On November 13, 2020 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 third quarter ended September 30, 2020 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 13, 2020, View Source [SID1234570935]).
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"We made meaningful progress across our programs throughout the third quarter despite continued headwinds related to the COVID-19 pandemic. Importantly, enrollment continues in Stage 2 of our Phase 2 trial of prexigebersen (BP1001), a liposomal Grb2 antisense, as a combination treatment for patients suffering with acute myeloid leukemia (AML)," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We further strengthened our intellectual property portfolio with a strategic patent providing broad protection for application of prexigebersen in the treatment of a variety of cancers in combination with front-line therapies."
"We remain on track to initiate a Phase 1 study of prexigebersen for the treatment of solid tumors by year end. This is a particularly important advancement for Bio-Path as it marks our first-in-human study in solid tumors, an area of significant need where current treatment options are often ineffective," continued Mr. Nielsen.
Recent Corporate Highlights
Received Notice of Allowance for Strategic Patent for Prexigebersen in Combination with Front-Line Therapies. In October, Bio-Path announced that the United States Patent and Trademark Office had issued a notice of allowance for claims related to the Company’s lead product candidate, prexigebersen, in combination with either a cytidine analogue, such as decitabine, or the Bcr-Abl tyrosine kinase inhibitors dasatinib and nilotinib. The patent provides broad protection for application of prexigebersen in the treatment of a variety of cancers in combination with front-line therapies.
Announced First Patient Dosed in Amended Stage 2 of the Phase 2 Clinical Trial Evaluating Prexigebersen in Acute Myeloid Leukemia. In August, Bio-Path announced the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen for the treatment of AML in combination with front-line therapy decitabine and venetoclax.
Financial Results for the Third Quarter Ended September 30, 2020
The Company reported a net loss of $3.0 million, or $0.80 per share, for the three months ended September 30, 2020, compared to a net loss of $2.2 million, or $0.78 per share, for the three months ended September 30, 2019.
Research and development expenses for the three months ended September 30, 2020 increased to $2.0 million, compared to $1.4 million for the three months ended September 30, 2019 primarily due to increased enrollment for our Phase 2 clinical trial of prexigebersen in AML, as well as increased preclinical study expenses.
General and administrative expenses for the three months ended September 30, 2020 increased to $1.0 million, compared to $0.9 million for the three months ended September 30, 2019 primarily due to increased franchise tax expense.
As of September 30, 2020, the Company had cash of $12.1 million, compared to $20.4 million at December 31, 2019. Net cash used in operating activities for the nine months ended September 30, 2020 was $8.4 million compared to $6.1 million for the comparable period in 2019. Subsequent to September 30, 2020, Bio-Path issued 850,000 shares of its common stock for gross proceeds of approximately $4.6 million through its at-the-market offering agreement with H.C. Wainwright.
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 third quarter 2020 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 5878804. 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.