Bio-Path Holdings, Inc., (OTCBB: BPTH) ("Bio-Path"), a biotechnology
company developing a liposomal delivery technology for nucleic acid
cancer drugs, today announced operational and financial results for the
year ended December 31, 2011.
2011 OPERATIONAL AND FINANCIAL HIGHLIGHTS
Recent Operational Highlights
Enrollment continues in the Phase I clinical trial of Bio-Path's
lead antisense cancer drug product Liposomal Grb-2 (also
"BP-100-1.01"). To date, the Company has successfully completed
the first two cohorts of the study. The drug has been well
tolerated and possible anti-leukemia has been demonstrated. At the
end of March 2012, a total of 24 patients have been enrolled in
the study, of which 10 have been evaluable. The trial is in
the third cohort treating patients with the third dose level of 20
mg/m2. Liposomal Grb-2 is a novel, systemic liposomal
antisense treatment for blood cancers. Patients eligible for
enrollment have refractory or relapsed Acute Myeloid Leukemia
(AML), Philadelphia Chromosome Positive Chronic Myelogenous
Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), or
Myelodysplastic Syndrome (MDS) and who have failed other approved
The 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 trial seeks a total of 18 to 30
evaluable patients and will evaluate five doses of Liposomal Grb-2
in five cohorts. An evaluable patient is a patient who has been
able to complete the four-week treatment cycle. The protocol for
the clinical trial includes five cohorts with dose escalation of
5, 10, 20, 40 and 50 mg/m2. The expected dose for
treatment is 45 mg/m2 based on pre-clinical studies in
animals. The clinical trial is being conducted at The University
of Texas MD Anderson Cancer Center.
It is important to
note three patients who completed the full four week treatment
cycle of the Phase I trial were placed on continuing treatment for
additional cycles based on the Principal Investigator's assessment
that they were receiving benefit from treatment with Liposomal
Grb-2. Two patients in the first cohort were treated for five
months demonstrating stable disease before coming off study, and
currently one patient in the third cohort has recently started to
receive extended treatment. The Company expects that it can
complete the Phase I clinical trial during 2012, subject to
patient accrual rates.
In December of 2011, data from
Liposomal Grb-2 was presented in a poster presentation at the 53rd
Annual Meeting of the American Society of Hematology (ASH) held in
San Diego, California. Jorge Cortes, M.D., Professor at the MD
Anderson Cancer Center, lead author of the poster and Principal
Investigator for the clinical trial, reported that preliminary
results suggest that Liposomal Grb-2, at a dose of 5 mg/m2
is well tolerated and there is suggestion of some possible
anti-leukemia activity. Lab parameters for the six evaluable
patients show each of these patients experienced transient
reductions for blasts and bone marrow results. Two patients had
transient improvement and/or stable disease and received a total
of five cycles each. Two patients also had transient improvements
in leukemia cutis lesions.
In the second quarter of 2011, Dr. Ana Tari, PhD, MBA joined
Bio-Path as Director Preclinical Operations and Research. As an
expert in liposomal antisense therapeutics and a key member of the
research team that performed the basic research and preclinical
development of the Company's liposomal delivery technology, Dr.
Tari brings a wealth of experience and knowledge that will be
instrumental as Bio-Path progresses its research programs.
In July of 2011, Bio-Path announced the relocation of its
corporate office to a location near the Texas Medical Center, MD
Anderson Cancer Center and other life science entities.
From the fourth quarter 2010 through 2011, Bio-Path raised $2.5
million from several sources. In April of 2011, the Company
completed a private placement sale of common stock raising
approximately $1.8 million. At the end of September 2011 through
early October timeframe, investors exercised warrants to purchase
common stock, raising approximately $0.6 million. Finally, the
Company raised $125,000 from the sale of common stock to Lincoln
Park Capital Fund, LLC ("LPC"), a Chicago-based institutional
investor, in three separate transactions pursuant to Bio-Path's
equity purchase agreement with Lincoln Park Capital for the
purchase of up to $7 million in shares of the Company's common
At the end of the first quarter 2012, the Company commenced a new
private placement fund raising campaign to raise up to $2 million
through the sale of shares of the Company's common stock.
