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 in cash, cash
equivalents, and short-term investments with no outstanding
debt.
- For the six months ended December 31, 2023, cash used in
operations was $29.5 million, compared to $29.1 million during the
six months ended December 31, 2022, primarily due to the timing of
payments on operating liabilities as compared to the prior period
combined with lower clinical spend due to the wind down of the
zandelisib program resulting from the discontinuation of
development activities announced in December 2022.
- Research and development expenses decreased by $11.4 million to
$3.9 million for the quarter ended December 31, 2023, compared to
$15.3 million for the quarter ended December 31, 2022. The decrease
was primarily related to a reduction in zandelisib program costs,
as well as reduced personnel and related costs from our reductions
in headcount. These decreases were slightly offset by increases
related to clinical and manufacturing costs associated with the
Phase 1b study for ME-344.
- General and administrative expenses decreased by $0.5 million
to $8.0 million for the quarter ended December 31, 2023, compared
to $8.5 million for the quarter ended December 31, 2022. The net
decrease was primarily related to reduced personnel and related
costs from our reductions in headcount, offset by higher external
legal expenses.
- MEI recognized no revenue for the quarter ended December 31,
2023, compared to $32.7 million for the quarter ended December 31,
2022. The decrease in revenue was due to all remaining noncash
deferred revenue associated with the Kyowa Kirin Commercialization
Agreement having been recognized in the first quarter of fiscal
year 2024 due to the termination of that agreement in July
2023.
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 31,2023
June 30,2023 (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 par value; 100 shares authorized; none outstanding
—
—
Common stock, $0.00000002 par value; 226,000 shares authorized;
6,663 shares issued and outstanding at December 31, 2023 and June
30, 2023
—
—
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 EndedDecember 31, Six Months EndedDecember
31,
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 MEI Pharma Tel: 858-369-7104
investor@meipharma.com
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