SAN DIEGO, Feb. 8, 2018 /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,
2017.
"We continue to build on the progress we reported last quarter
with important advances in the clinical development programs across
our pipeline," said Daniel P. Gold,
Ph.D., president and chief executive officer of MEI Pharma.
"Already in 2018, the Food and Drug Administration cleared the
Investigational New Drug Application for voruciclib, and
pracinostat was awarded Orphan Drug Designation from the European
Medicines Agency for the treatment of acute myeloid leukemia."
Dr. Gold added: "In the coming months we look forward to
separate data readouts in three programs: pracinostat's stage 1 of
a Phase 2 dose-optimization study in myelodysplastic syndrome
(MDS); ME-401's single agent safety and efficacy in
relapsed/refractory chronic lymphocytic leukemia (CLL) and
follicular lymphoma (FL); and ME-344's interim results from a
proof-of-concept study in combination with bevacizumab (marketed as
Avastin®) in human epidermal growth factor receptor 2 (HER2)
negative breast cancer. In addition, we look forward to the
initiation of our Phase 1 single-agent study with voruciclib in
relapsed/refractory B lymphocyte malignancies."
Recent Program Highlights
Pracinostat
- In January 2018, the European
Medicines Agency granted Orphan Drug Designation to pracinostat,
currently in a Phase 3 study in combination with azacitidine for
the treatment of acute myeloid leukemia (AML) in adult patients
unfit to induction chemotherapy.
MEI-401
- In November 2017, the safety
review committee found no dose limiting toxicities in the 180mg
cohort again with a response rate in excess of 50%. We determined
that no further dose escalation was required and we amended the
Phase 1b study protocol to open a 45
mg lower dose cohort as well as an additional arm to evaluate the
safety and efficacy of ME-401 in combination with rituximab
(marketed as Rituxan®) in patients with various B cell
malignancies.
Voruciclib
- In January 2018, the U.S. Food
and Drug Administration cleared the company's Investigational New
Drug Application (IND) for voruciclib. Under this IND, MEI Pharma
plans to initiate a Phase 1 study designed to determine the safety,
tolerability, pharmacokinetics, pharmacodynamics, and preliminary
clinical activity of voruciclib in patients with B-cell
malignancies.
- In December 2017, a preclinical
study of voruciclib was published in the journal Nature Scientific
Reports. Researchers found that the combination of voruciclib plus
the BCL-2 inhibitor venetoclax (marketed as Venclexta™) was capable
of inhibiting two master regulators of cell survival, MCL-1 and
BCL-2, and achieved synergistic antitumor efficacy in an aggressive
subset of Diffuse Large B-cell Lymphoma (DLBCL).
Upcoming Milestones
Pracinostat
- Expecting results from stage 1 of a Phase 2 dose-optimization
study in MDS in the second quarter of 2018.
ME-401
- Expecting results from a Phase 1b
study in relapsed/refractory CLL and FL to be presented at a
scientific meeting in the second quarter of 2018.
Voruciclib
- Expecting to initiate a Phase 1 single-agent study in
relapsed/refractory B cell 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 Phase 1 study in HER2
negative breast cancer in combination with bevacizumab (marketed as
Avastin®) in the second quarter of 2018.
Financial Highlights
- As of December 31, 2017, MEI
Pharma had $42.4 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 $11.3 million for the six months ended
December 31, 2017, compared to cash
provided by operating activities of $5.0
million for the six months ended December 31, 2016. Included in cash expenditures
for the six months ended December 31,
2017 was $1.9 million cash
paid for the acquisition of voruciclib. Included in the cash
provided by operating activities in the six months ended
December 31, 2016 was the
$15.0 million upfront payment from
Helsinn for pracinostat.
