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 financial results and business highlights
for the third quarter ended September 30, 2016.
The Company's net loss applicable to common shareholders for the
third quarter ended September 30, 2016 was $3.0 million, or $0.86
per basic and diluted share, compared to net loss applicable to
common shareholders of $2.8 million, or $0.95 per basic and diluted
share for the third quarter ended September 30, 2015. As of
September 30, 2016, cash and cash equivalents totaled $18.0
million.
"SEAMLESS, a Phase 3 study of oral sapacitabine capsules,
represents one of the largest clinical trials conducted in elderly
patients with AML who are unfit for or refused intensive
chemotherapy. Following completion of follow-up at the beginning of
the quarter, we have been conducting data validation operations,”
said Spiro Rombotis, President and Chief Executive Officer of
Cyclacel. “We are pleased to report that this process is nearing
completion following which the database will be locked and
transferred to our statistical analysis vendor. We anticipate
reporting top line results late in the fourth quarter of 2016 or in
early 2017.”
“The collection and processing of SEAMLESS Phase 3 data
represent many years of effort in our search to offer a new
treatment regimen for this older patient population. We will soon
analyze the data and determine whether the results warrant
regulatory submissions," said Dr. Judy Chiao, VP, Clinical
Development and Regulatory Affairs. "We are grateful to the
patients, their families, the investigators and their teams for
their valuable contributions to this study.”
“During the quarter data presented at a pediatric cancer meeting
demonstrated that CYC065, our second generation Cyclin Dependent
Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted
neuroblastoma models. The data further validate the mechanism of
CYC065 and provide a rationale for clinical investigation in
neuroblastoma with MYCN amplification, a major oncogenic driver of
this childhood cancer. MYC family proteins are important
therapeutic targets in other oncology indications, including
certain solid tumors, leukemias and lymphomas. Early clinical and
preclinical data from our DNA damage response program suggest that
our transcriptional CDK inhibitors may have a synergistic effect
with other anticancer agents, including sapacitabine. We look
forward to reporting new data from our ongoing clinical studies of
sapacitabine and seliciclib in BRCA positive patients and of CYC065
in patients with solid tumors,” continued Mr. Rombotis.
BUSINESS HIGHLIGHTS
SEAMLESS study
- Phase 3 study of oral sapacitabine capsules alternating with
intravenous decitabine compared to decitabine alone, as first-line
treatment in patients aged 70 years or older with AML who are unfit
for or refused intensive chemotherapy; cleaned and validated
dataset being finalized and database lock imminent.
DNA damage response program
- The Phase 1 combination of sapacitabine and seliciclib is
continuing enrollment in an extension study in an enriched
population of BRCA positive patients with advanced breast
cancer.
Cyclin dependent kinase (CDK) inhibitor
program
- Continued recruitment in Phase 1, first-in-human trial of
CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and
pharmacokinetics in patients with solid tumors. The sixth dose
escalation level has been reached.
- Preclinical data presented at the Childhood Cancer Meeting 2016
demonstrated effectiveness of CYC065 against neuroblastoma models
with an overexpression and amplification of MYCN, a driver of
neuroblastoma.
KEY UPCOMING MILESTONES
SEAMLESS study
- Report top-line data and determination of submissibility to
regulatory authorities, anticipated late fourth quarter 2016 or
early 2017.
- Progress the Paediatric Investigation Plan for sapacitabine
with the European Medicines Agency.
DNA damage response program
- Progress Phase 1 sapacitabine and seliciclib extension cohort
in a breast cancer patient population enriched for BRCA
mutations.
- Initiate Phase 1 part 3, to include BRCA mutation positive,
pancreatic and ovarian cancer patients.
CDK Inhibitor Program
- Report top-line results of the CYC065 Phase 1 trial in patients
with solid tumors.
- Report data when available from ongoing investigator sponsored
trials (ISTs) evaluating seliciclib in patients with Cushing’s
disease and rheumatoid arthritis. Additionally, seliciclib is being
evaluated in cystic fibrosis though a license and supply agreement
with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes
(MDS)
- Plan Phase 1/2 trial of sapacitabine in combination with other
agents to determine safety and tolerability.
- Plan a Phase 2 randomized controlled trial (RCT) of
sapacitabine in combination with other agents following review of
all relevant clinical data with mature follow-up.
THIRD QUARTER 2016 FINANCIAL RESULTS
Cash and cash equivalents totaled $18.0 million as of September
30, 2016 compared to $20.4 million at December 31, 2015.
Approximately $5.2 million was raised from the sale of common stock
through the Company’s at-the-market facility with FBR Capital
Markets. A further $1.5 million was received in October 2016
through this facility, resulting in a proforma cash balance as of
September 30, 2016 of $19.5 million. Based on current plans, the
Company estimates that it has capital resources to fund operations
through the second quarter of 2018.
Revenue for the three months ended September 30, 2016 was $0.2
million, compared to $0.7 million for the same period of the
previous year, with the decrease primarily related to grant revenue
related to CYC065, for which the grant ended in December 2015.
Research and development expenses were $2.4 million for the
three months ended September 30, 2016 and $2.9 million for the
three months ended September 30, 2015.
General and administrative expenses were $1.3 million for the
three months ended September 30, 2016 and $1.2 million for the
three months ended September 30, 2015.
