-- Conference Call Today at 5:00 p.m. Eastern
Time --
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 colorectal cancer.”
Fiscal Year 2023 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 July 2023, at the Company’s Special Meeting of Stockholders,
MEI did not obtain the necessary stockholder votes to approve a
merger agreement for an all-stock transaction pursuant to which
Infinity Pharmaceuticals would have become a wholly-owned
subsidiary of the Company. The certified results showed that 59.70%
of outstanding shares were voted, of which 47.86% voted in favor of
the proposed transaction, and 51.44% against. Accordingly, MEI
terminated the merger agreement.
- In June 2023, in connection with the Company’s succession plan,
David M. Urso was appointed president and chief executive officer
and also joined the Company’s board of directors. Mr. Urso replaced
Daniel P. Gold, Ph.D., president and chief Executive officer of MEI
since 2010. Dr. Gold continues to serve on MEI’s board. In June
2023, also as part of the Company’s succession planning, it was
announced that Jay File would be appointed chief financial officer,
replacing Brian Drazba. Mr. File’s appointment became effective on
August 1, 2023.
- In May 2023, MEI announced an update to the ongoing Phase 1
study evaluating voruciclib, its oral cyclin-dependent kinase 9
(CDK9) inhibitor, alone and in combination with venetoclax
(Venclexta®), a BCL2 inhibitor, in patients with acute myeloid
leukemia (AML) or B-cell malignancies. The Company announced that
early results demonstrated that voruciclib alone or in combination
with venetoclax was generally well tolerated with no significant
myelosuppression. The results further demonstrated encouraging
clinical activity in heavily pretreated patients administered with
voruciclib alone and at the initial dose level in combination with
venetoclax. These early results are consistent with the hypothesis
that voruciclib may address a common venetoclax resistance
mechanism by inhibiting MCL-1 via CDK9 inhibition.
- In May 2023, MEI regained compliance with the Nasdaq minimum
bid requirement after the Company implemented a 1-for-20 reverse
stock split in April 2023. The reverse stock split was approved by
MEI’s stockholders on January 5, 2023.
- In March 2023, the Safety Review Committee of the Phase 1 study
evaluating voruciclib plus venetoclax completed a safety assessment
of the initial dose escalation cohort evaluating the combination in
patients with AML and recommended opening the next cohort. The
combination stage of the study started after completing the
single-agent dose exploration stage of the Phase 1 study in
patients with either AML or B-cell malignancies.
- In December 2022, MEI announced a realignment of its clinical
development efforts following the discontinuation of zandelisib,
its PI3K delta inhibitor drug candidate. As part of the
realignment, the Company disclosed plans to streamline the
organization towards the development of its two earlier
clinical-stage assets, voruciclib and ME-344. We currently have 41
employees, which reflects a 61% reduction in full-time employees
since our announcement in December 2022.
- In December 2022, after receiving new guidance in an end of
Phase 2 meeting with the U.S. Food and Drug Administration (FDA),
MEI and Kyowa Kirin announced the discontinuation of global
development of zandelisib outside of Japan. The two companies
concluded that a clinical trial consistent with the new FDA
guidance, including modification of the then ongoing Phase 3
COASTAL trial, would likely not be feasible to complete within a
time period that would support further investment. Kyowa Kirin,
after meeting with the Pharmaceuticals and Medical Devices Agency
(PMDA), subsequently discontinued zandelisib development in Japan
after determining that conducting a randomized study consistent
with that agency’s guidance to support a marketing application
would also likely not be feasible to complete within a time period
that would support further investment. In July 2023, the Company
and Kyowa Kirin mutually entered a termination agreement between
the parties pursuant to which MEI regained full global rights to
zandelisib, subject to Kyowa Kirin receiving some limited rights to
use zandelisib for compassionate use.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
- Report clinical data from 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 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.
Fiscal Year 2023 Financial Results
- As of June 30, 2023, MEI had $100.7 million in cash, cash
equivalents, and short-term investments with no outstanding
debt.
- For the year ended June 30, 2023, cash used in operations was
$52.5 million, compared to $48.7 million during the year ended June
30, 2022. The increase in cash used in operations was primarily due
to changes in working capital associated with the close down of
zandelisib activities with Kyowa Kirin.
- Research and development expenses were $52.5 million for the
year ended June 30, 2023, compared to $85.6 million for the year
ended June 30, 2022. The decrease was primarily related to a
reduction in zandelisib costs as we continued the close down of
development activities announced in December 2022.
- General and administrative expenses increased by $2.6 million
to $33.1 million for the year ended June 30, 2023, compared to
$30.5 million for the year ended June 30, 2022. The net increase
was primarily related to severance costs due to our staggered
reductions in the workforce announced in December 2022 and higher
external professional services offset by a decrease in noncash
stock-based compensation.
- MEI recognized revenue of $48.8 million for the year ended June
30, 2023, compared to $40.7 million for the year ended June 30,
2022. The increase in revenue primarily results from the
discontinuation of the zandelisib program in December 2022 under
our global License, Development and Commercialization Agreement
with Kyowa Kirin that resulted in the recognition of $16.6 million
of previously deferred revenue related to performance obligations
that are being closed and $8.6 million of previously deferred
revenue related to performance obligations associated with clinical
trials that have not commenced and will no longer be
initiated.
- Net loss was $31.8 million, or $4.78 per share, for the year
ended June 30, 2023, compared to net loss of $54.5 million, or
$8.75 per share for the year ended June 30, 2022. The Company had
6,662,857 shares of common stock outstanding as of June 30, 2023,
compared with 6,657,602 shares as of June 30, 2022.
- The adjusted net loss (a non-GAAP measure) for the year ended
June 30, 2023 and 2022, excluding noncash gains recognized for
changes in the fair value of warrants, was $33.4 million and $75.2
million, respectively
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
- When: September 26, 2023, 5:00 p.m. ET
- Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771
(International)
- Please ask to join into the MEI Pharma earnings call
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.
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. 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
our business.
MEI PHARMA, INC,
CONSOLIDATED BALANCE
SHEETS
(In 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
MEI PHARMA, INC,
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
MEI PHARMA, INC,
Reconciliation of GAAP Net
Loss to Adjusted Net Loss
(In thousands)
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
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230926407028/en/
David A. Walsey MEI Pharma Tel: 858-369-7104
investor@meipharma.com
Joele Frank, Wilkinson Brimmer Katcher Dan Katcher / Aaron
Palash 212-355-4449 MEIP-jf@joelefrank.com
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