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Cyclacel Pharmaceuticals, Inc. Cyclacel Pharmaceuticals Reports FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS -Initial Data from Phase 1/2 Study of Oral Fadraciclib in Solid Tumors Expected in First Half of 2022 -

Key Takeaway: Pharmaceuticals Reports FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS Data from Phase 1/2 Study of Oral Fadraciclib in Solid Tumors Expected in First Half of 2022 - Call Scheduled for March 28, 2022, at 4:30 p.m. EDT- BERKELEY HEIGHTS, NJ, March 28, 2022 - Cyclacel Phar

Full Press Release Details

Pharmaceuticals Reports FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS
Data from Phase 1/2 Study of Oral Fadraciclib in Solid Tumors Expected in First Half of 2022 -
Call Scheduled for March 28, 2022, at 4:30 p.m. EDT-
BERKELEY HEIGHTS, NJ, March 28, 2022 - 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, 2021.
"2021 was a year of solid execution,
as the clinical and corporate objectives achieved by the Cyclacel team have positioned us to reach important milestones in 2022. These
include initial data from the dose escalation stage of the ongoing Phase 1/2 study of fadraciclib,
our CDK2/9 inhibitor, in advanced solid tumors", said Spiro Rombotis, President and Chief Executive Officer. "Enrollment has
gone well with three new patients treated at dose level 4 at our two U.S. sites and two internationally recognized,
cancer centers in Asia and Western Europe who recently joined the study. In 2022 we plan to report new clinical and preclinical
evidence supporting the unique properties and therapeutic potential of fadraciclib. We believe that fadraciclib is emerging as the only
transcriptional CDK inhibitor in development to have demonstrated single-agent activity and tolerable daily dosing by mouth in patients
with solid tumors. If confirmed with additional data, fadraciclib may emerge as an important alternative for the treatment of advanced
solid tumors in patients failing available therapies.
In addition, we expect imminent dosing
of the first patient with oral CYC140, our novel, PLK1 inhibitor, in a Phase 1/2 study in advanced solid tumors. We are also enrolling
patients with hematological malignancies in the dose escalation stage of a Phase
1/2 study of oral fadraciclib. We look forward to providing updates and further clinical and preclinical data from our ongoing
programs as they become available."
More information on our clinical trials can be found here.
Key Business Objectives for 2022
Financial Highlights
As of December 31, 2021,
cash and cash equivalents totaled $36.6 million, compared to $33.4 million as of December 31, 2020. The increase of $3.2 million was primarily
due to $21.7 million cash provided by financing activities, offset by $18.5 million net cash used in operating activities. The Company
estimates that available cash resources will fund currently planned programs through mid-2023.
Research and development (R&D) expenses were
$4.6 million and $15.5 million for the three months and year ended December 31, 2021, as compared to $1.4 million and $4.8 million for
the same periods in 2020. R&D expenses relating to fadraciclib were $3.4 million and $11.1 million for the three months and year ended
December 31, 2021, as compared to $1.1 million and $3.7 million for the same periods in 2020 due to clinical trial expenses for the evaluation
of fadraciclib in Phase 1/2 studies and clinical supply manufacturing. Additionally, R&D expenses related to CYC140 were $1.1 million
and $3.6 million for the three months and year ended December 31, 2021, as compared to $0.2 million and $0.6 million for the same periods
in 2020 as preclinical evaluation and clinical trial supply manufacturing of CYC140 progressed.
General and administrative (G&A) expenses for
the three months and year ended December 31, 2021, were $1.9 million and $7.5 million, compared to $1.8 million and $5.9 million for the
same periods of the previous year due to increased legal and professional and personnel costs and a lease assignment. G&A expenses
included non-cash stock compensation costs of $0.1 million and $0.8 million for the three months and full year ended December 31, 2021,
compared to $0.1 million and $0.3 million for the same periods in 2020. United Kingdom research & development tax credits were $1.2
million and $3.8 million for the three months and year ended December 31, 2021, as compared to $0.4 million and $1.2 million for the same
period in 2020 due to the increase in eligible R&D expenditure.
Net loss for the three months
and year ended December 31, 2021, was $5.3 million and $18.9 million, compared to $2.8 million and $8.4 million for the same periods in
Conference call information:
(866) 342-8591 / international call: (203) 518-9713
(800) 839-4199 / international archive: (402) 220-2989
for live and archived conference call is CYCCQ421. Webcast link.
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.
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
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, the potential effects of the COVID-19 pandemic, 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.
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Irina Koffler, LifeSci Advisors, LLC, (646) 970-4681, ikoffler@lifesciadvisors.com
Copyright 2022 Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2020 2021 2020 2021
Revenues:
Total revenues - - - -
Operating expenses:
Research and development 1,415 4,593 4,759 15,477
General and administrative 1,753 1,941 5,877 7,461
Total operating expenses 3,168 6,534 10,636 22,938
Operating loss (3,168 ) (6,534 ) (10,636 ) (22,938 )
Other income (expense):
Foreign exchange gains (losses) (20 ) 39 22 44
Interest income 6 4 42 16
Other income, net - - 891 144
Total other income (expense), net (14 ) 43 955 204
Loss before taxes (3,182 ) (6,491 ) (9,681 ) (22,734 )
Income tax benefit 378 1,197 1,236 3,847
Net loss (2,804 ) (5,294 ) (8,445 ) (18,887 )
Dividend on convertible exchangeable preferred shares (50 ) (50 ) (201 ) (201 )
Beneficial conversion feature of Series B preferred stock (3,775 ) - (3,775 ) -
Net loss applicable to common shareholders $ (6,629 ) $ (5,344 ) $ (12,421 ) $ (19,088 )
Basic and diluted earnings per common share:
Net loss per share - basic and diluted $ (1.34 ) $ (0.54 ) $ (3.42 ) $ (2.14 )
Weighted average common shares outstanding 4,931,543 9,840,428 3,633,385 8,926,173
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation
December 31, December 31,
2020 2021
ASSETS
Current assets:
Cash and cash equivalents $ 33,406 $ 36,559
Prepaid expenses and other current assets 2,063 4,383
Total current assets 35,469 40,942
Property and equipment, net 106 64
Right-of-use lease asset 1,227 30
Non-current deposits - 1,551
Total assets $ 36,802 $ 42,587
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 514 $ 2,117
Accrued and other current liabilities 1,972 3,177
Total current liabilities 2,486 5,294
Lease liability 1,057 30
Total liabilities 3,543 5,324
Stockholders' equity 33,259 37,263
Total liabilities and stockholders' equity $ 36,802 $ 42,587
SOURCE: Cyclacel Pharmaceuticals, Inc.
Last updated: Mar 28, 2022