-- MEI Begins Fourth Fiscal Quarter with $112.0
Million in Cash --
MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical
company focused on advancing new therapies for cancer, today
reported results for the quarter ended March 31, 2023, and
highlighted recent corporate events.
“We are making steady progress in advancing both of our
clinical-stage pipeline programs: voruciclib for hematologic
malignancies and ME-344 for relapsed colorectal cancer, both
expected to report data by around the end of the calendar year,”
said Dan Gold, Ph.D., President and Chief Executive Officer of MEI
Pharma. “With the clinical-data expected from these two programs
around year-end, funds to support operations for at least two years
based upon our current development plans, and the opportunity to
further strengthen our value proposition via the pending merger
with Infinity Pharmaceuticals, we are well positioned to deliver
progress in our mission to deliver improved benefits to patients
with cancer, as well as value to our shareholders.”
Third Quarter Fiscal Year 2023 and Recent
Developments
- Kyowa Kirin has been evaluating whether to continue developing
zandelisib in Japan and after meeting with the PMDA has concluded
this month that conducting a randomized study consistent with
agency guidance to support a marketing application would likely not
be feasible to complete within a time period that would support
further investment. As a result, Kyowa Kirin decided to discontinue
development of zandelisib in Japan. The discontinuation of
zandelisib in Japan was a business decision by Kyowa Kirin based on
the most recent regulatory guidance from the PMDA and is not
related to the zandelisib clinical data generated to date. In light
of Kyowa Kirin’s decision to discontinue development of zandelisib
in Japan, the parties intend to terminate the global license,
development and commercialization agreement executed in April
2020.
- In April 2023, MEI conducted a 1-for-20 reverse stock split.
The reverse stock split was approved by MEI’s stockholders on
January 5, 2023, and was implemented with the intent to increase
the per share trading price of the Company's common stock to enable
the Company to satisfy the minimum bid price requirement for
continued listing on Nasdaq. As per a notice received from the
Nasdaq dated May 2, 2023, MEI regained compliance with the Nasdaq
minimum bid requirement.
- In March 2023, the Safety Review Committee of the Phase 1 study
evaluating voruciclib, MEI’s orally administered cyclin-dependent
kinase 9 (CDK9) inhibitor, plus venetoclax (Venclexta®) completed a
safety assessment of the initial dose escalation cohort evaluating
the combination in patients with acute myeloid leukemia (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. CDK9 inhibition disrupts Mcl-1 production and
upregulation of Mcl-1 is a known escape mechanism of treatment with
venetoclax. Thus, the combination being evaluated presents an
opportunity to explore the synergistic potential to disrupt the
cell cycle and inhibition of pro-survival cell cycle pathways.
- In February 2023, MEI Pharma and Infinity Pharmaceuticals
announced a definitive merger agreement for an all-stock
transaction pursuant to which Infinity will become a wholly owned
subsidiary of MEI Pharma. The combined company would have a
projected cash balance of approximately $100 million at Closing
that would be expected to fund operations through mid-2025, and to
clinical data over the next 12 to 24 months across three
clinical-stage oncology development programs: eganelisib, an oral
immuno-oncology macrophage reprogramming product candidate,
voruciclib, an oral CDK9 inhibitor, and ME-344, a novel tumor
selective mitochondrial inhibitor.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell
malignancies and acute myeloid leukemia
- Report clinical data from the ongoing Phase 1b trial evaluating
voruciclib plus Venclexta® (venetoclax) in patients with acute
myeloid leukemia around calendar year-end 2023.
ME-344 – Tumor selective mitochondrial inhibitor
- Initiate a Phase 1b clinical trial evaluating ME-344 plus
Avastin® in relapsed colorectal cancer patients in the first half
of calendar year 2023.
- Report clinical data from the Phase 1b clinical trial
evaluating ME-344 plus Avastin in patients with relapsed colorectal
cancer around calendar year-end 2023.
Third Quarter Fiscal Year 2023 Financial Results
- As of March 31, 2023, MEI had $112.0 million in cash, cash
equivalents, and short-term investments with no outstanding
debt.
- For the quarter ended March 31, 2023, cash used in operations
was $12.1 million, compared to $17.0 million used in operations
during the quarter ended March 31, 2022. The decrease in cash used
in operations is due to a reduction in zandelisib costs as we
continued the close down of development activities and other
changes in working capital.
- Research and development expenses were $15.1 million for the
quarter ended March 31, 2023, compared to $22.3 million for the
quarter ended March 31, 2022. The decrease was primarily related to
a reduction in zandelisib costs as we continued the close down of
development activities in December 2022.
- General and administrative expenses were $7.2 million for the
quarter ended March 31, 2023, compared to $8.9 million for the
quarter ended March 31, 2022. The decrease primarily relates to
personnel costs related to the reduction in workforce.
- MEI recognized revenue of $5.9 million for the quarter ended
March 31, 2023, compared to $9.7 million for the quarter ended
March 31, 2022. The decrease in revenue comes as a result of the
discontinuation of the zandelisib program in December 2022 and the
associated reduction in expense reimbursement under our global
License, Development and Commercialization Agreement with Kyowa
Kirin.
