What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-14 compared with 2025-08-14 · 73 added, 68 removed, 238 unchanged (37% of the section changed)

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and uncertainties.

“Risk Factors” of our Form 10-K for the year ended December 31, 2024, available on the Security

“Risk Factors” of our Form 10-K for the year ended December 31, 2024, available on the Securities

and Exchange Commission's (“SEC”) EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions

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You should not rely upon forward-looking statements as predictions of future events.

We are under no duty to update any of these forward-looking

statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend

Except as required by law, we are under no duty to

update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised

expectations, and we do not intend to do so.

Forward-looking statements include, but are not

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we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of

We are a clinical pharmaceutical company organized

as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of brain and central

nervous system tumors, based on intellectual property that we license under license agreements with Cortice Biosciences, Inc.

and own pursuant to a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc.

We are a clinical-stage pharmaceutical company

organized as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of brain and

central nervous system tumors, based on intellectual property that we license under license agreements with Cortice Biosciences, Inc.

(“Cortice”) and own pursuant to a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc.

We believe our drug candidates, TPI 287 and Berubicin,

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statistically significant improvement can be shown relative to a randomized control arm.

On March 25, 2025, CNS released topline data from

a primary analysis of a clinical trial being conducted to evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme

On March 25, 2025, we released topline data from

a primary analysis for the clinical trial being conducted to evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme

who have failed primary treatment for their disease.

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the study without modification.

On March 25, 2025, we released topline data showed that although Berubicin produced clinically relevant

On March 25, 2025, we released topline data that showed that although Berubicin produced clinically relevant

outcomes that appear to be comparable (although the trial was not powered to determine non-inferiority) to Lomustine across multiple endpoints,

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in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of regulatory or marketing exclusivity

for such licensed product in such country, or (c) the expiration of the last to expire valid patent claim in such country covering such

for such licensed product in such country, or (iii) the expiration of the last to expire valid patent claim in such country covering such

licensed product.

Results of Operations for the Three Months Ended June 30, 2025 Compared

to the Three Months Ended June 30, 2024

Results of Operations for the Three Months Ended September 30,

2025 Compared to the Three Months Ended September 30, 2024

General and Administrative Expense

General and administrative expense was approximately

$1,242,000 for the three months ended June 30, 2025 compared to approximately $1,412,000 for the comparable period in 2024.

$1,057,000 for the three months ended September 30, 2025 compared to approximately $1,384,000 for the comparable period in 2024.

in general and administrative expense is attributable to decreases of approximately $207,000 in legal and professional expenses, $211,000

in travel expenses, $195,000 in stock-based compensation, which were offset by increases of approximately $51,000 in compensation expense

and $29,000 in insurance expense.

in stock-based compensation, and $22,000 in other expense, which were offset by increases of approximately $45,000 in travel expenses,

$41,000 in compensation expense and $27,000 in marketing expense.

Research and Development Expense

Research and development expense was approximately $1,167,000 for the

three months ended June 30, 2025 compared to approximately $1,117,000 for the comparable period in 2024.

The increase in research and

development expense during the period is primarily attributable to declining trial costs on the Berubicin trial offset by expenditures

preparing for a TPI 287 trial including drug manufacturing.

The net loss for the three months ended June 30,

Research and development expense was approximately

$2,197,000 for the three months ended September 30, 2025 compared to approximately $4,245,000 for the comparable period in 2024.

in research and development expense during the period is primarily attributable to an approximately $1,628,000 decline in trial costs

for the Berubicin trial and a reduction of approximately $979,000 in TPI 287 expense due to expenses incurred as part of the in-licensing

of TPI 287 in the prior year period which is partially offset by expenditures preparing for a TPI 287 trial including drug manufacturing.

The net loss for the three months ended September

30, 2025 was approximately $3,218,000 compared to approximately $5,606,000 for the comparable period in 2024.

The change in net loss is primarily

attributable to declining trial costs on the Berubicin trial.

Results of Operations for the Six Months Ended June 30, 2025 Compared

to the Six Months Ended June 30, 2024

The change in net loss is

primarily attributable to declining trial costs on the Berubicin trial and by lower general and administrative expenses.

Results of Operations for the Nine Months Ended September 30, 2025

Compared to the Nine Months Ended September 30, 2024

General and Administrative Expense

General and administrative expense was approximately

$2,337,000 for the six months ended June 30, 2025 compared to approximately $2,526,000 for the comparable period in 2024.

$3,394,000 for the nine months ended September 30, 2025 compared to approximately $3,910,000 for the comparable period in 2024.

in general and administrative expense is attributable to decreases of approximately $527,000 in stock-based compensation, $108,000 in

marketing and advertising expenses, which were offset by increases of approximately $40,000 in legal and professional expenses, $62,000

in travel expenses, $105,000 in compensation expense and $26,000 in other expenses.

marketing and advertising expenses, and $186,000 in legal and professional expenses, which were offset by increases of approximately $106,000

in travel expenses, $123,000 in compensation expense, $42,000 in insurance expense and $34,000 in other expenses.

Research and Development Expense

Research and development expense was approximately

$4,410,000 for the six months ended June 30, 2025 compared to approximately $3,547,000 for the comparable period in 2024.

in research and development expense during the period is primarily attributable to timing of trial costs on the Berubicin trial.

