Full Press Release Details
| Contact: | ||||
| Pete De Spain | ||||
| Vice President, Investor Relations & | ||||
| Corporate Communications | ||||
| (858) 792-3729 | ||||
| pdespain@meipharma.com |
MEI PHARMA REPORTS FISCAL YEAR 2014 RESULTS
San Diego September 9, 2014 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for
cancer, today announced results for its fiscal year ended June 30, 2014.
I am very proud of all that we have accomplished over the past year,
highlighted by significant progress toward the clinical development of our lead drug candidate Pracinostat, said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. Now we look forward to reporting additional data
from our Phase II study in previously untreated elderly patients with acute myeloid leukemia (AML) later this year, building on the encouraging early responses we saw in the first nine patients, while we await the unblinding of our randomized Phase
II study in front line myelodysplastic syndrome (MDS) in the first quarter of calendar year 2015.
Fiscal Year 2014 and Recent Highlights
Fiscal Year 2014 Financial Highlights
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 lead drug candidate is Pracinostat, a potential best-in-class, oral HDAC inhibitor currently in development for MDS and acute
myeloid leukemia AML. Results from a pilot Phase II clinical study of Pracinostat in combination with azacitidine in patients with advanced MDS demonstrated an overall response rate of 90% (9 of 10). Preliminary data from an ongoing Phase II study
of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML showed responses in six of the first nine patients enrolled in the study (67%), including three patients who achieved a CR or CRi as their initial response. MEI Pharma is
also developing ME-344, a mitochondrial inhibitor that has shown preliminary evidence of single-agent activity in a first-in-human clinical study in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who
achieved stable disease or better. In September 2013, the Company further expanded its pipeline of drug candidates with the acquisition of PWT143, a highly selective PI3K delta inhibitor. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials 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.
| Years Ended June 30, | ||||||||
| 2014 | 2013 | |||||||
| (In thousands, except share data) | ||||||||
| Statement of Operations Data: | ||||||||
| Operating expenses: | ||||||||
| Research and development | $ | (19,331 | ) | $ | (6,084 | ) | ||
| General and administrative | (7,897 | ) | (5,138 | ) | ||||
| Total operating expenses | (27,228 | ) | (11,222 | ) | ||||
| Loss from operations | (27,228 | ) | (11,222 | ) | ||||
| Other income (expense), net | 80 | 36 | ||||||
| Net loss | $ | (27,148 | ) | $ | (11,186 | ) | ||
| Net loss per share, basic and diluted | $ | (1.35 | ) | $ | (1.10 | ) | ||
| Shares used to calculate net loss per share, basic and diluted | 20,061,387 | 10,160,835 | ||||||
| As of June 30, | ||||||||
| 2014 | 2013 | |||||||
| (In thousands) | ||||||||
| Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 48,793 | $ | 35,573 | ||||
| Total assets | 49,808 | 36,547 | ||||||
| Total liabilities | 4,616 | 1,675 | ||||||
| Accumulated deficit | (123,445 | ) | (96,297 | ) | ||||
| Total stockholders equity | 45,192 | 34,872 |