SAN DIEGO, Aug. 30, 2018 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on
advancing new therapies for cancer, today reported results for
its fiscal year ended June 30, 2018.
"We begin the 2019 fiscal year in our strongest position ever,
with progress across all four clinical-stage oncology candidates,
and with particular focus on the planned initiation of the ME-401
Phase 2 accelerated approval study by year-end. With ME-401 joining
pracinostat as the second candidate in a global study to support
marketing authorization, along with our robust cash position, we
are well situated to pursue our development strategy,"
said Daniel P. Gold, Ph.D., president and chief executive
officer of MEI Pharma.
Dr. Gold continued, "We are also very pleased to report that in
recent discussions with FDA on a ME-401 accelerated approval
registration strategy, FDA expressed support of our proposed
randomized Phase 2 trial in which we will evaluate continuous and
intermittent dosing schedules in patients with relapsed or
refractory follicular lymphoma. As we execute on our plans to
start this study around year-end, we also look forward to reporting
additional progress across our pipeline over the coming quarters,
including clinical data from our CDK9 inhibitor, voruciclib, and
clinical updates on pracinostat and ME-344."
Fiscal Year 2018 and Recent Company Highlights
Financial
- In May 2018, the Company
completed a private placement of common stock, along with warrants
to purchase common stock, resulting in net proceeds to MEI of
approximately $70 million.
- As of June 30, 2018, MEI had $102.7 million in
cash, cash equivalents and short-term investments, with no
outstanding debt. The cash balance includes the proceeds of our
private placement completed in May
2018.
- Research and development expenses were $17.0
million for the year ended June 30, 2018, compared
to $7.2 million for 2017. The increase was primarily
related to increased activities in all clinical programs including
the acquisition and development costs associated with
voruciclib.
- General and administrative expenses were $9.8
million for the year ended June 30, 2018, compared
to $8.6 million for 2017. The increase primarily relates
to professional services expenses, share-based compensation, and
general corporate expenses incurred during the year ended
June 30, 2018.
- The Company recognized revenues of $1.6 million for
the year ended June 30, 2018. Revenues resulted from the
recognition of fees allocated to research and development
activities related to the Helsinn License Agreement. Revenue
decreased due to lower levels of research and development
activities during the year ended June 30,
2018.
- Cash expenditures for operations were $21.3
million for the year ended June 30, 2018, compared
to $16.5 million for 2017. Cash expenditures
were $3.8 million for the fourth quarter ended June
30, 2018, compared to $3.1 million for the same period in
2017.
- Net loss was $40.1 million, or $0.97 per share,
for the fiscal year ended June 30, 2018, compared to net
income of $2.7 million, or $0.07 per share for
2017. The Company's net loss includes a $9.7 million change in the fair value of the
warrants issued in connection with the May
2018 financing and $2.4
million in transaction costs related to the May 2018 financing recorded as financing expense
on the statement of operations. The Company is required to
calculate the change in fair value of the warrants and record the
non-cash charge to the statement of operations at each reporting
date.
ME-401 - a next-generation selective oral inhibitor of PI3K
delta
- In June 2018, the Company
presented results from a Phase 1b study evaluating ME-401
in patients with relapsed/refractory follicular lymphoma, chronic
lymphocytic leukemia and small lymphocytic lymphoma at the 2018
American Society of Clinical Oncology (ASCO) Annual Meeting as well
as the European Hematology Association Congress. The data
demonstrated a 90% overall objective response rate in patients.
Based on these data, the Company is advancing ME-401 into a Phase
2, single-agent study for the treatment of adults with relapsed or
refractory follicular lymphoma. The Phase 2 study is intended to
support accelerated approval and is planned to begin around the end
of 2018.
- In July 2018 the Company
discussed with FDA a ME-401 monotherapy accelerated approval
strategy in patients with relapsed or refractory follicular
lymphoma (FL). The FDA communicated support for the Company's
proposed randomized Phase 2 trial evaluating continuous and
intermittent dosing schedules. 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.
- MEI expects to report data updates from the Phase 1b study, including at a medical meeting late in
Q4 2018. By year-end 2018, MEI also plans to initiate the Phase 2
study to support accelerated approval of ME-401 in relapsed or
refractory follicular lymphoma.
Pracinostat - an oral HDAC inhibitor (partnered with Helsinn
Healthcare, SA)
- 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 for induction
chemotherapy.
- In May 2018, the Company and
Helsinn announced a successful interim analysis from the Phase 2
study evaluating the combination of pracinostat and azacitidine in
high and very high-risk myelodysplastic syndrome (MDS) patients
previously untreated with hypomethylating agents. Based on the
successful planned interim analysis, the study expanded open-label
enrollment to 60 patients. MEI is responsible for the conduct of
the Phase 2 study, the cost of which will be shared by Helsinn.
Helsinn is responsible for funding any further studies.
- MEI expects to provide updates to the pracinostat program at a
medical meeting late in Q4 2018.
