 2026 and 2025:

Results of Operations

1 unchanged sentence

Three Months Ended

September 30,

Cost of Revenues

Operating Expenses:

2 unchanged sentences

General and administrative

Share based compensation

Stock based compensation

Total Operating Expenses

4 unchanged sentences

Interest expense - related parties

Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit

$ (8,615,920 )

$ (2,184,500 )

$ (6,431,420 )

No revenue was generated for

fees for a “right to try” humanitarian program during the three months ended September 30, 2025 and 2024.

Other income (expense)

Gain on change in fair value of derivative liability

No revenue was generated for fees for a “right to try” humanitarian program during the three months ended March 31, 2026.

Revenue of $39,990 was generated during the three months ended March 31, 2025 from fees related to a “right to try” humanitarian program.

Research and Development Expenses

1 unchanged sentence

Three Months Ended

September 30,

Research and development costs by project:

Three Months Ended

September 30,

Clinical trial expense

1 unchanged sentence

Total research and development expense

Research and development expenses

were $715,038 and $956,725 for the three months ended September 30, 2025 and 2024, respectively.

A portion of these expenses amounting

to approximately $12,395 and $416,571 for the three months ended September 30, 2025 and 2024, respectively are from the University

of Southern California (USC), where Dr.

Chen is a member of the faculty.

The total decrease of $241,686 was primarily due to:

Pre-clinical laboratory work in 2024 was completed, such that there were no such costs in 2025.

The recruitment for NEO212.

Legal and Professional Expenses

Legal and professional expenses

were $276,378 and $496,803 for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $220,425 was primarily

due to the completion of the direct listing process which occurred in the first quarter of 2025.

General and Administrative Expenses

General and administrative

expenses were $902,985 and $243,659 for the three months ended September 30, 2025 and 2024, respectively.

The increase of $659,326

was primary due to a marketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses

and expense incurred in pursuit of the Middle East deal.

Share Based Compensation

Share based compensation resulted

from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original

date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date)

during the three months ended September 30, 2025.

Interest Expense

Interest expense was $869,815

and $0 for the three months ended September 30, 2025 and 2024, respectively.

The interest for the three months ended September 30,

2025 relates primarily to the accrued interest for a litigation matter and the accretion of the convertible note payable of $820,794.

Interest and other Income

Interest income was $6,815

and $12,687 for the three months ended September 30, 2025 and 2024, respectively.

The interest income for the three months ended

September 30, 2025 and 2024, relates primarily interest earned on the money market account.

Loss on Change in Fair

Value of Derivative Liability

on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 30, 2025 and 2024, respectively.

The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit,

which commenced in July 2025.

Amortization of Debt Issuance and Deferred Offering Costs

The amortization of debt issuance

costs was approximately $438,111 and $0 for the three months ended September 30, 2025 and 2024, respectively.

This represents the

amortization of the debt issuance costs associated with the warrants issued for the HCWG line of credit, offering costs relating to the

Mast Hill agreement and debt issuance cost associated with the convertible promissory notes.

The following table summarizes our results of operations for the periods presented:

Nine Months Ended

September 30,

Cost of Revenues

Operating Expenses:

Research and development

Legal and professional

General and administrative

Share based compensation

Advisory fees

Total Operating Expenses

Loss From Operations

(44,543,523 )

(39,514,733 )

Other Income (Expense):

Interest and other income

Amortization expense

Interest expense

Loss on extinguishment of Bridge loan - related party

Loss on settlement of common share purchases

$ (46,622,106 )

$ (9,645,482 )

$ (36,976,624 )

Revenue was generated for fees for a “right to try” humanitarian program during 2025 and 2024.

Research and Development Expenses

The following table summarizes the components of our research and development expenses for the periods presented:

Nine Months Ended

September 30,

Research and development costs by project:

Nine Months Ended

September 30,

Clinical trial expense

Research and laboratory

Total research and development expense

Research and development expenses

were $2,390,592 and $1,965,726 for the nine months ended September 30, 2025 and 2024, respectively.

A portion of these expenses amounting

to approximately $242,895 and $416,736 for the nine months ended September 30, 2025 and 2024, respectively are from the University

of Southern California (USC), where Dr.

Research and development expenses were $1,286,336 and $998,222 for the three months ended March 31, 2026 and 2025, respectively.

