Cyclacel Pharmaceuticals, Inc.

Good afternoon and welcome to the CycloCell Pharmaceuticals second quarter 2023 results conference call and webcast. At this time, all participants are in a listen-only mode. After today's calls, members of the financial community will have the 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 questions, we ask that you please pick up your handset to allow 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 conference call over to the company. Please go ahead.

Good afternoon, everyone, and thank you for joining today's conference call to discuss cyclical financial results and business highlights for the second quarter of 2023. 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 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 filing with the Securities and Exchange Commission, which include, among other things, our forms 10-Q and 10-K. All of our projections and other forward-looking statements represent our judgments as of today, and TycoSales does not take any responsibility to update such information. With us today, Vice-President and Chief Executive Officer. Paul McFerrin, Executive Vice President, Finance and Chief Operating Officer. And Dr. Mark Kirschbaum, Senior Vice President and Chief Medical Officer. Biro will begin with an overview of our business strategy in progress. Mark will provide details on CycloSelf clinical programs. And Paul will provide financial highlights for the second quarter of 2023, which will be followed by a Q&A session. At this time, I would like to turn the call over to Cyril.

Thank you, Grace, and thank you, everyone, for joining us today for our quarterly business update. Both clinical programs with Fadracyclib, or FADRA, and Plogocertib, or Plogo, are progressing well, and we are on track to deliver key data readouts over the coming months. We expect to report complete dose escalation data with FADRA and determination of the recommended phase 2 dose, or RP2D, and in the PLOGO study, dose escalation data and further elucidation of its novel epigenetic mechanism. In the FADRA 065-101 study in patients with solid tumors and lymphoma, our immediate task is to determine the recommended phase 2 dose, or RP2D, and we're very close to achieving this goal. Pharmacokinetic and pharmacodynamic data from the initial patients at this dose level suggest that we are achieving level above the predicted target engagement levels on our daily dosing. In addition to choosing RP2D, another parameter that may increase the chance of success in Phase II is the selection of the histologies in which we may expect to see anti-cancer activity. 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 also pancreatic cancer, all on FADRA monotherapy. Our Phase II sites have been selected with this in mind, and they are ready to participate once we declare RP2D and elect to start the Phase II proof of concept, or POC, stage of the study. Clinical data from this open-label POC stage will be reported as they become available. Based on the totality of data collected to date, we believe that FADRA's CDK2-9 profile is differentiated from other molecules in its class in terms of safety and anti-cancer activity reported thus far. Of note, a competitor recently disclosed that after a strategic portfolio prioritization, they have discontinued three clinical trials of their AZD4573 candidate. AZD4573 is a CDK9 inhibitor administered intravenously once a week. We believe that continuous pressure on CDK2 and CDK9 targets is required to enable apoptosis. Accordingly, FADRA is a CDK2-9 inhibitor administered by oral tablets on a daily schedule. Let us now turn to PLOGO. We are very excited that PLOGO could emerge as a PLK1 inhibitor with novel epigenetic activity. In our 140-101 study, we are evaluating PLOGO in escalating doses, now at dose level 5, as a treatment for patients with advanced solid tumors and lymphoma. PLOGO has shown early signals of anti-cancer activity at low concentrations in patients with adenoid cystic carcinoma, biliary tract, non-small cell lung, and ovarian cancer. Our preclinical program aiming to elucidate PLOGO's differentiated biological profile has revealed novel epigenetic activity at low concentrations. If further data corroborate these findings, we may enroll in the future one or more patient cohorts selected on the basis of specific biomarkers. I will now turn the call over to Dr. Mark Kirschbaum, our Chief Medical Officer, to provide details on recent clinical data. Mark?