Bio-Path Holdings Reports Full Year 2019 Financial Results
March 06 2020 - 7:00AM
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, today announced its financial results for the full year
ended December 31, 2019 and provided an update on recent corporate
developments.
“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.
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 the
treatment of blood cancers and has filed an IND for a Phase 1
clinical trial for solid tumors. The Company’s second pipeline
candidate BP1002, which targets the Bcl-2 protein and is planned to
be evaluated for the treatment of lymphoma and chronic lymphocytic
leukemia. In addition, an IND application for BP1003, a novel
liposome-incorporated STAT3 antisense oligodeoxynucleotide
developed by Bio-Path as a specific inhibitor of STAT3, is expected
to be filed in 2020.
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, Bio-Path's
ability to 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, the maintenance of intellectual property rights,
that patents relating to existing for future patent applications
will be issued or that any issued patents will provide meaningful
protection of our drug candidates, risks relating to maintaining
Bio-Path's listing on the Nasdaq Capital Market 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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