What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-31 compared with 2025-03-31 · 516 added, 550 removed, 342 unchanged (76% of the section changed)

We are a clinical pharmaceutical company organized

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

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

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

We believe our drug candidates, TPI 287 and Berubicin,

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

Food and Drug

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

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

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

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

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

Based on limited clinical

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

concentrations targeting brain cancer cells.

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

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

While our focus is currently on the development of TPI 287

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

develop into drugs to treat CNS and other cancers.

TPI 287 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 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.

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

manufacturing activities are contracted out to third parties.

Additionally, we do not have a sales organization.

On November 21, 2017, we entered into a Collaboration

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

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

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

intellectual property rights.

On December 28, 2017, we obtained the rights to

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

to as the HPI License.

HPI is affiliated with our founder, Dr.

Under the HPI License we obtained the exclusive right to develop

certain chemical compounds for use in the treatment of cancer anywhere in the world.

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;

and (v) 3 shares of our common stock.

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

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

the United States behind heart disease.

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

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

to represent nearly $100 billion in annual sales.

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.

The most common approved anthracyclines are daunorubicin

and doxorubicin and, prior to the expansion of their generic equivalents, annual revenues generated from anthracyclines have been estimated

in the range of $600 million.

Many cancers are currently treated with anthracyclines;

however, primary and metastatic brain cancers have

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

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

for which there are few available treatments.

The leading brain tumor drug is temozolomide (“TMZ”), a drug introduced under

the brand name Temodar®.

In 2012, one industry source reported annual revenues of approximately $882 million for Temodar before the

expiration of its patent protection, at which point generic versions of the drug began to enter the market and reduce prices.

overall survival when used in combination with radiation after preliminary surgery, followed by maintenance therapy as a single agent

The Orphan Drug Act and other legislative initiatives

provide incentives, including market exclusivity and accelerated approval pathways, for companies that pursue the development of treatments

for rare diseases and serious diseases for which there are few or no acceptable available treatment alternatives.

Orphan Drug exclusivity

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

If a product is a new

chemical entity (i.e., generally that the moiety has not previously been approved), it may receive five years of exclusivity, during which

period FDA may not accept for review certain NDAs for another product with the same moiety.

If approval of a product required new clinical

data, it may convey three years of exclusivity against approval of certain NDAs for similar products.

Over the last 10 years, an increasing

number of companies have begun using these designations to obtain new drug approvals for drugs where patent coverage has expired and/or

where accelerated approval appears possible.

An IMS Health report estimated that, in 2013, the sale of drugs with full or partial Orphan

Drug exclusivity represented approximately $29 billion in revenue.

We consider the receipt of Orphan Drug exclusivity and expedited pathways

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

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 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

had a median survival rate of only 14.6 months from glioblastoma diagnosis and few effective therapeutic options.

In this trial, 25 of

the 35 patients enrolled were evaluable for response, and there was 1 complete response, 1 partial response, and 1 minor response, all

indicative of tumor shrinkage.

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

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

(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

survival rate of glioblastoma ranges from 13% for younger aged patients (20 to 44 years) to 1% for older populations (over 44 years).

The current standard of care for first-line treatment is surgery, radiation, and chemotherapy with TMZ.

TMZ, the current chemotherapeutic

component of the first-line standard of care for glioblastoma, has limited efficacy.

In the TMZ final clinical trial performed before

submitting for FDA approval (573 patients), overall survival was improved by 2.5 months versus radiation alone, a clearly significant

improvement in survival.

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 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

anthracycline with a chemical structure similar to doxorubicin HCl, a cytotoxic anthracycline topoisomerase II inhibitor isolated from

cultures of Streptomyces peucetius var.

Doxorubicin HCl Injection and Doxorubicin HCl for Injection, drugs related in chemical

structure and mechanism of action to Berubicin, are approved by the FDA for the treatment of various cancers, including acute lymphoblastic

leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor,

metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional

cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, and metastatic bronchogenic carcinoma, as well as

part of a multiagent adjuvant chemotherapy for the treatment of women with axillary lymph node involvement after resection of primary

breast cancer.

A liposomal formulation of doxorubicin HCl is also approved for the treatment of ovarian cancer, AIDS-related Kaposi’s

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.

In an effort to develop a second-generation anthracycline

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

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 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

variation which makes their tumors initially more responsive to TMZ.

However, because nearly all these patients will quickly become resistant,

Berubicin could be prescribed after failure with TMZ.

The remaining 60% of patients initially fail to respond to TMZ, primarily due to

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

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.

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.

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.

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.

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

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,

remained on study through seven cycles of therapy and was withdrawn for adverse events unrelated to Berubicin.

The patient was disease

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.

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

study to determine the maximum tolerated dose starting with patients who were not taking concurrent enzyme-inducing anti-epileptic drugs

(EIAEDs) that could interfere with Berubicin drug metabolism.

