What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-12 compared with 2025-08-12 · 141 added, 103 removed, 213 unchanged (53% of the section changed)

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cause actual results to differ materially include without limitation:

risks and uncertainties as to the outcome and timing of the strategic review

process being conducted by the Company’s board of directors (the “Board”) and a special independent committee thereof,

including the possibility that the Board may decide not to undertake a strategic alternative following the evaluation process;

the Company’s

inability to consummate any proposed strategic alternative resulting from the review due to, among other things, market, regulatory and

other factors;

the potential for disruption to our business resulting from the review process;

and potential adverse effects on the Company’s

stock price from the announcement, suspension or consummation of the evaluation process and the results thereof, as well as risks and

uncertainties related to the potential impacts of consummation of a strategic transaction on the Company’s current business operations,

anticipated business strategy and product development plans;

uncertainty of the expected financial performance of the Company;

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our ability to implement our business strategy;

our failure to maintain compliance with the continued listing requirements of the Nasdaq Stock Market;

our failure to maintain compliance with the continued listing requirements of the Nasdaq Stock Market (“Nasdaq”);

our need to raise additional working capital in the future for the purpose of further developing our pipeline and to continue as a going concern;

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We are a biopharmaceutical company focused on

advancing innovative immune-oncology technologies addressing difficult to treat cancers.

advancing innovative immuno-oncology technologies addressing difficult to treat cancers.

Our proprietary DNase technology is designed

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Although we hold a broad patent portfolio, the focus of our internal efforts during

the six months ended June 30, 2025, was on the advancement of our DNase technology.

the nine months ended September 30, 2025, was on the advancement of our DNase technology.

Recent Developments

We and our Board have initiated a formal strategic

review process with the assistance of outside financial and legal advisors.

We are considering a wide range of alternatives to maximize

shareholder value, including, but not limited to, the sale of all or part of the Company or its assets or a business combination, including

a “reverse merger”.

An independent committee of the Board has engaged in preliminary discussions with third parties regarding

potential transactions.

Any such completed transaction could have a significant impact on our stockholders, including if the transaction

would result in the current investors of the counterparty holding a substantial majority of our outstanding common stock following consummation

of the potential transaction.

Given the preliminary stage of such discussions, at this time there is no way to quantify the potential

impact of a transaction, if any.

There is no deadline or definitive timetable set for the completion of the strategic alternatives process,

and there can be no assurance any proposal will be made or accepted, any agreement will be executed, or any transaction will be consummated

in connection with this review.

In addition, if we do enter into definitive agreements with respect to a potential transaction, we expect

that consummation of the potential transaction would be subject to a number of conditions, including approval by our stockholders and

Nasdaq, and other customary conditions, which would be out of our control and may never be satisfied.

We remain committed to advancing

our DNase technology and do not intend to make further announcements regarding the review process unless and until the Board approves

a specific transaction or otherwise determines that further disclosure is appropriate.

Impact of the Global Events and Conflicts on

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RESULTS OF OPERATIONS

Comparison of Quarter Ended June 30, 2025

Comparison of Quarter Ended September 30,

2025 and 2024

The comparison of our historical results of operations

for the fiscal quarter ended June 30, 2025 to the fiscal quarter ended June 30, 2024 is as follows:

for the fiscal quarter ended September 30, 2025 to the fiscal quarter ended September 30, 2024 is as follows:

Quarter Ended

June 30, 2025

September 30, 2025

Quarter Ended

June 30, 2024

September 30, 2024

Royalty revenue

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Loss from operations

Other income (expense):

Other income (expense)

Other income:

Interest income, net

$ (1,273,970 )

Revenue for the three months ended June 30, 2025

decreased by approximately $0.1 million, or 18.8%, to approximately $0.6 million from approximately $0.7 million for the three months

ended June 30, 2024.

This decrease represented a decrease in royalty revenue related to our sublicense agreement with Takeda Pharmaceuticals

(“Takeda”) as compared to the same period in 2024 due to the timing of rebates.

Revenue for the three months ended September 30,

2025 increased by approximately $0.4 million, or 67.2%, to approximately $1.0 million from approximately $0.6 million for the three months

ended September 30, 2024.