CONFERENCE CALL AND WEBCAST INFORMATION:
Cyclacel will conduct a conference call on November 14, 2016 at
4:30 p.m. Eastern Time to review the third quarter 2016 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 is 14223368 |
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.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical
company using cell cycle control and DNA damage response biology to
develop innovative, targeted medicines for cancer and other
proliferative diseases. The SEAMLESS randomized Phase 3 trial of
sapacitabine as front-line treatment for AML in the elderly under
an SPA with FDA has completed enrollment and follow-up. Cyclacel's
pipeline includes an oral combination of seliciclib (CDK inhibitor)
and sapacitabine in Phase 1 in advanced solid tumors, including
patients with BRCA mutations; sapacitabine in Phase 2 in MDS; and
CYC065 (CDK inhibitor) in Phase 1 in solid tumors with potential
utility based on preclinical data also in hematological
malignancies. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based
on a pipeline of novel drug candidates. Please visit
www.cyclacel.com for more information.
FORWARD-LOOKING STATEMENTS
This news release contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, the efficacy, safety and intended
utilization of Cyclacel's product candidates, the conduct and
results of future clinical trials, plans regarding regulatory
filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to
differ materially include the risk that product candidates that
appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later
clinical trials, trials may have difficulty enrolling, Cyclacel may
not obtain approval to market its product candidates, the risks
associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on
collaborative partners for further clinical trials, development and
commercialization of product candidates. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," or the negative of those words or
other comparable words to be uncertain and forward-looking. For a
further list and description of the risks and uncertainties the
Company faces, please refer to our most recent Annual Report on
Form 10-K and other periodic and other filings we file with the
Securities and Exchange Commission which are available at
www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and we assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
© Copyright 2016 Cyclacel Pharmaceuticals, Inc.
All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks
of Cyclacel Pharmaceuticals, Inc.
|
CYCLACEL
PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(In $000s,
except share and per share amounts) |
(Unaudited) |
|
|
Three Months Ended September
30, |
|
|
Nine Months Ended September
30, |
|
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
462 |
|
|
$ |
205 |
|
|
$ |
1,270 |
|
|
$ |
566 |
|
Collaboration and
research and development revenue |
|
|
253 |
|
|
|
— |
|
|
|
253 |
|
|
|
— |
|
Total
revenues |
|
|
715 |
|
|
|
205 |
|
|
|
1,523 |
|
|
|
566 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
2,904 |
|
|
|
2,409 |
|
|
|
9,826 |
|
|
|
7,545 |
|
General and
administrative |
|
|
1,205 |
|
|
|
1,273 |
|
|
|
4,006 |
|
|
|
4,002 |
|
Total operating
expenses |
|
|
4,109 |
|
|
|
3,682 |
|
|
|
13,832 |
|
|
|
11,547 |
|
Operating
loss |
|
|
(3,394 |
) |
|
|
(3,477 |
) |
|
|
(12,309 |
) |
|
|
(10,981 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in valuation of
financial instruments associated with stock purchase agreement |
|
|
(27 |
) |
|
|
— |
|
|
|
(51 |
) |
|
|
— |
|
Foreign exchange (loss)
gain |
|
|
(219 |
) |
|
|
51 |
|
|
|
(354 |
) |
|
|
369 |
|
Interest income |
|
|
2 |
|
|
|
8 |
|
|
|
5 |
|
|
|
31 |
|
Other income, net |
|
|
13 |
|
|
|
18 |
|
|
|
95 |
|
|
|
56 |
|
Total other income
(expense) |
|
|
207 |
|
|
|
77 |
|
|
|
(305 |
) |
|
|
456 |
|
Loss before
taxes |
|
|
(3,187 |
) |
|
|
(3,400 |
) |
|
|
(12,614 |
) |
|
|
(10,525 |
) |
Income tax benefit |
|
|
478 |
|
|
|
454 |
|
|
|
1,646 |
|
|
|
1,573 |
|
Net
loss |
|
|
(2,709 |
) |
|
|
(2,946 |
) |
|
|
(10,968 |
) |
|
|
(8,952 |
) |
Dividend on convertible
exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
|
|
(150 |
) |
|
|
(150 |
) |
Net loss
applicable to common shareholders |
|
$ |
(2,759 |
) |
|
$ |
(2,996 |
) |
|
$ |
(11,118 |
) |
|
$ |
(9,102 |
) |
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
|
$ |
(0.95 |
) |
|
$ |
(0.86 |
) |
|
$ |
(4.20 |
) |
|
$ |
(2.89 |
) |
Weighted average common
shares outstanding |
|
|
2,889,893 |
|
|
|
3,473,696 |
|
|
|
2,645,159 |
|
|
|
3,145,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEETS |
(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
December 31, |
|
|
September 30, |
|
|
|
2015 |
|
|
2016 |
|
|
|
|
|
|
|
(Unaudited) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
20,440 |
|
|
$ |
18,029 |
|
Prepaid
expenses and other current assets |
|
|
4,051 |
|
|
|
4,521 |
|
Current
assets of discontinued operations |
|
|
75 |
|
|
|
29 |
|
Total
current assets |
|
|
24,566 |
|
|
|
22,579 |
|
Property, plant and
equipment (net) |
|
|
198 |
|
|
|
73 |
|
Total
assets |
|
$ |
24,764 |
|
|
$ |
22,652 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,940 |
|
|
$ |
1,979 |
|
Accrued
and other current liabilities |
|
|
3,738 |
|
|
|
3,562 |
|
Current
liabilities of discontinued operations |
|
|
75 |
|
|
|
29 |
|
Total
current liabilities |
|
|
5,753 |
|
|
|
5,570 |
|
Other liabilities |
|
|
176 |
|
|
|
141 |
|
Total
liabilities |
|
|
5,929 |
|
|
|
5,711 |
|
Total stockholders’
equity |
|
|
18,835 |
|
|
|
16,941 |
|
Total
liabilities and stockholders’ equity |
|
$ |
24,764 |
|
|
$ |
22,652 |
|
CONTACTS
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
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