Full Press Release Details
Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results
-- Conference Call Scheduled March
28, 2018 at 4:30 p.m. EDT -
Berkeley Heights, NJ, March 28,
2018 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") a biopharmaceutical
company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious
disorders, today reported its financial results and business highlights for the fourth quarter and full year ended December 31,
2017. The Company's net loss applicable to common shareholders for the three months and year ended December 31, 2017 was $2.1 million
and $14.9 million, respectively. As of December 31, 2017, cash and cash equivalents totaled $23.9 million.
"We are greatly encouraged by
our clinical progress in 2017, particularly in our transcriptional regulation program with CYC065, our lead CDK inhibitor candidate,"
said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We have achieved clinical proof of mechanism with
CYC065 by demonstrating durable reduction of Mcl-1 expression in Phase 1 patients for at least 24 hours after a single dose. We
believe these unprecedented findings provide a strong rationale for evaluating CYC065 in combination with venetoclax in patients
with chronic lymphocytic leukemia, or CLL, and neuroblastoma, a predominantly pediatric cancer with poor prognosis. In collaboration
with an academic center and a pharmaceutical company we have developed a protocol for a Phase 1b/2 investigator-sponsored trial
to evaluate combination treatment of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer. We
have also completed analysis of the results from the SEAMLESS Phase 3 study of sapacitabine and plan
to discuss the data with regulatory authorities. Finally, we improved our cash resources raising
$14.9 million, net of expenses, which will fund currently planned programs through the first quarter of 2020. We look forward to
reporting our progress during the remainder of 2018, including clinical data from our studies as they arise, such as the previously
announced, oral presentation of Phase 1 data with CYC065 at the upcoming American Association for Cancer Research (AACR)
2018 Annual Meeting."
Fourth Quarter and Full-Year Highlights
Transcriptional Regulation Program:
CYC065 CDK Inhibitor
In part 1 of an ongoing, first-in-human, single agent, ascending
dose, Phase 1 study, prolonged reduction of Mcl-1 was observed in 11 out of 13 evaluable patients treated at the recommended Phase
2 dose, or RP2D, following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed
in 5 patients, of which 4 were treated at the RP2D and 3 were reported by investigators to have molecular features of their cancers
associated with CYC065's mechanism of action, including amplification of Mcl-1, MYC or cyclin E. The trial is being
conducted at the Dana Farber Cancer Institute in Boston. Part 2 of the Phase 1 translational study will evaluate additional dosing
schedules in patients with advanced solid tumors, in particular those with amplification of Mcl-1, MYC or cyclin E, including
subsets of high grade serous ovarian and uterine cancers. Several biomarkers relevant to CYC065's mechanism of action will
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The protocol for the Phase 1b study of a combination regimen
of CYC065 and venetoclax in patients with relapsed or refractory CLL has been submitted to the US Food and Drug Administration
or FDA. The study will evaluate safety, pharmacokinetics and pharmacodynamics of the combination, including biomarkers related
to the mechanism of action of CYC065.
Discussions with principal investigators and/or cooperative
groups progressed with the objective of evaluating CYC065 in both pediatric and adult patients with solid tumors. The Company is
discussing with an investigator cooperative group a potential evaluation of CYC065 in patients with neuroblastoma, a mostly pediatric,
life-threatening malignancy, frequently associated with MYCN amplification.
In another study, to be conducted as an investigator sponsored
trial, CYC065 will be evaluated in adult and pediatric patients with leukemias, including acute myeloid leukemia, or AML, acute
lymphocytic leukemia, or ALL, and in particular those with mixed lineage leukemia rearrangements, or MLL-r.
