Bio-Path Holdings Reports Second Quarter 2023 Financial Results
August 15 2023 - 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
second quarter ended June 30, 2023 and provided an update on recent
corporate developments.
"Our clinical progress this quarter was
highlighted by the compelling interim results from Stage 2 of our
Phase 2 study of prexigebersen as a treatment for acute myeloid
leukemia, a blood cancer for which there are limited treatment
options and for which the prognosis is grave," said Peter Nielsen,
President and Chief Executive Officer of Bio-Path Holdings. "The
data showed prexigebersen demonstrated meaningful clinical
improvement with a tolerable safety profile in these high-risk
patients. On the strength of these data, we now plan to file for
regulatory designations that may accelerate the pathway for
bringing this potentially life-expanding therapy to patients
battling this deadly hematologic cancer."
"We continue to advance our robust clinical
development program across a number of important programs that
leverage our innovative DNAbilize platform technology to deliver
RNAi nanoparticle therapeutics directly to cancer cells. We are
forging a new path in DNA-powered medicine that we believe will
give patients a fighting chance to beat these difficult to treat
cancers," continued Mr. Nielsen.
Recent Corporate Highlights
- Announced Positive Results from Interim Analysis of
Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid
Leukemia. In August, Bio-Path reported positive interim
data from Stage 2 of the Company’s Phase 2 study of prexigebersen
in combination with decitabine and venetoclax for the treatment of
acute myeloid leukemia (AML). Prexigebersen continues to be
well-tolerated and has now shown compelling efficacy results in two
reporting cohorts including evaluable newly diagnosed AML patients
and evaluable refractory/relapsed AML patients, which exceed
outcomes with combination treatment of decitabine and
venetoclax.
Financial Results for the Second Quarter Ended June 30,
2023
- The Company reported a net loss of $4.2 million, or $0.53 per
share, for the three months ended June 30, 2023, compared to a net
loss of $3.0 million, or $0.42 per share, for the three months
ended June 30, 2022.
- Research and development expense for the three months ended
June 30, 2023 increased to $3.1 million, compared to $1.9 million
for the three months ended June 30, 2022 primarily due to
manufacturing expenses related to drug product releases during the
second quarter of 2023 and increased patient enrollment related to
our Phase 2 clinical trial for prexigebersen in AML.
- General and administrative expense for both the three months
ended June 30, 2023 and June 30, 2022 was $1.2 million.
- As of June 30, 2023, the Company had cash of $3.4 million,
compared to $10.4 million as of December 31, 2022. Net cash used in
operating activities for the six months ended June 30, 2023 was
$6.9 million compared to $6.7 million for the comparable period in
2022.
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
2023 financial results and to provide a general update on the
Company. To access the conference call please dial (833) 630-1956
(domestic) or (412) 317-1837 (international). 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 transfusion. Bio-Path’s lead product candidate,
prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2
study for blood cancers, and a Phase 1/1b study of BP1001-A, a drug
product modification of prexigebersen, in solid tumors has
commenced. The Company’s second product, BP1002, which targets the
Bcl-2 protein, is being evaluated for the treatment of blood
cancers and solid tumors, including lymphoma and acute myeloid
leukemia. In addition, an IND application is expected to be filed
for BP1003, a novel liposome-incorporated STAT3 antisense
oligodeoxynucleotide developed by Bio-Path as a specific inhibitor
of STAT3.
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 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, 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, the maintenance of intellectual property rights,
that patents relating to existing or future patent applications
will be issued or that any issued patents will provide meaningful
protection of our drug candidates, the impact, risks and
uncertainties related to global pandemics, including the COVID-19
pandemic, and actions taken by governmental authorities or others
in connection therewith, 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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