What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-14 compared with 2023-05-15 · 67 added, 37 removed, 252 unchanged (29% of the section changed)

122 unchanged sentences

We have historically

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

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

Taking into account the recent rate of enrollment and the

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

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

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

Additional analyses that will be provided based on

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

We have not met the commercial diligence milestones required as of the date hereof.

As such, UTMDACC has the right to terminate the WP1244

Agreement upon notice to us.

As of the date of this report, UTMDACC has not notified us of its intention to terminate the WP1244 Agreement.

On May 7, 2020, pursuant to the WP1244 portfolio

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on March 31, 2023.

Results of Operations for the Three Months Ended March 31, 2023

Compared to the Three Months Ended March 31, 2022

Results of Operations for the Three Months Ended June 30, 2023 Compared

to the Three Months Ended June 30, 2022

General and Administrative Expense

General and administrative expense was approximately

$1,359,000 for the three months ended March 31, 2023 compared to approximately $1,260,000 for the comparable period in 2022.

in general and administrative expense was mainly attributable to increases of approximately $75,000 for legal and professional expenses,

$37,000 in advertising and marketing, $18,000 in board compensation, $19,000 in travel expenses and $15,000 in other expenses, which were

offset by a decrease of approximately $47,000 in stock compensation and $18,000 in insurance expenses.

Our general and administrative

expenses are expected to remain approximately at these levels for the remainder of this year.

$1,180,000 for the three months ended June 30, 2023 compared to approximately $1,343,000 for the comparable period in 2022.

in general and administrative expense was mainly attributable to decreases of approximately $176,000 for employee compensation and

taxes, $100,000 in legal and professional expenses, $22,000 in insurance expenses and $12,000 in other expenses, which were offset by increases

of approximately $60,000 in marketing and advertising, $24,000 in board compensation and $39,000 in travel expenses.

Research and Development Expense

Research and development expense was approximately

$3,568,000 for the three months ended March 31, 2023 compared to approximately $1,889,000 for the comparable period in 2022.

$2,846,000 for the three months ended June 30, 2023 compared to approximately $2,221,000 for the comparable period in 2022.

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 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,

to continued progress with our clinical trial for 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 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.

expect to incur increased research and development costs in the future as we continue our clinical trial for Berubicin.

The net loss for the three months ended June 30,

2023 was approximately $4,021,000 compared to approximately $3,566,000 for the comparable period in 2022.

The change in net loss is attributable

to an increase in CRO expenses related to continued progress with our Phase II clinical trial, a credit to research and development expense

in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their

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

to an increase in CRO expenses related to continued progress with our clinical trial for Berubicin, a credit to research and development

expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product

for their clinical trials, as well as increases in legal and professional fees and other expenses.

Results of Operations for the Six Months Ended June 30, 2023 Compared

to the Six Months Ended June 30, 2022

General and Administrative Expense

General and administrative expense was approximately

$2,539,000 for the six months ended June 30, 2023 compared to approximately $2,603,000 for the comparable period in 2022.

in general and administrative expense was mainly attributable to decreases of approximately $175,000 for employee compensation and

taxes, $43,000 in stock based compensation, $44,000 in legal and professional expenses, and $40,000 in insurance expenses, which were

offset by increases of approximately $97,000 in marketing and advertising, $42,000 in board compensation and $73,000 in travel expenses

and $26,000 in other expenses.

Research and Development Expense

Research and development expense was approximately

$6,413,000 for the six months ended June 30, 2023 compared to approximately $4,110,000 for the comparable period in 2022.

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 clinical trial for 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 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.

expect to incur increased research and development costs in the future as we continue our clinical trial for Berubicin.

The net loss for the six months ended June 30,

2023 was approximately $8,953,000 compared to approximately $6,718,000 for the comparable period in 2022.

The change in net loss is attributable

to an increase in CRO expenses related to continued progress with our clinical trial for Berubicin, a credit to research and development

expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product

for their clinical trials.

Liquidity and Capital Resources

On March 31, 2023, we had

cash of approximately $5,111,000 and we had working capital of approximately $3,049,000.

We fund our operations from proceeds from equity

On June 30, 2023, we had cash

of approximately $4,279,000 and we had working capital of approximately $2,074,000.

We fund our operations from proceeds from equity sales.

We believe that our cash on hand is sufficient

to fund our planned operations into, but not beyond, the third quarter of 2023.

to fund our planned operations into, but not beyond, the fourth quarter of 2023.

Our plan of operations is

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We estimate that we will require additional financing of approximately

$15.5 to $19.5 million to complete the Phase 2 trial for Berubicin (taking into account our cash on hand as of March 31, 2023 of approximately

$9.1 to $13.1 million to complete the clinical trial for Berubicin (taking into account our cash on hand as of June 30, 2023 of approximately

$4.3 million), approximately $5.0 million to support near-term WP1244/WP1874 preclinical work, plus such additional working capital to

1 unchanged sentence

Our current expectation is that our cash on hand is sufficient to fund our operations

into the third quarter of 2023.

into the fourth quarter of 2023.

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

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Net cash used in operating activities was approximately

$4,825,000 and $3,077,000 for the three months ended March 31, 2023 and 2022, respectively, and mainly included payments made for clinical

$8,227,000 and $6,440,000 for the six months ended June 30, 2023 and 2022, respectively, and mainly included payments made for clinical

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

Cash provided by financing activities

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.

Net cash provided by financing activities was approximately $10,513,000 for the three months ended March

31, 2022, related to the sale of common stock and exercise of warrants, which were offset by the repayment of notes

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 provided by financing activities was approximately $10,397,000 for the six

months ended June 30, 2022, 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, 2023, we did not have any relationships

As of June 30, 2023, 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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We do not have any material commitments for capital

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

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

JOBS Act Accounting Election

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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