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 first quarter 2020 and
business highlights, including an update on its progress with
fadraciclib, Cyclacel's novel CDK inhibitor. The Company's net loss
applicable to common shareholders for the three months ended March
31, 2020 was $1.3 million. As of March 31, 2020, cash and cash
equivalents totaled $8.9 million. Following net proceeds of $18.4
million from an equity financing in April 2020, pro forma cash and
cash equivalents total $27.3 million. Based on current spending,
the Company estimates it has sufficient resources to fund planned
operations, including research and development, to the end of 2022.
“The global pandemic is creating uncertainty in every business
sector and it is clear that we need novel, science-based solutions
to emerge from the crisis,” said Spiro Rombotis, President and
Chief Executive Officer. “While our priorities are ensuring patient
safety and addressing our social responsibility, we remain
committed to our business strategy of building an innovative
pipeline addressing the rising problem of cancer resistance.
Fadraciclib is establishing a leadership position among MCL1
suppressing compounds in clinical development. We are encouraged by
observations of deep response and prolonged stable disease with
tumor shrinkage in both intravenous schedules tested this far.
Importantly, initial clinical data with oral fadraciclib show
concordance with intravenous pharmacokinetics. After strengthening
our balance sheet, we will now turn our attention to executing a
precision medicine strategy to evaluate fadraciclib in patients
with solid tumors and achieve our other clinical milestones through
late 2022.”
Key Corporate Highlights
- In light of the pandemic caused by the novel coronavirus and to
ensure the health and wellbeing of our employees, patients and the
communities we serve, we have redesigned our work flow and business
processes in line with current standards and government
recommendations. In addition, we are working hard to provide
uninterrupted clinical supplies and maintain the integrity of our
clinical research. At present, we have not experienced recruitment
delays, and our clinical investigators continue to screen and
enroll patients. As the future course of the pandemic is uncertain,
we will continue to closely monitor developments.
- CYC065-01 Phase 1 part 2 single
agent i.v. - We have
previously reported that 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 and reduction in her
target tumor lesions is 79% after nine months. An additional
patient with cyclin E amplified ovarian cancer achieved stable
disease with 29% tumor shrinkage after approximately four months at
213mg. 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 three 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 the venetoclax. Evidence
of anticancer activity has been observed in multiple patients with
blast reductions in peripheral blood. 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 two dose cohorts in our DNA Damage Response
(DDR) program evaluating an oral combination of sapacitabine and
venetoclax in patients with R/R AML/MDS. 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 5 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.
- COVID-19 Collaboration - We
entered into an agreement with The University of Edinburgh to
evaluate the potential of our CDK inhibitors, fadraciclib and
seliciclib, for reducing runaway inflammation and subsequent lung
injury in patients with COVID-19 disease.
More information on our clinical trials can be found at
www.clinicaltrials.gov.
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 March 31, 2020, cash and cash equivalents totaled $8.9
million, compared to $11.9 million as of December 31, 2019. The
decrease of $3.0 million was primarily due to net cash used in
operating activities of $2.8 million and $0.1 million of net cash
used in financing activities. There were no revenues for each of
the three months ended March 31, 2020 and 2019.
Research and development expenses were $1.1 million for the
three months ended March 31, 2020 as compared to $1.0 million for
the same period in 2019. Research and development expenses relating
to transcriptional regulation increased by almost $0.3 million for
the three months ended March 31, 2020 as we continue to
progress the clinical evaluation of fadraciclib.
General and administrative expenses for the three months ended
March 31, 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 March 31,
2020 was $0.9 million, compared to $0.1 million for the same period
of the previous year. The increase of $0.8 million for the three
months ended March 31, 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 March 31, 2020 and
2019.
Net loss for the three months ended March 31, 2020 was $1.2
million, compared to $1.8 million for the same period in 2019.
The Company raised net proceeds of approximately $18.4 million
from an equity financing in April 2020.
The Company estimates that cash resources of $8.9 million as of
March 31, 2020 together with the $18.4 million net proceeds from
the April 2020 financing 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 4198767.
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 |
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
2019 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Total
revenues |
|
|
|
- |
|
|
|
- |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
|
1,012 |
|
|
|
1,106 |
|
General and administrative |
|
|
1,192 |
|
|
|
1,318 |
|
Total
operating expenses |
|
|
2,204 |
|
|
|
2,424 |
|
Operating
loss |
|
|
|
|
(2,204 |
) |
|
|
(2,424 |
) |
Other income
(expense): |
|
|
|
|
Foreign exchange gains (losses) |
|
|
15 |
|
|
|
69 |
|
Interest income |
|
|
79 |
|
|
|
28 |
|
Other income, net |
|
|
- |
|
|
|
817 |
|
Total other income (expense), net |
|
|
94 |
|
|
|
914 |
|
Loss
before taxes |
|
|
|
(2,110 |
) |
|
|
(1,510 |
) |
Income tax
benefit |
|
|
268 |
|
|
|
290 |
|
Net
loss |
|
|
|
|
|
|
(1,842 |
) |
|
|
(1,220 |
) |
Dividend on
convertible exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
Net loss
applicable to common shareholders |
|
$ |
(1,892 |
) |
|
$ |
(1,270 |
) |
Basic and
diluted earnings per common share: |
|
|
|
|
Net loss per share
– basic and diluted |
|
$ |
(2.77 |
) |
|
$ |
(1.48 |
) |
Weighted average
common shares outstanding |
|
|
681,910 |
|
|
|
859,998 |
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEET(In $000s,
except share, per share, and liquidation preference amounts)
|
December 31, |
|
March 31, |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
11,885 |
|
|
$ |
8,923 |
|
Prepaid expenses and other current assets |
|
2,132 |
|
|
|
2,888 |
|
Total current assets |
|
14,017 |
|
|
|
11,811 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
27 |
|
|
|
25 |
|
Right-of-use lease asset |
|
1,264 |
|
|
|
1,151 |
|
Total assets |
$ |
15,308 |
|
|
$ |
12,987 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
890 |
|
|
$ |
250 |
|
Accrued and other current liabilities |
|
1,530 |
|
|
|
1,273 |
|
Total current liabilities |
|
2,420 |
|
|
|
1,523 |
|
Lease
liability |
|
1,191 |
|
|
|
1,073 |
|
Other
liabilities |
|
- |
|
|
|
- |
|
Total liabilities |
|
3,611 |
|
|
|
2,596 |
|
Stockholders’
equity |
|
11,697 |
|
|
|
10,391 |
|
Total liabilities and stockholders’ equity |
$ |
15,308 |
|
|
$ |
12,987 |
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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