What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-08-14 · 62 added, 55 removed, 270 unchanged (30% of the section changed)

144 unchanged sentences

and (v) 134 shares of our common stock.

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.

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.

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

23 unchanged sentences

in the Agreement.

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

to the Three Months Ended June 30, 2023

Results of Operations for the Three Months Ended September 30, 2024

Compared to the Three Months Ended September 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.

General and administrative expense was approximately

$1,384,000 for the three months ended September 30, 2024 compared to approximately $1,123,000 for the comparable period in 2023.

in general and administrative expense was mainly attributable to increases of approximately $269,000 in legal and professional expenses,

$63,000 in stock- based compensation and $12,000 in other expenses, which were offset by decreases of approximately $60,000 in marketing

, advertising expenses and $23,000 in insurance expense.

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,

$4,245,000 for the three months ended September 30, 2024 compared to approximately $3,411,000 for the comparable period in 2023.

in research and development expenses during the period were mainly attributed to license expenses related to the Cortice Agreements entered

during the quarter.

The net loss for the three months ended September

30, 2024 was approximately $5,606,000 compared to approximately $4,523,000 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

The change in net loss

is attributable to an increase in CRO expenses related to continued progress with our potentially pivotal Phase II clinical trial of

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

Results of Operations for the Nine Months Ended September 30, 2024

Compared to the Nine Months Ended September 30, 2023

General and Administrative Expense

General and administrative expense was approximately

$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.

$3,910,000 for the nine months ended September 30, 2024 compared to approximately $3,662,000 for the comparable period in 2023.

in general and administrative expense was mainly attributable to increases of approximately $449,000 in professional expenses and

$11,000 in other expenses, which were offset by decreases of approximately $106,000 in marketing and advertising expense, $77,000 in insurance

expense and $18,000 in travel expenses and $11,000 in stock- based compensation.

Research and Development Expense

Research and development expense was approximately

$3,547,000 for the six months ended June 30, 2024 compared to approximately $6,413,000 for the comparable period in 2023.

$7,792,000 for the nine months ended September 30, 2024 compared to approximately $9,824,000 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

5 unchanged sentences

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,

The net loss for the nine months ended September

30, 2024 was approximately $11,681,000 compared to approximately $13,476,000 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.

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 contract labor.

Liquidity and Capital Resources

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

On September 30, 2024, we had cash of approximately

$6,973,000 and we had a working capital of approximately $3,331,000.

We fund our operations from proceeds from equity sales.

On January 29, 2024, we completed a public offering

33 unchanged sentences

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.

shares of the Company’s common stock with initial aggregate sales price of up to $5.2 million.

On July 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 September 30, 2024, the Company has sold 30,004,761 shares of common stock pursuant to the Agreement for net proceeds

of approximately $10.6 million.

On October 23, 2024, the Company entered into a

placement agency agreement (the “Placement Agency Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”)

in connection with the sale by the Company of:

(i) 3,700,000 shares (the “Shares”) of the Company’s common stock, and

(ii) pre-funded warrants to purchase 13,947,060 shares of common stock (the “Pre-Funded Warrants”), in a registered direct

offering (the “Offering”).

The per share purchase price of each share of common stock was $0.17 per share and the purchase

price for each Pre-Funded Warrant was $0.169 per Pre-Funded Warrant.

In connection with the Offering, the Company entered into a Securities

Purchase Agreement with certain institutional investors that participated in the Offering.

The closing of the Offering occurred on

October 24, 2024.

The gross proceeds to the Company from the Offering were approximately $3.0 million, before deducting the Placement

Agent fees and other estimated offering expenses payable by the Company.

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.

Subsequent to September 30, 2024, the

Company has sold 6,393,243 Shares pursuant to the Agreement for net proceeds of approximately $1.6 million.

Our plan of operations is primarily focused on

9 unchanged sentences

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

$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.

$11,642,000 and $11,604,000 for the nine months ended September 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.

Cash provided by financing activities

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 and payment of deferred offering costs.

$18,067,000 for the nine months ended September 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

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

$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.

Off-balance Sheet Arrangements

As of June 30, 2024, we did not have any relationships

As of September 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,

28 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