Cyclacel Pharmaceuticals, Inc.

Good afternoon and welcome to the CycloCell Pharmaceuticals Third 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 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 third 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 CycloSol 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 on Psychocell's clinical programs, and Paul will provide financial highlights for the third 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 updates. We have made excellent progress in our ongoing Phase 1-2 clinical programs with oral fadracycline, or FADRA, and CYC140, or 140, in patients with solid tumors and lymphoma. We were excited to provide new data with oral FADRA at last month's ENA 2022, or triple meeting, which exceeded our expectations for a Phase 1 study primarily designed to study safety and optimal dosing. Last week, we also reviewed FADRA and 140 clinical and preclinical data in our R&D day. In addition to the clinical data, which will be reviewed later on by Mark Kirschbaum, two of our principal investigators summarized the treatment landscape for T-cell lymphoma and hepatobiliary cancers. Each of these challenging indications has its own dedicated cohort in our Phase II study and are cancers of interest for FADRA for several reasons. One of these reasons was presented by the investigator from Seoul National University Hospital who shared preclinical data from her lab showing sensitivity to FADRA in biliary tract cancer cells, which suggests important potential for our drug, in this cancer type. The cells were obtained from patients in her clinic, one of the largest in the world specializing in biliary tract cancers. As for lymphoma, we were excited to see monotherapy PRs in patients with both cutaneous and peripheral T cell lymphoma. These included a PR in the angioimmunoblastic type of PTCL which is, as explained by the investigator from City of Hope, very difficult to treat. We also reported on exciting new findings from our 140 program, including early signals of clinical activity and further evidence of its differentiated biological profile. For those of you who were unable to join our R&D day, a replay of the event, including the key opinion leader presentations, is available on our website. Over the next 12 months, we expect multiple data readouts from the registration-directed Phase I-II studies for FADRA and 140. The dose escalation part of the FADRA study is approaching completion and will soon enter Phase II proof-of-concept stage Initial data from this stage with multiple cohorts by histology are expected around the middle of 2023. Dose escalation in the 140 study is a bit earlier as the sites are currently submitting patients for slots in dose level three. We expect initial data from this 140 study in mid 2023 as well. Before handing over to Mark, I would like to recognize the tremendous talent pool of skilled drug developers within the company and at our collaborating institutions. The CycloCell team is committed to our strategy of 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 will soon be in a position to potentially do the same for 140. We believe that our medicines are differentiated from other kinase inhibitors in their respective classes with properties which may be best in class. I will now turn the call over to our Chief Medical Officer, Dr. Mark Kirschbaum, to provide details on our recent clinical data. Mark?