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,
2016. The Company's net loss applicable to common shareholders for
the three months and year ended December 31, 2016 was $2.9 million
and $12.0 million, respectively. As of December 31, 2016, cash and
cash equivalents totaled $16.5 million.
“Following the outcome of the SEAMLESS study and a
review of our clinical development pipeline we will concentrate our
resources on our transcriptional regulation and DNA damage response
clinical stage programs,” said Spiro Rombotis, President and Chief
Executive Officer of Cyclacel. “While we will discuss the SEAMLESS
data with regulators after completing ongoing analyses, we are
looking ahead with a clear strategy. We are dedicating our
efforts and resources to progressing our CYC065 CDK inhibitor
program and the promise in our BRCA positive stratified,
sapacitabine and CDK inhibitor study. We are encouraged by the
support received from various stakeholders, the recent success of
commercial stage CDK inhibitors and early clinical data from our
own CDK inhibitor trials."
Fourth Quarter and Full Year
Highlights
Transcriptional Regulation Program
- Cyclin Dependent Kinase (CDK)
inhibitors
- 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. Expanded sixth dose
escalation level with the objective of determining maximum
tolerated dose and recommended dosing for Phase 2.
- Data presented at the 2016 Annual Meeting of the American
Association of Cancer Research demonstrated that CYC065 can induce
cell death and combine beneficially with anti-cancer drugs from the
Bcl-2 and BET (Bromodomain and Extra-Terminal) inhibitor classes,
in in vitro models of B-cell lymphoma, including double-hit
lymphomas. Combinations of CYC065 with the Bcl-2 inhibitor
venetoclax (ABT-199) or BET inhibitors were both synergistic.
- Preclinical data published in the Journal of the National
Cancer Institute demonstrated that CYC065 had promising antitumor
activity against certain lung cancer cells through anaphase
catastrophe, a novel, cancer-specific mechanism of action.
DNA Damage Response (DDR) program
- The extension of the Phase 1 study evaluating a sequential
regimen of sapacitabine and the CDK inhibitor seliciclib is
continuing enrollment in an enriched population of BRCA positive
patients with advanced breast cancer.
- A part 3 of this study has been initiated to include BRCA
positive patients with pancreatic and ovarian cancer.
SEAMLESS Study in Elderly Patients with Acute Myeloid
Leukemia (AML)
- In February 2017, the Company reported that the SEAMLESS study
did not reach statistically significant superiority in overall
survival (OS), although an improvement in complete remission rate
was observed. In the stratified subgroup of patients with low
baseline peripheral white blood cell count, comprising
approximately two-thirds of the study's population, an improvement
in OS was observed for the experimental arm.
- The Company is currently analyzing stratified and exploratory
subgroups to identify patients who are most likely to benefit from
treatment with the experimental arm. Depending on this analysis the
Company may initiate discussions with European and U.S. regulators
to determine a potential regulatory pathway.
Poster Presentation on the PLK Inhibitor CYC140 at the
AACR Annual Meeting
Today, Cyclacel also announced a poster presentation at the
American Association for Cancer Research 2017 Annual Meeting to be
held April 1-5 in Washington, D.C. The poster is titled “The novel
PLK1 inhibitor, CYC140: Identification of pharmacodynamic markers,
sensitive target indications and potential combinations” (Poster
Board 1, Abstract number 4178, Convention Center, Halls A-C, Poster
Section 7). The poster details Cyclacel’s preclinical study to
identify target indications including acute leukemia and esophageal
cancer. The results will be presented in a session titled
“Targeting Protein Kinases and DNA Repair” on Tuesday Apr 4, 2017
1:00 PM - 5:00 PM Eastern Time.
Data presented in December 2016 at the 28th EORTC-NCI-AACR
Molecular Targets and Cancer Therapeutics Symposium, demonstrated
anti-tumor activity of CYC140 in preclinical xenograft models of
acute leukemia and solid tumors, including esophageal cancer, with
tumor growth delay, tumor regression and cures being observed.
Several pharmacodynamic markers were identified and activity was
demonstrated in a majority of malignant cell lines derived from
AML, acute lymphoblastic leukemia (ALL) and esophageal cancer.
Financial Highlights
As of December 31, 2016, cash and cash equivalents totaled $16.5
million, compared to $20.4 million as of December 31, 2015. The
decrease of $3.9 million was primarily due to $10.1 million of net
cash used in operating activities, partially offset by net proceeds
of $6.8 million from the sale of common stock through the ATM sales
agreement with FBR Capital Markets & Co.
Revenue for the three months and year ended December 31, 2016
were $0.3 million and $0.8 million respectively, compared to $0.4
million and $1.9 million for the same periods of the previous year.
The revenue is primarily related to previously awarded grants from
the UK government being recognized over the period to progress
CYC065 to IND, which was completed in 2015, and IND-directed
preclinical development of CYC140, a novel, orally available,
Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November
2016.
Research and development expenses were $1.9 million and $9.5
million for the three months and year ended December 31, 2016
respectively, compared to $2.6 million and $12.4 million for the
same periods of the previous year. The decrease was primarily due
to reduced study and clinical supply costs associated with the
completion of the SEAMLESS study.
General and administrative expenses for the three months and
year ended December 31, 2016 were $1.5 million and $5.5 million
respectively, compared to $1.7 million and $5.7 million for the
same periods of the previous year.
Other income (expense), net for the three months and year ended
December 31, 2016 were $(0.1) million and $0.4 million, compared to
nil and $(0.3) million for the same period of the previous year.
The increase in other income (expense) is primarily related to
foreign exchange movements.
