What changed in this filing

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Item 1. Business

2024-04-01 compared with 2023-03-31 · 341 added, 471 removed, 602 unchanged (57% of the section changed)

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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.

Food and Drug Administration

(“FDA”), could give Glioblastoma patients an important new therapeutic alternative to the current standard of care.

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.

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

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.

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.

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.

Food and Drug

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

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.

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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 estimated 243

patients to Berubicin or Lomustine.

Patients receiving Berubicin will be 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).

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).

Lomustine is administered orally once every six weeks.

trial will include a pre-planned, non-binding interim futility analysis which will be conducted by an independent Data Safety Monitoring

Board (DSMB) to recommend whether this study should continue as planned based on Berubicin showing statistically significant value as

a second-line treatment for patients with glioblastoma compared with Lomustine.

We will conduct this analysis after at least 50% of the

patients in the interim analysis population (30-50% of total expected patients for the trial) can be evaluated as having failed the primary

efficacy endpoint (death).

This recommendation will review the number of deaths on each arm to ensure that the overall survival of patients

receiving Berubicin shows a statistically significant comparability to or is even higher than those receiving Lomustine.

The median survival

of patients receiving second-line treatment for glioblastoma has historically been shown to be approximately 6 months.

We have historically

used this 6 months as an estimate for the median time to a 50% mortality rate.

Taking into account the recent rate of enrollment and the

number of patients that can be adequately assessed for their follow-up outcomes, we are anticipating that the DSMB will be able to perform

this interim analysis and we can release the data during the third quarter of 2023.

Additional analyses that will be provided based on

this data will be comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

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.

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.

We do not have manufacturing facilities and all

manufacturing activities are contracted out to third parties.

Additionally, we do not have a sales organization.

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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 HPI in an agreement we refer to as the HPI

On December 28, 2017, we obtained the rights to

a worldwide, exclusive royalty-bearing, license to the chemical compound commonly known as Berubicin from HPI in an agreement we refer

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:

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;

(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) 6,667 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.

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

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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.

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

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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.

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.

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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 our development efforts of the WP1244 portfolio.

This agreement was extended and now expires

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

Cancer is the second leading cause of death in the

United States behind heart disease.

Cancer is the second leading cause of death in

the United States behind heart disease.

In 2019, there were an estimated 16.9 million cancer survivors in the United States.

American Cancer Society estimated that nearly 1.9 million new cases would be diagnosed and over 600,000 Americans would die from cancer.

Digestive, reproductive, breast and respiratory cancers

comprise 69% of expected cancer diagnoses in 2022, while cancers like leukemia and brain tumors are considered “rare diseases.”

the American Cancer Society estimated that nearly 1.9 million new cases would be diagnosed and over 600,000 Americans would die from cancer.

Digestive, reproductive, breast and respiratory

cancers comprise 69% of expected cancer diagnoses in 2022, while cancers like leukemia and brain tumors are considered “rare diseases.”

The worldwide cancer drug business has been estimated

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We believe that based on currently

limited pre-clinical and clinical data, Berubicin appears to show 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.

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.

Brain cancer in general is considered a rare disease

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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.

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).

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.

In the eight major markets for pharmaceuticals (the

US, France, Germany, Italy, Spain, the UK, Japan and China), approximately 55,000 new glioblastoma patients were diagnosed in 2021 with

a median survival rate for these patients of only 15 months (GlobalData, 2018).

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.

In the eight major markets for pharmaceuticals

(the US, France, Germany, Italy, Spain, the UK, Japan and China), approximately 55,000 new glioblastoma patients were diagnosed in 2021

with a median survival rate for these patients of only 15 months (GlobalData, 2018).

Due to the lack of effective therapies, the five-year

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data to power an additional registration 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®,

or Gleostine®) in patients with recurrent glioblastoma.

Randomization to the two therapies (Berubicin or Lomustine) will be on a 2:1

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

Lomustine is a drug considered effective in patients

with glioblastoma that has recurred or progressed following first line therapy.

From the data available from the Reata Phase 1 clinical

trial (RTA 744-C-0401), the FDA has agreed that the dosage for Berubicin will be at the maximum tolerated dose (“MTD”) determined

in that trial.

Thus, patients randomized to the Berubicin arm will receive a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily

for three consecutive days followed by 18 days off (21-day cycle).

Patients randomized to Lomustine will receive a single oral dose of

130 mg/m2 (rounded to the nearest 5 mg) every 6 weeks, or per the full prescribing information for Lomustine incorporating institutional

standards at each study site.

