SAN DIEGO, May 9, 2019 /PRNewswire/ -- MEI Pharma, Inc.
(NASDAQ: MEIP), a late-stage pharmaceutical company focused on
advancing new therapies for cancer, today reported results for its
third quarter ended March 31,
2019.
"As progress continues across our pipeline of four
clinical-stage oncology candidates, including two in clinical
studies that may support future submissions for FDA marketing
approval, we are particularly excited with the expanding data set
from the ME-401 intermittent dosing schedule as it continues to
mature and we look forward to presenting the data at upcoming
medical meetings, including next month at ASCO," said Daniel P. Gold, Ph.D., president and chief
executive officer of MEI Pharma. "Our immediate focus for MEI-401
is twofold: executing the ME-401 follicular lymphoma global Phase 2
study, data from which we intend to submit as an accelerated
approval marketing application with the FDA, and the expansion of
our investigation of ME-401 in combination with Rituxan® or
zanubrutinib, a BTK inhibitor being investigated pursuant to our
BeiGene collaboration, to earlier stages of follicular lymphoma as
well as other B-cell malignancies."
Upcoming Program Milestones
- Advancement of ME-401 Program for B-Cell Malignancies
-
- Phase 1b study initiation of new
arm to evaluate the combination of ME-401 with zanubrutinib under a
clinical collaboration with BeiGene.
- Updates and presentations of clinical data from the ME-401
clinical development program, including at 2019 American Society of
Clinical Oncology Annual Meeting (ASCO).
- Final Clinical Results: ME-344 for Breast Cancer
-
- Present complete results from the investigator-initiated study
of ME-344 in combination with bevacizumab (marketed as Avastin®) in
patients with breast cancer at ASCO 2019.
- Phase 1b Study Progress:
Voruciclib for B-Cell Malignancies and AML
-
- Report initial clinical results from ongoing Phase 1 study,
including single agent dose ranging data and results from the
combination with venetoclax in patients with B-cell malignancies
and relapsed and refractory acute myeloid leukemia around year end
2019.
- Phase 2 Results: Pracinostat for Myelodysplastic Syndrome
-
- Results from the Phase 2 clinical trial, including response and
1-year survival, expected to be available around year end
2019.
Financial Highlights
- As of March 31, 2019, MEI had
$82.3 million in cash, cash
equivalents and short-term investments, with no outstanding
debt.
- For the three months ending March 31,
2019, cash expenditures for operating activities were
$11.3 million, compared to
$6.2 million for 2018. For the nine
months ending March 31, 2019, cash
expenditures for operating activities were $31.4 million, compared to $17.6 million for 2018. The increase in cash used
for the nine months ended March 31,
2019 primarily relates to costs associated with our clinical
development programs, including start-up costs related to the
ME-401 Phase 2 study.
- Research and development expenses were $9.1 million for the quarter ended March 31, 2019, compared to $3.1 million for the same period in 2018.
Research and development expenses primarily reflect increased costs
associated with the development of ME-401.
- General and administrative expenses were $3.6 million for the quarter ended March 31, 2019, compared to $2.5 million for the same period in 2018. The
increase primarily relates to increased salary and share-based
compensation associated with increased headcount, and increased
professional services expenses.
- The Company recognized revenue of $1.2
million for the quarter ended March
31, 2019, compared to $0.4
million for the same period in 2018. The increase is related
to revenues from our agreement with KHK, and to higher levels of
research and development activities performed pursuant to the
Helsinn license agreement.
- Net loss for the quarter ended March 31,
2019, was $17.4 million, or
$0.24 per share compared to a net
loss of $5.9 million, or $0.16 per share for the same period in 2018. The
Company had 71,280,660 shares of common stock outstanding as of
March 31, 2019, compared with
37,323,441 shares as of March 31,
2018.
- 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 March 31,
2019, was $12.2 million.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical
company focused on developing potential new therapies for cancer.
Our portfolio of drug candidates contains four clinical-stage
assets, including one candidate in an ongoing global registration
trial and another candidate in a Phase 2 clinical trial which may
support an accelerated approval marketing application with the U.S.
