What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-04-01 · 250 added, 301 removed, 642 unchanged (46% of the section changed)

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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 Houston Pharmaceuticals, Inc.

and The University of Texas M.D.

Anderson Cancer Center (“UTMDACC”) and own pursuant to a collaboration and asset purchase

agreement with Reata Pharmaceuticals, Inc.

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 U.S.

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 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 an important new therapeutic alternative to the current standard

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.

These tumors are usually highly malignant (cancerous) because 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

Based on limited clinical data, we believe Berubicin is the first anthracycline that appears to cross the blood brain barrier

(“BBB”) in significant concentrations targeting brain cancer cells.

While 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 and other cancers.

Berubicin was discovered at UTMDACC by Dr.

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 IND

with the FDA to lapse for strategic reasons.

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 had previously 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

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

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.

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 (“UTMDACC”) 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.

This 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

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.

first patient on the trial was treated during the third quarter of 2021.

Correspondence between the Company and the FDA resulted in modifications

to our initial trial design, including designating 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.

The current trial being conducted will evaluate

the efficacy of Berubicin in patients with Glioblastoma Multiforme who have failed primary treatment for their disease, and results will

be compared to the efficacy 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 are 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 cycle).

On December 17, 2020,

we announced that our IND application with the FDA for Berubicin for the treatment of Glioblastoma Multiforme was in effect.

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 modifications to our initial trial

design, including designating 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, 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

who have failed primary treatment for their disease.

The trial, compares 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.

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”) is 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.

18, 2023, we released the DSMB’s recommendation which was to continue the study without modification.

Management remains blinded

to the data underlying the recommendation of the DSMB.

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.

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.

The recently released topline data 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

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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 a New Drug Application (“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 a New Drug Application

(“NDA”) for Berubicin;

and (v) 3 shares of our common stock.

The patents we licensed

from HPI expired in March 2020.

The patents we licensed from HPI expired in March 2020.

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.

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.

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 now constitutes our primary intellectual property protections although the Company is exploring if there are other patents

that could be filed related to Berubicin to extend additional protections.

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 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.

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 Agreement.

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;

that UTMDACC has the right to terminate the WP1244 Agreement in the event that we fail to meet certain commercial diligence milestones.

have not met the commercial diligence milestones required as of the date hereof.

As such, UTMDACC has the right to terminate the WP1244

Agreement upon notice to us.

As of March 19, 2024, UTMDACC has not notified us of its intention to terminate the WP1244 Agreement.

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.

paid and recorded $334,000 in 2020 related to this agreement in research and development expenses in the Company’s Statements of

The remaining $800,000 was paid in 2021.

The principal investigator for this agreement is Dr.

The work conducted under

this Sponsored Research Agreement has produced a new mesylate salt of WP1244 termed WP1874.

We believe the enhanced solubility of this

salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics.

As such, WP1874 will be the primary focus in any development efforts of the WP1244 portfolio.

This agreement was extended and expired

on March 31, 2023.

Market for Cancer Drugs and Berubicin

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 Biosciences, Inc.

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 (c) the expiration of the last to expire valid patent claim in

such country covering such licensed product.

Market for Cancer Drugs

Cancer is the second leading cause of death in

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to represent nearly $100 billion in annual sales.

Our lead drug candidate, Berubicin, is in a class of drugs referred to as anthracyclines,

Our drug candidate, Berubicin, is in a class of drugs referred to as anthracyclines,

which are chemotherapy drugs designed to destroy the DNA of targeted cancer cells.

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not been among them because heretofore no anthracyclines have been able to sufficiently penetrate the BBB.

We believe that based on currently

limited pre-clinical and clinical data, Berubicin appears to demonstrate that it can cross the BBB.

However, there is no assurance that

Berubicin will be able to demonstrate such traits in more fulsome clinical trials including our current potentially pivotal trial of Berubicin.

We believe that based on clinical

and preclinical data, Berubicin appears to cross the BBB despite not showing a statistically significant superiority to Lomustine, the

current standard of care in refractory and recurrent GBM.