This increase represented an increase in royalty revenue related to our sublicense agreement with Takeda Pharmaceuticals

(“Takeda”) as compared to the same period in 2024 primarily due to royalties recognized from certain countries during

the third quarter of 2025 compared to the same period in 2024.

Research and Development Expenses

Research & development (“R&D”)

expenses for the three months ended June 30, 2025 decreased by approximately $277,000, or 29.7%, to approximately $0.7 million from $0.9

million in the comparable quarter in 2024.

The table below sets forth the R&D costs incurred by the Company by category of expense

for the quarters ended June 30, 2025 and 2024:

expenses for the three months ended September 30, 2025 increased by approximately $0.4 million, or 105.6%, to approximately $0.8 million

from $0.4 million in the comparable quarter in 2024.

The table below sets forth the R&D costs incurred by the Company by category

of expense for the quarters ended September 30, 2025 and 2024:

Quarter Ended,

Category of Expense

June 30, 2025

June 30, 2024

September 30,

Outside services and contract research organizations

Personnel costs

Share-based expense

Total research and development expense

The decrease in personnel

costs during the second quarter of 2025 was related to certain severance and benefits expensed in connection with a separation agreement

entered into during the second quarter of 2024 with our former Chief Scientific Officer.

The increase in outside services and contract

research organizations expense was primarily due to increased consulting costs and spending in connection with the commencement of exploratory

studies during the three months ended June 30, 2025.

The increase in

outside services and contract research organizations expense was primarily due to increased manufacturing development efforts and

pre-clinical research as well as increased consulting costs during the three months ended September 30, 2025 compared to the same

period as last year.

General and Administrative Expenses

General and administrative expenses for the three

months ended June 30, 2025 decreased by approximately $472.000, or 41.8%, to approximately $0.7 million from approximately $1.1 million

in the comparable quarter in 2024.

The decrease was primarily due to certain severance and benefits expensed in connection with a separation

agreement entered into during the second quarter of 2024 with our former Chief Executive Officer.

Other Income (Expense)

Other income was $1,477 for the three months ended

June 30, 2025 compared to approximately $21 of other expense for the comparable quarter in 2024.

This increase in other income was primarily

related to favorable changes in foreign currency exchange rates during the three months ended June 30, 2025 as compared to the same period

months ended September 30, 2025 increased by approximately $0.1 million, or 9.3%, to approximately $0.8 million from approximately $0.7

million in the comparable quarter in 2024.

The increase was primarily due to increased legal costs in connection with our strategic review process.

Other income was approximately $4,000 for the

three months ended September 30, 2025 compared to approximately $1,500 of other income for the comparable quarter in 2024.

This increase

in other income was primarily related to favorable changes in foreign currency exchange rates during the three months ended September

30, 2025 as compared to the same period in 2024.

Interest Income, net

Interest income, net decreased to approximately

$34,000 during the three months ended June 30, 2025 as compared to approximately $63,000 for the same period in the prior year.

This decrease

is primarily due to lower average invested funds during the three months ended June 30, 2025 as compared to the same period in 2024.

Comparison of Six Months Ended June 30,

$31,000 during the three months ended September 30, 2025 as compared to approximately $61,000 for the same period in the prior year.

decrease is primarily due to lower average invested funds during the three months ended September 30, 2025 as compared to the same period

Comparison of Nine Months Ended September

30, 2025 and 2024

The comparison of our historical results of operations

for the six months ended June 30, 2025 to the six months ended June 30, 2024 is as follows:

for the nine months ended September 30, 2025 to the nine months ended September 30, 2024 is as follows:

September 30,

Royalty revenue

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Loss from operations

Other income (expense):

Other income:

Interest income, net

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$ (2,905,754 )

Revenue for the six months ended June 30, 2025

decreased by approximately $54,000, or 4.4%, to approximately $1.2 million from approximately $1.2 million for the six months ended June

This decrease represented a decrease in royalty revenue related to our sublicense agreement with Takeda as compared to the same

period in 2024 due to the timing of rebates.

Revenue for the nine months ended September 30,

2025 increased by approximately $0.4 million, or 19.4%, to approximately $2.2 million from approximately $1.9 million for the nine months

ended September 30, 2024.

