What changed in this filing

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Item 1. Financial Statements

2025-11-12 compared with 2025-08-12 · 207 added, 134 removed, 313 unchanged (52% of the section changed)

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CONDENSED CONSOLIDATED BALANCE SHEETS

September 30,

Current assets:

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Series B, $ 0.001 par value:

1,804,394 shares issued and outstanding as of June 30, 2025 and December 31, 2024

1,804,394 shares issued and outstanding as of September 30, 2025 and December 31, 2024

Common stock, $ 0.001 par value;

10,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

1,544,840 shares issued as of June 30, 2025 and December 31, 2024;

1,542,139 shares outstanding as of June 30, 2025 and December 31, 2024

10,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

1,544,840 shares issued as of September 30, 2025 and December 31, 2024;

1,542,139 shares outstanding as of September 30, 2025 and December 31, 2024

Additional paid in capital

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THREE MONTHS ENDED

SIX MONTHS ENDED

SEPTEMBER 30,

NINE MONTHS ENDED

SEPTEMBER 30,

Royalty revenue

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( 2,710,670 )

( 1,964,939 )

Total operating costs and expenses

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( 3,105,283 )

( 2,605,810 )

Other income (expense):

Other income (expense)

Other income:

Interest income, net

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CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'

THREE MONTHS ENDED JUNE 30, 2025

THREE MONTHS ENDED SEPTEMBER 30, 2025

Preferred Stock

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Total Stockholders'

Balance as of April 1, 2025

Balance as of July 1, 2025

$ 208,260,682

$ ( 198,786,315 )

$ ( 5,281,180 )

Share-based expense

Balance as of June 30, 2025

Balance as of September 30, 2025

$ 208,276,537

SIX MONTHS ENDED JUNE 30, 2025

$ ( 199,296,255 )

$ ( 5,281,180 )

NINE MONTHS ENDED SEPTEMBER 30, 2025

Preferred Stock

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$ 208,225,748

$ ( 197,194,471 )

$ ( 5,281,180 )

Share-based expense

Balance as of June 30, 2025

( 2,101,784 )

Balance as of September 30, 2025

$ 208,276,537

$ ( 199,296,255 )

$ ( 5,281,180 )

The accompanying notes are an integral part of

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CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'

THREE MONTHS ENDED JUNE 30, 2024

THREE MONTHS ENDED SEPTEMBER 30, 2024

Preferred Stock

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Total Stockholders'

Balance as of April 1, 2024

Balance as of July 1, 2024

$ 208,173,105

Issuance of common stock in connection with restricted stock

$ ( 195,703,279 )

$ ( 5,281,180 )

Exercise of purchase warrants

Share-based expense

Balance as of June 30, 2024

Balance as of September 30, 2024

$ 208,200,640

SIX MONTHS ENDED JUNE 30, 2024

$ ( 196,139,950 )

$ ( 5,281,180 )

NINE MONTHS ENDED SEPTEMBER 30, 2024

Preferred Stock

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$ 208,053,935

$ ( 193,234,196 )

$ ( 5,281,180 )

Exercise of purchase warrants

Issuance of common stock in connection with restricted stock

Share-based expense

Balance as of June 30, 202 4

( 2,905,754 )

Balance as of September 30, 2024

$ 208,200,640

$ ( 196,139,950 )

$ ( 5,281,180 )

The accompanying notes are an integral part of

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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended June 30,

Nine Months Ended September 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

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or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company

focused on advancing innovative immune-oncology technologies addressing hard to treat cancers.

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

The Company’s proprietary Deoxyribonuclease

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to fund the Company’s operations for a period of at least twelve months from the date of the issuance of these financial statements.

However, the Company anticipates it will need additional capital in the long-term to pursue its business initiatives.

While the Company

believes it has 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 its product development programs, its ability to identify and enter into

licensing or other strategic arrangements, its continued listing on the Nasdaq Stock Market, and factors related to financial, economic,

geo-political, industry and market conditions, many of which are beyond its 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, the Company raised approximately $3.9 million in an underwritten offering of common stock as more

fully described in Note 10 to the condensed consolidated interim financial statements.

However, the Company anticipates it will need additional

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

While the Company believes it will continue to 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 its product development programs, its ability to identify and enter into licensing or other strategic arrangements, its

continued listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry

and market conditions, many of which are beyond its control.

The capital markets for the biotech industry can be highly volatile, which

make the terms, timing and extent of any future financing uncertain.

