– Conference Call Scheduled March 27,
2019 at 4:30 p.m. EDT –
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company") a biopharmaceutical company developing
innovative medicines based on cancer cell biology, today reported
its financial results and business highlights for the fourth
quarter and full year ended December 31, 2018. The Company's
net loss applicable to common shareholders for the three months and
year ended December 31, 2018 was $2.1 million and $7.5 million,
respectively. As of December 31, 2018, cash and cash
equivalents totaled $17.5 million, not including net proceeds of
approximately $4.1 million from a Common Stock Sales Agreement.
"We are executing on our targeted oncology strategy with the
objective of delivering data readouts from multiple clinical
programs,” said Spiro Rombotis, President and Chief Executive
Officer. “At the heart of our business strategy is targeting
patients with overexpression of cancer resistance proteins,
including Mcl-1, MYC, cyclin E, and inherited mutations in DNA
damage pathways, such as BRCA. We believe CYC065 is the first
investigational drug to have consistently demonstrated durable
suppression of Mcl-1 at tolerable dosing in patients. We have
treated patients in two out of four studies under our MD Anderson
collaboration, the Phase 1 study of a combination of CYC065 and
venetoclax in relapsed/refractory CLL and the first-in-human, Phase
1 study of CYC140 in advanced leukemias. Protocols for the other
two studies have been finalized and will be submitted to
institutional review boards. The first two patients with BRCA
mutant breast cancer were treated in the sapacitabine and olaparib
IST. With estimated capital on hand until the end of 2020 we look
forward to reporting data from our ongoing clinical studies and
realizing shareholder value from our targeted drug pipeline.”
Fourth Quarter and Full-Year Highlights
Drug Development
CYC065 CDK InhibitorInitiated a Phase 1
clinical trial evaluating CYC065, a CDK2/9 inhibitor, in
combination with venetoclax in patients with relapsed/refractory
CLL. The first patient has been treated with this dose regimen
without dose-limiting toxicity. The strong biological rationale of
dual Mcl-1 and Bcl-2 suppression was presented at the 2018 AACR in
a poster titled “Strategic combination of the cyclin-dependent
kinase inhibitor CYC065 with venetoclax to target anti-apoptotic
proteins in chronic lymphocytic leukemia.” The data showed an
enhanced effect of the combination of CYC065 and venetoclax in CLL
tumor samples, including demonstrating activity in 17p deleted
samples which were resistant to either agent alone.
Data from the Phase 1 part 1 clinical study of CYC065
monotherapy administered intravenously over 4 hours every 3 weeks
in patients with advanced solid tumors were reported at an oral
presentation at the 2018 AACR. Prolonged reduction of Mcl-1
expression was observed in 11 out of 13 patients treated at the
recommended Phase 2 dose (RP2D) following a single dose of CYC065.
Cyclacel continues to enroll patients in part 2 of the study
evaluating CYC065 in a more intensive schedule for 2 days per week
over 2 weeks of a three-week cycle. Part 3 of the study is planned
to evaluate an oral CYC065 formulation.
Discussions with principal investigators and/or cooperative
groups progressed with the objective of evaluating CYC065 in
patients with certain hematological malignancies and solid
tumors.
DNA Damage Response (DDR) ProgramThe first two
patients have been dosed in the Phase 1b/2 investigator-sponsored
study of sapacitabine in combination with olaparib, an approved
PARP inhibitor, in patients with BRCA mutant breast cancer.
According to the investigators both patients achieved tumor
shrinkage. Dual targeting of the DNA damage response pathway with
the addition of sapacitabine to olaparib may enhance the efficacy
of the current standard of care for such patients.
Patient enrolment has continued in part 3 of a Phase 1 study
evaluating a revised dosing schedule of sequential sapacitabine and
seliciclib, Cyclacel’s first-generation CDK inhibitor, in BRCA
mutation positive patients with advanced breast, ovarian and
pancreatic cancer. New data on an expanded cohort from part 1 of
this study will be the subject of a poster titled “Expansion cohort
of Phase I study of oral sapacitabine and oral seliciclib in
patients with metastatic breast cancer and BRCA1/2 mutations” at
the 2019 AACR.
