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 first quarter 2018.
The Company's net loss applicable to common
shareholders for the three months ended March 31, 2018 was $1.4
million. As of March 31, 2018, cash and cash equivalents
totaled $21.7 million.
“Two presentations at the recent American
Association for Cancer Research Annual Meeting highlighted CYC065,
our lead CDK inhibitor drug candidate, confirming a strong
rationale for advancing its clinical development in certain liquid
and solid cancers,” said Spiro Rombotis, President and Chief
Executive Officer of Cyclacel. “The oral presentation confirmed
proof of mechanism in patients with advanced solid tumors. Durable
suppression of Mcl-1 in 11 of 13 patients was demonstrated for the
first time in the literature after a single dose at the recommended
Phase 2 level. In addition, anticancer activity was observed
in patients with MYC amplified tumors, confirming the promise of a
CDK inhibition strategy against this very difficult to treat tumor
type. The poster presentation demonstrated preclinical synergy of
CYC065 with venetoclax, supporting the Company’s plans to pursue a
venetoclax combination study in patients with relapsed/refractory
chronic lymphocytic leukemia, or CLL. We have also achieved another
important objective by submitting an IND for CYC140, an
internally-discovered, novel inhibitor of Polo-like-kinase 1, or
PLK1.”
Key Highlights
- CYC065, CDK2/9 inhibitor, Phase 1 data at oral presentation at
the 2018 American Association for Cancer Research (AACR) Annual
Meeting. In part 1 of this ongoing, first-in-human, single
agent, dose escalation study, prolonged reduction of Mcl-1
expression was observed in 11 out of 13 patients treated at the
recommended Phase 2 dose, or RP2D, following a single dose of
CYC065, which was generally well tolerated. Preliminary
anticancer activity was observed in 6 patients, of which 5 were
treated at the RP2D; genetic data was available for 3 out of 6
patients and all 3 were reported by investigators to have molecular
features of their cancers associated with CYC065’s mechanism of
action, including amplification of Mcl-1, MYC or cyclin
E.
- Following completion of part 1, Cyclacel has initiated part 2
of the study evaluating CYC065 in a more frequent dosing schedule
of 2 days per week for 2 weeks of a three-week cycle. Part 2
will enroll patients with advanced cancers and evaluate efficacy in
Mcl-1, MYC or cyclin E amplified cancers. Several biomarkers
relevant to CYC065’s mechanism of action will be
assessed.
- A poster was presented at the 2018 AACR meeting titled
“Strategic combination of the cyclin-dependent kinase inhibitor
CYC065 with venetoclax to target anti-apoptotic proteins in chronic
lymphocytic leukemia”. The preclinical study led by William
Plunkett, PhD, Professor and Deputy Chair, Department of
Experimental Therapeutics, The University of Texas MD Anderson
Cancer Center, highlighted data that showed the efficacy of CYC065
therapy in combination with the Bcl-2 inhibitor, venetoclax
(AbbVie), in CLL samples, including those with 17p deletions. The
CYC065-venetoclax combination was also active in two CLL samples
which were resistant to either agent alone. These findings support
the hypothesis that dual targeting of the Mcl-1- and
Bcl-2-dependent mechanisms could induce synergistic cell
death.
- The Company plans to initiate a clinical study in patients with
relapsed/refractory CLL in combination with venetoclax, in whom
durable suppression of Mcl-1 may be beneficial.
- Part 3 of the Phase 1 combination study of sapacitabine and
seliciclib (Cyclacel’s first generation CDK inhibitor) continues
enrolment with the objective of testing a revised dosing schedule
in patients with advanced cancer, including BRCA positive breast,
ovarian and pancreatic cancer patients.
- The Company has completed statistical and exploratory analyses
of the SEAMLESS Phase 3 study results and is preparing briefing
documents for submission to regulatory authorities with the
objective of determining a potential regulatory pathway for
sapacitabine in AML. The Company believes that the subgroup results
have defined a patient population for whom the sapacitabine regimen
may represent an improvement over low intensity treatment by
decitabine alone.
