SAN DIEGO, Sept. 9, 2020 /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,
2020.
"This past year was marked by progress on multiple fronts,
particularly for zandelisib, formerly called ME-401, which is our
PI3K delta inhibitor in the Phase 2 TIDAL study intended to support
an accelerated approval marketing application with FDA,"
said Daniel P. Gold, Ph.D., president and chief executive
officer of MEI Pharma. "The progress on zandelisib this past year
includes entering a global license, development and
commercialization agreement with Kyowa Kirin Company, maturing
Phase 1b study data that continues to
support best-in-class potential, as well as obtaining Fast Track
designation from FDA."
Dr. Gold continued: "With about $183
million in cash at the start of our fiscal year, we believe
we have an operational runway at least through 2023 and are well
positioned to advance our ongoing clinical programs. In particular,
we look forward to completing TIDAL enrollment as we initiate
additional clinical studies to fully explore zandelisib's potential
to benefit patients with B-cell malignancies while we continue our
staged build-out of a commercial infrastructure to optimally
capture value from the program."
Fiscal Year 2020 Zandelisib (ME-401) and Corporate
Highlights
Zandelisib (formerly called ME-401), an oral, once-daily,
investigational drug-candidate selective for phosphatidylinositol
3-kinase delta (PI3Kδ), for B-Cell Malignancies
- The World Health Organization approved "zandelisib" as the
International Nonproprietary Name, or INN, for ME-401, the
Company's investigational cancer treatment being developed as
an oral, once-daily, selective PI3Kδ inhibitor for the
treatment of B-cell malignancies.
- In May 2020, the Company and
Kyowa Kirin Co. presented updated data at the American Society of
Clinical Oncology (ASCO) 2020 Virtual Scientific Program from a
Phase 1b study of zandelisib (ME-401) for the treatment
of B-cell malignancies. These data evaluating patients on
an intermittent dosing schedule of zandelisib showed that treatment
was generally well tolerated and demonstrated an 83% overall
response rate in patients with relapsed or refractory follicular
lymphoma (n=36). The responses were durable with no median yet
reached (median follow-up of 13.2 months: range: 3.0-27.6).
- In April 2020, the Company entered into a global license,
development and commercialization agreement with Kyowa Kirin Co. to
further develop and commercialize MEI's zandelisib:
-
- MEI and Kyowa Kirin will co-develop and co-promote zandelisib
in the U.S.
-
- MEI to book U.S. sales on 50-50 profit and cost sharing.
- $100 million upfront cash
payment to MEI.
- $582.5 million in potential
development, regulatory and commercial milestones
- Kyowa Kirin obtains exclusive commercialization rights
ex-U.S.
-
- MEI to receive escalating tiered royalty payments starting in
the teens on ex-U.S. sales.
- In March 2020, the Company was granted Fast Track
designation by the U.S. FDA for zandelisib for the treatment of
adult patients with relapsed or refractory follicular
lymphoma.
Corporate Highlights
- In April 2020, Cheryl L. Cohen, former chief
commercial officer of Medivation, Inc. and a product launch and
commercialization veteran with over 25 years of service in the
pharmaceutical and biotechnology industry, joined the Board of
Directors.
- In December 2019, the Company
closed an underwritten public offering of 32,343,750 shares of its
common stock for total gross proceeds of
approximately $51,750,000. Additionally, during the year
ended June 30, 2020, MEI sold
5,471,684 shares under the ATM Sales Agreement for net proceeds of
$20.8 million.
- In July 2019, Tamar Howson, M.S., MBA, a highly
experienced business development executive with over 30 years of
service in the pharmaceutical and biotechnology industry, joined
the Board of Directors.
Fiscal Year 2020 Financial Results
- As of June 30, 2020, MEI had
$182.6 million in cash, cash
equivalents, and short-term investments with no outstanding debt.
Additionally, MEI has a receivable of $20.4
million that is expected to be received from the Japanese
taxing authorities in fiscal year 2021 that was withheld from the
$100 million paid by Kyowa Kirin Co.
under the terms of April 2020 global
license, development and commercialization agreement. The
withholding was a result of the US Internal Revenue Service being
closed because of the COVID pandemic, resulting in an inability to
provide the necessary documentation to support an exemption from
the required foreign withholding.
- For the year ended June 30, 2020,
cash used in operations was $45.3
million compared to $39.4
million for 2019.
- Research and development expenses were $34.1 million for the year ended June 30, 2020, compared to $32.3 million for 2019. The increase was
primarily related to increased development costs associated with
zandelisib, as well as increased personnel costs to support our
clinical trial activities.
- General and administrative expenses were $16.7 million for the year ended June 30, 2020, compared to $14.6 million for 2019. The increase primarily
relates to personnel costs and general corporate expenses incurred
during the year ended June 30,
2020.
- MEI recognized revenues of $28.9
million for the year ended June 30,
2020, compared to $4.9 million
for the year ended June 30, 2019.
Revenues resulted from the recognition of license revenue
associated with the Kyowa Kirin license agreement as well as fees
allocated to research and development activities related to the
Kyowa Kirin and Helsinn license agreements.