Recent Developments

The Company and its board of directors (the “Board”)

have initiated a formal strategic review process with the assistance of outside financial and legal advisors.

The Company is 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 the

Company’s stockholders, including if the transaction would result in the current investors of the counterparty holding a substantial

majority of the Company’s 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 the Company does

enter into definitive agreements with respect to a potential transaction, the Company expects that consummation of the potential transaction

would be subject to a number of conditions, including approval by the Company’s stockholders and Nasdaq, and other customary conditions,

which would be out of the Company’s control and may never be satisfied.

The Company remains committed to advancing its DNase technology

and does 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.

Risks and Uncertainties

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A reconciliation

to the condensed consolidated net loss for the three and six months ended June 30, 2025 and 2024 is as follows:

to the condensed consolidated net loss for the three and nine months ended September 30, 2025 and 2024 is as follows:

Schedule of consolidated net loss

Three Months Ended June 30,

Three Months Ended September 30,

Program expenses (1)

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$ ( 436,671 )

Six Months Ended June 30,

Nine Months Ended September 30,

Program expenses (1)

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Includes information technology, legal, intellectual property and other general and administrative expenses.

Includes stock-based compensation expense, interest income and other income (expense).

Includes stock-based compensation expense, interest income and other income.

Basic and Diluted Net Loss per Share

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that are outstanding during the period, except where such non-participating securities would be anti-dilutive.

Basic and diluted net loss per share are the

same in each respective three or six month period due to the Company’s net loss position in each period.

Potentially dilutive,

non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would be

anti-dilutive.

Basic and diluted net loss per share are the same

in each respective three or nine month period due to the Company’s net loss position in each period.

Potentially dilutive, non-participating

securities have not been included in the calculations of diluted net loss per share, as their inclusion would be anti-dilutive.

Significant Strategic Collaborations

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Royalty payments

of approximately $ 0.6 million and $ 1.2 million were recorded as revenue by the Company during the three and six months ended June 30,

2025, respectively, and approximately $ 0.7 million and $ 1.2 million were recorded as revenue by the Company during the three and six months

ended June 30, 2024, respectively.

of approximately $ 1 .0 million and $ 2.2 million were recorded as revenue by the Company during the three and nine months ended September

30, 2025, respectively, and approximately $ 0.6 million and $ 1.9 million were recorded as revenue by the Company during the three and nine

months ended September 30, 2024, respectively.

These payments are based on single digit royalties on net sales of certain covered products.

The Company’s

policy is to recognize royalty payments as revenue when they are reliably measurable, which is upon receipt of reports from Takeda.

Company receives these reports in the quarter subsequent to the actual sublicensee sales.

At the time the revenue was received, there

were no remaining performance obligations and all other revenue recognition criteria were met.

The Company’s policy is to recognize royalty payments as revenue when they are reliably measurable, which is upon receipt of reports

The Company receives these reports in the quarter subsequent to the actual sublicensee sales.

At the time the revenue was

received, there were no remaining performance obligations and all other revenue recognition criteria were met.

Catalent Pharma Solutions LLC (“Catalent”)

On June 30, 2022, the Company entered into a Statement

of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will

provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I.

On June 30, 2022, the Company entered into a Statement of Work (the “SOW”)

with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will provide certain services to

the Company to perform current Good Manufacturing Principles (“cGMP”) of the Company’s recombinant protein, Human DNase

agreed to enter into a Master Services Agreement that will contain terms and conditions to govern the project contemplated by the SOW

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The Company has paid Catalent approximately

$ 2.7 million through June 30, 2025, of which approximately $ 0.3 million has been recognized as an advance payment and is included in prepaid

expenses and other current assets as of June 30, 2025 , and approximately $ 0.2 million has been recognized as a liability and is included

in accounts payable and accrued expenses and other current liabilities as of June 30, 2025.

As of December 31, 2024, approximately $ 28,000

was recognized as an advance payment and is included in prepaid expenses and other current assets and approximately $ 0.1 million had been

recognized as a liability and is included in accrued expenses and other current liabilities.

In addition, approximately $ 0.3 million was

recognized within other assets as of December 31, 2024.

