BIO-PATH HOLDINGS, INC.

Previous wording

Our approved amended Phase 2 clinical trial currently has three cohorts of subjects. The first two cohorts treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients while the second cohort includes relapsed/refractory AML patients. The third cohort treats relapsed/refractory AML patients who are venetoclax-resistant or -intolerant with the two-drug combination of prexigebersen and decitabine. The full trial design plans have approximately 98 evaluable patients for the first cohort having newly diagnosed AML patients with a preliminary review performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The full trial design plans have approximately 54 evaluable patients for each of the second cohort, having relapsed/refractory AML patients, and the third cohort, having AML patients who are venetoclax-resistant or -intolerant, in each case with a review performed after 19 evaluable patients. The study is anticipated

Current wording

Our approved amended Phase 2 clinical trial currently has three cohorts of subjects. The first two cohorts treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients while the second cohort includes relapsed/refractory AML patients. The third cohort treats relapsed/refractory AML patients who are venetoclax-resistant or -intolerant with the two-drug combination of prexigebersen and decitabine. The full trial design plans have approximately 98 evaluable patients for the first cohort having newly diagnosed AML patients with a preliminary review performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The full trial design plans have approximately 54 evaluable patients for each of the second cohort, having relapsed/refractory AML patients, and the third cohort, having AML patients who are venetoclax-resistant or -intolerant, in each case with a review performed after 19 evaluable patients. The study is anticipated to be conducted at up to ten clinical sites in the U.S., and Gail J. Roboz, MD, is the national coordinating Principal Investigator for the Phase 2 trial. Dr. Roboz is a professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University (the “Weill Medical College”) and the New York-Presbyterian Hospital in New York City.

Previous wording

July 2020. BP1001-A incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. A BP1001-A Phase 1/1b clinical trial in patients with advanced or recurrent solid tumors is being conducted at several leading cancer centers in the United States, including Karmanos Cancer Institute, Mary Crowley Cancer Research and Holy Cross Hospital, Maryland. On July 17, 2023, we announced completion of the first cohort of the dose escalation portion of the Phase 1/1b clinical trial. A total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy over three dose levels in a standard 3+3 dose escalation design. The first dose cohort consisted of a starting dose of 60 mg/m 2, and there were no dose limiting toxicities.

Current wording

In addition, a modified product named BP1001-A, our fourth drug candidate, has shown to enhance chemotherapy efficacy in a preclinical study involving solid tumor models. Results of the preclinical study were published in the scientific journalOncotarget in July 2020. BP1001-A incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. A BP1001-A Phase 1/1b clinical trial in patients with advanced or recurrent solid tumors is being conducted at several leading cancer centers in the United States, including Karmanos Cancer Institute, Mary Crowley Cancer Research and Holy Cross Hospital, Maryland. On July 17, 2023, we announced completion of the first cohort of the dose escalation portion of the Phase 1/1b clinical trial. A total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy over three dose levels in a standard 3+3 dose escalation design. The first dose cohort consisted of a starting dose of 60 mg/m 2, and there were no dose limiting toxicities.

Previous wording

continues to seek financing or additional capital. The Board is currently discussing and evaluating a course of action in light of the Company’s limited capital resources, such operational pause and the resignations of Peter H. Nielsen, Heath Cleaver and Aline Sherwood.

Current wording

On June 24, 2025, the Company announced that it instituted a Company-wide operational pause in order to conserve capital. The Company has furloughed most of its employees and paused most of its operations until further notice while the Company continues to seek financing or additional capital. The Board is currently discussing and evaluating a course of action in light of the Company’s limited capital resources, such operational pause and the resignations of Peter H. Nielsen, Heath Cleaver and Aline Sherwood.

Previous wording

As of June 30, 2025, we had an accumulated deficit of $125.0 million. Our net loss was $4.6 million and $1.9 million for the three months ended June 30, 2025 and 2024, respectively. Our net loss was $7.4 million and $5.0 million for the six months ended June 30, 2025 and 2024, respectively. We expect to continue to incur significant operating losses, and we anticipate that our losses may increase substantially as we expand our drug development programs and commercialization efforts. To achieve profitability, we must enter into license or development agreements with third parties or successfully develop and obtain regulatory approval for one or more of our drug candidates and effectively commercialize any drug candidates we develop. In addition, if we obtain regulatory approval of one or more of our drug candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Even if we succeed in developing and commercializing one or more of our drug candidates, we may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