Intra-patient dose-escalation was allowed after a patient had received a

minimum of 4 cycles.

Berubicin injection was administered either daily for three consecutive days repeated every three weeks (Group A),

or once-weekly for four-consecutive weeks repeated every five weeks (Group C).

Enrollment for a planned dose escalation in Group B (patients

on EIAEDs) was not initiated after it was determined that the standard of care had changed and an insufficient number of patients being

treated with these anti-epileptic drugs would make it difficult to accrue the requisite number of patients.

The MTD for the remaining

groups was determined in a stepwise fashion such that once the MTD for Group A (three days in a row every 3 weeks) was determined, Group

C was initiated at the MTD from Group A, given on a weekly basis for 4 of every 5 weeks to evaluate the tolerability and MTD of Berubicin

on this alternative schedule.

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.

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 :

The Macdonald criteria,

similarly to other systems, divides response into four types of response based on imaging (MRI) and clinical features:

Imaging Features

Clinical Features

Complete Response (CR)

Disappearance of all enhancing disease (measurable and non-measurable)

Sustained for at least four weeks

No new lesions

No corticosteroids

Clinically stable or improved

Partial Response (PR)

50% or more decrease of measurable enhancing lesions

Sustained for at least four weeks

No new lesions

Stable or reduced corticosteroids

Clinically stable or improved

Stable Disease (SD)

§ Does not qualify for CR, PR or progression

§ Clinically stable

25% or more increase in enhancing lesions

Any new lesions

§ Clinical deterioration

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.

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

Summary of Adverse Events :

The adverse events

documented during Study RTA 744-C-0401 for all CTC grades of severity and regardless of relationship to study medication are identified

Serious Adverse Event

Number of Patients Experiencing Adverse Event

Pulmonary embolism

Urinary tract infection

Peripheral motor neuropathy

Peripheral sensory neuropathy

Urinary retention

Speech disorder

Pyramidal tract syndrome

Eyelid ptosis

Macular oedema

Deep vein thrombosis

Loss of consciousness

Hydrocephalus

Muscle atrophy

Thrombocytopenia

Disease progression

Mental status changes

Depressed level of consciousness

The larger number of events related to the central

nervous system is consistent with the impact of the underlying malignant disease in the brain of these patients.

Myelosupression, i.e.,

a decrease in the number of bone-marrow derived cells, is expected and consistent with the known toxicities of anthracyclines, which can

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 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) was 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 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 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 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

which form the basis for a request for approval of a New Drug Application.

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 at 6 months (PFS6).

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

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.

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

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

may have significantly greater financial, product development, manufacturing and marketing resources.

Additionally, many universities

and private and public research institutes are active in cancer research, and some may be in direct competition with us.

We may also compete

with these organizations to recruit scientists and clinical development personnel.

Smaller or early-stage companies may also prove to

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.

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.

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

has increased because of the use of TMZ, overall survival for GBM patients remains dismal.

There are currently at least 77 different experimental

therapies under clinical development in the United States for recurrent GBM based on the clinicaltrials.gov website.

Thus, we are operating

in a highly competitive clinical trial environment, moving towards the pharmaceutical market, which is also extremely competitive for

patients with GBM.

We also 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 may have significantly greater

cancer research capabilities, as well as financial, product development, manufacturing, and marketing resources.

Additionally, many universities

and private and public research institutes are active in cancer research, and some may be in direct competition with us.

we also compete with these organizations to recruit scientists and clinical development personnel.

Smaller or early-stage companies may

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

CNS Pharmaceuticals, Inc.

(“CNS,” the “Company,”

“we,” “us,” or “our”) is a biotechnology company focused on developing innovative therapies for serious

diseases in neurology and oncology.

Together, these therapeutic areas represent hundreds of billions of dollars in annual global pharmaceutical

spending, encompass some of the most prevalent and difficult to treat diseases affecting humanity, and are characterized by significant

unmet medical need.

Significant progress has been made in the biological and molecular understanding of these diseases, enabling a shift

to high-value disease-modifying therapies and precision medicine approaches.

Together with advancements in diagnostic capabilities to

aid in patient selection, there is the potential to improve the probability of success and reduce development timelines.

We believe this

combination of scale, urgency, and scientific development creates compelling opportunities for differentiated therapeutic approaches and

novel mechanisms of action.

Our executive team was purposefully built to focus on high-value therapeutic opportunities in these therapeutic

areas and the Company is working to build a differentiated portfolio of assets with best-in-class potential to address significant unmet

medical needs.

CNS Pharmaceuticals is committed to advancing novel treatments that have the potential to improve patient outcomes.

Recent Developments

On January 1, 2026, the Company appointed Rami Levin,

MBA, as President & Chief Executive Officer.

Following Mr.

Levin’s appointment, we engaged an independent life science focused

advisory firm to conduct a comprehensive data-driven analysis of the Company including our pipeline, development priorities and long-term

positioning (the “Strategic Analysis”).

