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Cyclacel Pharmaceuticals, Inc. Cyclacel Pharmaceuticals Reports FIRST Quarter 2021 Financial Results - Announces IND Authorization by FDA for Fadraciclib, a CDK2/9 Inhibitor, in Solid Tumors - - Recent Publication Report

Key Takeaway: Pharmaceuticals Reports FIRST Quarter 2021 Financial Results Announces IND Authorization by FDA for Fadraciclib, a CDK2/9 Inhibitor, in Solid Tumors - Recent Publication Reported that Overactive KRAS Mutants are Impeded by CDK9 Inhibition - Following Recent Financing, Cash Run

Full Press Release Details

Pharmaceuticals Reports FIRST Quarter 2021 Financial Results
Announces IND Authorization by FDA for Fadraciclib, a CDK2/9 Inhibitor, in Solid Tumors -
Recent Publication Reported that Overactive KRAS Mutants are Impeded by CDK9 Inhibition -
Following Recent Financing, Cash Runway Extended to Early 2023 -
Conference Call Scheduled May 12, 2021 at 4:30 p.m. ET -
Heights, NJ, May 12, 2021 - 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 2021 and business highlights, including an update on its progress with fadraciclib and CYC140, Cyclacel's novel CDK2/9
and PLK1 inhibitors, respectively.
the quarter, we have made significant progress in bringing our two oral targeted development candidates into mid-stage clinical development.
Following recent FDA authorization of our IND for oral fadraciclib, we will finalize contract discussions with sites and open our multi-cohort
Phase 1b/2 study in patients with solid tumors," said Spiro Rombotis, President and Chief Executive Officer. "We believe
fadraciclib is establishing a strong position among compounds in clinical development that specifically address cancer resistance mechanisms,
including suppression of MCL1, MYC and cyclin E. A recent publication identified potential utility of CDK9 inhibitors in KRAS mutant
colorectal cancer, one of the tumor types in our study. Together with our oral CYC140 PLK1 inhibitor program, which has shown in preclinical
models that KRAS mutant cancers are sensitive to CYC140 inhibition, we hope to provide valuable alternatives to patients with these difficult
to treat malignancies. After strengthening our balance sheet in the quarter, we are executing a precision medicine strategy to achieve
multiple milestones and data read outs over the next two years."
Key Corporate Highlights
Pui Lai L, et al, SLAS Discovery I-II 2021, https://journals.sagepub.com/doi/abs/10.1177/24725552211008853.
Somarelli JA, et al, Mol Cancer Ther, 2020 19 2516. DOI: 10.1158/1535-7163.MCT-20-0454.
Blake DR, et al, Science Signalling, 2019, https://pubmed.ncbi.nlm.nih.gov/31311847/.
Kawakami M, et al J Natl Cancer Inst, 2017 109, https://pubmed.ncbi.nlm.nih.gov/28376145/.
Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466
Key Near-Term Business Objectives and Expected Timeline
Financial Highlights
As of March 31, 2021, cash and cash equivalents
totaled $47.8 million, compared to $33.4 million as of December 31, 2020. The increase of $14.4 million was primarily due to $18.0 million
of net cash provided by financing activities, offset by net cash used in operating activities of $3.6 million. There were no revenues
for each of the three months ended March 31, 2021 and 2020.
Research and development expenses were $2.6 million for the three
months ended March 31, 2021 as compared to $1.1 million for the same period in 2020. Research and development expenses relating to the
CDK inhibitor program increased by approximately $0.8 million for the three months ended March 31, 2021 as clinical evaluation of
fadraciclib is progressing.
General and administrative expenses for the three months ended March
31, 2021 were $1.7 million, compared to $1.3 million for the same period of the previous year due to an increase in legal and professional
expenses and recruitment costs.
Total other income, net, for the three months
ended March 31, 2021 was $0.1 million, compared to $0.9 million for the same period of the previous year. The decrease of $0.8 million
for the three months ended March 31, 2021 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher
United Kingdom research & development
tax credits were $0.7 million for the three months ended March 31, 2021, as compared to $0.3 million for the same period in 2020 as a
direct consequence of increased qualifying research and development expenditure.
Net loss for the three months ended March
31, 2021 was $3.5 million, compared to $1.2 million for the same period in 2020.
The Company raised net proceeds of approximately
$13.5 million from an equity financing in March 2021. The Company also received an additional $4.5 million of proceeds from warrant exercises.
The Company estimates that cash resources
of $47.8 million as of March 31, 2021 will fund currently planned programs through early 2023.
Conference call information:
Conference ID 2763358 Webcast link
US/Canada call: (877) 493-9121 / international call: (973)
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
For the live and archived webcast, please
visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.
About Cyclacel Pharmaceuticals, Inc.
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, and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. 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 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.
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,
2020 2021
Revenues:
Total revenues - -
Operating expenses:
Research and development 1,106 2,566
General and administrative 1,318 1,739
Total operating expenses 2,424 4,305
Operating loss (2,424 ) (4,305 )
Other income (expense):
Foreign exchange gains (losses) 69 10
Interest income 28 4
Other income, net 817 126
Total other income (expense), net 914 140
Loss before taxes (1,510 ) (4,165 )
Income tax benefit 290 687
Net loss (1,220 ) (3,478 )
Dividend on convertible exchangeable preferred shares (50 ) (50 )
Beneficial conversion feature of Series B preferred stock - -
Net loss applicable to common shareholders $ (1,270 ) $ (3,528 )
Basic and diluted earnings per common share:
Net loss per share - basic and diluted $ (1.48 ) $ (0.50 )
Weighted average common shares outstanding 859,998 7,099,037
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation
December 31, March 31,
2020 2021
ASSETS
Current assets:
Cash and cash equivalents $ 33,406 $ 47,777
Prepaid expenses and other current assets 2,063 2,686
Total current assets 35,469 50,463
Property and equipment, net 106 173
Right-of-use lease asset 1,227 1,181
Total assets $ 36,802 $ 51,817
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 514 $ 871
Accrued and other current liabilities 1,972 1,901
Total current liabilities 2,486 2,772
Lease liability 1,057 996
Total liabilities 3,543 3,768
Stockholders' equity 33,259 48,049
Total liabilities and stockholders' equity $ 36,802 $ 51,817
SOURCE: Cyclacel Pharmaceuticals, Inc.
Last updated: May 12, 2021