What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-05-15 compared with 2024-11-14 · 163 added, 212 removed, 120 unchanged (76% of the section changed)

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

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

and The University of Texas M.D.

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

agreement with Reata Pharmaceuticals, Inc.

We believe our lead drug candidate, Berubicin,

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

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

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

We believe our drug candidates, TPI 287 and Berubicin,

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

Food and Drug

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

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

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

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

blood vessels.

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

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

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

While our focus is currently on the development of Berubicin,

we are also in the process of attempting to secure intellectual property rights to additional compounds that we plan to develop into drugs

to treat CNS and other cancers.

Berubicin was discovered at UTMDACC by Dr.

Priebe, the founder of the Company.

Through a series of transactions, Berubicin was initially licensed to Reata.

Reata initiated several

Phase I clinical trials with Berubicin for CNS malignancies, one of which was for malignant gliomas, but subsequently allowed their IND

with the FDA to lapse for strategic reasons.

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

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

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

Based on limited clinical

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

concentrations targeting brain cancer cells.

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

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

While our focus is currently on the development of TPI 287

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

develop into drugs to treat CNS and other cancers.

TPI 287 has been granted Orphan Drug Designation

(“ODD”) status by the FDA.

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

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

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

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

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

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

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

be filed related to TPI 287 to extend additional protections.

TPI 287 is an abeotaxane and is an investigational

chemotherapy agent classified as a third-generation taxane derivative.

It was developed to address some of the limitations of earlier

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

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

than its predecessors.

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

and induces apoptosis.

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

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

This feature gives TPI 287 potential utility in treating

drug-resistant cancers in the CNS.

TPI 287 has been studied in early-phase clinical

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

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

TPI 287 represents a promising

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

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

Berubicin was discovered at The University of Texas

Anderson Cancer Center (“UTMDACC”) by Dr.

Waldemar Priebe, the founder of the Company.

Through a series of transactions,

Berubicin was initially licensed to Reata.

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

which was for malignant gliomas, but subsequently allowed their Investigational New Drug (“IND”) with the FDA to lapse for

strategic reasons.

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

On December 17, 2020, we announced that our IND application with the FDA for Berubicin for the treatment of Glioblastoma Multiforme was

We initiated this trial for patient enrollment during the second quarter of 2021 with the first patient dosed during the third

quarter of 2021 to investigate the safety and efficacy of Berubicin in adults with Glioblastoma Multiforme who have failed first-line

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.

a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement

can be shown relative to a randomized control arm.

The current trial being conducted will evaluate

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

results will be compared to the safety and 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

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

Board (“DSMB”) was responsible for conducting.

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

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

modification or discontinuation of the study.

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

the study without modification.

The recently released topline data showed that although Berubicin produced clinically relevant outcomes

that appear to be comparable (although the trial was not powered to determine non-inferiority) to Lomustine across multiple endpoints,

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

Nevertheless, given the dearth

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

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

Any such path will be planned and executed

in consultation with the FDA.

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

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

We do not have manufacturing facilities and all

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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:

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

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

HPI is affiliated with our founder, Dr.

Under the HPI License

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

HPI License we agreed to pay HPI:

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

(ii) a 2% royalty on net sales;

(ii) a 2% royalty

on net sales;

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

(iv) milestone payments of $100,000 upon the commencement of a Phase II trial and $1.0 million upon

the approval of a New Drug Application (“NDA”) for Berubicin;

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

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

and (v) 3 shares of our common stock.

The patents we licensed

from HPI expired in March 2020.

On May 14, 2024, the Company provided notice to HPI of its intent to terminate the HPI License effective

on or about July 14, 2024.

patents we licensed from HPI expired in March 2020.

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

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

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

ODD from the FDA is available for drugs targeting diseases with

less than 200,000 cases per year.

ODD may enable market exclusivity of 7 years from the date of approval of a NDA in the United States.

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

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

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

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

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

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

We believe we have obtained all rights and intellectual

property necessary to develop Berubicin.

As stated earlier, it is our plan to obtain additional intellectual property covering other compounds

which, subject to the receipt of additional financing, may be developed into drugs for brain and other cancers.

On January 10, 2020, we entered into a Patent and

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

of the State of Texas, on behalf of the UTMDACC.

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

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

25, 2024, UTMDACC provided notice to us if its intent to terminate the WP1244 Agreement if we fail to pay the annual maintenance fee of

$50,000, as well as $1,300 in expenses.

On May 25, 2024 the WP1244 Agreement was terminated.

There are no termination penalty provisions

in the Agreement.

Results of Operations for the Three Months Ended September 30, 2024

Compared to the Three Months Ended September 30, 2023

General and Administrative Expense

General and administrative expense was approximately

$1,384,000 for the three months ended September 30, 2024 compared to approximately $1,123,000 for the comparable period in 2023.

in general and administrative expense was mainly attributable to increases of approximately $269,000 in legal and professional expenses,

$63,000 in stock- based compensation and $12,000 in other expenses, which were offset by decreases of approximately $60,000 in marketing

, advertising expenses and $23,000 in insurance expense.