While this Strategic Analysis was being completed, we rebuilt the Company’s

executive leadership team by appointing a new Chief Business Officer, Chief Financial Officer, Chief Medical Officer and Chief Technology

Officer effective March 2, 2026.

This executive team was assembled to execute on the findings and recommendations of the Strategic Analysis

and develop and execute a new corporate strategy.

On March 11, 2026, we announced a new corporate

growth strategy focused on building a high-value pipeline in neurology and oncology.

This strategy follows the comprehensive, data-driven

strategic review that incorporated clinical probability-of-success modeling, competitive landscape assessments, regulatory pathway analyses,

and risk-adjusted return evaluations.

Based on this work, we are pursuing a disciplined approach to identify, acquire or in-license differentiated

preclinical and clinical-stage assets with strong biological rationale, validated or emerging clinical data, and clear development and

regulatory pathways.

We are prioritizing opportunities with near- to mid-term value inflection points, meaningful commercial potential,

and relevance to our team’s expertise, while maintaining capital discipline.

We have initiated a global asset search and are actively

evaluating opportunities aligned with these criteria, with a focus on areas where investor interest, partnering activity, and long-term

value creation potential are strongest.

Also on March 11, 2026, as part of our new corporate

strategy, we announced that we are pivoting from the Company’s historical singular focus on glioblastoma multiforme (“GBM”).

The Company’s prior development programs centered on two investigational compounds, TPI 287 and Berubicin, both of which were designed

to penetrate the blood-brain barrier and target cancers of the central nervous system such as GBM.

We believe patients with GBM need better

treatment options and that TPI 287 and Berubicin have the potential to address those needs, but they are not in line with our new strategic

As a result, we intend to explore out-licensing opportunities for TPI 287 and Berubicin.

Market Opportunity:

Neurology & Oncology

Neurological disorders represent a staggering public

health crisis of global proportions.

The World Health Organization (“WHO”) and the Global Burden of Disease study identify

neurological conditions as among the leading causes of disability and death worldwide.

According to WHO, neurological disorders affect

more than one billion people globally and are the leading cause of disability-adjusted life years (“DALYs”) when all conditions

are aggregated across the spectrum of central nervous system (“CNS”) disease.

Neurological conditions share several characteristics

that make them particularly challenging to treat and commercially significant:

they are largely chronic and progressive, they carry high

caregiver burdens, they predominantly affect aging populations, and many remain without adequate disease-modifying treatments.

Cancer is among the foremost causes of morbidity and

mortality worldwide, imposing an enormous burden on individuals, healthcare systems, and economies globally.

According to the WHO, cancer

accounts for approximately 10 million deaths per year, which accounted for nearly one in six deaths globally.

In 2022, the International

Agency for Research on Cancer (“IARC”) recorded nearly 20 million new cancer cases and approximately 9.7 million cancer-related

deaths worldwide.

In the United States alone, the National Cancer Institute (“NCI”) estimated that approximately 2,041,910

new cancer cases will be diagnosed in 2025, with approximately 618,120 deaths attributable to the disease.

Our new strategic focus on neurology and oncology positions

us in two of the largest, fastest-growing, and most scientifically dynamic sectors in biopharmaceuticals.

Together, these therapeutic

areas represent hundreds of billions of dollars of investment.

The global neurological therapeutics market exceeds $138 billion while

the global oncology therapeutics market is projected to reach $400 billion in the next decade.

However, several large neurology and oncology

indications still lack disease-modifying therapies or have poor outcomes.

These large commercial opportunities have the potential to be

addressed by leveraging the recent advancements in the understanding of these diseases and breakthroughs in drug development.

As a result, there are significant research and development

efforts being undertaken across academia, non-profit institutions, governmental agencies, emerging biotechnology companies and multinational

pharmaceutical companies to address these disease indications.

In 2025, neurology and oncology focused companies received nearly 50 percent

of the venture capital investments in therapeutics.

They were also the most active therapeutic areas based on the number of business development

transactions completed from 2022 to 2025.

Oncology was the most active therapeutic area with 457 announced transactions completed during

this period and neurology was the second most active with 205 announced completed transactions.

During this period, total mergers &

acquisitions and licensing transactions exceeded $100 billion in total value for both neurology and oncology.

This activity spanned stage

of development from preclinical through approved products as well as therapeutic modality, which we believe demonstrates the potential

value that can be created in these therapeutic areas with novel and differentiated assets.

Based on this, we believe that 1) there are a significant

number of assets in neurology and oncology that are available for in-licensing, and 2) there is an established group of potential strategic

commercial partners.

Several global biopharmaceutical companies including but not limited to AstraZeneca, Astellas Pharma, Bristol Myers

Squibb, Biogen, GlaxoSmithKline, Merck, Novartis, Pfizer and Takeda have established franchises in neurology and/or oncology and have demonstrated

track records of acquiring or partnering with companies developing product candidates in our target areas.

