Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
("Cyclacel" or the "Company"), 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, today reported its
financial results and business highlights for the second quarter
ended June 30, 2017.
The Company's net loss applicable to common
shareholders for the three months ended June 30, 2017 was $2.2
million or $0.50 per share, compared to net loss applicable to
common shareholders of $3.0 million, or $1.01 per share for the
second quarter of 2016. As of June 30, 2017, cash and cash
equivalents totaled $13.6 million. Pro forma cash and cash
equivalents as of June 30, 2017 totaled $27.4 million after
including $13.8 million in proceeds, net of expenses, received in
the Company’s underwritten offering completed on July 21, 2017.
“As a result of the completion of our recent
offering, in which existing and new investors participated, we are
able to advance the clinical investigation of CYC065, our Cyclin
Dependent Kinase (CDK) 2/9 inhibitor, in selected,
molecularly-defined patient populations,” said Spiro Rombotis,
President and Chief Executive Officer of Cyclacel. “We have
selected a recommended Phase 2 dose for CYC065 from part 1 of a
dose-escalating, Phase 1, first-in-human, study of CYC065. Data
from this study evidenced durable target engagement and Mcl-1
biomarker suppression at well tolerated doses with initial evidence
of anticancer activity in patients with Mcl-1 and/or cyclin E
overexpression or amplification. Our top priority is to
finalize designs for a Phase 1/2 study testing CYC065 in
combination with venetoclax, a Bcl-2 inhibitor approved for chronic
lymphocytic leukemia, an indication in which we believe Mcl-1
suppression may be beneficial. In parallel, we will enroll a new
part 2 of the Phase 1 study in patients with advanced solid tumors
testing additional dosing schedules. We look forward to reporting
our progress, commencement of these studies and data, as they
arise."
Business Highlights
Transcriptional Regulation
Program: CYC065 CDK inhibitor
- Selected a recommended Phase 2 dose (RP2D) from part 1 of a
dose-escalating, Phase 1, first-in-human, clinical study. RP2D was
determined at dosing level 6, which enrolled 10 patients with
advanced cancers. Prolonged reduction of the Mcl-1 biomarker was
observed in 7 out of 9 evaluable patients for at least 24 hours
following a single dose of CYC065, which was generally well
tolerated. Preliminary anticancer activity was observed in three
patients with Mcl-1, MYC and Mcl-1/cyclin E amplified cancers. The
trial is being conducted at the Dana Farber Cancer Institute in
Boston.
- Part 2 of the study will enroll patients with advanced solid
tumors, in particular cyclin E amplified tumors. Such tumors
include subsets of high grade serous ovarian and uterine
cancers. Part 2 will evaluate CYC065 in a more intensive
schedule for 2 days per week, for 2 weeks of a three-week cycle.
Biospecimens will be collected for assessment of biomarkers related
to CYC065’s mechanism of action.
SEAMLESS Study
- An abstract of the results of the Phase 3 study of oral
sapacitabine in elderly patients with acute myeloid leukemia (AML)
has been submitted to the American Society of Hematology (ASH), and
if accepted, will be the subject of an oral or poster presentation
at the 59th ASH Annual Meeting to be held December 9 - 12,
2017.
July Underwritten Offering
- On July 21, 2017, the Company announced the closing of an
underwritten offering, with net proceeds of approximately $13.8
million after deducting underwriting discounts and commissions and
other estimated offering expenses, including full exercise of the
underwriters’ overallotment option. The Company issued and
sold in the offering (i) 3,154,000 Class A Units, each consisting
of one share of the Company’s common stock, and a warrant to
purchase one share of common stock, and (ii) 8,872 Class B Units,
each consisting of one share of the Company’s Series A Convertible
Preferred Stock convertible into 500 shares of common stock at the
initial conversion price, and a warrant to purchase a number of
shares of common stock equal to $1,000 divided by the conversion
price. The price to the public in the offering was $2.00 per Class
A Unit and $1,000 per Class B Unit.
- Subsequent to the closing of the offering, holders of 7,613
(86%) shares out of 8,872 shares outstanding of Series A Preferred
Stock elected to convert their shares into 3,806,500 shares of
common stock. Following such conversions, 11,400,447 shares of
common stock and 1,259 (14%) shares of Series A Preferred Stock
remain outstanding as of August 8, 2017.
Financial HighlightsAs of June 30, 2017, cash
and cash equivalents totaled $13.6 million, compared to $16.5
million on December 31, 2016. After the July offering, pro forma
cash and cash equivalents are $27.4 million.
Revenue for the three months ended June 30, 2017 were $0
compared to $0.2 million for the same period of the previous year.
Revenue is primarily related to previously awarded grants from the
UK government being recognized over the period to progress
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 $1.2 million compared to
$2.6 million for the same period in 2016. The decrease was
primarily due to reduced study and clinical supply costs associated
with completion of the SEAMLESS study and completion of preclinical
development of CYC140.
General and administrative expenses for the
three months ended June 30, 2016 and 2017 remained flat at $1.3
million.
Other income (expense), net for the three months ended June 30,
2017 was $34,000, compared to $0.2 million for the same period of
the previous year. The decrease in other income (expense) is
primarily related to foreign exchange movements.
