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,
2017. The Company's net loss applicable to common
shareholders for the three months and year ended December 31, 2017
was $2.1 million and $14.9 million, respectively. As of
December 31, 2017, cash and cash equivalents totaled $23.9 million.
“We are greatly encouraged by our clinical progress in 2017,
particularly in our transcriptional regulation program with CYC065,
our lead CDK inhibitor candidate,” said Spiro Rombotis, President
and Chief Executive Officer of Cyclacel. “We have achieved clinical
proof of mechanism with CYC065 by demonstrating durable reduction
of Mcl-1 expression in Phase 1 patients for at least 24 hours after
a single dose. We believe these unprecedented findings provide a
strong rationale for evaluating CYC065 in combination with
venetoclax in patients with chronic lymphocytic leukemia, or CLL,
and neuroblastoma, a predominantly pediatric cancer with poor
prognosis. In collaboration with an academic center and a
pharmaceutical company we have developed a protocol for a Phase
1b/2 investigator-sponsored trial to evaluate combination treatment
of an approved PARP inhibitor and sapacitabine in patients with
BRCA mutant breast cancer. We have also completed analysis of the
results from the SEAMLESS Phase 3 study of sapacitabine and plan to
discuss the data with regulatory authorities. Finally, we improved
our cash resources raising $14.9 million, net of expenses, which
will fund currently planned programs through the first quarter of
2020. We look forward to reporting our progress during the
remainder of 2018, including clinical data from our studies as they
arise, such as the previously announced, oral presentation of Phase
1 data with CYC065 at the upcoming American Association for Cancer
Research (AACR) 2018 Annual Meeting.”
Fourth Quarter and Full-Year Highlights
Drug DevelopmentTranscriptional
Regulation Program: CYC065 CDK
InhibitorIn part 1 of an ongoing, first-in-human, single
agent, ascending dose, Phase 1 study, prolonged reduction of Mcl-1
was observed in 11 out of 13 evaluable 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 5 patients, of which 4 were
treated at the RP2D and 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. The trial is being conducted at the Dana Farber
Cancer Institute in Boston. Part 2 of the Phase 1
translational study will evaluate additional dosing schedules in
patients with advanced solid tumors, in particular those with
amplification of Mcl-1, MYC or cyclin E, including subsets of high
grade serous ovarian and uterine cancers. Several biomarkers
relevant to CYC065’s mechanism of action will be assessed.
The protocol for the Phase 1b study of a combination regimen of
CYC065 and venetoclax in patients with relapsed or refractory CLL
has been submitted to the US Food and Drug Administration or
FDA. The study will evaluate safety, pharmacokinetics and
pharmacodynamics of the combination, including biomarkers related
to the mechanism of action of CYC065.
Discussions with principal investigators and/or cooperative
groups progressed with the objective of evaluating CYC065 in both
pediatric and adult patients with solid tumors. The Company
is discussing with an investigator cooperative group a potential
evaluation of CYC065 in patients with neuroblastoma, a mostly
pediatric, life-threatening malignancy, frequently associated with
MYCN amplification.
In
another study, to be conducted as an investigator sponsored trial,
CYC065 will be evaluated in adult and pediatric patients with
leukemias, including acute myeloid leukemia, or AML, acute
lymphocytic leukemia, or ALL, and in particular those with mixed
lineage leukemia rearrangements, or MLL-r.
Preclinical data on the molecular rationale and therapeutic
potential of CYC065 included an article published in the Journal of
National Cancer Institute, reporting prominent antitumor activity
against lung cancer cells through anaphase catastrophe, a novel,
cancer specific, mechanism. CYC065 was found to be effective
against lung cancer cell lines, including those with KRAS
mutations. Additional preclinical data presented at the 2017 AACR
Annual Meeting, demonstrated therapeutic potential of CYC065 as a
targeted anticancer agent. CYC065 substantially inhibited growth,
triggered apoptosis, and induced anaphase catastrophe in murine and
human lung cancer cells with known high metastatic potential. This
was in marked contrast to effects in immortalized pulmonary
epithelial murine and human cells. CYC065 markedly inhibited
migration and invasion of lung cancer cells and affected
distinctive pathways involved in DNA damage response, apoptosis,
cell cycle regulation and cell migration.
DNA Damage Response
(DDR) ProgramIn collaboration
with an academic center and a pharmaceutical company we have
developed a protocol for a Phase 1b/2 investigator-sponsored trial
to evaluate safety and efficacy of a combination regimen of an
approved PARP inhibitor and sapacitabine in patients with BRCA
mutant breast cancer.
