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Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results
2021-02-25
·
GlobeNewswire
合作
财报
AACR会议
BERKELEY HEIGHTS, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) --
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, 2020. The Company's net loss applicable to common shareholders for the three months and year ended December 31, 2020 was $6.6 million and $12.4 million, respectively. As of December 31, 2020, cash and cash equivalents totaled $33.4 million. Additional proceeds of $4.3 million were received from the exercise of warrants after December 31, 2020. Based on current spending, the proforma cash on hand of $37.7 million provides the Company with sufficient resources to fund planned operations including research and development through early 2023. “During 2020 we have reported on
fadraciclib
’s oral bioavailability and evidence of durable anticancer activity,” said Spiro Rombotis, President and Chief Executive Officer. “Independent evidence supporting the rationale for dual inhibition of
CDK2
and
CDK9
cancer
pathways, the targets of
fadraciclib
, were published in peer-reviewed communications. Meanwhile our team, led by Dr. Mark Kirschbaum, our newly appointed CMO, has prepared a streamlined clinical development strategy to evaluate oral
fadraciclib
in multi-cohort, Phase 1b/2, registration-directed, studies for both
solid and liquid cancers
. A similar trial design will be applied to the development of
CYC140
, our selective
PLK1 inhibitor
PLK1
inhibitor, supported by extensive preclinical data demonstrating
CYC140
’s antimitotic mechanism and broad therapeutic potential in both
solid and liquid cancers
. We look forward to providing further details of our clinical development plans and our progress with
fadraciclib
and
CYC140
to drive shareholder value.” Key 2020 Highlights Corporate Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. Most recently, Dr. Kirschbaum served as Vice President, Hematology/Oncology at
ArQule Inc.
Appointed two new Directors to strengthen and broaden our Board’s skill base: Brian Schwartz, M.D. has wide-ranging experience as a drug development expert in the biopharmaceutical industry primarily in
oncology
, hematology, and rare diseases. Brian was formerly Senior Vice President, Head of Research & Development and Chief Medical Officer of
ArQule Inc.
, which was acquired by
Merck & Co
. in 2020 for $2.7 billion. Dr. Schwartz is a member of the Company’s Science & Technology Committee. Karin L. Walker brings over 30 years of extensive finance experience in biopharmaceuticals, including public biotechnology and technology companies. Ms.
Walker
currently serves as the Chief Accounting Officer of
Prothena Corporation plc
. Ms. Walker has been appointed as Chair of the
Audit Committee
. Raised approximately $25 million in net cash in two equity financings, including a strategic investment by
Acorn Bioventures
of $6.9 million, net. An additional $8.8 million of proceeds have been received through warrant exercises ($4.3 million of which after year end). Clinical studies Reported data from a Phase 1 study of
fadraciclib
as a single agent at the Plenary Session of the 32 nd EORTC-NCI-AACR (ENA) Symposium: Radiographically confirmed partial response (PR) after a month and a half on i.v.
fadraciclib
in a patient with
MCL1-amplified endometrial cancer
MCL1-amplified
endometrial cancer, who failed seven lines of prior therapy and is continuing treatment for more than 18 months with 96% reduction in target
tumor
lesions. High bioequivalence observed in five patients treated with oral
fadraciclib
. EORTC-NCI-AACR (ENA) Symposium: Enrolled 19 patients with
relapsed or refractory AML
/
MDS
and
CLL
receiving i.v.
fadraciclib
in combination with
venetoclax
with evidence of antileukemic activity. Enrolled seven patients evaluating i.v.