Current wording

As of September 30, 2025, we had an accumulated deficit of $126.0 million. Our net loss was $1.0 million and $2.1 million for the three months ended September 30, 2025 and 2024, respectively. Our net loss was $8.4 million and $7.1 million for the nine months ended September 30, 2025 and 2024, respectively. We expect to continue to incur significant operating losses, and we anticipate that our losses may increase substantially as we expand our drug development programs and commercialization efforts. To achieve profitability, we must enter into license or development agreements with third parties or successfully develop and obtain regulatory approval for one or more of our drug candidates and effectively commercialize any drug candidates we develop. In addition, if we obtain regulatory approval of one or more of our drug candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Even if we succeed in developing and commercializing one or more of our drug candidates, we may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

Previous wording

On February 22, 2024, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the spilt-adjusted basis on the Nasdaq Capital Market at the commencement of trading on February 23, 2024. As a result of the reverse stock split, approximately 61,000 shares were added to our total shares outstanding due to rounding fractional shares of common stock up to a whole share of common stock. All common stock share and per share amounts in this Quarterly R­eport on Form 10-Q have been adjusted to give effect to the 1-for-20 reverse stock split.

Current wording

On February 22, 2024, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the spilt-adjusted basis on the Nasdaq Capital Market at the commencement of trading on February 23, 2024. As a result of the reverse stock split, approximately 61,000 shares were added to our total shares outstanding due to rounding fractional shares of common stock up to a whole share of common stock. All common stock share and per share amounts in this Quarterly Report on Form 10-Q have been adjusted to give effect to the 1-for-20 reverse stock split.

Previous wording

Costs and expenses that can be clearly identified as research and development are charged to expense as incurred. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense.

Current wording

Costs and expenses that can be clearly identified as research and development are charged to expense as incurred. Advance payments, including non-refundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods are not delivered, or services will not be rendered, then the capitalized advance payment is charged to expense.

Previous wording

Research and Development Expense. Our research and development expense for the three months ended June 30, 2025 was $4.0 million, an increase of $2.2 million compared to the three months ended June 30, 2024. The increase in research and development expense was primarily due to expenses related to pausing our clinical trials for BP1001 and BP1001-A which were partially offset by decreased manufacturing expenses. The following table sets forth our research and development expenses (in thousands):

Current wording

Research and Development Expense. Our research and development expense for the three months ended September 30, 2025 was $0.3 million, a decrease of $1.0 million compared to the three months ended September 30, 2024. The decrease in research and development expense was primarily due to cash flow constraints and related pausing our clinical trials for BP1001 and BP1001-A. The following table sets forth our research and development expenses (in thousands):

Previous wording

General and Administrative Expense. Our general and administrative expense for the three months ended June 30, 2025 was $0.5 million, a decrease of $0.7 million compared to the three months ended June 30, 2024. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expense as well as decreased professional and consulting fees. The following table sets forth our general and administrative expenses (in thousands):

Current wording

General and Administrative Expense. Our general and administrative expense for the three months ended September 30, 2025 was $0.2 million, a decrease of $1.1 million compared to the three months ended September 30, 2024. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expenses due to the curtailment of the Company’s activities, including the resignations and terminations of employment of corporate overhead.

Previous wording

*Net Operating Loss.*Our net loss from operations for the three months ended June 30, 2025 was $4.6 million, an increase of $1.5 million compared to the three months ended June 30, 2024.

Current wording

*Net Operating Loss.*Our net loss from operations for the three months ended September 30, 2025 was $0.5 million, a decrease of $2.1 million compared to the three months ended September 30, 2024.

Previous wording

Net Loss per Share. Net loss per share, both basic and diluted, for the three months ended June 30, 2025 was $0.55, compared to $1.16 for the three months ended June 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Current wording

Net Loss per Share. Net loss per share, both basic and diluted, for the three months ended September 30, 2025 was $0.11, compared to $1.70 for the three months ended September 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Previous wording

Comparisons of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024

Current wording

Comparisons of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024

Previous wording

Revenue. We had no revenue for each of the six months ended June 30, 2025 and 2024.

Current wording

Revenue. We had no revenue for each of the nine months ended September 30, 2025 and 2024.

Previous wording

Research and Development Expense. Our research and development expense for the six months ended June 30, 2025 was $6.0 million, an increase of $1.9 million compared to the six months ended June 30, 2024. The increase in research and development expense was primarily due to expenses related to pausing our clinical trials for BP1001 and BP1001-A as well as increased manufacturing expenses related to drug product releases in 2025. The following table sets forth our research and development expenses (in thousands):

Current wording

Research and Development Expense. Our research and development expense for the nine months ended September 30, 2025 was $6.3 million, an increase of $0.8 million compared to the nine months ended September 30, 2025. The increase in research and development expense was primarily due to expenses related to pausing our clinical trials for BP1001 and BP1001-A as well as increased manufacturing expenses related to drug product releases in 2025, prior to our cash flow restraints in the 3 rd Quarter.