Enrollment has been completed in an extension of part 1 of the
Phase 1 study evaluating a combination regimen of sapacitabine and
seliciclib, Cyclacel’s first generation CDK inhibitor, in an
enriched population of approximately 20 patients with BRCA positive
advanced breast cancer. An ongoing part 3 of this study is testing
a revised dosing schedule in additional patients, including BRCA
positive, patients with breast, ovarian and pancreatic cancers.
SEAMLESS Phase 3 Study Data from the SEAMLESS
Phase 3 study of sapacitabine in elderly patients with AML were the
subject of an oral presentation in December 2017 at the 59th
ASH Annual Meeting. The presentation included additional data
from prespecified and exploratory analysis of subgroups that may
benefit from treatment with the sapacitabine-decitabine alternating
regimen. 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.
The Company has completed further statistical and exploratory
analyses of the results from the SEAMLESS study and is preparing
briefing documents for submission to regulatory authorities with
the objective of determining a potential regulatory pathway for
sapacitabine in AML.
PLK1 Inhibitor; CYC140At the 2017 AACR Annual
Meeting, the Company presented preclinical data outlining the
potential therapeutic utility of CYC140, a novel, polo-like kinase
(PLK) 1 inhibitor, alone and in synergistic drug combinations, for
the treatment of esophageal cancer and acute leukemia.
Investigator-Sponsored Trials (ISTs): Seliciclib in
Rheumatoid Arthritis (RA)The Independent Data Monitoring
Committee, or IDMC, for the “TRAFIC” trial sponsored by the UK
Medical Research Council, (ISRCTN 36667085) determined that part 1
of the study was successfully completed per protocol. The IDMC
recommended continuation of the trial into part 2 to assess
potential efficacy of seliciclib as an addition to existing
anti-TNF therapy based on a composite outcome of response in
patients with moderate to severe RA.
Corporate DevelopmentsThe Company raised net
proceeds of approximately $13.7 million from an underwritten
offering of common stock.
Cyclacel received notice from the European Patent Office of
the grant of a European patent including claims to novel
pharmaceutical formulations of sapacitabine.
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 the Phase 1b/2 IST of a combination regimen
of an approved PARP inhibitor and sapacitabine in patients with
BRCA mutant breast cancer
- Start enrollment in the Phase 1b/2 IST of CYC065 in pediatric
patients with neuroblastoma
- Update mature data from the part 1 extension of the
sapacitabine and seliciclib combination in patients with BRCA
positive advanced breast and complete part 3 enrollment of the
sapacitabine and seliciclib combination in patients with BRCA
positive, breast, ovarian and pancreatic cancers
- Submit CYC140, PLK1 inhibitor, IND application
- Conduct regulatory authority meetings regarding the SEAMLESS
study of sapacitabine in AML
Financial HighlightsAs of December 31, 2017,
cash and cash equivalents totaled $23.9 million, compared to $16.5
million as of December 31, 2016. The increase of $7.4 million was
primarily due to net proceeds of $13.7 million from a direct
registered offering, $1.0 million from the sale of common stock
through the ATM sales agreement with FBR Capital Markets & Co.,
$0.2 million warrant exercises and offset by $7.5 million of net
cash used in operating activities.
There were no revenues for the three months and year ended
December 31, 2017 compared to $0.3 million and $0.8 million for the
same period of the previous year. The revenue is related to
previously awarded, UK government grants being recognized over the
period to progress IND-directed preclinical development of CYC140,
a novel, PLK-1 inhibitor, which was completed in November 2016.
Research and development expenses were $0.7 million and $4.2
million for the three months and year ended December 31, 2017 as
compared to $1.9 million and $9.5 million for the same periods in
2016. The decrease was primarily due to reduced study and clinical
supply costs associated with completion of the SEAMLESS study and
2016 expenditure related the development of CYC140.
General and administrative expenses for the three months and
year ended December 31, 2017 were $1.5 million and $5.3 million,
compared to $1.5 million and $5.5 million for the same period of
the previous year.
Other income (expense), net for the three months and year ended
December 31, 2017 were $0.1 million and $1.0 million, compared to
($0.1) million and $0.4 million for the same period of the previous
year. The increase is primarily related to income received under an
Asset Purchase Agreement with Life Technologies Corporation, or
LTC, (formerly Invitrogen Corporation and subsequently acquired by
ThermoFisher Scientific), resulting from certain assets and
intellectual property sold by the Company to LTC in December
2005.
