Robert Flamm - Senior Vice President with Russo Partners Spiro Rombotis - President and Chief Executive Officer Paul McBarron - Executive Vice President, Finance and Chief Operating Officer.

Good afternoon and welcome to the Cyclacel Pharmaceutical’s First 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 for via email to the address ir@cyclacel.com. It is now my pleasure to turn the floor over to Robert Flamm, Senior Vice President of Russo Partners. Please go ahead..

Thank you, Maria. 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 first quarter ended March 31, 2016.

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 on 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.

Spiro?.

Thank you, Robert, and good afternoon, everyone. On today’s call, we will provide an update with regard to the follow-up of patients in our SEAMLESS Phase 3 study and then discuss progress in three studies with our cyclin-dependent kinase or CDK inhibitor programs.

In this regard, we’re delighted that data from our Phase 1/2 combination study of seliciclib and sapacitabine in patient with advanced solid tumors has been selected for an oral presentation at the 2016 ASCO Annual Meeting. First, an update on SEAMLESS.

As of this call, 2.6% of the required events remained to be observed before mature data become available for initial analysis of top line results. As previously indicated, we anticipate that the required number of events will occur around the end of the first half of 2016.

In light of the reduced frequency of pooled events, precise forecasting of event-based study readouts is challenging. Once mature data become available, we will determine submissibility for marketing authorization. We have been encouraged by investigators participating in SEAMLESS to continue follow-up.

As a reminder, the last patient who was randomized in December 2014 or approximately 1.5 years ago. In preparation for marketing authorization submissions, we have been meeting with experts to claim our regulatory strategy. Let us now turn to our CDK inhibitor programs and in particular, our ongoing Phase 1/2 seliciclib, sapacitabine study.

As mentioned, the oral presentation at this year’s ASCO will take place in the morning of June 6. Dr.

Sara Tolaney of the Dana-Farber Cancer Institute in Boston will provide a safety and efficacy update on the treatment and follow-up of approximately 65 patients enrolled in escalating those parts 1 and 2 of the study, evaluating an all oral combination regiment of seliciclib and sapacitabine in patient with advanced solid tumors.

ASCO has announced that abstracts of communications accepted for the conference will become available at abstracts.asco.org at 5:00 PM Eastern on May 18. As previously disclosed, two ongoing patients with BRCA positive breast cancer have achieved PRs with durability of over 1.5 years and 4.5 years of treatments respectively.

Such durability is unexpected in this type of patients. At the 2013 AACR conference, we reported promising anticancer activity with this regiment, in the part 1 cohort of 38 [indiscernible] patients, 16 of whom were found to carry BRCA mutations.

In this BRCA positive sub group, durable clinical benefit including partial responses and stable disease of over 24 weeks was observed in approximately half of the patients. Of note, durable PRs were seen in patient with multiple cancer types, including BRCA positive breast, ovarian and pancreatic cancers.

No PRs were observed in BRCA negative patients. Because of the promising and durable activity signal observed with our combination regiment in BRCA positive patients, investigators at Dana-Farber have started enrolling an extension cohort of approximately 20 patients with breast cancer.

All patients in this cohort will have tested positive for BRCA and will undergo whole-exome sequencing with a goal of further characterizing the activity seen in earlier cohorts including prior treatments with platinum or PARP inhibitors.

Let me put in context our observation so far with this regimen with regard to the challenges of treating BRCA positive patient with breast cancer. BRCA 1 and BRCA 2 are tumor suppressor genes that quote for proteins that repair DNA damage or breaks in the single or double helix of DNA.

Disabling of the major DNA repair mechanism known as homologous combination or HR because of BRCA mutations significantly increases the risk of certain cancers including breast, ovarian, prostate and pancreatic cancers. Cancer cells with HR repair partly defects are particularly sensitive to sapacitabine.

Furthermore, seliciclib when given combination with sapacitabine enhances sapacitabine induced death of cancer cells via both the HR and NHEJ or non-homologous end joining. BRCA mutated cancers are aggressive and difficult to treat. Patients are frequently younger or middle-aged women and rarely men with an active lifestyle.

There are no approved therapies for BRCA positive breast cancers. Olaparib, a PARP inhibitor drug, received accelerated approval for BRCA positive advanced ovarian cancer, treated with three or more prior lines of chemotherapy. Approval was based on an objective response rate of 34% in a single arm study of 137 patients.

Medium duration of response was eight months with a range of 6 months to 10 months. Olaparib is myelosuppression and its labeled safety information includes a risk of secondary AML or MBS. Our investigational PARP inhibitor drugs are in clinical trials as single agents to treat patients with BRCA positive ovarian and breast cancer.

There is an unmet medical need in the population for well tolerated durable combination regimens that can control disease progression. Let us now turn to our Phase 1 first in human trial of CYC065, our second generation CDK29 inhibitor in patients with advance solid tumors and lymphoma as it continues to enroll. This study is led by Dr.

