
(Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedSeptember 30, 2025Or☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number:001-36333 Bio-Path Holdings,Inc.(Exact name of registrant as specified in its charter) (Registrant’s telephone number, including area code) Securities registered pursuant to Section12(b)of the Act: None. Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the SecuritiesExchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required to file such reports),and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period that theregistrant was required to submit such files).Yes☒No☐ by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Accelerated filer☐Smaller reporting company☒Emerging growth company☐ Large accelerated filer☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section13(a)of the Exchange Act.☐Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). Yes☐No☒ At January 9, 2026, the Company had9,242,151outstanding shares of common stock, par value $0.001 per share, with a total value of$542,514. Table of Contents Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “our,” “us,” “the Company”and “Bio-Path” refer to Bio-Path Holdings,Inc. and its subsidiary. Bio-Path Holdings,Inc.’s wholly-owned subsidiary, Bio-Path,Inc.,is sometimes referred to herein as “Bio-Path Subsidiary.” CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section27A of theSecurities Act of 1933, as amended (the “Securities Act”), and Section21E of the Securities Exchange Act of 1934, as amended (the“Exchange Act”). Forward-looking statements can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,”“seek,” “estimate,” “project,” “goal,” “strategy,” “future,” “likely,” “may,” “should,” “will” and variations of these words and similarreferences to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statementsare neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations andassumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economyand other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertaintiesand changes in circumstances, including those discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K forthe fiscal year ended December 31, 2024 and in other reports or documents we file with the U.S. Securities and Exchange Commission(“SEC”). As a result, our actual results and financial condition may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. We can give no assurances that any of the eventsanticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operationsand financial condition. Important factors that could cause our actual results and financial condition to differ materially from thoseindicated in the forward-looking statements include, among others, the following: •our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;•our need for substantial additional capital and our need to delay, reduce or eliminate our drug development andcommercialization efforts if we are unable to raise additional capital;•the highly competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;•the success of our plans to use collaboration arrangements to leverage our capabilities;•our ability to retai