Cyclacel Pharmaceuticals, Inc.

Good afternoon, and welcome to the CycloCell PharmaSchool's first quarter 2024 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. 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 Psychocell's financial results and business highlights for the first quarter ending March 31st 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 CycloSub does not take any responsibility to update such information. With us today are Spira Rombatis, President and Chief Executive Officer, Paul McFerrin, Executive Vice President, Finance and Chief Operating Officer, and Dr. Brian Schwartz, Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Brian will provide details on Cyclostyle's clinical program, and then Paul will provide financial highlights for the first quarter of 2024, which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.

Thank you, Grace, and thank you, everyone, for joining us today for our first quarter 2024 business update. As previously reported, we have closed the financing for $8 million in gross proceeds in a private placement priced at the market per NASDAQ rules. With additional resources in place, we have begun dosing patients in the Phase II proof-of-concept part of our 065-101 study evaluating fadrocyclib or FADRA for short, in patients with one or more chromosomal abnormalities, including CDKN2A and or CDKN2B deep deletions or loss of function. You will recall that we are pursuing a potential precision medicine approach for FADRA, an oral CDKN2A inhibitor, following findings in our clinical and preclinical data, which suggest the hypothesis that patients with one or more of these chromosomal abnormalities may be sensitive to FADRA. In the Phase II part, we are evaluating patients selected for their mutation or profile and or Phase I activity in various solid tumors and lymphoma. We're initially enrolling two patient cohorts, those with CDKN2A and or CDKN2B abnormalities and also T-cell lymphoma based on observation of anti-cancer activity, including responses in multiple Phase I patients. 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. CDKN2A 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. There are no approved drugs to treat patients with CDKN2A or B abnormalities. We expect two key data readouts for FADRA this year. Final data for the dose escalation part of the 065-101 study to be presented at the ASCO 2024 annual meeting in a few weeks and report on initial clinical activity from the phase two proof of concept part of the study in the second half of this year. I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the FADRA study. Brian?