Alex Fudukidis - Russo Partners Spiro Rombotis - CEO Paul McBarron - COO Judy Chiao - VP Clinical Development & Regulatory Affairs.

Analysts:.

Good afternoon and welcome to the Cyclacel Pharmaceutical’s Conference Call to discuss our results of the Phase 3 SEAMLESS trial. My name is Lory and I will be your coordinator. Initially, all participants will be in a listen-only mode with that he question-and-answer session to follow at the end. [Operator Instructions].

I’d now like to turn the call over to Alex Fudukidis of Russo Partners..

Good morning everyone and thank you for joining our conference call to discuss the results of the Phase 3 SEAMLESS trial.

Before turning the call with 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 filings with the SEC, which include, among other things, our Forms 10-K -- 10-Q and 10-K. These filings are available from the SEC and on our Web site.

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. As a note, management will be taking questions via email. So please feel free to send us your questions by emailing us at ir@cyclacel.com. At this time, I would like to turn the call over to Spiro Rombotis, our President and CEO.

Spiro?.

Thank you, Alex and good morning, everyone. Today, we will provide an overview of the top-line results of our SEAMLESS pivotal Phase 3 study of oral sapacitabine capsules as a front-line treatment in elderly patients with acute myeloid leukemia or AML, who are unfit for or have refused intensive induction chemotherapy.

The study compared a treatment of alternating cycles of decitabine and sapacitabine versus decitabine alone for every cycle. As we reported this morning in the company press release, the study did not reach statistically significant improvements in the primary endpoint of overall survival or OS.

However, we higher rate of complete remission or CR, a secondary endpoint of the study was observed in the experimental arm, which was considered by the chair of the study to be a remarkable finding. Other endpoints and safety were similar between the arms.

In the stratified subgroup of patients with low baseline peripheral white blood cell count, comprising approximately two-thirds of the study’s population, better OS was observed on the experimental arm. The opposite was observed in patient with high white blood cell counts.

Full results from the SEAMLESS studies will be submitted for presentation at an upcoming medical conference. It is clearly disappointing that the study did not achieve the primary endpoint.

This was not unexpected in light of an interim analysis by the study's independent Data Safety Monitoring Board or DSMB announced in December 2014 or shortly after completion of enrollment.

The DSMB found that the futility boundary have been crossed and based on interim data, it would be unlikely that statistically significant improvement in OS will be reached.

However, the DSMB saw no reasons why patients should discontinue treatments and recommended that recruited patients be followed up to ensure that any OS improvements emerging later in the study would not be missed. We followed the DSMB's recommendations and patient follow up was completed during the second half of 2016.

The improvement in CR rates indicates that we should complete subgroup analysis over the next few months to identify patients who are most likely to benefit from treatments with the experimental arm. Having summarizing the outcome let us provide a reminder of the rational for the study.

AML in elderly patients is a very challenging disease because there are few effective therapies that most elderly patients could tolerate. We designed SEAMLESS, one of the largest trails conducted in this setting to identify and improve front-line treatment for patients who are not candidates for or have refused intensive induction chemotherapy.

The trail was conducted at 110 EU and U.S. sites over an approximately three year period and randomized 491 patients stratified for antecedent hematologic disorders, base line peripheral white blood cells and base line bone marrow blasts. This regular [ph] to today and the review of the data package received from our statistical analysis vendor.

Overall we consider the study was well designed and conducted. The arms were well balanced including the stratified groups. Approximately two-thirds of patients were enrolling in the United States and one-third in Europe. Medium age of all enrolled patients was 77 years.

As the primary end point have been missed our data review will be centered on stratified subgroup and other exploratory analysis in order to identify the patients who are most likely to benefit from treatments with the sapacitabine regiment. We anticipate this will take several months at a modest incremental cost.

From our data review to date, we've observed the following. Although medium survival was numerically higher for the experimental arm compared to the active control arm, OS did not reach statistical significance by the [indiscernible] test.

In patients who have discontinued therapy at the time of analysis approximately double the rate of CR was observed for the experimental arm rest versus the active control. Complete remission without plater recovery or CRP, partial remission or PR and major hematologic improvement or major HI were similar between the arms.

This was also the case for days in hospital and transfusion requirements. The two arms were comparable in terms of safety. In the stratified subgroup of patients with low base line peripheral white blood cell counts comprising approximately two-thirds of the study population, higher medium survival and better OS were observed for the experimental arm.

The opposite was observed for patients with white blood cell count. Unfortunately, the SEAMLESS study share Dr. Kantarjian is enabled to join us today as he is traveling abroad. We would like to share his view as recorded in the press release issued today, which is "that sapacitabine is active and safe in elderly AML patients.

Although, the experimental arm of alternating the decitabine-sapacitabine did not reach statistically significant superiority in overall survival, it is remarkable that an improvement in complete remission rate was observed.