2018 Key Upcoming Business Objectives
- Report updated CYC065 Phase 1 data in patients with advanced
cancers;
- Initiate CYC065 Phase 1b in relapsed/refractory CLL in
combination with venetoclax;
- Start enrollment in a Phase 1b/2 IST of CYC065 in pediatric
patients with neuroblastoma;
- Start enrollment in a Phase 1b/2 IST of a combination regimen
of an approved PARP inhibitor and sapacitabine in patients with
BRCA mutant breast cancer;
- Conduct regulatory authority meetings regarding the SEAMLESS
study of sapacitabine in AML;
- Update mature data from the part 1 extension of the
sapacitabine and seliciclib combination in BRCA positive advanced
breast cancer patients and complete part 3 enrollment of the
sapacitabine and seliciclib combination in BRCA positive, breast,
ovarian and pancreatic cancer patients;
- IND review for CYC140 PLK1 inhibitor.
Financial Highlights
As of March 31, 2018, cash and cash equivalents totaled $21.7
million, compared to $23.9 million as of December 31, 2017. The
decrease of $2.2 million was primarily due to net cash used in
operating activities.
Research and development expenses were $0.8 million for the
three months ended March 31, 2018 as compared to $1.3 million for
the same period in 2017. The decrease was primarily due to reduced
study and related costs associated with completion of the SEAMLESS
study.
General and administrative expenses were $1.4
million for each of the three months ended March 31, 2018 and
2017.
Other income, net for the three months ended March 31, 2018 was
$0.6 million compared to $0.8 million for the same period of the
previous year. The decrease is primarily related to income received
under an Asset Purchase Agreement with ThermoFisher Scientific
Company, or TSC, (formerly Invitrogen Corporation), in respect of
certain assets and intellectual property related to chimeric
antigen receptor-T cell (CAR-T) manufacturing technology sold by
the Company to TSC in December 2005.
The United Kingdom research and tax credits were $0.2 million
for the three months ended March 31, 2018 compared to $0.3 million
for the same period in 2017.
Net loss for the three months ended March 31, 2018 was $1.3
million compared to $1.6 million for the same period in 2017.
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 6069578
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 BRCA positive patients with 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
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.
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|
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.
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|
CYCLACEL PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(In $000s, except share and per share amounts) |
|
|
|
|
|
Three Months EndedMarch
31, |
|
|
2017 |
|
2018 |
|
Revenues: |
|
|
|
|
Total
revenues |
$ |
— |
|
|
$ |
— |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
1,312 |
|
|
|
798 |
|
|
General
and administrative |
|
1,381 |
|
|
|
1,364 |
|
|
Total operating
expenses |
|
2,693 |
|
|
|
2,162 |
|
|
Operating
loss |
|
(2,693 |
) |
|
|
(2,162 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
Foreign
exchange gains (losses) |
|
(59 |
) |
|
|
(4 |
) |
|
Interest
income |
|
12 |
|
|
|
69 |
|
|
Other
income, net |
|
879 |
|
|
|
566 |
|
|
Total
other income (expense), net |
|
832 |
|
|
|
631 |
|
|
Loss from
continuing operations before taxes |
|
(1,861 |
) |
|
|
(1,531 |
) |
|
Income tax
benefit |
|
306 |
|
|
|
182 |
|
|
Net
loss |
|
(1,555 |
) |
|
|
(1,349 |
) |
|
Dividend on convertible
exchangeable preferred shares |
|
(50 |
) |
|
|
(50 |
) |
|
Net loss
applicable to common shareholders |
$ |
(1,605 |
) |
|
$ |
(1,399 |
) |
|
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
Net loss per share –
basic and diluted |
$ |
(0.38 |
) |
|
$ |
(0.12 |
) |
|
Weighted average common
shares outstanding |
|
4,271,324 |
|
|
|
11,997,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
|
CONSOLIDATED BALANCE SHEET |
|
(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
|
|
December 31,2017 |
|
|
March 31,2018 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
23,910 |
|
$ |
21,725 |
|
Prepaid
expenses and other current assets |
|
2,064 |
|
|
3,007 |
|
Total
current assets |
|
25,974 |
|
|
24,732 |
|
Property, plant and
equipment (net) |
|
29 |
|
|
45 |
|
Total
assets |
$ |
26,003 |
|
$ |
24,777 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
$ |
1,558 |
|
$ |
1,949 |
|
Accrued
and other current liabilities |
|
2,555 |
|
|
2,309 |
|
Total
current liabilities |
|
4,113 |
|
|
4,258 |
|
Other
liabilities |
|
124 |
|
|
124 |
|
Total
liabilities |
|
4,237 |
|
|
4,382 |
|
Stockholders’
equity |
|
21,766 |
|
|
20,395 |
|
Total
liabilities and stockholders’ equity |
$ |
26,003 |
|
$ |
24,777 |
|
|
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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