Cyclacel Pharmaceuticals, Inc.

Good afternoon and welcome to the CycloCell Pharmaceuticals first quarter 2023 results conference call and webcast. At this time, all participants are in a listen-only mode. After today's call, members of the financial community will have an opportunity to ask questions. If you would like to ask a question at that time, please press star 1 on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing star 2. In posing your question, we ask that you please pick up your handset to allow optimal sound quality. Please note today's call is being recorded. Lastly, if at any time during the call you should require operator assistance, please press star zero. I would now like to turn the conference call over to the company.

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclocell's financial results and business highlights for the first quarter of 2023. Before turning the call over to management, I'd like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the safe harbor provisions of the Private Securities Litigation and Reform Act of 1995 and Section 21E, of the Securities Exchange Act of 1934 as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the Securities and Exchange Commission, which include, among other things, our Form 10-Q and 10-K. All of our projections and other forward-looking statements represent our judgment as of today, and CycloCell does not take any responsibility to update state such information. With us today are Spiro Rombatis, President and Chief Executive Officer, Paul McBaron, Executive Vice President, Finance and Chief Operating Officer, and Dr. Mark Kirschbaum, Senior Vice President and Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Mark will provide details on CycloSelf's clinical programs and Paul will provide financial highlights for the first quarter of 2023, which will be followed by a Q&A session. At this time, it's my pleasure to turn the call over to Spiro.

Thank you, Grace, and thank you, everyone, for joining us today for our quarterly business update. We are on track to deliver key data readouts over the coming months from our two clinical programs, In the FADRA 065-101 study in patients with solid tumors and lymphoma, we are enrolling at dose level 6A. Pharmacokinetic and pharmacodynamic data from this dose level suggest that we are achieving predicted target engagement levels on continuous dosing at the higher level. Choosing the optimal dose schedule is one of many parameters to increase the chance of success in Phase II. Among others, correlative analysis and translational data can confirm whether we observe drug effects, our own mechanism, together with learning on how to deal with toxicities observed in early development. At this point in the program, we feel encouraged that our clinical observations support FADRA's presumed mechanism of action. The phase two proof of concept or POC stage will consist of multiple cohorts defined by histology. We expect that cohorts may enroll at different rates. For example, it is possible that the fastest ones will be those in which we have already seen anti-cancer activity during the dose escalation stage. As previously reported, we have seen PRs and stable disease in patients with T cell lymphoma, women's cancers, including cervical, endometrial, and ovarian, and pancreatic cancer, all on FADRA monotherapy. Clinical data from this open-label POC stage will be reported as they become available. When biotech companies enter negotiations for out-licensing assets or a strategic exit, preparing the commercial drug product, or DP, is often kicked down the road to be dealt with by the next owner of the asset. Such an election can have a profoundly negative impact on valuation, as the timelines to launch become apparent to the licensee or purchaser. Mindful of these matters, the cyclosol team has been proactively investing in a tablet formulation of FADRA to replace the capsule currently used in clinical trials. A tablet VP has further advantages to capsules in terms of patient convenience and increased compliance. As a tablet VP, OFADRA has recently become available. We will treat a few patients with it within the Phrase 1 part of our ongoing 065-101 study. We will provide further updates on this project as they emerge. Let us now turn to PLOGO. In our 140-101 study, we are evaluating PLOGO in dose escalation stage as a treatment for patients with advanced solid tumors and lymphoma. We are currently dosing patients at dose level four. PLOGO has previously shown early signals of anti-cancer activity at low dose levels in patients with biliary tracts, non-small cell lung, and ovarian cancer. Our preclinical program, aiming to elucidate PLOGO's differentiated biological profile, has revealed that, alongside the inhibition of PLK1, PLOGO has also demonstrated an epigenetic mechanism of action. This property may lead to a biomarker-driven clinical study in the future. Over the coming months, we expect key data readouts from the Phase I-II studies for FADRA and PLOGO. We expect to report complete dose escalation data with FADRA, followed by initial data from the FADRA Phase II POC stage, which is expected in the second half of 2023. Dose escalation in the PLOGO study continues, and we expect to report initial data in mid to late 2023. We believe that our medicines are differentiated from other molecules in their respective class with properties which may be best in class. I will now turn the call over to Dr. Mark Kirschbaum, our chief medical officer, to provide details on recent clinical data. Mark?