United Kingdom research & tax credits were $0.2 million and
$1.0 million for the three months and year ended December 31, 2017
as compared to $0.4 million and $2.0 million for the same periods
in 2016.Net loss for the three months and year ended December 31,
2017 were $1.9 million and $7.5 million compared to $2.8 million
and $11.8 million for the same periods 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
4857905For 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.
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
(LOSS) |
(In $000s, except share and per share amounts) |
|
|
|
Year Ended December 31, |
|
|
|
2016 |
|
|
2017 |
|
|
Revenues: |
|
|
|
|
|
|
Grant
revenue |
|
$ |
843 |
|
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
9,477 |
|
|
|
4,237 |
|
|
General
and administrative |
|
|
5,516 |
|
|
|
5,254 |
|
|
Total operating
expenses |
|
|
14,993 |
|
|
|
9,491 |
|
|
Operating
loss |
|
|
(14,150 |
) |
|
|
(9,491 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Foreign
exchange gains (losses) |
|
|
273 |
|
|
|
(39 |
) |
|
Interest
income |
|
|
37 |
|
|
|
118 |
|
|
Other
income, net |
|
|
66 |
|
|
|
949 |
|
|
Total
other income (expense), net |
|
|
376 |
|
|
|
1,028 |
|
|
Loss from
continuing operations before taxes |
|
|
(13,774 |
) |
|
|
(8,463 |
) |
|
Income tax benefit
|
|
|
1,983 |
|
|
|
993 |
|
|
Net
loss |
|
|
(11,791 |
) |
|
|
(7,470 |
) |
|
Dividend on convertible
exchangeable preferred shares |
|
|
(200 |
) |
|
|
(201 |
) |
|
Beneficial conversion
feature of Series A convertible stock |
|
|
— |
|
|
|
(3,638 |
) |
|
Conversion of Series A
convertible preferred stock |
|
|
— |
|
|
|
(3,537 |
) |
|
Net loss
applicable to common shareholders |
|
$ |
(11,991 |
) |
|
$ |
(14,846 |
) |
|
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted |
|
$ |
(3.50 |
) |
|
$ |
(1.95 |
) |
|
Weighted average common
shares outstanding |
|
|
3,424,976 |
|
|
|
7,631,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEET |
(In $000s, except share, per share, and liquidation
preference amounts) |
|
|
|
December 31, |
|
|
|
2016 |
|
|
2017 |
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
16,520 |
|
|
$ |
23,910 |
|
|
Prepaid
expenses and other current assets |
|
|
3,097 |
|
|
$ |
2,064 |
|
|
Total
current assets |
|
|
19,617 |
|
|
$ |
25,974 |
|
|
Property
and equipment, net |
|
|
45 |
|
|
$ |
29 |
|
|
Total
assets |
|
$ |
19,662 |
|
|
$ |
26,003 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,497 |
|
|
$ |
1,558 |
|
|
Accrued
and other current liabilities |
|
|
2,762 |
|
|
$ |
2,555 |
|
|
Total
current liabilities |
|
|
5,259 |
|
|
$ |
4,113 |
|
|
Other liabilities
|
|
|
130 |
|
|
$ |
124 |
|
|
Total
liabilities |
|
|
5,389 |
|
|
$ |
4,237 |
|
|
Commitments and
contingencies (Note 9) |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized at
December 31, 2016 and December 31, 2017; |
|
|
|
|
|
|
|
|
6%
Convertible Exchangeable preferred stock; 335,273 shares issued and
outstanding at December 31, 2016 and December 31, 2017.
Aggregate preference in liquidation of $4,006,512 at
December 31, 2016 and December 31, 2017 |
|
|
— |
|
|
|
— |
|
|
Series A
convertible preferred stock; 0 shares and 264 shares issued and
outstanding at December 31, 2016 and December 31, 2017,
respectively |
|
|
— |
|
|
|
— |
|
|
Common
stock, $0.001 par value; 100,000,000 shares authorized at
December 31, 2016 and December 31, 2017; 4,256,829 and
11,997,447 shares issued and outstanding at December 31, 2016
and December 31, 2017, respectively. |
|
|
4 |
|
|
|
12 |
|
|
Additional paid-in
capital |
|
|
350,051 |
|
|
$ |
365,057 |
|
|
Accumulated other
comprehensive loss |
|
|
(743 |
) |
|
$ |
(794 |
) |
|
Accumulated deficit
|
|
|
(335,039 |
) |
|
$ |
(342,509 |
) |
|
Total
stockholders’ equity |
|
|
14,273 |
|
|
$ |
21,766 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
19,662 |
|
|
$ |
26,003 |
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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