This increase represented an increase in royalty revenue related to our sublicense agreement with Takeda as

compared to the same period in 2024 primarily due to royalties recognized from certain countries during the nine months ended September

30, 2025 compared to the same period in 2024.

Research and Development Expenses

R&D expenses for the six months ended June

30, 2025 decreased by approximately $343,000, or 18.2%, to approximately $1.5 million from approximately $1.9 million in the comparable

R&D expenses for the nine months ended September

30, 2025 increased by approximately $46,000, or 2.0%, to approximately $2.3 million from approximately $2.2 million in the comparable

period in 2024.

The table below sets forth the R&D costs incurred by the Company by category of expense for the six months ended June

30, 2025 and 2024:

Six Months Ended,

The table below sets forth the R&D costs incurred by the Company by category of expense for the nine months ended

September 30, 2025 and 2024:

Nine Months Ended,

Category of Expense

June 30, 2025

June 30, 2024

September 30,

Outside services and contract research organizations

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Total research and development expense

The decrease in personnel

costs and share-based expense during the six months ended June 30, 2025 was related to certain severance and benefits expensed in connection

with a separation agreement entered into during the second quarter of 2024 with our former Chief Scientific Officer.

The increase in outside

services and contract research organizations expense was primarily due to increased consulting costs and spending in connection with the

commencement of exploratory studies during the six months ended June 30, 2025.

services and contract research organizations expense was primarily due to increased consulting and manufacturing development efforts as well as

costs incurred in connection with the commencement of exploratory studies during the nine months ended September 30, 2025.

in personnel costs and share-based expense during the nine months ended September 30, 2025 was related to certain severance and benefits

expensed in connection with a separation agreement entered into during the second quarter of 2024 with our former Chief Scientific Officer.

General and Administrative Expenses

General and administrative expenses for the six

months ended June 30, 2025 decreased by approximately $0.7 million, or 33.1%, to approximately $1.3 million from approximately $2.0 million

in the comparable period in 2024.

The decrease was primarily due to certain severance and benefits expensed in connection with a separation

agreement entered into during the second quarter of 2024 with our former Chief Executive Officer.

Other income was $1,555 for the six months ended

June 30, 2025 compared to approximately $31 for the comparable period in 2024.

This increase in other income was primarily related to

favorable changes in foreign currency exchange rates during the six months ended June 30, 2025 as compared to the same period in 2024.

General and administrative expenses for the nine

months ended September 30, 2025 decreased by approximately $0.6 million, or 21.4%, to approximately $2.1 million from approximately $2.7

million in the comparable period in 2024.

The decrease was primarily due to certain severance and benefits expensed in connection with

a separation agreement entered into during the second quarter of 2024 with our former Chief Executive Officer.

This decrease was partially

offset by an increase in legal costs.

Other income was approximately $5,600 for the

nine months ended September 30, 2025 compared to approximately $1,500 for the comparable period in 2024.

This increase in other income

was primarily related to favorable changes in foreign currency exchange rates during the nine months ended September 30, 2025 as compared

to the same period in 2024.

Interest Income

Interest income, net decreased to approximately

$73,000 during the six months ended June 30, 2025 as compared to approximately $137,000 for the same period in the prior year.

This decrease

is primarily due to lower average invested funds during the six months ended June 30, 2025 as compared to the same period in 2024.

$104,000 during the nine months ended September 30, 2025 as compared to approximately $198,000 for the same period in the prior year.

This decrease is primarily due to lower average invested funds during the nine months ended September 30, 2025 as compared to the same

period in 2024.

Liquidity and Capital Resources

We incurred a net loss

of approximately $1.6 million for the six months ended June 30, 2025.

We had an accumulated deficit of approximately $198.8 million at

June 30, 2025, as compared to an accumulated deficit of approximately $197.2 million at December 31, 2024.

Working capital was approximately

$4.5 million at June 30, 2025, and approximately $5.7 million at December 31, 2024.

During the six months ended June 30, 2024, our working

capital decreased by approximately $1.2 million primarily due to our net loss for the six months ended June 30, 2025.

of approximately $2.1 million for the nine months ended September 30, 2025.

