Bill Harris - Corporate Controller Spiro Rombotis - President and Chief Executive Officer Paul McBarron - Executive Vice President, Finance and Chief Operating Officer and Secretary Judy Chiao - Vice President, Clinical Development and Regulatory Affairs.

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..

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 ir@cyclacel.com. 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..

first, our lead candidate oral sapacitabine capsules and the status of SEAMLESS, our Phase 3 in acute myeloid leukemia or AML; second, our progress in our cyclin dependent kinase or CDK inhibitor program, highlighted by the initiation of our first-in-human Phase 1 trial of CYC065.

As you may recall, SEAMLESS is a pivotal study, evaluating sapacitabine in newly-diagnosed AML patients aged 70 years or older who are unable or have refused to receive induction chemotherapy. It is estimated that in the United States there are over 6,500 patients in this frontline setting.

There are no FDA approved medicines for these AML patients since chemotherapy was introduced 45 years ago. This is therefore an area of urgent medical need. The SEAMLESS study is being conducted under a special protocol assessment agreement with the FDA.

The primary endpoint is overall survival, comparing in the experimental arm a regimen of oral sapacitabine alternating with intravenous decitabine versus an active control arm of intravenous decitabine alone.

The trial is designed to detect a 27.5% improvement in overall survival, with final study analysis to occur after observation of 424 mortality events. With a sample size of approximately 485 patients recruited in over 100 US and European hospitals, SEAMLESS is one of the largest studies conducted in AML.

Enrollment was completed in December 2014 and we’re now 11 months into the follow-up phase of the study. As of this week, approximately 8% of the 424 events remained to be observed before mature data becomes available for analysis.

At that time, an independent data management vendor will, as per protocol, break randomization codes and will conduct an initial analysis of the top line results. Although it is difficult to precisely forecast when all required events will be observed, we estimate this to occur in the first half of 2016.

Following unblinding of the randomization code and communication of top line data, analysis of the full data set will be conducted over several weeks. At that point, the company will review the data to determine their suitability for regulatory submission.

Switching gears, even though our focus at the company has been on SEAMLESS and its upcoming outcome, we have also been advancing our cyclin dependent kinase or CDK2/9 inhibitor program.

CDK inhibitors, the subject of the 2001 Nobel Prize for Medicine, reached the market earlier this year when the FDA approved palbociclib, a CDK inhibitor targeting CDK enzymes 4 and 6 for a subgroup of breast cancer patients. This event marked the emergence of this therapeutic class as an important new weapon in the war against cancer.

In the early days of Cyclacel, our Scientific Founder, Professor David Lane concluded that a differentiated strategy would be to target CDK enzymes 2 and 9 with the aim of overcoming resistance in difficult-to-treat advanced cancers.

As a result, over the years, we’ve been out extensive preclinical and translation of clinical development expertise with CDK2/9 profile. To date, two Cyclacel’s CDK2/9 inhibitors are in clinical trials, CYC065 and seliciclib.

Our CDK business strategy is to develop CYC065, a second-generation CDK2/9 inhibitor, for oncology indications, building on our experience in clinical trials with seliciclib, our first generation molecule. We intend to opportunistically explore seliciclib in selected combination and single-agent applications, mostly outside oncology.

Let us first address CYC065. In recent scientific conferences, Cyclacel scientists and independent investigators have elucidated the mechanism of action of CYC065 and have identified CDK2 and CDK9-dependent tumors against which we expect CYC065 is to have activity and which are clinically relevant.

These cancer types include hematological cancers, such as MLL-rearranged or MLLr leukemias, lymphomas or solid tumors addicted to the MYC oncogene and solid tumors addicted to Cyclin E, the partner protein of CDK2 such as triple negative breast cancer and uterine cancer.

In addition, CYC065 was synergistic in combination with our own sapacitabine in breast cancer cells that are producing findings from previous studies with seliciclib/ sapacitabine combinations. Independent investigators published data showing synergy with trastuzumab in breast and uterine cancers.

Recently, our scientists have also identified highly synergistic combinations CYC065 with Bcl-2, Bcl-xL inhibitors such as venetoclax, also known as ABT-199 in both AML and acute lymphoblastic leukemias. We will be presenting additional preclinical data when our CDK2/9 program and CYC065, in particular, at two upcoming conferences.

The first is the 4th Neuroblastoma Symposium in Newcastle Upon Tyne, United Kingdom at the end of November and the second is the 2015 San Antonio Breast Cancer Symposium in December. Data from these studies provide a strong rationale for the clinical development strategy of CYC065.

After completing the first-in-human dose escalation PK and PD determination Phase 1 study in patients with advanced solid tumors or lymphomas, depending on the data, we plan to expand our Phase 1 program to patients with hematological malignancies.

Now, let us turn to our first-generation CDK inhibitor, seliciclib, which has been dosed in over 400 patients in Phase 1 and Phase 2 studies. Seliciclib is an ongoing Phase 1 trial of an all-oral combination with sapacitabine [indiscernible] patients with advanced solid tumors.

In this study, an overall response rate of 55% has been observed in heavily pretreated breast, ovarian and pancreatic cancer patients and in particular those with BRCA mutations.

The durability of responses has been very encouraging, with some patients achieving PR and staying on study for more than 30 and 60 cycles of treatment or approximately more than 90 or 180 weeks. Our clinical investigators are encouraged by the responses to date and we will continue to follow up these patients.

In addition, we’re planning an extension study with this combination, regiment of two Cyclacel drugs, this time in a BRCA positive enriched patient population.

As there is extensive preclinical and clinical data with seliciclib in literature, we have been approached by independent investigators to evaluate seliciclib as a treatment in non-oncological diseases of abnormal proliferation.

Enrollment has started in an investigator-sponsored trial or IST of seliciclib for the treatment of Cushing’s disease at Cedars-Sinai Hospital in Los Angeles. This is a Phase 2 proof-of-concept open-label single arm trial. 16 patients will receive seliciclib for four weeks prior to standard of care treatment.

The primary objective of this study is to study the extent of reduction of urinary free cortisol levels and safety. The principal investigator suggested that if the trial of seliciclib proves successful, it may need to improve treatment outcomes for patients with Cushing’s.

Although it is early in this study, the investigators have informed us that reductions in urinary free cortisol levels have been observed in the first two patients treated with seliciclib. During the quarter, we entered into an agreement with ManRos Therapeutics SA for the development of seliciclib in cystic fibrosis.

We have received milestone payments in line with this agreement and we’re informed that ManRos will initiate a Phase 2 clinical study of seliciclib in cystic fibrosis patients shortly. We’re excited about our CDK programs and, in particular, the potential of CYC065 as a potent and differentiated CDK inhibitor.

Before turning over the call to Paul, let me summarize our key upcoming milestones.

For sapacitabine, continue to follow-up enroll patients in SEAMLESS until the pre-specified number of events is observed, expected to occur during the first half of 2016; submit a pediatric investigation plan to the European Medicines Agency; extend the Phase 1/2 trial of a combination regimen of sapacitabine and seliciclib in a BRCA mutation enriched patient population; make a decision on Phase 2b randomized control trial in MDS following review of all relevant clinical data with mature follow-up.

For CYC065, continue enrolling patients in the first-in-human Phase 1 clinical trial in patients with advanced solid tumors and for seliciclib, support collaborators in industry and investigator-sponsored trials of seliciclib in patients with Cushing’s disease, rheumatoid arthritis and cystic fibrosis. 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, 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 Instructions].

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?.

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..

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 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..

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..

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