On August 13, 2021 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, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 13, 2021, View Source [SID1234586538]).
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"Throughout the second quarter and in recent weeks, we’ve made tremendous progress advancing our entire DNAbilize portfolio. In June, we were delighted to announce a new patent related to our BP1003 program which further bolsters our intellectual property portfolio," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Throughout the balance of the year, we look forward to executing on our clinical development plans, including the advancement of our Phase 1 clinical trial evaluating BP1002 in refractory/relapsed acute myeloid leukemia patients."
Recent Corporate Highlights
Granted Key Mechanism of Action U.S. Patent for BP1003. In June, Bio-Path announced that the United States Patent and Trademark Office has granted a new patent relating to the Company’s BP1003 program, a novel liposome-incorporated oligodeoxynucleotide inhibitor against Signal Transduction and Activator of Transcription-3 (STAT3). The new patent builds on earlier patents that have been granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug platform.
Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.
Presented BP1002 Data at 2021 AACR (Free AACR Whitepaper) Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.
Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Financial Results for the Second Quarter Ended June 30, 2021
The Company reported a net loss of $1.8 million, or $0.26 per share, for the three months ended June 30, 2021, compared to a net loss of $2.0 million, or $0.55 per share, for the three months ended June 30, 2020.
Research and development expense for the three months ended June 30, 2021, decreased to $0.8 million, compared to $1.0 million for the three months ended June 30, 2020, primarily due to timing of activities related to our clinical trials for BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A in solid tumors.
General and administrative expense for the three months ended June 30, 2021, were $1.0 million, consistent with the comparable period in 2020.
As of June 30, 2021, the Company had cash of $28.1 million, compared to $13.8 million at December 31, 2020. Net cash used in operating activities for the six months ended June 30, 2021, was $4.2 million compared to $6.0 million for the comparable period in 2020. Net cash provided by financing activities for the six months ended June 30, 2021, was $18.6 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 second quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 4739446. 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.