We had an accumulated deficit of approximately $199.3 million

at September 30, 2025, as compared to an accumulated deficit of approximately $197.2 million at December 31, 2024.

Working capital was

approximately $4.0 million at September 30, 2025, and approximately $5.7 million at December 31, 2024.

During the nine months ended September

30, 2025, our working capital decreased by approximately $1.7 million primarily due to our net loss for the nine months ended September

Our principal source

of liquidity consists of cash.

At June 30, 2025, we had approximately $4.8 million in cash and approximately $0.9 million in current liabilities.

At September 30, 2025, we had approximately $4.1 million in cash and approximately $1.1 million in current

At December 31, 2024, we had approximately $6.2 million in cash and $0.9 million in current liabilities.

We have historically relied upon

sales of our equity securities to fund our operations.

We have historically

relied upon sales of our equity securities to fund our operations.

We evaluate whether there

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for a period of at least twelve months from the date of the issuance of these financial statements.

However, we anticipate we will need

additional capital in the long-term to pursue our business initiatives.

While we believe we have access to capital resources through possible

public or private equity offerings, debt financings, corporate collaborations, related party funding, or other means to continue as a

going concern, the terms, timing and extent of any future financing will depend upon several factors, including the achievement of progress

in our clinical development programs, our ability to identify and enter into licensing or other strategic arrangements, our continued

listing on the Nasdaq Stock Market, and factors related to financial, economic, geo-political, industry and market conditions, many of

which are beyond our control.

The capital markets for the biotech industry can be highly volatile, which make the terms, timing and extent

of any future financing uncertain.

In addition, subsequent to quarter

end, we raised approximately $3.9 million in an underwritten offering of common stock.

However, we anticipate we will need additional

capital in the long-term to pursue our business initiatives.

While we believe we have access to capital resources through possible public

or private equity offerings, debt financings, corporate collaborations, related party funding, or other means to continue as a going concern,

the terms, timing and extent of any future financing will depend upon several factors, including the achievement of progress in our clinical

development programs, our ability to identify and enter into licensing or other strategic arrangements, our continued listing on the Nasdaq,

and factors related to financial, economic, geo-political, industry and market conditions, many of which are beyond our control.

markets for the biotech industry can be highly volatile, which make the terms, timing and extent of any future financing uncertain.

Cash Flows from Operating Activities

Cash flows used in operating activities for the

six months ended June 30, 2025 totaled approximately $1.4 million, which was primarily due to our net loss for the period, partially offset

by non-cash charges associated with share-based expense.

The decrease in other assets was due to the reclassification of long-term assets

to prepaid expenses and other current assets as of June 30, 2025.

Cash flows used in operating activities for the six months ended June

30, 2024 totaled approximately $1.7 million, which was primarily due to our net loss for the period, partially offset by non-cash charges

associated with share-based expense during the period.

nine months ended September 30, 2025 totaled approximately $2.0 million, which was primarily due to our net loss for the period, partially

offset by non-cash charges associated with share-based expense.

The decrease in other assets was due to the reclassification of long-term

assets to prepaid expenses and other current assets as of September 30, 2025.

In addition to the increase of $0.3 million due to the reclassification

from other assets, prepaid expenses and other increased approximately $0.2 million and current liabilities increased approximately $0.2

million during the period.

Cash flows used in operating activities for the nine months ended September 30, 2024 totaled approximately

$2.1 million, which was primarily due to our net loss for the period, partially offset by non-cash charges associated with share-based

expense during the period.

In addition, prepaid expenses and other decreased approximately $0.4 million and current liabilities increased

approximately $0.2 million during the period.

Cash Flows from Investing Activities

There were no cash flows from investing activities

for the six months ended June 30, 2025 and 2024.

for the nine months ended September 30, 2025 and 2024.

Cash Flow from Financing Activities

There were no cash flows from financing activities

for the six months ended June 30, 2025 and 2024.

for the nine months ended September 30, 2025 and 2024.

Contractual Obligations and Commitments

As of June 30, 2025, there were no material changes

in our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December 31,

As of September 30, 2025, there were no material

changes in our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December

31, 2024, filed with the SEC on March 18, 2025, as amended on April 29, 2025 and May 13, 2025.

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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