Research and Development Expense

Research and development expense was approximately

$4,245,000 for the three months ended September 30, 2024 compared to approximately $3,411,000 for the comparable period in 2023.

in research and development expenses during the period were mainly attributed to license expenses related to the Cortice Agreements entered

during the quarter.

The net loss for the three months ended September

30, 2024 was approximately $5,606,000 compared to approximately $4,523,000 for the comparable period in 2023.

The change in net loss

is attributable to an increase in CRO expenses related to continued progress with our potentially pivotal Phase II clinical trial of

Berubicin, as well as increases in legal and professional fees and other expenses.

Results of Operations for the Nine Months Ended September 30, 2024

Compared to the Nine Months Ended September 30, 2023

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.

Results of Operations for the Three Months Ended March 31, 2025

Compared to the Three Months Ended March 31, 2024

General and Administrative Expense

General and administrative expense was approximately

$3,910,000 for the nine months ended September 30, 2024 compared to approximately $3,662,000 for the comparable period in 2023.

in general and administrative expense was mainly attributable to increases of approximately $449,000 in professional expenses and

$11,000 in other expenses, which were offset by decreases of approximately $106,000 in marketing and advertising expense, $77,000 in insurance

expense and $18,000 in travel expenses and $11,000 in stock- based compensation.

$1,095,000 for the three months ended March 31, 2025 compared to approximately $1,114,000 for the comparable period in 2024.

in general and administrative expense was attributable to increases of approximately $76,000 in legal and professional expenses, $54,000

in compensation expense, $80,000 in travel expenses, and $13,000 in other expenses, which were offset by decreases of approximately $120,000

in stock-based compensation, $103,000 in marketing, advertising expenses and $19,000 in insurance expense.

Research and Development Expense

Research and development expense was approximately

$7,792,000 for the nine months ended September 30, 2024 compared to approximately $9,824,000 for the comparable period in 2023.

in research and development expenses during the period were mainly attributed to the timing of research organization (CRO) expenses related

to continued progress with our Phase II clinical trial.

Our CRO expenditures are primarily for labor related to activating selected trial

sites, managing patient enrollment processes, collecting and managing data from patient treatments throughout the trial, processing reimbursement

to the sites for patient treatment, and assisting with necessary submissions to amend the IND.

CRO expenditures are expected to continue

to decline throughout the remainder of the trial as the final patients complete treatment and enter follow-up.

The net loss for the nine months ended September

$3,243,000 for the three months ended March 31, 2025 compared to approximately $2,430,000 for the comparable period in 2024.

in research and development expenses during the period were mainly attributed to the costs of data clean-up, preparation and analysis

for the topline primary data release on the Berubicin trial.

The net loss for the three months ended March 31,

2025 was approximately $4,301,000 compared to approximately $3,545,000 for the comparable period in 2024.

in net loss is attributable to a decrease in CRO expenses related to continued progress with our potentially pivotal Phase II clinical

trial of Berubicin, as well as decreases in contract labor.

The change in net loss is attributable

to license expenses related to the Cortice Agreements entered in July 29, 2024 as well as the costs of data preparation and analysis for

the topline data release on the Berubicin trial.

Liquidity and Capital Resources

On September 30, 2024, we had cash of approximately

On March 31, 2025, we had cash of approximately

$13,048,000 and we had a working capital of approximately $10,943,000.

We fund our operations from proceeds from equity sales.

On January 29, 2024, we completed a public offering

of (i) 44,314 shares of our common stock;

(ii) pre-funded warrants to purchase 222,354 shares of common stock;

(iii) Series A Warrants

to purchase up to an aggregate of 266,667 shares of common stock;

and (iv) Series B Warrants to purchase up to an aggregate of 266,667

shares of common stock.

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

$15 and the combined purchase price of one pre-funded warrant and accompanying Series A & B common warrants was $14.95 (with the pre-funded

warrants having an exercise price of $0.001).

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

The gross proceeds

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

On June 14, 2024, we entered into agreements with

institutional investors for the sale of 336,000 shares of our common stock and pre-funded warrants to purchase 30,000 shares of common

stock in lieu thereof (the “June 14 Pre-Funded Warrants”) in a registered direct offering.

In a concurrent private placement,

we also sold to the investors unregistered warrants to purchase up to an aggregate of 366,000 shares of common stock (the “June

14 Common Warrants”).

The combined purchase price of one share of common stock (or pre-funded warrant in lieu thereof) and accompanying

June 14 Common Warrant was $3.75.

The gross proceeds from the offering were approximately $1.37 million, resulting in net proceeds, after

payment of commissions and expenses, received by us of $1,203,267.

On June 26, 2024, we entered into agreements with

institutional investors for the sale of 568,000 shares of our common stock in a registered direct offering.

In a concurrent private placement,

we also sold to the investors unregistered warrants to purchase up to an aggregate of 568,000 shares of common stock (the “June

26 Common Warrants”).

The combined purchase price of one share of common stock and accompanying June 26 Common Warrant was $2.45.

The gross proceeds from the offering were approximately $1.39 million resulting in net proceeds, after payment of commissions and expenses,

received by the Company of $1,221,146.

