On Target:
Developing Best-in-Class Cancer Therapies
January 2022
Forward-Looking Statements
This presentation contains, and our officers and representatives may from time to time make,
statements that are "forward-looking
statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements include, among others, statements regarding our development strategy; potential advantages of our product candidates; the initiation and completion of preclinical and clinical studies and the reporting of the results thereof; the timing of regulatory submissions and actions; the sufficiency of our existing cash; and all other statements relating to our plans, objectives, expectations and beliefs regarding future performance, operations, financial condition and other future events (including assumptions underlying or relating to any of the foregoing).
These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control. Important factors that could cause our actual results and financial condition to differ materially from those indicated in forward-looking statements include, among others: uncertainties relating to the initiation and completion of preclinical and clinical studies; whether preclinical and clinical study results will validate and support the safety and efficacy of our product candidates; the outcome of regulatory reviews of our product candidates; varying interpretation of research and development and market data; 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; risks and uncertainties relating to intellectual property and the other factors discussed under the caption "Item 1A. Risk Factors" in our most recent annual report on Form 10-K and our most recent quarterly report on Form 10-Q.
Any forward-looking statement made by us in this presentation is based only on information currently available to us and speaks only as of the date on which it is made. In addition, we operate in a highly competitive and rapidly changing environment, and new risks may arise. Accordingly, you should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking statement. You are urged to carefully review and consider the various disclosures in our most recent annual report on Form 10-K, our most recent Form 10-Q and our other public filings with the SEC since the filing of our most recent annual report.
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MEI Pharma: Dedicated to Developing Best-in-Class Cancer Therapies
Clinical Development Company Building a Leading Oncology Franchise with 3
Clinical-Stage Programs:
Focus On HemOnc
Zandelisib, a PI3Kδ Inhibitor with Potential to Set Standard-of-Care In Clinical Trials to Support Marketing Approvals with the U.S. FDA and Other Regulatory Authorities Globally
Well-Capitalized with ~$200
Million*
* Pro forma based on 9/30/21 financial disclosures plus $10M milestone paid by Kyowa Kirin in October 2021 and approximately $50 million in proceeds from December 2021 public offering of common stock
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Late-Stage Diversified Clinical Pipeline
INVESTIGATIONAL AGENTS | THERAPEUTIC AREA | COMBINATION | PHASE 1/1B | PHASE 2 | PHASE 3 |
Zandelisib | Follicular & Marginal | ||||||||
COASTAL Study | |||||||||
Oral PI3K Delta Inhibitor | Zone Lymphomas | Rituximab | |||||||
Relapsed/refractory (2L+) | |||||||||
Follicular & Marginal | |||||||||
Monotherapy | TIDAL (FL) Study1 | ||||||||
Zone Lymphomas | |||||||||
TIDAL (MZL) Study1 | |||||||||
Relapsed/refractory (3L+) | |||||||||
B-Cell Malignancies | Monotherapy | ||||||||
Rituxan® (rituximab) | |||||||||
Relapsed/refractory | |||||||||
Brukinsa® 2 (zanubrutinib) | |||||||||
Commercial Rights: | |||||||||
Diffuse Large-B-cell | R-CHOP3 | ||||||||
Lymphoma (1L) | |||||||||
Voruciclib | B-Cell Malignancies & | Monotherapy | |||||||
Oral CDK9 Inhibitor | |||||||||
AML | |||||||||
Venclexta® (venetoclax)4 | |||||||||
Commercial Rights: | Relapsed/refractory (2L+) | ||||||||
ME-344 | |||||||||
Mitochondrial Inhibitor | Solid Tumors | ® | 3 | ||||||
Avastin (bevacizumab) | |||||||||
Commercial Rights: | |||||||||
1. Phase 2 study intended to support accelerated approval marketing applications with FDA, subject to results and discussions with the FDA. 2. Study arm | |
initiated under clinical collaboration with BeiGene, Ltd. 3. Investigator-initiated trial. R-CHOP = rituximab plus cyclophosphamide, doxorubicin, vincristine, | 4 |
prednisone. 4. Initiation of clinical studies is subject to opening of a new Investigational New Drug Application with FDA | |
Zandelisib:
The Potential to Deliver the Promise of PI3Kδ Inhibition
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MEI Pharma Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 18:37:03 UTC.