A portion of these expenses amounting to approximately $38,409 and $103,224 for the three months ended March 31, 2026 and 2025, respectively are from the University of Southern California (USC), where Dr.

Chen is a member of the faculty.

4 unchanged sentences

Increased patient recruitment efforts.

Legal and Professional

Legal and Professional Expenses

were $1,754,287 and $1,652,141 for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $102,146 was

primarily due to completion of the direct listing process.

General and Administrative

General and administrative

expenses were $2,736,732 and $973,923 for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $,762,809

was primary due to amarketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses.

Share Based Compensation

Share based compensation resulted

from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original

date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date)

through September 30, 2025.

The advisory fee was earned on the Listing Date March 26, 2025.

Legal and professional expenses were $1,188,220 and $957,545 for the three months ended March 31, 2026 and 2025, respectively.

The increase of $230,675 was primarily attributable to investment banking fees and incremental legal and audit fees incurred in connection with the preparation and filing of our Annual Report on Form 10-K for the year ended December 31, 2025, our Registration Statement on Form S-3, and related prospectus supplement.

General and Administrative Expenses

General and administrative expenses were $488,709 and $849,485 for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $360,776 was primarily driven by a reduction in marketing and advertising expense in connection with the direct public listing, as well as a reduction of rent, travel, and other costs incurred in Q1 2025 in pursuit of the Middle East deal.

Stock Based Compensation

Stock-based compensation expense, which is a non-cash expense, for the three months ended March 31, 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 March 31, 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.

Advisory fee expense, primarily to a related party, was $1,360,000 and $11,737,806 for the three months ended March 31, 2026 and 2025, respectively.

Advisory fee expense for the three months ended March 31, 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).

Advisory fee expense for the three months ended March 31, 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.

Interest Expense

Interest expense was $1,227,487

and $2,559,456 for the nine months ended September 30, 2025 and 2024, respectively.

The interest for the nine months ended September 30,

2025 relates to the short-term loan in March from a related party in the amount of $300,000 and $146,250 interest for a litigation matter,

and the accretion of the convertible note payable of $820,794.

The OID interest for the nine months ended September 30, 2024 relates

to the OID for the related party bridge loan that was converted into common stock in June of 2024.

Amortization of Debt Issuance and Deferred Offering Costs

The amortization of debt issuance

costs was $798,311 and $0 for the nine months ended September 30, 2025 and 2024, respectively.

This represents the amortization of

the warrants issued for the HCWG line of credit and deferred offering costs relating to the Mast Hill agreement.

Loss on Change in Fair

Value of Derivative Liability

on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 2025 and 2024, respectively.

The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit,

which commenced in July 2025.

Interest expense was $982,624 and $308,922 for the three months ended March 31, 2026 and 2025, respectively.

Interest expense for the three months ended March 31, 2026 related to the short-term loan and accrued interest for a litigation matter.

Interest and other Grant Income

Interest and grant income was $52,319 and $51,699 for the three months ended March 31, 2026 and 2025, respectively.

Interest and other grant income for the three months ended March 31, 2026 related primarily to interest earned on our money market account and grant income pursuant to the two NIH grants which commenced in late 2025.

Interest and other income for the three months ended March 31, 2025 related primarily to interest earned on our money market account.

Amortization of Debt Issuance Costs

Amortization of debt issuance costs was $192,165 and $167,951 for the three months ended March 31, 2026 and 2025, respectively.

Amortization of debt issuance costs in both periods primarily reflected the ongoing amortization of debt issuance costs associated with (i) the warrants issued in connection with the line of credit with HCWG and (ii) the offering costs related to the equity purchase agreement with Mast Hill Fund, LP.

Gain on Change in Fair Value of Derivative Liability

Gain on change in fair value of derivative liability was $2,801 and $0 for the three months ended March 31, 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 three months ended March 31, 2025, and no related loss was recognized in that period.

Other Income (Expense)

Other expense was $644,601 and $0 for the three months ended March 31, 2026 and 2025, respectively.

Other expense for the three months ended March 31, 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 March 31, 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.

