Cyclacel Pharmaceuticals, Inc.

Good afternoon, and welcome to the CycloCell Pharmaceuticals fourth quarter and full year 2022 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 for optimal sound quality. Lastly, if at any time during the call you should require operator assistance, please press star zero. Please note today's call is being recorded. I would now like to turn the 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 fourth quarter and full year of 2022. Before turning the call over to management, I would 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 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 SEC, which include, among other things, our Form 10-K. This filing is available from the SEC or our website. All of our projections and other forward-looking statements represent our judgment as of today, and Cyclasel does not take any responsibility to update 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 CycloCell's clinical programs and Paul will provide financial highlights for the fourth quarter and full year of 2022, which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.

Thank you, Irina, and thank you, everyone, for joining us today for our quarterly business update. In 2022, we made excellent progress in our ongoing Phase I-II clinical programs with oral Fadracycline or FADRA and oral Plogocytib or Plogo in patients with solid tumors and lymphoma. Both programs are registration-directed and are well-positioned to deliver on key milestones during 2023. In the FADRA study in patients with solid tumors and lymphoma, we have enrolled three patients at dose level 6A. Recent pharmacokinetic and pharmacodynamic data from this dose level suggest that we are achieving target engagement levels on continuous dosing, which are commensurate or better than those observed in dose level 5 patients. We will enroll three more patients at dose level 6A per protocol, with the objective of determining the recommended phase 2 dose, or RP2D. At our R&D day in October 2022, we reviewed clinical activity observed in the first five dose levels of the study. We were excited to see monotherapy partial responses, or PRs, after the first treatment cycle in lymphoma patients with both cutaneous T-cell lymphoma, or CTCL, and peripheral T-cell lymphoma, or PTCL. This included a PR with a difficult-to-treat type of PTCL. In addition, 11 patients with various solid tumors achieved stable disease with target lesion reductions, and a pancreatic patient maintained stable disease for five cycles of treatment. As we approach the completion of the phase one dose escalation stage of the FADRA study, we look forward to starting the phase two proof of concept or POC stage. This will consist of multiple cohorts defined by histology, which are designed to be recruited in parallel, thus avoiding the delays inherent in sequentially designed studies. We expect that cohorts may enroll at different rates. It is possible that the fastest ones will be those in which we have already seen anti-cancer activity during the dose escalation stage. Clinical data from this open-label POC stage will be reported as they become available. At the R&D day, we also reported exciting new findings from our PLOGO program, which focuses on PLK1 inhibition for the treatment of advanced solid tumors and lymphoma. PLOGO has already shown early signals of anti-cancer activity at the first dose level in patients with non-small cell lung and ovarian cancer. We also have evidence demonstrating PLOGO's differentiated biological profile. Dose escalation in the PLOGO study has advanced, and sites are currently submitting patients for dose level four. Over the course of this year, we expect key data readouts from the phase one slash two studies for FADRA and PLOGO. We expect to report complete dose escalation data with FADRA around the middle of the year. Initial data from the FADRA phase two POC stage are expected in the second half of 2023. Dose escalation in the PLOGO study continues, and we expect initial data in mid to late 2023. Before handing over to Mark, I would like to reiterate that the CycloCell team is concentrating our efforts on bringing our two molecules to proof-of-concept stage and creating shareholder value. We are well on our way to achieving that with FADRA, and we will soon be in a position to potentially do the same for PLOGO. We are fortunate to be working with world-class institutions across the globe who are participating in our studies. 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?