Preclinical data on the molecular rationale and therapeutic
potential of CYC065 included an article published in the Journal of National Cancer Institute, reporting prominent antitumor
activity against lung cancer cells through anaphase catastrophe, a novel, cancer specific, mechanism. CYC065 was found to be effective
against lung cancer cell lines, including those with KRAS mutations. Additional preclinical data presented at the 2017 AACR
Annual Meeting, demonstrated therapeutic potential of CYC065 as a targeted anticancer agent. CYC065 substantially inhibited growth,
triggered apoptosis, and induced anaphase catastrophe in murine and human lung cancer cells with known high metastatic potential.
This was in marked contrast to effects in immortalized pulmonary epithelial murine and human cells. CYC065 markedly inhibited migration
and invasion of lung cancer cells and affected distinctive pathways involved in DNA damage response, apoptosis, cell cycle regulation
DNA Damage Response (DDR) Program
In collaboration with an academic center and a pharmaceutical
company we have developed a protocol for a Phase 1b/2 investigator-sponsored trial to evaluate safety and efficacy of a combination
regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer.
Enrollment has been completed in an extension of part 1 of the
Phase 1 study evaluating a combination regimen of sapacitabine and seliciclib, Cyclacel's first generation CDK inhibitor,
in an enriched population of approximately 20 patients with BRCA positive advanced breast cancer. An ongoing part 3 of this study
is testing a revised dosing schedule in additional patients, including BRCA positive, patients with breast, ovarian and pancreatic
SEAMLESS Phase 3 Study
Data from the SEAMLESS Phase 3 study of sapacitabine in elderly patients with AML were the subject of
an oral presentation in December 2017 at the 59th ASH Annual Meeting. The presentation included additional data from prespecified
and exploratory analysis of subgroups that may benefit from treatment with the sapacitabine-decitabine alternating regimen. The
Company believes that the subgroup results have defined a patient population for whom the sapacitabine regimen may represent an
improvement over low intensity treatment by decitabine alone.
The Company has completed further statistical and exploratory
analyses of the results from the SEAMLESS study and is preparing briefing documents for submission to regulatory authorities with
the objective of determining a potential regulatory pathway for sapacitabine in AML.
PLK1 Inhibitor; CYC140
At the 2017 AACR Annual Meeting, the Company presented preclinical
data outlining the potential therapeutic utility of CYC140, a novel, polo-like kinase (PLK) 1 inhibitor, alone and in synergistic
drug combinations, for the treatment of esophageal cancer and acute leukemia.
Investigator-Sponsored Trials
(ISTs): Seliciclib in Rheumatoid Arthritis (RA)
The Independent Data Monitoring Committee, or IDMC, for the
"TRAFIC" trial sponsored by the UK Medical Research Council, (ISRCTN 36667085) determined that part 1 of the study
was successfully completed per protocol. The IDMC recommended continuation of the trial into part 2 to assess potential efficacy
of seliciclib as an addition to existing anti-TNF therapy based on a composite outcome of response in patients with moderate to
Corporate Developments
The Company raised net proceeds of approximately $13.7 million
from an underwritten offering of common stock.
Cyclacel received notice from the European Patent Office of
the grant of a European patent including claims to novel pharmaceutical formulations of sapacitabine.
2018 Key Upcoming Business Objectives
Financial Highlights
As of December 31, 2017, cash and cash
equivalents totaled $23.9 million, compared to $16.5 million as of December 31, 2016. The increase of $7.4 million was primarily
due to net proceeds of $13.7 million from a direct registered offering, $1.0 million from the sale of common stock through the
ATM sales agreement with FBR Capital Markets & Co., $0.2 million warrant exercises and offset by $7.5 million of net cash used
in operating activities.
There were no revenues for the three
months and year ended December 31, 2017 compared to $0.3 million and $0.8 million for the same period of the previous year. The
revenue is related to previously awarded, UK government grants being recognized over the period to progress IND-directed preclinical
development of CYC140, a novel, PLK-1 inhibitor, which was completed in November 2016.
Research and development expenses were
$0.7 million and $4.2 million for the three months and year ended December 31, 2017 as compared to $1.9 million and $9.5 million