What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-14 compared with 2025-11-14 · 85 added, 229 removed, 82 unchanged (79% 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 Securities

“Risk Factors” of our Form 10-K for the year ended December 31, 2025, available on the Security

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

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and uncertainties described under Item 1A.

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

Quarterly Reports on Form 10-Q, and in other filings made by us from time to time with the SEC.

“Risk Factors” of our Form 10-K for the year ended December 31, 2025 and in other

filings made by us from time to time with the SEC.

While we believe we have identified material risks,

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

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.

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

In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking

statements contained in the Private Securities Litigation Reform Act of 1995.

Forward-looking statements include, but are not

limited to, statements about:

our ability to maintain our listing on the Nasdaq Capital Market;

our ability to obtain additional funding to develop our product candidates;

our ability to secure rights to new pipeline assets;

our ability to obtain additional funding to develop pipeline assets;

our ability to maintain compliance with the NASDAQ Capital Market’s continued listing requirements, including any new continued listing requirements that are approved in the future;

the success of our research and development efforts and clinical trials through all phases of clinical development;

the need to obtain regulatory approval of our product candidates;

the success of our clinical trials through all phases of clinical development;

compliance with obligations under intellectual property licenses with third parties;

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We caution you not to place undue reliance on the

forward-looking statements contained in this Form 10-Q or any other document, which speak only as of their respective dates.

You should not rely upon forward-looking statements

as predictions of future events.

Our actual results and financial condition may differ materially from those indicated in the forward-looking

We qualify all of our forward-looking statements by these cautionary statements.

Although we believe that the expectations

reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Therefore, you should not rely on any of the forward-looking statements.

In addition, with respect to all of our forward-looking statements,

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-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,

may be significant developments in the treatment of Glioblastoma and other CNS malignancies, and if approved by the U.S.

Food and Drug

Administration (“FDA”), could give Glioblastoma patients important new therapeutic alternatives to the current standard of

Glioblastomas are tumors that arise from astrocytes, which are star-shaped cells making up the supportive tissue of the brain.

tumors are usually highly malignant (cancerous) because the cells reproduce quickly, and they are supported by a large network of blood

Berubicin is an anthracycline, which is a class of drugs that are among the most powerful and extensively used chemotherapy drugs

TPI 287 is an abeotaxane, and is related to the family of common chemotherapy drugs known as taxanes.

Based on limited clinical

and preclinical data, we believe TPI 287 is the first taxane that appears to cross the blood brain barrier (“BBB”) in significant

concentrations targeting brain cancer cells.

Based on clinical and preclinical data, Berubicin is the first anthracycline that appears

to cross the BBB in significant concentrations targeting brain cancer cells.

While our focus is currently on the development of TPI 287

and Berubicin, we are also in the process of attempting to secure intellectual property rights to additional compounds that we plan to

develop into drugs to treat CNS and other cancers.

TPI 287 has been granted Orphan Drug Designation

(“ODD”) status by the FDA.

ODD from the FDA is available for drugs targeting diseases with less than 200,000 cases per year.

ODD may enable market exclusivity of 7 years from the date of approval of a New Drug Application (“NDA”) in the United States.

During that period the FDA generally could not approve another product containing the same drug for the same designated indication.

drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same

active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy

or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market

The ODD strengthens our intellectual property protections although the Company is exploring if there are other patents that could

be filed related to TPI 287 to extend additional protections.

TPI 287 is an abeotaxane and is an investigational

chemotherapy agent classified as a third-generation taxane derivative.

It was developed to address some of the limitations of earlier

taxanes like paclitaxel (Taxol) and docetaxel (Taxotere), particularly issues related to drug resistance and poor penetration of the BBB.

As a synthetic, lipophilic compound, TPI 287 is designed to be brain-penetrant, potentially allowing it to reach CNS tumors more effectively

than its predecessors.

Like other taxanes, TPI 287’s mechanism of action is to stabilize microtubules, which disrupts cell division

and induces apoptosis.

However, one of its notable advantages is its reduced susceptibility to drug efflux pumps such as P-glycoprotein

(P-gp), a common mechanism by which cancer cells develop resistance to chemotherapy.

This feature gives TPI 287 potential utility in treating

drug-resistant cancers in the CNS.

TPI 287 has been studied in early-phase clinical

trials (Phase I and II) in over 300 patients for several indications, including Glioblastoma, metastatic breast cancer with brain metastases,

non-small cell lung cancer (“NSCLC”), castration-resistant prostate cancer, and neuroblastoma.

TPI 287 represents a promising

candidate for treating cancers involving the CNS, as well as those that have become resistant to traditional taxane therapies.

has shown promise in limited clinical trials, further clinical development is necessary to determine its future in neuro-oncology.

Berubicin was discovered at The University of Texas

Anderson Cancer Center by Dr.

