MEI Pharma Reports Second Quarter Fiscal Year 2024 Results and Operational Highlights
SAN DIEGO – February 13, 2024 – MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today reported results for the three and six months ended December 31, 2023, and highlighted recent corporate events.
“In the ongoing clinical studies for both voruciclib, our oral CDK9 inhibitor, and ME-344, our inhibitor of mitochondrial oxidative phosphorylation, we are gratified by strong investigator support and enrollment that remains on-track, and we look forward to preliminary study read-outs in the near future," said David M. Urso, president and chief executive officer of MEI Pharma. “We are planning to report initial safety and efficacy data during the first half of this calendar year for both voruciclib and ME-344, which are intended to provide preliminary clinical validation and support the further development of our programs.”
Select Second Quarter Fiscal Year 2024 and Recent Highlights
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
This updated voruciclib program guidance reflects continuation of the dose escalation portion of the study evaluating the combination with venetoclax in patients with r/r AML. Because we are seeing clinical activity, including complete responses, and no dose limiting toxicities, we decided in agreement with the investigators to evaluate additional dose levels before selecting a dose for the expansion cohort. We have completed enrollment of the group evaluating a 300 mg dose of voruciclib in combination with venetoclax.
ME-344 – Mitochondrial inhibitor in Phase 1b Study
Three and Six Month Fiscal Year 2024 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 Phase 1 and ME-344 Phase 1b clinical programs.
About MEI Pharma
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 small molecule inhibitor of mitochondrial oxidative phosphorylation. For more information, please visit www.meipharma.com. Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn.
Forward-Looking Statements
Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and 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; our future financial position, including the sufficiency of our cash, cash equivalents and short-term investments to fund our operations and our ability to fund future capital returns; and the objectives of management for future 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 projections about future events. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, 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; geopolitical conflicts; 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.
Contacts:
David A. Walsey
MEI Pharma
Tel: 858-369-7104
investor@meipharma.com
MEI Pharma, Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except par value amounts) |
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December 31, |
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June 30, |
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(Unaudited) |
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(Audited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,174 |
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$ |
16,906 |
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Short-term investments |
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54,306 |
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83,787 |
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Unbilled receivables |
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— |
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85 |
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Prepaid expenses and other current assets |
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6,692 |
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6,750 |
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Total current assets |
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66,172 |
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107,528 |
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Operating lease right-of-use asset |
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11,222 |
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11,972 |
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Property and equipment, net |
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1,144 |
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1,309 |
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Total assets |
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$ |
78,538 |
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$ |
120,809 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,378 |
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$ |
6,134 |
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Accrued liabilities |
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5,645 |
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12,461 |
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Deferred revenue |
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— |
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317 |
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Operating lease liability |
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1,015 |
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1,428 |
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Total current liabilities |
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8,038 |
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20,340 |
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Deferred revenue, long-term |
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— |
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64,545 |
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Operating lease liability, long-term |
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11,012 |
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11,300 |
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Total liabilities |
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19,050 |
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96,185 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.01 par value; 100 shares authorized; none outstanding |
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— |
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— |
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Common stock, $0.00000002 par value; 226,000 shares authorized; 6,663 |
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— |
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— |
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Additional paid-in capital |
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420,174 |
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430,621 |
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Accumulated deficit |
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(360,686 |
) |
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(405,997 |
) |
Total stockholders’ equity |
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59,488 |
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24,624 |
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Total liabilities and stockholders’ equity |
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$ |
78,538 |
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$ |
120,809 |
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MEI Pharma, Inc. |
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Condensed Consolidated Statements of Operations |
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(Unaudited) |
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(in thousands, except per share amounts) |
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Three Months Ended |
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Six Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenues |
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$ |
— |
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$ |
32,735 |
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$ |
65,297 |
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$ |
41,465 |
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Operating expenses: |
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Research and development |
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3,912 |
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15,313 |
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7,397 |
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34,776 |
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General and administrative |
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8,018 |
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8,496 |
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14,549 |
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15,982 |
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Total operating expenses |
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11,930 |
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23,809 |
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21,946 |
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50,758 |
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(Loss) income from operations |
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(11,930 |
) |
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8,926 |
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43,351 |
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(9,293 |
) |
Other income (expense): |
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Change in fair value of warrant liability |
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— |
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486 |
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— |
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1,603 |
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Interest and dividend income |
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|
869 |
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|
845 |
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1,963 |
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1,325 |
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Other expense, net |
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(2 |
) |
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(4 |
) |
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(3 |
) |
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(6 |
) |
Net (loss) income |
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$ |
(11,063 |
) |
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$ |
10,253 |
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$ |
45,311 |
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$ |
(6,371 |
) |
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Net (loss) income per share - basic and diluted |
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$ |
(1.66 |
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$ |
1.54 |
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$ |
6.80 |
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$ |
(0.96 |
) |
Weighted-average shares used in computing net (loss) |
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6,663 |
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6,663 |
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6,663 |
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6,663 |
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