$ 2.8 million through September 30, 2025, of which approximately $ 0.3 million has been recognized as an advance payment and is included

in prepaid expenses and other current assets as of September 30, 2025, and approximately $ 140,000 has been recognized as a liability including

approximately $ 70,000 in accounts payable and approximately $ 70,000 in accrued expenses and other current liabilities as of September

As of December 31, 2024, approximately $ 28,000 was recognized as an advance payment and is included in prepaid expenses and

other current assets and approximately $ 0.1 million had been recognized as a liability and is included in accrued expenses and other current

In addition, approximately $ 0.3 million was recognized within other assets as of December 31, 2024.

Scripps Research Institute (“Scripps

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to fund continuing research.

The research funding is payable by the Company to Scripps Research on a monthly basis in accordance with

a negotiated budget, which provides for an initial payment of approximately $65,000 on the date of the Second Amendment and subsequent

The research funding was payable by the Company to Scripps Research on a monthly basis in accordance with

a negotiated budget, which provided for an initial payment of approximately $65,000 on the date of the Second Amendment and subsequent

monthly payments of approximately $65,000 over a 5-month period.

All other terms of the Agreement remain unchanged.

All other terms of the Agreement remained unchanged.

Effective May 1, 2025, the Company and Scripps

Research entered into a Third Amendment to the Agreement (the “Third Amendment”), pursuant to which the Company amended the

Agreement in order to expand the services to be performed under the Agreement and to provide Scripps Research additional funding in an

Research entered into a Third Amendment to the Agreement (the “Third Amendment”), pursuant to which the Company expanded the services to be performed under the Agreement and provided Scripps Research additional funding in an

aggregate amount of up to approximately $ 0.4 million to fund continuing research.

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Agreement remain unchanged.

The Company has paid Scripps Research approximately

$ 1.4 million under the Agreement through June 30, 2025, of which approximately $ 0.1 million was accrued as of June 30, 2025.

As of December

31, 2024, approximately $ 0.4 million was recognized as an advance payment and was included in prepaid expenses and other current assets.

There were no advance payments as of June 30, 2025.

Subsequent to quarter end, the Company and

Scripps Research entered into a Fourth Amendment to the Agreement (the “Fourth Amendment”), pursuant to which the

Company extended and expanded the services to be performed under the Agreement and to provide Scripps Research additional funding in an

aggregate amount of up to approximately $ 0.3

Effective November 1, 2025, the research funding is payable by the Company to Scripps Research on a monthly basis in

accordance with a negotiated budget, which provides for an initial payment of approximately $85,000 on the effective date of the

Fourth Amendment and subsequent monthly payments of approximately $85,000 over a 3-month period.

All other terms of the Agreement

remain unchanged.

The Company has incurred approximately $ 1.7 million

under the Agreement through September 30, 2025, of which approximately $ 0.1 million was included in accounts payable.

At December 31, 2024, approximately $ 0.4 million was recognized as

an advance payment and was included in prepaid expenses and other current assets.

There were no advance payments as of September 30,

In addition, approximately

$ 0.1 million was accrued and reflected in accrued expenses and other current liabilities as of September 30, 2025.

There were no amounts

accrued as of December 31, 2024.

University of Virginia (“UVA”)

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Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair

of the Department of Surgery at the UVA School of Medicine, will oversee the research conducted

of the Department of Surgery at the UVA School of Medicine, oversees the research conducted

under the UVA Agreement.

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to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer.

paid UVA approximately $ 0.4 million under the UVA Agreement through June 30, 2025, of which $ 0.1 million had been recognized as an advance

payment and was included within prepaid expenses and other current assets as of December 31, 2024.

There were no advance payments as of

June 30, 2025.

paid UVA approximately $ 0.5 million under the UVA Agreement through September 30, 2025, of which approximately $ 30,000 and $ 0.1 million

had been recognized as an advance payment and was included within prepaid expenses and other current assets as of September 30, 2025 and

December 31, 2024, respectively.

Other Agreements

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The Company and its collaborative partners continue

to engage in research and development activities with no resultant commercial products through June 30, 2025.

to engage in research and development activities with no resultant commercial products through September 30, 2025.

No amounts were recognized

as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and six months ended June 30, 2025 and 2024,

respectively.

as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and nine months ended September 30, 2025

and 2024, respectively.

Fair Value Measurements

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for the asset or liability at the measurement date.

As of June 30, 2025 and December 31, 2024, the carrying amounts of the Company’s

As of September 30, 2025 and December 31, 2024, the carrying amounts of the Company’s

financial instruments approximates fair value due to their short maturities.

