Bio-Path Holdings Reports Third Quarter 2020 Financial Results
November 13 2020 - 7:00AM
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, today announced its financial results for the
third quarter ended September 30, 2020 and provided an update on
recent corporate developments.
“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.
About Bio-Path Holdings,
Inc.
Bio-Path is a biotechnology company developing
DNAbilize®, a novel technology that has yielded a pipeline of RNAi
nanoparticle drugs that can be administered with a simple
intravenous infusion. Bio-Path’s lead product candidate,
prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2
study for blood cancers and prexigebersen-A, a drug product
modification of prexigebersen, is under consideration by the FDA to
commence Phase 1 studies in solid tumors. This is followed by
BP1002, targeting the Bcl-2 protein, where it is being evaluated in
lymphoma clinical studies.
For more information, please visit the Company's
website at http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking
statements that are made pursuant to the safe harbor provisions of
the federal securities laws. These statements are based on
management's current expectations and accordingly are subject to
uncertainty and changes in circumstances. Any express or implied
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Any statements that are not historical facts contained in this
release are forward-looking statements that involve risks and
uncertainties, including the impact, risks and uncertainties
related to COVID-19 and actions taken by governmental authorities
or others in connection therewith, Bio-Path’s ability to raise
needed additional capital on a timely basis in order for it to
continue its operations, have success in the clinical development
of its technologies, the timing of enrollment and release of data
in such clinical studies and the accuracy of such data, limited
patient populations of early stage clinical studies and the
possibility that results from later stage clinical trials with much
larger patient populations may not be consistent with earlier stage
clinical trials, and such other risks which are identified in
Bio-Path's most recent Annual Report on Form 10- K, in any
subsequent quarterly reports on Form 10-Q and in other reports that
Bio-Path files with the Securities and Exchange Commission from
time to time. These documents are available on request from
Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact Information:
Investors
Will O’ConnorStern Investor Relations,
Inc.212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path
Holdings, Inc. 832-742-1369
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