Bio-Path Holdings Reports Third Quarter 2019 Financial Results
November 15 2019 - 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 third quarter
ended September 30, 2019 and provided an update on recent corporate
developments.
“Throughout the third quarter we continued to make progress
across all of our innovative RNAi nanoparticle therapeutic
programs. Importantly, we continued treating patients and are
nearing completion of the safety portion of the Phase 2 clinical
study of prexigebersen in combination with decitabine in untreated
AML and high risk MDS patients and refractory/relapsed AML and high
risk MDS patients. Upon completion of this key milestone, we expect
to begin the study of prexigebersen with decitabine plus
venetoclax,” said Peter Nielsen, President and Chief Executive
Officer of Bio-Path Holdings. “Additionally, we filed an
Investigational New Drug (IND) application for our second pipeline
candidate, BP1002, and further strengthened and expanded our patent
portfolio with the addition of a key new patent that protects our
DNAbilize® platform and underscores its novelty. In addition, an
IND for prexigebersen in the treatment of solid tumors starting
with ovarian and endometrial cancer is being finalized for filing.
Patients diagnosed with recurrent ovarian or endometrial cancer
often have poor outcomes and it is our hope that prexigebersen may
provide clinical benefit for such patients.”
“We are working toward completing IND enabling studies of
BP1003, a 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. Pancreatic
cancer patients have extremely limited treatment options,
consequently, we are dedicated to moving this therapy forward as
quickly as possible,” added Mr. Nielsen.
Recent Corporate Highlights
- Appointed Martina Molsbergen to the Board of
Directors. In October 2019, Bio-Path announced the
appointment of Martina Molsbergen, Chief Executive Officer of C14
Consulting, to its Board of Directors. Her considerable experience
in business development will be invaluable as Bio-Path seeks a
variety of partnerships and collaborations in order to advance the
Company’s DNAbilize platform technology.
- Updated Intellectual Property Portfolio with Addition
of Recently Issued Second Platform Technology Patent. In
September 2019, Bio-Path announced that the United States Patent
and Trademark Office issued a patent with claims related to the
Company’s proprietary liposomal delivery and antisense technology,
DNAbilize®, including its use in the treatment of cancers,
autoimmune diseases and infectious diseases. This is the
second U.S. patent issued for the Company’s platform
technology.
- Dosed Patient in Amended Phase 2 Prexigebersen Trial in
Acute Myeloid Leukemia. In August 2019, Bio-Path announced
patient dosing in the amended Phase 2 trial of prexigebersen for
the treatment of acute myeloid leukemia (AML), which was updated to
include patients with high risk myelodysplastic syndrome (MDS) and
refractory/relapsed AML patients. Bio-Path continues treating
patients and is nearing completion of the safety portion of the
amended Phase 2 study, which is evaluating prexigebersen in
combination with decitabine. Upon successful completion of this
safety assessment, the Company plans to add venetoclax to the
prexigebersen/decitabine combination treatment.
Financial Results for the Third Quarter Ended September
30, 2019
- The Company reported a net loss of $2.2 million, or $0.78 per
share, for the three months ended September 30, 2019, compared to a
net loss of $3.1 million, or $5.38 per share, for the three months
ended September 30, 2018.
- Research and development expenses for the three months ended
September 30, 2019 decreased to $1.4 million, compared to $2.3
million for the three months ended September 30, 2018 primarily due
to lower expenses in 2019 related to drug material releases for the
Company’s Phase 2 clinical trials for prexigebersen in AML and CML.
- General and administrative expenses for the three months ended
September 30, 2019 increased to $0.9 million, compared to $0.7
million for the three months ended September 30, 2018 primarily due
to increased legal fees and insurance costs.
- As of September 30, 2019, the Company had cash of $15.4
million, compared to $1.0 million at December 31, 2018. Net
cash used in operating activities for the nine months ended
September 30, 2019 was $6.1 million compared to $4.8 million for
the comparable period in 2018. Net cash provided by financing
activities for the nine months ended September 30, 2019 was $20.5
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 third quarter 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 2095674. 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 is in the process of filing an IND
for a Phase 1 clinical trial for solid tumors. The Company is also
developing BP1002, which targets the Bcl-2 protein and is expected
to be evaluated for the treatment of lymphoma and solid tumors. In
addition, BP1003, a novel liposome-incorporated STAT3 antisense
oligodeoxynucleotide developed by Bio-Path as a specific inhibitor
of STAT3, is expected to enter Phase 1 studies 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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