MEI Pharma Reports First Quarter Fiscal Year 2018 Results
Quarter highlighted by dosing of first patient in pivotal Phase 3 study of pracinostat and exclusive license agreement for voruciclib
SAN DIEGO, Nov. 8, 2017 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today reported results for its first quarter ended September 30, 2017.
"In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We are well positioned for a momentous year ahead, with a healthy cash balance and a series of key milestones in each of our clinical programs."
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 Ib 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) September 30, June 30, 2017 2017 ---- ---- (unaudited) ASSETS Current assets: Cash and cash equivalents $6,958 $8,458 Short term investments 40,065 45,107 ------ ------ Total cash, cash equivalents and short-term investments 47,023 53,565 Prepaid expenses and other current assets 641 1,758 Total current assets 47,664 55,323 Intangible assets, net 322 331 Property and equipment, net 45 50 Total assets $48,031 $55,704 ======= ======= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $751 $585 Accrued liabilities 2,767 3,285 Deferred revenues 947 996 Total current liabilities 4,465 4,866 Commitments and contingencies Stockholders' equity: Preferred stock, $0.01 par value; 100 shares authorized; none outstanding - - Common stock, $0.00000002 par value; 113,000 shares authorized; 36,950 and 36,772 shares issued and outstanding at September 30, 2017 and June 30, 2017, respectively - - Additional paid-in-capital 226,685 225,169 Accumulated deficit (183,119) (174,331) Total stockholders' equity 43,566 50,838 ------ ------ Total liabilities and stockholders' equity $48,031 $55,704 ======= =======
MEI PHARMA, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended September 30, ------------------- 2017 2016 ---- ---- Revenues: Research and development revenue $283 $1,096 Total revenues 283 1,096 --- ----- Operating expenses: Cost of research and development revenue 618 1,094 Research and development 6,064 1,646 General and administrative 2,488 2,680 Total operating expenses 9,170 5,420 ----- ----- Loss from operations (8,887) (4,324) Other income (expense): Interest and dividend income 100 55 Income tax expense (1) (1) Net loss $(8,788) $(4,270) ======= ======= Net loss per share, basic $(0.24) $(0.12) ====== ====== Net loss per share, diluted $(0.24) $(0.12) ====== ====== Shares used in computing net loss per share: Basic 37,245 35,747 ====== ====== Diluted 37,245 35,747 ====== ======
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SOURCE MEI Pharma, Inc.
Company Codes: NASDAQ-SMALL:MEIP