Conference Call Scheduled November 12, 2018
at 4:30 p.m. ET
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, today
reported financial results and business highlights for the third
quarter 2018. The Company's net loss applicable to common
shareholders for the three months ended September 30, 2018 was $2.1
million. As of September 30, 2018, cash and cash equivalents
totaled $19.0 million.
“We continue to execute on our strategy to rapidly develop
CYC065 and CYC140 in hematological malignancies and CYC065 in
advanced solid tumors,” said Spiro Rombotis, President and Chief
Executive Officer of Cyclacel. “The Phase 1 study evaluating CYC065
in combination with venetoclax in patients with relapsed/refractory
CLL and the CYC140 first-in-human study are open for enrollment.
Two further protocols evaluating combinations of CYC065 and
sapacitabine are in development. Our alliance with MD Anderson
allows us to parallel track the development of our drugs in a
cash-sparing manner while utilizing MD Anderson’s expertise to
recruit patients across four studies. We estimate that our cash
resources will be sufficient to fund operations until the second
quarter of 2020. We are also pleased to report that the IST
evaluating sapacitabine and olaparib in BRCA positive patients with
breast cancer has started to enroll.”
Key Company Highlights
- Announced a three-year strategic alliance agreement with The
University of Texas MD Anderson Cancer Center enabling clinical
evaluation of three Cyclacel medicines in patients with
hematological malignancies. MD Anderson will conduct four clinical
studies, with a total projected enrollment of up to 170 patients,
investigating CYC065, CYC140 and sapacitabine either as single
agents or in combination with approved drugs.
- Opened for enrollment the Phase 1 clinical trial evaluating
CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in
patients with relapsed/refractory CLL. Preclinical data presented
at AACR 2018 showed enhanced activity of CYC065 and venetoclax
combination in CLL tumor samples, including those with 17p
deletions. The combination also demonstrated activity in two CLL
samples resistant to either agent alone, suggesting that dual
targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce
synergistic cell death.
- First patient dosed in the Phase 1b/2 investigator-sponsored
trial (IST) of sapacitabine with olaparib, an approved PARP
inhibitor, in BRCA positive patients with breast cancer.
Preclinical data support the hypothesis that dual targeting of the
DNA damage response pathway by combining olaparib with sapacitabine
may enhance the efficacy of standard of care treatment for BRCA
positive patients with breast cancer.
- Activated the CYC140 first-in-human study in advanced
leukemias. CYC140 is a novel, small molecule, selective
polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from
other PLK1 inhibitors, demonstrating potent and selective target
inhibition and high activity in xenograft models of human cancers
when dosed orally at non-toxic doses.
- Progressed patient enrollment in part 2 of the Phase 1 study
evaluating CYC065 monotherapy in patients with advanced solid
tumors including those with Mcl-1, MYC or cyclin E amplified
cancers relevant to CYC065’s mechanism of action. Part 2 is
evaluating increased dosing frequency of two days per week for two
weeks of a three-week cycle.
- Completed meetings with three European regulatory authorities
with the objective of determining a potential regulatory pathway
for sapacitabine in elderly AML. The regulators provided consistent
guidance on next steps and Cyclacel is evaluating a potential
request for a meeting with the Scientific Advice Working Party of
the European Medicines Agency.
- Appointed Robert J. Spiegel, M.D. to the Board of Directors.
Dr. Spiegel brings over 30 years of R&D and operational
experience in the biopharmaceutical industry as well as advisory
experience to venture capital and private equity funds.
- Entered into a Common Stock Sales Agreement with H.C.
Wainwright & Co., LLC as sales agent, pursuant to which the
agent may sell shares of common stock having an aggregate offering
price of up to $5.0 million by any method that is deemed to be an
“at the market offering” as defined in Rule 415 under the
Securities Act of 1933 as amended.
Financial HighlightsAs of September 30, 2018,
cash and cash equivalents totaled $19.0 million compared to $23.9
million as of December 31, 2017. The decrease of $4.9 million in
the nine-months was primarily due to net cash used in operating
activities, including $1.2 million of R&D tax credit received
from the United Kingdom government.
Research and development expenses were $1.2 million for the
three months ended September 30, 2018 compared to $1.0 million for
the same period in 2017.
General and administrative expenses were $1.3
million for the three months ended September 30, 2018 compared to
$1.2 million for the same period in 2017.
Other income, net for the three months ended
September 30, 2018 was $0.1 million compared to $36,000 for the
same period of the previous year.
The United Kingdom R&D and tax credits were
$0.3 million for the three months ended September 30, 2018 compared
to $0.2 million for the same period in 2017.
Net loss for the three months ended September
30, 2018 was $2.1 million compared to $1.9 million for the same
period in 2017. With the cash-sparing benefits accruing from
the MD Anderson alliance the Company believes that cash and
marketable securities, which were approximately $19.0 million as of
September 30, 2018, will be sufficient to finance operations until
the second quarter of 2020.
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
3775807
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 its expertise in cell cycle, transcriptional
regulation and DNA damage response biology in cancer cells to
develop innovative medicines. The transcriptional regulation
program is evaluating CYC065, a CDK inhibitor, in patients with
advanced solid cancers and in combination with venetoclax in
patients with advanced hematological malignancies. The DNA damage
response program is evaluating a combination of sapacitabine and
seliciclib, a CDK inhibitor, in BRCA positive patients with
advanced solid cancers and sapacitabine and olaparib, a PARP
inhibitor, in BRCA positive patients with breast cancer. CYC140, a
PLK inhibitor, is ready to start investigation in cancer patients.
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.