During 2011, Bio-Path continued to increase its profile and
presented at four industry conferences including the Biotech
Showcase™ in San Francisco, the OneMedForum in New York City, the
Rodman and Renshaw Annual Global Investor Conference in New York
City and the BIO Investor Forum 2011 in San Francisco.
Recently, Bio-Path entered into a services agreement with Los
Angeles-based investor relations firm PondelWilkinson to assist
the Company in implementing an investor and public relations
program geared to the individual retail investment community.
Bio-Path also has an active services communications engagement
with Rx Communications, LLC, based in New York City, for
communications strategy and interface targeted to institutional
investors, investment banking firms and industry analysts.
Increasing awareness of the Bio-Path story, including our recent
clinical success and the potential of the Company, to both the
individual and institutional investor communities is an important
mission as the Company endeavors to increase shareholder value in
the near term.
Net loss for the year 2011 was $(2,363,344), compared to a net
loss of $(2,081,500) for the year 2010. The increased net loss was
primarily due to a reduction of $242,658 in other income. In 2010,
the Company received a one-time grant award totaling $244,479 that
was recorded in other income and which was not similarly matched
in 2011. General and administrative expense increased $97,822 in
2011, primarily as a result of an active program that commenced in
2011 involving the Company's travel to and participation in
industry conferences. Research and development expenses were lower
in 2011 by $58,636, primarily the result of lower expenses for
drug material for testing, which more than offset an increase in
clinical trial expense and expense for technology impairment. For
the year 2011, the Company reported a net loss per share of
$(0.04) based on 53,844,195 weighted average shares outstanding,
compared to a net loss per share of $(0.04) for the year 2010.
Operating expenses for 2011 increased by approximately two percent
to $2,365,615 versus 2010. Operating expenses in 2011 included a
one-time technology impairment expense of $345,000, which is
included in related party research and development expense.
Reductions in 2011 for research and development expense for drug
material for testing and lower stock option expense in 2011
substantially offset the technology impairment expense.
As of December 31, 2011, the Company had cash of $952,252 compared
to $238,565 in cash and $244,479 in grants receivable at December
31, 2010. Net cash used in operating activities for the year 2011
increased by $1,755, or less than one percent.
"Significant progress in key areas was made in 2011 and the Company
continues to gain momentum," said Peter Nielsen, President and Chief
Executive Officer of Bio-Path. "After a frustratingly slow start to our
clinical trial, it appears that we are starting to progress through
trial cohorts at a faster pace. The fact that our principal investigator
for the clinical trial continues to see possible anti-leukemia benefits
in patients, supported by some patients reaching stable disease for a
period of time with extended treatments, may be helping in recruiting
Mr. Nielsen continued, "In the first quarter of 2012, the Company's
Board of Directors made a decision to focus the Company's efforts
strictly on developing antisense RNA interference due to the progress
that has been made in developing our lead liposomal antisense drug
candidate Liposomal Grb-2. As such, the Company will stop any further
development of liposomal siRNA and make an appropriate reduction to the
carrying value of our technology license other asset, effective as of
December 31, 2011. Concentrating our focus in one area of RNA
interference will avoid duplicating development costs and speed
time-to-market of additional liposomal antisense drug candidates."
Finally, Mr. Nielsen commented, "During 2011, Bio-Path successfully
launched a communications program involving the Company's participation
as a presenting company at several large biotech investor conferences.
We are starting to see signs that recognition of Bio-Path among key
investor groups is increasing. In addition, Bio-Path continued to have
success raising additional capital to finance our Phase I clinical trial
and on-going operations. We have commenced a new private placement with
the goal of raising up to $2 million over the next several months
through the sale of shares of the Company's common stock."