On November 9, 2017 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2017 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 9, 2017, View Source [SID1234521855]).
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"The third quarter was marked by growth and progress as we continue to advance our clinical and preclinical pipeline candidates. Following our recent financing, we are well-positioned to achieve several important milestones, including an interim update from our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia," said Peter Nielsen, President and CEO of Bio-Path Holdings. "In addition, the selection of BP1003 as a new drug candidate for the treatment of pancreatic cancer highlights the exciting and expansive potential of our DNAbilize technology platform to produce targeted drug candidates that can address many different diseases with high unmet need."
Recent Corporate Highlights
· Completed Registered Direct Public Offering. On November 3, 2017, Bio-Path agreed to the sale and issuance of 13,333,332 shares of common stock and warrants to purchase up to 6,666,666 shares of common stock to healthcare focused institutional investors in a registered direct offering with gross proceeds of approximately $4.0 million. The offering closed on November 6, 2017.
· Selected Third Drug Candidate, BP1003, for Treatment of Pancreatic Cancer. In November, Bio-Path announced that BP1003, which targets the Stat3 protein, has been moved into preclinical development for the treatment of pancreatic cancer. The candidate is currently being studied in a patient-derived tumor model, and previous models have shown it to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.
· Demonstrated Promising Preclinical Results for Prexigebersen in Solid Tumors. In November, Bio-Path announced that prexigebersen, targeting the Grb2 protein, showed ovarian tumor penetration in recently completed preclinical studies. Bio-Path plans to initiate a Phase 1 trial of prexigebersen in several solid tumor types in 2018. Prexigebersen is currently in Phase 2 development for the treatment of blood cancers and has demonstrated clinical benefit as a monotherapy and in combination with standard frontline treatments in both acute myeloid leukemia and chronic myeloid leukemia.
· Announced Encouraging Preclinical Results for BP1002. In November, Bio-Path announced that, BP1002, targeting the Bcl2 protein, demonstrated strong anti-non-Hodgkin’s lymphoma activity in cell lines and in an animal model. The Company intends to initiate a Phase 1 trial of BP1002 in lymphoma in 2018.
Financial Results for the Third Quarter Ended September 30, 2017
The Company reported a net loss attributable to common stockholders of $2.5 million, or $0.02 per share, for the three months ended September 30, 2017, compared to a net loss attributable to common stockholders of $1.6 million, or $0.02 per share, for the three months ended September 30, 2016. The increase was primarily due to the benefit received from the change in fair value of the warrant liability in 2016. The Company reported a net loss attributable to common stockholders of $5.9 million, or $0.06 per share, for the nine months ended September 30, 2017, compared to a net loss attributable to common stockholders of $5.4 million, or $0.06 per share, for the nine months ended September 30, 2016. The increase was primarily due to the deemed dividend related to the warrant conversion of $1.0 million during the period.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, compared to $2.3 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017, research and development expenses decreased to $4.1 million, compared to $4.5 million for the nine months ended September 30, 2016. The decreases were primarily due to the release of drug material for our Phase 2 clinical trial for prexigebersen in AML in 2016.
General and administrative expenses for the three months ended September 30, 2017 increased to $0.9 million, compared to $0.7 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017, general and administrative expenses increased to $2.7 million, compared to $2.3 million for the nine months ended September 30, 2016.
As of September 30, 2017, the Company had cash of $4.6 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the nine months ended September 30, 2017 was $5.7 million compared to $6.5 million for the comparable period in 2016. Net cash used in investing activities for the nine months ended September 30, 2017 was $0.5 million. Net cash provided by financing activities for the nine months ended September 30, 2017 was $1.5 million.
Conference Call and Webcast Information
Bio-Path Holdings will host a conference call tomorrow to review these third quarter 2017 financial results, as well as to provide a general update on the Company, via a webcast and conference call at 8:30 a.m. ET. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229- 8838 (international) and refer to the conference ID number 3166609. 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.