MEI Pharma (NASDAQ:MEIP) provided updates on its two clinical-stage programs, voruciclib and ME-344, during its Fiscal Year-End Earnings Call. The company revealed promising data from early-stage trials and expressed optimism about potential market opportunities. The call also included updates on the company's financial position, with MEI holding $100.7 million in cash as of June 30, 2023, which aligns with the InvestingPro Tip that MEIP holds more cash than debt on its balance sheet.
Key takeaways from the call include:
- MEI's President and CEO, David Urso, discussed the termination of the merger agreement with Infinity Pharmaceuticals and emphasized the company's commitment to independently developing its clinical-stage programs.
- Voruciclib, a CDK9 inhibitor, is being evaluated in combination with venetoclax. The drug has shown potential in inhibiting the protein MCL-1 and MYC pathway in hematologic malignancies. The company is currently enrolling patients for the combination with venetoclax group.
- ME-344, an OXPHOS inhibitor, is being studied in combination with bevacizumab. The company reported positive results from a proof-of-concept study in breast cancer patients and plans to conduct a Phase 1/2 study for the ME-344 and Avastin combination in relapsed colorectal cancer patients.
- The company expects data readouts for both programs in early 2024 and believes the potential value of these programs is significant given the market opportunities for their respective combinations.
- MEI had $100.7 million in cash as of June 30th, 2023, which is expected to be sufficient for at least the next 12 months. This aligns with the InvestingPro Tip that MEIP is quickly burning through cash.
- The company expects R&D expenses to decrease in the next fiscal year due to the winding down of certain trials.
During the call, Urso also highlighted the potential of voruciclib and ME-344 to improve patient outcomes by overcoming resistance mechanisms. The company presented non-clinical data showing synergistic effects of voruciclib and venetoclax in acute myeloid leukemia (AML), as well as promising results in CLL and diffuse large cell lymphoma models.
ME-344, a mitochondrial inhibitor, showed disease stabilization in 49% of patients in a Phase 1 study. Preclinical studies revealed a decrease in tumor growth and improved survival when ME-344 was combined with Avastin or other VEGF inhibitors. The company plans to explore this combination further in a Phase 1/2 study in colorectal cancer patients.
Urso clarified questions about the company's approach to combining a VEGF inhibitor with a mitochondrial inhibitor for colorectal cancer, emphasizing that the focus is on time to progression rather than response rate. He also addressed questions about retreatment with venetoclax for AML and the patient population for the ME-344 study.
The company expects a 20-30% response rate for venetoclax retreatment and clarified the eligibility criteria for the ME-344 study. They also discussed the 20% threshold for enrollment in the study and how the patient population will determine their level of excitement.
Lastly, MEI Pharma announced that R&D expenses for the fourth quarter will be down significantly compared to the previous year due to the wind down of certain trials and cost reductions. The call concluded with the company thanking participants for their participation.
According to InvestingPro Data, MEI Pharma has a market cap of 47.44M USD and a negative P/E ratio of -1.49, indicating that the company is not profitable. This is consistent with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year. Despite this, the company has seen a strong return over the last month, with a 24.35% 1-month price total return. This aligns with the InvestingPro Tip that MEIP has seen a large price uptick over the last six months. For more insights, consider checking out the additional tips available on InvestingPro.
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