SAN DIEGO, Nov. 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 first quarter ended September 30,
2017.
"In this first quarter of the new fiscal year we announced an
important milestone with the dosing of the first patient in the
pivotal Phase 3 study of pracinostat in combination with
azacitidine in adults with newly diagnosed acute myeloid leukemia
(AML) who are unfit to receive intensive induction chemotherapy. In
addition, we announced that we had further strengthened our
oncology clinical pipeline with the addition of the clinical-stage
cyclin-dependent kinase (CDK) inhibitor voruciclib," said
Daniel P. Gold, Ph.D., president and
chief executive officer of MEI Pharma. "We are well positioned for
a momentous year ahead, with a healthy cash balance and a series of
key milestones in each of our clinical programs."
Upcoming Milestones
Pracinostat
- Expecting results from Stage 1 of a Phase 2 dose-optimization
study in myelodysplastic syndrome (MDS) in the first half of
2018.
ME-401
- Expecting to initiate combination study with Rituxan® in
indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in
the fourth quarter of 2017.
- Expecting results from proof-of-concept study in
relapsed/refractory chronic lymphocytic leukemia (CLL) and
follicular lymphoma to be presented at a scientific meeting in the
first half of 2018.
Voruciclib
- Expecting to initiate Phase1/2 single-agent study in
relapsed/refractory B lymphocyte malignancies and subsequently in a
combination study with venetoclax (marketed as Venclexta™) in the
second quarter of 2018.
ME-344
- Expecting interim results from the proof-of-concept study in
human epidermal growth factor receptor 2 (HER2) negative breast
cancer in combination with bevacizumab (marketed as Avastin®) in
the first half of 2018.
Financial Highlights
- As of September 30, 2017, MEI
Pharma had $47.0 million in cash,
cash equivalents and short-term investments, with no outstanding
debt. The Company believes its cash position will be sufficient to
fund operations into calendar year 2019.
- Cash used in operating activities was $6.6 million for the three months ended
September 30, 2017, compared to cash
provided by operating activities of $8.8
million for 2016. Included in cash expenditures for the
three months ended September 30, 2017
was $1.9 million cash paid for the
voruciclib acquisition. Included in the cash provided by
operating activities in 2016 is the $15
million upfront payment from Helsinn for pracinostat.
- Research and development expenses, including cost of research
and development revenue, were $6.7
million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The increase was primarily
due to the acquisition of voruciclib and increased costs for
ME-401, offset by a reduction in expenses related to
pracinostat.
- General and administrative expenses were $2.5 million for the three months ended
September 30, 2017, compared to
$2.7 million for 2016. The decrease
was primarily due to professional service costs incurred in 2016
related to the Helsinn license agreement.
- Revenues were $0.3 million for
the three months ended September 30,
2017, compared to $1.1 million
in 2016. The decrease is related to activities performed
pursuant to the Helsinn license agreement.
- Net loss was $8.8 million, or
$0.24 per share, for the three months
ended September 30, 2017, compared to
a net loss of $4.3 million, or
$0.12 per share for the three months
ended September 30, 2016.
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 has been 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
acute myeloid leukemia (AML) who are unfit for intensive
chemotherapy. Pracinostat is also being developed in combination
with azacitidine for the treatment of patients with high and very
high-risk myelodysplastic syndrome (MDS). MEI Pharma's clinical
development pipeline also includes ME-401, a highly differentiated
oral PI3K delta inhibitor currently in a Phase Ib study in patients
with relapsed/refractory CLL or follicular lymphoma, and
voruciclib, an oral, selective CDK inhibitor shown to suppress
MCL1, a known mechanism of resistance to BCL2 inhibitors. The
Company is also developing ME-344, a novel mitochondrial inhibitor
currently in an investigator-sponsored study in combination with
bevacizumab for the treatment of HER2-negative breast cancer.
Pracinostat, ME-401, ME-344 and voruciclib are investigational
agents and are not approved for use in the U.S. 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.
|
CONDENSED BALANCE
SHEETS
|
(In thousands, except
per share amounts)
|
|
|
September
30,
|
|
June
30,
|
|
2017
|
|
2017
|
|
(unaudited)
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
6,958
|
|
$
8,458
|
Short term
investments
|
40,065
|
|
45,107
|
Total cash, cash
equivalents and short-term investments
|
47,023
|
|
53,565
|
Prepaid expenses and
other current assets
|
641
|
|
1,758
|
Total current
assets
|
47,664
|
|
55,323
|
Intangible assets,
net
|
322
|
|
331
|
Property and
equipment, net
|
45
|
|
50
|
Total
assets
|
$
48,031
|
|
$
55,704
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
751
|
|
$
585
|
Accrued
liabilities
|
2,767
|
|
3,285
|
Deferred
revenues
|
947
|
|
996
|
Total current
liabilities
|
4,465
|
|
4,866
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.01 par value; 100 shares authorized; none outstanding
|
-
|
|
-
|
Common stock,
$0.00000002 par value; 113,000 shares authorized; 36,950 and 36,772
shares issued and outstanding at September 30, 2017 and June 30,
2017, respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
226,685
|
|
225,169
|
Accumulated
deficit
|
(183,119)
|
|
(174,331)
|
Total stockholders'
equity
|
43,566
|
|
50,838
|
Total liabilities and
stockholders' equity
|
$
48,031
|
|
$
55,704
|
MEI PHARMA,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(In thousands, except
per share amounts)
|
(Unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
2017
|
|
2016
|
|
|
|
|
Revenues:
|
|
|
|
Research and
development revenue
|
$
283
|
|
$
1,096
|
Total
revenues
|
283
|
|
1,096
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of research and
development revenue
|
618
|
|
1,094
|
Research and
development
|
6,064
|
|
1,646
|
General and
administrative
|
2,488
|
|
2,680
|
Total operating
expenses
|
9,170
|
|
5,420
|
|
|
|
|
Loss from
operations
|
(8,887)
|
|
(4,324)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest and dividend
income
|
100
|
|
55
|
Income tax
expense
|
(1)
|
|
(1)
|
Net loss
|
$ (8,788)
|
|
$ (4,270)
|
|
|
|
|
Net loss per share,
basic
|
$
(0.24)
|
|
$
(0.12)
|
Net loss per share,
diluted
|
$
(0.24)
|
|
$
(0.12)
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
Basic
|
37,245
|
|
35,747
|
Diluted
|
37,245
|
|
35,747
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/mei-pharma-reports-first-quarter-fiscal-year-2018-results-300551614.html
SOURCE MEI Pharma, Inc.