Cyclacel Pharmaceuticals, Inc.

Good afternoon and welcome to the Cyclocell Pharmaceuticals second quarter 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 optimal sound quality. The company will also be accepting a limited number of questions submitted via email to the address ir at cyclacel.com. 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 over to the company.

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclasel's financial results and business highlights for the second quarter 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-Q. 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 CycloCell 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 review Cyclocell's clinical programs, and Paul will provide financial highlights for the second quarter 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. The major highlight of the second quarter is was our mid-year update on June 30th, at which we reported initial clinical results with oral Fadracycline, or FADRA for short. FADRA, our lead product candidate, is an orally available CDK2 and CDK9 inhibitor enrolling patients in a Phase I-II study for the treatment of solid tumors and lymphomas designated 065-101. Thus far, we have enrolled 17 patients in the dose escalation part of the study, reaching dose level five without dose-limiting toxicity. Based upon preliminary results in the first five dose levels with FADRA, dosed daily, we are highly encouraged with the evolving safety and anti-cancer activity profile of oral FADRA as monotherapy. Importantly, this anti-cancer activity has been observed during the phase one dose escalation stage, which typically treats all-comer, sicker patients who have received multiple prior therapies. Ordinarily, we do not expect to see much or any significant evidence of clinical benefit in such a heavily pretreated Phase I population. Initial observations of all FADRA activity as a single agent dose daily build on those in a prior clinical study which dose FADRA intravenously, albeit with a suboptimal dosing schedule. These included a patient with heavily pretreated MCO1-amplified endometrial cancer who achieved a confirmed complete response after initially achieving partial response. This patient remains on study after more than two and a half years of treatment. The 065-101 study of oral FADRA continues to enroll very well at four U.S., South Korean, and Spanish sites and is on track to establish recommended Phase II dose, or RP2D, within 2022. We anticipate starting the Phase II stage of this study shortly after RP2D. Dr. Mark Kirschbaum, our chief medical officer, will provide further details on this study and our other programs. As clinical data with all FADRA in 065-101 are starting to emerge, we're also encouraged by FADRA's competitive attributes, particularly as we survey the next generation CDK inhibitor landscape. Relative to other development stage CDK inhibitors, We believe that oral FADRA has the potential for best in class thus far based on dual targeting of CDK2 and CDK9, very good tolerability at higher dose levels, a daily dosing schedule, and preliminary anti-cancer activity in patients with lymphomas, endometrial, and pancreatic cancers. We note that targeting CDK2 appears to be gaining more visibility as an important target for the biopharma industry. For example, Pfizer recently disclosed plans to advance its CDK2 inhibitor into a substantial Phase II study for the treatment of breast cancer, which clearly represents a sizable investment and a vote of confidence in the class. Notably, this Pfizer molecule does not inhibit CDK9. Data from cyclocells clinical studies show that patients with gynecological cancers often overexpress multiple proteins that can be suppressed by targeting both CDK2 and CDK9. Hence, a dual inhibitor may have advantages over inhibitors that target a single enzyme. Our second clinical protocol, designated 065-102, is evaluating oral FADRA in leukemias or myelodysplastic syndromes and is now dosing patients at dose level 4. 065-102 may provide further opportunity to differentiate FADRA from other CDK inhibitors if it is effective in both solid tumors and blood cancers. Let me also briefly mention our third protocol, 140-101, which is actively enrolling patients with solid tumors and lymphomas in a streamlined phase 1-2 trial of our oral PLK1 inhibitor, CYC140. We believe that preclinical and early clinical data generated thus far support the potential of CYC140 single-agent activity. Importantly, This molecule is differentiated from the only other PLK1 inhibitor in clinical development on several attributes. We will have more to report on this compound, including details of its mechanisms of action, at our upcoming R&D day. I'd like to now turn the call over to Mark, who will provide additional details on the FADRA clinical development program and the rest of our pipeline. Mark?