Cyclacel Pharmaceuticals' (CYCC) CEO Spiro Rombotis on Q4 2015 Results - Earnings Call Transcript

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC)

Q4 2015 Earnings Conference Call

March 24, 2016 04:30 PM ET

Executives

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

Dr. Judy Chiao - Vice President of Clinical Development and Regulatory Affairs

Analysts

Operator

Good afternoon and welcome to the Cyclacel Pharmaceuticals’ Fourth Quarter And Full Year 2015 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 questions following the presentation. [Operator Instructions]

It is now my pleasure to turn the floor over to Robert Flamm, Senior Vice President with Russo Partners.

Robert Flamm

Thank you, [Indiscernible]. 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 fourth quarter ended December 31, 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.

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.

Spiro Rombotis

Thank you, Robert, and good afternoon everyone. On today’s call, in addition to our year-end business update, we will review progress with our clinical programs: first, we will review the status of our lead candidate oral sapacitabine capsules and its development in haematological malignancies with particular attention to SEAMLESS, our Phase 3 trial in acute myeloid leukaemia or AML; and second, we will review our cyclin dependent kinase or CDK inhibitor programs, including the Phase 1/2 combination study of seliciclib and sapacitabine and the Phase 1 study of CYC065, our second generation CDK inhibitor.

Our SEAMLESS study is approaching redoubts. As of this call, 4% of the required events remain to be observed before mature data become available for a mature analysis of topline results.

It is difficult to predict exactly when this will occur, but our current estimate is around the end of the first half of 2016. As you may recall SEAMLESS is a pivotal study, evaluating sapacitabine in newly diagnosed AML patients aged 70 years or older who are unfit or have refused to receive induction chemotherapy.

SEAMLESS is being conducted under a special protocol assessment agreement with the U.S. FDA. The primary endpoint is overall survival, comparing an experimental regimen of oral sapacitabine alternating with intravenous decitabine versus an active control arm of intravenous decitabine given alone as per label.

SEAMLESS was based on promising data from a pilot leading study demonstrating a median overall survival of eight months for the SEAMLESS regimen. The sophistical plan of the SEAMLESS study requires observation of 424 events or debts before mature data analysis.

As a reminder, in December 2014 or approximately 15 months ago, the data safety monitoring board or DSMB notified the company that the boundary for futility have been crossed, however the DSMB also said that there were no safety concerns and that survival could not be reliably estimated beyond six months recommended that the study continue to study final analysis.

Following 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 the suitability for regulatory submission.

The decision to submit a dose K [ph] for regulatory approval will depend on the totality of the data from SEAMLESS and supporting data from earlier studies. We consider that the case for submisibility will depend on an outcome of either superiority or equivalence versus control that is clinically relevant.

Of particular relevance maybe the case of decitabine’s European approval as a frontline treatment for AML in a somewhat younger population despite the fact that its Phase 3 trial called DACO-016 did not achieve statistical significance at the specified analysis versus a control arm of chemotherapy and best supported care.

We anticipate making the decision before the end of 2016 if data are available as expected around the end of the first half. Before moving on, it may be worth reflecting on the potential paradigm shift represented by the SEAMLESS approach in the frontline treatment of elderly patients with AML

The goal of the 45-year old mainstay intensive regimen of two chemotherapies given after admission to hospital is to induce complete remission. Because of its toxicity and high rate of death within the first two months, this intensive regimen is often unsuitable for the elderly patients studied in SEAMLESS.

Since there are no treatment alternatives, patients are typically offered either a clinical trial or end of life hospice care. We believe that we need to do better for these patients. SEAMLESS represents a low intensity treatment approach designed to offer a well tolerated treatment for elderly patients with the added benefit of staying in home to receive an oral medicine.

We are pleased to have the support of over 110 European and U.S. investigators and their IRBs to explore whether this approach has meted for elderly patients and eagerly await the results from SEAMLESS.