Neurology Market Drivers

The need for differentiated and novel neurology therapeutics

is being driven by multiple factors including aging global demographics.

The global population aged 65 and over is projected to more than

double from approximately 700 million in 2020 to 1.5 billion by 2050, according to UN demographic projections.

Because the incidence of

most major neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease, increases sharply with age, this demographic

shift is expected to dramatically expand patient populations and healthcare costs worldwide.

As an example, the U.S.

Alzheimer's Association

has estimated that if no disease-modifying treatment is found, the number of Americans with Alzheimer's could grow to 13 million by 2050.

However, significant unmet medical need remains across nearly all areas of neurodegeneration.

Until 2023 and 2024, there were no approved

therapies that demonstrated an ability to slow underlying neurodegeneration in Alzheimer’s disease.

Current treatments for Parkinson's

disease manage symptoms but do not arrest neurodegeneration.

No approved neuroprotective or disease-modifying therapies exist for amyotrophic

lateral sclerosis (“ALS”) or Huntington's disease, among many others.

According to the National Institute of Neurological

Disorders and Stroke, there are a total of 131 neurologic disorders.

However, a 2024 analysis by Thomas et al.

published in Neurology

(A Comprehensive Review of Novel FDA-approved Neurological Medications from 2018-2023, P7-4.009, Vol.

102) found that only 32 novel neurological

therapies were approved by the FDA from 2018 – 2023 for patients with migraines (9), multiple sclerosis (4), Alzheimer’s disease

(3), Parkinson’s disease (3), Epilepsy/seizures (3), ALS (2), Neuromyelitis Optica (2), and several others for rare neurological

This unmet need underpins both the scientific urgency, medical need and the commercial opportunity.

Advancement in the biological understanding of these

diseases, aided by biomarker discovery and enhanced diagnostic capabilities, are also leading to advancement in the field and uncovering

new opportunities for drug development.

The development of blood-based biomarkers for neuroinflammation, including amyloid tau protein

for Alzheimer’s, has dramatically reduced the cost and complexity of patient stratification in clinical trials, increasing feasibility

and accelerating development timelines.

Fluid and imaging biomarkers are increasingly accepted by the FDA as surrogate endpoints, potentially

lowering the bar for early-stage proof of concept.

Small and mid-sized biotechnology companies now originate the majority of novel neurology

compounds entering clinical development.

According to the industry research and contract research organization, IQVIA, neurology is among

the fastest-growing areas of Phase II/III clinical trial activity.

In addition, neurological disorders have the potential

for accelerated regulatory pathways including breakthrough therapy, fast track, and priority review designations, which have the potential

to shorten development and approval timelines and enable increased interaction with the FDA.

Finally, several commercial neurology therapies

are facing loss of exclusivity (“LOE”) by 2030.

Based on these demographic, biological, medical, pharmacoeconomic and commercial

considerations, we believe neurology is a therapeutic area on which to focus and deploy our resources.

Oncology Market Drivers

Cancer rates increase dramatically with age, and

all major developed-market nations are experiencing rapid population aging.

As noted above, IARC projects 33 million new cases per year

This represents a 65% increase over 2022 levels and is being driven in large part by demographic shifts rather than changes in

per-capita risk.

In the United States alone, the National Cancer Institute (NCI) estimated that approximately 2,041,910 new cancer cases

will be diagnosed in 2025, with approximately 618,120 deaths attributable to the disease.

Estimated national expenditures for cancer care

in the United States reached approximately $208.9 billion in 2020 and are expected to grow materially as the population ages.

the global oncology pharmaceutical market is the largest and fastest-growing category within biopharmaceuticals.

The past decade has witnessed transformative advances

in cancer biology and drug development.

Immune checkpoint inhibition, which is led by anti-programmed cell death 1 (anti-PD-1/PD-L1) and

anti-cytotoxic T-lymphocyte associated protein 4 (“CTLA-4”) antibodies have become foundational to the treatment of dozens

These therapies generate over $40 billion in annual worldwide sales and have catalyzed billions of dollars in follow-on investment.

Chimeric antigen receptor T-cell (“CAR-T”) therapy has achieved durable remissions in subsets of hematologic malignancies.

Antibody-drug conjugate (“ADC”) technologies have experienced a major resurgence, with multiple approvals in breast cancer,

bladder cancer, lung cancer, and other solid tumors.

However, there continues to be a need for targeted therapies that can improve overall

survival, quality of life and overall outcomes of patients with cancer.

Several new modalities are emerging as promising cancer treatments

including but not limited to protein degraders, bispecific antibodies, and next-generation immunotherapies.

We believe the robust investment

in cancer drug discovery has created an opportunity to identify and select assets, including those with an underlying validated platform

technology, to establish a differentiated oncology pipeline.

Recent treatment approaches in oncology also demonstrate

the shift towards precision medicine and the development of therapies with improved efficacy and safety profiles compared to non-targeted

chemotherapies and radiation.

