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 for the second quarter 2020 and
business highlights, including an update on its progress with
fadraciclib, Cyclacel's novel CDK2/9 inhibitor.
The Company's net loss applicable to common shareholders for the
three months ended June 30, 2020 was $2.2 million. As of June 30,
2020, cash and cash equivalents totaled $25.3 million. Based on
current spending, the Company estimates it has sufficient resources
to fund planned operations, including research and development,
through the end of 2022.
“We believe fadraciclib is establishing a leadership position
among MCL1 suppressing compounds in development. Our recent,
peer-reviewed publication elaborates the mechanistic rationale for
fadraciclib as an anti-cancer therapy signifying the benefits of
inhibiting CDK2 and CDK9, two complementary cancer pathways,” said
Spiro Rombotis, President and Chief Executive Officer. “We continue
to be encouraged by observations of deep partial response and
prolonged stable disease with tumor shrinkage as an intravenously
administered monotherapy in patients with advanced solid tumors and
antileukemic activity in combination with venetoclax. In parallel
with evaluating fadraciclib in certain leukemias, we are executing
a precision medicine strategy to evaluate the compound in patients
with solid tumors with study enrollment expected to begin by the
first quarter of 2021. As the global pandemic continues to unfold,
our priorities are to ensure patient and employee safety and
support efforts to stem COVID-19 disease as part of our corporate
social responsibility. Despite the challenges we remain committed
to our strategy of building an innovative pipeline addressing the
rising problem of cancer resistance and achieving our clinical
milestones to drive shareholder value.”
Key Corporate Highlights
- Announced publication of a peer-reviewed study of fadraciclib,
in PLOS ONE. The publication, authored by scientists from Cyclacel
and The Institute of Cancer Research, London, describes the
discovery of fadraciclib and shows its ability to target CDK2 and
CDK9, leading to broad therapeutic potential.
- CYC065-01 Phase 1 part 2 single
agent i.v. – As
previously reported a heavily pretreated patient with MCL1
amplified endometrial cancer achieved a radiographically confirmed
partial response (PR) after a month and a half on fadraciclib at
213mg. This patient continues on therapy for more than a year and
reduction in her target tumor lesions is 83%. An additional patient
with cyclin E amplified ovarian cancer achieved stable disease with
29% tumor shrinkage after approximately four months at 213mg. We
have submitted data for publication at a cancer conference later in
the year.
- Based on data thus far, we are designing a Phase 1/2 precision
medicine study to further evaluate fadraciclib as monotherapy and
in combinations in patients with advanced solid tumors.
- CYC065-01 Phase 1 part 3 single
agent p.o. - Initial
data from an oral capsule formulation of fadraciclib given once
daily to four patients with advanced solid tumors demonstrated a
predictable pharmacokinetic profile closely overlapping the
intravenous form with encouraging exposure levels.
- CYC065-03 Phase 1 fadraciclib i.v. and venetoclax
p.o. in AML/MDS
- We have dosed 11 heavily pretreated patients
with relapsed/refractory (R/R) AML in five dose levels up to 200
mg/m2 of fadraciclib in combination with venetoclax. Evidence of
anticancer activity has been observed in four out of eleven
patients treated. Preclinical data in AML suggest that targeting
both MCL1 and BCL2 may be more beneficial than inhibiting either
protein alone.
- CYC065-02 Phase 1 fadraciclib i.v. and venetoclax
p.o. in CLL - We have
dosed 5 patients with R/R CLL in four dose levels up to 150 mg/m2
of fadraciclib in combination with venetoclax. Evidence of
anticancer activity has been observed in two patients who achieved
MRD negativity on the combination. Preclinical data suggest that
targeting both BCL2 and MCL1 in CLL may be more beneficial than
single agent treatment in this setting as well.
- CYC682-11 Phase 1 part 2 sapacitabine p.o.
and venetoclax p.o. - We have
enrolled 12 patients in a dose escalation study in our DNA Damage
Response (DDR) program evaluating an oral combination of
sapacitabine and venetoclax in patients with R/R AML/MDS. Two
patients, previously treated with combination therapies including
hypomethylating agents, have achieved 5 and 6 cycles of treatment
respectively. Sapacitabine is a nucleoside analogue that is active
in AML and MDS R/R to prior therapy such as cytarabine or
hypomethylating agents. Preclinical data demonstrated synergy of
sapacitabine with BCL2 inhibition, which may offer an effective,
oral treatment regimen for patients who have failed front-line
therapy.
- CYC140-01 Phase 1 CYC140 i.v. - We have
enrolled 6 patients in our first-in-human, dose escalation 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. In addition to
hematological malignancies we are evaluating studies of CYC140 in
solid tumors.
More information on our clinical trials can be found here.
Key Business Objectives
- Report updated fadraciclib Phase 1 safety and efficacy data
with frequent i.v. dosing schedule in patients with advanced solid
cancers;
- Report initial safety and PK data from Phase 1 study of
fadraciclib oral formulation;
- Treat first patient in fadraciclib Phase 1/2 precision medicine
study;
- Report initial data from fadraciclib-venetoclax Phase 1 study
in R/R AML/MDS & CLL;
- Report initial data from sapacitabine-venetoclax Phase 1 study
in R/R AML/MDS;
- Report initial data from CYC140 Phase 1 first-in-human study in
R/R leukemias; and
- Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA
mutant metastatic breast cancer when reported by the
investigators.
