Full Press Release Details
MEI Pharma Reports Third Quarter Fiscal Year 2023 Results and Operational Highlights
MEI Begins Fourth Fiscal Quarter with $112.0 Million in Cash
SAN DIEGO May 11, 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 March 31, 2023, and highlighted recent corporate events.
steady progress in advancing both of our clinical-stage pipeline programs: voruciclib for hematologic malignancies and ME-344 for relapsed colorectal cancer, both expected to report data by around the end of
the calendar year, said Dan Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. With the clinical-data expected from these two programs around year-end, funds to support operations
for at least two years based upon our current development plans, and the opportunity to further strengthen our value proposition via the pending merger with Infinity Pharmaceuticals, we are well positioned to deliver progress in our mission to
deliver improved benefits to patients with cancer, as well as value to our shareholders.
Third Quarter Fiscal Year 2023 and Recent Developments
In light of Kyowa Kirin s decision to discontinue development of zandelisib in
Japan, the parties intend to terminate the global license, development and commercialization agreement executed in April 2020.
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
Third 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 our 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; the sufficiency of our cash, cash equivalents and short-term investments to fund our operations and our ability to
consummate the potential merger with Infinity Pharmaceuticals. 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; potential economic downturn, the impact of the ongoing 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
| March 31, 2023 | June 30, 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,812 | $ | 15,740 | ||||
| Short-term investments | 103,224 | 137,512 | ||||||
| Total cash, cash equivalents and short-term investments | 112,036 | 153,252 | ||||||
| Unbilled receivables | 4,580 | 10,044 | ||||||
| Prepaid expenses and other current assets | 3,867 | 3,830 | ||||||
| Total current assets | 120,483 | 167,126 | ||||||
| Operating lease right-of-use asset | 12,338 | 9,054 | ||||||
| Property and equipment, net | 1,366 | 1,660 | ||||||
| Total assets | $ | 134,187 | $ | 177,840 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,389 | $ | 7,918 | ||||
| Accrued liabilities | 16,264 | 10,820 | ||||||
| Deferred revenue | 1,583 | 4,834 | ||||||
| Operating lease liability | 1,385 | 871 | ||||||
| Total current liabilities | 23,621 | 24,443 | ||||||
| Deferred revenue, long-term | 64,545 | 90,610 | ||||||
| Operating lease liability, long-term | 11,667 | 8,771 | ||||||
| Warrant liability | 1,603 | |||||||
| Total liabilities | 99,833 | 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; 6,663 and 6,658 shares issued and outstanding at March 31, 2023 and June 30, 2022, respectively | ||||||||
| Additional paid-in capital | 430,322 | 426,572 | ||||||
| Accumulated deficit | (395,968 | ) | (374,159 | ) | ||||
| Total stockholders equity | 34,354 | 52,413 | ||||||
| Total liabilities and stockholders equity | $ | 134,187 | $ | 177,840 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | 5,894 | $ | 9,694 | $ | 47,359 | $ | 29,283 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 15,104 | 22,318 | 49,880 | 63,802 | ||||||||||||
| General and administrative | 7,181 | 8,934 | 23,163 | 24,769 | ||||||||||||
| Total operating expenses | 22,285 | 31,252 | 73,043 | 88,571 | ||||||||||||
| Loss from operations | (16,391 | ) | (21,558 | ) | (25,684 | ) | (59,288 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of warrant liability | 12,773 | 1,603 | 20,819 | |||||||||||||
| Interest and dividend income | 957 | 60 | 2,282 | 78 | ||||||||||||
| Other expense, net | (4 | ) | (10 | ) | ||||||||||||
| Net loss | $ | (15,438 | ) | $ | (8,725 | ) | $ | (21,809 | ) | $ | (38,391 | ) | ||||
| Net loss: | ||||||||||||||||
| Basic | $ | (15,438 | ) | $ | (8,725 | ) | $ | (21,809 | ) | $ | (38,391 | ) | ||||
| Diluted | $ | (15,438 | ) | $ | (8,725 | ) | $ | (21,809 | ) | $ | (46,437 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (2.32 | ) | $ | (1.31 | ) | $ | (3.27 | ) | $ | (6.31 | ) | ||||
| Diluted | $ | (2.32 | ) | $ | (1.31 | ) | $ | (3.27 | ) | $ | (7.58 | ) | ||||
| Shares used in computing net loss per share: | ||||||||||||||||
| Basic | 6,663 | 6,653 | 6,663 | 6,080 | ||||||||||||
| Diluted | 6,663 | 6,653 | 6,663 | 6,124 |
Reconciliation of GAAP Net Loss to Adjusted Net Loss
| Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net loss | $ | (15,438 | ) | $ | (8,725 | ) | $ | (21,809 | ) | $ | (38,391 | ) | ||||
| Add: Change in fair value of warrant liability | (12,773 | ) | (1,603 | ) | (20,819 | ) | ||||||||||
| Adjusted net loss | $ | (15,438 | ) | $ | (21,498 | ) | $ | (23,412 | ) | $ | (59,210 | ) |