On March 6, 2020 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 full year ended December 31, 2019 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 6, 2020, View Source [SID1234555265]).
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"The significant progress we made throughout 2019 has laid the foundation for Bio-Path to achieve a number of key clinical milestones in the coming year and beyond. Importantly, we strengthened our balance sheet in 2019, giving us the financial underpinning to support our clinical programs through to a number of value-creating inflection points," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
"We entered 2020 well positioned to execute on our clinical development strategy. Following the successful completion of the safety testing in Stage 2 of our Phase 2 Clinical Trial of prexigebersen in Acute Myeloid Leukemia (AML), we now plan to advance this program to its next stage in the first half of 2020. In addition, we filed an Investigational New Drug (IND) application for prexigebersen in the treatment of solid tumors including ovarian and endometrial cancer and expect to start that study later this year.
"We also are in the process of initiating a Phase 1 study of our second pipeline candidate, BP1002 (liposomal Bcl-2), in the first half of this year to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients. Finally, we are nearing completion of IND-enabling studies of BP1003, our novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of solid tumors, and expect to file an IND application for a Phase 1 study of BP1003 for the treatment of solid tumors, including pancreatic cancer, in 2020," concluded Mr. Nielsen.
Recent Corporate Highlights
·Raised $8.0 Million in Registered Direct Offering. In November 2019, Bio-Path issued and sold 808,080 shares of its common stock and warrants to purchase up to 606,060 shares of its common stock, at a combined purchase price of $9.90 per share and associated warrant, for aggregate gross proceeds of approximately $8.0 million.
·Announced Clearance of Investigational New Drug Application for BP1002. In November 2019, Bio-Path announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the IND application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate. An initial Phase 1 clinical trial will evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients.
·Successfully Completed Safety Testing in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia. In November 2019, Bio-Path announced the successful completion of the safety testing of prexigebersen in combination with decitabine in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients in Stage 2 of the Phase 2 clinical study. The safety segment of Stage 2 of the Phase 2 clinical trial comprised six evaluable patients who were treated with the combination of prexigebersen and decitabine.
Financial Results for the Full Year Ended December 31, 2019
·The Company reported a net loss of $8.6 million, or $3.24 per share, for the year ended December 31, 2019, compared to a net loss of $8.6 million, or $14.38 per share, for the year ended December 31, 2018.
·Research and development expense for each of the years ended December 31, 2019 and December 31, 2018 was $4.6 million.
·General and administrative expense for the year ended December 31, 2019 increased to $4.1 million, compared to $3.4 million for the year ended December 31, 2018, primarily due to increased legal fees and salaries and benefits expense.
·As of December 31, 2019, the Company had cash of $20.4 million, compared to $1.0 million at December 31, 2018. Net cash used in operating activities for the year ended December 31, 2019 was $8.4 million compared to $6.1 million for the comparable period in 2018. Net cash provided by financing activities for the year ended December 31, 2019 was $27.8 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 2019 financial results and to provide a general update on the Company. To access the conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to conference ID 7152658. A live audio webcast of the call and the archived webcast will be available on the Company’s website at www.biopathholdings.com.