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 second quarter ended June 30, 2016.
The Company's net loss applicable to common shareholders for the
second quarter ended June 30, 2016 was $3.0 million, or $1.01 per
basic and diluted share, compared to net loss applicable to common
shareholders of $3.4 million, or $1.19 per basic and diluted share
for the second quarter ended June 30, 2015. As of June 30, 2016,
cash and cash equivalents totaled $15.9 million.
"Subsequent to the end of the quarter, we achieved a key
milestone in our acute myeloid leukemia (AML) SEAMLESS Phase 3
study,” said Spiro Rombotis, President and Chief Executive Officer
of Cyclacel. “The required number of events has been reached and
preparations for final analysis and reporting of SEAMLESS outcomes
are underway. Over the next several weeks, we will complete data
cleaning and validation operations after which the database will be
transferred to our statistical analysis vendor. We will
subsequently report outcomes for the primary (overall survival) and
secondary endpoints and determination of submissibility of the
SEAMLESS data set to regulatory authorities in Europe and the
United States.
In our DNA damage response program, durable antitumor activity
was reported at an oral presentation at the 2016 ASCO Annual
Meeting with a combination of sapacitabine and seliciclib, our
CDK2/9 inhibitor, in heavily pretreated patients with breast,
ovarian and pancreatic cancers who tested positive for BRCA
mutations. A disease control rate of 35.6% was observed, with
ongoing responding patients achieving treatment durations exceeding
1 and 4.7 years, respectively. We continue to enroll patients with
solid tumors in a first-in-human, Phase 1 study of CYC065, our
second-generation CDK2/9 inhibitor.”
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
or refused intensive chemotherapy, reached the number of events
required for final analysis.
- Preparations are underway for final analysis of study
data.
DNA damage response program
- Oral presentation of data at 2016 American Society of Clinical
Oncology (ASCO) Annual Meeting.
- Phase 1 combination of sapacitabine and seliciclib as
orally-administered treatment in 67 heavily-pretreated patients.
Antitumor activity in subgroup of 45 patients with breast, ovarian
and pancreatic cancers who tested positive for BRCA mutations.
Disease control rate of 35.6% (1 CR, 5 PR and 10 SD). No CR or PR
observed in BRCA negative patients.
- Ongoing extension cohort in BRCA positive patients with 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 and lymphomas.
Corporate
- Received notification from the Listing Qualifications Staff of
NASDAQ that the Company regained compliance with the minimum bid
price rule for continued listing on The NASDAQ Capital Market.
- Effected a one-for-twelve reverse stock split of the Company’s
outstanding shares of common stock.
- Entered into an At Market Issuance Sales Agreement
with FBR Capital Markets & Co. under which the Company
may, from time to time, sell shares of the Company’s common
stock.
- Terminated Controlled Equity OfferingSM sales agreement with
Cantor Fitzgerald & Co.
KEY UPCOMING MILESTONES
SEAMLESS study
- Study database locked in preparation for final data
analysis.
- Report top-line data and determination of submissibility to
regulatory authorities, anticipated in the fourth quarter
2016.
- 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.
- Plan to add 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 and lymphomas.
- 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 a 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.
SECOND QUARTER 2016 FINANCIAL RESULTS
Grant Revenue
Revenue for the three months ended June 30, 2016 was $0.2
million, compared to $0.3 million for the same period of the
previous year. The revenue is related to previously awarded grants
from the UK government being recognized over the period to progress
CYC065 to IND and complete IND-directed preclinical development of
CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1)
inhibitor.
Research and Development Expenses
Research and development expenses were $2.6 million for the
three months ended June 30, 2016 and $2.6 million for the three
months ended June 30, 2015.
General and Administrative Expenses
General and administrative expenses were $1.3 million for the
three months ended June 30, 2016 and $1.3 million for the three
months ended June 30, 2015.
Based on current plans, the Company estimates that it has
capital resources to reach beyond the final analysis of SEAMLESS
and continue existing programs through the first quarter of
2018.
