Full Press Release Details
MEI Pharma Reports Fiscal Year 2023 Results and Operational Highlights
Conference Call Today at 5:00 p.m. Eastern Time
SAN DIEGO September 26, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on
advancing new therapies for cancer, today reported results for its fiscal year ended June 30, 2023.
Over just the next few quarters we look
forward to data readouts from two ongoing clinical studies of voruciclib and ME-344, advancing our strategy of assessing drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs, said David M. Urso, president and chief executive officer of MEI Pharma. Focusing on the
execution of these two clinical studies voruciclib evaluated in combination with Venclexta in acute myeloid leukemia and ME-344 in combination
with Avastin in colorectal cancer we expect data readouts beginning with voruciclib early in calendar 2024 and in the first half of 2024 for
ME-344. Positive data from the studies would provide important support for the further development of these therapies to address significant unmet medical needs among patients with acute myeloid leukemia and
Fiscal Year 2023 and Recent Highlights
Expected Drug Candidate Pipeline Developments
Voruciclib Oral CDK9 inhibitor in Phase 1 Study
ME-344 Mitochondrial inhibitor in Phase 1b Study
Fiscal Year 2023 Financial Results
The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts
from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.
Conference Call & Webcast Information
Please join the conference call at least 10 minutes early to register. You can access the live webcast here or under the investor relations section of
MEI s website at: www.meipharma.com. A replay of the conference call will be archived for at least 30 days after the call.
MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company committed to developing novel and differentiated cancer
therapies. We build our pipeline by acquiring promising cancer agents and creating value in programs through development, strategic partnerships, out-licensing and commercialization, as appropriate. Our
approach to oncology drug development is to evaluate our drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and
address clear medical needs to provide improved patient benefit. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 ( CDK9 ) inhibitor, and ME-344, an intravenous
Forward-Looking Statements
Certain information contained 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. 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; uncertainty regarding the impact of rising inflation and the increase
in interest rates as a result; potential economic downturn; activist investors; 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. 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.
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 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 as net loss, adjusted to exclude noncash gains recognized for changes in the fair value of warrants. We have presented adjusted
net loss because we believe excluding noncash gains recognized for changes in the fair value of warrants can produce a useful measure for period-to-period comparisons of
Joele Frank, Wilkinson Brimmer Katcher
CONSOLIDATED BALANCE SHEETS
thousands, except per share amounts)
| June 30, | ||||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,906 | $ | 15,740 | ||||
| Short-term investments | 83,787 | 137,512 | ||||||
| Unbilled receivables | 85 | 10,044 | ||||||
| Prepaid expenses and other current assets | 6,750 | 3,830 | ||||||
| Total current assets | 107,528 | 167,126 | ||||||
| Operating lease right-of-use asset | 11,972 | 9,054 | ||||||
| Property and equipment, net | 1,309 | 1,660 | ||||||
| Total assets | $ | 120,809 | $ | 177,840 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,134 | $ | 7,918 | ||||
| Accrued liabilities | 12,461 | 10,820 | ||||||
| Deferred revenue | 317 | 4,834 | ||||||
| Operating lease liability | 1,428 | 871 | ||||||
| Total current liabilities | 20,340 | 24,443 | ||||||
| Deferred revenue, long-term | 64,545 | 90,610 | ||||||
| Operating lease liability, long-term | 11,300 | 8,771 | ||||||
| Warrant liability | 1,603 | |||||||
| Total liabilities | 96,185 | 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; 6,663 and 6,658 shares issued and outstanding at June 30, 2023 and 2022, respectively | ||||||||
| Additional paid-in-capital | 430,621 | 426,572 | ||||||
| Accumulated deficit | (405,997 | ) | (374,159 | ) | ||||
| Total stockholders equity | 24,624 | 52,413 | ||||||
| Total liabilities and stockholders equity | $ | 120,809 | $ | 177,840 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| Years Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 48,816 | $ | 40,697 | ||||
| Operating expenses: | ||||||||
| Research and development | 52,450 | 85,641 | ||||||
| General and administrative | 33,130 | 30,540 | ||||||
| Total operating expenses | 85,580 | 116,181 | ||||||
| Loss from operations | (36,764 | ) | (75,484 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liability | 1,603 | 20,752 | ||||||
| Interest and dividend income | 3,345 | 284 | ||||||
| Other expense, net | (22 | ) | (6 | ) | ||||
| Net loss | $ | (31,838 | ) | $ | (54,454 | ) | ||
| Net loss: | ||||||||
| Basic | $ | (31,838 | ) | $ | (54,454 | ) | ||
| Diluted | $ | (31,838 | ) | $ | (62,500 | ) | ||
| Net loss per share: | ||||||||
| Basic | $ | (4.78 | ) | $ | (8.75 | ) | ||
| Diluted | $ | (4.78 | ) | $ | (9.99 | ) | ||
| Shares used in computing net loss per share: | ||||||||
| Basic | 6,663 | 6,224 | ||||||
| Diluted | 6,663 | 6,257 |
Reconciliation of GAAP Net Loss to Adjusted Net Loss
| Years Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Net loss: | $ | (31,838 | ) | $ | (54,454 | ) | ||
| Add: Change in fair value of warrant liability | (1,603 | ) | (20,752 | ) | ||||
| Adjusted net loss: | $ | (33,441 | ) | $ | (75,206 | ) |