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

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

Pursuant to the terms

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

shares of the Company’s common stock with initial aggregate sales price of up to $5.2 million.

On July 30, 2024, the Company increased

the aggregate sales price of common shares that may be sold under the AGP ATM Sales Agreement to $25.0 million (not including the original

$5.2 million).

As of September 30, 2024, the Company has sold 30,004,761 shares of common stock pursuant to the Agreement for net proceeds

of approximately $10.6 million.

On October 23, 2024, the Company entered into a

placement agency agreement (the “Placement Agency Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”)

in connection with the sale by the Company of:

(i) 3,700,000 shares (the “Shares”) of the Company’s common stock, and

(ii) pre-funded warrants to purchase 13,947,060 shares of common stock (the “Pre-Funded Warrants”), in a registered direct

offering (the “Offering”).

The per share purchase price of each share of common stock was $0.17 per share and the purchase

price for each Pre-Funded Warrant was $0.169 per Pre-Funded Warrant.

In connection with the Offering, the Company entered into a Securities

Purchase Agreement with certain institutional investors that participated in the Offering.

The closing of the Offering occurred on

October 24, 2024.

The gross proceeds to the Company from the Offering were approximately $3.0 million, before deducting the Placement

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

Pursuant to the terms of the AGP ATM Sales Agreement,

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

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

Subsequent to September 30, 2024, the

Company has sold 6,393,243 Shares pursuant to the Agreement for net proceeds of approximately $1.6 million.

Our plan of operations is primarily focused on

completing a clinical trial for Berubicin.

Our current expectation is that our cash on hand as of the date of this filing is sufficient

to fund our operations through the first quarter of 2025.

We currently expect to release final top-line data for our potentially pivotal

trial of Berubicin in the first half of 2025.

If capital is available to fund TPI 287 clinical preparations and drug manufacturing for

a potentially pivotal Phase 2 trial of TPI 287, we would need to raise an additional $4.0 million to support near-term development of

that program.

The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances

and as such the foregoing estimates may prove to be inaccurate.

On July 26, 2024, we entered into a Sales Agreement

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

During the period ended March 31,

2025, we sold 1,530,985 shares of common stock pursuant to the Agreement for net proceeds of approximately $9 million.

As of March 31,

2025, we had sold 2,522,758 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $22.8 million.

Subsequent to March 31, 2025, on May 13, 2025,

the Company completed a public offering with net proceeds to the Company of approximately $4.5 million,

Including the capital raised in the public offering

on May 13, 2025, we estimate that we have sufficient capital to take us into the second half of 2026.

At that point, we expect to have

already initiated a trial of TPI 287, as well as completed the Berubicin trial including its final analysis.

In addition, we have working

capital to fund our operations during the intervening period (with such operations estimated at $4.5 to $5.0 million per annum).

not currently have a firm trial design for TPI 287 so estimates of development cost are not available, however, regardless of trial design,

the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing.

The timing and costs

of clinical trials are difficult to predict and as such the foregoing estimates may prove to be inaccurate.

We have no commitments for

such additional needed financing and will likely be required to raise such financing through the sale of additional equity or debt securities.

We will need to raise significant

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

If we are unable to raise sufficient

funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our

business plan until sufficient additional capital is raised to support further operations.

There can be no assurance that such a plan

will be successful and if it is not successful we may need to cease operations entirely.

Summary of Cash Flows

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Net cash used in operating activities was approximately

$11,642,000 and $11,604,000 for the nine months ended September 30, 2024 and 2023, respectively, and mainly included payments made for

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

$3,242,000 and $3,192,000 for the three months ended March 31, 2025 and 2024, respectively, and mainly included payments made for clinical

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

Cash provided by financing activities

Net cash provided by financing activities was approximately

$18,067,000 for the nine months ended September 30, 2024, related to the sale of common stock and exercise of warrants, which were offset

by the repayment of notes payable and payment of deferred offering costs.

Net cash provided by financing activities was approximately

$2,460,000 for the nine months ended September 30, 2023, related to the sale of common stock and exercise of warrants, which were offset

by the repayment of notes payable.

$9,828,000 for the three months ended March 31, 2025, related to the sale of common stock, which were offset by the repayment of notes

Net cash provided by financing activities was approximately $3,459,000 for the three months ended March 31, 2024, related to

the sale of common stock and exercise of warrants, which were offset by the repayment of notes payable.

Off-balance Sheet Arrangements

As of September 30, 2024, we did not have any relationships

As of March 31, 2025, we did not have any relationships

with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities,

2 unchanged sentences

We do not have any material commitments for capital

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

JOBS Act Accounting Election

The Jumpstart Our Business Startups Act of 2012,

or the JOBS Act, exempts an “emerging growth company” such as us from being required to comply with new or revised financial

accounting standards until private companies are required to comply with the new or revised financial accounting standards.

provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging

growth companies but any such election to opt out is irrevocable.

We elected not to opt out of such extended transition period which means

that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth

company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.

This may make comparison

of our financial statements with another public company which is neither an emerging growth company nor an emerging growth company which

has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards

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

Critical Accounting Policies and Estimates

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis