On March 31, 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 year ended December 31, 2022 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 31, 2023, View Source [SID1234629650]).

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"We entered 2023 from a position of strength and will continue to build on the momentum generated last year to advance our important clinical programs in hard-to-treat cancers," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We see continued enthusiasm from clinical investigators and patients alike and hope to make even more progress toward completing these key studies. We have an exciting year ahead as we look forward to reporting data from a number of clinical trials evaluating our DNAbilize platform across solid tumors and acute myeloid leukemia, all cancers with limited treatment options."

Recent Corporate Highlights

• Announced First Patient Dosed in Phase 1/1b Clinical Trial of BP1001-A in Solid Tumors. In December, Bio-Path announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer.

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 expected before 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 in the second quarter of 2023.

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 Year Ended December 31, 2022

• The Company reported a net loss of $13.9 million, or $1.91 per share, for the year ended December 31, 2022, compared to a net loss of $10.4 million, or $1.55 per share, for the year ended December 31, 2021.

• Research and development expense for the year ended December 31, 2022, increased to $9.2 million, compared to $5.9 million for the year ended December 31, 2021, primarily due to manufacturing expenses related to drug product releases in 2022, increased enrollment in our Phase 2 clinical trial for prexigebersen in AML and start-up costs related to our Phase 1 clinical trial for BP1002 in refractory/relapsed AML patients.

• General and administrative expense for the year ended December 31, 2022, increased to $4.7 million, compared to $4.5 million for the year ended December 31, 2021, primarily due to increased legal fees.

• As of December 31, 2022, the Company had cash of $10.4 million, compared to $23.8 million at December 31, 2021. Net cash used in operating activities for the year ended December 31, 2022, was $15.1 million compared to $9.9 million for the comparable period in 2021.

Net cash provided by financing activities for the year ended December 31, 2022, was $1.7 million.

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 full-year 2022 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.