What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-15 · 93 added, 70 removed, 213 unchanged (43% of the section changed)

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and uncertainties described under Item 1A.

“Risk Factors” of our Form 10-K for the year ended December 31, 2024 and in other

filings made by us from time to time with the SEC.

“Risk Factors” of our Form 10-K for the year ended December 31, 2024, our subsequent

Quarterly Reports on Form 10-Q, and in other filings made by us from time to time with the SEC.

While we believe we have identified material risks,

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We caution you not to place undue reliance on the

forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this

forward-looking statements contained in this Form 10-Q or any other document, which speak only as of their respective dates.

You should not rely upon forward-looking statements

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Berubicin was discovered at The University of Texas

Anderson Cancer Center (“UTMDACC”) by Dr.

Anderson Cancer Center 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.

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.

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.

We initiated this trial for patient

enrollment during the second quarter of 2021 with the first patient dosed during the third quarter of 2021 to investigate the efficacy

of Berubicin in adults with Glioblastoma Multiforme who have failed first-line therapy.

The first patient on the trial was treated during

the third quarter of 2021.

Correspondence between the Company and the FDA resulted in a trial design with 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

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who have failed primary treatment for their disease.

The trial, compares the efficacy of Berubicin to that of Lomustine, a current standard

The trial compared 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.

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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,

On March 25, 2025, we 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.

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

and (v) 3 shares of our common stock.

and (v) one share of our common stock.

patents we licensed from HPI expired in March 2020.

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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

License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice 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 June 30, 2025 Compared

to the Three Months Ended June 30, 2024

General and Administrative Expense

General and administrative expense was approximately

$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.

$1,242,000 for the three months ended June 30, 2025 compared to approximately $1,412,000 for the comparable period in 2024.

in general and administrative expense is attributable to decreases of approximately $36,000 in legal and professional expenses, $19,000

in travel expenses, $195,000 in stock-based compensation, which were offset by increases of approximately $51,000 in compensation expense

and $29,000 in insurance expense.

Research and Development Expense

Research and development expense was approximately $1,167,000 for the

three months ended June 30, 2025 compared to approximately $1,117,000 for the comparable period in 2024.

The increase in research and

development expense during the period is primarily attributable to declining trial costs on the Berubicin trial offset by expenditures

preparing for a TPI 287 trial including drug manufacturing.

The net loss for the three months ended June 30,

2025 was approximately $2,375,000 compared to approximately $2,531,000 for the comparable period in 2024.

The change in net loss is primarily

attributable to declining trial costs on the Berubicin trial.

Results of Operations for the Six Months Ended June 30, 2025 Compared

to the Six Months Ended June 30, 2024

General and Administrative Expense

General and administrative expense was approximately

$2,337,000 for the six months ended June 30, 2025 compared to approximately $2,526,000 for the comparable period in 2024.

in general and administrative expense is attributable to decreases of approximately $316,000 in stock-based compensation, $106,000 in

marketing and advertising expenses, which were offset by increases of approximately $40,000 in legal and professional expenses, $62,000

in travel expenses, $105,000 in compensation expense and $26,000 in other expenses.

Research and Development Expense

Research and development expense was approximately

$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,

$4,410,000 for the six months ended June 30, 2025 compared to approximately $3,547,000 for the comparable period in 2024.

in research and development expense during the period is primarily attributable to timing of trial costs on the Berubicin trial.

The net loss for the six months ended June 30,

2025 was approximately $6,676,000 compared to approximately $6,076,000 for the comparable period in 2024.

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.

The change in net loss is primarily

attributable to timing of trial costs on the Berubicin trial partially offset by lower G&A expenses.

Liquidity and Capital Resources

On March 31, 2025, we had cash of approximately

On June 30, 2025, we had cash of approximately

$12,130,000 and we had a working capital of approximately $12,755,000.

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(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.

During the six months ended June

30, 2025, we sold 127,582 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9 million.

As of June 30, 2025, we had sold 210,230 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately

$22.8 million.

On May 13, 2025, the Company entered into a placement

agency agreement with AGP for the public offering of (i) 27,084 shares) of common stock;

(ii) pre-funded warrants to purchase 302,298

shares of common stock (the “Pre-Funded Warrants”);

and (iii) Series F Warrants to purchase up to an aggregate of 329,381

shares of common stock (the “Common Warrants”).

The net proceeds from the offering were approximately $4.5 million.

We estimate that we have sufficient working 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).

We do not currently have a firm trial design for TPI 287 so estimates

of development cost are not available, however, regardless of trial design, the cost of bringing TPI 287 to regulatory approval for marketing

will require significant additional financing.

The timing and costs of clinical trials are difficult to predict and as such the foregoing

estimates may prove to be inaccurate.

We have no commitments for such additional needed financing and will likely be required to raise

such financing through the sale of additional equity or debt securities.

We will need to raise significant

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Net cash used in operating activities was approximately

$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.

$8,585,000 and $4,842,000 for the six months ended June 30, 2025 and 2024, respectively, and mainly included payments made for clinical

trial costs, drug manufacturing and development, 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

$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.

$14,254,000 for the six months ended June 30, 2025, related to the sale of common stock, which were offset by the repayment of notes payable.

Net cash provided by financing activities was approximately $5,785,000 for the six months ended June 30, 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 March 31, 2025, we did not have any relationships

As of June 30, 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,

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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