United Kingdom research & tax credits were $0.4 million and
$2.0 million for the three months and year ended December 31, 2016
respectively, compared to $0.5 million and $2.1 million for the
same periods of the previous year. The cash receipt for the 2016
tax credit of $2.0 million is expected to be received in the second
quarter of 2017, which results in proforma cash and cash
equivalents of $18.5 million as of December 31, 2016.
Net loss for the three months and year ended December 31, 2016
was $2.8 million and $11.8 million respectively, compared to $3.4
million and $14.3 million for the same periods of the previous
year.
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 91915665
For the live and archived webcast, please visit the Corporate
Presentations 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, transcriptional regulation and DNA damage
response biology to develop innovative, targeted medicines for
cancer and other proliferative diseases. The transcriptional
regulation program is evaluating CYC065, a CDK inhibitor, in
patients with advanced cancers. The DNA damage response program is
evaluating a sequential regimen of sapacitabine and seliciclib, a
CDK inhibitor, in patients with BRCA positive, advanced solid
cancers. Cyclacel is analyzing stratified and exploratory
subgroups from a Phase 3 study of sapacitabine in elderly patients
with AML. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based
on a pipeline of novel drug candidates. For additional information,
please visit www.cyclacel.com.
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 and 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 2017 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) |
|
|
|
|
|
|
|
|
|
Three Months Ended December
31, |
|
|
|
Years Ended December
31, |
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
revenue |
$ |
424 |
|
|
|
$ |
277 |
|
|
|
$ |
1,694 |
|
|
|
$ |
843 |
|
Collaboration and research and development revenue |
|
— |
|
|
|
|
— |
|
|
|
|
250 |
|
|
|
|
— |
|
Total
revenues |
|
424 |
|
|
|
|
277 |
|
|
|
|
1,944 |
|
|
|
|
843 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
2,559 |
|
|
|
|
1,932 |
|
|
|
|
12,382 |
|
|
|
|
9,477 |
|
General
and administrative |
|
1,726 |
|
|
|
|
1,513 |
|
|
|
|
5,732 |
|
|
|
|
5,516 |
|
Total operating
expenses |
|
4,285 |
|
|
|
|
3,446 |
|
|
|
|
18,114 |
|
|
|
|
14,993 |
|
Operating
loss |
|
(3,861 |
) |
|
|
|
(3,169 |
) |
|
|
|
(16,170 |
) |
|
|
|
(14,150 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in
valuation of financial instruments associated with stock purchase
agreement |
|
— |
|
|
|
|
— |
|
|
|
|
(51 |
) |
|
|
|
— |
|
Foreign
exchange gains |
|
(14 |
) |
|
|
|
(96 |
) |
|
|
|
(368 |
) |
|
|
|
273 |
|
Interest
income |
|
4 |
|
|
|
|
6 |
|
|
|
|
9 |
|
|
|
|
37 |
|
Other
income, net |
|
(1 |
) |
|
|
|
(10 |
) |
|
|
|
94 |
|
|
|
|
66 |
|
Total
other income (expense), net |
|
(11 |
) |
|
|
|
(80 |
) |
|
|
|
(316 |
) |
|
|
|
376 |
|
Loss from
operations before taxes |
|
(3,872 |
) |
|
|
|
(3,249 |
) |
|
|
|
(16,486 |
) |
|
|
|
(13,774 |
) |
Income tax benefit |
|
498 |
|
|
|
|
409 |
|
|
|
|
2,144 |
|
|
|
|
1,983 |
|
Net
loss |
|
(3,374 |
) |
|
|
|
(2,839 |
) |
|
|
|
(14,342 |
) |
|
|
|
(11,791 |
) |
Dividend on convertible
exchangeable preferred shares |
|
(51 |
) |
|
|
|
(50 |
) |
|
|
|
(201 |
) |
|
|
|
(200 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common shareholders |
$ |
(3,425 |
) |
|
|
$ |
(2,945 |
) |
|
|
$ |
(14,543 |
) |
|
|
$ |
(11,991 |
) |
Net loss per share —
basic and diluted |
$ |
(1.18 |
) |
|
|
$ |
(0.69 |
) |
|
|
$ |
(5.36 |
) |
|
|
$ |
(3.50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding |
|
2,914,689 |
|
|
|
|
4,256,706 |
|
|
|
|
2,713,096 |
|
|
|
|
3,424,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE
SHEETS(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
|
|
December 31, |
|
|
2015 |
|
|
|
|
2016 |
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
20,440 |
|
|
|
$ |
16,520 |
Prepaid
expenses and other current assets |
|
|
4,126 |
|
|
|
|
3,097 |
Total
current assets |
|
|
24,566 |
|
|
|
|
19,617 |
Property, plant and
equipment (net) |
|
|
198 |
|
|
|
|
45 |
Total
assets |
|
$ |
24,764 |
|
|
|
$ |
19,662 |
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,940 |
|
|
|
$ |
2,497 |
Accrued
and other current liabilities |
|
|
3,813 |
|
|
|
|
2,762 |
Total
current liabilities |
|
|
5,753 |
|
|
|
|
5,259 |
Other liabilities |
|
|
176 |
|
|
|
|
130 |
Total
liabilities |
|
|
5,929 |
|
|
|
|
5,389 |
Stockholders’
equity |
|
|
18,835 |
|
|
|
|
14,273 |
Total
liabilities and stockholders’ equity |
|
$ |
24,764 |
|
|
|
$ |
19,662 |
Contacts
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Apr 2023 to Apr 2024