Efficacy will be measured by the benefit of Berubicin

Lomustine in terms of overall survival (OS), considered the preferred standard as an endpoint for clinical trials in Neuro-Oncology.

Secondary endpoints using accepted radiologic methodology (magnetic resonance imaging (“MRI”)), including both pre- and post-gadolinium

T1-weighted scans and T2/fluid attenuated inversion recovery (“FLAIR”) images will evaluate objective response rates (ORR),

which include complete responses (CR) and partial responses (PR) as per RANO (Response Assessment for Neuro-Oncology), and progression

free survival (PFS).

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.

The trial will include a

pre-planned, non-binding interim futility analysis which will be conducted by an independent Data Safety Monitoring Board (DSMB) to recommend

whether this study should continue as planned based on Berubicin showing statistically significant value as a second-line treatment for

patients with glioblastoma compared with Lomustine.

We will conduct this analysis after at least 50% of the patients in the interim analysis

population (30-50% of total expected patients for the trial) can be evaluated as having failed the primary efficacy endpoint (death).

This recommendation will review the number of deaths on each arm to ensure that the overall survival of patients receiving Berubicin shows

a statistically significant comparability to or is even higher than those receiving Lomustine.

The median survival of patients receiving

second-line treatment for glioblastoma has historically been shown to be approximately 6 months.

We have historically used this 6 months

as an estimate for the median time to a 50% mortality rate.

Taking into account the recent rate of enrollment and the number of patients

that can be adequately assessed for their follow-up outcomes, we are anticipating that the DSMB will be able to perform this interim analysis

and we can release the data during the third quarter of 2023.

Additional analyses that will be provided based on this data will be comparisons

of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

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 approval to market Berubicin from relevant regulatory

authorities, we may look for a partner with which to conduct a Phase 3 study, if this is required by authorities based on the strength

of the data submitted, 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

Our first product under development is Berubicin, a

development stage anthracycline intended to treat glioblastoma.

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

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sarcoma, and multiple myeloma.

Doxorubicin HCl is not indicated for cancers of the

brain, where it has limited efficacy due to its poor penetration through the blood-brain barrier.

Further, even for those cancers that

doxorubicin HCl is indicated, development of drug resistance remains a problem.

Doxorubicin HCl is not indicated for cancers of

the brain, where it has limited efficacy due to its poor penetration through the blood-brain barrier.

Further, even for those cancers

that doxorubicin HCl is indicated, development of drug resistance remains a problem.

In an effort to develop a second-generation anthracycline

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in clinical trials.

Glioblastoma has an unfavorable prognosis mainly due

to its high propensity for tumor recurrence, which is inevitable after a median survival time of 32–36 weeks.

A plethora of monotherapy

and combination chemotherapy strategies have been evaluated in patients with recurrent glioblastoma.

Although these can result in some

minor improvements in progression-free survival, with an estimation of approximately 30% after six months, no obvious increase in survival

has been associated with any particular regimen since the Stupp regimen of TMZ and radiation (2005).

Glioblastoma has an unfavorable prognosis mainly

due to its high propensity for tumor recurrence, which is inevitable after a median survival time of 32–36 weeks.

A plethora of

monotherapy and combination chemotherapy strategies have been evaluated in patients with recurrent glioblastoma.

Although these can result

in some minor improvements in progression-free survival, with an estimation of approximately 30% after six months, no obvious increase

in survival has been associated with any particular regimen since the Stupp regimen of TMZ and radiation (2005).

Despite aggressive initial treatment, most patients

develop recurrent diseases which can be treated with reresection, systemic treatment with targeted agents or cytotoxic chemotherapy, reirradiation,

or radiosurgery.

Research into novel therapies is investigating alternative temozolomide regimens, convection-enhanced delivery, immunotherapy,

gene therapy, antiangiogenic agents, poly ADP ribose polymerase inhibitors, or cancer stem cell signaling pathways.

Overall, the 5-year

survival rate is <10%, with a final mortality rate of close to 100%.

Therefore, the development of novel therapeutic options for patients

with recurrent glioblastoma remains a priority.

Given the short-term efficacy and low survival rate of glioblastoma and other central

nervous system patient groups, we believe there is a significant unmet need, and financial opportunity.

develop recurrent diseases which can be treated with re-resection, systemic treatment with targeted agents or cytotoxic chemotherapy,

reirradiation, or radiosurgery.

Research into novel therapies is investigating alternative temozolomide regimens, convection-enhanced

delivery, immunotherapy, gene therapy, antiangiogenic agents, poly ADP ribose polymerase inhibitors, or cancer stem cell signaling pathways.

Overall, the 5-year survival rate is <10%, with a final mortality rate of close to 100%.

Therefore, the development of novel therapeutic

options for patients with recurrent glioblastoma remains a priority.

Given the short-term efficacy and low survival rate of glioblastoma

and other central nervous system patient groups, we believe there is a significant unmet need, and financial opportunity.

Less than 40% of glioblastoma patients have a genetic

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in this patient population.

Reata licensed in berubicin HCl with the intent of

developing it for commercialization.

Reata licensed in berubicin HCl with the intent

of developing it for commercialization.

On December 28, 2004, Reata filed an initial IND (IND 68,279;

000) for an injection formulation

of berubicin HCl (RTA 744 Injection) for the treatment of anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma,

glioblastoma, and gliosarcoma.

Three clinical trials were initiated under IND 68,279, two phase 1 trials and one phase 2 trial.

phase 1 trial (Study RTA 744-C-0401) was completed and the maximum tolerated dose determined.

A 44% disease control response rate was

000) for an injection

formulation of berubicin HCl (RTA 744 Injection) for the treatment of anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic

mixed oligo-astrocytoma, glioblastoma, and gliosarcoma.

Three clinical trials were initiated under IND 68,279, two phase 1 trials and

one phase 2 trial.

The initial phase 1 trial (Study RTA 744-C-0401) was completed and the maximum tolerated dose determined.

A 44% disease

control response rate was observed.

The disease control rate was based on patients with stable disease plus responses.

In the trial, out of 25 patients, one patient

achieved a complete response, 1 patient had a partial response, 1 patient had a minor response, and 8 patients achieved a stable response.

In the trial, out

of 25 patients, one patient achieved a complete response, 1 patient had a partial response, 1 patient had a minor response, and 8 patients

achieved a stable response.

The 44% disease control response rate is based on these 11 patients (out of 25 patients).

Regardless, in 2008, Reata decided to curtail

development of RTA 744 Injection for strategic reasons.

Further enrollment in the two other ongoing berubicin clinical trials was halted.

Regardless, in 2008,

Reata decided to curtail development of RTA 744 Injection for strategic reasons.

Further enrollment in the two other ongoing berubicin

clinical trials was halted.

Reata submitted a request to inactivate the IND on March 17, 2011 (Serial No.

054) and requested that the IND be withdrawn on June 10,

2016 (Serial No.

IND 68,279 was not withdrawn due to safety or efficacy concerns, but rather due to the above noted corporate reprioritization.

054) and requested that the

IND be withdrawn on June 10, 2016 (Serial No.

IND 68,279 was not withdrawn due to safety or efficacy concerns, but rather due to

the above noted corporate reprioritization.

CNS was formed in 2017, with Dr.

Priebe as the Scientific

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.

On May 24, 2019, our sublicensee, WPD, signed the Granting

Agreement with the Polish National Center for Research and Development for co-funding of research and development work in the amount of

22,033,066 PLN (approximately US $5,798,875) for new drug development as a part of the project “New approach to glioblastoma treatment

addressing the critical unmet medical need”, undertaken pursuant to the WPD Sublicense.

The grant will be co-funded by the European

Union, under the Smart Growth Operational Program 2014-2020, Sectoral Programme InnoNeuroPharm, Priority Axis I:

Support R&D carried

out by enterprises, Measure 1.2 Sectorial programs R&D.

This grant funding is dependent upon WPD funding a portion of the trial estimated

at 35-40% of the total cost, and we can provide no assurance that they can or will be able to do so.

The main goal of the WPD Project

is to implement the first in the world multicenter pediatric phase I clinical trial and phase II clinical trials in adults, in order to

continue to explore the safety and efficacy of Berubicin.

The WPD Project will also include preclinical tests to determine the prospective

use of Berubicin with temozolomide and with other compounds being developed by WPD as candidates for anticancer drugs.

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

In the first clinical trial for Berubicin, which was

referred to as Study RTA 744-C-0401, 25 of the 35 patients enrolled were evaluable for response.

In the first clinical trial for Berubicin, which

was referred to as Study RTA 744-C-0401, 25 of the 35 patients enrolled were evaluable for response.

One patient achieved a complete response,

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free as of November 2022.

Study RTA 744-C-0401 was a Phase 1 dose-finding, safety

and pharmacokinetic (PK) study of intravenous Berubicin injection in patients with recurrent or refractory anaplastic astrocytoma, anaplastic

oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme or gliosarcoma.

