On August 15, 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 second quarter ended June 30, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2023, View Source [SID1234634418]).
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"Our clinical progress this quarter was highlighted by the compelling interim results from Stage 2 of our Phase 2 study of prexigebersen as a treatment for acute myeloid leukemia, a blood cancer for which there are limited treatment options and for which the prognosis is grave," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "The data showed prexigebersen demonstrated meaningful clinical improvement with a tolerable safety profile in these high-risk patients. On the strength of these data, we now plan to file for regulatory designations that may accelerate the pathway for bringing this potentially life-expanding therapy to patients battling this deadly hematologic cancer."
"We continue to advance our robust clinical development program across a number of important programs that leverage our innovative DNAbilize platform technology to deliver RNAi nanoparticle therapeutics directly to cancer cells. We are forging a new path in DNA-powered medicine that we believe will give patients a fighting chance to beat these difficult to treat cancers," continued Mr. Nielsen.
Recent Corporate Highlights
• Announced Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia. In August, Bio-Path reported positive interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with combination treatment of decitabine and venetoclax. Financial Results for the Second Quarter Ended June 30, 2023
• The Company reported a net loss of $4.2 million, or $0.53 per share, for the three months ended June 30, 2023, compared to a net loss of $3.0 million, or $0.42 per share, for the three months ended June 30, 2022.
• Research and development expense for the three months ended June 30, 2023 increased to $3.1 million, compared to $1.9 million for the three months ended June 30, 2022 primarily due to manufacturing expenses related to drug product releases during the second quarter of 2023 and increased patient enrollment related to our Phase 2 clinical trial for prexigebersen in AML.
• General and administrative expense for both the three months ended June 30, 2023 and June 30, 2022 was $1.2 million.
• As of June 30, 2023, the Company had cash of $3.4 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the six months ended June 30, 2023 was $6.9 million compared to $6.7 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 second 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.