What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-14 compared with 2023-08-14 · 90 added, 92 removed, 227 unchanged (44% of the section changed)

104 unchanged sentences

to a randomized control arm.

The current trial being conducted will evaluate

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

be compared to the efficacy of Lomustine, a current standard of care in this setting, with a 2 to 1 randomization of the estimated 243

patients to Berubicin or Lomustine.

Patients receiving Berubicin will be 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 weeks.

trial will include a pre-planned, non-binding interim futility analysis which will be conducted by an independent Data Safety Monitoring

Board (DSMB) to recommend whether this study should continue as planned based on Berubicin showing statistically significant value as

a second-line treatment for patients with glioblastoma compared with Lomustine.

We will conduct this analysis 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 (death).

This recommendation will review the number of deaths on each arm to ensure that the overall survival of patients

receiving Berubicin shows a statistically significant comparability to or is even higher than those receiving Lomustine.

The median survival

of patients receiving second-line treatment for glioblastoma has historically been shown to be approximately 6 months.

We have historically

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 fourth quarter of 2023.

Additional analyses that will be provided based on

this data will be comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

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.

current trial being conducted will evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme who have failed primary

treatment for their disease, and results will be compared to the efficacy of Lomustine, a current standard of care in this setting, with

a 2 to 1 randomization of the estimated 243 patients to Berubicin or Lomustine.

Patients receiving Berubicin will be 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).

is administered orally once every six weeks.

The trial will include a pre-planned, non-binding interim futility analysis which will be

conducted by an independent Data Safety Monitoring Board (DSMB) to recommend whether this study should continue as planned based on Berubicin

showing statistically significant value as a second-line treatment for patients with glioblastoma compared with Lomustine.

We will conduct

this analysis 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 (death).

recommendation will review the number of deaths on each arm to ensure that the overall survival of patients receiving Berubicin shows

a statistically significant comparability to or is even higher than those receiving Lomustine.

The median survival of patients receiving

second-line treatment for glioblastoma has historically been shown to be approximately 6 months.

We have historically 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 fourth quarter of 2023.

Additional analyses that will be provided based on this data will be comparisons

of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

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 March 31, 2023.

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

to the Three Months Ended June 30, 2022

of Operations for the Three Months Ended September 30, 2023 Compared to the Three Months Ended September 30, 2022

General and Administrative Expense

General and administrative expense was approximately

$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.

$1,123,000 for the three months ended September 30, 2023 compared to approximately $1,211,000 for the comparable period in 2022.

in general and administrative expense was mainly attributable to decreases of approximately $73,000 in legal and professional expenses,

$29,000 in insurance expenses and $68,000 in stock compensation and $6,000 in other general and administrative expenses, which were offset

by increases of approximately $15,000 in marketing and advertising, $28,000 in board compensation and $45,000 in travel expenses.

Research and Development Expense

Research and development expense was approximately

$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 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,

$3,411,000 for the three months ended September 30, 2023 compared to approximately $2,208,000 for the comparable period in 2022.

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

patient treatment costs 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

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.

We expect to incur increased research and development costs in the future as we continue our clinical

trial for Berubicin primarily due to higher patient enrollment and the associated cost of treating these patients.

The net loss for the three months ended September

30, 2023 was approximately $4,523,000 compared to approximately $3,420,000 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, 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

The change in net loss is

attributable to an increase in CRO expenses and patient treatment costs 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.

of Operations for the Nine Months Ended September 30, 2023 Compared to the Nine Months Ended September 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.

$3,662,000 for the nine months ended September 30, 2023 compared to approximately $3,815,000 for the comparable period in 2022.

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

4 unchanged sentences

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,

$9,824,000 for the nine months ended September 30, 2023 compared to approximately $6,318,000 for the comparable period in 2022.

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

patient treatment costs 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

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.

We expect to incur increased research and development costs in the future as we continue our clinical

trial for Berubicin primarily due to higher patient enrollment and the associated cost of treating these patients.

The net loss for the nine months ended September

30, 2023 was approximately $13,476,000 compared to approximately $10,137,000 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.

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 June 30, 2023, we had cash

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

On September 30, 2023, we had cash of approximately

$910,000 and we had a working capital deficit of approximately $2,007,000.

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 fourth quarter of 2023.

Our plan of operations is

primarily focused on completing a clinical trial for Berubicin.

We estimate that we will require additional financing 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

fund our operations during the pendency of the trial.

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

into the fourth quarter of 2023.

believe that our cash on hand is sufficient to fund our planned operations into, but not beyond, the fourth quarter of 2023, and with

the cash received subsequent to September 30, 2023 for the Inducement Warrant Shares, is sufficient to fund our planned operations through

the end of the fourth quarter of 2023.

Our plan of operations is primarily focused on

completing a clinical trial for Berubicin.

We estimate that we will require additional financing of approximately $9.4 to $13.4 million

to complete the clinical trial for Berubicin (taking into account our cash on hand as of September 30, 2023 of approximately $0.9 million),

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

during the pendency of the trial.

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 order to meet our 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.

We will need to raise additional capital in order

to meet our 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.

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Net cash used in operating activities was approximately

$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.

$11,604,000 and $8,252,000 for the nine months ended September 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 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.

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.

Net cash provided by financing activities was approximately $10,280,000 for the nine months ended September

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 June 30, 2023, we did not have any relationships

As of September 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,

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”

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

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