Genomic profiling using next-generation sequencing (“NGS”), liquid biopsy, and companion diagnostics

has transformed the standard of care for many cancers, enabling the matching of patients to targeted therapies based on specific molecular

This trend drives demand for biomarker-guided therapy development and creates opportunities for companies developing therapies

against specific genomic targets (e.g., KRAS, EGFR, ALK, BRAF, HER2, FGFR, RET, and many others).

As of 2025, over 50 cancer-specific

molecular targets have FDA-approved companion diagnostics.

Precision medicine has uncovered a broad array of validated biological targets

that continues to expand.

This shift has created clearly defined addressable patient populations for which there are established clinical

benchmarks and potential accelerated regulatory pathways.

We expect neurology and oncology will continue

to evolve rapidly, which will reshape the competitive landscape in these areas, thereby creating opportunities for us to build our pipeline

and focus our future development efforts.

Leveraging our team’s collective experience in these therapeutic areas and relevant functions,

we believe we are well positioned to capitalize on evolving market dynamics and a broad set of assets to build a pipeline that is novel,

differentiated and has the potential to be best-in-class.

To execute our neurology and oncology focused strategy,

the Company appointed a new executive team in the first quarter of 2026 that brings decades of hands-on experience in neurology and oncology,

including rare diseases and across several therapeutic modalities.

Our executive team has diverse experience in clinical development,

regulatory affairs, chemistry, manufacturing and controls (“CMC”), business development, finance, capital markets, commercialization

and company transformation.

The Company’s newly formed executive team includes:

· Rami Levin, Chief Executive Officer, appointed January 1, 2026

· Lynne Kelley, M.D., FACS, Chief Medical Officer, appointed March 2, 2026

· Dylan Wenke, Chief Business Officer, appointed March 2, 2026

· Steve O’Loughlin, Chief Financial Officer, appointed March 2, 2026

· Eric Faulkner, Chief Technology Officer, appointed March 2, 2026

Rami Levin, MBA, brings nearly 30 years of global

leadership experience across oncology, CNS, rare diseases, endocrinology, and cell and gene therapy, with a proven track record of scaling

organizations, advancing late-stage clinical programs, and driving transformative value creation.

Previously, Mr.

Levin held senior

leadership roles as President & Chief Executive Officer of Saniona and CEO of ImStem Biotechnology.

He led strategic turnarounds,

sharpened pipeline focus, secured significant financing, and advanced multiple programs toward clinical and regulatory milestones.

has also held senior commercial and operational leadership roles at Sobi, Merck Serono, and Schering AG, where he successfully launched

and scaled global brands including Rebif®, Betaseron®, Kuvan®, Orfadin®, and Gamifant®.

Earlier in his career, he

played a central role in global brand strategy and lifecycle management for Rebif®, one of the world’s leading multiple sclerosis

Levin holds an MBA from the Recanati Business School at Tel Aviv University and a BSc in Biology from Tel Aviv University.

Lynne Kelley, M.D., served as Chief Medical Officer

at multiple public and private biotechnology and medical device companies, including TISSIUM, Servier Pharmaceuticals, X4 Pharmaceuticals

and Senseonics.

She has led clinical development programs resulting in INDs, NDAs, PMAs, and breakthrough and orphan drug designations,

and has presented safety and efficacy data to FDA advisory committees resulting in unanimous approval votes.

Kelley has also played

key roles in corporate strategy, fundraising and M&A, including contributing to multi-billion-dollar oncology transactions.

in her career, Dr.

Kelley held senior leadership roles at Becton Dickinson, where she oversaw global medical affairs and regulatory strategy

across devices, drugs and combination products.

She began her career in academic medicine as an Assistant Professor of Surgery and Interventional

Radiology at Yale University.

Kelley holds an MD from Dartmouth Medical School and a BA in Biology from Boston University.

board certified in General Surgery and Vascular Surgery and is a Fellow of the American College of Surgeons.

Dylan Wenke, MBA, is an experienced corporate development

and strategic transactions leader with a strong track record in biotechnology business development, licensing and financing.

He has originated

and executed high-value transactions across multiple therapeutic areas and modalities.

Previously, he held senior business development

roles at Corbus Pharmaceuticals, Bluejay Therapeutics and EuMentis Therapeutics, where he led portfolio-shaping transactions, financings

and global partnering initiatives.

Dylan holds an MBA from the Kelley School of Business at Indiana University and a B.Sc.

from the University of North Florida.

Steve O’Loughlin brings nearly 20 years of

corporate finance, capital markets, and business development experience in the biopharmaceutical industry.

Most recently, he served as

Chief Financial Officer of Actinium Pharmaceuticals, Inc.

(NYSE American:

ATNM), a clinical-stage radiopharmaceutical company, where he

played a central role in the company’s growth and strategic development over a decade-long tenure.

