MEI Pharma Reports Second Quarter Fiscal Year 2019 Results and Operational Highlights
SAN DIEGO, Feb. 7, 2019 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its second quarter ended December 31, 2018.
"MEI remains in a strong position to continue to build on the clinical data presented at ASCO 2018 and at ASH 2018 across our pipeline of four clinical-stage oncology candidates - including two candidates in clinical studies that may support future submissions for potential marketing approval by FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In particular, ME-401 continues to attract increasing notice from physicians for its emerging clinical profile, and there's been a heightened scientific focus on PI3K delta as a target with the potential to mechanistically match BTK inhibition in importance for targeting B-cell malignancies."
Upcoming Milestones and Recent Program Highlights
Upcoming Milestones
-- Dosing of the first patient in the global Phase 2 study to support
accelerated approval of ME-401 in relapsed or refractory follicular
lymphoma in the first calendar quarter of 2019.
-- Updates and presentations of clinical data from the ME-401 clinical
development program, including at select 2019 medical/oncology meetings.
-- Initial clinical results from the ongoing Phase 1 study of voruciclib,
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, by end of 2019.
-- Results from the investigator-initiated study of ME-344 in combination
with bevacizumab (marketed as Avastin®) in patients with breast cancer
at a medical/oncology meeting mid-year.
-- Pracinostat results from the Phase 2 clinical trial evaluating patients
with myelodysplastic syndrome, including response and 1-year survival,
expected to be available by the end of 2019.
Clinical Development Highlights
-- In December 2018, the Company opened the first clinical trial sites in
its Phase 2 study that will evaluate both a continuous (CS) and
intermittent (IS) dosing schedule of ME-401 in patients with third-line
follicular lymphoma. The Phase 2 study is intended to support MEI's
accelerated approval registration strategy, if successful.
-- In December 2018, at the 2018 American Society of Hematology Annual
Meeting, the Company presented data from three clinical programs:
-- Interim results presented from the ongoing Phase 1b study evaluating
ME-401, a selective phosphatidylinositol 3-kinase ("PI3K") delta
inhibitor, support the complementary potential of intermittent and
continuous dosing schedules of ME-401 to optimize the clinical
risk-benefit ratio in patients with relapsed/refractory follicular
lymphoma. The data demonstrate that ME-401, as both a single agent
and in combination with rituximab, continues to be associated with
overall high objective response rates. In addition, low rates of
Grade 3 immune-related adverse events (irAEs) were observed in
patients on the intermittent dosing schedule while maintaining a
high level of clinical response.
-- Interim results presented from the ongoing Phase 2 study evaluating
pracinostat, a histone deacetylase inhibitor, in combination with
azacitidine for the treatment of patients with IPSS-R high/very
high-risk of Myelodysplastic Syndrome ("MDS") demonstrate a 9%
discontinuation rate due to adverse events, a substantially lower
rate than observed in an earlier study. Additionally, the data
presented demonstrated an encouraging 36% complete response rate
among patients receiving at least 6 cycles of treatment.
-- Preclinical data presented demonstrate that voruciclib, MEI's orally
available CDK9 inhibitor, synergistically induced apoptosis at
clinically relevant concentrations when combined with venetoclax
(marketed as Venclexta®) in human derived acute myeloid leukemia
("AML") cells lines and patient samples. Voruciclib is currently
being evaluated in a Phase 1b dose ranging study in patients with
B-cell malignancies and AML.
-- In October 2018, MEI entered into a clinical collaboration to evaluate
the safety and efficacy of MEI's ME-401, an investigational PI3K delta
inhibitor, in combination with BeiGene's zanubrutinib, an
investigational Bruton's tyrosine kinase ("BTK") inhibitor, for the
treatment of patients with B-cell malignancies.
Corporate Highlights
-- In November 2018, MEI entered into a license, development and
commercialization agreement granting Kyowa Hakko Kirin ("KHK") exclusive
rights to develop and commercialize ME-401 in Japan. Under the terms of
the agreement, MEI received a $10.0 million upfront payment and is
eligible to receive up to $87.5M in additional development and
commercialization milestones, and royalties on sales.
Financial Highlights
-- As of December 31, 2018, MEI had $93.4 million in cash, cash equivalents
and short-term investments, with no outstanding debt.