Food and Drug Administration. Each of our pipeline candidates
leverages a different mechanism of action with the objective of
developing therapeutic options that are: (1) differentiated, (2)
address unmet medical needs and (3) deliver improved benefit to
patients either as standalone treatments or in combination with
other therapeutic options. 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)
|
|
|
|
|
|
March
31,
|
|
June
30,
|
|
2019
|
|
2018
|
|
(unaudited)
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
7,426
|
|
$
13,309
|
Short term
investments
|
74,864
|
|
89,434
|
Total cash, cash
equivalents and short-term investments
|
82,290
|
|
102,743
|
Prepaid expenses and
other current assets
|
3,153
|
|
1,586
|
Total current
assets
|
85,443
|
|
104,329
|
Intangible assets,
net
|
270
|
|
296
|
Property and
equipment, net
|
213
|
|
32
|
Total
assets
|
$
85,926
|
|
$
104,657
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,969
|
|
$
3,643
|
Accrued
liabilities
|
5,685
|
|
3,454
|
Deferred
revenue
|
4,197
|
|
788
|
Total current
liabilities
|
11,851
|
|
7,885
|
Deferred revenue,
long-term
|
4,222
|
|
-
|
Warrant
liability
|
31,971
|
|
46,313
|
Total
liabilities
|
48,044
|
|
54,198
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.01 par value; 100 shares authorized;
|
|
|
|
none outstanding
|
-
|
|
-
|
Common stock,
$0.00000002 par value; 226,000 shares
|
|
|
|
authorized; 71,281 and
70,406 shares issued and outstanding
|
|
|
|
at March 31, 2019 and June
30, 2018, respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
272,153
|
|
264,858
|
Accumulated
deficit
|
(234,271)
|
|
(214,399)
|
Total stockholders'
equity
|
37,882
|
|
50,459
|
Total liabilities and
stockholders' equity
|
$
85,926
|
|
$
104,657
|
MEI PHARMA,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
Nine Months
Ended
March 31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Revenues
|
$
1,249
|
|
$
433
|
|
$
3,785
|
|
$
1,074
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
1,163
|
|
930
|
|
3,161
|
|
2,276
|
Research and
development
|
9,071
|
|
3,071
|
|
24,268
|
|
12,579
|
General and
administrative
|
3,631
|
|
2,486
|
|
10,853
|
|
7,332
|
Total operating
expenses
|
13,865
|
|
6,487
|
|
38,282
|
|
22,187
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(12,616)
|
|
(6,054)
|
|
(34,497)
|
|
(21,113)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant liability
|
(5,201)
|
|
-
|
|
13,274
|
|
-
|
Interest and dividend
income
|
462
|
|
106
|
|
1,352
|
|
299
|
Income tax
expense
|
-
|
|
-
|
|
(1)
|
|
(1)
|
Net loss
|
$ (17,355)
|
|
$ (5,948)
|
|
$ (19,872)
|
|
$ (20,815)
|
|
|
|
|
|
|
|
|
Net loss:
|
|
|
|
|
|
|
|
Basic
|
$ (17,355)
|
|
$ (5,948)
|
|
$ (19,872)
|
|
$ (20,815)
|
Diluted
|
$ (17,355)
|
|
$ (5,948)
|
|
$ (43,309)
|
|
$ (20,815)
|
Net loss per
share:
|
|
|
|
|
|
|
|
Basic
|
$
(0.24)
|
|
$
(0.16)
|
|
$
(0.28)
|
|
$
(0.56)
|
Diluted
|
$
(0.24)
|
|
$
(0.16)
|
|
$
(0.60)
|
|
$
(0.56)
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
|
Basic
|
71,200
|
|
37,449
|
|
71,069
|
|
37,369
|
Diluted
|
71,200
|
|
37,449
|
|
72,011
|
|
37,369
|
MEI PHARMA,
INC.
|
Reconciliation of
GAAP Net Loss to Adjusted Net Loss
|
(In
thousands)
|
(Unaudited)
|
|
|
|
Three Months
Ended
March 31,
|
|
Nine Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ (17,355)
|
|
$ (5,948)
|
|
$ (19,872)
|
|
$ (20,815)
|
Add: Change in fair
value of warrant liability
|
|
5,201
|
|
-
|
|
(13,274)
|
|
-
|
Adjusted net
loss
|
|
$ (12,154)
|
|
$ (5,948)
|
|
$ (33,146)
|
|
$ (20,815)
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/mei-pharma-reports-third-quarter-fiscal-year-2019-results-and-operational-highlights-300846857.html
SOURCE MEI Pharma, Inc.