Bio-Path Holdings, Inc., (NASDAQ:BPTH) (“Bio-Path”), a biotechnology
company developing a liposomal delivery technology for nucleic acid
cancer drugs, today announced operational and financial results for the
first quarter ended March 31, 2014.
Recent Operational Highlights
Bio-Path is working toward completing the sixth dosage cohort of
the Phase I clinical trial evaluating Bio-Path’s lead product
candidate, BP-100-1.01 (Liposomal Grb-2) in blood cancers. It is
anticipated that the next batch of drug will arrive in the second
quarter 2014, at which point the sixth cohort should fully enroll.
The Company intends to evaluate patient results at the end of
Cohort 6 to determine if the optimal biological dose has been
reached, which would bring a close to the Phase I clinical trial.
FIRST QUARTER 2014 OPERATIONAL AND FINANCIAL HIGHLIGHTS
Grb-2 is a novel, systemic liposomal antisense treatment for blood
cancers. Patients eligible for enrollment have refractory or
relapsed disease and have failed other approved treatments, and
recent enrollment has focused on older age Acute myelogenous
leukemia (AML) patients.
Bio-Path completed initial preclinical testing of Liposomal Grb-2,
in combination therapy with current treatments for Chronic
myelogeneous leukemia (CML) and AML. These studies provided
preclinical evidence that using Liposomal Grb-2 in combination
with these frontline therapies can potentially produce additional
benefits in treating CML and AML patients. Currently, Bio-Path
plans to evaluate Liposomal Grb-2 in Phase II clinical trials in
combination therapy with frontline treatments for CML and AML. The
definitive Phase II clinical trial protocol is being finalized.
Development of scaled-up manufacturing processes continued in the
first quarter to support anticipated future requirements of
Bio-Path’s liposomal antisense products.
During the quarter, Bio-Path started to build out its operations
and team. Dr. Ulrich W. Mueller was appointed Chief Operating
Officer. He brings years of clinical oncology development
experience to the Company. Other strategic hires include a
Director, Clinical Operations and Project Management; Controller;
and Director, IT and Data Management Systems. Bio-Path intends to
add additional experienced management in the areas of
manufacturing and drug supply, intellectual property and
licensing. These personnel are in addition to Dr. Ana Tari, who
has been serving as Director, Preclinical Operations and Research.
In March of 2014 Bio-Path was uplisted to the NASDAQ Capital
Market. Bio-Path’s shares began trading on this Exchange March 10,
In January 2014 the Company raised $15 million in a direct
offering of shares and warrants to an institutional investor,
receiving net proceeds of approximately $13.75 million.
The Company reported a net loss of $504,876 for the three month
period ended March 31, 2014, compared to a net loss of $656,002
for the three month period ended March 31, 2013. The decrease was
due to research and development expenses being lower in the
quarter ended March 31, 2014 due to lower drug material and
clinical trial expenses, offset to some extent by higher general
and administrative expense. The increased general and
administrative expense was primarily due to the exchange listing
fee for the Company’s common stock to be listed on the NASDAQ
Capital Market and non-cash expense from vesting of previously
granted stock options to officers, directors and management. For
the first quarter 2014, the Company reported a net loss per share
of $(0.01) based on 89,237,872 weighted average shares
outstanding, compared to $(0.01) per share for the same period in
Operating expenses of $510,210in the first quarter of 2014
were lower by $145,700 compared to the first quarter of 2013 due
to lower research and development expenses, offsetting higher
general and administrative expense resulting from exchange listing
fee and non-cash stock option expense from a grant made to
officers, directors and management.
As of March 31, 2014, the Company had cash of $16,819,783, compared
to $3,551,832 at December 31, 2013.Net cash used in
operating activities for the first three months of 2014 was
$544,422 compared to $551,004 for the first three months of 2013.
Increases in cash for working capital in the three month period
ending March 31, 2014 substantially offset a lower net loss
compared to the three month period ending March 31, 2013.
“The past several months have been significant for Bio-Path as the
Company expands its internal capabilities in order to more efficiently
progress its technology. Our balance sheet is the strongest it has ever
been and gives us sufficient funding to ensure operations into 2016. We
will also continue to bring experienced management into the organization
in areas that are necessary to implement our clinical and business
development plans,” said Peter Nielsen, President and Chief Executive
Officer of Bio-Path. “In regard to research and development, we
completed preclinical combination therapy testing of our lead drug
candidate with positive results and continued manufacturing development.
As drug supply issues improve, we look forward to enrolling the last
patient into Cohort six of the Phase I trial. Furthermore, we are
gearing up to screen new protein targets that could potentially become
additional liposomal antisense drug candidates. This reflects the true
potential of Bio-Path and we look forward to this next phase in the
Company’s development in 2014.”
About Bio-Path’s Delivery Technology
Bio-Path’s drug delivery technology involves microscopic-sized liposome
particles that distribute nucleic acid drugs systemically and safely
throughout the human body, via simple intravenous infusion. The delivery
technology is applied to single stranded (antisense) nucleic acid
compounds with the potential to revolutionize the treatment of cancer
and other diseases where drugable targets of disease are well
characterized. The Company is currently focused on developing liposomal
antisense drug candidates. Bio-Path also anticipates developing liposome
tumor targeting technology, representing next-generation enhancements to
the Company’s core liposome delivery technology.
About Growth Receptor Bound protein-2 (Grb-2)
The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential
to cancer cell signaling because it is utilized by oncogenic tyrosine
kinases to induce cancer progression. Suppressing the function or
expression of Grb-2 should interrupt its vital signaling function and
have a therapeutic application in cancer. BP-100.1.01is a
neutral-charge, liposome-incorporated antisense drug substance designed
to inhibit Grb-2 expression.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company focused on developing therapeutic
products utilizing its proprietary liposomal delivery technology
designed to systemically distribute nucleic acid drugs throughout the
human body with a simple intravenous transfusion. Bio-Path’s lead
product candidate, Liposomal Grb-2, is in a Phase I study for blood
cancers and in preclinical studies for triple negative and inflammatory
breast cancers. Bio-Path’s second drug candidate, also a liposomal
antisense drug, is ready for the clinic where it will be evaluated in
lymphoma and solid tumors.
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,
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 the Company's most recent Annual Report on Form
10-K and in any subsequent quarterly reports on Form 10-Q.These
documents are available on request from Bio-Path Holdings or at www.sec.gov.Bio-Pathdisclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Bio-Path Holdings, Inc.
Peter Nielsen, 832-971-6616
& Chief Executive Officer
Communications Group, LLC
Rhonda Chiger, 917-322-2569
Source: Bio-Path Holdings, Inc.