CYC140 PLK1 InhibitorThe first patient has been
dosed in a Phase 1 first-in-human study evaluating CYC140 in
patients with advanced leukemias. CYC140 is a small molecule,
selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated
potent and selective target inhibition and high activity in
xenograft models of human cancers.
SEAMLESS Phase 3 Study Stratified and
exploratory subgroup analyses have defined a subgroup of patients
for whom the sapacitabine regimen may represent an improvement over
low intensity treatment by decitabine alone. Following consultation
with three European regulatory authorities regarding a potential
approval pathway for sapacitabine the Company intends to submit a
request for scientific advice to the Scientific Advice Working
Party (SAWP) of the European Medicines Agency.
Corporate Developments
Entered into a collaboration with The University of Texas MD
Anderson Cancer Center to evaluate three Cyclacel medicines in
patients with hematological malignancies. MD Anderson will evaluate
CYC065, CYC140 and sapacitabine either as single agents or in
combination with approved drugs, in up to 170 enrolled patients
across four clinical trials.
Added Robert J. Spiegel, M.D. to the Company’s 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.
2019 Key Upcoming Business Objectives
- Report expansion cohort, Phase 1 clinical data with an oral
sequential regimen of sapacitabine and seliciclib in patients with
BRCA mutant metastatic breast cancer at the 2019 AACR
- Initiate CYC065-venetoclax Phase 1 study in patients with
relapsed or refractory AML or MDS
- Initiate sapacitabine-venetoclax Phase 1 study in patients with
relapsed or refractory AML or MDS
- Report initial data from the CYC065-venetoclax Phase 1 studies
in leukemias
- Report initial data from the CYC140 Phase 1 First-in-Human
study
- Report initial data and bioavailability from the Phase 1 study
of an oral formulation of CYC065
- Report updated CYC065 Phase 1 data in patients with advanced
solid cancers
- Report data from the IST Phase 1b/2 trial of
sapacitabine-olaparib combination in patients with BRCA mutant
metastatic breast cancer when reported by the investigators
- Determine regulatory pathway and submissibility of sapacitabine
in elderly AML
Financial Highlights
As of December 31, 2018, cash and cash equivalents totaled $17.5
million, compared to $23.9 million as of December 31, 2017. The
decrease of $6.4 million was primarily due to net cash used in
operating activities of $6.7 million, net cash used in investing
activities of $0.1 million, offset by $0.4 million of net cash
provided by financing activities.
Revenues for the three months and year ended December 31, 2018
amounted to $0.2 million compared to nil revenue for the same
periods in 2017. The revenue is related to a June 2015
collaboration, licensing and supply agreement with ManRos
Therapeutics SA.
Research and development expenses were $1.1 million and $4.3
million for the three months and year ended December 31, 2018 as
compared to $0.7 million and $4.2 million for the same periods in
2017. Research and development expenses relating to transcriptional
regulation increased by $1.5 million from $1.1 million for the year
ended December 31, 2017 to $2.5 million for the year ended December
31, 2018, as the clinical evaluation of CYC065 progresses. Research
and development expenses relating to sapacitabine decreased by $1.7
million from $2.5 million for the year ended December 31, 2017 to
$0.8 million for the year ended December 31, 2018, primarily as a
result of a reduction in expenditures associated with the SEAMLESS
Phase 3 trial and related costs.
General and administrative expenses for the three months and
year ended December 31, 2018 were $1.5 million and $5.3 million,
respectively compared to $1.5 million and $5.3 million for the same
period of the previous year.
Total other income, net for the three months and year ended
December 31, 2018 were $0.1 million and $0.9 million, compared to
$0.1 million and $1.0 million for the same period of the previous
year. The decrease of $0.1 million for the year ended December 31,
2018 is primarily related to a reduction in income received under
an Asset Purchase Agreement with ThermoFisher Scientific Company
and offset by a $0.2 million increase in interest income.