Additional analysis of stratified and exploratory subgroups is warranted to identify patients who are most likely to benefit from treatments with the experimental arm." Depending on our analysis of the SEAMLESS data including subgroups and discussions with European and U.S.

regulators, we will evaluate our continued investment in sapacitabine in hematological malignancies. We will provide update on our progress and further plans as they develop. In closing, our comments about the SEAMLESS study, we would like to thank the patients, their families and the clinical investigators in the U.S.

and Europe for their support and the efforts during the several years it took to conduct the study and analyze the data. We will now turn to our clinical development priorities going forward.

For the past several years in parallel with the SEAMLESS study, Cyclacel has been working diligently to advance our pipeline by targeting biomarker selected patient populations in oncology. Broadly our strategy is to combine an approved drug with our investigational agents and compare them with the approve drug alone.

We are excited that we have been able to make progress in the strategy using Cyclacel’s long standing expertise in the area of cell cycle biology and CDK inhibitors. We have also benefited by advancing two of our programs with non-diluted financing by accessing UK government grant funding totaling approximately $5.6 million.

Our clinical development activities in oncology will now concentrate on our two ongoing clinical programs in DNA damage response and transcriptional regulation, which include our area of the historical expertise in CDK inhibitors.

These program’s target bio-market selective patients such as though with BRCA mutations or resistance to existing chemotherapy. The DNA damage response program is evaluating an orally administered sequential regiment of sapacitabine and seliciclib, a CDK2/9 inhibitor, in patients with BRCA positive, advanced solid cancers.

The transcriptional regulation program is evaluating CYC065, a CDK2/9 inhibitor in patients with advanced cancers, with emphasis on down regulation of the MCL-1 biomarker. Here is some background on these programs. First, the DNA damage response program.

Phase 1 data from this program in six to seven patients with various advance cancers were reported at an overall presentation at the 2016 American Society of Clinical Oncology or ASCO annual meeting.

Antitumor activity with durable clinical responses was demonstrated in a subgroup of 45 patients with breast, ovarian and pancreatic cancers, who tested positive for BRCA mutations. No responses were observed in BRCA negative patients.

We believe these are the antitumor activities observed in such patients by a targeted approach other than part inhibition. It may therefore present an opportunity to bring therapeutic benefits to the patient group. The regimen was orally administered in Part 1 of the study as sequential and in Part 2 as concomitant treatment.

More responses were observed using the Part 1 schedule. Since then Dana-Farber Cancer Institute investigators expanded the study and are currently enrolling a new cohort with only BRCA positive patients with breast cancer. Data from this expansion cohort are expected to become available in the second half of 2017.

We also are preparing Part 3 of this study to evaluate an alternative schedule and collect more data in BRCA positive patients with solid tumors other than blood cancer. It is worth nothing that our historical experience with sapacitabine including the AML study will be useful in the solid tumor development program.

This is particularly the case in terms of our understanding of its safety profile from a sizable data base of approximately 1,000 patients.

Turning to our transcriptional regulation program with our CDK inhibitor molecules and CYC065, which is a second generation CDK2/9 inhibitor with similar CDK selectivity, but 40 fold higher potency and improved pharmaceutical properties verses seliciclib.

We're enrolling a first in human Phase 1 trial for CYC065 in patients with advanced solid tumors. The study is evaluating CYC065's safety, tolerability and pharmacokinetics. In addition the study aims to investigate CYC065's effects on the MCO1 biomarker which is implicated in the evolution of resistance in cancer.

The study has reached the seventh dose escalation level without unexpected toxicities.

Target engagement of prolonged MCO1 separation in peripheral blood cells was observed in patient samples from the study as well as decreases in relations kinase substrate phosphorylation and increases in PARP cleavage [ph] which were consistent with the Company's per clinical data.

Similar to the first CDK inhibitor approved by FDA in 2015 palbociclib, CYC065 may be most useful as a therapy for patient with both liquid and solid tumors in combination with other anti-cancer agents.

We've published promising clinical data of CYC065 with such continent drugs including Bcl-2 antagonist such as venetoclax and HER2 inhibitors such as trastuzumab. When the CDK inhibitor class has been validated in the last few years with at least one approved drug generating substantial revenues.

We believe that we have a competitive position, with CYC065 as a potent and differentiated CDK inhibitor. Finally, in addition to the program just discussed we have a Polo-like Kinase 1 PLK inhibitor, CYC140 that has finished IND directive for clinical development.

For clinical studies CYC140 has shown promising results in various leukemias and esophageal cancer. With our current cash, we project to fund operations through the end of 2018 including the ongoing programs described above.

Our catalyst for the remainder of 2017 includes progress sapacitabine and seliciclib expansion cohort in BRCA positive breast cancer patients. Initiate Part 3 in BRCA positive patients with solid tumors other than breast cancer.

Report top-line results of the CYC065 Phase 1 trial in patients with advance solid tumors and initiated CYC065 development in patient with advance hematological malignancies. I will now hand over the call to the operator to take your questions.

Operator?.

Operator:.

Thank you, operator and thank all of your for joining us on today’s call to review the results of our Phase 3 study in AML and our strategy going forward. Operator at this time you can end the call..

Thank you for participating in today’s conference call. You may now disconnect your lines and have a wonderful day..