MEI Pharma Reports Second Quarter Fiscal Year 2021 Results and Operational Highlights
SAN DIEGO, Feb. 4, 2021 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended December 31, 2020.
"We remain well positioned and focused on advancing zandelisib toward commercialization to deliver an improved therapeutic option to people living with B-cell malignancies," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We anticipate multiple important milestones from the zandelisib program this year, including topline data from our Phase 2 TIDAL study in the fourth quarter as we closely monitor for potential negative impacts related to the ongoing COVID 19 pandemic on the study, as well as more broadly across our business and development pipeline. In addition we look forward to reporting clinical data updates from the ongoing Phase 1b study and the continued expansion of the zandelisib clinical program evaluating additional indications and combinations, in particular the start of the Phase 3 study evaluating zandelisib in combination with rituximab in patients with second line follicular lymphoma around mid-year."
Dr. Gold continued: "Beyond the zandelisib development program, this year we look forward to the potential for more advances across our pipeline, including clinical data updates from the Phase 1 voruciclib program and our plans to advance ME-344 into a Phase 2 pilot study evaluating patients with solid tumors."
Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments
Zandelisib - PI3K delta inhibitor for the treatment of various B-cell malignancies
-- Completion of enrollment in the Phase 2 TIDAL study evaluating
zandelisib as a monotherapy for patients with relapsed or refractor
follicular lymphoma followed by the reporting of top line clinical data
from the Phase 2 TIDAL study.
-- Initiation of a second arm in the Phase 2 TIDAL study enrolling patients
with relapsed or refractory marginal zone lymphoma.
-- Initiation of the Phase 3 study of zandelisib in combination with
rituximab evaluating follicular and marginal zone lymphoma patients who
received one or more prior lines of treatment; this study is intended to
act as the required confirmatory study for the potential accelerated
approval of zandelisib in patients with relapsed or refractory
follicular lymphoma.
-- Clinical updates for the Phase 1b study of zandelisib, including the
combination with zanubrutinib.
Voruciclib - CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
-- Program updates, including data from the Phase 1 program evaluating
voruciclib.
ME-344 - tumor selective mitochondrial inhibitor
-- Update plans for a potential Phase 2 pilot study of ME-344 in solid
tumors.
Recent and Second Quarter Fiscal Year 2021 Corporate Highlights
-- In January 2021, the Phase 1b trial arm exploring zandelisib in
combination with zanubrutinib (marketed as BRUKINSA®), developed by
BeiGene, Ltd., enrolled the first patient in a disease specific
expansion cohort. The phase 1b study arm evaluating the combination is
conducted under a clinical collaboration with BeiGene to evaluate safety
and efficacy for the treatment of patients with various relapsed or
refractory B-cell malignancies.
-- In January 2021, MEI announced that the Phase 1b trial arm exploring
zandelisib in combination with zanubrutinib in collaboration with
BeiGene completed the safety evaluation stage in patients with B-cell
malignancies and is expanding into disease specific B-cell malignancy
cohorts. The Safety Review Committee recommended moving forward with a
dosing regimen found to be generally well tolerated and active following
a planned safety analysis.
-- In October 2020, Kyowa Kirin Co. Ltd. and MEI announced that the first
patient was dosed in the pivotal Phase 2 study of zandelisib in patients
with indolent B-cell non-Hodgkin's lymphoma (iNHL) without small
lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and
Waldenström's macroglobulinemia (WM) in Japan. This Phase 2,
multicenter is intended to support regulatory approval in Japan.
Second Quarter Fiscal Year 2021 Financial Results
-- As of December 31, 2020, MEI had $180.1 million in cash, cash
equivalents, and short-term investments with no outstanding debt.
-- For the quarter ended December 31, 2020, cash provided by operations was
$4.1 million compared to $10.5 million used in operations for the
quarter ended December 31, 2019. Cash provided by operations in the 2020
period reflects $20.9 million cash received from the Japanese taxing
authorities as a refund of withholding tax associated with the Kyowa
Kirin commercialization agreement signed in April 2020.
-- Research and development expenses were $22.2 million for the quarter
ended December 31, 2020, compared to $8.3 million for the quarter ended
December 31, 2019. The increase was primarily related to increased
development costs associated with zandelisib, including increased
activity in the TIDAL study and start-up costs related to the Phase 3
study, as well as increased personnel costs to support clinical trial
activities.
