Full Press Release Details
MEI Pharma Reports Fiscal Year 2015 Results
Company Begins New Fiscal Year with $63.8 Million and Three Drug Candidates in the Clinic
San Diego September 2, 2015 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, 2015.
Despite a challenging end to the fiscal year, I am quite pleased with
how the Company is positioned entering fiscal year 2016, said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. While we were obviously disappointed with the top-line data from our randomized study of
Pracinostat in front-line myelodysplastic syndrome (MDS), our subsequent findings from the study, combined with the continued maturation of data from our ongoing study in acute myeloid leukemia (AML) and discussions with our clinical advisors,
suggest that Pracinostat, in combination with hypomethylating agents (HMA) or other drug candidates, may still play a meaningful role in the treatment of patients with advanced hematologic diseases.
Meanwhile, continued Dr. Gold, recent data surrounding the two other drug candidates currently in our pipeline, ME-344 and PWT143, only
increase our enthusiasm regarding the potential of these assets and help to inform the next clinical studies anticipated to commence during the first half of calendar year 2016. In the meantime, abstracts relating to all three of our drug candidates
have been submitted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in December 2015. We are poised for an exciting year ahead and I look forward to providing updates on our progress.
Fiscal Year 2015 Company Highlights
Fiscal Year 2015 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 portfolio of drug candidates includes Pracinostat, a potential best-in-class, oral HDAC inhibitor currently in development for the
treatment of advanced hematologic diseases, such as AML and MDS. The Company is also developing ME-344, a novel mitochondrial inhibitor that showed evidence of activity in a Phase I dose-escalation study in refractory solid tumors. In addition, the
Company initiated a first-in-human study of PWT143, a highly selective PI3K delta inhibitor, in June 2015. 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
| Years Ended June 30, | ||||||||
| 2015 | 2014 | |||||||
| (In thousands, except share and per share data) | ||||||||
| Statement of Operations Data: | ||||||||
| Operating expenses | ||||||||
| Research and development | $ | (23,823 | ) | $ | (19,331 | ) | ||
| General and administrative | (8,948 | ) | (7,897 | ) | ||||
| Total operating expenses | (32,771 | ) | (27,228 | ) | ||||
| Loss from operations | (32,771 | ) | (27,228 | ) | ||||
| Other income (expense), net | 77 | 80 | ||||||
| Net loss | $ | (32,694 | ) | $ | (27,148 | ) | ||
| Net loss per share, basic and diluted | $ | (1.16 | ) | $ | (1.35 | ) | ||
| Shares used to calculate net loss per share, basic and diluted | 28,204,356 | 20,061,387 | ||||||
| As of June 30, | ||||||||
| 2015 | 2014 | |||||||
| (In thousands) | ||||||||
| Balance Sheet Data | ||||||||
| Cash, cash equivalents and short-term investments | $ | 63,779 | $ | 48,793 | ||||
| Total assets | 64,750 | 49,808 | ||||||
| Total liabilities | 4,959 | 4,616 | ||||||
| Accumulated deficit | (156,139 | ) | (123,445 | ) | ||||
| Total stockholders equity | 59,791 | 45,192 |