Voruciclib - an oral, selective CDK inhibitor with robust
CDK9 inhibition
- In January 2018, the U.S. Food and Drug Administration
cleared the Company's Investigational New Drug Application (IND)
for voruciclib.
- MEI expects to report updates regarding the ongoing Phase 1
study, and the initiation of dosing of voruciclib in combination
with VENCLEXTA® (venetoclax) in relapsed or refractory B-cell
malignancies, at medical meetings in 2019.
ME-344 - a novel mitochondrial inhibitor
- In June 2018, the Company
presented interim results from an investigator-initiated Phase 1
study in HER2 negative breast cancer in combination with
bevacizumab (marketed as Avastin®) at ASCO. ME-344 in
combination with Avastin demonstrated inhibition of tumor
proliferation as measured by Ki-67 reductions in HER2 negative
breast cancer patients. These results support continuation of
the ongoing Phase 1 study.
- MEI expects to report additional data from the
investigator-sponsored Phase 1 study at medical meetings in
2019.
Operational Highlights
- In February 2018, the Company
announced the appointment of industry veteran Frederick W. Driscoll to the board of directors.
Mr. Driscoll serves on the audit committee.
- 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.
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast
today, August 30, 2018, at 5:00 p.m. Eastern time to
provide a corporate update. To access the live call, please dial
(866) 939-3921 (United States) or
(678) 302-3550 (International), conference ID 47469059. The
conference call will also be webcast live and can be accessed
at www.meipharma.com. A replay of the webcast will be
available approximately one hour after the conclusion of the
call.
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 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
follicular lymphoma or CLL, 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-initiated
study in combination with bevacizumab evaluating patients with
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)
|
|
|
|
|
|
June
30,
|
|
2018
|
|
2017
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
13,309
|
|
$
8,458
|
Short-term
investments
|
89,434
|
|
45,107
|
Total cash, cash
equivalents and short-term investments
|
102,743
|
|
53,565
|
Prepaid expenses and
other current assets
|
1,586
|
|
1,758
|
Total current
assets
|
104,329
|
|
55,323
|
Intangible assets,
net
|
296
|
|
331
|
Property and
equipment, net
|
32
|
|
50
|
Total
assets
|
$ 104,657
|
|
$
55,704
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
3,643
|
|
$
585
|
Accrued
liabilities
|
3,454
|
|
3,285
|
Deferred
revenues
|
788
|
|
996
|
Total current
liabilities
|
7,885
|
|
4,866
|
Warrant
liability
|
46,313
|
|
-
|
Total
liabilities
|
54,198
|
|
4,866
|
|
|
|
|
Commitments and
contingencies (Note 9)
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.01 par value; 100 shares authorized; none outstanding
|
-
|
|
-
|
Common stock,
$0.00000002 par value; 113,000 shares authorized;
70,406 and 36,772 shares issued and
outstanding at June 30, 2018 and
2017, respectively.
|
-
|
|
-
|
Additional
paid-in-capital
|
264,858
|
|
225,169
|
Accumulated
deficit
|
(214,399)
|
|
(174,331)
|
Total stockholders'
equity
|
50,459
|
|
50,838
|
Total liabilities and
stockholders' equity
|
$ 104,657
|
|
$
55,704
|
MEI PHARMA,
INC.
STATEMENTS OF
OPERATIONS
(In thousands, except
per share amounts)
|
|
|
|
|
|
Years Ended June
30,
|
|
|
2018
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
-
|
|
$ 20,880
|
|
$
-
|
Research and
development revenue
|
|
1,622
|
|
2,369
|
|
-
|
|
|
1,622
|
|
23,249
|
|
-
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Cost of research and
development revenue
|
|
3,383
|
|
5,000
|
|
-
|
Research and
development
|
|
17,038
|
|
7,237
|
|
13,403
|
General and
administrative
|
|
9,787
|
|
8,628
|
|
7,601
|
Total operating
expenses
|
|
30,208
|
|
20,865
|
|
21,004
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
(28,586)
|
|
2,384
|
|
(21,004)
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
Change in fair value
of warrant liability
|
|
(9,705)
|
|
-
|
|
-
|
Financing costs
associated with warrants
|
|
(2,367)
|
|
-
|
|
-
|
Interest and dividend
income
|
|
591
|
|
287
|
|
143
|
Income tax
expense
|
|
(1)
|
|
(1)
|
|
(1)
|
Net (loss)
income
|
|
$ (40,068)
|
|
$
2,670
|
|
$ (20,862)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
share, basic
|
|
$
(0.97)
|
|
$
0.07
|
|
$
(0.61)
|
Net (loss) income per
share, diluted
|
|
$
(0.97)
|
|
$
0.07
|
|
$
(0.61)
|
|
|
|
|
|
|
|
Shares used in
computing net (loss) income per share:
|
|
|
|
|
Basic
|
|
41,431
|
|
36,813
|
|
34,400
|
Diluted
|
|
41,431
|
|
36,938
|
|
34,400
|
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SOURCE MEI Pharma, Inc.