On May 12, 2023 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 12, 2023, View Source [SID1234631588]).

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"We continue to make important progress advancing our clinical programs as we await topline results from several key cohorts in our Phase 1/1b study of BP1001-A in solid tumors, Phase 1/1b study of BP1002 in relapsed/refractory AML, and Phase 2 study of prexigebersen in AML," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Despite advances in the field, cancer deaths continue to rise. We believe our DNAbilize platform can overcome the challenges with current treatment options to address the urgent need for safe and effective new treatments."

Important Near-Term Clinical Milestones

BP1001-A Phase 1/1b Clinical Trial in Solid Tumors

● Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout currently expected mid-year.

BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML

● Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected mid-year.

Prexigebersen (BP1001) Phase 2 Clinical Trial in AML

● Two of the three cohorts in the clinical trial already exceed the minimum efficacy required for enrollment expansion.
● Assess safety and efficacy of each cohort treatment combination therapy with potential to qualify for expedited program status after cohort’s initial interim analysis, which are expected to commence by cohort in the second quarter of 2023.

Financial Results for the First Quarter Ended March 31, 2023

● The Company reported a net loss of $5.3 million, or $0.66 per share, for the three months ended March 31, 2023, compared to a net loss of $3.4 million, or $0.47 per share, for the three months ended March 31, 2022.

● Research and development expense for the three months ended March 31, 2023 increased to $4.0 million, compared to $2.1 million for the three months ended March 31, 2022, primarily due to manufacturing expenses related to drug product releases during the quarter.

● General and administrative expense for both the three months ended March 31, 2023 and March 31, 2022 was $1.3 million.

● As of March 31, 2023, the Company had cash of $6.7 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the three months ended March 31, 2023 was $3.7 million, compared to $2.5 million for the comparable period in 2022.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2023 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.