At Actinium, Mr.

oversaw SEC and NYSE compliance, investor relations, FP&A, corporate governance, and treasury management.

He coordinated the execution

of multiple capital markets and business development transactions including the exclusive European license agreement for a Phase 3 radiopharmaceutical

asset with Immedica Pharma AB, generating $35 million in upfront proceeds and up to $417 million in potential milestone payments, as well

as a preclinical research collaboration with Astellas Pharma, Inc.

Prior to Actinium, Mr.

O’Loughlin served as Vice President of

Finance and Corporate Development at Protea Biosciences Group, Inc., where he executed capital raises, supported the growth of the Company’s

bioanalytical services business built around its proprietary LAESI® mass spectrometry imaging technology and drove strategic

collaborations with leading research institutions including Memorial Sloan Kettering Cancer Center and Yale University.

began his corporate career at Caliber I.D.

(formerly Lucid Technologies) supporting the commercial launch of the FDA approved VivaScope® diagnostic

imaging device and the Company’s IPO.

O’Loughlin started his career in investment banking at Jesup & Lamont and Forge

Financial Group focused on the life sciences industry.

O’Loughlin holds a B.S.

in Business with a concentration in Finance from

Ramapo College of New Jersey.

Eric Faulkner, MS, MBA, brings over 30 years of

global leadership, technical operations, quality management, product launch, and commercial experience within the biotechnology / pharma

Faulkner has extensive experience in product development, validation, manufacturing operations, supply chain, commercialization,

and quality management systems across the following therapeutic areas:

CNS, endocrinology, immunology, neurology, oncology, rare diseases,

and gene therapy.

Previously, Mr.

Faulkner was CTO at IO Biotech where he built and led the Technical Operations organization on the BLA

enabling submission of Cylembio®, a therapeutic cancer vaccine.

Faulkner also held senior roles at Homology Medicines as Head

of CMC Management & External Manufacturing for the IND submissions of multiple AAV vector programs.

In addition, Mr.

also the Product Operations Lead for the Rare Disease Business Unit at Shire (Takeda) overseeing product launch, commercialization and

life cycle management activities for Elaprase® (intrathecal delivery), Gattex®, Natpara®, and Plenadren®.

also spent over 15 years at Biogen involved in the product development, technology transfers, validation, registration, and commercialization

of Avonex®, Avonex Pen®, Tysabri®, and Tecfidera®.

Faulkner obtained an MBA from Boston University, a MS in Biotechnology

and Biomedical Science from the University of Massachusetts, Boston, and a BS in Biology from the State University of New York, Fredonia.

Faulkner is a Lean Six Sigma Green Belt and is an ISO 13485 certified auditor.

Our goal is to build a pipeline of neurology and

oncology focused assets that have the potential to be best-in-class and to improve outcomes for patients.

We are executing a decisive

strategic pivot to reposition the company for long-term success.

Our strategy to achieve this is to:

· Identify, evaluate and select assets with best-in-class potential .

In doing so, we intend to simultaneously develop clinical development plans

and regulatory strategies to transition to development efforts as efficiently as possible.

Our focus is on novel, differentiated assets

that are supported by a strong biological rationale.

Our parameters for asset selection will also include clinical development and regulatory

pathways, near-term milestones as well as commercial market viability.

We have initiated a global asset search and will continue to identify

and evaluate opportunities with the goal of securing the rights to an asset or assets that meet our criteria.

· Be data-driven in our decision making .

We recognize that drug development

is inherently risky.

We will prioritize assets with clear pathways to demonstrate differentiation and meaningfully de-risk development.

Our asset selection process is grounded in objective analysis of biological hypotheses that are supported by human genetics, translational

data, and early clinical evidence but remain unvalidated.

We will seek to prioritize programs with clearly defined development and clinical

inflection points that have the potential to meaningfully validate the underlying biology, target, and modality.

In evaluating potential

assets, we will consider development feasibility, regulatory pathways, commercial dynamics, and the ability to generate interpretable

data through near term clinical milestones.

· Deploy capital efficiently and with discipline.

Leveraging our team’s

experience across relevant therapeutic and functional areas, we believe we are well positioned to advance assets across their lifecycles.

This experience enables a holistic assessment of each program, including development timelines, capital requirements, and probability

weighted outcomes.

Drug development is a capital intensive, multi-year process, and we intend to pursue development strategies and regulatory

pathways designed to generate high quality data that support clinical advancement, informed decision making, and, where successful, regulatory

submissions for product approval.

· Patient focused development addressing serious unmet medical needs.

development efforts are centered on patients with serious diseases for which there are limited or inadequate treatment options.

we advance is grounded in a strong scientific rationale, with the potential to deliver clinically meaningful benefit and improve patient

In neurology, we focus on therapies that have the potential to modify disease progression rather than solely address symptoms.

In oncology, we prioritize programs with the potential to improve overall survival, durability of response, and quality of life for patients.

· Transform every aspect of CNS Pharmaceuticals.

