Alexander Fudukidis - Investor Relations, Russo Partners LLC Spiro Rombotis - President and CEO Paul McBarron - Executive Vice President, Finance and COO Judy Chiao - Vice President, Clinical Development and Regulatory Affairs.

Analysts:.

Good afternoon and welcome to the Cyclacel Pharmaceutical's Third 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 via email to the address ir@cyclacel.com. It is now my pleasure to turn the floor over to the company..

Thank you, operator. Good afternoon and welcome everyone 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, 2016.

Before turning the call over to management, I would like to remind everyone that during this conference call forward-looking statements made by management are intended to be 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 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 filings with the SEC, which include, among other things, our Form 10-K. These filings are available from the SEC or on our website.

As of the 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.

Spiro?.

Thank you, Alex. And good afternoon, everyone. On today’s call, we will update the progress of two of our clinical programs. First, an update on the timetable for the final data analysis of our SEAMLESS Phase 3 study in acute myeloid leukemia, or AML, and the next step in our regulatory planning.

And second, a brief review preclinical data from CYC065, our second generation cyclin dependent kinase inhibitor, which were presented at the annual Childhood Cancer Meeting in September. SEAMLESS represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy.

The follow-up of patient was completed late in the quarter and we have been undertaking data validation operations.

Given the sample size of the study, this takes time, but we are pleased to report that the process is nearing completion and we plan an eminent database lock after which the database will be transferred to our statistical analysis vendor.

Once the analysis is completed, we will report outcomes for the primary endpoints of overall survival, as well as secondary endpoints. It is difficult to precisely forecast when the analysis will be finished, but we anticipate reporting top line results in the coming weeks, at the latest in early 2017.

After thorough termination of the analyzed data we will determine submissibility to the regulatory authorities in Europe and the United States. We have engaged regulatory experts to help plan our filing strategy and prepare submission documents.

In this regard, we have submitted a pediatric investigation plan, or PIP for sapacitabine with the European Medicines Agency or EMA, which is required before a marketing authorization application can be accepted or validated by the EMA.

Since we're approaching the long-awaited reporting of top line results, we would like to take this opportunity to remind you of our strategy behind SEAMLESS. SEAMLESS is a pivotal study, evaluating sapacitabine as a front-line treatment in newly diagnosed AML patients age 70 years or older who are unfit or have refused induction chemotherapy.

There are no FDA approved medicines for these AML patients since intensive chemotherapy was introduced 47 years ago. It is estimated that approximately 17,000 patients in these frontline setting in Europe and the United States making this orphan indication an area of urgent medical need.

The study is being conducted under a Special Protocol Assessment agreement or SPA 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 was powered at 90% to detect a 27.5% improvement in overall survival, with final study analysis after observation of 424 mortality events which occurred in the quarter. With approximately 500 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 after nearly 2 years of follow-up we are preparing for the final analysis.

We have previously discussed on these calls, the outcome of the interim analysis in late 2014 allow you that the decision to make submissions for regulatory approval will depend on the totality of the data and data clinical relevance in these patient population.

We have also previously indicated that decitabine's sole European approval in AML in 2012 is a front-line treatment in patients aged 65 years or older based on the DACO-016. Study data may have relevance to our specimen of submissibility of the SEAMLESS data.

DACO-016 did not achieve statistically significant improvement in its primary endpoint of overall survival.

Let us caution that it will be inappropriate to suggest that such examples constitute precedents, not only are the investigational and control drugs and patient populations different, but so are the proposals and the clinical settings, suggesting that cross study comparisons could be misleading.

Let us remind you of the rationale for the SEAMLESS study design. Elderly patients have limited options after an initial diagnosis of AML. Most of them are unfit for or refused to be treated with a nearly 50-year old chemotherapy cocktail of two intravenous drugs, faced with bleak choices and a pour expected survival, we often elect hospice care.

In recent years AML opinion leaders have been suggesting that for elderly AML patients low intensity therapies should be considered. The SEAMLESS study is a scarce, low intensity treatment alternative which may explain the high level of interest of the study and participation from over 100 US and EU hospitals.

SEAMLESS offers AML patients hope of an improved outcome without the half-blood [ph] mission to receive intensive treatment which may also expose the compromised the new systems for infectious pathogens.

