HOUSTON -- (BUSINESS WIRE) --
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
2013 OPERATIONAL AND FINANCIAL HIGHLIGHTS
2013 Operational Highlights
Two patients have completed treatment in 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. The
Company is currently awaiting the next batch of drug, expected to
arrive mid-second quarter 2014, in order to complete the sixth
cohort of the clinical trial. The drug’s safety profile continues
to be favorable with no treatment-related serious adverse events
reported and data continues to suggest possible anti-leukemia
activity. The trial is being conducted at The University of Texas
MD Anderson Cancer Center (MD Anderson Cancer Center). Liposomal
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 AML patients.
date, the Company has successfully completed five cohorts of the
Phase I study and has completed two-thirds of the sixth cohort. A
total of 33 patients have been enrolled into the clinical trial,
of which 20 have been evaluable. It is worth noting that only one
additional evaluable patient is required to complete Cohort 6.
on-going Phase I clinical trial is a dose-escalating study to
determine the safety and tolerance of escalating doses of
Liposomal Grb-2, as well as the optimal biologically active dose
for further development. 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. The new down-regulation assay of
inhibition is expected to be available for use in that
In the fourth quarter of 2013, Bio-Path initiated preclinical
testing of its lead product candidate, Liposomal Grb-2, into two
additional indications: triple negative breast cancer (TNBC) and
inflammatory breast cancer (IBC), two cancers characterized by
formation of aggressive tumors and relatively high mortality
rates. During the quarter, Bio-Path also initiated preclinical
testing of Liposomal Grb-2 in combination with front-line
therapies for blood cancers. This testing is being performed to
provide supporting evidence for Bio-Path’s Phase II clinical trial
program, which is currently being planned to evaluate Liposomal
Grb-2 in combination with front-line therapies.
Dr. Jorge Cortes, deputy chair and professor of medicine in the
Department of Leukemia at The
University of Texas MD Anderson Cancer Center, presented
results through Cohort 5 of the Phase I clinical trial at the 55th
Annual Meeting of the American Society of Hematology (ASH) in New
Orleans in December.
In 2013 Bio-Path sold approximately $6 million in shares of common
stock, in two private placements that have been closed, receiving
net proceeds of approximately $5.3 million.
The accomplishments in 2013 culminated in Bio-Path uplisting to the
NASDAQ Capital Market. Bio-Path’s shares began trading on this Exchange
March 10, 2014.
Additional Recent Highlights:
Subsequent to the close of the fourth quarter, 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. As a result of this financing, the Company currently has
approximately $17 million in cash and cash equivalents.
Bio-Path intends to build-out the organization during 2014 in order to
more fully implement its business plan. Last week, Bio-Path announced
the appointment of Dr. Ulrich W. Mueller as Chief Operating Officer.
Additional hires include a Director, Clinical Operations and Project
Management; a Controller; and a Director, IT and Data Management
Systems. These personnel are in addition to Dr. Ana Tari, who has been
serving as Director, Preclinical Operations and Research.
Net loss for the year 2013 was $(3,266,013), compared to a Net
Loss of $(2,582,537) for the year 2012. The increase in net loss
was due to an increase of $648,553 in general and administrative
expense, which was due to an increase in stock option expense for
management, officers and directors totaling $661,861, a non-cash
expense that is based upon the Black Scholes fair value of the
options grants. Research and development expense increased by
$386,173, due primarily to higher drug product expense from higher
doses administered in the trial and testing, which was
substantially offset by lower research and development expense –
related party from technology impairment expense which occurred in
2012. Excluding the non-cash stock options expense, general and
administrative expenses were lower in 2013 by $13,308 compared to
2012. For the full year 2013, the Company reported a net loss per
share of $(0.05) based on 71,372,672 weighted average shares
outstanding, compared to $(0.04) per share for the year 2012.
Operating expenses increased by $686,561 to $3,269,240 for
the year 2013 compared to the year 2012, primarily due to
increased stock options expense and drug material expense, offset
to some extent with the absence of related party technology
impairment expense during 2013.
As of December 31, 2013, the Company had cash of $3,551,832, compared
to $534,046 at December 31, 2012. Net cash used in operating
activities for the year 2013 was $(2,313,160) compared to
$(1,993,404) for the year 2012. The primary reasons for the
increase in net cash used in operations for the year over year
period is the increased cash cost of clinical trial operations,
including drug material. As previously noted, the Company raised
an additional $15 million during the first quarter of 2014.
“2013 was a pivotal year for Bio-Path as the Company shored up its
balance sheet, attracted institutional investor interest and achieved
significant milestones on the research front, particularly confirming
through an assay that Liposomal Grb-2 inhibits the disease causing
protein in patients with blood cancers,” said Peter Nielsen, President
and Chief Executive Officer of Bio-Path. “We look forward to enrolling
the last patient into Cohort six of the Phase I trial and going forward,
expect the drug supply issues to improve. We have recently added to our
management team and in 2014 look toward further building out the Company
and its clinical programs.”
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-100.1.01 is 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-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.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Copyright © Business Wire 2014
Bio-Path Holdings, Inc.
Peter Nielsen, 832-971-6616
& Chief Executive Officer
Communications Group, LLC
Rhonda Chiger, 917-322-2569