The following table summarizes our cash flow for the periods indicated:

Nine Months Ended

September 30,

Three Months Ended

Net cash provided by (used in):

Operating activities

$ (16,772,777 )

$ (3,259,512 )

$ (13,513,265 )

Financing activities

Net increase (decrease) in cash

Net increase in cash

Operating Activities

During the nine months ended

September 30, 2025, net cash used in operating activities was $16,772,777 consisting primarily of our net loss of $46,622,106, offset

by share based compensation of $25,964,096, accretion of original issue discounts of $820,794, amortization of assets of $1,161,331 and

the accrued advisory fee of $3,675,569.

These were offset by decreases in accrued compensation in the amount of $479,775 and prepaid expenses

in the amount of $267,161.

During the nine months ended

September 30, 2024, net cash used in operating activities was $3,259,512 consisting primarily of our net loss of $9,645,482 less

the non-cash charge of the accretion of the original issue discount on the bridge loan in the amount $2,558,241, less the non-cash charge

for the loss on extinguishment of convertible debt of $2,069,923 and an increase in accounts payable of $957,162.

During the three months ended March 31, 2026, net cash used in operating activities was $6,991,773 consisting primarily of our net loss of $8,819,932, offset by stock based compensation of $2,732,397, accretion of original issue discount on the convertible promissory notes of $714,600, amortization of debt issuance of $192,165, amortization of right of use asset of $20,406, amortization of intangible asset of $11,574, and increase in accrued expense of $1,437,582.

These were offset by decreases in accrued advisory fee of $1,757,141, accounts payable of $390,550, accounts payable and accrued expenses - related parties of $463,513, and lease liability of $15,760, an increase in prepaid expenses of $650,800, and a gain on change in fair value of derivative liability of $2,801.

During the three months ended March 31, 2025, net cash used in operating activities was $5,650,055 consisting primarily of our net loss of $32,326,016, offset by stock based compensation of $17,397,774, accretion of original issue discount on related-party advances of $300,000, amortization of debt issuance costs of $577,192, increase in accrued advisory fee of $8,828,565, and increase in accounts payable – related parties of $628,276.

These were offset by an increase in prepaid expenses of $765,738 and a decrease in accrued compensation of $290,108.

Financing Activities

During the nine months ended

September 30, 2025, cash provided by financing activities was $18,221,108 consisting primarily of the sale of common stock of $11,324,522,

proceeds from the issuance of the convertible note of $4,000,000 and proceeds from the sales of common stock under the equity line of

credit of $3,196,736.

During the nine months ended

September 30, 2024, cash used in financing activities was $4,562,277, consisting primarily of proceeds from the sale of common stock

of $4,615,789.

During the three months ended March 31, 2026, cash provided by financing activities was $7,071,645 consisting primarily of proceeds from the issuance of common stock and warrants in connection with our PIPE financing of $13,071,783 and proceeds from the sales of common stock under the equity line of credit of $666,528, offset by the repayment of the OID convertible promissory notes of $6,666,667.

During the three months ended March 31, 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.

Liquidity and Capital Resources

Sources of Liquidity/Going Concern

Since our inception, we have funded our operations through the sale and issuance of preferred and common stock and debt financing rounds from related and third parties.

During the nine months ended

September 30, 2025, the Company sold 727,750 shares of common stock at a price of $16.00 per share for gross proceeds of $11,644,005

pursuant to a private placement of its securities, issued 46,000 shares as part of advisory services related to the listing and as part

of the private placement fee for our equity line of credit, 162,500 shares were issued for the cashless exercise of warrants and issued

447,527 shares from the sale of shares under the equity line of credit,

The accompanying 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

consolidated financial statements, we have incurred recurring net losses since our inception.

For the three and nine months ended September 30,

2025, the Company incurred a net loss of $8,615,920 and $46,622,106, respectively, and had an accumulated deficit of $97,230,551 at September 30,

At September 30, 2025, the Company had cash totaling $1,513,224.

These factors raise substantial doubt about our ability to

continue as a going concern.

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 consolidated financial statements do not include any adjustments

that might be necessary if we are unable to continue as a going concern.

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 three months ended March 31, 2026 except as described below.

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 three months ended March 31, 2026, we incurred a net loss of $8,819,932, and we had an accumulated deficit of $121,574,587 at March 31, 2026.

At March 31, 2026, we had cash totaling $138,601.

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.