If they are randomized to the sapacitabine arm of the study, they can also benefit by staying in home, while receiving sapacitabine cycles via mouth. Quality of life and avoiding exposure to infections are important issues for this patient population.

If it reaches the market sapacitabine could become an attractive alternative for elderly patients with AML. We are deeply grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study.

Let me now turn to our CDK inhibitor program and in particular CYC065, our second-generation candidate in this important class. Preclinical data presented at September's annual Childhood Cancer Meeting demonstrated that CYC065 prolongs survival in MYCN addicted neuroblastoma models.

MYCN is a major oncogenic driver of neuroblastoma and orphan fatal childhood cancer. Addiction to MYCN is a characteristic of several solid tumors and hematological malignancies and many efforts have been directed at disrupting this cancer pathway.

However, these have been unsuccessful in the pathway escorts [ph] to be undruggable, which means that blocking MYCN directly has not been feasible. There are no approved drugs that act against the MYCN gene or MYCN proteins.

The study led by Professor Louis Chesle from the Institute of Cancer Research in London adds to the growing evidence of the value of CDK inhibition as a novel approach to treat certain types of cancer. The study showed that CYC065 reduces MYCN transcription and MYCN protein levels and have antitumor activity in neuroblastoma models.

Treatment with either CYC065 or a related Cyclacel significantly reduced tumor burden and prolonged survival in several in vivo models of neuroblastoma.

We are encouraged whether clinical data which expands and support earlier findings showing that Cyclacel Transcriptional CDK inhibitors target key molecular features of cancers with poor prognosis such as MLLr leukemias, or mixed driven lymphomas.

Furthermore, evidence from early clinical trials show that CDK 29 inhibitors can have a synergistic effect with other anticancer agents, including sapacitabine.

We look forward to reporting data from our ongoing CDK inhibitor clinical programs, including a first in human Phase 1 study of CYC065 in patients with solid tumors which has reached the sixth dose escalation level and also our DNA damage response program in ongoing clinical studies of sapacitabine and seliciclib live in BRCA positive patients with breast, ovarian and pancreatic cancers.

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

SEAMLESS study report top line data and determination of submissibility to regulatory authorities, anticipated in the fourth quarter 2016 or early 2017, progress the pediatric investigation plan for sapacitabine with a European medicines agency, DNA damage response program progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations plan to add Phase 1, part 3 to include BRCA mutation positive, ovarian and pancreatic cancer patients, CDK inhibitor program report top line results over the CYC065 Phase 1 trial in patient with solid tumors.

Report data when available from ongoing investigator sponsored trials evaluating seliciclib in patients with Cushing's disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis through a license and supply agreement with ManRos Therapeutics.

Sapacitabine Myelodysplastic Syndromes or MDS, plan a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and probability, plan A Phase 2 randomized controlled trial of sapacitabine in combination with other agents following a review of all relevant clinical data with mature follow-up.

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 quarter ended September 30, 2016 and September 30, 2015, our cash and cash equivalents were $18 million.

During the quarter, approximately $5.2 million was raised from the sale of common stock to the company's at-the market facility with FBR Capital Markets. A further $1.5 million was received in October through this facility. This results in a pro forma cash balance as of September 30, 2016 of $19.5 million.

Based on current plans, the company estimates that it has capital resources to fund operations through the second quarter of 2918. We have no debt.

Revenue for the three months ended September 30, 2016 was $0.2 million compared $0.7 million for the same period of the previous year, with a decrease primarily related to grant revenue related to CYC065 for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the same period last year. General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.

Operator, we are now ready to take questions..

[Operator Instructions] There are currently no questions..

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Thank you, operator and thank you for participating in our quarterly call and your support of Cyclacel's efforts to serve patients in need.

We are excited that after many years of hard work in our quest to offer a new treatment option for older AML patients, we are finally approaching analysis of the data from SEAMLESS in determining whether they were warrant regulatory submissions.

We look forward to reporting top line results, anticipated late in the fourth quarter of 2016 or in early 2017. Operator, at this time you may disconnect the call..

Thank you. That does conclude today’s conference call. You may now disconnect. And have a wonderful day..