Bio-Path Holdings Reports Full Year 2018 Financial Results
March 20 2019 - 9:15AM
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, 2018 and provided an update on recent corporate
developments.
“Throughout 2018, we made great progress in pursuit of our
mission of bringing innovative new RNAi nanoparticle therapeutics
to cancer patients with high unmet medical need,” said Peter
Nielsen, President and Chief Executive Officer of Bio-Path
Holdings. “This progress was highlighted by the recent
updated interim analysis of our Phase 2 trial of prexigebersen in
acute myeloid leukemia (AML). Of the 17 evaluable patients, 65% had
a response, including 29% who achieved a complete response, one of
which achieved a morphologic leukemia free state. With these
interim results in hand, we are even more confident as we move this
program forward in combination with venetoclax and decitabine.”
“Beyond prexigebersen, we continue to make headway across our
development pipeline. We are on track to submit our Investigational
New Drug application to begin a Phase 1 study of our second drug
candidate, BP1002, which targets the Bcl-2 protein. This trial will
seek to treat both Non-Hodgkin’s Lymphoma and chronic lymphocytic
leukemia patients that have failed Venetoclax. We recently
strengthened our balance sheet through a $18.5 million registered
direct offering and we now have the resources to achieve a number
of key milestones that should significantly enhance shareholder
value. We entered 2019 on strong footing and expect to build on
that momentum throughout the balance of the year as we continue to
advance these important programs,” continued Mr. Nielsen.
Recent Corporate Highlights
- Reported Updated Interim Analysis from Phase 2 Clinical
Trial of Prexigebersen for the Treatment of AML. In March
2019, Bio-Path reported updated interim data from 17 evaluable
patients showing that 11 patients (65%) had a response, including
five patients (29%) who achieved CR, one of which was a morphologic
leukemia free state (MLFS), and six patients achieving stable
disease. Importantly, after further analysis by the principal
investigators, it was observed that 68% of these patients were
secondary AML patients, an extremely difficult class to treat. As a
result of these updated data, Bio-Path now intends to enroll two
registration-directed cohorts of the triple combination of
prexigebersen + decitabine + venetoclax in untreated AML and high
risk MDS patients, and refractory/relapsed AML and high risk MDS
patients. In December 2018, earlier data from this program were
presented in a poster at the 2018 American Society of Hematology
(ASH) Annual Meeting and Exposition.
- Raised $18.5 Million in Registered Direct
Offering. In March 2019, Bio-Path issued 712,910 shares of
its common stock at a price of $25.95 per share, for gross proceeds
of approximately $18.5 million.
Financial Results for the Full Year Ended December 31,
2018
- The Company reported a net loss attributable to common
stockholders of $8.6 million, or $14.38 per share, for the year
ended December 31, 2018, compared to a net loss attributable to
common stockholders of $8.1 million, or $15.99 per share, for the
year ended December 31, 2017.
- Research and development expenses for the year ended December
31, 2018 decreased to $4.6 million, compared to $5.5 million for
the year ended December 31, 2017 primarily due to decreased
salaries and benefits expense.
- General and administrative expenses for the year ended December
31, 2018 decreased to $3.4 million, compared to $3.5 million for
the year ended December 31, 2017 primarily due to decreased
professional and consulting fees.
- As of December 31, 2018, the Company had cash of $1.0 million,
compared to $6.0 million at December 31, 2017. Net cash used
in operating activities for the year ended December 31, 2018 was
$6.1 million compared to $8.0 million for the comparable period in
2017. Net cash provided by financing activities for the year
ended December 31, 2018 was $1.2 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 2018 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 1794629. 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 in preclinical studies for solid tumors. This is
followed by BP1002, targeting the Bcl-2 protein, which the Company
anticipates entering into clinical studies where it will be
evaluated in Non-Hodgkin’s Lymphoma and chronic lymphocytic
leukemia.
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
statements regarding the offering, the intended use of proceeds and
the timing of the closing of the offering, 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, 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, except as required by
law.
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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