SAN DIEGO, Nov. 9, 2016 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today reported results
for its first quarter ended September 30,
2016. The Company also highlighted recent progress with its
pipeline of drug candidates and previewed upcoming data
presentations.
"The past quarter was one of unprecedented achievement for the
company, highlighted by the receipt of Breakthrough Therapy
Designation and a global strategic partnership for Pracinostat,"
said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of MEI Pharma. "Now we
approach the end of the calendar year in a position of significant
strength, armed with a fully funded Phase III program, a pipeline
of drug candidates advancing in the clinic and a healthy cash
position that affords us the ability to not only execute our
clinical development plan, but also to enhance our pipeline with
the right opportunity."
Pipeline Update
- Strategic partnership for development and commercialization
of Pracinostat. In August 2016,
the Company entered into an exclusive licensing, development and
commercialization agreement with Helsinn Healthcare, SA, a Swiss
pharmaceutical corporation, for Pracinostat, an investigational
agent currently being evaluated in clinical studies for acute
myeloid leukemia (AML) and other potential indications. Under the
terms of the agreement, Helsinn is granted a worldwide exclusive
license to Pracinostat and is responsible for funding its global
development and commercialization. As compensation, MEI Pharma will
receive near-term payments of $20
million, including a $15
million upfront payment and a $5
million payment upon the earlier of (i) dosing of the first
patient in the upcoming Phase III study of Pracinostat in newly
diagnosed AML patients unfit to receive induction therapy, or (ii)
March 1, 2017. In addition, MEI
Pharma will be eligible to receive up to $444 million in potential regulatory and
sales-based milestones, along with royalty payments on the net
sales of Pracinostat. In a related transaction, Helsinn made a
$5 million equity investment in MEI
Pharma.
- Dose-optimization study of Pracinostat plus azacitidine in
high-risk MDS. As part of the license, development and
commercialization agreement, the Company will work with Helsinn to
determine an optimal dosing regimen of Pracinostat in combination
with azacitidine for the treatment of high and very high risk
myelodysplastic syndrome (MDS). Based on its clinical experience
with the combination, the Company believes that an optimized dose
may improve tolerability in this population, which in turn could
result in increased efficacy of the combination vs. azacitidine
alone. MEI Pharma will be responsible for the conduct of the study
and Helsinn will share the cost. The study is anticipated to
commence in the first half of calendar year 2017.
- Breakthrough Therapy Designation from U.S. Food and Drug
Administration (FDA). In August
2016, the Company announced that the FDA granted
Breakthrough Therapy Designation for Pracinostat in combination
with azacitidine for the treatment of patients with newly diagnosed
AML who are ≥75 years of age or unfit for intensive chemotherapy.
According to the FDA, Breakthrough Therapy Designation is intended
to expedite the development and review of drugs for serious or
life-threatening conditions. The criteria for Breakthrough Therapy
Designation require preliminary clinical evidence that demonstrates
the drug may have substantial improvement on at least one
clinically significant endpoint over available therapy. In
addition, the Company announced that agreement has been reached
with the FDA on the proposed Phase III AML study design.
- Phase Ib study of PI3K delta inhibitor ME-401 open for
enrollment. In September 2016,
the Company's Phase 1b clinical study of ME-401 in patients with
relapsed/refractory chronic lymphocytic leukemia/small lymphocytic
lymphoma or follicular lymphoma was opened for enrollment. ME-401
is a potent and highly selective oral PI3K delta inhibitor with the
potential for a wide therapeutic window that may lead to safer
treatment options, including combination treatment options, for
patients with lymphomas. This study will allow the Company to study
the safety and tolerability of ME-401 over time as it seeks to
identify an optimal dose for future Phase 2 studies. Interim data
from the study is expected by the middle of calendar year
2017.
- Investigator-sponsored study of mitochondrial inhibitor
ME-344 open for enrollment. In August
2016, an investigator-sponsored study of ME-344 in
combination with the vascular endothelial growth factor (VEGF)
inhibitor bevacizumab (marketed as Avastin®) in patients
with HER2-negative breast cancer was opened for enrollment. The
study is being conducted in collaboration with the Spanish National
Cancer Research Centre in Madrid.
Pre-clinical data from the collaboration showed substantially
enhanced anti-tumor activity of ME-344 in cancer cells when
combined with VEGF inhibitors due to a disruption of both
mitochondrial and glycolytic metabolism. Data from the
investigator-sponsored study are expected by the end of calendar
year 2017.
Upcoming Data Presentations
- Long-term survival and response data from Phase II study of
Pracinostat in AML. Data from a multi-center Phase II clinical
study of Pracinostat and azacitidine in older patients with AML who
are not eligible for induction chemotherapy have been selected for
oral presentation at the upcoming ASH Annual Meeting in
San Diego on December 3, 2016. The presentation by principal
investigator Dr. Guillermo
Garcia-Manero, MD Anderson Cancer Center, is expected to
highlight the durable responses and long-term survival benefit
achieved in this investigational study, which appeared to compare
favorably to azacitidine alone in a recent international Phase III
study (AZA-AML-001). Pracinostat is an investigational agent and is
not approved for use in the U.S.
