Full Press Release Details
MEI Pharma Reports Second Quarter Fiscal Year 2023 Results and Operational Highlights
MEI Begins Third Fiscal Quarter with $124 Million in Cash
SAN DIEGO February 9, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on
advancing new therapies for cancer, today reported results for the quarter ended December 31, 2022, and highlighted recent corporate events.
MEI anticipates reporting key clinical data readouts on two clinical-stage oncology candidates, voruciclib and
ME-344, around the end of the calendar year for each program, said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. These clinical data will inform future plans in two
promising areas of oncology drug development: CDK9 inhibition and mitochondrial inhibition, respectively. With approximately $124 million at the end of the quarter, we remain well capitalized to pursue these objectives and estimate that we
will be able to fund operations for two years based upon our current development plans.
Second Quarter Fiscal Year 2023 Recent Developments
Expected Drug Candidate Pipeline Developments
Voruciclib Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
ME-344 Tumor selective mitochondrial inhibitor
Zandelisib Oral PI3K delta inhibitor for the treatment of indolent B-cell
Non-Hodgkin s Lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenstr m s macroglobulinemia in Japan
Second Quarter Fiscal Year 2023 Financial Results
MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma s
portfolio of drug candidates includes clinical stage candidates with differentiated or novel mechanisms of action intended to address unmet medical needs and deliver improved benefit to patients, either as standalone treatments or in combination
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 including, without limitation, statements regarding: the potential, safety, efficacy, and regulatory and clinical
progress of zandelisib and our other product candidates, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing
thereof, our business strategy and plans; and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations. 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; the
availability or appropriateness of utilizing the FDA s accelerated approval pathway for
our product candidates; final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from
ongoing studies and trials; 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; adverse effects on the
Company s business as a result of the restatement of our previously issued financial statements; uncertainty regarding the impact of rising inflation and the increase in interest rates as a result; 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.
Non-GAAP Financial Measures
To supplement our financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States
( GAAP ), we provide investors with a non-GAAP financial measure, adjusted net income (loss), which we believe is helpful to our investors. We use adjusted net income (loss) for financial and
operational decision-making purposes and as a means to evaluate period-to-period comparisons. We believe this non-GAAP financial
measure provides useful information about our operating results, enhances the overall understanding of past financial performance and future prospects and allows for greater transparency with respect to metrics used by our management in its
financial and operational decision-making.
The presentation of adjusted net income (loss) is not meant to be considered in isolation or as a
substitute for net loss, the directly comparable financial measure prepared in accordance with GAAP. While we believe adjusted net income (loss) is an important tool for financial and operational decision-making and for evaluating our own operating
results over different periods of time, we urge investors to review the reconciliation of this financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate our business.
We define adjusted net income (loss) as net income (loss), adjusted to exclude non-cash expenses related
to changes in the fair value of the warrants. We have presented adjusted net income (loss) because we believe excluding the non-cash expenses related to changes in the fair value of warrants can produce a
useful measure for period-to-period comparisons of our business.
Canale Communications for MEI
CONDENSED BALANCE SHEETS
thousands, except per share amounts)
| December 31, 2022 | June 30, 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,917 | $ | 15,740 | ||||
| Short-term investments | 113,256 | 137,512 | ||||||
| Total cash, cash equivalents and short-term investments | 124,173 | 153,252 | ||||||
| Unbilled receivables | 5,704 | 10,044 | ||||||
| Prepaid expenses and other current assets | 3,568 | 3,830 | ||||||
| Total current assets | 133,445 | 167,126 | ||||||
| Operating lease right-of-use asset | 12,698 | 9,054 | ||||||
| Property and equipment, net | 1,456 | 1,660 | ||||||
| Total assets | $ | 147,599 | $ | 177,840 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,067 | $ | 7,918 | ||||
| Accrued liabilities | 14,346 | 10,820 | ||||||
| Deferred revenue | 2,897 | 4,834 | ||||||
| Operating lease liability | 1,343 | 871 | ||||||
| Total current liabilities | 22,653 | 24,443 | ||||||
| Deferred revenue, long-term | 64,545 | 90,610 | ||||||
| Operating lease liability, long-term | 12,027 | 8,771 | ||||||
| Warrant liability | 1,603 | |||||||
| Total liabilities | 99,225 | 125,427 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.01 par value; 100 shares authorized; none outstanding | ||||||||
| Common stock, $0.00000002 par value; 226,000 shares authorized; 133,261 and 133,152 shares issued and outstanding at December 31, 2022 and June 30, 2022, respectively | ||||||||
| Additional paid-in capital | 428,904 | 426,572 | ||||||
| Accumulated deficit | (380,530 | ) | (374,159 | ) | ||||
| Total stockholders equity | 48,374 | 52,413 | ||||||
| Total liabilities and stockholders equity | $ | 147,599 | $ | 177,840 |
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| Three Months Ended December 31, | Six Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 32,735 | $ | 11,832 | $ | 41,465 | $ | 19,589 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 15,313 | 21,531 | 34,776 | 41,484 | ||||||||||||
| General and administrative | 8,496 | 7,926 | 15,982 | 15,835 | ||||||||||||
| Total operating expenses | 23,809 | 29,457 | 50,758 | 57,319 | ||||||||||||
| Income (loss) from operations | 8,926 | (17,625 | ) | (9,293 | ) | (37,730 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of warrant liability | 486 | 5,458 | 1,603 | 8,046 | ||||||||||||
| Interest and dividend income | 845 | 11 | 1,325 | 18 | ||||||||||||
| Other expense, net | (4 | ) | (6 | ) | ||||||||||||
| Net income (loss) | $ | 10,253 | $ | (12,156 | ) | $ | (6,371 | ) | $ | (29,666 | ) | |||||
| Net income (loss): | ||||||||||||||||
| Basic | $ | 10,253 | $ | (12,156 | ) | $ | (6,371 | ) | $ | (29,666 | ) | |||||
| Diluted | $ | 10,253 | $ | (17,614 | ) | $ | (6,371 | ) | $ | (37,712 | ) | |||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | $ | 0.08 | $ | (0.10 | ) | $ | (0.05 | ) | $ | (0.26 | ) | |||||
| Diluted | $ | 0.08 | $ | (0.14 | ) | $ | (0.05 | ) | $ | (0.32 | ) | |||||
| Shares used in computing net income (loss) per share: | ||||||||||||||||
| Basic | 133,261 | 126,725 | 133,258 | 115,982 | ||||||||||||
| Diluted | 133,261 | 128,160 | 133,258 | 118,657 |
Reconciliation of GAAP Net Loss to Adjusted Net Loss
| Three Months Ended December 31, | Six Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net income (loss) | $ | 10,253 | $ | (12,156 | ) | $ | (6,371 | ) | $ | (29,666 | ) | |||||
| Add: Change in fair value of warrant liability | (486 | ) | (5,458 | ) | (1,603 | ) | (8,046 | ) | ||||||||
| Adjusted net income (loss) | $ | 9,767 | $ | (17,614 | ) | $ | (7,974 | ) | $ | (37,712 | ) |