Change in Certifying Accountants (Form 8-K)

Item 4.01 Changes in Registrant's Certifying Accountant.

(a) Dismissal of Previous Independent Registered Public Accounting Firm.

On August 13, 2025, the Board of Directors of Bio-Path Holdings, Inc. (the "Company") approved the dismissal of Ernst & Young LLP ("EY") as the Company's independent registered public accounting firm, and notified EY of the dismissal on the same date with an effective date of August 13, 2025.

EY's reports on the Company's financial statements for the fiscal years ended December 31, 2024 and 2023 did not contain an adverse opinion or a disclaimer of opinion, and were not qualified or modified as to uncertainty, audit scope, or accounting principles, except for the explanatory paragraph relating to the Company's ability to continue as a going concern contained in EY's reports on the Company's financial statements for each of the fiscal years ended December 31, 2024 and 2023.

During the Company's two most recent fiscal years ended December 31, 2024 and 2023, and the subsequent interim period through August 13, 2025, there were (i) no "disagreements" within the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto with EY on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of EY, would have caused it to make reference to the subject matter of the disagreements in connection with its reports on the financial statements of the Company for such years, and (ii) no "reportable events" within the meaning of Item 304(a)(1)(v) of Regulation S-K.

The Company has provided EY with a copy of the foregoing disclosures and has requested that EY furnish the Company with a letter addressed to the SEC stating whether it agrees with such disclosures and, if not, stating the respects in which it does not agree. EY's letter is filed as Exhibit 16.1 to this Current Report on Form 8-K.

The Company is actively seeking a new independent registered public accounting firm and intends to engage a firm as soon as practicable. However, there can be no assurance as to the timing of such engagement. Once a new firm is engaged, the Company will file a Current Report on Form 8-K disclosing such engagement. The Company expects to authorize EY to respond fully to the inquiries of the successor independent accounting firm once engaged, including those related to prior years' audits.