Geoffrey Shapiro of Dana-Farber. In this those escalation study, we have reached the fourth dosing level without severe toxicity thus far. CYC065 operates by the same mechanism of action as seliciclib, but it is more potent and has improved pharmaceutical properties. The study will evaluate CYC065 safety, tolerability and pharmacokinetics.

The findings from this translational study including data from patient bio-specimens will allow us to determine the effect of 065 on pharmacodynamics markers of biological activity such as MCL 1 protein levels and then form next steps in the molecule’s development.

Preclinical data with CYC065 represented last month at the American Association for Cancer Research, AACR, 2016 Annual Meeting and demonstrated the drugs therapeutic potential as a targeted on the cancer agent in B-cell lymphoma including double hit lymphoma.

The data also support beneficial combinations with BCL 2 inhibitors including the recently approved drug venetoclax and BET bromodomain inhibitors.

Taken together the data validate the putative mechanism of action of CYC065, which is to reduce levels of MCL 1 and notably also levels of the Myc oncoprotein, both of which can be elevated in B-Cell lymphoma. Lastly, let us turn to another seliciclib clinical study, the Phase 2 investigator sponsored trial or IST in Cushing disease.

Cushing’s is an endocrinological disease associated with the presence of a small tumor in the pituitary gland, resulting in a harmful excessive secretion of cortisol in the blood resulting in a condition called hypercortisolemia. Cushing’s an orphan diseases with limited treatment options especially after surgical failure.

The only approved non-surgical alternative is an injectable drug called corticosteroid. Unfortunately it only helps a small sub group of patients and is associated with the risk of diabetes onset.

On our last earnings call, we disclosed that the investigators reported that the first two patients treated with seliciclib achieved a normalization of elevated cortisol levels. The investigators have informed us that the third patient enrolled in the study also achieved normalization of hypercortisolemia.

The effect appears to occur rapidly after seliciclib administration by mouth, at dosing levels with which we have extensive safety data in oncology patients. Although, it is still early in the study, we are encouraged by results to date and will continue to monitor progress in this IST as we become aware of it.

Before turning over the call to Paul, let me summarize our key upcoming milestones for 2016. sapacitabine and SEAMLESS continue follow-up of patients until the requisite number of events occur, which is anticipated around the end of the first half of 2016.

Report top line results, determine submissibility to regulatory authorities for marketing approval following analysis of the matured data set, progress a pediatric investigation plan for sapacitabine with the EMA.

Sapacitabine in myelodysplastic syndromes or MDS initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.

Plan a Phase 2 randomized control trial of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow up, CDK inhibitor programs, progress the seliciclib and sapacitabine Phase 1/2 extension study in a breast cancer patient population enriched for BRCA mutations.

Report and an oral presentation at the 2016 ASCO Annual Meeting updated seliciclib and sapacitabine’s Phase 1/2 data in patients with advanced solid tumors.

Report top line results of the CYC065 Phase 1 trial in patient with solid tumors and lymphomas and report data when available from ongoing ISTs evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Seliciclib is also being evaluated in cystic fibrosis through a license and supply agreement with ManRos Therapeutics.

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 March 31, 2016 and March 31, 2015, our cash and cash equivalents were $17.1 million. We have no debt.

Revenue for the three months ended March 31, 2016 was $0.1 million compared to $0.5 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 to IND and complete IND directed preclinical development of CYC140, a novel orally available polo-like Kinase 1 or PLK 1 inhibitor in 2016.

Research and development expense decreased to $2.5 million for the three months ended March 31, 2016 compared to $4.3 million for the same period in the previous year.

The decrease was primarily due to reduced study and clinical supply costs associated with the SEAMLESS Phase 3 trial, which completed enrolment in December 2014 offset by increased expenditures primarily related to the first in human Phase 1 study of CYC065 and grant supported research and development.

General and administrative expenses for the three months ended March 31, 2016 decreased slightly to $1.4 million, compared to $1.5 million for the same period in 2015. As I mentioned earlier, as of March 31, 2016, our cash and cash equivalents were $17.1 million.

During the second quarter, we will add approximately $2.1 million to this balance with a receipt of R&D tax credits from the UK government.

Based on current plans, the company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs, including the all oral combination of seliciclib and sapacitabine and completion of the Phase 1 study of CYC065 in advanced solid tumors with a cash runway through the end of 2017.

Operator, we are now ready to take questions..

Operator:.

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 programs and seeing some of you at 2016 ASCO Annual Meeting. Operator, at this time you may end the call..

Thank you. Ladies and gentlemen, this does conclude today’s Cyclacel Pharmaceuticals’ first quarter 2016 earnings conference call. You may now disconnect and have a wonderful day..