There were no financial instruments classified as Level 3

in the fair value hierarchy during the three and six months ended June 30, 2025 and 2024.

in the fair value hierarchy during the three and nine months ended September 30, 2025 and 2024.

Stockholders’ Equity

had warrants to purchase approximately 462,963 shares of the Company’s common stock (the “Series A Warrants”) outstanding

as of December 31, 2024.

The Series A Warrants were immediately exercisable at a price of $ 33.00 per share of common stock.

A Warrants were exercised or forfeited during the three and six months ended June 30, 2025 and 2024.

These warrants expired in February

2025 and, as a result, no Series A Warrants were outstanding as of June 30, 2025.

Company had warrants to purchase approximately 462,963

shares of the Company’s common stock (the “Series A Warrants”) outstanding as of December 31, 2024.

These warrants

expired in February

2025 and, as a result, no

Series A Warrants were outstanding as of September 30, 2025.

The Series A Warrants were immediately exercisable at a price of $ 33.00

per share of common stock.

Series A Warrants were exercised or forfeited during the three and nine months ended September 30, 2025 and 2024.

The Company also has warrants to purchase approximately

800 shares of the Company’s common stock outstanding as of both June 30, 2025 and December

800 shares of the Company’s common stock outstanding as of both September 30, 2025

and December 31, 2024.

These warrants have an exercise price of $ 29.09 per share of common stock and expire on July 3, 2026 .

None of these warrants

were exercised or forfeited during the three and six months ended June 30, 2025 and 2024.

None of these

warrants were exercised or forfeited during the three and nine months ended September 30, 2024.

Share-Based Expense

Total share-based expense related to stock options

and restricted stock units (“RSUs”) was approximately $ 16,000 and $ 42,000 for the three months ended June 30, 2025 and 2024,

respectively, and approximately $ 35,000 and $ 0.1 million for the six months ended June 30, 2025 and 2024, respectively.

and restricted stock units (“RSUs”) was approximately $ 16,000 and $ 28,000 for the three months ended September 30, 2025 and

2024, respectively, and approximately $ 0.1 million for both the nine months ended September 30, 2025 and 2024.

Share-based expense is classified in the condensed consolidated statements

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Schedule of share-based compensation expense

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development expenses

General and administrative expenses

Employee Stock Options and RSU’s

Employee Stock Options and RSUs

No stock option awards to purchase shares of common

stock were granted during the three and six months ended June 30, 2025.

During the three and six months ended June 30, 2024, 20,000 stock

options to purchase shares of common stock were granted by the Company.

No RSUs were granted during each of the three and six months ended

June 30, 2025 and 2024.

The Company recognized a total of approximately $ 16,000 and $ 42,000 of share-based expense related to employee

stock options during the three months ended June 30, 2025 and 2024, respectively, and approximately $ 35,000 and $ 0.1 million during the

six months ended June 30, 2025 and 2024, respectively.

No employee stock options or RSUs were exercised during the three and six months

ended June 30, 2025.

The Company issued 417 shares of common stock during the three and six months ended June 30, 2024 related to RSUs

representing all RSUs outstanding.

No employee stock options were exercised during the three and six months ended June 30, 2024.

the three and six months ended June 30, 2025, options to purchase 64,062 shares and 89,878 shares of common stock expired.

three and six months ended June 30, 2024, stock options to purchase 11,667 shares of common stock were forfeited.

stock were granted during the three and nine months ended September 30, 2025.

During the nine months ended September 30, 2024, 20,000

stock options to purchase shares of common stock were granted by the Company.

No stock options to purchase shares of common stock were

granted during the three months ended September 30, 2024.

No RSUs were granted during each of the three and nine months ended September

30, 2025 and 2024.

The Company recognized a total of approximately $ 16,000 and $ 28,000 of share-based expense related to employee stock

options during the three months ended September 30, 2025 and 2024, respectively, and approximately $ 0.1 million during both the nine months

ended September 30, 2025 and 2024.

No employee stock options or RSUs were exercised during the three and nine months ended September 30,

The Company issued 417 shares of common stock during the nine months ended September 30, 2024 related to RSUs representing all RSUs

No employee stock options were exercised during the three and nine months ended September 30, 2024.

During the three and

nine months ended September 30, 2025, options to purchase 1,585 shares and 91,463 shares of common stock expired.

During each of the three

and nine months ended September 30, 2024 stock options to purchase 20,847 shares of common stock were cancelled and, during the nine months

ended September 30, 2024, stock options to purchase 11,667 shares of common stock were forfeited.