Study RTA 744-C-0401 was a Phase 1 dose-finding,

safety and pharmacokinetic (PK) study of intravenous Berubicin injection in patients with recurrent or refractory anaplastic astrocytoma,

anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme or gliosarcoma.

The study was an open-label, accelerated dose-escalation

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Study Results

The first patient was enrolled into the study in November

2005 and as of February 2009, the study was closed to accrual with no active patients remaining on study.

Berubicin was administered to

a total of 54 patients (35 male and 19 female) with ages ranging from 25 to 70 years.

Thirty-seven of the patients (69%) entered the study

with a diagnosis of glioblastoma multiforme, seven of which were secondary to transformation from anaplastic astrocytoma.

The time from

the initial brain tumor diagnosis to enrollment on the study ranged from four months to 301 months (this last timing for a patient diagnosed

with childhood anaplastic astrocytoma).

Twenty-five of the 35 patients enrolled

in Group A were evaluable for response (under the Macdonald criteria described below).

One patient receiving Berubicin at 2.4 mg/m2/day

achieved a complete response.

The patient remained on study through 7 cycles of therapy before being withdrawn for elevated liver function

tests unrelated to study drug, and in follow-up remains disease free and clinically stable as of November 2022.

One additional patient receiving Berubicin at 7.5 mg/m2/day

achieved an unconfirmed partial response as their best recorded response, unconfirmed since the scan showing the partial response required

a second scan corroborating the response.

Although the patient had an 80% reduction in tumor volume after two cycles of therapy, at the

end of four cycles of therapy when an additional scan was obtained, despite the fact that the initial lesion remained reduced, the patient

developed a new lesion and was assessed as having disease progression, thus the PR could not be confirmed.

Ten additional patients in

Group A had stable disease of 2-to-8 cycles in duration, with a median progression free survival of four cycles (12 weeks).

seven patients were evaluable for response and all had progressive disease.

Twelve patients were discontinued from the study prior to

the end of cycle 2 due to clinical deterioration and/or disease progression.

The first patient was enrolled into the study in

November 2005 and as of February 2009, the study was closed to accrual with no active patients remaining on study.

Berubicin was administered

to a total of 54 patients (35 male and 19 female) with ages ranging from 25 to 70 years.

Thirty-seven of the patients (69%) entered the

study with a diagnosis of glioblastoma multiforme, seven of which were secondary to transformation from anaplastic astrocytoma.

from the initial brain tumor diagnosis to enrollment on the study ranged from four months to 301 months (this last timing for a patient

diagnosed with childhood anaplastic astrocytoma).

Twenty-five of the 35 patients

enrolled in Group A were evaluable for response (under the Macdonald criteria described below).

One patient receiving Berubicin at 2.4

mg/m2/day achieved a complete response.

The patient remained on study through 7 cycles of therapy before being withdrawn for elevated

liver function tests unrelated to study drug, and in follow-up remains disease free and clinically stable as of November 2022.

One additional patient receiving Berubicin at 7.5

mg/m2/day achieved an unconfirmed partial response as their best recorded response, unconfirmed since the scan showing the partial response

required a second scan corroborating the response.

Although the patient had an 80% reduction in tumor volume after two cycles of therapy,

at the end of four cycles of therapy when an additional scan was obtained, despite the fact that the initial lesion remained reduced,

the patient developed a new lesion and was assessed as having disease progression, thus the PR could not be confirmed.

Ten additional

patients in Group A had stable disease of 2-to-8 cycles in duration, with a median progression free survival of four cycles (12 weeks).

In Group C, seven patients were evaluable for response and all had progressive disease.

Twelve patients were discontinued from the study

prior to the end of cycle 2 due to clinical deterioration and/or disease progression.

Macdonald criteria :

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§ Clinical deterioration

Measurements of lesions are obtained from axial post

contrast T1 images.

Measurements of lesions are obtained from axial

post contrast T1 images.

The maximal diameter is obtained, and then the second diameter is obtained at right angles to the first.

of these measurements is then used as the size of the lesion for the purpose of comparison.

product of these measurements is then used as the size of the lesion for the purpose of comparison.

Summary of Adverse Events :

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be managed by the use of effective supportive care.

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®,

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®,

or Gleostine®) in patients with recurrent glioblastoma.

Randomization to the two therapies (Berubicin or Lomustine) will be on a 2:1

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

Lomustine is a drug considered effective in patients

with glioblastoma that has recurred or progressed following first line therapy.