- Net loss was $46.0 million, or
$0.51 per share, for the fiscal year
ended June 30, 2020, compared to net
loss of $16.8 million, or
$0.24 per share for 2019. The Company
had 111,513,689 shares of common stock outstanding as of
June 30, 2020, compared with
73,544,576 shares as of June 30,
2019.
- The adjusted net loss for the fiscal year ended June 30, 2020, 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), was $23.1
million.
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast
today, September 9, 2020, 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
49919899. 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 late-stage pharmaceutical
company focused on developing potential new therapies for cancer.
MEI Pharma's portfolio of drug candidates contains four
clinical-stage assets, including zandelisib, currently in an
ongoing Phase 2 clinical trial which may support an accelerated
approval marketing application with the U.S. Food and Drug
Administration. Each of MEI Pharma's 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.
Forward-Looking Statements
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; the impact of the COVID-19 pandemic on our
industry and individual companies, including on our counterparties,
the supply chain, the execution of our clinical development
programs, our access to financing and the allocation of government
resources; 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,
|
|
2020
|
|
2019
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
12,331
|
|
$
9,590
|
Short term
investments
|
170,299
|
|
64,899
|
Total cash, cash
equivalents and short-term investments
|
182,630
|
|
74,489
|
Receivable for
foreign tax withholding
|
20,420
|
|
-
|
Common stock proceeds
receivable
|
-
|
|
5,274
|
Prepaid expenses and
other current assets
|
5,594
|
|
2,435
|
Total current
assets
|
208,644
|
|
82,198
|
Intangible assets,
net
|
-
|
|
261
|
Property and
equipment, net
|
1,084
|
|
204
|
Total
assets
|
$
209,728
|
|
$
82,663
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,437
|
|
$
4,787
|
Accrued
liabilities
|
6,090
|
|
4,559
|
Deferred
revenue
|
14,777
|
|
4,955
|
Total current
liabilities
|
23,304
|
|
14,301
|
Deferred revenue,
long-term
|
67,723
|
|
2,819
|
Warrant
liability
|
40,483
|
|
17,613
|
Total
liabilities
|
131,510
|
|
34,733
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.01 par value; 100 shares authorized;
|
|
|
|
none outstanding
|
-
|
|
-
|
Common stock,
$0.00000002 par value; 226,000 shares
|
|
|
|
authorized; 111,514 and
73,545 shares issued and outstanding
|
|
|
at June 30, 2020 and 2019,
respectively
|
-
|
|
-
|
Additional
paid-in-capital
|
355,452
|
|
279,148
|
Accumulated
deficit
|
(277,234)
|
|
(231,218)
|
Total stockholders'
equity
|
78,218
|
|
47,930
|
Total liabilities and
stockholders' equity
|
$
209,728
|
|
$
82,663
|
MEI PHARMA,
INC.
|
STATEMENTS OF
OPERATIONS
|
(In thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
Years Ended June
30,
|
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Revenue
|
|
$
28,913
|
|
$
4,915
|
|
$
1,622
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Cost of
revenue
|
|
2,671
|
|
4,263
|
|
3,383
|
Research and
development
|
|
34,065
|
|
32,300
|
|
17,038
|
General and
administrative
|
|
16,717
|
|
14,597
|
|
9,787
|
Total operating
expenses
|
|
53,453
|
|
51,160
|
|
30,208
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(24,540)
|
|
(46,245)
|
|
(28,586)
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
Change in fair value
of warrant liability
|
|
(22,870)
|
|
27,632
|
|
(9,705)
|
Financing costs
associated with warrants
|
|
-
|
|
-
|
|
(2,367)
|
Interest and dividend
income
|
|
1,395
|
|
1,795
|
|
591
|
Income tax
expense
|
|
(1)
|
|
(1)
|
|
(1)
|
Net loss
|
|
$
(46,016)
|
|
$
(16,819)
|
|
$
(40,068)
|
|
|
|
|
|
|
|
Net loss:
|
|
|
|
|
|
|
Basic
|
|
$
(46,016)
|
|
$
(16,819)
|
|
$
(40,068)
|
Diluted
|
|
$
(46,016)
|
|
$
(54,613)
|
|
$
(40,068)
|
Net loss per
share:
|
|
|
|
|
|
|
Basic
|
|
$
(0.51)
|
|
$
(0.24)
|
|
$
(0.97)
|
Diluted
|
|
$
(0.51)
|
|
$
(0.75)
|
|
$
(0.97)
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
Basic
|
|
91,080
|
|
71,139
|
|
41,431
|
Diluted
|
|
91,080
|
|
72,385
|
|
41,431
|
MEI PHARMA,
INC.
|
Reconciliation of
GAAP Net Loss to Adjusted Net Loss
|
(In
thousands)
|
|
|
|
Years Ended June
30,
|
|
|
2020
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Net loss:
|
|
$
(46,016)
|
|
$
(16,819)
|
|
$
(40,068)
|
Add: Change in fair
value of warrant liability
|
|
22,870
|
|
(27,632)
|
|
9,705
|
Adjusted net
loss:
|
|
$
(23,146)
|
|
$
(44,451)
|
|
$
(30,363)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivable for
foreign tax withholding
|
|
|
|
|
|
|
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SOURCE MEI Pharma, Inc.