Financial Highlights
As of June 30, 2020, cash and cash equivalents totaled $25.3
million, compared to $11.9 million as of December 31, 2019. The
increase of $13.4 million was primarily due to net proceeds of
$18.3 million from an equity financing in April 2020 and net cash
used in operating activities of $4.7 million. There were no
revenues for each of the three months ended June 30, 2020 and
2019.
Research and development expenses were $1.2 million for each of
the three months ended June 30, 2020 and 2019. Research and
development expenses relating to transcriptional regulation
increased by approximately $0.2 million for the three months
ended June 30, 2020 as we continue to progress the clinical
evaluation of fadraciclib.
General and administrative expenses for the three months ended
June 30, 2020 were $1.3 million, compared to $1.2 million for the
same period of the previous year.
Total other income, net, for the three months ended June 30,
2020 was $20,000, compared to $0.2 million for the same period of
the previous year. The decrease of approximately $0.2 million for
the three months ended June 30, 2020 is primarily related to income
received under an Asset Purchase Agreement with Thermo Fisher
Scientific Inc.
United Kingdom research & development tax credits were $0.3
million for each of the three months ended June 30, 2020 and
2019.
Net loss for the three months ended June 30, 2020 was $2.2
million compared to $1.8 million for the same period in 2019.
The Company estimates that cash resources of $25.3 million as of
June 30, 2020 will fund currently planned programs through
2022.
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 2477369.
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 developing innovative cancer medicines based on cell cycle,
transcriptional regulation and DNA damage response biology. The
transcriptional regulation program is evaluating fadraciclib as a
single agent in solid tumors and in combination with venetoclax in
patients with relapsed or refractory AML/MDS and CLL. The DNA
damage response program is evaluating an oral combination of
sapacitabine and venetoclax in patients with relapsed or refractory
AML/MDS. An investigator-sponsored trial (IST) is evaluating an
oral combination of sapacitabine and olaparib in patients with BRCA
mutant breast cancer. The anti-mitotic program is evaluating
CYC140, a PLK1 inhibitor, in advanced leukemias/MDS 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, Jan Medina, (646) 942-5632,
Jan.Medina@russopartnersllc.com
© Copyright 2020 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)
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
|
|
|
|
|
June
30, |
|
|
|
|
|
|
|
|
|
2019 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
Total revenues |
|
|
- |
|
|
|
- |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
1,153 |
|
|
|
1,163 |
|
|
General and administrative |
|
|
1,184 |
|
|
|
1,309 |
|
Total operating expenses |
|
|
2,337 |
|
|
|
2,472 |
|
Operating loss |
|
|
(2,337 |
) |
|
|
(2,472 |
) |
Other income (expense): |
|
|
|
|
|
Foreign exchange gains (losses) |
|
|
21 |
|
|
|
(2 |
) |
|
Interest income |
|
|
56 |
|
|
|
4 |
|
|
Other income, net |
|
|
170 |
|
|
|
18 |
|
|
|
Total other income (expense), net |
|
|
247 |
|
|
|
20 |
|
Loss before taxes |
|
|
(2,090 |
) |
|
|
(2,452 |
) |
Income tax benefit |
|
|
307 |
|
|
|
286 |
|
Net loss |
|
|
|
|
(1,783 |
) |
|
|
(2,166 |
) |
Dividend on convertible exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
Net loss applicable to common shareholders |
|
$ |
(1,833 |
) |
|
$ |
(2,216 |
) |
Basic and diluted earnings per common share: |
|
|
|
|
Net loss per share – basic and diluted |
|
$ |
(2.13 |
) |
|
$ |
(0.58 |
) |
Weighted average common shares outstanding |
|
|
859,998 |
|
|
|
3,850,228 |
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEET(In $000s,
except share, per share, and liquidation preference amounts)
|
|
|
December 31, |
|
June 30, |
|
|
|
2019 |
|
2020 |
|
|
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
11,885 |
|
$ |
25,342 |
|
Prepaid expenses and other current assets |
|
2,132 |
|
|
2,591 |
|
|
Total current assets |
|
14,017 |
|
|
27,933 |
|
|
|
|
|
|
Property and equipment, net |
|
27 |
|
|
20 |
Right-of-use lease asset |
|
1,264 |
|
|
1,218 |
|
|
Total
assets |
$ |
15,308 |
|
$ |
29,171 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
890 |
|
$ |
342 |
|
Accrued and other current liabilities |
|
1,530 |
|
|
1,170 |
|
|
Total
current liabilities |
|
2,420 |
|
|
1,512 |
Lease liability |
|
1,191 |
|
|
1,081 |
Other liabilities |
|
- |
|
|
- |
|
|
Total
liabilities |
|
3,611 |
|
|
2,593 |
Stockholders’ equity |
|
11,697 |
|
|
26,578 |
|
Total liabilities and stockholders’ equity |
$ |
15,308 |
|
$ |
29,171 |
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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