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Pipeline advancement continues, including clearance of voruciclib IND by FDA and pracinostat Orphan Drug Designation by EMA
Data readouts in three programs expected in the second quarter of 2018
SAN DIEGO, Feb. 8, 2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ:MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today reported results for its second quarter ended December 31, 2017.
"We continue to build on the progress we reported last quarter with important advances in the clinical development programs across our pipeline," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Already in 2018, the Food and Drug Administration cleared the Investigational New Drug Application for voruciclib, and pracinostat was awarded Orphan Drug Designation from the European Medicines Agency for the treatment of acute myeloid leukemia."
Dr. Gold added: "In the coming months we look forward to separate data readouts in three programs: pracinostat's stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS); ME-401's single agent safety and efficacy in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL); and ME-344's interim results from a proof-of-concept study in combination with bevacizumab (marketed as Avastin®) in human epidermal growth factor receptor 2 (HER2) negative breast cancer. In addition, we look forward to the initiation of our Phase 1 single-agent study with voruciclib in relapsed/refractory B lymphocyte malignancies."
Recent Program Highlights
Pracinostat
In January 2018, the European Medicines Agency granted Orphan Drug Designation to pracinostat, currently in a Phase 3 study in combination with azacitidine for the treatment of acute myeloid leukemia (AML) in adult patients unfit to induction chemotherapy.
MEI-401
In November 2017, the safety review committee found no dose limiting toxicities in the 180mg cohort again with a response rate in excess of 50%. We determined that no further dose escalation was required and we amended the Phase 1b study protocol to open a 45 mg lower dose cohort as well as an additional arm to evaluate the safety and efficacy of ME-401 in combination with rituximab (marketed as Rituxan®) in patients with various B cell malignancies.
Voruciclib
In January 2018, the U.S. Food and Drug Administration cleared the company's Investigational New Drug Application (IND) for voruciclib. Under this IND, MEI Pharma plans to initiate a Phase 1 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of voruciclib in patients with B-cell malignancies.
In December 2017, a preclinical study of voruciclib was published in the journal Nature Scientific Reports. Researchers found that the combination of voruciclib plus the BCL-2 inhibitor venetoclax (marketed as Venclexta™) was capable of inhibiting two master regulators of cell survival, MCL-1 and BCL-2, and achieved synergistic antitumor efficacy in an aggressive subset of Diffuse Large B-cell Lymphoma (DLBCL).
Upcoming Milestones
Pracinostat
Expecting results from stage 1 of a Phase 2 dose-optimization study in MDS in the second quarter of 2018.
ME-401
Expecting results from a Phase 1b study in relapsed/refractory CLL and FL to be presented at a scientific meeting in the second quarter of 2018.
Voruciclib
Expecting to initiate a Phase 1 single-agent study in relapsed/refractory B cell malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta™) in the second quarter of 2018.
ME-344
Expecting interim results from the Phase 1 study in HER2 negative breast cancer in combination with bevacizumab (marketed as Avastin®) in the second quarter of 2018.
Financial Highlights
As of December 31, 2017, MEI Pharma had $42.4 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019.
Cash used in operating activities was $11.3 million for the six months ended December 31, 2017, compared to cash provided by operating activities of $5.0 million for the six months ended December 31, 2016. Included in cash expenditures for the six months ended December 31, 2017 was $1.9 million cash paid for the acquisition of voruciclib. Included in the cash provided by operating activities in the six months ended December 31, 2016 was the $15.0 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $4.2 million for the three months ended December 31, 2017, compared to $3.4 million for the three months ended December 31, 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
General and administrative expenses were $2.4 million for the three months ended December 31, 2017, compared to $2.0 million for the three months ended December 31, 2016. The increase was primarily due to professional service costs incurred in the three months ended December 31, 2017 related to the Presage license agreement.
Revenues were $0.4 million for the three months ended December 31, 2017, compared to $17.2 million in the three months ended December 31, 2016. The decrease was related to activities performed pursuant to the Helsinn license agreement.
Net loss was $6.1 million, or $0.16 per share, for the three months ended December 31, 2017, compared to net income of $11.9 million, or $0.32 per share for the three months ended December 31, 2016.
About MEI Pharma
MEI Pharma, Inc. (NASDAQ:MEIP) is a San Diego-based oncology company focused on the clinical development of novel 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 CLL or follicular lymphoma, and voruciclib, an oral, selective CDK inhibitor shown to suppress MCL1, a known mechanism of resistance to BCL2 inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-sponsored 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,
2017
2017
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 7,339
$ 8,458
Short term investments
35,102
45,107
Total cash, cash equivalents and short-term investments
42,441
53,565
Prepaid expenses and other current assets
772
1,758
Total current assets
43,213
55,323
Intangible assets, net
314
331
Property and equipment, net
40
50
Total assets
$ 43,567
$ 55,704
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$ 1,089
$ 585
Accrued liabilities
3,230
3,285
Deferred revenues
890
996
Total current liabilities
5,209
4,866
Commitments and contingencies (Note 5)
Stockholders' equity:
Preferred stock, $0.01 par value; 100 shares authorized; none outstanding
-
-
Common stock, $0.00000002 par value; 113,000 shares authorized; 37,052 and 36,772 shares issued and outstanding at December 31, 2017 and June 30, 2017, respectively
-
-
Additional paid-in-capital
227,556
225,169
Accumulated deficit
(189,198)
(174,331)
Total stockholders' equity
38,358
50,838
Total liabilities and stockholders' equity
$ 43,567
$ 55,704
MEI PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended December 31,
Six Months Ended December 31,
2017
2016
2017
2016
Revenues:
License revenue
$ -
$ 17,101
$ -
$ 17,101
Research and development revenue
358
98
641
1,194
Total revenues
358
17,199
641
18,295
Operating expenses:
Cost of research and development revenue
728
1,771
1,346
2,865
Research and development
3,444
1,642
9,508
3,288
General and administrative
2,358
1,970
4,846
4,650
Total operating expenses
6,530
5,383
15,700
10,803
(Loss) income from operations
(6,172)
11,816
(15,059)
7,492
Other income (expense):
Interest and dividend income
93
69
193
124
Income tax expense
-
-
(1)
(1)
Net (loss) income
$ (6,079)
$ 11,885
$ (14,867)
$ 7,615
Net (loss) income per share, basic
$ (0.16)
$ 0.32
$ (0.40)
$ 0.21
Net (loss) income per share, diluted
$ (0.16)
$ 0.32
$ (0.40)
$ 0.21
Shares used in computing net (loss) income per share:
