On March 8, 2024 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, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 8, 2024, View Source [SID1234640963]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "In the fourth quarter, we were delighted to announce important enrollment updates in our Phase 1/1b clinical trial of BP1002 in refractory/relapsed Acute Myeloid Leukemia (AML) and our Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and refractory/relapsed Chronic Lymphocytic Leukemia (CLL). As we look to the months and year ahead, we expect to build on the clinical progress achieved to date to bring potentially life-saving new medicines to patients battling cancers."

Recent Corporate Highlights

● Hosted Key Opinion Leader (KOL) Event to Discuss Prexigebersen and Advances in the AML Treatment Landscape. In October, Bio-Path hosted a virtual KOL event to discuss the current AML treatment landscape and the growing body of clinical evidence in support of prexigebersen as a treatment for AML. The event featured presentations from Jorge Cortes, M.D., Director, Georgia Cancer Center, Augusta University and Maro Ohanian, D.O., Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

● Successfully Completed First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia. In December, the Company announced the completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, to treat refractory/relapsed AML patients including venetoclax-resistant patients.

● Completed First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients. In December, Bio-Path announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002 for the treatment of refractory/relapsed lymphoma and refractory/relapsed CLL patients.

Financial Results for the Year Ended December 31, 2023

● The Company reported a net loss of $16.1 million, or $33.63 per share, for the year ended December 31, 2023, compared to a net loss of $13.9 million, or $38.12 per share, for the year ended December 31, 2022.

● Research and development expense for the year ended December 31, 2023 increased to $11.6 million, compared to $9.2 million for the year ended December 31, 2022 primarily due to manufacturing expenses related to drug product releases in 2023 as well as an increase in expense related to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023.

● General and administrative expense for the year ended December 31, 2023 decreased to $4.2 million, compared to $4.7 million for the year ended December 31, 2022 primarily due to decreased salaries and benefits expense as well as franchise tax expenses.

● Change in fair value of the Company’s warrant liability for the year ended December 31, 2023 resulted in a non-cash loss of $0.3 million. The company did not have the warrant liability in 2022.

● As of December 31, 2023, the Company had cash of $1.1 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the year ended December 31, 2023 was $11.5 million compared to $15.1 million for the comparable period in 2022. Net cash provided by financing activities for the year ended December 31, 2023 was $2.2 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 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.