Let us now turn to our CDK inhibitor programs. We continue to follow patients in the ongoing Phase 1/2 dose escalation trial of an all oral combination regimen of seliciclib and sapacitabine in patients with incurable solid tumors. Promising and the counter activity have been previously reported with this regimen in an initial cohort of 38 patients, 16 of whom were found to carry BRCA mutations.

In particular, clinical benefit including PRs and stable disease of over 24 weeks were observed in approximately half of the patients found to carry BRCA mutations. Of note, durable PRs were seen in patient with multiple cancer type including BRCA positive breast, ovarian and pancreatic cancers.

In particular, two ongoing patients with BRCA positive breast cancer have achieved PR with durability of over one and four and a half years of treatment respectively. Such durability is unexpected in extensively treated patients. No PRs were observed in BRCA negative patients.

We expect to report updated data from this ongoing study at an upcoming medical conference. As of this call a total or approximately 60 patients have been enrolled around two thirds of which are BRCA positive.

Two different schedules with either sequential or a concomikent [ph] administration of the continence have been evaluated. The study objectives are safety and preliminary anti cancer activity.

In light of these data and investigator interest we have started an expansion cohorts in an enriched population of patients with BRCA positive breast cancer with a goal of further categorizing the activity seen in the original Phase 1 cohort of all commerce with advanced solid tumors.

In December 2015, we initiated a Phase 1 trial with CYC065, our second generation CDK2/9 inhibitor, in patients with solid tumors and lymphomas. CYC065 operates by the same mechanism as seliciclib our first generation CDK2/9 inhibitor but is more potent and specific.

The study is evaluating CYC065 safety, tolerability and pharmacokinetics. The results of this study will enable us to better determine next steps in the molecule development. Similar to palbociclib, the first CDK inhibitor approved in March of 2015 we anticipate that CYC065 may be best employed in combination with one or more anticancer agents in patients with both solid and liquid tumors.

We are excited by 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 2016.

For sapacitabine and SEAMLESS, continue follow up of patients until the requisite number of events occurs, which is anticipated around the end of the first half of 2016. Report topline results determine submasibility to regulatory authorities for marketing approval following analysis of the mature data set.

Progress, a pediatric investigation plan for sapacitabine with the EMA. For 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 controlled trial of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.

For our CDK inhibitor programs, progress the seliciclib and sapacitabine Phase 1/2 study in an extension cohort of breast cancer patients enriched for BRCA mutations.

Report updated Phase 1 seliciclib and sapacitabine combination data in approximately 60 patients with advanced solid tumors.

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.

Present additional preclinical data on CYC065 at the upcoming AACR conference in April.

Report data when available from on-going investigator sponsored trials 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?

Paul McBarron

Thank you, Spiro. As you saw from today’s press release regarding our consolidated financial statements for the quarters ended December 31, 2015 and December 31, 2014, our cash and cash equivalents was $20.4 million. The change in our cash position is a result of approximately $11.1 million of net proceeds from the sale of common stock in the year ended December 31, 2015 and approximately $2.9 million received in 2015 in respect of research and development tax credits related to 2014, offset by net cash utilized in operating activities. We have no debt.

Revenue for the three months ended December 31, 2015 was $0.4 million compared to $0.2 million for the same period of the previous year and the revenue was related to previously awarded grants from the U.K. government being recognized over the period to progress CYC065 into its IND and complete IND-directed preclinical development of CYC140, a novel orally available Polo-Like Kinase 1 or PLK 1 inhibitor.

Research and development expenses decreased to $2.5 million for the three months ended December 31, 2015 compared to $4.4 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 of 2014 offset by increased expenditures primarily related to the first inhuman Phase 1 study of CYC065 and grant supported research and development.

General and administrative expenses for the three months ended December 31, 2015 increased slightly to $1.7 million compared to $1.6 million for the same period in 2014.

Based on current plans, the company estimate 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 through to the end of 2017.

Operator, we’re now ready to take questions.

Question-and-Answer Session

Operator

Spiro Rombotis

Thank you, [Indiscernible]. 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. Operator, at this time you may disconnect the call.

Operator

This does conclude today’s conference call. You may now disconnect.

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