Waldemar Priebe, the founder of the Company.

Through a series of transactions, Berubicin was initially

licensed to Reata.

Reata initiated several Phase I clinical trials with Berubicin for CNS malignancies, one of which was for malignant

gliomas, but subsequently allowed their Investigational New Drug (“IND”) with the FDA to lapse for strategic reasons.

required us to obtain a new IND for Berubicin before beginning further clinical trials.

On December 17, 2020, we announced that our IND

application with the FDA for Berubicin for the treatment of Glioblastoma Multiforme was in effect.

We initiated this trial for patient

enrollment during the second quarter of 2021 with the first patient dosed during the third quarter of 2021 to investigate the efficacy

of Berubicin in adults with Glioblastoma Multiforme who have failed first-line therapy.

The first patient on the trial was treated during

the third quarter of 2021.

Correspondence between the Company and the FDA resulted in a trial design with overall survival (OS) as the

primary endpoint of the study.

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a

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

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.

The trial compared the efficacy of Berubicin to that of Lomustine, a current standard

of care in this setting, with a 2 to 1 randomization of the 252 patients to Berubicin or Lomustine.

Patients receiving Berubicin were

administered a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily for three consecutive days followed by 18 days off (a 21-day

Lomustine is administered orally once every six weeks.

The trial design included a pre-planned, non-binding interim futility analysis.

We reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent Data Safety Monitoring

Board (“DSMB”) was responsible for conducting.

The DSMB’s charter mandated that they review the primary endpoint, Overall

Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants

modification or discontinuation of the study.

On December 18, 2023, we released the DSMB’s recommendation which was to continue

the study without modification.

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,

it did not demonstrate a statistically significant difference in overall survival, the primary endpoint.

Nevertheless, given the dearth

of alternative approved therapies for GBM, we believe Berubicin has demonstrated potential value as a possible treatment for Glioblastoma.

As such we are currently evaluating whether any potential paths forward exist for the program.

Any such path will be planned and executed

in consultation with the FDA.

Even if Berubicin is approved, there is no assurance that patients will choose an infusion treatment, as

compared to the current standard of care, which requires oral administration.

We do not have manufacturing facilities and all

manufacturing activities are contracted out to third parties.

Additionally, we do not have a sales organization.

On November 21, 2017, we entered into a Collaboration

and Asset Purchase Agreement with Reata (the “Reata Agreement”).

Pursuant to the Reata Agreement we purchased all of Reata’s

intellectual property and development data regarding Berubicin, including all trade secrets, knowhow, confidential information and other

intellectual property rights.

On December 28, 2017, we obtained the rights to

a worldwide, exclusive royalty-bearing, license to the chemical compound commonly known as Berubicin from Houston Pharmaceuticals, Inc.

(“HPI”) in an agreement we refer to as the HPI License.

HPI is affiliated with our founder, Dr.

Under the HPI License

we obtained the exclusive right to develop certain chemical compounds for use in the treatment of cancer anywhere in the world.

HPI License we agreed to pay HPI:

(i) development fees of $750,000 over a three-year period beginning November 2019;

(ii) a 2% royalty

on net sales;

(iii) a $50,000 per year license fee;

(iv) milestone payments of $100,000 upon the commencement of a Phase II trial and

$1.0 million upon the approval of a New Drug Application (“NDA”) for Berubicin;

and (v) one share of our common stock.

patents we licensed from HPI expired in March 2020.

On March 23, 2025, the Company terminated the HPI License.

On June 10, 2020, the FDA granted Orphan Drug Designation

for Berubicin for the treatment of malignant gliomas.

The ODD now constitutes our primary intellectual property protections related to

Berubicin although the Company is exploring other patents that could be filed related to Berubicin to extend additional protections.

believe we have all rights and intellectual property necessary to develop Berubicin.

As stated earlier, it is our plan to obtain additional

intellectual property covering other compounds which, subject to the receipt of additional financing, may be developed into drugs for

brain and other cancers.

On July 29, 2024, we entered into an Exclusive

License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice pursuant to which Cortice

granted us an exclusive license to the intellectual property rights related to certain patents around the compound TPI 287 in the United

States, Canada, Mexico and Japan.

The term of the license will expire, other than due to a breach of the Cortice Agreements, at the end

of the royalty term with respect to any licensed product in any of the included territories, which begins upon the first commercial sale

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 (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 September 30,

2025 Compared to the Three Months Ended September 30, 2024

General and Administrative Expense

General and administrative expense was approximately

$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 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

$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 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

forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this

We are a biotechnology company organized as a Nevada

corporation in July 2017.

