SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- MEI Pharma,
Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on
advancing new therapies for cancer, today reported results for its
first quarter ended September 30,
2018.
"Fiscal 2019 is off to a strong start both financially and
strategically, with more than $90
million in cash and investments on our balance sheet at the
start of the quarter, $10 million
additional cash due under the recently executed Japan licensing agreement with Kyowa Hakko
Kirin, a new clinical collaboration with BeiGene, and progress in
preparations to start the ME-401 Phase 2 study around year-end,"
said Daniel P. Gold, Ph.D.,
president and chief executive officer of MEI Pharma. "With the
planned start of the ME-401 Phase 2 study, we will have two ongoing
clinical trials with the potential to support FDA marketing
approval."
Dr. Gold continued: "We are also excited by our continued
progress in the other programs across our pipeline, including
interim data from the Phase 2 study of pracinostat in MDS, the
evaluation of our CDK9 inhibitor, voruciclib, in B-cell
malignancies and data from the investigator-initiated study of
ME-344 in breast cancer."
Recent Program Highlights and Upcoming Milestones
Upcoming Milestones
- MEI will present data from three clinical stage drug
development programs at the 2018 American Society of Hematology
(ASH) Annual Meeting to be held December
1-4, 2018 in San
Diego:
-
- Updated results from the Phase 1b
study evaluating ME-401 in relapsed/refractory follicular lymphoma
(FL) and other indolent B-cell malignancies.
- Data from an interim analysis of pracinostat in an ongoing
Phase 2 study evaluating patients with high/very high-risk
myelodysplastic syndrome (MDS).
- Results from a preclinical study demonstrating that voruciclib
and venetoclax synergistically induce apoptosis in acute myeloid
leukemia (AML) cells in vitro.
- MEI plans to initiate the Phase 2 study to support accelerated
approval of ME-401 in relapsed or refractory FL around year-end of
calendar 2018.
- MEI expects to report updates regarding the ongoing voruciclib
Phase 1 study at medical meetings in 2019.
- MEI expects to report additional data from the
investigator-sponsored Phase 1 study evaluating ME-344 at medical
meetings in 2019.
Clinical Development Highlights
- In October 2018, MEI
announced a clinical collaboration to evaluate the safety and
efficacy of MEI's ME-401, an investigational phosphatidylinositol
3-kinase (PI3K) delta inhibitor, in combination with BeiGene's
zanubrutinib, an investigational Bruton's tyrosine kinase (BTK)
inhibitor, for the treatment of patients with B-cell
malignancies.
- In July 2018, the Company discussed with FDA a ME-401
monotherapy accelerated approval strategy in patients with relapsed
or refractory FL. Informed by the discussions with the FDA, the
Company is advancing ME-401 into a Phase 2, single-agent study for
the treatment of adults with relapsed or refractory FL. The Phase 2
study is intended to support accelerated approval and is planned to
begin around the end of 2018. Accelerated approval of ME-401 will
be subject to FDA review of the improvement provided by ME-401 over
other therapies available at the time of the regulatory
action.
Corporate Highlights
- In November 2018, MEI announced
the execution of a license development and commercialization
agreement granting Kyowa Hakko Kirin exclusive rights to develop
and commercialize ME-401 in Japan.
Under the terms of the agreement, MEI will receive a $10.0 million upfront payment and is eligible to
receive up to $87.5M in additional
development and commercialization milestones, and royalties on
sales.
- In July 2018, the Company announced that David M.
Urso, J.D., senior vice president of corporate development and
general counsel, was promoted to chief operating officer. Mr. Urso
is also continuing as the Company's general counsel and head of
corporate development.
Financial Highlights
- As of September 30, 2018, MEI had $90.8
million in cash, cash equivalents and short-term investments,
with no outstanding debt. Additionally, a $10 million upfront payment is due under the
Japan license agreement executed
with Kyowa Hakko Kirin.
- Research and development expenses were $6.1
million for the quarter ended September 30, 2018,
compared to $6.1 million for the same period in 2017.
Research and development expenses reflect increased costs for the
development of ME-401, offset by a reduction in expenses related to
voruciclib, as the prior year amounts included acquisition costs
for voruciclib.
- General and administrative expenses were $3.4
million for the quarter ended September 30, 2018,
compared to $2.5 million for the same period in 2017. The
increase primarily relates to professional services expenses,
share-based compensation, and general corporate expenses.
- The Company recognized revenues of $0.5 million for the
quarter ended September 30, 2018, compared to $0.3 million for the same period in 2017. The
increase is related to higher levels of research and development
activities performed pursuant to the Helsinn license
agreement.
