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 quarter ended September 30, 2023 and
highlighted recent corporate events.
“Our ongoing clinical studies evaluating the combination of
voruciclib, our CDK9 inhibitor, with Venclexta in
relapsed/refractory AML patients and ME-344, our mitochondrial
inhibitor, combined with Avastin in metastatic colorectal cancer
patients, continue to have strong investigator support and cohort
enrollment remains on track in each program,” said David M. Urso,
president and chief executive officer of MEI Pharma. “We expect to
report data from the dose escalation portion of the Phase 1
clinical trial evaluating voruciclib in combination with venetoclax
in early calendar 2024, and data from the first cohort of patients
in Phase 1b clinical trial evaluating ME-344 in the first half of
2024.”
First Quarter Fiscal Year 2024 and Recent Highlights
- In August 2023, MEI announced the dosing of the first patient
in a Phase 1b study evaluating ME-344 in combination with
bevacizumab (AVASTIN®) in patients with previously treated
metastatic colorectal cancer. ME-344 is a novel mitochondrial
inhibitor targeting energy production through the OXPHOS pathway,
which is important for supporting tumor cell survival and
proliferation for many forms of cancer, including colorectal
cancer. Bevacizumab, a vascular endothelial growth factor (VEGF)
inhibitor, and other antiangiogenics, inhibit energy production
through glycolysis and, thereby, increase tumor reliance on
mitochondrial energy production, providing an opportunity to
evaluate a combination with ME-344 to inhibit energy production in
tumor cells and induce an antitumor effect. The Company anticipates
announcing safety and efficacy data from the first cohort of 20
patients in the first half of 2024.
- In November 2023, MEI announced that an abstract highlighting
clinical data from the monotherapy dose escalation stage of the
ongoing Phase 1 study evaluating voruciclib, a selective oral
cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in
combination with venetoclax (Venclexta®), a B-cell lymphoma 2
("BCL2") inhibitor, in patients with acute myeloid leukemia (AML)
or B-cell malignancies, will be presented during a poster session
at the upcoming 65th American Society of Hematology (ASH) Annual
Meeting and Exposition to be held December 9 – 12, 2023.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
- Report clinical data from the dose escalation portion of the
ongoing Phase 1 clinical trial evaluating voruciclib plus
Venclexta® (venetoclax) in patients with AML early in calendar
2024.
ME-344 – Mitochondrial inhibitor in Phase 1b Study
- Report clinical data from Cohort 1 of the Phase 1b clinical
trial evaluating ME-344 plus Avastin® (bevacizumab) in patients
with relapsed colorectal cancer in the first half of calendar-year
2024.
First Quarter Fiscal Year 2024 Financial Results
- As of September 30, 2023, MEI had $82.2 million in cash, cash
equivalents, and short-term investments with no outstanding
debt.
- For the quarter ended September 30, 2023, cash used in
operations was $18.5 million, compared to $14.8 million during the
quarter ended September 30, 2022. The increase in cash used in
operations was primarily due to changes in working capital
associated with the wind down of zandelisib activities with Kyowa
Kirin and professional services primarily related to advisory and
legal fees associated with various stockholder-related activities,
including stockholder-initiated consent solicitations.
- Research and development expenses were $3.5 million for the
quarter ended September 30, 2023, compared to $19.5 million for the
quarter ended September 30, 2022. The decrease was primarily
related to a reduction in zandelisib costs as we continued the wind
down of development activities announced in December 2022, as well
as reduced personnel and related costs from our fiscal year 2023
reduction in headcount.
- General and administrative expenses decreased by $1.0 million
to $6.5 million for the quarter ended September 30, 2023, compared
to $7.5 million for the quarter ended September 30, 2022. The net
decrease was primarily related to reduced personnel and related
costs from our fiscal year 2023 reduction in headcount, partially
offset by higher external professional services and legal
expenses.
- MEI recognized revenue of $65.3 million for the quarter ended
September 30, 2023, compared to $8.7 million for the quarter ended
September 30, 2022. The increase in revenue is due to the
recognition of deferred revenue associated primarily with the
termination of the Kyowa Kirin Commercialization Agreement in July
2023. As of September 30, 2023, all deferred revenue associated
with that agreement has been recognized.
- Net income was $56.4 million, or $8.46 per share, for the
quarter ended September 30, 2023, compared to net loss of $16.6
million, or $2.49 per share for the quarter ended September 30,
2022. The Company had 6,662,857 shares of common stock outstanding
as of September 30, 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 and ME-344 Phase 1 and Phase 1b clinical programs,
respectively.
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 mitochondrial inhibitor targeting the
oxidative phosphorylation pathway. 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 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 fund future capital returns. 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.
MEI PHARMA, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (In thousands, except par value amounts)
September 30,
June 30,
2023
2023
(Unaudited) (Audited)
ASSETS Current assets: Cash and cash
equivalents
$
3,372
$
16,906
Short-term investments
78,830
83,787
Unbilled receivables
—
85
Prepaid expenses and other current assets
6,220
6,750
Total current assets
88,422
107,528
Operating lease right-of-use asset
11,600
11,972
Property and equipment, net
1,229
1,309
Total assets
$
101,251
$
120,809
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:
Accounts payable
$
3,220
$
6,134
Accrued liabilities
4,289
12,461
Deferred revenue
—
317
Operating lease liability
1,055
1,428
Total current liabilities
8,564
20,340
Deferred revenue, long-term
—
64,545
Operating lease liability, long-term
11,326
11,300
Total liabilities
19,890
96,185
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 September 30, 2023 and June
30, 2023
—
—
Additional paid-in-capital
430,984
430,621
Accumulated deficit
(349,623
)
(405,997
)
Total stockholders' equity
81,361
24,624
Total liabilities and stockholders' equity
$
101,251
$
120,809
MEI PHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (In thousands, except per share amounts)
(Unaudited) For the Three MonthsEnded September
30,
2023
2022
Revenues: Revenue from customers
$
752
$
8,730
Revenue from collaboration agreements
64,545
—
Total revenues
65,297
8,730
Operating expenses: Research and development
3,485
19,463
General and administrative
6,531
7,486
Total operating expenses
10,016
26,949
Income (loss) from operations
55,281
(18,219
)
Other income (expense): Change in fair value of warrant liability
—
1,117
Interest and dividend income
1,094
480
Other expense, net
(1
)
(2
)
Total other income, net
1,093
1,595
Net income (loss)
$
56,374
$
(16,624
)
Net income (loss) per share - basic and diluted
$
8.46
$
(2.49
)
Weighted-average shares used in computing net income (loss) per
share - basic and diluted
6,663
6,663
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version on businesswire.com: https://www.businesswire.com/news/home/20231109870434/en/
David A. Walsey MEI Pharma Tel: 858-369-7104
investor@meipharma.com
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