Brain cancer in general is considered a rare disease

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to approval or further development to be an important part of our development strategy for our drug candidates.

The Berubicin Clinical Therapeutic Opportunity

The Clinical Therapeutic Opportunity

The Company was created to specialize in the discovery

and development of novel treatments for brain tumors.

Our main focus is currently the development and testing of Berubicin.

Based on limited

clinical data, we believe Berubicin is the first anthracycline that appears in animal models and limited clinical data derived from a

Phase 1 human clinical trial to cross the BBB and target cancer cells.

In 2009, Reata, the prior developer of Berubicin, completed its

Phase 1 clinical trial in patients diagnosed with brain cancers, including glioblastoma, the most aggressive form of brain cancer.

Currently, there are no curative therapies for

glioblastoma.

In the clinical trial completed by Reata in February 2009, Berubicin demonstrated one durable complete response lasting

over 14 years in a patient treated on the original Phase 1 clinical trial.

This patient remains disease free and clinically stable as

of November 2022 (the date of the patient’s most recent MRI).

Our main focus is currently the development and testing of TPI 287 and Berubicin.

We believe TPI 287 is the first taxane and Berubicin is the first anthracycline that appears to cross the BBB and target cancer cells

based upon preclinical animal models and limited clinical data derived from Phase 1 human clinical trials, and in the case of Berubicin,

based on Phase 2 clinical data.

Currently, there are no curative therapies for glioblastoma.

TPI 287 has been investigated in neuro-oncology

for its potential to treat brain tumors due to its apparent ability to cross the blood-brain barrier.

A Phase 1/2 clinical trial evaluated

TPI 287 in combination with bevacizumab in patients with recurrent glioblastoma multiforme (GBM).

The study reported an objective response

rate of 54%, including two complete responses, and a disease control rate of 92%.

The combination therapy was generally well-tolerated,

with no dose-limiting toxicities observed up to doses of 170 mg/m².

These early trials suggest that TPI 287 shows potential in neuro-oncology.

In 2009, Reata, the prior developer of Berubicin,

completed its Phase 1 clinical trial in patients diagnosed with brain cancers, including glioblastoma, the most aggressive form of brain

In the clinical trial completed by Reata in February 2009, Berubicin demonstrated one durable complete response lasting over 17

years in a patient treated on the original Phase 1 clinical trial.

This patient remains disease free and clinically stable as of November

2022 (the date of the patient’s most recent confirmed MRI).

The Phase 1 trial was in a patient population that

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In addition, 8 other patients had stable disease, for a disease control rate (“DCR”) of 44%.

If these results are reproducible and if regulatory approval is secured to market Berubicin, based on its apparent ability to cross the

BBB combined with its mechanism of action, more thoroughly discussed below, we believe this drug has the potential to become an effective

treatment for this deadly cancer.

If in consultation with the FDA we determine a path forward exists for Berubicin, despite not showing statistically significant superiority

to Lomustine, and regulatory approval is secured to market it, we believe this drug has the potential to become an important therapeutic

option for this deadly cancer.

In the eight major markets for pharmaceuticals

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improvement in survival.

However, at least 50% of TMZ treated patients do not respond to TMZ (or respond very poorly), primarily due to

the O6-methylguanine methyltransferase (“MGMT”) enzyme, which is a DNA repair pathway in glioblastoma cells.

When methylated,

the enzyme has reduced DNA repair activity, and increases the activity of TMZ;

thus unmethylated patients have greater DNA repair activity,

and this confers a poorer prognosis.

Given the different mechanism of action of Berubicin, patients with unmethylated MGMT may show a

better outcome and this will be explored by stratification to the MGMT methylation status of patients on the current trial.

potentially be used to support an application for approval of Berubicin as a frontline therapy, however, we believe that the most prudent

initial investigational objective is the current stratified trial that can either serve as a registration trial or provide sufficient

data to power an additional registration trial.

However, at least 50% of TMZ treated patients do not respond to TMZ (or have responded very poorly), primarily

due to the O6-methylguanine methyltransferase (“MGMT”) enzyme, which is a DNA repair pathway in glioblastoma cells.