Contacts |
|
|
Company: |
|
Paul McBarron, (908)
517-7330, pmcbarron@cyclacel.com |
Investor
Relations: |
|
Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@russopartnersllc.com |
© Copyright 2018 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 September
30, |
|
|
Nine Months Ended September
30, |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
2018 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues |
|
$ |
— |
|
|
|
$ |
— |
|
|
|
$ |
— |
|
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
958 |
|
|
|
|
1,205 |
|
|
|
|
3,491 |
|
|
|
|
3,185 |
|
General and
administrative |
|
|
1,154 |
|
|
|
|
1,250 |
|
|
|
|
3,802 |
|
|
|
|
3,898 |
|
Total operating
expenses |
|
|
2,112 |
|
|
|
|
2,455 |
|
|
|
|
7,293 |
|
|
|
|
7,083 |
|
Operating
loss |
|
|
(2,112 |
) |
|
|
|
(2,455 |
) |
|
|
|
(7,293 |
) |
|
|
|
(7,083 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange gains
(losses) |
|
|
(22 |
) |
|
|
|
1 |
|
|
|
|
(65 |
) |
|
|
|
(42 |
) |
Interest income |
|
|
30 |
|
|
|
|
85 |
|
|
|
|
59 |
|
|
|
|
238 |
|
Other income, net |
|
|
28 |
|
|
|
|
- |
|
|
|
|
907 |
|
|
|
|
632 |
|
Total other income |
|
|
36 |
|
|
|
|
86 |
|
|
|
|
901 |
|
|
|
|
828 |
|
Loss before
taxes |
|
|
(2,076 |
) |
|
|
|
(2,369 |
) |
|
|
|
(6,392 |
) |
|
|
|
(6,255 |
) |
Income tax benefit |
|
|
219 |
|
|
|
|
301 |
|
|
|
|
793 |
|
|
|
|
985 |
|
Net
loss |
|
|
(1,857 |
) |
|
|
|
(2,068 |
) |
|
|
|
(5,599 |
) |
|
|
|
(5,270 |
) |
Dividend on convertible
exchangeable preferred shares |
|
|
(50 |
) |
|
|
|
(50 |
) |
|
|
|
(151 |
) |
|
|
|
(151 |
) |
Beneficial conversion
feature of Series A convertible stock |
|
|
(3,638 |
) |
|
|
|
- |
|
|
|
|
(3,638 |
) |
|
|
|
- |
|
Conversion of Series A
convertible preferred stock |
|
|
(3,373 |
) |
|
|
|
- |
|
|
|
|
(3,373 |
) |
|
|
|
- |
|
Net loss
applicable to common shareholders |
|
$ |
(8,918 |
) |
|
|
$ |
(2,118 |
) |
|
|
$ |
(12,761 |
) |
|
|
$ |
(5,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
|
$ |
(0.91 |
) |
|
|
$ |
(0.18 |
) |
|
|
$ |
(2.06 |
) |
|
|
$ |
(0.45 |
) |
Weighted average common
shares outstanding |
|
|
9,835,441 |
|
|
|
|
11,997,447 |
|
|
|
|
6,200,783 |
|
|
|
|
11,997,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEET |
(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
September 30, |
|
|
|
|
|
|
|
2017 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
|
$ |
23,910 |
|
|
$ |
18,973 |
|
|
Prepaid
expenses and other current assets |
|
|
|
2,064 |
|
|
|
1,696 |
|
|
|
|
|
Total current
assets |
|
|
|
25,974 |
|
|
|
20,669 |
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
|
29 |
|
|
|
38 |
|
|
|
|
|
Total assets |
|
|
$ |
26,003 |
|
|
$ |
20,707 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
|
$ |
1,558 |
|
|
$ |
1,411 |
|
|
Accrued and
other current liabilities |
|
|
|
2,555 |
|
|
|
2,592 |
|
|
|
|
|
Total current
liabilities |
|
|
|
4,113 |
|
|
|
4,003 |
|
Other
liabilities |
|
|
|
124 |
|
|
|
106 |
|
|
|
|
|
Total liabilities |
|
|
|
4,237 |
|
|
|
4,109 |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized at
December 31, 2017 and September 30, 2018; |
|
|
|
|
|
|
|
6%
Convertible Exchangeable preferred stock; 335,273 shares issued and
outstanding at |
|
|
|
|
|
|
|
December 31, 2017 and September 30, 2018. Aggregate preference
in liquidation of $4,006,512 as |
|
|
|
|
|
|
|
of
December 31, 2017 and September 30, 2018. |
|
|
|
- |
|
|
|
- |
|
|
Series A
convertible preferred stock, $0.001 par value; 264 shares issued
and outstanding |
|
|
|
|
|
|
|
at December
31, 2017 and September 30, 2018. |
|
|
|
- |
|
|
|
- |
|
|
Common
stock, $0.001 par value; 100,000,000 shares authorized at
December 31, 2017 and September 30, 2018; |
|
|
|
|
|
|
|
11,997,447
shares issued and outstanding at December 31, 2017 and
September 30, 2018. |
|
|
|
12 |
|
|
|
12 |
|
Additional paid-in capital |
|
|
|
365,057 |
|
|
|
365,160 |
|
Accumulated other comprehensive loss |
|
|
|
(794 |
) |
|
|
(796 |
) |
Accumulated deficit |
|
|
|
(342,509 |
) |
|
|
(347,778 |
) |
|
|
Total
stockholders’ equity |
|
|
|
21,766 |
|
|
|
16,598 |
|
|
|
Total
liabilities and stockholders’ equity |
|
|
$ |
26,003 |
|
|
$ |
20,707 |
|
|
|
|
|
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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