2023 ANNUAL REPORT
What is most rewarding about working in the biopharmaceutical industry is the opportunity to develop therapies that can benefit patients. Our business at MEI Pharma is to develop cancer therapies that address meaningful unmet medical needs, that if successful, would present valuable commercial opportunities and in turn create significant value for our stockholders.
I assumed the role of MEI’s President and CEO in June 2023, inspired to lead the Company’s two clinical stage oncology drug development programs, voruciclib and ME-344. At the time, a proposed acquisition of Infinity Pharmaceuticals was pending to augment the pipeline with a later-stage clinical asset in an area of significant company expertise. While we believed the potential upside of the Infinity merger was compelling for stockholders, the transaction, ultimately, was not approved by a narrow margin. We value the views of our stockholders, and since the termination of the merger we've turned our focus fully toward advancing our two promising clinical-stage programs - which are both now a year more advanced - as a standalone company.
We expect to report clinical data during the first half of 2024 that will help inform the potential of each program to benefit patients and to create value for our stockholders. We are just months away from reporting the first human data for voruciclib, a CDK9 inhibitor, combined with Venclexta® (venetoclax) in patients with relapsed/refractory AML, and for ME-344, a mitochondrial inhibitor, combined with Avastin® (bevacizumab) in patients with previously treated metastatic colorectal cancer. We expect to report data from the dose escalation portion of the Phase 1 clinical trial evaluating voruciclib plus Venclexta in early calendar 2024, and data from Cohort 1 of the Phase 1b clinical trial evaluating ME-344 plus Avastin in the first half of 2024.
The programs represent differentiated and novel drug combinations with the potential to overcome resistance mechanisms to two standard-of-care therapies: the BCL2 inhibitor Venclexta in the case of voruciclib and the VEGF inhibitor Avastin in the case of ME-344. We chose these combination approaches based on strong scientific hypotheses to address known resistance mechanisms of each standard-of-care therapy, clear medical need and the consequent significant commercial opportunities associated with each program.
Our excitement about these programs is reinforced by promising nonclinical and clinical data, including early data from our ongoing voruciclib Phase 1 study evaluating voruciclib as a single agent and in combination with Venclexta – which is a standard-of-care in acute myeloid leukemia and used in other hematologic malignancies as well. The supporting data for our other candidate, ME-344, includes results from a 42-patient, controlled window-of-opportunity clinical study evaluating the combination of ME-344 with Avastin in HER2 negative breast cancer patients in which we observed decreases in the proliferation biomarker Ki67. We are collaborating with some of the leading oncologists in the country in both of our clinical studies, and they share our enthusiasm for these programs.
Looking ahead, the opportunities for each program are potentially significant. Venclexta use across acute myeloid leukemia, chronic lymphocytic leukemia and double-hit diffuse large B-cell lymphoma generated approximately $2.0 billion in 2022 worldwide sales. Venclexta sales are continuing to grow and are expected to generate $3.4 billion in revenue by 2028. Avastin and bevacizumab biosimilars are used to treat a variety of cancers, including colorectal cancer and ovarian cancer. Worldwide in 2022, Avastin and bevacizumab biosimilars sales reached $2.0 billion and are expected to grow to $3.3 billion by 2028.
With the progression of our development pipeline, and capital to support our near-term development plans, we believe that MEI is well-positioned to continue pursuing improved therapeutic options to cancer patients and create value for our stockholders.
In closing, I want to thank our employees for their hard work and dedication. It is their expertise and commitment to science that enable us to move forward with the important work we do every day to improve outcomes for patients.
Thank you for your investment in MEI and your continued support.
President and CEO
DANIEL GOLD, PhD
President & Chief Executive Officer
October 23, 2020