- Research and development expenses, including cost of research
and development revenue, were $4.2
million for the three months ended December 31, 2017, compared to $3.4 million for the three months ended
December 31, 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 $2.4 million for the three months ended
December 31, 2017, compared to
$2.0 million for the three months
ended December 31, 2016. The increase
was primarily due to professional service costs incurred in the
three months ended December 31, 2017
related to the Presage license agreement.
- Revenues were $0.4 million for
the three months ended December 31,
2017, compared to $17.2
million in the three months ended December 31, 2016. The decrease was related
to activities performed pursuant to the Helsinn license
agreement.
- Net loss was $6.1 million, or
$0.16 per share, for the three months
ended December 31, 2017, compared to
net income of $11.9 million, or
$0.32 per share for the three months
ended December 31, 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 1b 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)
|
|
|
|
|
|
|
December
31,
|
|
June
30,
|
|
2017
|
|
2017
|
|
(unaudited)
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
7,339
|
|
$
8,458
|
Short term
investments
|
35,102
|
|
45,107
|
Total cash, cash
equivalents and short-term investments
|
42,441
|
|
53,565
|
Prepaid expenses and
other current assets
|
772
|
|
1,758
|
Total current
assets
|
43,213
|
|
55,323
|
Intangible assets,
net
|
314
|
|
331
|
Property and
equipment, net
|
40
|
|
50
|
Total
assets
|
$
43,567
|
|
$
55,704
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,089
|
|
$
585
|
Accrued
liabilities
|
3,230
|
|
3,285
|
Deferred
revenues
|
890
|
|
996
|
Total current
liabilities
|
5,209
|
|
4,866
|
|
|
|
|
Commitments and
contingencies (Note 5)
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.01 par value; 100 shares authorized; none outstanding
|
-
|
|
-
|
Common stock,
$0.00000002 par value; 113,000 shares authorized; 37,052 and 36,772
shares issued and outstanding at December 31, 2017 and June 30,
2017, respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
227,556
|
|
225,169
|
Accumulated
deficit
|
(189,198)
|
|
(174,331)
|
Total stockholders'
equity
|
38,358
|
|
50,838
|
Total liabilities and
stockholders' equity
|
$
43,567
|
|
$
55,704
|
|
|
|
|
MEI PHARMA,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(In thousands, except
per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Six Months
Ended
December 31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
17,101
|
|
$
-
|
|
$
17,101
|
Research and
development revenue
|
358
|
|
98
|
|
641
|
|
1,194
|
Total
revenues
|
358
|
|
17,199
|
|
641
|
|
18,295
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of research and
development revenue
|
728
|
|
1,771
|
|
1,346
|
|
2,865
|
Research and
development
|
3,444
|
|
1,642
|
|
9,508
|
|
3,288
|
General and
administrative
|
2,358
|
|
1,970
|
|
4,846
|
|
4,650
|
Total operating
expenses
|
6,530
|
|
5,383
|
|
15,700
|
|
10,803
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
(6,172)
|
|
11,816
|
|
(15,059)
|
|
7,492
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest and dividend
income
|
93
|
|
69
|
|
193
|
|
124
|
Income tax
expense
|
-
|
|
-
|
|
(1)
|
|
(1)
|
Net (loss)
income
|
$
(6,079)
|
|
$
11,885
|
|
$
(14,867)
|
|
$
7,615
|
|
|
|
|
|
|
|
|
Net (loss) income per
share, basic
|
$
(0.16)
|
|
$
0.32
|
|
$
(0.40)
|
|
$
0.21
|
Net (loss) income per
share, diluted
|
$
(0.16)
|
|
$
0.32
|
|
$
(0.40)
|
|
$
0.21
|
|
|
|
|
|
|
|
|
Shares used in
computing net (loss) income per share:
|
|
|
|
|
|
|
|
Basic
|
37,414
|
|
37,172
|
|
37,390
|
|
36,460
|
Diluted
|
37,414
|
|
37,217
|
|
37,390
|
|
36,501
|
|
|
|
|
|
|
|
|
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SOURCE MEI Pharma, Inc.