-- For the three months ending December 31, 2018, cash expenditures for
operating activities were $7.2 million, compared to $4.7 million for
2017. For the six months ending December 31, 2018, cash expenditures for
operating activities were $20.0 million, compared to $11.3 million for
2017. The increase in cash used for the six months ended December 31,
2018 primarily relates to changes in working capital 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 December 31, 2018, compared to $3.4 million for the same period in
2017. Research and development expenses primarily reflect increased
costs associated with the development of ME-401.
-- General and administrative expenses were $3.8 million for the quarter
ended December 31, 2018, compared to $2.4 million for the same period in
2017. The increase primarily relates to increased salary and share-based
compensation associated with increased headcount, and increased
professional services expenses.
-- The Company recognized revenues of $2.0 million for the quarter ended
December 31, 2018, compared to $0.4 million for the same period in 2017.
The increase is related to new license revenues from our agreement with
KHK, and to higher levels of research and development activities
performed pursuant to the Helsinn license agreement.
-- Net income for the quarter ended December 31, 2018, was $12.0 million,
or $0.17 per share compared to a net loss of $6.1 million, or $0.16 per
share for the same period in 2017. The Company had 71,131,486 shares of
common stock outstanding as of December 31, 2018, compared with
37,052,361 shares as of December 31, 2017.
-- 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 December 31, 2018,
was $11.4 million.
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 (AML) 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 chronic lymphocytic leukemia (CLL) or FL, and voruciclib, an oral, selective cyclin-dependent kinase (CDK) inhibitor shown to suppress myeloid leukemia cell differentiation protein (MCL1), a known mechanism of resistance to B-cell lymphoma (BCL2) inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab for the treatment of 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.
CONDENSED BALANCE SHEETS
(In thousands, except per share amounts)
December 31, June 30,
2018 2018
ASSETS
Current assets:
Cash and cash equivalents $8,748 $13,309
Short term investments 84,667 89,434
Total cash, cash equivalents and short-term investments 93,415 102,743
Prepaid expenses and other current assets 2,418 1,586
Total current assets 95,833 104,329
Intangible assets, net 279 296
Property and equipment, net 193 32
Total assets $96,305 $104,657
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,158 $3,643
Accrued liabilities 4,766 3,454
Deferred revenue 3,980 788
Total current liabilities 10,904 7,885
Deferred revenue, long-term 5,161 -
Warrant liability 26,770 46,313
Total liabilities 42,835 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; 71,131 and 70,406 shares issued and outstanding
at December 31, 2018 and June 30, 2018, respectively -
Additional paid-in-capital 270,387 264,858
Accumulated deficit (216,917) (214,399)
Total stockholders' equity 53,470 50,459
Total liabilities and stockholders' equity $96,305 $104,657
===
MEI PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Three Months Ended Six Months Ended
December 31, December 31,
---
2018 2017 2018 2017
---
Revenues $2,048 $358 $2,536 $641
Operating expenses:
Cost of revenue 1,009 728 1,998 1,346
Research and development 9,066 3,444 15,197 9,508
General and
administrative 3,821 2,358 7,222 4,846
Total operating expenses 13,896 6,530 24,417 15,700
---
Loss from operations (11,848) (6,172) (21,881) (15,059)
Other income (expense):
Change in fair value of
warrant liability 23,437 18,475 -
Interest and dividend
income 436 93 890 193
Income tax expense (1) (1)
Net income (loss) $12,025 $(6,079) $(2,517) $(14,867)
Net income (loss):
Basic $12,025 $(6,079) $(2,517) $(14,867)
Diluted $(11,412) $(6,079) $(25,954) $(14,867)
===
Net income (loss) per share:
Basic $0.17 $(0.16) $(0.04) $(0.40)
Diluted $(0.15) $(0.16) $(0.36) $(0.40)
Shares used in computing net income (loss) per share:
Basic 71,124 37,414 71,005 37,390
===
Diluted 73,951 37,414 72,418 37,390
===
MEI PHARMA, INC.
Reconciliation of GAAP Net Loss to Adjusted Net Income (Loss)
(In thousands)
Three Months Ended Six Months Ended
December 31, December 31,
2018 2017 2018 2017
Net income (loss) $12,025 $(6,079) $(2,517) $(14,867)
Add: Change in
fair value of
warrant liability (23,437) (18,475)
Adjusted net loss $(11,412) $(6,079) $(20,992) $(14,867)
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SOURCE MEI Pharma, Inc.
