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Share Name | Share Symbol | Market | Type |
---|---|---|---|
MEI Pharma Inc | NASDAQ:MEIP | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.14 | 4.58% | 3.20 | 3.03 | 3.33 | 3.30 | 3.06 | 3.06 | 15,184 | 22:12:07 |
SAN DIEGO, May 9, 2019 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its third quarter ended March 31, 2019.
"As progress continues across our pipeline of four clinical-stage oncology candidates, including two in clinical studies that may support future submissions for FDA marketing approval, we are particularly excited with the expanding data set from the ME-401 intermittent dosing schedule as it continues to mature and we look forward to presenting the data at upcoming medical meetings, including next month at ASCO," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Our immediate focus for MEI-401 is twofold: executing the ME-401 follicular lymphoma global Phase 2 study, data from which we intend to submit as an accelerated approval marketing application with the FDA, and the expansion of our investigation of ME-401 in combination with Rituxan® or zanubrutinib, a BTK inhibitor being investigated pursuant to our BeiGene collaboration, to earlier stages of follicular lymphoma as well as other B-cell malignancies."
Upcoming Program Milestones
Financial Highlights
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. 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) | |||
March 31, | June 30, | ||
2019 | 2018 | ||
(unaudited) | |||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 7,426 | $ 13,309 | |
Short term investments | 74,864 | 89,434 | |
Total cash, cash equivalents and short-term investments | 82,290 | 102,743 | |
Prepaid expenses and other current assets | 3,153 | 1,586 | |
Total current assets | 85,443 | 104,329 | |
Intangible assets, net | 270 | 296 | |
Property and equipment, net | 213 | 32 | |
Total assets | $ 85,926 | $ 104,657 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 1,969 | $ 3,643 | |
Accrued liabilities | 5,685 | 3,454 | |
Deferred revenue | 4,197 | 788 | |
Total current liabilities | 11,851 | 7,885 | |
Deferred revenue, long-term | 4,222 | - | |
Warrant liability | 31,971 | 46,313 | |
Total liabilities | 48,044 | 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; 71,281 and 70,406 shares issued and outstanding | |||
at March 31, 2019 and June 30, 2018, respectively | - | - | |
Additional paid-in-capital | 272,153 | 264,858 | |
Accumulated deficit | (234,271) | (214,399) | |
Total stockholders' equity | 37,882 | 50,459 | |
Total liabilities and stockholders' equity | $ 85,926 | $ 104,657 |
MEI PHARMA, INC. | |||||||
CONDENSED STATEMENTS OF OPERATIONS | |||||||
(In thousands, except per share amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended | Nine Months Ended | ||||||
2019 | 2018 | 2019 | 2018 | ||||
Revenues | $ 1,249 | $ 433 | $ 3,785 | $ 1,074 | |||
Operating expenses: | |||||||
Cost of revenue | 1,163 | 930 | 3,161 | 2,276 | |||
Research and development | 9,071 | 3,071 | 24,268 | 12,579 | |||
General and administrative | 3,631 | 2,486 | 10,853 | 7,332 | |||
Total operating expenses | 13,865 | 6,487 | 38,282 | 22,187 | |||
Loss from operations | (12,616) | (6,054) | (34,497) | (21,113) | |||
Other income (expense): | |||||||
Change in fair value of warrant liability | (5,201) | - | 13,274 | - | |||
Interest and dividend income | 462 | 106 | 1,352 | 299 | |||
Income tax expense | - | - | (1) | (1) | |||
Net loss | $ (17,355) | $ (5,948) | $ (19,872) | $ (20,815) | |||
Net loss: | |||||||
Basic | $ (17,355) | $ (5,948) | $ (19,872) | $ (20,815) | |||
Diluted | $ (17,355) | $ (5,948) | $ (43,309) | $ (20,815) | |||
Net loss per share: | |||||||
Basic | $ (0.24) | $ (0.16) | $ (0.28) | $ (0.56) | |||
Diluted | $ (0.24) | $ (0.16) | $ (0.60) | $ (0.56) | |||
Shares used in computing net loss per share: | |||||||
Basic | 71,200 | 37,449 | 71,069 | 37,369 | |||
Diluted | 71,200 | 37,449 | 72,011 | 37,369 |
MEI PHARMA, INC. | ||||||||
Reconciliation of GAAP Net Loss to Adjusted Net Loss | ||||||||
(In thousands) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | Nine Months Ended | |||||||
2019 | 2018 | 2019 | 2018 | |||||
Net loss | $ (17,355) | $ (5,948) | $ (19,872) | $ (20,815) | ||||
Add: Change in fair value of warrant liability | 5,201 | - | (13,274) | - | ||||
Adjusted net loss | $ (12,154) | $ (5,948) | $ (33,146) | $ (20,815) |
View original content to download multimedia:http://www.prnewswire.com/news-releases/mei-pharma-reports-third-quarter-fiscal-year-2019-results-and-operational-highlights-300846857.html
SOURCE MEI Pharma, Inc.
Copyright 2019 PR Newswire
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