Bio-Path Holdings Reports First Quarter 2020 Financial Results
May 15 2020 - 6:00AM
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
first quarter ended March 31, 2020 and provided an update on recent
corporate developments.
“We continued to make meaningful progress throughout the first
quarter across all of our promising DNAbilize clinical development
programs, even in the face of challenges associated with COVID-19.
During 2020, we expect to initiate safety testing of the
triple combination of our lead candidate, prexigebersen, with
decitabine and venetoclax as part of Stage 2 of our Phase 2 trial
in patients with acute myeloid leukemia,” said Peter Nielsen,
President and Chief Executive Officer of Bio-Path Holdings.
“We were also excited to present a poster at the American
Association for Cancer Research Annual Meeting, which highlighted
the robust clinical trial design of the planned Phase 1 study of
our therapeutic candidate, BP1002, in patients with advanced
lymphoid malignancies. This is an important study as we expect it
will not only establish safety but may also provide insight into
dosing and potential therapeutic activity. Finally, we look
forward to initiating a Phase 1 study of prexigebersen-A for the
treatment of solid tumors in 2020. Solid tumors represent key
indications for Bio-Path to pursue as there are so few effective
treatment options and they represent the vast majority of
cancers.”
Recent Corporate Highlights
- Announced Presentation at the 2020 American Society of
Clinical Oncology Annual Meeting. In May, Bio-Path
announced a virtual poster presentation at the upcoming 2020
American Society of Clinical Oncology (ASCO) Annual Meeting, taking
place from May 29-31, 2020. Dr. Maro Ohanian, Department of
Leukemia, University of Texas M.D. Anderson Cancer Center, will
discuss the Phase 2 study design of prexigebersen (liposomal Grb2
antisense), the Company’s lead drug candidate, in combination with
decitabine as a potential treatment for patients diagnosed with
acute myeloid leukemia or high-risk myelodysplastic syndrome.
- Presented a Poster at the American Association for
Cancer Research Annual Meeting 2020. In April, Bio-Path
presented a poster highlighting the clinical trial design of its
Phase 1 study of its therapeutic candidate BP1002 in patients with
advanced lymphoid malignancies. The Phase 1 clinical trial is
expected to be conducted at several leading cancer centers,
including The University of Texas MD Anderson Cancer Center, the
Georgia Cancer Center and the Sarah Canon Research Institute. This
poster was presented at the virtual American Association for Cancer
Research (AACR) Annual Meeting 2020.
- Appointed Ernst & Young as New Auditor. In
March, the Audit Committee of Bio-Path’s Board of Directors
approved the appointment of Ernst & Young LLP as the Company’s
new independent registered public accounting firm.
- Impact of COVID-19. To date, COVID-19’s
impact on operations has been limited to the inability to travel to
clinical trial sites and clinical trial sites not allowing
nonessential personnel on site for the purpose of monitoring
activity. We anticipate COVID-19 may have an effect on patient
recruiting in the near term as social distancing mandates are in
effect.
Financial Results for the First Quarter Ended March 31,
2020
- The Company reported a net loss of $3.3 million, or $0.90 per
share, for the three months ended March 31, 2020, compared to a net
loss of $1.5 million, or $0.89 per share, for the three months
ended March 31, 2019.
- Research and development expenses for the three months ended
March 31, 2020 increased to $2.0 million, compared to $0.4 million
for the three months ended March 31, 2019 primarily due to the
manufacture of drug material in preparation for our Phase 1
clinical trial of prexigebersen-A in solid tumors, an increase in
clinical trial expenses related to increased enrollment in our
Phase 2 clinical trial of prexigebersen in AML and start-up
activities for our Phase 1 clinical trial of BP1002 in lymphoma, as
well as increased preclinical study expenses.
- General and administrative expenses for the three months ended
March 31, 2020 increased to $1.3 million, compared to $1.1 million
for the three months ended March 31, 2019 primarily due to
increased franchise tax expense.
- As of March 31, 2020, the Company had cash of $17.9
million, compared to $20.4 million at December 31,
2019. Net cash used in operating activities for the three
months ended March 31, 2020 was $2.5 million compared to $2.0
million for the comparable period in 2019.
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 first 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 7973458. 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 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 will be evaluated in lymphoma and solid
tumors 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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