What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-04-01 · 175 added, 108 removed, 118 unchanged (71% of the section changed)

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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 HPI and UTMDACC and own pursuant

to a collaboration and asset purchase agreement with Reata.

We believe our lead drug candidate, Berubicin,

may be a significant development in the treatment of Glioblastoma and other CNS malignancies, and if approved by the FDA could give Glioblastoma

central nervous system tumors, based on intellectual property that we license under license agreement Cortice and own pursuant to a collaboration

and asset purchase agreement with Reata.

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 FDA could give Glioblastoma

patients an important new therapeutic alternative to the current standard of care.

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the cells reproduce quickly, and they are supported by a large network of blood vessels.

Berubicin is an anthracycline, which is a class

of drugs that are among the most powerful and extensively used chemotherapy drugs known.

Based on limited clinical data, we believe Berubicin

is the first anthracycline that appears to cross the blood brain barrier in significant concentrations targeting brain cancer cells.

our focus is currently on the development of 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 cancers.

TPI 287 is an abeotaxane (derived from the taxane

family of drugs) and Berubicin is an anthracycline.

Both of these are classes of drugs that are among the most powerful and extensively

used chemotherapy drugs known.

Based on clinical and preclinical data, we believe TPI 287 is the first taxane to appear to cross the BBB

and Berubicin is the first anthracycline to appear to cross the BBB, both 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 cancers.

TPI 287 represents a promising candidate for treating

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

While it has shown promise in

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

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, 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 had previously been granted Orphan Drug Designation

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 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.

Orphan 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 demand.

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.

Berubicin was discovered at UTMDACC by Dr.

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to as the HPI License.

HPI is affiliated with Dr.

Priebe, who controls a majority of our shares.

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.

In the HPI License we

agreed to pay HPI:

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

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.

In the 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 an NDA for Berubicin;

(iv) milestone payments of $100,000 upon the commencement of a Phase II trial and $1.0 million upon the approval of an NDA for Berubicin;

and (v) 3 shares of our common stock.

The patents we licensed from HPI expired in March 2020.

With the Reata Agreement and the HPI License, we

believe we have obtained 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 January 10, 2020, we entered into a Patent and

Technology License Agreement (the “WP1244 Agreement”) with The Board of Regents of The University of Texas System, an agency

of the State of Texas, on behalf of The University of Texas M.

Anderson Cancer Center (“UTMDACC”).

Pursuant to the WP1244

Agreement, we obtained a royalty-bearing, worldwide, exclusive license to certain intellectual property rights, including patent rights,

related to our WP1244 drug technology.

In consideration, we must make payments to UTMDACC including an up-front license fee, annual maintenance

fee, milestone payments and royalty payments (including minimum annual royalties) for sales of licensed products developed under the WP1244

The term of the WP1244 Agreement expires on the last to occur of:

(a) the expiration of all patents subject to the WP1244 Agreement,

or (b) fifteen years after execution;

provided that UTMDACC has the right to terminate the WP1244 Agreement in the event that we fail

to meet certain commercial diligence milestones.

On May 7, 2020, pursuant to the WP1244 Portfolio

license agreement described above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating to

novel anticancer agents targeting CNS malignancies.

The Company agreed to fund approximately $1,134,000 over a two-year period, which

has been fully paid by the Company in 2021.

This agreement was extended and expired on March 31, 2023.

The principal investigator for

this agreement is Dr.

Waldemar Priebe, our founder.

Results of Operations for the Year Ended December 31, 2023 Compared

to the Year Ended December 31, 2022

On March 23, 2025, the Company terminated

the HPI License.

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

(“ODD”) for Berubicin for the treatment of malignant gliomas.

The ODD now constitutes our primary intellectual property protection

for Berubicin although the Company is exploring if there are other patents that could be filed related to Berubicin to extend additional

On January 10, 2020, we entered into a Patent and Technology License Agreement

(the “WP1244 Agreement”) with The Board of Regents of The University of Texas System, an agency of the State of Texas, on

behalf of the UTMDACC.

Pursuant to the WP1244 Agreement, we obtained a royalty-bearing, worldwide, exclusive license to certain intellectual

property rights, including patent rights, related to our portfolio of WP1244 drug technology.

On April 25, 2024, UTMDACC provided notice

to us if its intent to terminate the WP1244 Agreement if we fail to pay the annual maintenance fee of $50,000, as well as $1,300 in expenses.

On May 25, 2024 the WP1244 Agreement was terminated.

There are no termination penalty provisions in the Agreement.

On July 24, 2021, the Company received Fast Track

Designation from the FDA for Berubicin.

Fast Track Designation is designed to facilitate the development and expedite the review

of drugs to treat serious conditions and fill an unmet medical need

On July 29, 2024, the Company entered into an

Exclusive License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences,

(“Cortice”) pursuant to which Cortice granted the Company 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 (c) the expiration of the last to

expire valid patent claim in such country covering such licensed product.

