SAN DIEGO, Feb. 8, 2017 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today reported results
for its second quarter ended December 31,
2016. The Company also highlighted recent clinical progress
and outlined key milestones for the year ahead.
"We begin the new calendar year with all of the pieces we need
to be successful," said Daniel P.
Gold, Ph.D., President and Chief Executive Officer of MEI
Pharma. "We now have a partner with the operational and financial
capabilities to support our Phase 3 AML program while we retain
substantial long-term upside. We have a unique opportunity to
return to MDS and apply what we learned in our prior studies with
the prospect of significantly increasing the market potential for
Pracinostat. We have two emerging drug candidates, ME-401 and
ME-344, each expected to hit meaningful clinical inflection points
in this year. And we have a healthy cash position to complement a
strong clinical and regulatory team, all working to ensure that we
execute on our development strategies. We're poised for an exciting
year ahead and I'm eager to share our progress as it unfolds."
Clinical Highlights
- Prolonged survival evaluated in Phase 2 study of Pracinostat
and azacitidine in AML. In December
2016, response and long-term survival data from a
multi-center Phase 2 clinical study of the investigational drug
candidate Pracinostat and azacitidine in elderly patients with
acute myeloid leukemia (AML) who were not eligible for induction
chemotherapy were presented at the American Society of Hematology
Annual Meeting. Dr. Guillermo
Garcia-Manero, MD Anderson Cancer Center, principal
investigator of the study, reported a median overall survival of
19.1 (95%CI: 10.7-26.5) months, one-year survival of 62% and a
complete response rate of 42%. The combination of Pracinostat and
azacitidine was generally well tolerated, with no unexpected
toxicities. The most common grade 3/4 treatment-emergent adverse
events included febrile neutropenia, thrombocytopenia, anemia and
fatigue. Pracinostat is an investigational agent and is not
approved for use in the U.S.
- Publication provides preliminary data for optimized dose of
Pracinostat and azacitidine in MDS. In January 2017, results from a Phase 2, randomized,
double-blind study of Pracinostat and azacitidine in patients with
untreated, higher risk myelodysplastic syndromes (MDS) were
published online ahead of print in the journal Cancer. The
preliminary study data suggest that poor tolerability, which led to
more frequent and earlier drug discontinuations in the Pracinostat
group, likely limited the overall efficacy of the combination.
However, in an analysis of patients who received at least 4 cycles
of therapy, a tendency toward improved response duration and
overall survival was observed in the Pracinostat group. The authors
conclude that alternative dosing should be evaluated to determine
the potential of the combination.
- First patients dosed in Phase 1b study of PI3K delta
inhibitor ME-401. In November
2016, a Phase 1b clinical study of ME-401 in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL) or
follicular lymphoma began dosing patients. 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
for patients with lymphomas. This study will enable the Company to
study the safety and efficacy of ME-401 over time as it seeks to
identify an optimal dose for Phase 2 studies.
- Exposure data from Phase 1 study of ME-401 support improved
therapeutic window. In November
2016, data from a first-in-human clinical study of ME-401 in
healthy volunteers were presented at the American Association of
Pharmaceutical Scientists Annual Meeting. The presentation
highlighted the formulation selection and development of ME-401,
including levels of drug exposure that support the potential for an
improved therapeutic window compared to first-generation PI3K delta
inhibitors.
- First patients dosed in clinical study of mitochondrial
inhibitor ME-344. In October
2016, an investigator-sponsored study of ME-344 in
combination with the VEGF inhibitor bevacizumab (marketed as
Avastin®) in patients with recently diagnosed
HER2-negative breast cancer began dosing patients. The randomized,
placebo-controlled study is expected to enroll a total of 40
patients and 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.
Upcoming Milestones
- Phase 3 study of Pracinostat in AML. In August 2016, the Company entered into an
exclusive license, development and commercialization agreement with
Helsinn Healthcare, SA (Helsinn License Agreement) for Pracinostat
in AML and other potential indications. Under the terms of the
Helsinn License Agreement, the Company will receive a $5 million milestone payment upon the earlier of
(i) dosing of the first patient in a Phase 3 study of Pracinostat
and azacitidine in newly diagnosed AML patients who are unfit to
receive induction therapy or (ii) March 1,
2017.
- Phase 2 study of Pracinostat in MDS. As part of the
Helsinn License Agreement, the Company and Helsinn will work to
explore an optimal dosing regimen of Pracinostat and azacitidine
for the treatment of high and very high risk MDS. Enrollment in
this study is anticipated to commence in the second quarter of
calendar year 2017.
- Phase 1b study of ME-401. This study of ME-401 in
patients with relapsed/refractory CLL or follicular lymphoma is now
actively dosing patients and interim data is expected in the second
quarter of calendar year 2017.
- Investigator-sponsored study of ME-344. This
study of ME-344 and Avastin® in patients with
HER2-negative breast cancer is now actively dosing patients and
interim data is expected in the second half of calendar year
2017.
Financial Highlights
- As of December 31, 2016, the
Company had $55.2 million in cash,
cash equivalents and short-term investments, compared to
$58.9 million as of September 30, 2016, with no outstanding debt. The
Company believes its cash position will be sufficient to fund
operations through at least fiscal year 2018.
