Cyclacel Pharmaceuticals, Inc.

Good afternoon and welcome to the Psychocell Pharmaceuticals fourth quarter and full year 2023 earnings 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 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 question, 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 Cyclasel's financial results and business highlights to the fourth quarter and financial year ended December 31st, 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 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 forms 10-Q and 10-K. All of our projections and other forward-looking statements represent our judgment as of today, and Cyclone South does not take any responsibility to update such information. With us today are Ciro Lombatis, President and Chief Executive Officer. Paul MacDarren, Executive Vice President, Finance and Chief Operating Officer. And Dr. Brian Schwartz, Chief Medical Officer. Zero will begin with an overview of our business strategy and progress. Brian will provide details on PsychoSelf clinical programs, and then Paul will provide financial highlights for the fourth quarter in full year 2023, which will be followed by a Q&A session. At this time, I'd like to turn the call over to Spiro.

Thank you, Grace, and thank you, everyone, for joining us today for our fourth quarter and full year 2023 business update. We are delighted to be joined on today's call by Dr. Brian Schwartz, who has recently joined CycloCell as Chief Medical Officer. Many of you may know Brian when he was CMO at RQ prior to the acquisition by Merck in 2020, at which time he joined our board of directors. He has extensive clinical and product development experience, which will be instrumental in guiding our team to deliver key value inflection milestones. We are pleased to report on the progress of Hydrocyclet our CDK2 and 9 inhibitor, or FADRA for short. Having recently discovered a potential precision medicine approach for FADRA, we have determined the recommended phase 2 dose, or RP2D, and are ready to start the phase 2 proof-of-concept part of our 065-101 study. Taken together, our clinical and preclinical data suggest the hypothesis that patients with one or more chromosomal abnormalities, including CDKN2A, CDKN2B, and or MTAP, including deep deletions or loss of function, may be sensitive to FADRA. In this part, We will evaluate patient cohorts selected for their mutation or profile and or Phase I activity in various solid tumors and lymphoma. We will initially focus on two patient cohorts with CDKN2A and or CDKN2B abnormalities and T-cell lymphoma, from both of which we saw Phase I signals of activity, including responses. We believe that there is great unmet medical need and industry interest in the cancer patient populations identified by these abnormalities, which are closely located on chromosome 9 and are often co-deleted. TBKN2A gene deletions occur in several solid tumors, including bladder, breast, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous, melanoma, ovarian, pancreatic, and also in certain T-cell lymphomas. CDKN2B deletions occur in several solid tumors, including bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous and mesothelioma, melanoma, pancreatic, and others. As mentioned in our press release, we expect two key data readouts for FADRA this year. final data from the dose escalation part of the O6-5-101 study at a major medical conference, and later on, initial clinical activity from the Phase II proof of concept part. Also, at the upcoming AACR 2024 meeting, independent investigators will present the clinical proof of concept data for FADRA in various tumor types. I will now turn the call over to Brian to review our progress in the FADRA and PLOGO studies and discuss some of our clinical results. Brian?