From the data available from the Reata Phase 1 clinical

trial (RTA 744-C-0401), the FDA has agreed that the dosage for Berubicin will be at the maximum tolerated dose (“MTD”) determined

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

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

Lomustine is a drug considered effective in patients with

glioblastoma that has recurred or progressed following first line therapy.

From the data available from the Reata Phase 1 clinical trial

(RTA 744-C-0401), the FDA has agreed that the dosage for Berubicin will be at the maximum tolerated dose (“MTD”) determined

in that trial.

Thus, patients randomized to the Berubicin arm will receive a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily

Thus, patients randomized to the Berubicin arm receive a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily

for three consecutive days followed by 18 days off (21-day cycle).

Patients randomized to Lomustine will receive a single oral dose of

130 mg/m2 (rounded to the nearest 5 mg) every 6 weeks, or per the full prescribing information for Lomustine incorporating institutional

standards at each study site.

Patients randomized to Lomustine receive a single oral dose of 130

mg/m2 (rounded to the nearest 5 mg) every 6 weeks, or per the full prescribing information for Lomustine incorporating institutional standards

at each study site.

Efficacy will be measured by the benefit of Berubicin

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

The trial will include a pre-planned, non-binding interim futility analysis

which will be conducted by an independent Data Safety Monitoring Board (DSMB) to recommend whether this study should continue as planned

based on Berubicin showing statistically significant value as a second-line treatment for patients with glioblastoma compared with Lomustine.

We will conduct this analysis after at least 50% of the patients in the interim analysis population (30-50% of total expected patients

for the trial) can be evaluated as having failed the primary efficacy endpoint (death).

This recommendation will review the number of

deaths on each arm to ensure that the overall survival of patients receiving Berubicin shows a statistically significant comparability

to or is even higher than those receiving Lomustine.

The median survival of patients receiving second-line treatment for glioblastoma

has historically been shown to be approximately 6 months.

We have historically used this 6 months as an estimate for the median time to

a 50% mortality rate.

Taking into account the recent rate of enrollment and the number of patients that can be adequately assessed for

their follow-up outcomes, we are anticipating that the DSMB will be able to perform this interim analysis and we can release the data

during the third quarter of 2023.

Additional analyses that will be provided based on this data will be comparisons of secondary endpoints,

including progression-free survival (PFS), response rates, and safety assessments.

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 operate in a highly competitive segment of the pharmaceutical

market, which market is highly competitive as a whole.

We face competition from numerous sources including commercial pharmaceutical and

biotechnology enterprises, academic institutions, government agencies, and private and public research institutions.

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

futility analysis which was conducted by an independent DSMB to recommend whether this study should continue as planned, be discontinued,

or be modified to address safety concerns.

The trial design called for this interim analysis to be conducted after at least 50% of the

patients in the interim analysis population (30-50% of total expected patients for the trial) can be evaluated as having failed the primary

efficacy endpoint of Overall Survival.

The median survival of patients receiving second-line treatment for glioblastoma has historically

been shown to be approximately 6 months.

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.

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 operate in a highly competitive segment of the

pharmaceutical market, which market is highly competitive as a whole.

We face competition from numerous sources including commercial pharmaceutical

and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions.

Many of our competitors

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be significant competitors, particularly through collaborative arrangements with large and established companies.

The unmet medical need for more effective cancer therapies

is such that oncology drugs are one of the leading class of drugs in development.

These include a wide array of products against cancer

targeting many of the same indications as our drug candidates.

The unmet medical need for more effective cancer

therapies is such that oncology drugs are one of the leading class of drugs in development.

These include a wide array of products against

cancer targeting many of the same indications as our drug candidates.

While the introduction of newer targeted agents may result in extended

overall survival, induction therapy regimens are likely to remain a cornerstone of cancer treatment in the foreseeable future.

The current standard for the initial treatment of glioblastoma

is surgery, followed by radiation in combination with TMZ, followed by maintenance TMZ.

Treatment with Lomustine is considered to be the

standard of care for recurrent glioblastoma even though it is not formally approved by the FDA for this purpose, a fact which highlights

the lack of available options for treatment.

The current standard for the initial treatment

of glioblastoma is surgery, followed by radiation in combination with TMZ, followed by maintenance TMZ.

Treatment with Lomustine is considered

to be the standard of care for recurrent glioblastoma even though it is not formally approved by the FDA for this purpose, a fact which

highlights the lack of available options for treatment.

