Bill Harris – Corporate Controller Spiro Rombotis – President and CEO Paul McBarron – EVP-Finance and COO Dr. Judy Chiao – VP, Clinical Development and Regulatory Affairs.

Mike King, Jr – JMP Securities.

Good afternoon and welcome to Cyclacel Pharmaceutical Third 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, Krista. 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, 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 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..

Announced the results of the SEAMLESS interim analysis for futility and safety analysis of approximately 400 randomized patients around the end of this year or early 2015; completion of enrollment in SEAMLESS around the end of this year or early 2015; complete visibility assessment of the MDS, RCT; begin patient enrollment of the MDC, RCT in 2015; announce top line outcomes of the SEAMLESS trial during second half 2015 or first half 2016; report updated Phase I sapacitabine and seliciclib combination data in patients with solid tumors; advance our earlier pipeline assets.

We will now review our financials.

Paul?.

Thank you, Spiro. As you saw from today’s press release regarding our consolidated financial statements, for the quarters ended September 30, 2014 and September 30, 2013, our cash position was $26.7 million as of September 30, 2014 compared to 31.1 million at the end of 2013.

The movement of $4.4 million was primarily due to approximately $10.8 million of net proceeds from the sale of common stock, partially offset by $50 million of net cash used in operating activities. There is no outstanding debt.

Revenue for the three months ended September 30, 2014 was $0.7 million compared to 0.3 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, our CDK inhibitor, to IND and to complete IND directed preclinical development of CYC140, a novel oral available Polo-Like Kinase 1 or PLK1 inhibitor.

Research and development expenses increased to $5 million for the three months ended September 30, 2014 compared to 4.6 million for the same period in the previous year.

The increase was primarily due to cost related to grant funded research and development, partially offset by the absence of drug manufacturing costs related to the SEAMLESS study that were incurred during the three months ended September 30, 2013.

Research and development tax credits for the three months ended September 30, 2014 and 2013 were approximately $0.7 million. The R&D tax credit related to cash we elect to receive annually from the UK tax authorities for eligible R&D expenditure which also includes our clinical studies.

General and administrative expenses for the three months ended September 30, 2014 decreased to $1.4 million compared to 1.5 million for the same period in 2013 with the decrease primarily due to lower legal and professional fees.

In summary, we continue to have sufficient capital resources to fund our operations beyond the projected top-line data readout of SEAMLESS.

Spiro?.

Thank you, Paul. We’re now ready to take your questions..

The floor is now open for questions. (Operator Instructions) Our first question comes from the line of Mike King with JMP Securities..

A couple of things that I wanted to ask about and I hopefully I won’t run too long. First of all, I just wanted to ask about the MDS study, just curious about the definition of feasibility.

Based on your formal remarks Spiro, it sounded to me like that’s more of a matter of contracting as opposed to any other technical aspect of the study, but perhaps you can clarify that a little bit..

This is a question for Judy to answer..

I think that the feasibility is a formal assessment to looking at the interest of investigators to participate in the randomized Phase 2 study as designed which included that whether they think that the control arm is appropriate and whether they have the suitable patient populations.

So I think it’s a pretty formal process and we have awarded the project [indiscernible]. Also, I think that we really would take a look at the results to decide whether it’s feasible to do that or not..

Could you say anything about what you’re thinking about as far as the control treatment would be?.

It’s going to be monotherapy..

Is there any data in the literature to support the use of [indiscernible] in an HMA failure population that gives us any expectation that there will be activity there?.

The [indiscernible] has been used the most extensively. They have not been used exclusively, should I say, in such a population. But it's wonderful choice. In a recently completed a Phase 3 study by Onconova, I believe it’s one of the physicians' choice.

So it is, we think, synthetically acceptable and we see this as one of the most active agents in leukemia. Its activity in this patient population of hypomethylating agent failures has not been fully extensively studied in large scales, but it definitely has been used in other studies..

And from an FDA standpoint, you don’t think they would be convinced that a single arm trial would be acceptable given that there is no agreed upon standard of care?.

Mike, I think a single arm study is always difficult because it depends on what the endpoint that you want to look at it, that if it's a survival endpoint, that would be a non-go with any regulatory agencies.

Thinking here that the hypomethylating agent themselves in the front line has CR and PR in the single digits, I think to expect it to have a highly refractory population to go in full response rate is probably not a very good strategy..

And to remind the audience, in our randomized study in MDS, the active arm will be an alternating schedule of sapacitabine with low dose [indiscernible] and as you’ve already heard from Judy, the control arm will be [indiscernible]. So we have very clear separation of the effect that may be observed in this design..

Let me just turn quickly to SEAMLESS, a couple of questions there. I know we talked about both of these before, Spiro, but I'd love to get an update on each.

And the first one is sort of the enrollment, the shape of the enrollment curve with Europe coming on this year, you pointed out that the enrollment time has been -- as how I get to that of the DACO-016 study, but I wonder if the -- it would seem like in DACO-016 your enrollment might have been steadier but slower, whereas you might be sort of [indiscernible].

