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SAN DIEGO--(BUSINESS WIRE)--Nov 14, 2022--
MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended September 30, 2022, and highlighted recent corporate events.
“As we move through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3Kδ inhibitors to treat indolent lymphomas, as well as the impact of these concerns and other global factors on our Phase 3 COASTAL study, we also look forward to reporting advances across our clinical development pipeline. This includes reporting updated data from multiple zandelisib studies at the ASH annual meeting in December, and also reporting advances in our other development programs, including initiation of a trial evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and a trial evaluating the combination of ME-344 plus bevacizumab in patients with relapsed and refractory colorectal cancer,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “We remain well capitalized with $138 million to advance our pipeline and continue operations for approximately two years.”
First Quarter Fiscal Year 2023 Recent Developments and Financial Highlights
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
ME-344 – Tumor selective mitochondrial inhibitor
First Quarter Fiscal Year 2023 Financial Results
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates contains multiple clinical-stage assets, including zandelisib, currently in ongoing clinical trials which may support marketing approvals with the U.S. Food and Drug Administration and other regulatory authorities globally. Each of MEI Pharma's pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) 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 zandelisib and our other 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; and 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; adverse effects on the Company's business as a result of the restatement of our previously issued financial statements; the impact of the 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 consolidated 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, adjusted to exclude non-cash expenses related to changes in the fair value of the warrants. We have presented adjusted net 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 BALANCE SHEETS(In thousands, except per share amounts) September 30,June 30,
2022
2022
(unaudited)ASSETSCurrent assets: Cash and cash equivalents
$
14,653
$
15,740
Short-term investments
123,714
137,512
Total cash, cash equivalents and short-term investments
138,367
153,252
Unbilled receivables
7,758
10,044
Prepaid expenses and other current assets
2,782
3,830
Total current assets
148,907
167,126
Operating lease right-of-use asset
13,052
9,054
Property and equipment, net
1,624
1,660
Total assets
$
163,583
$
177,840
LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities: Accounts payable
$
8,418
$
7,918
Accrued liabilities
9,216
10,820
Deferred revenue
4,500
4,834
Operating lease liabilities
1,301
871
Total current liabilities
23,435
24,443
Deferred revenue, long-term
89,973
90,610
Operating lease liabilities, long-term
12,381
8,771
Warrant liability
486
1,603
Total liabilities
126,275
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; 133,261 and 133,152 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively
-
-
Additional paid-in-capital
428,091
426,572
Accumulated deficit
(390,783
)
(374,159
)Total stockholders' equity
37,308
52,413
Total liabilities and stockholders' equity
$
163,583
$
177,840
MEI PHARMA, INC.CONDENSED STATEMENTS OF OPERATIONS(In thousands, except per share amounts)(Unaudited) Three Months Ended
September 30,
2022
2021
Revenue
$
8,730
$
7,757
Operating expenses: Research and development
19,463
19,953
General and administrative
7,486
7,909
Total operating expenses
26,949
27,862
Loss from operations
(18,219
)
(20,105
) Other income (expense): Change in fair value of warrant liability
1,117
2,587
Interest and dividend income
480
8
Other expense, net
(2
)
-
Net loss
$
(16,624
)
$
(17,510
) Net loss: Basic
$
(16,624
)
$
(17,510
)Diluted
$
(16,624
)
$
(20,097
)Net loss per share: Basic
$
(0.12
)
$
(0.16
)Diluted
$
(0.12
)
$
(0.18
)Shares used in computing net loss per share: Basic
133,255
112,677
Diluted
133,255
113,917
MEI PHARMA, INC.Reconciliation of GAAP Net Loss to Adjusted Net Loss(In thousands)(Unaudited)Three Months Ended
September 30,
2022
2021
Net loss
$
(16,624
)
$
(17,510
)Add: Change in fair value of warrant liability
(1,117
)
(2,587
)Adjusted net loss
$
(17,741
)
$
(20,097
)
View source version on businesswire.com:https://www.businesswire.com/news/home/20221114005972/en/
CONTACT: David A.. Walsey
Tel: 858-369-7104
investor@meipharma.comJason I. Spark
Canale Communications for MEI
Tel: 619-849-6005
jason.spark@canale.com
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: MEI Pharma, Inc.
Copyright Business Wire 2022.
PUB: 11/14/2022 04:05 PM/DISC: 11/14/2022 04:06 PM
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