Previous wording

General and Administrative Expense. Our general and administrative expense for the six months ended June 30, 2025 was $1.8 million, a decrease of $0.8 million compared to the six months ended June 30, 2024. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expense, professional and consulting fees and shareholder meeting expenses related to our special shareholder meeting held in the first quarter of 2024. The following table sets forth our general and administrative expenses (in thousands):

Current wording

General and Administrative Expense. Our general and administrative expense for the nine months ended September 30, 2025 was $2.0 million, a decrease of $1.9 million compared to the nine months ended September 30, 2024. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expense, professional and consulting fees and shareholder meeting expenses related to our special shareholder meeting held in the first quarter of 2024, as well as the curtailment of the Company’s activities, including the resignations and terminations of employment of corporate overhead in the 3 rd Quarter.

Previous wording

*Net Operating Loss.*Our net loss from operations for the six months ended June 30, 2025 was $7.8 million, a decrease of $1.1 million compared to the six months ended June 30, 2024.

Current wording

*Net Operating Loss.*Our net loss from operations for the nine months ended September 30, 2025 was $8.3 million, a decrease of $1.1 million compared to the nine months ended September 30, 2024.

Previous wording

Net Loss per Share. Net loss per share, both basic and diluted, for the six months ended June 30, 2025 was $0.97, compared to $4.45 for the six months ended June 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Current wording

Net Loss per Share. Net loss per share, both basic and diluted, for the nine months ended September 30, 2025 was $1.06, compared to $4.05 for the nine months ended September 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Previous wording

We had a cash balance of $0.0 million as of June 30, 2025, a decrease of $1.2 million compared to December 31, 2024. We do not believe that our available cash at June 30, 2025 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for the next 12 months from the date of this Quarterly Report on Form 10-Q. The Company’s ability to

Current wording

We had a cash balance of $0.0 million as of September 30, 2025, a decrease of $1.2 million compared to December 31, 2024. We do not believe that our available cash at September 30, 2025 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for the next 12 months from the date of this Quarterly Report on Form 10-Q. The Company’s ability to continue as a going concern is dependent upon obtaining funding through one or more sources as described above to meet its planned obligations and pay its liabilities.

Previous wording

*Operating Activities.*Net cash used in operating activities for the six months ended June 30, 2025 was $1.6 million. Excluding non-cash change in fair value of the warrant liability of $0.4 million, stock-based compensation expense of $0.1 million and amortization expense of $0.1 million, net cash used in operating activities for the six months ended June 30, 2025 consisted primarily of the net loss for the period of $7.4 million, an increase in accounts payable and accrued expenses of $4.1 million, a decrease in other current assets of $1.3 million and a decrease in prepaid drug product of $0.6 million. Net cash used in operating activities for the six months ended June 30, 2024 was $4.3 million. Excluding non-cash change in fair value of the warrant liability of $1.7 million and stock-based compensation expense of $0.3 million, net cash used in operating activities for the six months ended June 30, 2024 consisted primarily of the net loss for the period of $5.0 million and a decrease in lease liabilities of $0.1 million. These are partially offset by an increase in accounts payable and accrued expenses of $1.2 million and a decrease of $1.0 million in other current assets.

Current wording

*Operating Activities.*Net cash used in operating activities for the nine months ended September 30, 2025 was $1.6 million. Excluding non-cash expenses of $0.4 million, net cash used in operating activities for the nine months ended September 30, 2025 consisted primarily of the net loss for the period of $8.4 million, an increase in accounts payable and accrued expenses of $4.6 million, a decrease in other current assets of $1.3 million and a decrease in prepaid drug product of $0.6 million.

Previous wording

*Financing Activities.*Net cash provided by financing activities for the six months ended June 30, 2025 was $0.4 million from the Warrant Exercises (as defined below), the March 2025 Promissory Notes and the April Promissory Note. Net cash provided by financing activities for the six months ended June 30, 2024 was $7.2 million from the March 2024 Registered Direct Offering, the April 2024 Registered Direct Offering, the Offering Agreement (as defined below) and the June 2024 PIPE.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $7.2 million from the March 2024 Registered Direct Offering, the April 2024 Registered Direct Offering, the Offering Agreement (as defined below) and the June 2024 PIPE.

Previous wording

exercise price of $1.00 per share for gross proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with the June 2024 PIPE, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.5 million.

Current wording

On October 8, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private placement, an aggregate of (i) pre-funded warrants to purchase up to 4,597,702 shares of our common stock at an exercise price of $0.001 per share, (ii) series A warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share and (iii) series B warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share for gross proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with the June 2024 PIPE, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.5 million.