Our plan of operations is primarily focused on

completing a clinical trial for TPI 287 and finishing the on-going trial of Berubicin.

We estimate that we have sufficient capital to

take us into the first quarter of 2026, a period during which we would likely expect to initiate a trial of TPI 287, as well as complete

the Berubicin trial including its final analysis.

In addition, we have working capital to fund our operations during this 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.

Results of Operations for

the Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023

General and Administrative Expense

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$5,612,000 for the year ended December 31, 2024 compared to approximately $4,770,000 for 2023.

The decrease in general and administrative

expense was mainly attributable to decreases of approximately $792,000 in professional expenses, $488,000 in employee compensation,

$141,000 in stock-based compensation and $92,000 in insurance expenses.

These changes were offset by increases of approximately $145,000

in travel expenses, board of director compensation of $96,000, advertising and marketing of $68,000 and other general and administrative

The increase in general and administrative

expense was mainly attributable to increase of approximately $756,000 in professional expenses, $440,000 in employee compensation.

These changes were offset by decrease of approximately $104,000 in stock-based compensation, $49,000 in insurance expenses, $21,000 in

travel expenses, board of director compensation of $9,000, advertising and marketing of $119,000 and other general and administrative

expenses of $52,000.

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$9,290,000 for the year ended December 31, 2024 compared to approximately $14,096,000 for 2023.

The increase in research and development

The decrease in research and development

expenses during the period was mainly attributed to the timing of research organization (CRO) expenses and patient treatment costs related

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January 2024.

We expect our research and development costs to taper off in the future as we move toward completion of our clinical trial

for Berubicin primarily due to patients moving from active treatment to follow-up leading to decreasing costs of treating and following

these patients as more patients eventually succumb to their disease.

We expect our research and development costs to taper off in the near future as we move toward completion of our clinical

trial for Berubicin primarily due to patients moving from active treatment to follow-up leading to decreasing costs of treating and following

these patients as more patients eventually succumb to their disease, then toward year end 2025 we expect costs related to the future trial

of TPI 287 to begin increasing to levels similar to those seen during our trial of Berubicin.

Other Income (Expense)

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On December 31, 2024, we had cash of approximately

$549,000 and we had a working capital deficit of approximately $4,542,000.

We have historically funded our operations from proceeds from

debt and equity sales.

In January 2022, we completed a financing with

several institutional investors for the sale of (i) 316,316 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate

of 87,193 shares of common stock and (iii) warrants to purchase up to an aggregate of 403,509 shares of common stock.

The combined purchase

price of one share of common stock (or one pre-funded warrant) and accompanying common warrant was $28.50.

The gross proceeds from the

private placement were approximately $11.5 million, before deducting the placement agent’s fees and other offering expenses.

In November 2022, we completed a financing

with an institutional investor for the sale of (i) 147,000 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate

of 1,742,764 shares of common stock and (iii) warrants to purchase up to an aggregate of 1,889,764 shares of common stock.

purchase price of one share of common stock (or one pre-funded warrant) and accompanying common warrant was $3.175.

The gross proceeds

from the offering were approximately $5.98 million, before deducting the placement agent’s fees and other offering expenses.

On January 29, 2024, we entered into a placement

agency agreement with A.G.P./Alliance Global Partners (“AGP”) and Maxim Group LLC (“Maxim”) for the public offering

of (i) 2,215,667 shares of our common stock;

(ii) pre-funded warrants to purchase 11,117,667 shares of common stock;

(iii) Series A Warrants

to purchase up to an aggregate of 13,333,334 shares of common stock;

and (iv) Series B Warrants to purchase up to an aggregate of 13,333,334

$6,461,000 and we had a working capital of approximately $6,134,000.

We have historically funded our operations from proceeds from debt

and equity sales.

February 1, 2024, the Company completed a public offering of (i) 889 shares of common stock;

(ii) pre-funded warrants to purchase

4,448 shares of common stock;

The combined purchase price of one share of common stock and accompanying Series A & B common warrants was

$0.30 and the combined purchase price of one pre-funded warrant and accompanying Series A & B common warrants was $0.299 (with the

pre-funded warrants having an exercise price of $0.001).

The closing of the sales of these securities occurred on February 1, 2024.

gross proceeds from the offering were approximately $4.0 million, before deducting the placement agent’s fees and other offering

Our plan of operations is

primarily focused on completing a clinical trial for Berubicin.

We estimate that we will require additional financing of approximately

$15 to $17 million to complete the potentially pivotal Phase 2 trial for Berubicin (taking into account our cash on hand as of December

31, 2023 of approximately $0.5 million) plus such additional working capital to fund our operations during the pendency of the trial (with

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

If capital is available to fund WP1244/WP1874 preclinical work to prepare

for a Phase 1 trial, we would need to raise an additional $5.0 million to support near-term development of that program.