- Exposure data from clinical study of ME-401 supporting wide
therapeutic window. Additional data from a first-in-human
clinical study of ME-401 in healthy volunteers will be presented at
the American Association of Pharmaceutical Scientists (AAPS) Annual
Meeting in Denver on November 15, 2016. The presentation will
highlight formulation selection and development for ME-401,
including exposure margins based on clinical data and preclinical
toxicity supporting the potential for an improved therapeutic
window from repeated dosing compared to the approved PI3K delta
inhibitor idelalisib (marketed as Zydelig®).
Financial Highlights
- As of September 30, 2016, MEI
Pharma had $58.9 million in cash,
cash equivalents and short-term investments, which the Company
believes will be sufficient to fund operations through at least
calendar year 2017.
- Net loss was $4.3 million, or
$0.12 per share, for the three months
ended September 30, 2016, compared to
$5.7 million, or $0.17 per share, for the previous quarter, and
$4.6 million, or $0.13 per share for the same period in 2015.
- Research and development expenses were $1.6 million for the three months ended
September 30, 2016, compared to
$2.8 million for the same period in
2015. The decrease was primarily due to a reduction in clinical
trial expenses for Pracinostat and ME-344.
- General and administrative expenses were $2.7 million for the three months ended
September 30, 2016, compared to
$1.8 million for the same period in
2015. The increase was primarily due to professional service costs
associated with the Helsinn license agreement.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on
the clinical development of novel therapies for cancer. The
Company's portfolio of drug candidates includes Pracinostat, an
oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA.
Pracinostat is being developed in combination with azacitidine for
the treatment of patients with newly diagnosed AML who are ≥75
years of age or unfit for intensive chemotherapy and high-risk MDS.
The Company's clinical development pipeline also includes ME-401,
an oral PI3K delta inhibitor currently in a Phase Ib study in
patients with recurrent chronic lymphocytic leukemia or follicular
non-Hodgkin's lymphoma, and ME-344, a mitochondrial inhibitor
currently in an investigator-sponsored study in combination with
bevacizumab for the treatment of HER2-negative breast cancer. For
more information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studies and approved by the FDA as
being safe and effective for the intended use. Statements included
in this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in
clinical trial results; our inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products; competitive factors; our inability to protect our
patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business;
our inability to operate our business without infringing the
patents and proprietary rights of others; general economic
conditions; the failure of any products to gain market acceptance;
our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events. We do not intend to update any of
these factors or to publicly announce the results of any revisions
to these forward-looking statements.
MEI PHARMA,
INC. BALANCE SHEETS (In thousands, except share
and per share data)
|
|
|
September
30,
|
|
June
30,
|
|
2016
|
|
2016
|
|
(unaudited)
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
13,789
|
|
$
10,837
|
Short term
investments
|
45,112
|
|
35,081
|
Total cash, cash
equivalents and short-term investments
|
58,901
|
|
45,918
|
Prepaid expenses and
other current assets
|
1,741
|
|
831
|
Total current
assets
|
60,642
|
|
46,749
|
Intangible assets,
net
|
357
|
|
366
|
Property and
equipment, net
|
46
|
|
49
|
Total
assets
|
$
61,045
|
|
$
47,164
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
749
|
|
$
1,079
|
Accrued
liabilities
|
2,428
|
|
4,433
|
Deferred revenues,
current portion
|
14,043
|
|
-
|
Total current
liabilities
|
17,220
|
|
5,512
|
Deferred revenues,
less current portion
|
1,494
|
|
-
|
Total
liabilities
|
18,714
|
|
5,512
|
|
|
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock, $0.01 par value; 100,000
shares authorized;
none
outstanding
|
-
|
|
-
|
Common
stock, $0.00000002 par value; 113,000,000 shares
authorized;
36,772,428 and 34,155,997 shares issued and outstanding
at September 30, 2016 and June 30, 2016,
respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
223,602
|
|
218,653
|
Accumulated
deficit
|
(181,271)
|
|
(177,001)
|
Total stockholders'
equity
|
42,331
|
|
41,652
|
Total liabilities and
stockholders' equity
|
$
61,045
|
|
$
47,164
|
MEI PHARMA,
INC. STATEMENTS OF OPERATIONS (In thousands,
except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
2016
|
|
2015
|
|
|
|
|
Revenues:
|
|
|
|
Research and
development revenue
|
$
1,096
|
|
$
-
|
Total
revenues
|
1,096
|
|
-
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of research and
development revenue
|
(1,094)
|
|
-
|
Research and
development
|
(1,646)
|
|
(2,816)
|
General and
administrative
|
(2,680)
|
|
(1,830)
|
Total operating
expenses
|
(5,420)
|
|
(4,646)
|
|
|
|
|
Loss from
operations
|
(4,324)
|
|
(4,646)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest and dividend
income
|
55
|
|
27
|
Income tax
expense
|
(1)
|
|
(1)
|
Net loss
|
$
(4,270)
|
|
$
(4,620)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.12)
|
|
$
(0.13)
|
Weighted average
shares outstanding - basic and diluted
|
35,747,367
|
|
34,334,257
|
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SOURCE MEI Pharma, Inc.