Full Press Release Details
MEI Pharma Reports First Quarter Fiscal Year 2023 Results and Operational Highlights
MEI Begins Second Fiscal Quarter with $138 Million in Cash
SAN DIEGO November 14, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing
new therapies for cancer, today reported results for the quarter ended September 30, 2022, and highlighted recent corporate events.
through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3K inhibitors to treat indolent lymphomas, as well as the impact of these concerns and other
global factors on our Phase 3 COASTAL study, we also look forward to reporting advances across our clinical development pipeline. This includes reporting updated data from multiple zandelisib studies at the ASH annual meeting in December, and also
reporting advances in our other development programs, including initiation of a trial evaluating voruciclib s potential to synergize with venetoclax in patients with AML, and a trial evaluating the combination of ME-344 plus bevacizumab in patients with relapsed and refractory colorectal cancer, said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. We remain well capitalized with
$138 million to advance our pipeline and continue operations for approximately two years.
First Quarter Fiscal Year 2023 Recent
Developments and Financial Highlights
Candidate Pipeline Developments
Zandelisib Oral PI3K delta inhibitor for the treatment of various
Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
ME-344 Tumor selective mitochondrial inhibitor
First Quarter Fiscal Year
2023 Financial Results
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 multiple clinical-stage assets, including zandelisib, currently in ongoing clinical trials which may support marketing approvals with the U.S. Food and Drug Administration and other regulatory authorities globally.
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
Forward-Looking Statements
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; 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 consolidated 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 loss, which we believe is helpful to our investors. We use adjusted net 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 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 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 loss, adjusted to exclude non-cash expenses related to changes in the fair value of the
warrants. We have presented adjusted net 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
(In thousands, except per share amounts)
| September 30, 2022 | June 30, 2022 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,653 | $ | 15,740 | ||||
| Short-term investments | 123,714 | 137,512 | ||||||
| Total cash, cash equivalents and short-term investments | 138,367 | 153,252 | ||||||
| Unbilled receivables | 7,758 | 10,044 | ||||||
| Prepaid expenses and other current assets | 2,782 | 3,830 | ||||||
| Total current assets | 148,907 | 167,126 | ||||||
| Operating lease right-of-use asset | 13,052 | 9,054 | ||||||
| Property and equipment, net | 1,624 | 1,660 | ||||||
| Total assets | $ | 163,583 | $ | 177,840 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,418 | $ | 7,918 | ||||
| Accrued liabilities | 9,216 | 10,820 | ||||||
| Deferred revenue | 4,500 | 4,834 | ||||||
| Operating lease liabilities | 1,301 | 871 | ||||||
| Total current liabilities | 23,435 | 24,443 | ||||||
| Deferred revenue, long-term | 89,973 | 90,610 | ||||||
| Operating lease liabilties, long-term | 12,381 | 8,771 | ||||||
| Warrant liability | 486 | 1,603 | ||||||
| Total liabilities | 126,275 | 125,427 | ||||||
| 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 September 30, 2022 and June 30, 2022, respectively | ||||||||
| Additional paid-in-capital | 428,091 | 426,572 | ||||||
| Accumulated deficit | (390,783 | ) | (374,159 | ) | ||||
| Total stockholders equity | 37,308 | 52,413 | ||||||
| Total liabilities and stockholders equity | $ | 163,583 | $ | 177,840 |
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| Three Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Revenue | $ | 8,730 | $ | 7,757 | ||||
| Operating expenses: | ||||||||
| Research and development | 19,463 | 19,953 | ||||||
| General and administrative | 7,486 | 7,909 | ||||||
| Total operating expenses | 26,949 | 27,862 | ||||||
| Loss from operations | (18,219 | ) | (20,105 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liability | 1,117 | 2,587 | ||||||
| Interest and dividend income | 480 | 8 | ||||||
| Other expense, net | (2 | ) | ||||||
| Net loss | $ | (16,624 | ) | $ | (17,510 | ) | ||
| Net loss: | ||||||||
| Basic | $ | (16,624 | ) | $ | (17,510 | ) | ||
| Diluted | $ | (16,624 | ) | $ | (20,097 | ) | ||
| Net loss per share: | ||||||||
| Basic | $ | (0.12 | ) | $ | (0.16 | ) | ||
| Diluted | $ | (0.12 | ) | $ | (0.18 | ) | ||
| Shares used in computing net loss per share: | ||||||||
| Basic | 133,255 | 112,677 | ||||||
| Diluted | 133,255 | 113,917 |
Reconciliation of GAAP Net Loss to Adjusted Net Loss
| Three Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Net loss | $ | (16,624 | ) | $ | (17,510 | ) | ||
| Add: Change in fair value of warrant liability | (1,117 | ) | (2,587 | ) | ||||
| Adjusted net loss | $ | (17,741 | ) | $ | (20,097 | ) |