The UK government research & development tax credit for the
quarter was $0.3 million, compared to $0.6 million for the same
period of the previous year. During the quarter, we also recognized
cash received for the 2016 tax credit of $1.8 million.
Net loss for the three months June 30, 2017 was $2.2 million
compared to $3.0 million for the same period in 2016.
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 64524973
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. Cyclacel's 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'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 StatementsThis 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)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended June
30, |
|
|
Six months Ended June 30, |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
222 |
|
|
|
$ |
- |
|
|
|
$ |
361 |
|
|
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
2,637 |
|
|
|
|
1,222 |
|
|
|
|
5,136 |
|
|
|
|
2,534 |
|
|
General and
administrative |
|
|
1,345 |
|
|
|
|
1,267 |
|
|
|
|
2,729 |
|
|
|
|
2,648 |
|
|
Total operating
expenses |
|
|
3,982 |
|
|
|
|
2,489 |
|
|
|
|
7,865 |
|
|
|
|
5,182 |
|
|
Operating
loss |
|
|
(3,760 |
) |
|
|
|
(2,489 |
) |
|
|
|
(7,504 |
) |
|
|
|
(5,182 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange gains
(losses) |
|
|
138 |
|
|
|
|
16 |
|
|
|
|
318 |
|
|
|
|
(43 |
) |
|
Interest income |
|
|
13 |
|
|
|
|
18 |
|
|
|
|
23 |
|
|
|
|
30 |
|
|
Other income, net |
|
|
18 |
|
|
|
|
- |
|
|
|
|
38 |
|
|
|
|
879 |
|
|
Total other income
(expense) |
|
|
169 |
|
|
|
|
34 |
|
|
|
|
379 |
|
|
|
|
866 |
|
|
Loss before
taxes |
|
|
(3,591 |
) |
|
|
|
(2,455 |
) |
|
|
|
(7,125 |
) |
|
|
|
(4,316 |
) |
|
Income tax benefit |
|
|
626 |
|
|
|
|
268 |
|
|
|
|
1,119 |
|
|
|
|
574 |
|
|
Net
loss |
|
|
(2,965 |
) |
|
|
|
(2,187 |
) |
|
|
|
(6,006 |
) |
|
|
|
(3,742 |
) |
|
Dividend on convertible
exchangeable preferred shares |
|
|
(50 |
) |
|
|
|
(50 |
) |
|
|
|
(100 |
) |
|
|
|
(100 |
) |
|
Net loss
applicable to common shareholders |
|
$ |
(3,015 |
) |
|
|
$ |
(2,237 |
) |
|
|
$ |
(6,106 |
) |
|
|
$ |
(3,842 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
|
$ |
(1.01 |
) |
|
|
$ |
(0.50 |
) |
|
|
$ |
(2.05 |
) |
|
|
$ |
(0.88 |
) |
|
Weighted average common
shares outstanding |
|
|
3,000,192 |
|
|
|
|
4,434,441 |
|
|
|
|
2,982,508 |
|
|
|
|
4,353,333 |
|
|
The accompanying notes are an integral part of
these consolidated financial statements.
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
|
(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
|
|
|
(Unaudited) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
16,520 |
|
|
|
$ |
13,591 |
|
Prepaid
expenses and other current assets |
|
|
3,097 |
|
|
|
|
2,460 |
|
Total
current assets |
|
|
19,617 |
|
|
|
|
16,051 |
|
Property, plant and
equipment (net) |
|
|
45 |
|
|
|
|
32 |
|
Total
assets |
|
$ |
19,662 |
|
|
|
$ |
16,083 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,497 |
|
|
|
$ |
2,038 |
|
Accrued
and other current liabilities |
|
|
2,762 |
|
|
|
|
2,281 |
|
Total
current liabilities |
|
|
5,259 |
|
|
|
|
4,319 |
|
Other liabilities |
|
|
130 |
|
|
|
|
128 |
|
Total
liabilities |
|
|
5,389 |
|
|
|
|
4,447 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized at
December 31, 2016 and June 30, 2017; 335,273 shares issued and
outstanding at December 31, 2016 and June 30, 2017. Aggregate
preference in liquidation of $4,006,512 at December 31, 2016
and June 30, 2017. |
|
|
— |
|
|
|
|
— |
|
Common
stock, $0.001 par value; 100,000,000 shares authorized at
December 31, 2016 and June 30, 2017; 4,256,829 and 4,439,947
shares issued and outstanding at December 31, 2016 and June
30, 2017 respectively. |
|
|
4 |
|
|
|
|
4 |
|
Additional paid-in
capital |
|
|
350,051 |
|
|
|
|
351,148 |
|
Accumulated other
comprehensive loss |
|
|
(743 |
) |
|
|
|
(736 |
) |
Accumulated
deficit |
|
|
(335,039 |
) |
|
|
|
(338,780 |
) |
Total
stockholders’ equity |
|
|
14,273 |
|
|
|
|
11,636 |
|
Total
liabilities and stockholders’ equity |
|
$ |
19,662 |
|
|
|
$ |
16,083 |
|
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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