Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS FOURTH
FULL YEAR 2013 FINANCIAL RESULTS
European Expansion of SEAMLESS Phase
3 Study Initiated; Potentially Trebling Participating Sites
- Conference Call Scheduled March
25, 2014 at 4:30 p.m. EDT -
Berkeley Heights, NJ, March 25, 2014
- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") announced today
its financial results and business highlights for the fourth quarter and full year 2013. The Company's net loss applicable
to common shareholders for the fourth quarter of 2013 was $3.6 million, or $0.19 per basic and diluted share, compared to a net
loss applicable to common shareholders of $4.9 million, or $0.59 per basic and diluted share, for the fourth quarter of 2012.
For the year ended December 31, 2013, the Company reported a net loss applicable to common shareholders of $19.5 million, or $1.28
per basic and diluted share, compared to a net loss applicable to common shareholders of $13.9 million or $1.68 per basic and
diluted share, for the year ended December 31, 2012. As of December 31, 2013, cash and cash equivalents totaled $31.1 million.
"We are pleased to report initiation
of our first European study centers as we execute on our plan to potentially treble the number of sites in our Phase 3 SEAMLESS
trial in AML," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Following the recent European
launch of decitabine, we conducted a pre-qualification survey in which more than 100 European hospitals expressed interest in
participating in SEAMLESS. We expect to open approximately 80 of these, resulting in a trebling of SEAMLESS sites, including 39
in the US. With just US sites enrolling until now, we are approaching the fourth periodic safety review by the study's DSMB.
With a total of over 100 sites participating in the AML study, we estimate completion of enrollment by the end of this year and
topline data next year. Following Phase 2 data reported at ASH 2013, demonstrating a near doubling of expected median survival
of older patients with MDS after treatment failure of hypomethylating agents, we are designing a randomized, controlled trial
of sapacitabine in this underserved patient population. We plan to disclose our registration plans for this new indication later
this year after consultation with regulatory and clinical experts and evaluation of feasibility."
Fourth Quarter 2013 and Recent Highlights
Cyclacel's Key Milestones for 2014
Financial Highlights
Revenue from the three months and year ended
December 31, 2013, was $0.3 million and $1.1 million as compared to $5,000 and $69,000 for the same period of the previous year.
The revenue is a grant award from the UK government, totaling $1.9 million, to progress CYC065, the Company's Cyclin Dependent
Kinase inhibitor, to IND.
Research and development expenses increased
to $2.5 million and $11.3 million for the three months and year ended December 31, 2013, as compared to $2.0 million and $6.6
million for the same period of the previous year. The increases in 2013 were primarily due to enrollment-related activities of
the SEAMLESS registration study, including drug manufacturing costs and other outsourced services.
General & administrative expenses for
the three months and year ended December 31, 2013, were $1.8 million and $7.8 million as compared to $2.7 million and $8.6 million
for the previous year. The decreases in 2013 were primarily due to lower legal and professional fees.
The income tax benefit, which is a refund
the Company elects to receive from the UK tax authorities based on eligible research and development expenses, was $1.7 million
for the year ended December 31, 2013 compared to $1.4 million for the previous year.
Net loss from continuing operations for the
fourth quarter of 2013 was $3.6 million compared to a net loss from continuing operations of $4.4 million for the fourth quarter
of 2012. Net loss from continuing operations for the year ended December 31, 2013 was $10.2 million compared to $13.8 million
for the year ended December 31, 2012. Net loss applicable to common shareholders was $3.6 million, or $0.19 per basic and diluted
share, and $19.5 million, or $1.28 per basic and diluted share, for the fourth quarter and year ended December 31, 2013 compared
to a net loss applicable to common shareholders of $4.9 million, or $0.59 per basic and diluted share, and $13.9 million, or $1.68
per basic and diluted share for the fourth quarter and year ended December 31, 2012.
Cash position at year end was $31.1 million
compared to $16.4 million at the end of 2012. The increase is attributable to net proceeds from an underwritten offering of $19.0
million, $8.6 million from sales of common stock through the equity line with Aspire Capital LLC and $5.5 million from the sale
to Celgene Corporation of romidepsin-related patents, a non-core program, offset by $18.2 million used in operating activities.
Conference call and Webcast Information:
Cyclacel will conduct a conference call on
March 25, 2014 at 4:30 p.m. Eastern Time to review the fourth quarter and year-end 2013 results. Conference call and webcast
details are as follows:
Conference call information:
US/Canada call: (877) 493-9121/ international
call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international
archive: (404) 537-3406
Code for live and archived conference call
For the live and archived webcast, please
visit the Corporate Presentations and Events page on the Cyclacel website at www.cyclacel.com. The webcast will be archived
for 90 days and the audio replay for 7 days.
Sapacitabine (CYC682),
an orally-available nucleoside analog, is being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in elderly
patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. Sapacitabine
is also in Phase 2 trials in patients with AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic
leukemia and small lymphocytic lymphoma, and non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with seliciclib
in patients with advanced solid tumors. Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production
of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced
DSBs is dependent on the homologous recombination DNA repair (HR) pathway. Both sapacitabine and CNDAC, its major metabolite,
have demonstrated potent anti-tumor activity in preclinical studies.
Over 800 patients have received sapacitabine
in clinical studies in patients with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. Data, presented at the
2012 American Society of Hematology Meeting and Exposition (ASH), from the pilot study and lead-in phase of SEAMLESS showed promising
response rate, overall survival and low 30-day and 60-day mortality in elderly patients with AML aged 70 years or older receiving
sapacitabine alternating with decitabine. Results from a randomized Phase 2, single-
agent study of sapacitabine, including promising
1-year survival in elderly patients with AML aged 70 years or older, were published in The Lancet Oncology in November
2012. Data, presented at the 2013 ASH from an ongoing, multicenter, Phase 2 randomized trial of single-agent oral sapacitabine
capsules in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line
hypomethylating agents, such as azacitidine and/or decitabine, showed sapacitabine nearly doubled expected survival of elderly
patients with MDS after front-line therapy failure. In a Phase 1 study, sapacitabine, in combination with Cyclacel's seliciclib,
showed antitumor activity, including durable partial responses, in patients with breast, ovarian and pancreatic cancers found
to be carriers of gBRCA mutations. The FDA and the European Medicines Agency have designated sapacitabine as an orphan drug for
the treatment of both AML and MDS. Sapacitabine is part of Cyclacel's pipeline of small molecule drugs designed to target and
stop uncontrolled cell division.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing
oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Sapacitabine,
Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the
FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic syndromes (MDS),
chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer and in particular those
carrying gBRCA mutations. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology
and oncology based on a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information.
Forward-looking Statements