What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-11-10 compared with 2022-08-12 · 85 added, 91 removed, 239 unchanged (42% of the section changed)

181 unchanged sentences

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

Results of Operations for the Three Months Ended June 30, 2022 Compared

to the Three Months Ended June 30, 2021

Results of Operations for the Three Months Ended September 30, 2022

Compared to the Three Months Ended September 30, 2021

General and Administrative Expense

General and administrative expense was approximately

$1,343,000 for the three months ended June 30, 2022 compared to approximately $1,146,000 for the comparable period in 2021.

in general and administrative expense was mainly attributable to an increase of approximately $189,000 for employee compensation

(due to the timing of annual employee incentive compensation) and taxes and $149,000 in legal and professional fees, which were offset

with decreases of approximately $170,000 in stock-based compensation and $29,000 in other expenses.

Our general and administrative expenses

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

$1,211,000 for the three months ended September 30, 2022 compared to approximately $1,235,000 for the comparable period in 2021.

in general and administrative expense was mainly attributable to decreases of approximately $204,000 for stock-based compensation,

$46,000 in advertising and marketing, $32,000 in insurance and $31,000 in other expenses, which were offset by an increase of approximately

$289,000 in legal and professional expenses.

Our general and administrative expenses are expected to remain approximately at these levels

for the remainder of this year.

Research and Development Expense

Research and development expense was

approximately $2,221,000 for the three months ended June 30, 2022 compared to approximately $2,665,000 for the comparable period in

The decrease in research and development expenses during the period were mainly attributed to the timing of drug development

expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year, and

this lower level of manufacturing activity is expected to continue throughout this year), as well as a credit to research and

development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their

clinical trials, partially offset by an increase in contract 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 level 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 Phase II clinical trial.

The net loss for the three months ended June 30,

Research and development expense was approximately

$2,208,000 for the three months ended September 30, 2022 compared to approximately $2,578,000 for the comparable period in 2021.

in research and development expenses during the period were mainly attributed to the timing of drug development expenses (significant

manufacturing activity occurred in the prior year period with much less occurring in the current year, and this lower level of manufacturing

activity is expected to continue throughout this year), as well as a credit to research and development expense for the funds collected

from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase

in contract 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 Q3 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

Phase II clinical trial.

The net loss for the three months ended September

30, 2022 was approximately $3,420,000 compared to approximately $3,814,000 for the comparable period in 2021.

The change in net loss is attributable

to decreases the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less

occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals

related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related

to continued progress with our Phase II clinical trial as well as increases in legal and professional fees and other expenses.

Results of Operations for the Six Months Ended June 30, 2022 Compared

to the Six Months Ended June 30, 2021

The change in net loss is

attributable to decreases the timing of drug development expenses (significant manufacturing activity occurred in the prior year period

with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD

Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO

expenses related to continued progress with our Phase II clinical trial as well as increases in legal and professional fees and other

Results of Operations for the Nine Months Ended September 30, 2022

Compared to the Nine Months Ended September 30, 2021

General and Administrative Expense

General and administrative expense was approximately

$2,603,000 for the six months ended June 30, 2022 compared to approximately $2,549,000 for the comparable period in 2021.

$3,815,000 for the nine months ended September 30, 2022 compared to approximately $3,785,000 for the comparable period in 2021.

in general and administrative expense was mainly attributable to increases of $638,000 in legal and professional fees and $6,000 in other

expenses, which were offset with decreases of approximately $110,000 for employee compensation and taxes and $238,000 in stock-based

compensation.

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

expenses, which were offset with decreases of approximately $109,000 for employee compensation and taxes, $442,000 in stock-based

compensation and $63,000 in advertising and marketing.

Our general and administrative expenses are expected to remain approximately at

these levels for the remainder of this year.

Research and Development Expense

Research and development expense was

approximately $3,743,000 for the six months ended June 30, 2022 compared to approximately $4,872,000 for the comparable period in

The decrease in research and development expenses during the period were mainly attributed to the timing of drug development

expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year, and

this lower level of manufacturing activity is expected to continue throughout this year), as well as a credit to research and

development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their

clinical trials, partially offset by an increase in contract 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 level 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 Phase II clinical trial.

