Bio-Path Holdings Reports First Quarter 2021 Financial Results
May 14 2021 - 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
first quarter ended March 31, 2021 and provided an update on recent
corporate developments.
“The start of 2021 has been marked by
substantial progress across our portfolio of targeted nucleic
cancer drugs which included both presented and published data in
support of our DNAbilize platform,” stated Peter Nielsen, President
and Chief Executive Officer of Bio-Path Holdings. “We recently
announced the successful completion of the safety run-in of Stage 2
of the Phase 2 clinical study of prexigebersen for the treatment of
acute myeloid leukemia (AML) in combination with frontline
therapies, decitabine and venetoclax. This was particularly
important as the efficacy portion of this study will include de
novo fragile AML patients for whom a clean safety profile will be
critical.”
“Last month, we were particularly pleased to
have supportive preclinical data from our BP1002 program presented
before an audience of world-leading cancer specialists at the AACR
Annual Meeting and to have published an analysis highlighting the
potential of prexigebersen within the oligonucleotide drug delivery
landscape in the peer-reviewed journal, Biomedicines. This
presentation and publication significantly enhanced the oncology
community’s awareness of the potential for our DNAbilize platform
in a variety of hard to treat cancers and we look forward to
building on this momentum throughout the remainder of this year,”
continued Mr. Nielsen.
Recent Corporate Highlights
- Announced Publication in Biomedicines. In
April, Bio-Path announced the publication of an analysis
highlighting the potential of prexigebersen (BP1001) within the
antisense oligonucleotide drug delivery landscape in the
peer-reviewed journal, Biomedicines.
- Presented BP1002 Data at 2021 AACR Annual
Meeting. In April, Bio-Path presented a poster
highlighting preclinical BP1002 data at the 2021 American
Association for Cancer Research (AACR) Annual Meeting. BP1002
targets the protein Bcl-2, which is responsible for driving cell
survival in up to 60% of all cancers. High expression of Bcl-2 has
been correlated with poor prognosis for patients diagnosed with
AML. The data presented in the AACR poster show that
venetoclax-resistant cells are sensitive to the inhibitory effects
of BP1002 combined with decitabine, suggesting that this
combination is a potential treatment for patients who have relapsed
from frontline venetoclax-based therapies.
- Successfully Completed Safety Cohort of Triple
Combination in Stage 2 of Phase 2 Clinical
Trial in AML. In April, Bio-Path announced the successful
completion of the safety run-in of Stage 2 of the Phase 2 clinical
study of prexigebersen (BP1001), a liposomal Grb2 antisense, for
the treatment of acute myeloid leukemia (AML), in combination with
frontline therapies, decitabine and venetoclax, in acute myeloid
leukemia (AML) patients. The safety run-in of Stage 2 of the Phase
2 clinical trial was comprised of six evaluable patients who were
treated with the triple combination of prexigebersen, decitabine
and venetoclax.
- Raised $13.0 Million in Public Offering. In
February, Bio-Path announced the closing of a public offering for
1,710,600 shares of common stock at a price of $7.60 per share, for
aggregate gross proceeds to the Company of approximately $13.0
million, before deducting the fees and estimated offering expenses
payable by the Company.
- Received Third U.S. Patent Grant Related to Manufacture
of Platform Technology. In February, Bio-Path announced
that the United States Patent and Trademark Office granted U.S.
Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal
formulation." The new patent builds on earlier patents granted that
protect the platform technology for DNAbilize®, the Company’s novel
RNAi nanoparticle drug.
Financial Results for the First Quarter Ended March 31,
2021
- The Company reported a net loss of $2.4 million, or $0.43 per
share, for the three months ended March 31, 2021, compared to a net
loss of $3.3 million, or $0.90 per share, for the three months
ended March 31, 2020.
- Research and development expense for the three months ended
March 31, 2021 decreased to $1.3 million, compared to $2.0 million
for the three months ended March 31, 2020 primarily due to
decreased preclinical expense related to timing of activities for
BP1003 as well as decreased clinical trial expense due to timing of
activities for our Phase 2 clinical trial of prexigebersen in AML
and our Phase 1 clinical trial of BP1002 in lymphoma.
- General and administrative expense for the three months ended
March 31, 2021 decreased to $1.2 million, compared to $1.3 million
for the three months ended March 31, 2020 primarily due to
decreased franchise tax expense.
- As of March 31, 2021, the Company had cash of $30.8 million,
compared to $13.8 million as of December 31, 2020. Net cash used in
operating activities for the three months ended March 31, 2021 was
$1.6 million compared to $2.5 million for the comparable period in
2020. Net cash provided by financing activities for the three
months ended March 31, 2021 was $18.6 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 first quarter 2021 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 5064037. 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 infusion. 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 a Phase 1 study in solid
tumors. This is followed by BP1002, targeting the
Bcl-2 protein, where it is being evaluated in a Phase 1 study
in advanced lymphoma and CLL patients.
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, 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,
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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