Cyclacel Pharmaceuticals, Inc.
Q3 2015 Earnings Call Transcript

Published: 12 Nov 2015

[Operator:]

Good afternoon and welcome to the Cyclacel Pharmaceuticals’ Third Quarter Earnings 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 questions following the presentation. [Operator Instructions] It is now my pleasure to turn the floor over to Bill Harris, Cyclacel’s Corporate Controller. Sir, you may begin.

[Bill Harris:]

Thank you. 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 third quarter ended September 30, 2015. 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 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 Rombotis:]

Thank you, Bill, and good afternoon everyone. On today’s call, in addition to our business update, I would like to bring you up to speed on the progress of our clinical programs

[Paul McBarron:]

Thank you, Spiro. As you saw from today’s press release regarding our consolidated financial statements for the quarters ended September 30, 2015 and September 30, 2014, our cash position was $22.7 million. The change in our cash position is a result of approximately $9.2 million of net proceeds from the sale of common stock year-to-date and approximately $2.9 million received for 2014 R&D tax credits, offset by net cash utilized in operating activities. We have no debt. Revenue was $0.7 million for both the three months ended September 30, 2015 and 2014. Revenue is partly related to previously awarded grants from the United Kingdom government being recognized over the period to progress CYC065 to the clinic and to complete IND-directed preclinical development of CYC140, a Polo-Like Kinase 1 or PLK 1 inhibitor. We also recognized $0.3 million during the three months ended September 30, 2015 from our license and supply agreement entered into last quarter with ManRos. Research and development expenses for the quarter were $2.9 million compared to $5 million for the same period last year. The decrease was primarily a result of reduced expenditures in the SEAMLESS Phase 3 study this quarter compared to the same period last year, which included study and startup costs associated with the expansion of SEAMLESS into Europe. General and administrative expenses for the three months ended September 30, 2015 remained relatively flat at $1.2 million as compared to $1.4 million for the same period in 2014. Based on current plans, we estimate that our current cash provides resources to reach beyond the availability of mature data for final analysis of SEAMLESS, to continue to explore the all-oral combination of sapacitabine and seliciclib, and completion of the first-in-human Phase 1 study of CYC065 in advanced solid tumors and lymphomas. The current cash balance excludes any amounts available under the controlled equity offering sales agreement we have with Cantor Fitzgerald and to date we have not drawn down from this facility. Operator, we’re now ready to take questions.

[Operator:]

[Operator Instructions]

[Bill Harris:]

We do have a question that we received via email. I’ll go ahead and read those questions now. We have a question that says what is the company plan for further clinical trials of sapacitabine in refractory MDS? And a follow-up question is further progress into clinical trials contingent on [CMOS] results?

[Judy Chiao:]

We currently are waiting for the mature one-year survival data from the single agent sapacitabine study in MDS patients, that’s our [indiscernible] 682-06 study, the study [indiscernible] looking at three different dosing schedules with the primary endpoint of one-year survival.

[Spiro Rombotis:]

And I should remind audience that MDS is a very different disease, although there might be some information read through from AML into MDS, we think it does not necessarily going to determine strategy in MDS. This would depend on the follow-up and also evolution of any other options for these patients who have either received in their frontline setting hypomethylating agents before becoming eligible to enroll in the Cyclacel sapacitabine study.

[Operator:]

[Operator Instructions] And there appear to be no questions. I would now like to turn the conference over to Spiro for any additional or closing remarks.

[Spiro Rombotis:]

Thank you, operator. And 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 progress and meeting some of you at upcoming conferences.

[Operator:]

Thank you. This concludes today’s conference call. You may now disconnect.