So I am just wondering if are you going to need to do any kind of statistical adjustment on the population when you unblind to account for the different enrollment periods?.

Mike, you are exactly correct. Unlike DACO-016, we have the adding hurdle to jump over of the lack of approval of the decitabine in Europe for AML for quite sometime, almost two years into the study. But then as many of you may remember, the EMA approved decitabine on its own in the DACO-016 negative trial and the drug reached the market.

And following registration and pricing approvals, we opened the study for European investigator. So you're correct, we have this very rapid increase in the slope of the enrollment curve early this year as we open the European sites. And as you already heard, we have more than trebled the total number of sites.

At this point we don’t expect based on our analysis of the pool data that we have to make any adjustments to this study ASCO specifically because we’re very much around what was predicted some three years plus ago in terms of the rate of events and enrollment time to complete the study. So at this point not that we expected..

And also can you tell from the pooled analysis whether the patients in Europe are analogous to the patients in the U.S.

in terms of baseline characteristics, demographics, flat count, et cetera?.

Mike, we have just met for one DSMB. We haven't met with the next DSMB yet. The last DSMB we don't believe there were substantial differences between the U.S. and European patients just on the limited numbers that we pooled the data. We’re not allowed to locate [indiscernible] of course but we will look at the data..

One point of this differentiation for the demographic and patient characteristics in DACO-016 Mike, is that we’re enrolling 90% plus of our study in the U.S. and the Western European sites. There are very few below 10%.

At the end of the day patients from Easter Europe and from AGM Australia which were important components of the geographical diversity in DACO-016. So in that regard, there is less heterogeneity as a practice characteristics. But as Judy said, until we see the firm demographic analysis before next year, so maybe it will be hard to speculate..

And then my second question on the SEAMLESS trial. Again, we talked about this.

But I forget if you're able to see the number of cycles and whether the -- given again the blinded data, whether the patients are getting the expected number of cycles so that's indicative of the tolerability and potential longer therapy?.

Mike, we can say that because the European sites came onboard this year. So the some patients are still on. So it's not a fair thing to do to compare to U.S. patients who we have been enrolling for the previous two years, so if that’s what you meant..

Well, I am not sure. I just didn’t know if there was any ability, even maybe even before you opened Europe, to see if patients were getting at least two cycles of sapa and Dacogen..

We’ll, I think all I can say is that based on the DSMB review, whether we look at core data, the mortalities is not any different than what we would have expected on the 30-day and 60-day..

In other words, there is no pattern of discontinuation or [indiscernible] Mike that [Multiple Speakers] pool data. So until one have the benefit of unblinding, it's going to be hard to deduce what's going on. But there's been nothing unexpected in all the trial that has unfolded. It's pretty much according to design and has actually taken place.

So, we don’t see an early gradient of withdrawal or some other kind of reason. I believe that they have ongoing as expected..

No, I am thinking the opposite. I am thinking that patients are getting more cycles than what we had expected.

How many average cycles in DACO-016 was four if I remember correctly?.

That’s right, it was four..

And then finally switch gears on 065, just wondering what additional work if any needs to be done before the IND can be dropped? And maybe you can talk a little bit about why targeting CD case 209 are of interest as opposed to palbo or ELI011 which are hitting 46..

The first question is, there is nothing left to be done as far as the formal part of filing the IND. As we mentioned in the earlier remarks, we’re now discussing with our advisors and second, top key opinion leaders of total populations to explore the drug in Phase 1.

Clearly in a program like this we’re following on the footsteps of our extensive clinical experience with seliciclib, we have some opportunity to do this right efficiently, to pass it [indiscernible] in certain specified population that we have talked about in the earlier section of the call.

The next question you asked is about the [indiscernible] profile and David Blake, our Head of Research, but Dr.

Blake if he was here would tell you that Cyclacel was informed in this topic from the work of our founding scientist Professor David Lane who has for long time favored the CDK29 profile because it's highly differentiated mechanistic and cell cycle biologic effects on cancer cells.

I think very briefly at the risk of oversimplifying complex biology, 46-inhibitors tend to operate on the G1 stage of the cell cycle, delaying the transit of cancer cells at that point and often times associated with synapses.

CDK209 inhibitors tend to be involved later cell cycle check point control, the G2M checkpoint, on a dose dependent basis and do induce [indiscernible] death of cancer cells, not synapses.

So for these historical reasons as well as our preclinical and clinical data, we have steered our pipeline evolution evidently in the CDK29 group of drugs and that's why we're not overlapping with the two that you mentioned.

This doesn’t suggest that if on future date a combination of a CDK46 inhibitor could not be contemplated with a CDK2 9 inhibitor. Why? Because if the 46 specific compounds eventually in resistance, it is plausible that CDK29 profile drugs could reverse this resistance exactly as those sides are showing with another drug with trastuzumab.

So no overlapping other forms, possibly different mechanistic and biological effects, but possibly down the road [indiscernible] appropriate rational for combinations in clinical trials..

There are no further questions. I will now turn the floor back over to Spiro Rombotis for any additional or closing remarks..

Thank you, operator. Thank you everyone for listening to our quarter 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 end 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..