- Research and development expenses were $1.6
million for the three months ended December 31, 2016, and
$3.3 million during the six months
ended December 31, 2016. This
compares with research and development expenses of $3.2 million for the three months ended
December 31, 2015, and $6.0 million for the six months ended
December 31, 2015. The decrease was
primarily due to a reduction in clinical trial expenses for
Pracinostat and ME-344.
- General and administrative expenses were $2.0
million for the three months ended December 31, 2016, and
$4.7 million for the six months ended
December 31, 2016, compared
to $1.9 million and $3.8
million, respectively, for the same periods in 2015.
The year over year increase was primarily due to professional
service costs associated with the Helsinn License Agreement.
- Revenues were $17.2 million
during the three months ended December 31,
2016, and $18.3 million during
the six months ended December 31,
2016, related to the Helsinn License Agreement. During the
three and six months ended December 31,
2016, the cost of research and development revenue was
$1.8 million and $2.9 million respectively. Cost of research and
development revenue is comprised primarily of reimbursable
third-party pass-through costs.
- Net income was $11.9 million, or $0.32 per basic
and diluted share, for the three months ended December 31,
2016, and $7.6 million, or
$0.21 per basic and diluted share,
for the six months ended December 31,
2016. This compares to a net loss of $5.1 million,
or $0.15 per basic and diluted share, for the quarter
ended December 31, 2015, and a net
loss of $9.7 million,
or $0.28 per basic and diluted share for the six months
ended December 31, 2015.
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 was granted Breakthrough Therapy Designation from the
U.S. Food and Drug Administration for use in combination with
azacitidine for the treatment of patients with newly diagnosed AML
who are unfit for intensive chemotherapy. The Company's clinical
development pipeline also includes ME-401, a potent and highly
selective PI3K delta inhibitor, and ME-344, a novel mitochondrial
inhibitor. 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)
|
|
|
|
|
|
December
31,
|
|
June
30,
|
|
2016
|
|
2016
|
|
(unaudited)
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
15,050
|
|
$
10,837
|
Short term
investments
|
40,104
|
|
35,081
|
Total cash, cash
equivalents and short-term investments
|
55,154
|
|
45,918
|
Prepaid expenses and
other current assets
|
2,668
|
|
831
|
Total current
assets
|
57,822
|
|
46,749
|
Intangible assets,
net
|
348
|
|
366
|
Property and
equipment, net
|
40
|
|
49
|
Total
assets
|
$
58,210
|
|
$
47,164
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
382
|
|
$
1,079
|
Accrued
liabilities
|
2,938
|
|
4,433
|
Total current
liabilities
|
3,320
|
|
5,512
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
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 December 31,
2016 and June 30, 2016, respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
224,276
|
|
218,653
|
Accumulated
deficit
|
(169,386)
|
|
(177,001)
|
Total stockholders'
equity
|
54,890
|
|
41,652
|
Total liabilities and
stockholders' equity
|
$
58,210
|
|
$
47,164
|
MEI PHARMA,
INC.
STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Six Months
Ended
December 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
License
revenue
|
$
17,101
|
|
$
-
|
|
$
17,101
|
|
$
-
|
Research and
development revenue
|
98
|
|
-
|
|
1,194
|
|
-
|
Total
revenues
|
17,199
|
|
-
|
|
18,295
|
|
-
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of research and
development revenue
|
(1,771)
|
|
-
|
|
(2,865)
|
|
-
|
Research and
development
|
(1,642)
|
|
(3,182)
|
|
(3,288)
|
|
(5,998)
|
General and
administrative
|
(1,970)
|
|
(1,945)
|
|
(4,650)
|
|
(3,775)
|
Total operating
expenses
|
(5,383)
|
|
(5,127)
|
|
(10,803)
|
|
(9,773)
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
11,816
|
|
(5,127)
|
|
7,492
|
|
(9,773)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest and dividend
income
|
69
|
|
26
|
|
124
|
|
53
|
Income tax
expense
|
-
|
|
-
|
|
(1)
|
|
(1)
|
Net income
(loss)
|
$
11,885
|
|
$
(5,101)
|
|
$
7,615
|
|
$
(9,721)
|
|
|
|
|
|
|
|
|
Earnings (loss) per
share, basic
|
$
0.32
|
|
$
(0.15)
|
|
$
0.21
|
|
$
(0.28)
|
Earnings (loss) per
share, diluted
|
$
0.32
|
|
$
(0.15)
|
|
$
0.21
|
|
$
(0.28)
|
|
|
|
|
|
|
|
|
Shares used in
computing earnings (loss) per share:
|
|
|
|
|
|
|
|
Basic
|
37,172,428
|
|
34,422,663
|
|
36,459,898
|
|
34,378,460
|
Diluted
|
37,216,532
|
|
34,422,663
|
|
36,501,134
|
|
34,378,460
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mei-pharma-reports-second-quarter-fiscal-year-2017-results-300403911.html
SOURCE MEI Pharma, Inc.