The net loss for the six months ended June 30,

Research and development expense was approximately

$5,951,000 for the nine months ended September 30, 2022 compared to approximately $7,450,000 for the comparable period in 2021.

in research and development expenses during the period were mainly attributed to the timing of drug development expenses (significant

manufacturing activity occurred in the prior year period with much less occurring in the current year, and this lower level of manufacturing

activity is expected to continue throughout this year), as well as a credit to research and development expense for the funds collected

from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase

in contract 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 year-to-date run-rate 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 Phase II clinical trial.

The net loss for the nine months ended September

30, 2022 was approximately $9,770,000 compared to approximately $11,241,000 for the comparable period in 2021.

The change in net loss is attributable

to decreases in employee compensation and stock-based compensation, the timing of drug development expenses (significant manufacturing

activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development

expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials,

partially offset by an increase in CRO expenses related to continued progress with our Phase II clinical trial as well as increases in

legal and professional fees and other expenses.

The change in net loss

is attributable to decreases in employee compensation and stock-based compensation, the timing of drug development expenses (significant

manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research

and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their

clinical trials, partially offset by an increase in CRO expenses related to continued progress with our Phase II clinical trial as well

as increases in legal and professional fees and other expenses.

Liquidity and Capital Resources

On June 30, 2022, we had cash

of approximately $8,959,000 and we had working capital of approximately $10,474,000.

We fund our operations from proceeds

from equity sales.

On September 30, 2022, we

had cash of approximately $7,027,000 and we had working capital of approximately $7,456,000.

We fund our operations from proceeds from

equity sales.

In January 2022, we completed a financing with

7 unchanged sentences

We estimate that we will require additional financing of approximately $13 - $17 million

to complete the trial, 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 first quarter of 2023.

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.

to complete the trial (taking into account our cash on hand as of September 30, 2022 of approximately $7.0 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 first quarter of 2023.

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

7 unchanged sentences

Net cash used in operating activities was approximately

$6,440,000 and $8,306,000 for the six months ended June 30, 2022 and 2021, respectively, and mainly included payments made for clinical

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

$8,252,000 and $10,302,000 for the nine months ended September 30, 2022 and 2021, respectively, and mainly included payments made for

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

Cash used in investing activities

Net cash used by investing activities was approximately

$3,000 and $4,000 for the six months ended June 30, 2022 and 2021, respectively.

The amount used in 2022 and 2021 are related to the purchase

of furniture and equipment.

$4,000 for the nine months ended September 30, 2022 and 2021.

The amount used in 2022 and 2021 are related to the purchase of furniture

and equipment.

Cash provided by financing activities

Net cash provided by financing activities was $10,280,000

for the six months ended June 30, 2022 related to the sale of common stock and warrants, and from the exercise of warrants, offset by

the repayment of notes payable.

Net cash used in financing activities was $1,156,000 for the six months ended June 30, 2021 related to

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

for the nine months ended September 30, 2022 related to the sale of common stock and warrants, and from the exercise of warrants, offset

by the repayment of notes payable.

Net cash provided by financing activities was $4,592,000 for the nine months ended September 30, 2021

related to the sale of common stock and exercise of warrants, offset by the repayment of notes payable.

Off-balance Sheet Arrangements

As of June 30, 2022, we did not have any relationships

As of September 30, 2022, 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,

19 unchanged sentences

that affect the amounts reported in the financial statements, including the notes thereto.

We consider critical accounting policies to

be those that require more significant judgments and estimates in the preparation of our financial statements, including the following:

long lived assets;

intangible assets valuations;

and income tax valuations.

Management relies on historical experience and other assumptions

believed to be reasonable in making its judgment and estimates.

Actual results could differ materially from those estimates.

Management believes its application of accounting

policies, and the estimates inherently required therein, are reasonable.

These accounting policies and estimates are periodically reevaluated,

and adjustments are made when facts and circumstances dictate a change.

As a result, management is required to routinely

make judgments and estimates about the effects of matters that are inherently uncertain.

Actual results may differ from these estimates

under different conditions or assumptions.

Management determined there were no critical accounting estimates.

Quantitative and Qualitative Disclosures About Market Risk

2 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