Non-Employee Stock Options

There were no non-employee stock options granted

or exercised during each of the three and six months ended June 30, 2025 and 2024.

No non-employee stock option grants expired during

each of the three and six months ended June 30, 2025 and 2024.

The Company did not recognize any expense related to non-employee stock

options during each of the three and six months ended June 30, 2025 and 2024.

During each of the three and six months ended

June 30, 2025 and 2024, there was no provision for income taxes as the Company incurred losses during both periods.

Deferred tax assets

and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial

or exercised during each of the three and nine months ended September 30, 2025 and 2024.

During the three and nine months ended September

30, 2025, options to purchase 253 shares of common stock expired.

As of September 30, 2025 no non-employee stock options were outstanding.

No non-employee stock option grants expired during each of the three and nine months ended September 30, 2025 and 2024.

The Company did

not recognize any expense related to non-employee stock options during each of the three and nine months ended September 30, 2025 and

During each of the three and nine months ended

September 30, 2025 and 2024, there was no provision for income taxes as the Company incurred losses during both periods.

assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial

reporting purposes and the amounts used for income tax purposes.

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The valuation allowance against deferred

tax assets was approximately $ 41.6 million and $ 41.1 million as of June 30, 2025 and December 31, 2024, respectively.

As of June 30, 2025 and December 31, 2024,

tax assets was approximately $ 41.7 million and $ 41.1 million as of September 30, 2025 and December 31, 2024, respectively.

As of September 30, 2025 and December 31,

2024, the Company did no t record any unrecognized tax positions.

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The Company has entered into various research,

development, license and supply agreements with PeriNess Ltd.

(“PeriNess”), Serum Institute and Pharmsynthez, each a related

development, license and supply agreements with Peri-Ness Ltd.

(“Peri-Ness”), Serum Institute and Pharmsynthez, each a related

party whose relationship has not materially changed from that disclosed in the Company’s 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.

The Company paid PeriNess

approximately $ 55,000 during the six months ended June 30, 2025.

As of June 30, 2025 and December 31, 2024, approximately $ 50,000 was

recorded as an advanced payment and included in Prepaid expenses and other.

The Company paid Peri-Ness

approximately $ 83,000 during the nine months ended September 30, 2025.

As of September 30, 2025 and December 31, 2024, approximately $ 50,000

was recorded as an advanced payment and included in prepaid expenses and other.

In addition, approximately $ 9,000 and $ 8,000 was reflected

in accounts payable as of June 30, 2025 and December 31, 2024, respectively.

No amounts were incurred in connection with agreements with

Serum Institute and Pharmsynthez during the six months ended June 30, 2025 and 2024.

in accounts payable as of September 30, 2025 and December 31, 2024, respectively.

No amounts were incurred in connection with agreements

with Serum Institute and Pharmsynthez during the nine months ended September 30, 2025 and 2024.

During the first quarter of 2025, the Company

entered into a Consulting Agreement with Dr.

Dmitry Genkin, Chairman of our Board of Directors, to provide consulting services to the

Company’s DNase-based oncology program.

Dmitry Genkin, Chairman of our Board, to provide consulting services related to the Company’s

DNase-based oncology program.

This agreement was effective January 1, 2025 and the Company paid Dr.

Genkin approximately

$ 0.1 million and $ 0.2 million during the three and six months ended June 30, 2025, of which approximately $ 30,000 was reflected within

accounts payable as of June 30, 2025.

Genkin does not receive any fees for his service as a member of the Board of Directors.

Genkin approximately $ 0.1 million

and $ 0.3 million during the three and nine months ended September 30, 2025, of which approximately $ 30,000 was reflected within accounts

payable as of September 30, 2025.

Genkin does not receive any fees for his service as a member of the Board.

Subsequent Events

The Company performed a review of events subsequent

to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring

recognition or disclosure in the financial statements except as described in Note 4 and below.

Underwritten Offering

On October 10, 2025, the Company entered into an underwriting agreement

(the “Underwriting Agreement”) with Canaccord Genuity LLC as representative of the underwriters named therein, relating to

an underwritten public offering (the “Offering”) of 735,000 shares of the Company’s common stock, par value $0.001 per

share, at a public offering price of $6.12 per share.

The Company estimates that the net proceeds from the Offering will be approximately

$3.9 million after deducting underwriting discounts and commissions and other estimated offering expenses to be paid by the Company.

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 1. Financial Statements