-- General and administrative expenses were $5.7 million for the quarter
ended December 31, 2020, compared to $4.2 million for the quarter ended
December 31, 2019. The increase primarily relates to general corporate
expenses and personnel costs incurred during the quarter ended December
31, 2020.
-- MEI recognized revenue of $9.2 million for the quarter ended December
31, 2020, compared to $1.0 million for the quarter ended December 31,
2019. The increase in revenue primarily related to the license agreement
with Kyowa Kirin and included the recognition of fees allocated to
research and development obligations, and reflect Kyowa Kirin's share of
zandelisib costs which were $9.9 million for the quarter ended December
31, 2020.
-- Net loss was $11.5 million, or $0.10 per share, for the quarter ended
December 31, 2020, compared to net loss of $20.2 million, or $0.26 per
share for the quarter ended December 31, 2019. The Company had
112,527,860 shares of common stock outstanding as of December 31, 2020,
compared with 105,998,677 shares as of December 31, 2019.
-- The adjusted net loss for the quarter ended December 31, 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 $18.5 million, compared to an adjusted net loss of $11.8 million for
the quarter ended December 31, 2019.
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.
CONDENSED BALANCE SHEETS
(In thousands, except per share amounts)
December 31, June 30,
2020 2020
(unaudited)
ASSETS
Current assets:
Cash and cash
equivalents $9,877 $12,331
Short-term
investments 170,267 170,299
Total cash, cash
equivalents and
short-term
investments 180,144 182,630
Receivable for
foreign tax
withholding - 20,420
Prepaid expenses
and other
current assets 13,888 5,594
Total current
assets 194,032 208,644
Operating lease
right-of-use
asset 8,207 -
Property and
equipment, net 1,641 1,084
Total assets $203,880 $209,728
===
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $5,555 $2,437
Accrued
liabilities 11,102 6,090
Deferred revenue 19,482 14,777
Operating lease
liability 873 -
Total current
liabilities 37,012 23,304
Deferred revenue,
long-term 65,352 67,723
Operating lease
liability, long-
term 7,842 -
Warrant liability 20,176 40,483
Total liabilities 130,382 131,510
Stockholders' equity:
Preferred stock, $0.01 par value; 100 shares
authorized;
none outstanding -
Common stock, $0.00000002 par value; 226,000
shares
authorized; 112,528 and 111,514 shares issued
and outstanding
at December 31,
2020 and June
30, 2020,
respectively -
Additional paid-
in-capital 364,278 355,452
Accumulated
deficit (290,780) (277,234)
Total
stockholders'
equity 73,498 78,218
Total liabilities
and
stockholders'
equity $203,880 $209,728
===
MEI PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
---
2020 2019 2020 2019
---
Revenue $9,167 $1,008 $13,001 $2,165
Operating expenses:
Cost of revenue 494 641 1,003 1,329
Research and development 22,224 8,281 35,220 17,243
General and administrative 5,650 4,195 11,565 8,325
Total operating expenses 28,368 13,117 47,788 26,897
---
Loss from operations (19,201) (12,109) (34,787) (24,732)
Other income (expense):
Change in fair value of warrant liability 7,083 (8,439) 20,307 830
Interest and dividend income 164 318 439 692
Other income (expense) 500 13 495 (1)
Net loss $(11,454) $(20,217) $(13,546) $(23,211)
===
Net loss:
Basic $(11,454) $(20,217) $(13,546) $(23,211)
===
Diluted $(18,537) $(20,217) $(33,853) $(23,211)
===
Net loss per share:
Basic $(0.10) $(0.26) $(0.12) $(0.30)
Diluted $(0.16) $(0.26) $(0.30) $(0.30)
Shares used in computing net loss per share:
Basic 112,524 78,577 112,480 76,103
===
Diluted 114,461 78,577 114,709 76,103
===
MEI PHARMA, INC.
Reconciliation of GAAP Net Loss to Adjusted Net Loss
(In thousands)
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
2020 2019 2020 2019
Net loss $(11,454) $(20,217) $(13,546) $(23,211)
Add: Change in fair value of warrant liability (7,083) 8,439 (20,307) (830)
Adjusted net loss $(18,537) $(11,778) $(33,853) $(24,041)
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SOURCE MEI Pharma, Inc.