Our executive team

was purpose-built to drive the Company’s strategic transformation.

In addition to building a new, high-value pipeline in neurology

and oncology, we are focused on transforming the way we operate and execute.

As our pipeline builds and advances, we will work to also

build our team, systems and capabilities in a stage-appropriate manner and with the intent of supporting our future growth.

Legacy GBM Assets

TPI 287 is an investigational chemotherapy agent

belonging to the abeotaxane class of compounds and is structurally related to the taxane family of microtubule-stabilizing agents.

such as paclitaxel and docetaxel are widely used in oncology but historically have demonstrated limited penetration across the blood-brain

barrier, which has restricted their use in treating cancers involving the central nervous system.

TPI 287 was designed as a synthetic, lipophilic

taxane derivative capable of penetrating the blood-brain barrier and achieving therapeutic concentrations within the central nervous system.

Like other taxanes, TPI 287 stabilizes microtubules, disrupting cell division and inducing apoptosis in rapidly proliferating tumor cells.

TPI 287 has been evaluated in multiple early-phase

clinical studies involving more than 300 patients across several oncology indications, including glioblastoma, metastatic breast cancer

with brain metastases, non-small cell lung cancer, castration-resistant prostate cancer and neuroblastoma.

A Phase 1/2 clinical study evaluated TPI 287 in

combination with bevacizumab in patients with recurrent glioblastoma.

In that study, the combination demonstrated an objective response

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

The regimen was generally

well tolerated in the study population.

In July 2024, the Company entered into an Exclusive

License Agreement with Cortice Biosciences, Inc.

pursuant to which the Company obtained exclusive rights to certain intellectual property

related to TPI 287 in the United States, Canada, Mexico and Japan.

The Company is currently exploring out-licensing

opportunities for TPI 287 to advance its development.

Berubicin is an investigational anthracycline chemotherapy

agent originally discovered at The University of Texas M.D.

Anderson Cancer Center.

Anthracyclines represent one of the most widely

used classes of chemotherapy agents in oncology.

Historically, however, anthracyclines have demonstrated limited penetration of the blood-brain

barrier, which has restricted their use in treating cancers of the central nervous system.

Preclinical and early clinical studies have suggested

that Berubicin may be capable of penetrating the blood-brain barrier and achieving therapeutic concentrations in brain tumors.

Berubicin was previously evaluated in Phase 1 clinical

trials conducted by Reata Pharmaceuticals in patients with recurrent malignant gliomas.

In that study, 25 patients were evaluable for

response and the trial observed one complete response, one partial response and several cases of stable disease, representing a disease

control rate of approximately 44%.

One patient who achieved a complete response remained disease-free more than 17 years following treatment

before passing away from causes unrelated to his GBM diagnosis.

The Company subsequently conducted a randomized

Phase 2 superiority clinical trial, known as CNS-201, evaluating Berubicin compared to lomustine in patients with recurrent glioblastoma

who had failed first-line therapy.

In March 2025, the Company announced topline results from the primary analysis of the trial.

Berubicin demonstrated clinical activity and outcomes that appeared comparable to lomustine across several endpoints, the trial did not

meet its primary end point in showing superiority compared to lomustine in overall survival.

The Company’s current plan for the Berubicin

program is to complete the trial, close the trial sites and prepare the Clinical Study Report for the CNS-201 trial.

As with TPI 287,

we are currently exploring out-licensing opportunities that would enable further development of Berubicin.

The biotechnology and pharmaceutical industries

are characterized by intense and rapidly evolving competition.

We face significant competition from a variety of companies, including

major pharmaceutical and biotechnology companies, early stage biotechnology companies, academic research institutions and other public

and private research organizations.

Many of our competitors have substantially greater financial, technical, manufacturing, marketing,

and human resources than we do.

Our competitors may succeed in developing products that are safer, more effective, or less costly than

any product candidates we may develop, which could render our product candidates non-competitive or obsolete.

Our strategic expansion into neurology brings us

into competition with one of the broadest and most active therapeutic areas in the pharmaceutical industry.

Neurological disorders including,

but not limited to, neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and ALS, as well as epilepsy, multiple

sclerosis, and neuropathic pain conditions represent large markets with substantial commercial interest.

Competitors in neurology include

major pharmaceutical companies with dedicated CNS franchises, such as Biogen, UCB, Novartis, AbbVie, and Eisai, as well as a large and

growing number of clinical-stage biotechnology companies.

The neurology space has experienced a significant resurgence of investment and

pipeline activity, driven in part by recent regulatory approvals for novel disease-modifying therapies in Alzheimer's disease and other

conditions, which has further increased competition for development resources, clinical investigators, and patient populations in clinical

The broader oncology market is among the most competitive

segments in the pharmaceutical industry.

Large, well-capitalized companies such as AstraZeneca, Bristol-Myers Squibb, Roche, Merck &

Co., Pfizer, Eli Lilly, and Johnson & Johnson, among many others, maintain extensive oncology pipelines with significant clinical,

regulatory, and commercial infrastructure.