The net loss for the six months ended June 30,

$6,607,000 for the nine months ended September 30, 2025 compared to approximately $7,792,000 for the comparable period in 2024.

in research and development expense during the period is primarily attributable to an approximately $1,087,000 decline in trial costs

for the Berubicin trial and a reduction of approximately $982,000 in TPI 287 expense due to expenses incurred as part of the in-licensing

of TPI 287 in the prior year period which is partially offset by approximately $864,000 of expenditures preparing for a TPI 287 trial

including drug manufacturing as well as other expenses.

The net loss for the nine months ended September

30, 2025 was approximately $9,895,000 compared to approximately $11,681,000 for the comparable period in 2024.

The change in net loss is primarily

attributable to timing of trial costs on the Berubicin trial partially offset by lower G&A expenses.

The change in net loss

is primarily attributable to timing of trial costs on the Berubicin trial and by lower general and administrative expenses.

Liquidity and Capital Resources

On June 30, 2025, we had cash of approximately

On September 30, 2025, we had cash of approximately

$9,864,000 and we had a working capital of approximately $9,447,000.

We fund our operations from proceeds from equity sales.

We have historically funded our operations with proceeds from equity

sales and expect this to continue for the foreseeable future.

On July 26, 2024, we entered into a Sales Agreement

(the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”).

During the six months ended June

During the nine months ended September

30, 2025, we sold 127,582 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9 million.

As of June 30, 2025, we had sold 210,230 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately

As of November 14, 2025, we had sold 255,940 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately

$23.2 million.

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agency agreement with AGP for the public offering of (i) 27,084 shares of common stock;

(ii) pre-funded warrants to purchase 302,298

shares of common stock (the “Pre-Funded Warrants”);

and (iii) Series F Warrants to purchase up to an aggregate of 329,381

shares of common stock (the “Common Warrants”).

(ii) pre-funded warrants to purchase 302,295 shares

of common stock (the “Pre-Funded Warrants”);

and (iii) Series F Warrants to purchase up to an aggregate of 329,381 shares

of common stock (the “Common Warrants”).

The net proceeds from the offering were approximately $4.5 million.

We estimate that we have sufficient working capital

We estimated that we have sufficient working capital

to take us into the second half of 2026.

At that point, we expect to have already initiated a trial of TPI 287, as well as completed the

Berubicin trial including its final analysis.

In addition, we have working capital to fund our operations during the intervening period

(with such operations estimated at $4.5 to $5.0 million per annum).

We do not currently have a firm trial design for TPI 287 so estimates

of development cost are not available, however, regardless of trial design, the cost of bringing TPI 287 to regulatory approval for marketing

will require significant additional financing.

The timing and costs of clinical trials are difficult to predict and as such the foregoing

estimates may prove to be inaccurate.

We have no commitments for such additional needed financing and will likely be required to raise

such financing through the sale of additional equity or debt securities.

We will need to raise significant

additional capital in the future in order to meet our future obligations and execute our business plan.

If we are unable to raise sufficient

funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our

business plan until sufficient additional capital is raised to support further operations.

There can be no assurance that such a plan

will be successful and if it is not successful we may need to cease operations entirely.

This estimate is based on the assumption that our core operations expense run rate is approximately

$5.5 million per year;

that the TPI 287 trial is initiated in the second quarter of 2026;

and our Berubicin trial and final analysis is

completed by the end of the second quarter of 2026.

Based on a preliminary assessment of the trial design, we estimate our TPI 287 trial

will cost between $12 to 15 million, however this range could materially change as a result of the final trial design.

Regardless of the

final trial design, the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing, which

we may be unable to obtain on acceptable terms or at all.

Further, the timing and costs of clinical trials are difficult to estimate even

with a locked design, and as such, the foregoing estimates may materially change.

We have no commitments for such additional needed financing

and will likely be required to raise such financing through the sale of additional equity or debt securities to execute our business plans.

If we are unable to raise sufficient funds, we will be required to develop and implement an alternative plan to further extend payables,

reduce overhead or scale back our business until sufficient additional capital is raised to support continued operations.

no assurance that such a plan will be successful and if it is not successful, we may need to cease operations entirely.

Summary of Cash Flows

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Net cash used in operating activities was approximately

$8,585,000 and $4,842,000 for the six months ended June 30, 2025 and 2024, respectively, and mainly included payments made for clinical

trial costs, drug manufacturing and development, officer compensation, insurance, marketing and professional fees to our consultants,

attorneys and accountants.

$10,759,000 and $11,642,000 for the nine months ended September 30, 2025 and 2024, respectively, and mainly included payments made for

clinical trial costs, drug manufacturing and development, officer compensation, insurance, marketing, professional fees to our consultants,

attorneys and accountants and stock-based compensation.

Cash provided by financing activities

Net cash provided by financing activities was approximately

$14,254,000 for the six months ended June 30, 2025, related to the sale of common stock, which were offset by the repayment of notes payable.

Net cash provided by financing activities was approximately $5,785,000 for the six months ended June 30, 2024, related to the sale of

common stock and exercise of warrants, which were offset by the repayment of notes payable.

$14,162,000 for the nine months ended September 30, 2025, related to the sale of common stock, which were partially offset by the repayment

of notes payable.

Net cash provided by financing activities was approximately $18,067,000 for the nine months ended September 30, 2024,

related to the sale of common stock and exercise of warrants, which were partially offset by the repayment of notes payable.

Off-balance Sheet Arrangements

As of June 30, 2025, we did not have any relationships

As of September 30, 2025, we did not have any relationships

with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities,

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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