MEI Pharma Reports Second Quarter Fiscal Year 2024 Results and Operational Highlights
MEI Pharma, Inc. reported positive results for the three and six months ended December 31, 2023. The company highlighted ongoing clinical studies for voruciclib and ME-344, with strong investigator support. MEI presented data from Phase 1 trials at major conferences. Financially, MEI had $59.5 million in cash with no debt, and operational expenses decreased due to program changes. The company expects to report more clinical data in the near future.
Positive
Positive results for three and six months ended December 31, 2023.
Strong investigator support and enrollment for ongoing clinical studies.
Presentation of Phase 1 trial data at major conferences.
Financially stable with $59.5 million in cash and no debt.
Operational expenses decreased due to program changes.
Expectation to report more clinical data in the near future.
MEI Pharma's financial results indicate a strategic shift, marked by a reduction in R&D expenses due to the wind-down of the zandelisib program. This has resulted in a narrower focus on their remaining drug candidates, voruciclib and ME-344. The company's cash burn rate appears stable, with $29.5 million used in operations over the six months, comparable to the prior year. However, the lack of revenue generation, as highlighted by the absence of revenue in the recent quarter compared to $32.7 million in the same quarter of the previous year, is a significant change. This is attributed to the termination of the Kyowa Kirin Commercialization Agreement. The reported cash reserves of $59.5 million are expected to sustain the company for at least 12 months, which provides a runway through key clinical data readouts. These financial metrics are crucial for investors as they gauge the company's fiscal health and its capacity to continue funding its clinical trials without the immediate need for additional capital raising, which could dilute existing shareholder value.
The clinical progress of MEI Pharma's drug candidates, voruciclib and ME-344, is noteworthy. Voruciclib, a CDK9 inhibitor, has shown clinical activity and complete responses in the dose escalation portion of the Phase 1 trial, which is promising for patients with R/R AML. The decision to explore additional dose levels prior to expanding the cohort is indicative of positive clinical findings and suggests potential for a more effective treatment regimen. ME-344's progress in the Phase 1b study, targeting mitochondrial oxidative phosphorylation, is also significant, particularly as enrollment for Cohort 1 is complete with data expected soon. These developments are critical as they could potentially address resistance mechanisms to standard cancer therapies, filling a significant unmet need in oncology. The implications of these trials for MEI Pharma are substantial, as positive outcomes could lead to partnership opportunities, additional funding and ultimately, revenue generation through commercialization.
MEI Pharma's position within the biopharmaceutical sector is one of high risk and potential high reward, common in the industry. The company's focus on addressing resistance mechanisms in cancer therapy could capture a significant market share if clinical trials prove successful. However, the biopharmaceutical market is highly competitive and sensitive to clinical trial outcomes. The upcoming clinical data readouts will be pivotal in determining investor confidence and the company's market valuation. Positive data could lead to stock price appreciation, while any setbacks could have a detrimental effect. It's also important to consider the broader market dynamics, including regulatory changes, competitor developments and overall investor sentiment towards the biotech sector, which can influence MEI Pharma's stock performance independent of its own clinical and financial results.
02/13/2024 - 05:05 PM
SAN DIEGO --(BUSINESS WIRE)--
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
In January 2024, MEI presented a Trials in Progress poster of the ongoing Phase 1b study of ME-344, our mitochondrial oxidative phosphorylation (OXPHOS) inhibitor, evaluating the combination with bevacizumab (Avastin®) in refractory metastatic colorectal cancer patients at the 2024 ASCO Gastrointestinal Cancers Symposium.
In December 2023, MEI presented a poster reporting complete clinical data from the monotherapy dose escalation stage of the Phase 1 study evaluating voruciclib, our selective oral cyclin-dependent kinase 9 (“CDK9”) inhibitor, in patients with relapsed or refractory (“R/R”) acute myeloid leukemia (“AML”) or B-cell malignancies at the 65th American Society of Hematology Annual Meeting and Exposition. Also reported was the early experience of voruciclib in combination with venetoclax (Venclexta®), a B-cell lymphoma 2 ("BCL2") inhibitor, in the ongoing stage of the study evaluating the combination.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
We expect to report clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial evaluating voruciclib plus venetoclax in patients with R/R AML in the first calendar quarter of 2024.