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 three months ended March 31, 2026, we completed closings under three Securities Purchase Agreements for an aggregate of 1,815,528 shares of common stock and warrants to purchase 1,815,528 shares of common stock, resulting in gross proceeds of $13,071,808.

Subsequent to March 31, 2026, on April 20, 2026, we entered into a fourth Securities Purchase Agreement and completed an additional closing thereunder for an aggregate of 277,777 shares of common stock and warrants to purchase 277,777 shares of common stock, resulting in gross proceeds of approximately $2,000,000.

The offering of securities under the PIPE Financing terminated on April 30, 2026.

The ability to continue as a going concern is dependent on us raising additional capital and attaining and maintaining profitable operations in the future to meet our obligations and repay our liabilities arising from normal business operations when they come due.

Since inception, we have funded our operations primarily through equity and debt financings and licensing income and we expect to continue to rely on these sources of capital in the future.

No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us.

Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our shareholders, in the case of equity financing, or grant unfavorable terms in licensing agreements.

We have the following financing facilities available to us:

On October 11, 2024, the Company entered into a Line of Credit Agreement (“the Agreement”) with HCWG for borrowings of up to $10.0 million.

No amounts have been borrowed under the facility through December 31, 2025.

On October 22, 2024, we entered into an equity purchase agreement (the “Equity Purchase Agreement”) with Mast Hill Fund, LP (“Mast Hill”) pursuant to which the Company may sell and issue to the investor, and the investor may purchase from the Company, up to $50,000,000 of Company’s common shares.

During the three months ended March 31, 2026, the Company sold 76,648 shares of common stock at prices ranging from $8.40 to $8.97 per share under the Equity Purchase Agreement, resulting in net proceeds of $663,727.

No assurance can be given that we will be able to draw upon such facilities if needed.

Further, no assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us.

Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing, or grant unfavorable terms in licensing agreements.

Funding Requirements

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If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We expect to finance our operations over the next 12 months primarily through existing cash balances and the proceeds from the aforementioned private placements and supplemented as necessary by funds available through our Line of Credit Agreement with HCWG and sales under the Equity Purchase Agreement, each as described below.

We intend to finance our operations over the next 12 months primarily through existing cash balances and the proceeds from the funds available through our Line of Credit Agreement with HCWG and sales under the Equity Purchase Agreement, each as described above.

We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.

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our ability to establish and maintain collaborations on favorable terms, if at all;

achievement of milestones or the occurrence of other developments that trigger payments under any license or collaboration

agreements we might have at such time;

the achievement of milestones or the occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;

the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

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Critical Accounting Estimates

We account for stock-based compensation, including restricted stock units (RSUs), in accordance with ASC 718.

RSUs are measured at fair value on the grant date based on our common stock price and expense over the vesting period.

Stock-Based Compensation

We account for stock-based compensation, including restricted stock, in accordance with ASC 718 (Accounting Standards Codification Topic 718, Compensation—Stock Compensation).

Shares of restricted stock are measured at fair value on the grant date based on our common stock price and expense over the vesting period.

For awards with performance or market conditions, expense is recognized based on the probability of achievement and may be accelerated.

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Management reviews these assumptions quarterly and updates estimates as necessary.

We consider the accounting for RSUs a critical estimate due to the judgment involved and its material impact on our financial results.

We consider the accounting for restricted stock a critical estimate due to the judgment involved and its material impact on our financial results.

Common Stock Purchase Warrants

We consider the valuation of our common stock purchase warrants a critical accounting estimate.

The fair value of our warrants is determined using a Monte Carlo Simulation model.

The Monte Carlo Simulation model requires significant judgment in the selection of key inputs, including expected volatility, expected term, risk-free interest rate, and the fair value of our common stock.

Expected volatility is estimated based on the historical volatility of a peer group of guideline public companies, given our limited trading history as a public company.

The expected term reflects, among other factors, our assumptions regarding the likelihood and timing of liquidity events.

For warrants with down-round protective provisions, additional judgment is required in modeling the timing, probability, and pricing of assumed future financing events that could trigger an adjustment to the warrant exercise price.

Changes in these assumptions, particularly expected volatility, expected term, and stock price, can materially affect the estimated fair value of our warrants and, for liability-classified warrants, our reported results of operations in any given period.

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 2. Management’s Discussion and Analysis