MEI Pharma Reports Fiscal Second-Quarter 2020 Results and Operational Highlights
SAN DIEGO, Feb. 6, 2020 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its second quarter ended December 31, 2019.
"We're off to a good start in calendar year 2020. Our pipeline of clinical oncology candidates continues to advance, and the successful equity offering this past December gives us added resources to execute on our clinical strategy through key value-creating inflection points," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We have several important milestones across our pipeline in 2020 including completing enrollment in the ME-401 TIDAL study, data updates from the Phase 1b study of ME-401 administered as a monotherapy and in combination with other agents to treat patients with B-cell malignancies, one year survival data from the Phase 2 pracinostat study in patients with MDS, and voruciclib updates in patients with AML and B-cell malignancies."
Dr. Gold added, "We remain very encouraged by the ME-401 clinical program; the maturing data on the intermittent dosing schedule in the Phase 1b study continue to demonstrate high overall response rates and durable responses, and the intermittent schedule also continues to be well tolerated. Based on the strength of the data set from these intermittent schedule patients, the TIDAL study was amended to consolidate the remaining study enrollment into the intermittent dosing arm. We expect to complete enrollment in the TIDAL study this summer and plan a submission for accelerated approval with the FDA based on the results of this study."
Recent Highlights
-- In December 2019, the Company completed a public offering of common
stock resulting in net proceeds to the Company of approximately $48.5
million.
-- In December 2019, the Company amended the study protocol for TIDAL
(Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), the Phase 2 trial
evaluating ME-401 in patients with relapsed or refractory follicular
lymphoma ("FL"). TIDAL is intended to support an accelerated approval
marketing application with the FDA.
-- The amendment consolidates the remaining enrollment into the dosing
arm in which patients receive ME-401 administered on the
intermittent schedule ("IS").
-- The amendment was prompted by maturing data from the Phase 1b trial
of ME-401 demonstrating that the IS regimen is as active as the
continuous daily dosing regimen, is associated with durable
responses to date, and is also associated with improved
tolerability.
-- Approximately 120 patients will be enrolled in the IS arm and
completion of enrollment is expected to complete in the summer of
2020.
-- In October 2019, the Company reported updated data from the ongoing
Phase 1b study of ME-401, an investigational selective oral inhibitor of
phosphatidylinositol 3-kinase ("PI3K") delta. The data demonstrate:
-- Overall response rates of 78% in relapsed or refractory FL and 89%
in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma
("CLL/SLL").
-- Rates of Grade 3 adverse events of special interest related to
ME-401 exposure were observed in <10% of patients dosed on an IS.
-- Median duration of response was not reached in patients with FL or
CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL
patients was 9.2 months (range 3.4-20.7 months) and 7.4 months
(range 2.6-14.7 months), respectively.
Fiscal Second-Quarter Fiscal Year 2020 Financial Results
-- As of December 31, 2019, MEI had $103.9 million in cash, cash
equivalents and short-term investments, with no outstanding debt.
-- For the quarter ended December 31, 2019, cash used in operations was
$10.5 million, compared to $7.2 million for 2018.
-- Research and development expenses were $8.3 million for the quarter
ended December 31, 2019, compared to $9.1 million for 2018. The decrease
was primarily related to decreased drug manufacturing costs associated
with ME-401.
-- General and administrative expenses were $4.2 million for the quarter
ended December 31, 2019, compared to $3.8 million for 2018. The increase
primarily relates to increased headcount and increased professional
services expenses to support our activities.
-- Revenue was $1.0 million for the quarter ended December 31, 2019,
compared to revenue of $2.0 million for the quarter ended December 31,
2018. Revenue resulted from the recognition of fees allocated to
research and development activities related to the Helsinn and Kyowa
Kirin License Agreements. During the quarter ended December 31, 2018,
revenue also included $0.9 million from transfer of the license to Kyowa
Kirin.
-- Net loss was $20.2 million, or $0.26 per share, for the quarter ended
December 31, 2019, compared to net income of $12.0 million, or $0.17 per
share for 2018. Net loss increased primarily as a result of a non-cash
expense in the current quarter and a non-cash gain in the prior quarter
related to changes in the fair value of the warrant liability associated
with the May 2018 financing. The Company had 105,998,677 shares of
common stock outstanding as of December 31, 2019, compared with
71,131,486 shares as of December 31, 2018.
-- The adjusted net loss for the quarter ended December 31, 2019, excluding
a non-cash expense related to changes in the fair value of the warrants
(a non-GAAP measure), was $11.8 million, compared to an adjusted net
loss of $11.4 million for 2018.
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)
December 31,
June 30,
2019 2019
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $8,638 $9,590
Short-term investments 95,243 64,899
Total cash, cash equivalents
and short-term investments 103,881 74,489
Common stock proceeds
receivable - 5,274
Prepaid expenses and other
current assets 2,564 2,435
Total current assets 106,445 82,198
Intangible assets, net 244 261
Property and equipment, net 416 204
Total assets $107,105 $82,663
===
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,038 $4,787
Accrued liabilities 3,835 4,559
Deferred revenue 3,056 4,955
Total current liabilities 9,929 14,301
Deferred revenue, long-term 3,108 2,819
Warrant liability 16,783 17,613
Total liabilities 29,820 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; 105,999 and
73,545 shares issued and
outstanding at December 31,
2019 and June 30, 2019,
respectively -
Additional paid-in-capital 331,714 279,148
Accumulated deficit (254,429) (231,218)
Total stockholders' equity 77,285 47,930
Total liabilities and
stockholders' equity $107,105 $82,663
===
MEI PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
---
2019 2018 2019 2018
---
Revenue $1,008 $2,048 $2,165 $2,536
Operating expenses:
Cost of revenue 641 1,009 1,329 1,998
Research and development 8,281 9,066 17,243 15,197
General and
administrative 4,195 3,821 8,325 7,222
Total operating expenses 13,117 13,896 26,897 24,417
---
Loss from operations (12,109) (11,848) (24,732) (21,881)
Other income (expense):
Change in fair value of
warrant liability (8,439) 23,437 830 18,475
Interest and dividend
income 318 436 692 890
Other income (expense) 13 (1) (1)
Net (loss) income $(20,217) $12,025 $(23,211) $(2,517)
Net (loss) income:
Basic $(20,217) $12,025 $(23,211) $(2,517)
Diluted $(20,217) $(11,412) $(23,211) $(25,954)
Net (loss) income per share:
Basic $(0.26) $0.17 $(0.30) $(0.04)
Diluted $(0.26) $(0.15) $(0.30) $(0.36)
Shares used in computing net (loss) income per share:
Basic 78,577 71,124 76,103 71,005
===
Diluted 78,577 73,951 76,103 72,418
===
MEI PHARMA, INC.
Reconciliation of GAAP Net (Loss) Income to Adjusted Net Loss
(In thousands)
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
2019 2018 2019 2018
Net (loss) income $(20,217) $12,025 $(23,211) $(2,517)
Add: Change in fair
value of warrant
liability 8,439 (23,437) (830) (18,475)
Adjusted net loss $(11,778) $(11,412) $(24,041) $(20,992)
View original content to download multimedia:http://www.prnewswire.com/news-releases/mei-pharma-reports-fiscal-second-quarter-2020-results-and-operational-highlights-301000467.html
SOURCE MEI Pharma, Inc.