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
We have completed enrollment in Cohort 1 of the Phase 1b clinical study evaluating ME-344 plus bevacizumab in patients with relapsed colorectal cancer. We expect to report data from Cohort 1 in the first half of calendar-year 2024.
Three and Six Month Fiscal Year 2024 Financial Results
As of December 31, 2023, MEI had $59.5 million
For the six months ended December 31, 2023, cash used in operations was $29.5 million $29.1 million
Research and development expenses decreased by $11.4 million $3.9 million $15.3 million
General and administrative expenses decreased by $0.5 million $8.0 million $8.5 million
MEI recognized no revenue for the quarter ended December 31, 2023, compared to $32.7 million
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.
MEI Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except par value amounts)
December 31, June 30,
(Unaudited) (Audited)
ASSETS
Current assets:
Cash and cash equivalents
$
5,174
$
16,906
Short-term investments
54,306
83,787
Unbilled receivables
—
85
Prepaid expenses and other current assets
6,692
6,750
Total current assets
66,172
107,528
Operating lease right-of-use asset
11,222
11,972
Property and equipment, net
1,144
1,309
Total assets
$
78,538
$
120,809
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
1,378
$
6,134
Accrued liabilities
5,645
12,461
Deferred revenue
—
317
Operating lease liability
1,015
1,428
Total current liabilities
8,038
20,340
Deferred revenue, long-term
—
64,545
Operating lease liability, long-term
11,012
11,300
Total liabilities
19,050
96,185
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01
—
—
Common stock, $0.00 000002
—
—
Additional paid-in capital
420,174
430,621
Accumulated deficit
(360,686
)
(405,997
)
Total stockholders’ equity
59,488
24,624
Total liabilities and stockholders’ equity
$
78,538
$
120,809
MEI Pharma, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
Three Months Ended Six Months Ended
2023
2022
2023
2022
Revenues
$
—
$
32,735
$
65,297
$
41,465
Operating expenses:
Research and development
3,912
15,313
7,397
34,776
General and administrative
8,018
8,496
14,549
15,982
Total operating expenses
11,930
23,809
21,946
50,758
(Loss) income from operations
(11,930
)
8,926
43,351
(9,293
)
Other income (expense):
Change in fair value of warrant liability
—
486
—
1,603
Interest and dividend income
869
845
1,963
1,325
Other expense, net
(2
)
(4
)
(3
)
(6
)
Net (loss) income
$
(11,063
)
$
10,253
$
45,311
$
(6,371
)
Net (loss) income per share - basic and diluted
$
(1.66
)
$
1.54
$
6.80
$
(0.96
)
Weighted-average shares used in computing net (loss) income per share - basic and diluted:
6,663
6,663
6,663
6,663
View source version on businesswire.com: https://www.businesswire.com/news/home/20240213003753/en/
David A. Walsey
investor@meipharma.com
Source: MEI Pharma, Inc.
MEI Pharma had $59.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.
MEI Pharma highlighted ongoing clinical studies for voruciclib, an oral CDK9 inhibitor, and ME-344, an inhibitor of mitochondrial oxidative phosphorylation.
MEI Pharma presented a Trials in Progress poster of the ongoing Phase 1b study of ME-344, evaluating the combination with bevacizumab in refractory metastatic colorectal cancer patients.
MEI Pharma reported complete clinical data from the monotherapy dose escalation stage of the Phase 1 study evaluating voruciclib in patients with relapsed or refractory acute myeloid leukemia or B-cell malignancies.
MEI Pharma expects to report clinical data from the dose escalation portion of the Phase 1 trial evaluating voruciclib plus venetoclax in patients with relapsed or refractory AML in the first calendar quarter of 2024. For ME-344, data from Cohort 1 of the Phase 1b study is expected in the first half of 2024.