While the percentage of patients who survive two years from the diagnosis of glioblastoma

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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.

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

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

On July 24, 2021,

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

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Governmental Regulation

Government authorities in the United States, at the

federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture,

quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring

and reporting, marketing and export and import of products such as those we are developing.

The pharmaceutical drug product candidates

that we develop must be approved by the FDA before they may be marketed and distributed.

Government authorities in the United States, at

the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing,

manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval

monitoring and reporting, marketing and export and import of products such as those we are developing.

The pharmaceutical drug product

candidates that we develop must be approved by the FDA before they may be marketed and distributed.

In the United States, the FDA regulates pharmaceutical

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FDA review and approval of the NDA.

The lengthy process of seeking required approvals and

the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources and approvals,

The lengthy process of seeking required approvals

and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources and approvals,

and continued compliance is inherently uncertain.

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that suspend or terminate such clinical study.

Clinical studies involve the administration of the

pharmaceutical product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians

Clinical studies involve the administration of

the pharmaceutical product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians

not employed by or under the clinical study sponsor’s control.

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form that must be provided to each clinical study subject or his or her legal representative and must monitor the clinical study until

Human clinical studies are typically conducted in three

sequential phases that may overlap or be combined:

Human clinical studies are typically conducted

in three sequential phases that may overlap or be combined.

While such designations are not officially defined by the regulatory agencies

(including the FDA), the generally accepted meanings are:

The pharmaceutical product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

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the pharmaceutical product has been associated with unexpected serious harm to patients.

Concurrent with clinical studies, companies may complete

additional animal studies and must also develop additional information about the chemistry and physical characteristics of the pharmaceutical

product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

manufacturing process must be capable of consistently producing quality batches of the pharmaceutical product candidate and, among other

things, must develop methods for testing the identity, strength, quality and purity of the final pharmaceutical product.

Concurrent with clinical studies, companies may

complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the

pharmaceutical product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the pharmaceutical product candidate and, among

other things, must develop methods for testing the identity, strength, quality and purity of the final pharmaceutical product.

Additionally,

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candidate does not undergo unacceptable deterioration over its shelf life.

The results of product development, preclinical studies

and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the pharmaceutical

product, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the

The results of product development, preclinical

studies and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the

pharmaceutical product, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval

to market the product.

The submission of an NDA is subject to the payment of substantial user fees.

A waiver of such fees may be obtained under certain

limited circumstances.

A waiver of such fees may be obtained

under certain limited circumstances.

The FDA reviews all NDAs submitted before it accepts

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its PDUFA goal dates for standard and priority NDAs.

After the NDA submission is accepted for filing, the

FDA reviews the NDA application to determine, among other things, whether the proposed product is safe and effective for its intended

After the NDA submission is accepted for filing,

the FDA reviews the NDA application to determine, among other things, whether the proposed product is safe and effective for its intended

use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength,

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the FDA will not approve the NDA without a REMS, if required.

Before approving an NDA, the FDA will inspect the facilities

at which the product is manufactured.

The FDA will not approve the product unless it determines that the manufacturing processes and facilities

are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Additionally,

before approving an NDA, the FDA will typically inspect one or more clinical sites as well as the site where the pharmaceutical product

is manufactured to assure compliance with GCP and cGMP.

Before approving an NDA, the FDA will inspect the

facilities at which the product is manufactured.

The FDA will not approve the product unless it determines that the manufacturing processes

and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites as well as the site where the pharmaceutical

product is manufactured to assure compliance with GCP and cGMP.

If the FDA determines the application, manufacturing process or manufacturing

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In addition, the FDA will require the review and approval of product labeling.

The NDA review and approval process is lengthy and

difficult, and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional

The NDA review and approval process is lengthy

and difficult, and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional

clinical data or other data and information.

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letter, or withdraw the application.

If a product receives regulatory approval, the approval

may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict

the commercial value of the product.

Further, the FDA may require that certain contraindications, warnings, or precautions be included

in the product labeling.

In addition, the FDA may require Phase 4 testing which involves clinical studies designed to further assess pharmaceutical

product safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have

been commercialized.

If a product receives regulatory approval, the

approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could

restrict the commercial value of the product.

Further, the FDA may require that certain contraindications, warnings, or precautions be

included in the product labeling.

In addition, the FDA may require Phase 4 testing which involves clinical studies designed to further

assess pharmaceutical product safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved

products that have been commercialized.