United Kingdom research & development tax credits were $0.4
million and $1.3 million for the three months and year ended
December 31, 2018 as compared to $0.2 million and $1.0 million for
the same periods in 2017.
Net loss for the three months and year ended December 31, 2018
were $2.0 million and $7.3 million compared to $1.9 million and
$7.5 million for the same periods in 2017.
The Company raised net proceeds of approximately $4.7 million,
of which $4.1 million was received in 2019, from its Common Stock
Sales Agreement with H.C. Wainwright. This agreement is now
complete. Together with cash resources of $17.5 million as of
December 31, 2018 the Company estimates cash resources will fund
currently planned programs through the end 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 9719419.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, including CLL and AML. 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 and a concomitant regimen of sapacitabine
and olaparib, a PARP inhibitor, in patients with BRCA mutant,
metastatic breast cancer. CYC140, a PLK inhibitor, is in a Phase 1
first-in-human study in patients with advanced leukemias.
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 2019 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)
|
|
|
|
Twelve Months Ended |
|
|
|
|
December 31, |
|
|
|
|
|
2017 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Grant
revenue |
|
$ |
- |
|
|
$ |
- |
|
|
Collaboration and research and development revenue |
|
|
- |
|
|
|
150 |
|
Total revenues |
|
|
- |
|
|
|
150 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,237 |
|
|
|
4,327 |
|
|
General and
administrative |
|
|
5,254 |
|
|
|
5,371 |
|
Total operating expenses |
|
|
9,491 |
|
|
|
9,698 |
|
Operating loss |
|
|
(9,491 |
) |
|
|
(9,548 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
Change in valuation of financial instruments
associated with stock purchase agreement |
|
|
- |
|
|
|
- |
|
|
Foreign
exchange gains (losses) |
|
|
(39 |
) |
|
|
(90 |
) |
|
Interest
income |
|
|
118 |
|
|
|
331 |
|
|
Other
income, net |
|
|
949 |
|
|
|
682 |
|
|
|
Total other income
(expense), net |
|
|
1,028 |
|
|
|
923 |
|
Loss from continuing operations before taxes |
|
|
(8,463 |
) |
|
|
(8,625 |
) |
Income tax
benefit |
|
|
993 |
|
|
|
1,342 |
|
Corporation
Tax |
|
|
- |
|
|
|
(5 |
) |
Net
loss from continuing operations |
|
|
(7,470 |
) |
|
|
(7,288 |
) |
Net
loss |
|
|
(7,470 |
) |
|
|
(7,288 |
) |
Dividend on
convertible exchangeable preferred shares |
|
|
(201 |
) |
|
|
(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 |
|
$ |
(14,846 |
) |
|
$ |
(7,489 |
) |
Basic and diluted earnings per common share: |
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
|
$ |
(1.95 |
) |
|
$ |
(0.62 |
) |
Weighted
average common shares outstanding |
|
|
7,631,152 |
|
|
|
12,094,131 |
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEET(In $000s,
except share, per share, and liquidation preference amounts)
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2017 |
|
2018 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
23,910 |
|
$ |
17,504 |
|
Prepaid
expenses and other current assets |
|
2,064 |
|
2,283 |
|
|
Total current
assets |
|
25,974 |
|
19,787 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
29 |
|
36 |
|
|
Total assets |
|
$ |
26,003 |
|
$ |
19,823 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
1,558 |
|
$ |
2,719 |
|
Accrued and
other current liabilities |
|
2,555 |
|
1,732 |
|
|
Total current
liabilities |
|
4,113 |
|
4,451 |
Other
liabilities |
|
124 |
|
100 |
|
|
Total liabilities |
|
4,237 |
|
4,551 |
Stockholders’ equity |
|
21,766 |
|
15,272 |
|
Total liabilities and stockholders’ equity |
|
$ |
26,003 |
|
$ |
19,823 |
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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