In March 2026, we announced a new corporate strategy focused on developing innovative therapies for serious

We are leveraging our executive team’s multi-functional experiences across high-value therapeutic areas to execute our

new corporate strategy, which also includes pivoting from a singular focus on glioblastoma multiforme and exploring out-licensing opportunities

for our legacy assets TPI 287 and Berubicin for which we have intellectual property rights under license agreement with Cortice and own

pursuant to a collaboration and asset purchase agreement with Reata.

Results of Operations for the Three Months Ended March 31, 2026

Compared to the Three Months Ended March 31, 2025 (rounded to the nearest thousand):

General and Administrative Expense

General and administrative expense was approximately

$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, 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.

$1,431,000 for the three months ended March 31, 2026 compared to approximately $1,095,000 for the comparable period in 2025.

in general and administrative expense was attributable to increases of approximately $31,000 in advertising and marketing expenses, $315,000

in legal and professional expenses, $99,000 in insurance expense and $58,000 in other expenses, which were offset by decreases of approximately

$52,000 in travel expenses, $49,000 in stock-based compensation and $66,000 in compensation expense.

Research and Development Expense

Research and development expense was approximately

$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

$3,544,000 for the three months ended March 31, 2026 compared to approximately $3,243,000 for the comparable period in 2025.

in research and development expense during the period is primarily attributable to an increase in professional expenses of $240,000, increased

headcount expenses of $61,000, drug manufacturing expenditures related to TPI 287 as well as other expenses.

R&D expense includes

activity related to completing and closing out the clinical trial for Berubicin as enrollment and patient treatment is complete.

in Berubicin clinical trial costs offset the increase in expenses above.

Our future research and development expense will be dependent

on the timing and nature of any new asset we in-license or acquire and the development expenses related to such asset.

The net loss for the three months ended March 31,

2026 was approximately $4,937,000 compared to approximately $4,301,000 for the comparable period in 2025.

The change in net loss

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

The change in net loss is primarily

attributable to increased research and development costs and increase in professional expenses.

Liquidity and Capital Resources

On September 30, 2025, we had cash of approximately

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

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 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 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.

On May 13, 2025, the Company entered into a placement

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

(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 estimated that we have sufficient working capital

to take us into the second half of 2026.

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.

On March 31, 2026, we had cash of approximately

$2,951,000 and we had a working capital deficit of approximately $504,000.

We have historically funded our operations from proceeds from

debt and equity sales.

On July 26, 2024, the Company entered into a Sales

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

Pursuant to the terms

of the AGP ATM Sales Agreement, we are permitted to sell from time to time through AGP, as sales agent or principal, shares of our common

During the period ended March 31, 2026, the Company sold 178,933 shares of common stock pursuant to the AGP ATM Sales Agreement

for net proceeds of approximately $501,000.

As of March 31, 2026, the Company sold 447,102 shares of common stock pursuant to the AGP

ATM Sales Agreement for net proceeds of approximately $23.7 million.

On May 4, 2026, the Company entered into Securities

Purchase Agreements (“SPAs”) for a private placement financing that resulted in gross proceeds of approximately $22.5 million.

Pursuant to the terms of the securities purchase agreements, the Company sold an aggregate of (i) 650,000 shares of its common stock (“Common

Stock”) at a purchase price of $2.30 per share and (ii) pre-funded warrants to purchase 9,143,479 shares of Common Stock at

a purchase price of $2.299 per pre-funded warrant.

The pre-funded warrants have an exercise price of $0.001 per share.

The private placement

closed on May 5, 2026.

We estimate that with the proceeds from the May

2026 private placement together with our existing cash on hand we have sufficient capital to fund operations beyond twelve months from

the issuance of these financial statements.

Our strategy is focused on identifying and securing the rights to development stage assets

and advancing any assets we obtain the rights to.

The timing, cost and ultimate success of which are all difficult to predict and as such

the foregoing estimate may prove to be inaccurate.

The cost of advancing any drug candidate will require significant additional capital.

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

Summary of Cash Flows

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Net cash used in operating activities was approximately

$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.

$4,649,000 and $3,242,000 for the three months ended March 31, 2026 and 2025, respectively, and mainly included payments made for clinical

trial costs, officer compensation, insurance, marketing and professional fees to our consultants, attorneys and accountants.

Cash used in investing activities

Net cash used in investing activities was approximately

$6,000 for the three months ended March 31, 2026, related to the purchase of property and equipment.

Net cash used in investing activities

was $0 for the three months ended March 31, 2025.

Cash provided by financing activities

Net cash provided by financing activities was approximately

$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.

$405,000 for the three months ended March 31, 2026, related to the sale of common stock, which was partially offset by the repayment of

notes payable.

Net cash provided by financing activities was approximately $9,828,000 for the three months ended March 31, 2025, related

to the sale of common stock, which was partially offset by the repayment of notes payable.

Off-balance Sheet Arrangements

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

As of March 31, 2026, 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