CYC140
in patients with
advanced leukemias
. Enrolled 12 patients with relapsed or refractory AML/MDS in a Phase 1/2 study evaluating an oral regimen of
sapacitabine
in combination with
venetoclax
. Announced a peer-reviewed publication describing the discovery of
fadraciclib
in PLOS ONE. Authored by scientists from Cyclacel and
The Institute of Cancer Research
Cancer
Research, London, the publication shows that targeting of
CDK2
and
CDK9
holds broad therapeutic potential. More information on our clinical trials can be found here. Key Business Objectives for 2021 First patient dosed with oral
fadraciclib
in Phase 1b/2
advanced solid tumor
and
leukemia
studies First patient dosed with oral
CYC140
in Phase 1/2
advanced solid tumor
and
leukemia
studies Manufacture clinical supplies of oral
fadraciclib
and oral
CYC140
for registration-enabling studies Data on safety and antileukemic activity from the i.v.
fadraciclib
-
venetoclax
Phase 1 study in
relapsed/refractory AML
and
CLL
Data from the
sapacitabine
-venetoclax Phase 1/2 study in relapsed/refractory AML or MDS Initial data from the i.v. CYC140 Phase 1 First-in-Human study in patients with
advanced leukemias
Data from the Phase 1b/2 IST of
sapacitabine
-
olaparib
combination in patients with BRCA
mutant metastatic breast cancer
when reported by the investigators. Financial Highlights As of December 31, 2020, cash and cash equivalents totaled $33.4 million, compared to $11.9 million as of December 31, 2019. The increase of $21.5 million was primarily due to $29.5 million of net cash provided by financing activities, offset by net cash used in operating activities of $7.9 million and $0.1 million of net cash used in investing activities. Research and development expenses were $1.4 million and $4.8 million for the three months and year ended December 31, 2020 as compared to $1.4 million and $4.7 million for the same periods in 2019. Research and development expenses relating to the transcriptional regulation, CDK inhibitor program with
fadraciclib
increased by $0.5 million from $3.1 million for the year ended December 31, 2019 to $3.6 million for the year ended December 31, 2020, as the clinical evaluation of
fadraciclib
progressed. Research and development expenses relating to
CYC140
decreased by $0.1 million from $0.7 million for the year ended December 31, 2019 to $0.6 million for the year ended December 31, 2020, primarily as a result of a reduction in expenditures associated with drug supply manufacturing which were not required in 2020. Research and development expenses relating to other research and development decreased by $0.1 million from $0.4 million for the year ended December 31, 2019 to $0.3 million for the year ended December 31, 2020, due to a reduction in consultancy costs. General and administrative expenses for the three months and year ended December 31, 2020 were $1.7 million and $5.9 million respectively, compared to $1.4 million and $5.0 million for the same periods of the previous year. Total other income, net for the three months and year ended December 31, 2020 were $14,000 expense and $1.0 million income, compared to $41,000 and $0.6 million income for the same periods of the previous year. The increase of $0.4 million for the year ended December 31, 2020 is primarily related to income received under an Asset Purchase Agreement with ThermoFisher Scientific. United Kingdom research & development tax credits were $0.4 million and $1.2 million for the three months and year ended December 31, 2020 as compared to $0.4 million and $1.3 million for the same periods in 2019. Net loss for the three months and year ended December 31, 2020 were $2.8 million and $8.4 million compared to $2.3 million and $7.8 million for the same periods in 2019. The Company raised net proceeds of approximately $29.7 million during 2020, from agreements to sell securities and warrant conversions. An additional $4.3 million in proceeds from warrant conversions was received after year end. The Company estimates that proforma cash resources, including proceeds of recent warrant exercises after December 31, 2020, of $37.7 million, will fund currently planned programs through early 2023. 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 7389616. Webcast link For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at . 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 mitosis biology. The transcriptional regulation program is evaluating
fadraciclib
, a
CDK2/9 inhibitor
CDK2/9
inhibitor, in
solid tumors
and
hematological malignancies
. The anti-mitotic program is evaluating
CYC140
, a
PLK1 inhibitor
PLK1
inhibitor, in
advanced cancers
.
Cyclacel
's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit . 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 . 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. © Copyright 2021
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)
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET (In $000s, except share, per share, and liquidation preference amounts) SOURCE:
Cyclacel Pharmaceuticals, Inc.
机构
ArQule, Inc.
Walker Crips Group Plc
Innovation Enterprise
[+5]
适应症
急性髓性白血病
慢性淋巴细胞白血病
子宫内膜癌
[+7]
靶点
CDK2
CDK9
PLK1
[+1]
药物
Fadraciclib
CYC-140
TKM-PLK1
[+4]
标准版
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16800
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