Our first product under development is Berubicin,

a development stage anthracycline intended to treat glioblastoma.

Berubicin is an anthracycline, a class of drugs that are among the most

powerful chemotherapy drugs known.

Berubicin intercalates into DNA and interrupts topoisomerase II activity, resulting in the inhibition

of DNA replication and repair, and ultimately RNA and protein synthesis.

Based on evidence developed from animal models and limited clinical

data derived from a Phase 1 human clinical trial, Berubicin appears to cross the blood brain barrier and target cancer cells, specifically

glioblastoma, more effectively and efficiently than any other known anthracyclines.

a development stage anthracycline intended to treat glioblastoma and with potential to treat other neuro-oncology indications.

is an anthracycline, a class of drugs that are among the most powerful chemotherapy drugs known.

Berubicin intercalates into DNA and interrupts

topoisomerase II activity, resulting in the inhibition of DNA replication and repair, and ultimately RNA and protein synthesis.

on clinical and preclinical data, Berubicin appears to cross the blood brain barrier and target cancer cells, specifically glioblastoma,

more effectively and efficiently than any other known anthracyclines.

Berubicin hydrochloride (HCl) is a novel synthetic

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In an effort to develop a second-generation anthracycline

topoisomerase II inhibitor that can circumvent the BBB and the development of drug resistance, Dr.

Priebe created a library of high-affinity

and sequence-selective deoxyribonucleic acid (“DNA”)-binding agents and screened against a panel of P-glycoprotein 1 (Pgp)

and multidrug resistance-associated protein 1 (MRP1)-overexpressing cells.

This led to the identification of berubicin HCl, which preclinical

studies appear to show to be less affected by multidrug transporters than doxorubicin, to be potentially more potent as an inhibitor of

cell growth and inducer of apoptosis than doxorubicin, to sequester preferentially in tumor tissue versus brain tissue, and to improve

overall survival in an intracranial orthotopic glioma model.

There is no assurance that Berubicin will be able to demonstrate such traits

in clinical trials.

topoisomerase II inhibitor that can circumvent the BBB and the development of drug resistance, a library of high-affinity and sequence-selective

deoxyribonucleic acid (“DNA”)-binding agents was created and screened against a panel of P-glycoprotein 1 (Pgp) and multidrug

resistance-associated protein 1 (MRP1)-overexpressing cells.

This led to the identification of berubicin HCl, which preclinical studies

appear to show to be less affected by multidrug transporters than doxorubicin, to be potentially more potent as an inhibitor of cell growth

and inducer of apoptosis than doxorubicin, to sequester preferentially in tumor tissue versus brain tissue, and to improve overall survival

in an intracranial orthotopic glioma model.

There is no assurance that Berubicin will be able to demonstrate such traits in clinical trials.

Glioblastoma has an unfavorable prognosis mainly

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the over-expression of O6-methylguanine methyltransferase (MGMT) conferring a lack of a DNA repair pathway in glioblastoma cells.

shows efficacy in clinical trials, of which there is no assurance, it could become the primary drug treatment because TMZ is ineffective

in this patient population.

Reata licensed in berubicin HCl with the intent

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the above noted corporate reprioritization.

CNS was formed in 2017, with Dr.

Priebe as the

Scientific Founder.

Reata sold CNS all rights to the berubicin investigational drug data, including the data submitted under IND 68,279,

and CNS has assumed sole authority, discretion, and responsibility with respect to the development of the drug.

As a result of the Reata

Agreement, we are the direct beneficiaries of the 4 years of active clinical development work performed by Reata, including the execution

of multiple Phase 1 human clinical trials.

Berubicin Clinical Trial

CNS was formed in 2017.

Reata sold CNS all rights

to the berubicin investigational drug data, including the data submitted under IND 68,279, and CNS has assumed sole authority, discretion,

and responsibility with respect to the development of the drug.

As a result of the Reata Agreement, we are the direct beneficiaries of

the 4 years of active clinical development work performed by Reata, including the execution of multiple Phase 1 human clinical trials.