Our current expectation

is that our cash on hand, combined with capital raised subsequent to December 31, 2023, is sufficient to fund our operations into the

latter half of the second quarter of 2024.

The timing and costs of clinical trials are difficult to predict and trial plans may change

in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

We will need to raise very

significant additional capital in the near term in order to meet our past due and future obligations and execute our business plan.

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.

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

(iii) Series A Warrants to purchase up to an aggregate of 5,342 shares of common stock ;

and (iv) Series

B Warrants to purchase up to an aggregate of 5,342 shares of common stock The net proceeds to the Company from the offering were $3,331,000,

after deducting the placement agents’ fees and other offering expenses.

On June 14, 2024, the Company entered into securities

purchase agreements with institutional investors for the sale by the Company of 6,720 shares of common stock and pre-funded warrants to

purchase 601 shares of common stock in lieu thereof in a registered direct offering.

In a concurrent private placement, the Company also

sold to the investors unregistered warrants to purchase up to an aggregate of 7,321 shares of common stock.

The gross proceeds to the

Company from the offering was approximately $1.37 million, resulting in net proceeds, after payment of commissions and expenses, received

by the Company of $1,203,267.

On June 26, 2024, the Company entered into securities

purchase agreements with institutional investors for the sale by the Company of 11,360 shares of common stock in a registered direct offering.

In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 11,360

shares of common stock.

The gross proceeds to the Company from the offering were approximately $1.39 million resulting in net proceeds,

after payment of commissions and expenses, received by the Company of $1,221,146.

On July 3, 2024, the Company entered into securities

purchase agreements with institutional investors for the sale by the Company of 28,500 shares of common stock in a registered direct offering.

In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 28,500

shares of common stock.

The gross proceeds to the Company from the offering were approximately $1.98 million, before deducting the financial

advisor fees and other estimated offering expenses payable by the Company.

After payment of commissions and expenses, the proceeds received

by the Company was $1,787,000.

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, the Company originally was permitted to sell from time to time through AGP, as sales agent or principal,

shares of the Company’s common stock, par value $0.001 per share with initial aggregate sales price of up to $5.2 million.

30, 2024, the Company increased the aggregate sales price of common shares that may be sold under the AGP ATM Sales Agreement to $25.0

million (not including the original $5.2 million).

On March 20, 2025, the Company increased the aggregate sales price of common shares

that may be sold under the AGP ATM Sales Agreement to $43.5 million (including $6.4 million remaining from the previous increase).

of December 31, 2024, the Company has sold 991,773 shares pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $13.7

$882,539 of the net proceeds was deposited on January 10, 2025.

As of December 31, 2024, the Company recorded a subscription

receivable for $882,539.

On October 23, 2024, the Company entered into securities

purchase agreements with institutional investors for the sale by the Company of 74,000 shares of common stock in a registered direct offering.

In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 278,943

shares of common stock.

The gross proceeds to the Company from the offering were approximately $3 million, before deducting the financial

advisor fees and other estimated offering expenses payable by the Company.

After payment of commissions and expenses, the proceeds received

by the Company was $2,725,907.

We estimate that we have sufficient capital to take us into the first quarter

of 2026, a period during which we would likely expect to initiate a trial of TPI 287, as well as complete the Berubicin trial including

its final analysis.

In addition, we have working capital to fund our operations during this 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

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.

Summary of Cash Flows

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$17,113,000 and $14,140,000 for the years ended December 31, 2024 and 2023, respectively, and mainly included payments made for drug development

(including the cost of our potentially pivotal trial of Berubicin), contract labor, officer compensation, marketing and professional fees

to our consultants, attorneys and accountants.

(including the cost of our trial of Berubicin), contract labor, officer compensation, stock-based compensation, marketing

and professional fees to our consultants, attorneys and accountants.

Cash used in investing activities

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We received net proceeds of approximately

$2,318,000 from the issuance of common stock and $2,961,000 from the exercise of warrants during the year ended December 31, 2023.

$23,376,000 from the issuance of common stock during the year ended December 31, 2024.

Off-balance Sheet Arrangements

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We do not have any material commitments for capital

expenditures, although we are required to pay certain milestone fees and royalties to HPI and Reata as described in the section “Overview”

expenditures, although we are required to pay certain milestone fees and royalties to Reata and Cortice as described in the section “Overview”

JOBS Act Accounting Election

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and adjustments are made when facts and circumstances dictate a change.

As of December 31, 2024, there was no critical audit estimates.

Quantitative and Qualitative Disclosure About Market Risk.

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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-K

Item 7. Management’s Discussion and Analysis