CONFERENCE CALL AND WEBCAST INFORMATION:
Cyclacel will conduct a conference call on August 10, 2016 at
4:30 p.m. Eastern Time to review the second 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 59985383 |
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. Cyclacel's pipeline
includes an oral combination of seliciclib (CDK2/9 inhibitor) and
sapacitabine in Phase 1 in advanced solid tumors, including
patients with BRCA mutations; sapacitabine in Phase 2 in MDS; and
CYC065 (CDK2/9 inhibitor) in Phase 1 in solid tumors and lymphomas
with potential utility based on preclinical data in other
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 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 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 June
30, |
|
|
Six Months Ended June
30, |
|
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
296 |
|
|
$ |
222 |
|
|
$ |
808 |
|
|
$ |
361 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
2,580 |
|
|
|
2,637 |
|
|
|
6,922 |
|
|
|
5,136 |
|
General and
administrative |
|
|
1,333 |
|
|
|
1,345 |
|
|
|
2,801 |
|
|
|
2,729 |
|
Total operating
expenses |
|
|
3,913 |
|
|
|
3,982 |
|
|
|
9,723 |
|
|
|
7,865 |
|
Operating
loss |
|
|
(3,617 |
) |
|
|
(3,760 |
) |
|
|
(8,915 |
) |
|
|
(7,504 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in valuation of
financial instruments associated with stock purchase agreement |
|
|
(4 |
) |
|
|
— |
|
|
|
(24 |
) |
|
|
— |
|
Foreign exchange (loss)
gain |
|
|
(195 |
) |
|
|
138 |
|
|
|
(573 |
) |
|
|
318 |
|
Interest income |
|
|
2 |
|
|
|
13 |
|
|
|
3 |
|
|
|
23 |
|
Other income, net |
|
|
62 |
|
|
|
18 |
|
|
|
82 |
|
|
|
38 |
|
Total other income
(expense) |
|
|
(135 |
) |
|
|
169 |
|
|
|
(512 |
) |
|
|
379 |
|
Loss before
taxes |
|
|
(3,752 |
) |
|
|
(3,591 |
) |
|
|
(9,427 |
) |
|
|
(7,125 |
) |
Income tax benefit |
|
|
405 |
|
|
|
626 |
|
|
|
1,168 |
|
|
|
1,119 |
|
Net
loss |
|
|
(3,347 |
) |
|
|
(2,965 |
) |
|
|
(8,259 |
) |
|
|
(6,006 |
) |
Dividend on convertible
exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
|
|
(100 |
) |
|
|
(100 |
) |
Net loss
applicable to common shareholders |
|
$ |
(3,397 |
) |
|
$ |
(3,015 |
) |
|
$ |
(8,359 |
) |
|
$ |
(6,106 |
) |
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
|
$ |
(1.19 |
) |
|
$ |
(1.01 |
) |
|
$ |
(3.32 |
) |
|
$ |
(2.05 |
) |
Weighted average common
shares outstanding |
|
|
2,865,707 |
|
|
|
3,000,192 |
|
|
|
2,520,897 |
|
|
|
2,982,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEETS |
(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2015 |
|
|
2016 |
|
|
|
|
|
|
|
(Unaudited) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
20,440 |
|
|
$ |
15,931 |
|
Prepaid expenses and other current assets |
|
|
4,051 |
|
|
|
2,762 |
|
Current assets of discontinued operations |
|
|
75 |
|
|
|
75 |
|
Total
current assets |
|
|
24,566 |
|
|
|
18,768 |
|
Property, plant and
equipment (net) |
|
|
198 |
|
|
|
109 |
|
Total
assets |
|
$ |
24,764 |
|
|
$ |
18,877 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,940 |
|
|
$ |
1,898 |
|
Accrued and other current liabilities |
|
|
3,738 |
|
|
|
3,592 |
|
Current liabilities of discontinued operations |
|
|
75 |
|
|
|
75 |
|
Total
current liabilities |
|
|
5,753 |
|
|
|
5,565 |
|
Other liabilities |
|
|
176 |
|
|
|
150 |
|
Total
liabilities |
|
|
5,929 |
|
|
|
5,715 |
|
Total stockholders’
equity |
|
|
18,835 |
|
|
|
13,162 |
|
Total
liabilities and stockholders’ equity |
|
$ |
24,764 |
|
|
$ |
18,877 |
|
|
|
|
|
|
|
|
|
|
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 Aug 2024 to Sep 2024
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Sep 2023 to Sep 2024