MEI Pharma, Inc.

Good day, and welcome to the MEI Fiscal Year-End Earnings Call. My name is Gary, and I will be the conference facilitator today. All participants will be in a listen-only mode. After today's prepared remarks, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on a touch-tone phone. To withdraw your question, please press star, then 2. Please note, today's event is being recorded. I would now like to turn the conference over to David Walsey, Senior Vice President of Corporate Affairs at MEI Pharma. Please go ahead, sir.

Thank you, Gary. Hello, and thank you for joining the MEI Pharma conference call today. My name is David Walsey, and I'm Senior Vice President of Corporate Affairs for MEI. With me today on the call from MEI are David Erso, President and Chief Executive Officer, Jay Feil, Chief Financial Officer, and Dr. Richard Golley, Chief Medical Officer. Before turning the call over to David for opening remarks, I'd like to remind you that during today's call, we'll be making forward-looking statements. Certain information contained in this communication that are not historical in nature are forward-looking statements in 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 the initiation of clinical trials and the 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, 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 preclinical 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 the clinical trial results, uncertainty regarding the impact of rising inflation and the increase in interest rates as a result, Potential economic downturn, activist investors, our inability to maintain or enter into, and the risk resulting from our dependence upon collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales, and distribution of any products. Competitive factors are 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. 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. With that, I'll now turn the call over to David Arsuff.

Thank you, David, and thank you all for joining us today. On today's call, I'll make some opening remarks and then turn the call over to Richard Ghaly, our Chief Medical Officer, to review our programs. Jay Feil, our Chief Financial Officer, will then provide some brief financial comments before moving to Q&A. Before getting started, I want to welcome Jay. He was just appointed our CFO as of August 1st, so this is his first earnings call at MEI, and we're very happy to have him on the team. With that said, I'll make a brief statement regarding the termination of the merger agreement with Infinity Pharmaceuticals before moving on to review our business. Regarding that proposed transaction, while we believe the potential upside of the Infinity merger was compelling for MEI stockholders, we value the perspective of our stockholders. With the proposed transaction behind us, we're committed to pursuing our two promising clinical stage programs as a standalone company. Looking ahead over the next few quarters, we see important opportunities in the continued progress of our two clinical stage oncology programs, Voracyclib and ME344. I would like to use this call to provide an update on the status of these programs and why we're optimistic about their potential. Both of our assets represent novel mechanisms of action. Voracycloid is an oral CDK9 inhibitor, and ME344 is a mitochondrial inhibitor that inhibits the OXFOS pathway. We're investigating the potential of these compounds to overcome resistance mechanisms to standard-of-care therapies. the BCL2 inhibitor venetoclax for voracyclin, and the VEGF inhibitor bevacizumab in the case of ME344. The ongoing advancement of each program is based on non-clinical, and in the case of ME344, clinical data supporting proof of principle for their respective combinations. We chose these combination approaches based on clear hypotheses to address known resistance mechanisms of each standard of care therapy, clear medical need, and significant commercial opportunities. We're working with some of the leading oncologists in the country in both of our clinical studies, and we're pleased with their level of engagement and interest in our programs. We expect data readouts from each program in the coming months. With respect to voracycloid, as previously reported, we've seen promising data from our ongoing Phase I study. Recall that voracycloid, as a selective CDK9 inhibitor, regulates the transcription of MCL1, and through that mechanism holds the potential to address a known venetoclax resistance mechanism. The ongoing Phase I study is evaluating voracycloid as a single agent and in combination with venetoclax. which is standard of care in AML and used in other hematologic malignancies as well. Richard will provide more detail shortly, but in brief, borocycloid alone and in combination with venetoclax has been generally well tolerated in the Phase I study to date with no significant myelosuppression in patients with B-cell malignancies or AML. The results further demonstrate encouraging early clinical activity in heavily pretreated patients that progressed on venetoclax who were administered voracyclic monotherapy and at the initial dose level in combination with venetoclax. The planned voracyclic data readout in early 2024 is expected to include data from the dose ascending cohorts in the Phase I study evaluating voracyclic plus venetoclax in patients with AML. Here are some of the leading KOLs we're working with. We're pleased with how the study is enrolling. As for ME344, we're pursuing a novel approach to cancer therapy with a combination of ME344, an OXFOS inhibitor that inhibits the production of ATP in mitochondria, and Bevacizumab, a VEGF inhibitor which inhibits the production of ATP through glycolysis. to deprive cancer cells of the energy needed to proliferate. Bevacizumab is an established standard of care in multiple solid tumors, including colorectal cancer. Our ongoing Phase 1B study is evaluating metastatic colorectal cancer patients with ME344 plus Bevacizumab. This novel approach to treatment has also generated enthusiasm among our investigators in the ongoing study. In earlier clinical studies, ME344 was generally well tolerated at the dose we're currently investigating, and there was evidence of clinical activity as a single agent. We had a first look at the potential for this combination in a 42-patient controlled window of opportunity clinical study in HER2-negative breast cancer patients waiting for mastectomy. Richard will discuss the decrease in the proliferation in biomarker KI67 observed in that study. We expect that the ME344 data readout planned in the first half of 2024 will include initial safety and efficacy data from the first 20-patient cohort in the Phase 1b study evaluating ME344 in combination with Bevacizumab in patients with myofascial colorectal cancer. We believe the potential value of both programs is notable given that the addressable market opportunities for voracyclic in combination with venetoclax and ME344 in combination with bevacizumab are significant. Venetoclax is currently used across AML, CLL, and double-hit DLBCL and generated approximately $2 billion in 2022 worldwide sales. Venetoclax sales are continuing to grow and are expected to generate $3.4 billion by 2028. Avastin and Bevacizumab biosimilars are used to treat a variety of cancers, including colorectal cancer and ovarian cancer. 2022 worldwide Avastin and Bevacizumab biosimilar sales reached $2 billion in 2022 and are expected to grow to $3.3 billion by 2028. In short, MEI's pipeline is promising and presents substantial opportunity for delivering novel therapeutics for patients and value creation for MEI. MEI stockholders. Both Foracyclib and ME344 have the potential in combination with current standard of care therapies to overcome known resistance mechanisms and improve patient outcomes. Each program is supported by non-clinical, and in the case of ME344, clinical data demonstrating anti-tumor activity and mechanistic proof of concept for the combinations being evaluated. We anticipate reporting data for voricyclids early in calendar 2024 and in the first half of 2024 for ME344. We look forward to these data readouts and the next steps these data will inform. I'll now turn the call over to Richard Ghaly, our Chief Medical Officer, to provide additional details on our pipeline. Following Richard's remarks, Jay Feil, our Chief Financial Officer, will provide a brief financial overview before moving to Q&A.