Berubicin Phase 1 Clinical Trial

In the first clinical trial for Berubicin, which

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be managed by the use of effective supportive care.

Berubicin Phase 2 Clinical Trial

Based on data relating to the mechanism of action

of Berubicin, as well as clinical results from the Phase 1 study in brain tumors performed by Reata, the prior developer of Berubicin,

we are conducting a randomized, controlled multicenter study that will evaluate the efficacy of Berubicin versus Lomustine (CCNU, CeeNU®,

we initiated a randomized, controlled multicenter study intended to evaluate the efficacy of Berubicin versus Lomustine (CCNU, CeeNU®,

or Gleostine®) in patients with recurrent glioblastoma.

Randomization to the two therapies (Berubicin or Lomustine) are on a 2:1 basis

Randomization to the two therapies (Berubicin or Lomustine) was on a 2:1 basis

with 2 patients receiving Berubicin for every patient randomized to Lomustine.

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at each study site.

Efficacy will be measured by the benefit of Berubicin

Efficacy was measured by the benefit of Berubicin

Lomustine in terms of overall survival (OS), considered by the FDA as the only endpoint acceptable for clinical trials in Neuro-Oncology

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(PR) as per RANO (Response Assessment for Neuro-Oncology), and progression free survival at 6 months (PFS6).

Additional information to

be collected include event free survival (EFS), corticosteroid usage, neurologic status, quality of life, and safety, and for Berubicin,

the pharmacokinetics (PK) at the dose and schedule employed.

Additional information collected

include event free survival (EFS), corticosteroid usage, neurologic status, quality of life, and safety, and for Berubicin, the pharmacokinetics

(PK) at the dose and schedule employed.

On March 25, 2025, we released the results of the primary analysis of the Berubicin trial.

Berubicin showed clinically relevant outcomes 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.

The trial included a pre-planned, non-binding interim

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modification.

Assuming data from the above-described study is

positive (and depending on the strength and quality of such data) at its completion we may seek an expedited pathway to approval to market

Berubicin from relevant regulatory authorities, we may look for a partner with which to conduct a Phase 3 study, or we may attempt to

raise sufficient capital to conduct such a study on our own.

The goal of these potential Phase 3 studies, should they be necessary, is

to develop a body of evidence to support a successful application with the FDA and/or other similar regulatory agencies around the world.

Should we obtain approval from the FDA or other international regulatory agencies to market Berubicin, we will either partner with third

parties to sell and distribute it to physicians and patients, or we will develop our own sales force to do so.

We are currently exploring what path forward, if

any, may be available for Berubicin.

Our planning process will involve consultation with and input from the FDA.

If a path forward is

identified, we may look for a partner with which to conduct any additional studies which may be required, or we may attempt to raise sufficient

capital to conduct such studies on our own.

The goal of these additional studies, should they be necessary, would be to develop a body

of evidence to support a successful application with the FDA and/or other similar regulatory agencies around the world.

Should we obtain

approval from the FDA or other international regulatory agencies to market Berubicin, we will either partner with third parties to sell

and distribute it to physicians and patients, or we will develop our own sales force to do so.

We operate in a highly competitive segment of the

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Intellectual Property

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.

We have licensed the right to certain

intellectual property covering products comprised of anthracycline antibiotic compound, methods for manufacture and use for the treatment

The licensed intellectual property originally included certain material patents in the United States and their foreign counterparts

throughout the world.

patents have expired, and as such, we may be subject to increased competition.

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

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

ODD from the FDA is available for drugs targeting diseases with

less than 200,000 cases per year.

When we licensed TPI 287 from Cortice on July 29,

2024, it had previously been granted Orphan Drug Designation (“ODD”)by the FDA.

On June 10, 2020, the FDA granted Orphan Drug

Designation for Berubicin for the treatment of malignant gliomas.

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.

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 now constitutes our primary intellectual property protections although the Company is exploring if there are other patents

that could be filed related to Berubicin to extend additional protections.

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

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.

do not hold or license any patents related to Berubicin and the ODD now constitutes our primary intellectual property protections although

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

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.

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.

We are exploring the possibility to file additional

patent applications that potentially might allow for further increase of the exclusive market protection for use of Berubicin.

we can provide no assurance that we will be able to file or receive additional patent protection.

The failure to receive such additional

patent protection will reduce the barrier to entry for competition for Berubicin, which may adversely affect our operations.

patent applications that potentially might allow for further increase of the exclusive market protection for use of TPI 287 and Berubicin.

However, we can provide no assurance that we will be able to file or receive additional patent protection.

The failure to receive such

additional patent protection will reduce the barrier to entry for competition for TPI 287 and Berubicin, which may adversely affect our

Governmental Regulation

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Expedited Development and Review Programs

On July 24, 2021,

the Company received Fast Track Designation from the FDA for Berubicin.

The Company intends to seek Fast Track Designation for TPI 287

The FDA’s Fast Track program is intended

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on the basis of an effect on an intermediate clinical endpoint.

We believe that our potentially pivotal CNS-201 study of Berubicin for

the treatment of recurrent GBM is such a study.

As a condition of accelerated approval, the FDA may require the sponsor to perform adequate

and well-controlled post-marketing clinical studies.

In addition, the FDA currently requires pre-approval of promotional materials for

products receiving accelerated approval, which could impact the timing of the commercial launch of the product.

Fast Track designation,

priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process.

As a condition of accelerated approval, the FDA may require the sponsor

to perform adequate and well-controlled post-marketing clinical studies.

In addition, the FDA currently requires pre-approval of promotional

materials for products receiving accelerated approval, which could impact the timing of the commercial launch of the product.

designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval

Post-Approval Requirements

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License Agreements

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 November 21, 2017, we entered into the Reata

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, the Company entered into

a Technology Rights and Development Agreement with Houston Pharmaceuticals, Inc.

HPI is affiliated with Dr.

Priebe, our founder.

Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly

known as WP744.

a Technology Rights and Development Agreement with HPI.

Pursuant to this agreement, the Company obtained a worldwide exclusive license

to the chemical compound commonly known as WP744.

In exchange for these rights, the Company agreed to pay consideration to HPI as follows:

(i) a royalty of 2% of net sales

of any product utilizing WP744 for a period of ten years after the first commercial sale of such;

and (ii) $100,000 upon beginning Phase

II clinical trials (paid in 2021);

and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any product utilizing

and (iv) a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of

$7,000,000 of investment capital.

In addition, the Company issued 6,667 shares of the Company’s common stock valued at $1.35 per

share to HPI upon execution of the agreement.

On November 13, 2019, the Company closed its IPO, thereby fulfilling all conditions precedent

and completing the acquisition of the intellectual property discussed in the HPI agreement.

During the years ended December 31, 2023 and

2022, the Company recognized $50,000 and $275,000 related to this agreement, respectively.

Unrelated to this agreement, from time to time,

the Company purchases pharmaceutical products from HPI which are necessary for the manufacturing of Berubicin API and drug product in

related party transactions which are reviewed and approved by the Company’s audit committee based upon the standards of providing

superior pricing and time to delivery than that available from unrelated third parties.

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 August 30, 2018, we entered into a sublicense

agreement with WPD Pharmaceuticals, Inc., or WPD, pursuant to which we granted WPD an exclusive sublicense, even as to us, for the patent

rights we licensed pursuant to the HPI License within the following countries:

Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova,

Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan, Georgia, Montenegro, Bosnia, Croatia, Slovenia, Slovakia, Czech Republic,

Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Greece, Austria, and Russia.

The sublicense agreement

provides that WPD must use commercially reasonable development efforts to attempt to develop and commercialize licensed products in the

above mentioned territories, which means the expenditure of at least $2.0 million on the development, testing, regulatory approval or

commercialization of the licensed products during the three year period immediately following the date of the sublicense agreement.

of December 31, 2021, WPD has demonstrated that it has exercised commercially reasonable development efforts under this agreement.

consideration for the rights granted under the sublicense agreement, to the extent we are required to make any payments to HPI pursuant

to the HPI License as a result of this sublicense agreement, WPD agreed to advance us such payments, and to pay us a royalty equal to

1% of such payments.

WPD is a Polish corporation that is majority-owned by an entity controlled by Dr.

Priebe, our founder.

On August 31, 2018, we entered into a sublicense

agreement with Animal Life Sciences, LLC, or ALI, pursuant to which we granted ALI an exclusive sublicense, even as to us, for the patent

rights we licensed pursuant to the HPI License solely for the treatment of cancer in non-human animals through any type of administration.

In consideration for the rights granted under the sublicense agreement, ALI agreed to issue us membership interests in ALI equal to 1.52%

of the outstanding ALI membership interests.

As additional consideration for the rights granted, to the extent we are required to make

any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, ALI agreed to advance us such payments, and

to pay us a royalty equal to 1% of such payments.

Priebe, our founder, holds 38% of the membership interests of ALI.

On January 10, 2020, Company 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 UTMDACC.

Pursuant to the WP1244 Agreement, the Company obtained a royalty-bearing, worldwide,

exclusive license to certain intellectual property rights, including patent rights, related to the WP1244 drug technology.

In consideration,

the Company must make payments to UTMDACC including an up-front license fee, annual maintenance fee, milestone payments and royalty payments

(including minimum annual royalties) on sales of licensed products developed under the Agreement.

The term of the Agreement expires on

the last to occur of:

(a) the expiration of all patents subject to the Agreement, or (b) fifteen years after execution;

provided that

UTMDACC has the right to terminate this Agreement in the event that the Company fails to meet certain commercial diligence milestones.

The commercial diligence milestones are as follows (i) initiated PC toxicology to support filing of Investigational New Drug Application

(“IND”) or New Drug Application (“NDA”) for the Licensed Product within the eighteen (18) month period following

the Effective Date (ii) file and IND for the Licensed Product within three (3) year period following the Effective Date and (iii) Commencement

of Phase I Study within the five (5) year period following the Effective Date.

During the years ended December 31, 2023 and 2022, the

Company paid $55,092 and $58,223 to UTMDACC related to this agreement, respectively.

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.

As of April 1, 2024, we had three full time employees.

We also have two part-time employees serving as our chief medical and scientific officers, and accordingly, a high percentage of the

work performed for our development projects is conducted by qualified part-time staff and independent contractors.

(i) a royalty of 2% of net sales of any product utilizing WP744 for a period of ten years after the first commercial sale of such;

(ii) $100,000 upon beginning Phase II clinical trials (paid in 2021);

and (iii) $200,000 upon the approval by the FDA of a New Drug Application

for any product utilizing WP744;

and (iv) a series of quarterly development payments totaling $750,000 beginning immediately after the

Company’s raise of $7,000,000 of investment capital.

In addition, the Company issued 3 shares of the Company’s common stock

valued at $3,000 per share to HPI upon execution of the agreement.

On November 13, 2019, the Company closed its IPO, thereby fulfilling

all conditions precedent and completing the acquisition of the intellectual property discussed in the HPI agreement.

During the years

ended December 31, 2024 and 2023, the Company recognized $50,000 and $50,000 related to this agreement, respectively.

Unrelated to this

agreement, from time to time, the Company purchases pharmaceutical products from HPI which are necessary for the manufacturing of Berubicin

API and drug product.

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

On July 29, 2024, the Company entered into the Cortice

Agreements, 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.

As of March 31, 2025, we had four full time employees.

We also have one part-time employee serving as our chief scientific officer, and accordingly, a high percentage of the work performed

for our development projects is conducted by qualified part-time staff and independent contractors.

Legal Proceedings

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legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.

Our corporate and executive offices are located

in a leased facility in Houston, Texas.

We believe our facilities are sufficient to meet our current needs and that suitable space will

be available as and when needed.

Our corporate headquarter is located in a leased facility

in Houston, Texas.

We believe our facilities are sufficient to meet our current needs and that suitable space will be available as and

We do not own any real property.

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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 1. Business