- Net loss for the quarter ended September 30, 2018,
was $14.5 million, or $0.21 per share compared
$8.8 million, or $0.24 per
share for the same period in 2017. The Company had 71,115,444
shares of common stock outstanding as of September 30, 2018, compared with 36,950,177
shares as of September 30, 2017.
- The adjusted net loss, excluding non-cash expenses related to
changes in the fair value of the warrants issued in connection with
the May 2018 financing (a non-GAAP measure) for the
quarter ended September 30, 2018, was
$9.6 million, or $0.14 per share.
- Cash expenditures for operating activities were $12.8
million for the quarter ended September 30, 2018,
compared to $6.6 million for 2017. The increase in cash
used for the three months ended September
30, 2018 primarily relates to changes in working capital
associated with our clinical development programs, including
start-up costs related to the ME-401 Phase 2 accelerated approval
study.
About MEI Pharma
MEI Pharma, Inc. (NASDAQ: MEIP) is a San Diego-based pharmaceutical company focused
on leveraging its extensive development and oncology expertise to
identify and advance new 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
chronic lymphocytic leukemia (CLL) or FL, and voruciclib, an oral,
selective cyclin-dependent kinase (CDK) inhibitor shown to
suppress myeloid leukemia cell differentiation protein (MCL1), a
known mechanism of resistance to B-cell lymphoma (BCL2) inhibitors.
The Company is also developing ME-344, a novel mitochondrial
inhibitor currently in an investigator-initiated 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.
|
BALANCE
SHEETS
|
(In thousands, except
per share amounts)
|
|
|
|
|
|
September
30,
|
|
June
30,
|
|
2018
|
|
2018
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
6,118
|
|
$
13,309
|
Short term
investments
|
84,646
|
|
89,434
|
Total cash, cash
equivalents and short-term investments
|
90,764
|
|
102,743
|
Prepaid expenses and
other current assets
|
3,671
|
|
1,586
|
Total current
assets
|
94,435
|
|
104,329
|
Intangible assets,
net
|
287
|
|
296
|
Property and
equipment, net
|
28
|
|
32
|
Total
assets
|
$
94,750
|
|
$ 104,657
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,555
|
|
$
3,643
|
Accrued
liabilities
|
2,489
|
|
3,454
|
Deferred
revenue
|
740
|
|
788
|
Total current
liabilities
|
4,784
|
|
7,885
|
Warrant
liability
|
50,207
|
|
46,313
|
Total
liabilities
|
54,991
|
|
54,198
|
|
|
|
|
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; 71,115 and 70,406
shares issued and outstanding at September 30, 2018 and June 30,
2018, respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
268,700
|
|
264,858
|
Accumulated
deficit
|
(228,941)
|
|
(214,399)
|
Total stockholders'
equity
|
39,759
|
|
50,459
|
Total liabilities and
stockholders' equity
|
$
94,750
|
|
$ 104,657
|
MEI PHARMA,
INC.
|
STATEMENTS OF
OPERATIONS
|
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
2018
|
|
2017
|
|
|
|
|
Revenues:
|
|
|
|
Research and
development revenue
|
$
488
|
|
$
283
|
Total
revenues
|
488
|
|
283
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of research and
development revenue
|
989
|
|
618
|
Research and
development
|
6,131
|
|
6,064
|
General and
administrative
|
3,401
|
|
2,488
|
Total operating
expenses
|
10,521
|
|
9,170
|
|
|
|
|
Loss from
operations
|
(10,033)
|
|
(8,887)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Change in fair value
of warrant liability
|
(4,962)
|
|
-
|
Interest and dividend
income
|
454
|
|
100
|
Income tax
expense
|
(1)
|
|
(1)
|
Net loss
|
$ (14,542)
|
|
$ (8,788)
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.21)
|
|
$
(0.24)
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
Basic
|
70,885
|
|
37,245
|
Diluted
|
70,885
|
|
37,245
|
MEI PHARMA,
INC.
|
Reconciliation of
GAAP Net Loss to Adjusted Net Loss
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
2018
|
|
2017
|
|
|
|
|
Net loss
|
$ (14,542)
|
|
$ (8,788)
|
Add: Change in fair
value of warrant liability
|
4,962
|
|
-
|
Adjusted net
loss
|
$
(9,580)
|
|
$ (8,788)
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.21)
|
|
$
(0.24)
|
|
|
|
|
Adjusted net loss per
share - basic and diluted
|
$
(0.14)
|
|
$
(0.24)
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
Basic and
Diluted
|
70,885
|
|
37,245
|
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SOURCE MEI Pharma, Inc.