Good afternoon and welcome to Cyclacel Pharmaceuticals’ Second Quarter 2014 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 your 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.
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 second quarter ended June 30, 2014.
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 the 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 Forms, 10-Q and 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.
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.
Thank you, Bill and good afternoon everyone. In this second quarter of 2014, we have been working hard on our SEAMLESS Phase 3 study as it enters its final stages and approaches completion of enrollment. In parallel we have continued to work on line extensions for sapacitabine and advancing our pipeline. We are making excellent progress with SEAMLESS our Phase 3 study of oral sapacitabine capsules as first line therapy in elderly patients with newly diagnosed Acute Myeloid Leukemia or AML, who are not candidates for or have refused standard intensive therapy.
As of today, over 70% of the required patients for the study have been enrolled with approximately 90 sites now open in both the U.S. and in Europe. The European expansion of SEAMLESS has progressed as planned with over 50 sites currently opened for enrollment alongside U.S. sites.
Notwithstanding the search of EU sites, we still forecast that the majority of patients in SEAMLESS will have been recruited in the United States. Based on these facts we continue to expect completion of SEAMLESS enrollments at the end of 2014 with top-line data readout in the second half of 2015.
During the quarter, we surpassed the 300 patient enrollment mark for SEAMLESS. This triggers the next schedule safety review by the Data Safety Monitoring Board or DSMB, which will review the data once 60 days or follow-up have been observed. Consistently with our past practice, we will make an announcement once the DSMB has met and advices us of their recommendations.
The next important milestone for SEAMLESS is the interim analysis for futility. This will occur when 212 events or deaths are recorded. Again once advised by the DSMB, we will report the outcome of their review.
During our first quarter call, we mentioned that we have begun preparations for compiling potential NDA and MAA submissions to regulators in the U.S. and Europe once data is analyzed with the advice of external experts. This includes those elements of the submissions which can be prepared in advance for final clinical data, including the non-clinical biopharmaceutical and manufacturing sections.
In addition drug substance or ADI validation campaigns are ongoing which would provide sapacitabine drug product for commercial launch. As recently announced, we are advancing our planning for the clinical development of sapacitabine and then second indication for patients with MDS after treatment failure of front line hypomethylating agents or HMAs.
This will be a Phase 2b randomized control clinical trial of a regimen of sapacitabine alternating with low dose cytarabine or ara-C versus an active control of low dose cytarabine. The trial will be sized for approximately 250 patients aged 60 years older with intermediate-2 and high-risk MDS will have failed prior HMA therapy.
The study’s primary end point will be over a survival and will be preceded by a leading stage. These plans were discussed in detail during a conference call with the key opinion leader Dr. Hagop Kantarjian at the end of May 2014 and a webcast of this discussion is available on our website www.cyclacel.com.
During the call, the heterogeneity of MDS was highlighted as well as how poorly this disease indication has been studied. Our proposed trial design provides the opportunity to collect further data for sapacitabine and importantly data on a contemporary news control arm.
We are currently conducting an assessment of feasibility for our proposed MDS study design in the U.S. and Europe. There is a significant unmet medical need in patients with MDS and we look forward to providing you with more details on our MDS program in the upcoming months.
Before turning over the call to Paul, let me summarize our key upcoming milestones, announced the outcome of the approximately 300 patient reviews by the DSMB, announced the outcome of the SEAMLESS futility analysis after 212 events. Completion of enrollment in SEAMLESS begin patient enrollment of the Phase 2b RCT in MDS after completing feasibility updated Phase 1 data of sapacitabine and seliciclib in patients with solid tumors.
We will now turn to review of our financials. Paul?
Thank you, Spiro. As you saw from today’s press release regarding our consolidated financial statements for the three months ended June 30, 2014 and June 30, 2013. Our cash position was $33.5 million as of June 30, 2014 compared to $31.1 million at the end of 2013 and we are well funded to complete the SEAMLESS study. Revenue for the three months ended June 30, 2014 was $0.4 million compared to $0.3 million for the same period last year.
The revenue it is related to grant awards from the UK government to progress CYC065 Cyclin Dependent kinase inhibitor to IMD and to complete IMD directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 or PLK inhibitor. Research and development expenses increased to $4.5 million for the three months ended June 30, 2014 compared to $2.6 million for the same period last year.
The increase was primarily due to study and site starter costs associated with the expansion of the SEAMLESS registration study into Europe. General and administrative expenses for the three months ended June 30, 2014 decreased to $1.4 million compared to $1.8 million for the same period in 2013.
The decrease was primarily due to higher legal and professional fees to the three months ended June 30, 2013. We have sufficient funds to complete enrollment in SEAMLESS and beyond the projected top-line data readout around the middle of next year. Our efforts remain focused on executing our strategy around SEAMLESS and advancing sapacitabine in MDS.
In addition, we continue to progress our earlier programs including CYC065, a novel CDK inhibitor supported by non-dilutive growth funding. Spiro?
Thank you, Paul. Operator, we are now ready to take questions.
[Operator Instructions] Our first question comes from the line of Kim Lee with Janney Capital.
Kim Lee – Janney Capital
Good afternoon, thanks for taking the question. Just a couple of questions here, the 50 sites right now currently in Europe, are you still on, or how many more sites you plan on adding in Europe, I know previously you guided to approximately 80 is that true?
Kim thanks for your question, yes that’s approximately correct. It depends of course as we approach the end of the summer if those last few sites will be able to open and enrolled, to that some point the study has been the entry its final straightaway and therefore it may not or make a lot of sense. But at the moment we expect all of the above approximately 80 to 85 sites are still there much of the running.
Kim Lee – Janney Capital
Okay, great. Can you give us any clarity when the 300 patients was enrolled?
We cannot give a precise time point and happened during the quarter, we’re not reversing the 60 day follow-up period.
Kim Lee – Janney Capital
And the DSMB will occur, the review that DSMB will occur as soon as that data becomes available for analysis.
Kim Lee – Janney Capital
Kim did you have a follow-on question?
That we have line and have been disconnected.
[Operator Instructions] There are no further questions, me operator will now turn the floor back over to Spiro Rombotis for any additional or closing remarks.
I think we have Kim Lee back on, so maybe operator, can you give her a chance to reconnect.
Kim Lee – Janney Capital
There is a follow-up question from Kim Lee with Janney Capital.
Kim Lee – Janney Capital
Yes, I apologize that I had a poor signal there. But the – are you able, Spiro my other questions are you look how many deaths so far has occurred in the study and is it reasonable to expect particularly now to announce that?
I think the question you’re asking is for Judy regarding the number of events. Judy you could answer Kim’s point.
Yes, we are monitoring the number of deaths, but we cannot predict when the total number of 212 death list would have occurred for the futility analysis.
But we expect Kim that this one happens soon after the DSMB review of the 300 patients for safety. So we think it’s probably a late 2014 early 2015 event. But as Judy said it’s hard to stimulate that, because over the rapid increase in the number of sites by joining the trial in Europe and that could set the run rate on historical extrapolations of the events not very reliable.
And then if we still have Kim on the line?
I will now turn the floor back over to Spiro for any additional or closing remarks.
Thank you, operator. And thank all of you for listening to our quarterly conference call. We look forward to updating you on upcoming events and meeting some of you at our upcoming investor conferences. Operator, at this time please conclude the call.
Thank you. This does conclude today’s teleconference. Please disconnect your line and close your webcast browser at this time. And have a wonderful day.
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