- Net loss was $15.4 million, or $2.32 per share, for the quarter
ended March 31, 2023, compared to net loss of $8.7 million, or
$1.31 per share for the quarter ended March 31, 2022. The Company
had 6,662,857 shares of common stock outstanding as of March 31,
2023, compared with 6,657,602 shares as of March 31, 2022.
- The adjusted net income (a non-GAAP measure) for the quarter
ended March 31, 2023, excluding non-cash expenses related to
changes in the fair value of the warrants, was $15.4 million,
compared to an adjusted net loss of $21.5 million for the quarter
ended March 31, 2022.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage
pharmaceutical company focused on developing potential new
therapies for cancer. MEI Pharma's portfolio of drug candidates
includes clinical stage candidates with differentiated or novel
mechanisms of action intended to address unmet medical needs and
deliver improved benefit to patients, either as standalone
treatments or in combination with other therapeutic options. For
more information, please visit www.meipharma.com. Follow us on
Twitter @MEI_Pharma and on LinkedIn.
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. Statements included 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 consummate
the potential merger with Infinity Pharmaceuticals. 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; adverse effects on the Company's business as a result of
the restatement of our previously issued financial statements;
uncertainty regarding the impact of rising inflation and the
increase in interest rates as a result; potential economic
downturn, the impact of the ongoing COVID-19 pandemic on our
industry and individual companies, including on our counterparties,
the supply chain, the execution of our clinical development
programs, our access to financing and the allocation of government
resources; 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.
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 income (loss), which we
believe is helpful to our investors. We use adjusted net income
(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 income (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 income (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 income (loss) as net income (loss),
adjusted to exclude non-cash expenses related to changes in the
fair value of the warrants. We have presented adjusted net income
(loss) because we believe excluding the non-cash expenses related
to changes in the fair value of warrants can produce a useful
measure for period-to-period comparisons of our business.
MEI PHARMA, INC,
CONDENSED CONSOLIDATED BALANCE
SHEETS
(In thousands, except per share
amounts)
March 31,2023 June 30,2022 (Unaudited)
ASSETS Current assets: Cash and cash equivalents
$
8,812
$
15,740
Short-term investments
103,224
137,512
Total cash, cash equivalents and short-term investments
112,036
153,252
Unbilled receivables
4,580
10,044
Prepaid expenses and other current assets
3,867
3,830
Total current assets
120,483
167,126
Operating lease right-of-use asset
12,338
9,054
Property and equipment, net
1,366
1,660
Total assets
$
134,187
$
177,840
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable
$
4,389
$
7,918
Accrued liabilities
16,264
10,820
Deferred revenue
1,583
4,834
Operating lease liability
1,385
871
Total current liabilities
23,621
24,443
Deferred revenue, long-term
64,545
90,610
Operating lease liability, long-term
11,667
8,771
Warrant liability
—
1,603
Total liabilities
99,833
125,427
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 and 6,658 shares issued and outstanding at March 31, 2023 and
June 30, 2022, respectively
—
—
Additional paid-in capital
430,322
426,572
Accumulated deficit
(395,968
)
(374,159
)
Total stockholders’ equity
34,354
52,413
Total liabilities and stockholders’ equity
$
134,187
$
177,840
MEI PHARMA, INC,
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
(In thousands, except per share
amounts)
(Unaudited)
Three Months Ended March
31,
Nine Months Ended March
31,
2023
2022
2023
2022
Revenue
$
5,894
$
9,694
$
47,359
$
29,283
Operating expenses: Research and development
15,104
22,318
49,880
63,802
General and administrative
7,181
8,934
23,163
24,769
Total operating expenses
22,285
31,252
73,043
88,571
Loss from operations
(16,391
)
(21,558
)
(25,684
)
(59,288
)
Other income (expense): Change in fair value of warrant liability
—
12,773
1,603
20,819
Interest and dividend income
957
60
2,282
78
Other expense, net
(4
)
—
(10
)
—
Net loss
$
(15,438
)
$
(8,725
)
$
(21,809
)
$
(38,391
)
Net loss: Basic
$
(15,438
)
$
(8,725
)
$
(21,809
)
$
(38,391
)
Diluted
$
(15,438
)
$
(8,725
)
$
(21,809
)
$
(46,437
)
Net loss per share: Basic
$
(2.32
)
$
(1.31
)
$
(3.27
)
$
(6.31
)
Diluted
$
(2.32
)
$
(1.31
)
$
(3.27
)
$
(7.58
)
Shares used in computing net loss per share: Basic
6,663
6,653
6,663
6,080
Diluted
6,663
6,653
6,663
6,124
MEI PHARMA, INC,
Reconciliation of GAAP Net Loss
to Adjusted Net Loss
(In thousands)
(Unaudited)
Three Months Ended March
31,
Nine Months Ended March
31,
2023
2022
2023
2022
Net loss
$
(15,438
)
$
(8,725
)
$
(21,809
)
$
(38,391
)
Add: Change in fair value of warrant liability
—
(12,773
)
(1,603
)
(20,819
)
Adjusted net loss
$
(15,438
)
$
(21,498
)
$
(23,412
)
$
(59,210
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005830/en/
David A. Walsey MEI Pharma Tel: 858-369-7104
investor@meipharma.com
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