What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-08-14 compared with 2024-05-15 · 104 added, 75 removed, 221 unchanged (45% of the section changed)

44 unchanged sentences

limited to, statements about:

our ability to maintain our listing on the Nasdaq Capital Market;

our ability to obtain additional funding to develop our product candidates;

97 unchanged sentences

and (v) 134 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.

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.

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

18 unchanged sentences

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

In consideration,

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

minimum annual royalties) for sales of licensed products developed under the WP1244 Agreement.

The term of the WP1244 Agreement expires

on the last to occur of:

(a) the expiration of all patents subject to the WP1244 Agreement, or (b) fifteen years after execution;

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

have not met the commercial diligence milestones and have not paid the annual maintenance fee required as of the date hereof.

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.

As of the date hereof, the we have not determined whether to cure the foregoing defaults.

fail to cure the defaults, on May 25, 2024, the WP1244 Agreement will terminate.

On May 7, 2020, pursuant to the WP1244 portfolio

license agreement described above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating to

novel anticancer agents targeting CNS malignancies.

The Company agreed to fund approximately $1,134,000 over a two-year period.

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

The remaining $800,000 was paid in 2021.

The principal investigator for this agreement is Dr.

The work conducted under

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

We believe the enhanced solubility of this

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

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

This agreement was extended and expired

on March 31, 2023.

Results of Operations for the Three Months Ended March 31, 2024

Compared to the Three Months Ended March 31, 2023

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 June 30, 2024 Compared

to the Three Months Ended June 30, 2023

General and Administrative Expense

General and administrative expense was

approximately $1,412,000 for the three months ended June 30, 2024 compared to approximately $1,180,000 for the

comparable period in 2023.

The increase in general and administrative expense was mainly attributable to increases of approximately

$333,000 in legal and professional expenses, which were offset by decreases of approximately $65,000 in marketing and advertising

expenses, $34,000 in insurance expense and $2,000 in other expenses.

Research and Development Expense

Research and development expense was approximately

$1,117,000 for the three months ended June 30, 2024 compared to approximately $2,846,000 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 potentially pivotal Phase II clinical trial of Berubicin.

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

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 three months ended June 30,

2024 was approximately $2,531,000 compared to approximately $4,021,000 for the comparable period in 2023.

The change 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 legal and professional fees and other expenses.

Results of Operations for the Six Months Ended June 30, 2024 Compared

to the Six Months Ended June 30, 2023

General and Administrative Expense

General and administrative expense was approximately

$1,114,000 for the three months ended March 31, 2024 compared to approximately $1,359,000 for the comparable period in 2023.

in general and administrative expense was mainly attributable to decreases of approximately $118,000 in legal and professional expenses,

$20,000 in insurance expenses and $58,000 in stock compensation, $39,000 in travel expenses and $29,000 in other general and administrative

expenses, which were offset by increases of approximately $19,000 in marketing and advertising expenses.

$2,526,000 for the six months ended June 30, 2024 compared to approximately $2,539,000 for the comparable period in 2023.

The increase in general and administrative expense was mainly attributable to increases of approximately $179,000 in legal and professional

expenses, which were offset by decreases of approximately $75,000 in stock- based compensation, $46,000 in marketing and advertising expense

and $54,000 in insurance expense.

Research and Development Expense

Research and development expense was approximately

$2,430,000 for the three months ended March 31, 2024 compared to approximately $3,568,000 for the comparable period in 2023.

$3,547,000 for the six months ended June 30, 2024 compared to approximately $6,413,000 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

3 unchanged sentences

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

CRO expenditures are expected to remain

relatively consistent with the current quarter throughout the remainder of the trial as site activation efforts and the associated costs

thereof transition into reimbursing clinical trial sites for patient treatment costs as site and patient enrollment increases.

to incur increased research and development costs in the future as we continue our Phase II clinical trial.

The net loss for the three months ended March 31, 2024 was approximately

$3,545,000 compared to approximately $4,932,000 for the comparable period in 2023.

The change in net loss is attributable to an decrease

in CRO expenses related to continued progress with our Phase II clinical trial, as well as decreases in legal and professional fees and

other expenses.

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 six months ended June 30,

2024 was approximately $6,076,000 compared to approximately $8,953,000 for the comparable period in 2023.

The change 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 legal and professional fees and other expenses.

Liquidity and Capital Resources

On March 31, 2024, we had cash of approximately

On June 30, 2024, we had cash of approximately

$1,492,000 and we had a working capital deficit of approximately $4,617,000.

We fund our operations from proceeds from equity sales.

On January 29, 2024, we entered into a placement

agency agreement with A.G.P./Alliance Global Partners (“AGP”) and Maxim Group LLC (“Maxim”) for the public offering

We fund our operations from proceeds from equity

On January 29, 2024, we completed a public offering

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

5 unchanged sentences

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

$0.30 and the combined purchase price of one pre-funded warrant and accompanying Series A & B common warrants was $0.299 (with the

pre-funded warrants having an exercise price of $0.001).

$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.

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

Our plan of operations is

primarily focused on completing a clinical trial for Berubicin.

We estimate that we will require additional financing of approximately

$13 to $15 million to complete the potentially pivotal Phase 2 trial for Berubicin (taking into account our cash on hand as of March 31,

2024 of approximately $0.8 million) plus such additional working capital to fund our operations during the pendency of the trial (with

such operations estimated at $4.5 to $5.0 million per annum).

If capital is available to fund WP1244/WP1874 preclinical work to prepare

for a Phase 1 trial, we would need to raise an additional $5.0 million to support near-term development of that program.

Our current expectation

is that our cash on hand is sufficient to fund our operations into the latter half of the second quarter of 2024.

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.

We will need to raise very

significant additional capital in the near term in order to meet our past due and future obligations and execute our business plan.

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.

be no assurance that such a plan will be successful and if it is not successful we may need to cease operations entirely.

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

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 August 14, 2024, the Company has sold 28,704,761 Shares pursuant to the Agreement

for net proceeds of approximately $10.5 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.

We will need to raise additional capital in the

near term in order to continue to meet the Nasdaq minimum equity requirement.

If we are unable to raise sufficient funds, we may be delisted

by Nasdaq and 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

1 unchanged sentence

Net cash used in operating activities was approximately

$3,192,000 and $4,825,000 for the three months ended March 31, 2024 and 2023, respectively, and mainly included payments made for clinical

$4,842,000 and $8,227,000 for the six months ended June 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.

1 unchanged sentence

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

$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 and payment of deferred offering costs.

Net cash provided by financing activities was approximately $2,451,000

for the six months ended June 30, 2023, related to the sale of common stock and exercise of warrants, which were offset

by the repayment of notes payable.

Net cash used in financing activities was approximately $120,000 for the three months ended March 31,

2023, related to the repayment of notes payable, which were offset by the exercise of warrants.

Off-balance Sheet Arrangements

As of March 31, 2024, we did not have any relationships

As of June 30, 2024, 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 as described in the section “Overview” above.

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

23 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-Q

Item 2. Management’s Discussion and Analysis