Expedited Development and Review Programs

On July 24, 2021,

2021, the Company received Fast Track Designation from the FDA for Berubicin.

The FDA’s Fast Track program is intended to expedite

or facilitate the process for reviewing new pharmaceutical products that meet certain criteria.

Specifically, new pharmaceutical products

are eligible for Fast Track designation if they are intended to treat a serious condition and demonstrate the potential to address unmet

medical needs for the condition.

Fast Track designation applies to the combination of the product and the specific indication for which

it is being studied.

Unique to a Fast Track product, the FDA may consider for review sections of the NDA on a rolling basis before the

complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, if the FDA determines

The FDA’s Fast Track program is intended

to expedite or facilitate the process for reviewing new pharmaceutical products that meet certain criteria.

Specifically, new pharmaceutical

products are eligible for Fast Track designation if they are intended to treat a serious condition and demonstrate the potential to address

unmet medical needs for the condition.

Fast Track designation applies to the combination of the product and the specific indication for

which it is being studied.

Unique to a Fast Track product, the FDA may consider for review sections of the NDA on a rolling basis before

the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, if the FDA determines

that the schedule is acceptable and if the sponsor pays any required user fees upon submission of the first section of the NDA.

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Post-Approval Requirements

Any pharmaceutical products for which the Company receives

FDA approvals are subject to continuing regulation by the FDA, including, among other things, cGMP compliance, record-keeping requirements,

reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and

distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising

requirements, which include, among others, standards for direct-to-consumer advertising, prohibitions on promoting pharmaceutical products

for uses or in patient populations that are not described in the pharmaceutical product’s approved labeling (known as “off-label

Any pharmaceutical products for which the Company

receives FDA approvals are subject to continuing regulation by the FDA, including, among other things, cGMP compliance, record-keeping

requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product

sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion

and advertising requirements, which include, among others, standards for direct-to-consumer advertising, prohibitions on promoting pharmaceutical

products for uses or in patient populations that are not described in the pharmaceutical product’s approved labeling (known as “off-label

use”), industry-sponsored scientific and educational activities and promotional activities involving the internet.

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Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and

reimbursement status of any pharmaceutical product candidates for which we may obtain regulatory approval.

In the United States and in

markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part upon

the availability of reimbursement from third-party payers.

Significant uncertainty exists as to the coverage

and reimbursement status of any pharmaceutical product candidates for which we may obtain regulatory approval.

In the United States and

in markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part

upon the availability of reimbursement from third-party payers.

Third-party payers include government payers such as Medicare and Medicaid,

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of our products and/or reimburse our products at a lower rate.

Orphan Drug exclusivity prevents for seven years the

approval of another product with the same active moiety for the same rare disease.

Orphan Drug exclusivity prevents for seven years

the approval of another product with the same active moiety for the same rare disease.

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

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certain NDAs for similar products.

The marketability of any pharmaceutical product candidates

for which we may receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to provide adequate

coverage and reimbursement.

In addition, emphasis on managed care in the United States has increased and we expect this will continue

to increase the pressure on pharmaceutical pricing.

Coverage policies and third-party reimbursement rates may change at any time.

if favorable coverage and reimbursement status is attained for one or more products for which we may receive regulatory approval, less

favorable coverage policies and reimbursement rates may be implemented in the future.

The marketability of any pharmaceutical product

candidates for which we may receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to

provide adequate coverage and reimbursement.

In addition, emphasis on managed care in the United States has increased and we expect this

will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and third-party reimbursement rates may change at

Even if favorable coverage and reimbursement status is attained for one or more products for which we may receive regulatory

approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

International Regulation

In addition to regulations in the United States, we

will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our future drugs.

In addition to regulations in the United States,

we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our future drugs.

Whether or not we obtain FDA approval for a drug, we must obtain approval of a drug by the comparable regulatory authorities of foreign

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intellectual property rights.

On December 28, 2017, the Company entered into a Technology

Rights and Development Agreement with Houston Pharmaceuticals, Inc.

On December 28, 2017, the Company entered into

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

HPI is affiliated with Dr.

Waldemar Priebe, our

Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly known as WP744.

Priebe, our founder.

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 WP744;

(iv) a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of $7,000,000

(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, 2022 and 2021, the Company

recognized $275,000 and $450,000 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:

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,

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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.

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

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.

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

On May 7, 2020, pursuant to the WP1244 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.

During the year ended December

31, 2020, the Company paid $334,000 and accrued $400,000 related to this agreement in research and development expenses in the Company’s

Consolidated Statements of Operations.

