SAN DIEGO, Sept. 9, 2020 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its fiscal year ended June 30, 2020.
"This past year was marked by progress on multiple fronts, particularly for zandelisib, formerly called ME-401, which is our PI3K delta inhibitor in the Phase 2 TIDAL study intended to support an accelerated approval marketing application with FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The progress on zandelisib this past year includes entering a global license, development and commercialization agreement with Kyowa Kirin Company, maturing Phase 1b study data that continues to support best-in-class potential, as well as obtaining Fast Track designation from FDA."
Dr. Gold continued: "With about $183 million in cash at the start of our fiscal year, we believe we have an operational runway at least through 2023 and are well positioned to advance our ongoing clinical programs. In particular, we look forward to completing TIDAL enrollment as we initiate additional clinical studies to fully explore zandelisib's potential to benefit patients with B-cell malignancies while we continue our staged build-out of a commercial infrastructure to optimally capture value from the program."
Fiscal Year 2020 Zandelisib (ME-401) and Corporate Highlights
Zandelisib (formerly called ME-401), an oral, once-daily, investigational drug-candidate selective for phosphatidylinositol 3-kinase delta (PI3K?), for B-Cell Malignancies
Corporate Highlights
Fiscal Year 2020 Financial Results
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast today, September 9, 2020, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 49919899. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates contains four clinical-stage assets, including zandelisib, currently in an ongoing Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of MEI Pharma's 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.
Forward-Looking Statements
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; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; 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. | |||
BALANCE SHEETS | |||
(In thousands, except per share amounts) | |||
June 30, | |||
2020 | 2019 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 12,331 | $ 9,590 | |
Short term investments | 170,299 | 64,899 | |
Total cash, cash equivalents and short-term investments | 182,630 | 74,489 | |
Receivable for foreign tax withholding | 20,420 | - | |
Common stock proceeds receivable | - | 5,274 | |
Prepaid expenses and other current assets | 5,594 | 2,435 | |
Total current assets | 208,644 | 82,198 | |
Intangible assets, net | - | 261 | |
Property and equipment, net | 1,084 | 204 | |
Total assets | $ 209,728 | $ 82,663 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 2,437 | $ 4,787 | |
Accrued liabilities | 6,090 | 4,559 | |
Deferred revenue | 14,777 | 4,955 | |
Total current liabilities | 23,304 | 14,301 | |
Deferred revenue, long-term | 67,723 | 2,819 | |
Warrant liability | 40,483 | 17,613 | |
Total liabilities | 131,510 | 34,733 | |
Stockholders' equity: | |||
Preferred stock, $0.01 par value; 100 shares authorized; | |||
none outstanding | - | - | |
Common stock, $0.00000002 par value; 226,000 shares | |||
authorized; 111,514 and 73,545 shares issued and outstanding | |||
at June 30, 2020 and 2019, respectively | - | - | |
Additional paid-in-capital | 355,452 | 279,148 | |
Accumulated deficit | (277,234) | (231,218) | |
Total stockholders' equity | 78,218 | 47,930 | |
Total liabilities and stockholders' equity | $ 209,728 | $ 82,663 |
MEI PHARMA, INC. | ||||||
STATEMENTS OF OPERATIONS | ||||||
(In thousands, except per share amounts) | ||||||
Years Ended June 30, | ||||||
2020 | 2019 | 2018 | ||||
Revenue | $ 28,913 | $ 4,915 | $ 1,622 | |||
Operating expenses: | ||||||
Cost of revenue | 2,671 | 4,263 | 3,383 | |||
Research and development | 34,065 | 32,300 | 17,038 | |||
General and administrative | 16,717 | 14,597 | 9,787 | |||
Total operating expenses | 53,453 | 51,160 | 30,208 | |||
Loss from operations | (24,540) | (46,245) | (28,586) | |||
Other income (expense): | ||||||
Change in fair value of warrant liability | (22,870) | 27,632 | (9,705) | |||
Financing costs associated with warrants | - | - | (2,367) | |||
Interest and dividend income | 1,395 | 1,795 | 591 | |||
Income tax expense | (1) | (1) | (1) | |||
Net loss | $ (46,016) | $ (16,819) | $ (40,068) | |||
Net loss: | ||||||
Basic | $ (46,016) | $ (16,819) | $ (40,068) | |||
Diluted | $ (46,016) | $ (54,613) | $ (40,068) | |||
Net loss per share: | ||||||
Basic | $ (0.51) | $ (0.24) | $ (0.97) | |||
Diluted | $ (0.51) | $ (0.75) | $ (0.97) | |||
Shares used in computing net loss per share: | ||||||
Basic | 91,080 | 71,139 | 41,431 | |||
Diluted | 91,080 | 72,385 | 41,431 |
MEI PHARMA, INC. | ||||||
Reconciliation of GAAP Net Loss to Adjusted Net Loss | ||||||
(In thousands) | ||||||
Years Ended June 30, | ||||||
2020 | 2019 | 2018 | ||||
Net loss: | $ (46,016) | $ (16,819) | $ (40,068) | |||
Add: Change in fair value of warrant liability | 22,870 | (27,632) | 9,705 | |||
Adjusted net loss: | $ (23,146) | $ (44,451) | $ (30,363) | |||
Receivable for foreign tax withholding |
SOURCE MEI Pharma, Inc.
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