In addition, numerous mid-size and emerging biotechnology companies are actively developing

oncology programs across modalities including targeted therapies, immunooncology agents, cell and gene therapies, radiopharmaceuticals,

and RNA-based medicines.

We expect competition in oncology to intensify as scientific understanding of tumor biology continues to advance

and as additional modalities enter clinical development.

Our ability to compete will depend on our ability to identify differentiated

targets and mechanisms of action, advance product candidates through clinical development efficiently, establish intellectual property

positions that provide meaningful market exclusivity, and enter into strategic partnerships or licensing arrangements that augment our

resources and expertise.

Our strategy depends on our ability to identify

and secure assets that are differentiated.

In addition to pharmaceutical and biotechnology companies with established pipelines, we also

face competition from companies that also seek to acquire or in-license assets including companies such as Roivant, Ligand Pharmaceuticals,

Fortress Biosciences and several other private and public companies.

These companies have more established track records of acquiring

or in-licensing assets, advancing assets through development and regulatory requirements and commercial capabilities than we do.

Many of our current or future competitors have

significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical

trials, obtaining regulatory approvals, obtaining reimbursement for and marketing of approved products than we do.

Mergers and acquisitions

in the biotechnology, pharmaceutical and diagnostic industries may result in even more resources being concentrated among a smaller number

of our competitors.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies.

These competitors also compete with us in recruiting and retaining qualified personnel

and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary

to, or necessary for, our programs.

Intellectual Property

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.

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,

Our intellectual property is comprised of patents

and know-how related to our legacy assets TPI 287 and Berubicin.

Existing TPI 287 patents will expire in 2028.

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

New Drug Application (“NDA”) in the United States.

During that period the FDA generally could not approve another product

containing the same drug for the same designated indication.

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.

We 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.

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 TPI 287 and Berubicin.

patent applications that potentially will 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.

1 unchanged sentence

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

Governmental Regulation

ability to out-license either of these programs.

G overnmental Regulation

Government authorities in the United States, at

164 unchanged sentences

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

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.

July 24, 2021, the Company received Fast Track Designation from the FDA for Berubicin.

The Company believes that TPI 287 has the potential

to qualify for Fast Track Designation as well.

However, at this time, we do not intend to develop Berubicin or TPI 287 further and are

instead focused on evaluating opportunities to out-license these programs.

Any product submitted to the FDA for market, including

126 unchanged sentences

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

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

In addition, the Company issued 1 share of the Company’s common stock

valued at $40,500 per share to HPI upon execution of the agreement.

3 unchanged sentences

ended December 31, 2025 and 2024, the Company recognized $0 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.

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.

5 unchanged sentences

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.

of regulatory or marketing exclusivity for such licensed product in such country, or (iii) the expiration of the last to expire valid

patent claim in such country covering such licensed product.

Employees and Human Capital

As of March 31, 2026, we had eight full time employees.

Five of our employees are members of our executive team.

Our human capital objectives include identifying, recruiting, retaining, incentivizing

and integrating our existing and new employees, advisors and consultants to support our operations as we obtain pipeline assets or the

rights to pipeline assets.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

our relationship with our employees to be good.

Working Capital

As a development-stage biotechnology

company, we have not generated any revenue from product sales and do not expect to generate product revenue unless and until we successfully

complete development of, obtain regulatory approval for, and commercialize one or more of our drug candidates.

We have incurred significant

operating losses since inception and expect to continue to incur losses for the foreseeable future as we invest in business development

activities to expand our pipeline, advance in-licensed drug candidates through clinical development and seek regulatory approvals.

of December 31, 2025, we had cash of approximately $7,201,000 and we had a working capital of approximately $4,002,000.

Currently, we

expect our cash on hand to fund operations into the third quarter of 2026.

We will need to raise significant additional capital in the

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

If we are unable to raise sufficient funds, we will be required

to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business plan until sufficient

additional capital is raised to support further operations.

There can be no assurance that such a plan will be successful and if it is

not successful we may need to cease operations entirely.

We have historically funded our operations primarily

through the sale of equity securities in public and private offerings.

We expect to continue to fund our operations through equity financings,

debt financings, collaborations, strategic alliances, licensing arrangements or other sources of capital as may be available to us.

ability to fund ongoing operations depends on our ability to raise additional capital through one or more of these methods.

be no assurance that we will be able to obtain additional financing on acceptable terms, or at all.

Our primary working capital needs relate to business

development activities to identify, evaluate and secure funding for research and development activities, including payments to contract

research organizations, contract manufacturing organizations and other third-party service providers, as well as general and administrative

expenses necessary to operate as a public company.

Legal Proceedings

9 unchanged sentences

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

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

Our corporate headquarters 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 when needed.

We do not own any real property.

17 unchanged sentences

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