During the year ended December 31, 2021, the Company paid $800,000 to UTMDACC related to this agreement.

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 our

development efforts of the WP1244 portfolio.

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.

On March 20, 2020, we entered into a Development Agreement

with WPD Pharmaceuticals (“WPD”) (the “Development Agreement”), a company founded by Dr.

Pursuant to the

Development Agreement, WPD agreed to use its commercially reasonable efforts in good faith to develop and commercialize certain products

that WPD had previously sublicensed, solely in the field of pharmaceutical drug products for the treatment of any viral infection in humans,

with a goal of eventual approval of in certain territories consisting of:

Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Romania,

Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary, Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey,

Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland.

Pursuant to the Development Agreement,

we agreed to pay WPD the following payments:

(i) an upfront payment of $225,000 to WPD (paid in April 2020);

and (ii) within thirty days

of the verified achievement of the Phase II Milestone, (such verification shall be conducted by an independent third party mutually acceptable

to the parties hereto), we will make a payment of $775,000 to WPD.

WPD agreed to pay us a development fee of 50% of the net sales for

any products in the above territories;

provided that Poland shall not be included as a territory after WPD receives marketing approval

for a product in one-half of the countries included in the agreed upon territories or upon the payment by WPD to us of development fees

of $1.0 million.

The term of the Development Agreement will expire on the expiration of the sublicense pursuant to which WPD has originally

sublicensed the products, which will occur upon the expiration of the patents subject to the sublicense agreement, the earliest of which

expires in 2024.

On February 19, 2021, CNS entered into an Investigational

Medicinal Product Supply Agreement with WPD, a related party.

CNS agreed to sell the Berubicin drug product to WPD at historical cost

of manufacturing without markup so that WPD may conduct the clinical trials contemplated by the sublicense agreement.

WPD agreed to pay

CNS the following payments:

(i) an upfront payment of $131,073 upon execution of the agreement, (ii) a payment of $262,145 upon

final batch release and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon Clinical Trial

Application acceptance by the relevant regulatory authority.

All three milestones were met as of December 31, 2021.

In addition, as of

December 31, 2021, the drug product with a cost of approximately $655,000 was delivered to WPD and was held at a third party depot.

of December 31, 2021, CNS invoiced the three amounts plus pass through cost for a total of $656,938.

As of September 30, 2022, the Company

received payments for the first and second amounts due for a total of $393,182 and entered into a settlement agreement whereby WPD agreed

to return 168 vials (approximately 40% of the total) to us in settlement of the final amount owed.

On October 24, 2022, the Company received

confirmation from our third party depot service provider that the vials had been transferred into our inventory.

As such, this matter

is now fully resolved.

On November 21, 2022, CNS entered into an Investigational

Medicinal Product Supply Agreement with Pomeranian Medical University (“PUM”) in Szczecin, Poland.

CNS agreed to sell berubicin

hydrochloride drug product (and related reference standards) to PUM at a discount to the historical cost of manufacturing so that PUM

may conduct an investigator-initiated clinical trial of Berubicin in CNS lymphomas.

PUM agreed to pay CNS the following payments:

PLN 5,870.27 upon delivery of 2 vials each of berubicin and berubicinol reference standards, (ii) PLN 873,201.00 upon delivery of

a first batch of 150 berubicin drug product vials, and (iii) PLN 873,201.00 upon delivery of a second batch of 150 berubicin drug

product vials.

As of December 31, 2022, the reference standards had been delivered and were recognized in Accounts Receivable

and as a reduction to research & development expense.

As of March 29, 2023, the first batch of berubicin drug product vials have been

ordered but not yet delivered.

As of March 29, 2023, 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.

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.

Legal Proceedings

From time to time in the ordinary course of our business,

we may be involved in legal proceedings, the outcomes of which may not be determinable.

The results of litigation are inherently unpredictable.

Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of

management time and result in diversion of significant resources.

We have insurance policies covering any potential losses where such

coverage is cost effective.

From time to time in the ordinary course of our

business, we may be involved in legal proceedings, the outcomes of which may not be determinable.

The results of litigation are inherently

unpredictable.

Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant

amounts of management time and result in diversion of significant resources.

We have insurance policies covering any potential losses

where such coverage is cost effective.

We are not at this time involved in any additional

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 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.

We do not own any real property.

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Our Internet address is www.cnspharma.com .

this Web site, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to

On this Web site, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished

Securities and Exchange Commission (“SEC”):

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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