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11/13/2023
Good afternoon and welcome to the Sly Cassell Pharmaceuticals third quarter 2023 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 Eccles Health's financial results and business highlights for the third 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 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 Psychosauce does not take any responsibility to update such information. With us today are Spira Lombatis, 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. Biro will begin with an overview of our business strategy and progress. Mark will provide details on psychosocial clinical programs, and then Paul will provide financial highlights for the third quarter of 2023, which will be followed by a Q&A session. At this time, I would like to turn the call over to Biro.
Thank you, Grace, and thank you, everyone, for joining us today for our quarterly business update. Both our clinical stage cell cycle programs with FADRA CycliBor FADRA and Plogocertib, or Plogo, are progressing well. We expect to shortly report complete dose escalation data with FADRA and determination of the recommended Phase II dose, or RP2D, to be used in subsequent studies. We also expect to report interim dose escalation data from the PLOGO study and disclose preclinical data supporting its novel epigenetic mechanism. Both FADRA and PLOGO have demonstrated single-agent anticancer activity. With oral FADRA, we have observed complete response, partial response, and stable disease in patients across a number of solid tumors and lymphoma with good tolerability. With oral PROGO, we have seen stable disease in several patients with various solid tumors at low dosing levels, which is novel for this class of medicines. We believe that based on the innovative properties and demonstrated clinical activity, both FADRA and PLOGO have the potential to be best in class in their respective classes. Based on encouraging results in the FADRA program, we have implemented a capsule-to-tablet switch with patients now receiving the more convenient tablet form of the drug. We expect that the tablet is more convenient for patients and reduces the burden of taking many capsules by mouth. As the tablet would ultimately be used in a commercial put-up of FADRA if it reaches the market, the switch also represents strategic value to an acquirer or licensee. At the present time, small-cap biotech companies are not in favor by the investment community. However, the CycloCell team has been hard at work building pharmaceutical value for the long term. This is attested by the enthusiasm demonstrated by our clinical investigators across the globe and their interest in doing the clinical work and offering our medicines as clinical trial options to patients in their care. By developing two innovative, high-value medicines, both of which were discovered by CycloCell, we hope to offer our stockholders the opportunity to realize strategic value. I will now turn the call over to Mark to review our progress in the FADRA and PLOGO studies and discuss some of the clinical results. Mark?
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