Cyclacel Pharmaceuticals, Inc.
Q1 2016 Earnings Call Transcript

Published: 12 May 2016

[Operator:]

Good afternoon and welcome to the Cyclacel Pharmaceutical’s First Quarter 2016 Results Conference Call and Webcast. Today’s call is being recorded. At this time, all participants have been placed in a listen-only mode and the floor will be opened for your questions following the presentation. [Operator Instructions] The company will also be accepting a limited number of questions submitted for via email to the address [e-mail]. It is now my pleasure to turn the floor over to Robert Flamm, Senior Vice President of Russo Partners. Please go ahead.

[Robert Flamm:]

Thank you, Maria. Good afternoon and welcome to our quarterly conference call. During today’s call, members of our senior management team will review Cyclacel’s financial performance and business highlights for the first quarter ended March 31, 2016. Before turning the call over to senior management, I would like to remind everyone that during this conference call any 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-K. These filings are available from the SEC or on our website. All of our projections and other forward-looking statements represent our judgment as of today and Cyclacel does not take any responsibility to update such information. For those of you on the phone or listening via webcast, please note that we will be accepting and answering a limited number of questions submitted via email to the address [e-mail]. With us today are Spiro Rombotis, President and Chief Executive Officer; Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs. At this time, I would like to turn the call over to Spiro Rombotis, our President and CEO. Spiro?

[Spiro Rombotis:]

Thank you, Robert, and good afternoon, everyone. On today’s call, we will provide an update with regard to the follow-up of patients in our SEAMLESS Phase 3 study and then discuss progress in three studies with our cyclin-dependent kinase or CDK inhibitor programs. In this regard, we’re delighted that data from our Phase 1/2 combination study of seliciclib and sapacitabine in patient with advanced solid tumors has been selected for an oral presentation at the 2016 ASCO Annual Meeting. First, an update on SEAMLESS. As of this call, 2.6% of the required events remained to be observed before mature data become available for initial analysis of top line results. As previously indicated, we anticipate that the required number of events will occur around the end of the first half of 2016. In light of the reduced frequency of pooled events, precise forecasting of event-based study readouts is challenging. Once mature data become available, we will determine submissibility for marketing authorization. We have been encouraged by investigators participating in SEAMLESS to continue follow-up. As a reminder, the last patient who was randomized in December 2014 or approximately 1.5 years ago. In preparation for marketing authorization submissions, we have been meeting with experts to claim our regulatory strategy. Let us now turn to our CDK inhibitor programs and in particular, our ongoing Phase 1/2 seliciclib, sapacitabine study. As mentioned, the oral presentation at this year’s ASCO will take place in the morning of June 6. Dr. Sara Tolaney of the Dana-Farber Cancer Institute in Boston will provide a safety and efficacy update on the treatment and follow-up of approximately 65 patients enrolled in escalating those parts 1 and 2 of the study, evaluating an all oral combination regiment of seliciclib and sapacitabine in patient with advanced solid tumors. ASCO has announced that abstracts of communications accepted for the conference will become available at abstracts.asco.org at 5

[Paul McBarron:]

Thank you, Spiro. As you saw from today’s press release regarding our consolidated financial statements for the quarter ended March 31, 2016 and March 31, 2015, our cash and cash equivalents were $17.1 million. We have no debt. Revenue for the three months ended March 31, 2016 was $0.1 million compared to $0.5 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND directed preclinical development of CYC140, a novel orally available polo-like Kinase 1 or PLK 1 inhibitor in 2016. Research and development expense decreased to $2.5 million for the three months ended March 31, 2016 compared to $4.3 million for the same period in the previous year. The decrease was primarily due to reduced study and clinical supply costs associated with the SEAMLESS Phase 3 trial, which completed enrolment in December 2014 offset by increased expenditures primarily related to the first in human Phase 1 study of CYC065 and grant supported research and development. General and administrative expenses for the three months ended March 31, 2016 decreased slightly to $1.4 million, compared to $1.5 million for the same period in 2015. As I mentioned earlier, as of March 31, 2016, our cash and cash equivalents were $17.1 million. During the second quarter, we will add approximately $2.1 million to this balance with a receipt of R&D tax credits from the UK government. Based on current plans, the company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs, including the all oral combination of seliciclib and sapacitabine and completion of the Phase 1 study of CYC065 in advanced solid tumors with a cash runway through the end of 2017. Operator, we are now ready to take questions.

[Spiro Rombotis:]

Thank you all for participating in our update call and your support of Cyclacel’s efforts to serve patients in need. We look forward to updating you on our programs and seeing some of you at 2016 ASCO Annual Meeting. Operator, at this time you may end the call.

[Operator:]

Thank you. Ladies and gentlemen, this does conclude today’s Cyclacel Pharmaceuticals’ first quarter 2016 earnings conference call. You may now disconnect and have a wonderful day.