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Cyclacel Pharmaceuticals, Inc. Cyc lacel Pharmaceuticals Reports first quarter 2022 financial results and provides business update - Oral Fadraciclib Demonstrating Strong Safety Profile with Continuous Dosing; anticipate

Key Takeaway: Pharmaceuticals Reports first quarter 2022 financial results and provides business update Oral Fadraciclib Demonstrating Strong Safety Profile with Continuous Dosing; anticipate entering Phase 2 POC in 2H 2022 - First Patients Dosed in Phase 1/2 Study of Oral PLK1 Inhibitor CYC

Full Press Release Details

Pharmaceuticals Reports first quarter 2022 financial results and provides business update
Oral Fadraciclib Demonstrating Strong Safety Profile with Continuous Dosing; anticipate entering Phase 2 POC in 2H 2022 -
First Patients Dosed in Phase 1/2 Study of Oral PLK1 Inhibitor CYC140 for Treatment of Advanced Solid Tumors and Lymphomas -
Publication Confirming Fadraciclib Suppresses MCL1 and Synergistic Activity with Venetoclax in CLL -
Cash Runway through Mid-2023 -
- Conference Call Scheduled for May 11,
2022 at 4:30 pm EDT -
HEIGHTS, NJ, May 11, 2022 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or
the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced first
quarter 2022 financial results and provided a business update.
are pleased to report another productive quarter for Cyclacel, which included continued expansion of our three, registration-directed,
clinical trials and publication of research findings supporting our drug development strategy," said Spiro Rombotis, Chief Executive
Officer of Cyclacel. "Oral fadraciclib, our CDK2/9 drug candidate, is proving to be well tolerated in 065-101, our Phase 1/2 solid
tumor and lymphoma study, having reached dose level 5 in the dose escalation stage which provides for daily dosing over 4 out of 4 weeks.
In our PLK1 program, we have dosed the first patients in the streamlined Phase 1/2 trial of CYC140 for the treatment of solid tumors
and lymphomas. We have optimized the properties
of CYC140 to fit its apoptosis-driven mechanism, including short half-life and differentiated structural and biological properties, compared
to other PLK1 inhibitors in development. We therefore believe CYC140 has the potential to demonstrate activity across a wide range
of solid tumors, as a single agent and in combinations."
growing body of preclinical research supports the clinical development plan of fadraciclib. In April, we announced publication of research
from The University of Texas MD Anderson Cancer Center highlighting fadraciclib's antileukemic activity in CLL. Fadraciclib treatment
resulted in suppression of MCL1, a key target protein. In addition, synergy of fadraciclib in combination with venetoclax was observed
against primary CLL cell lines, including those with 17p deletion. With funding estimated through mid-2023, we are continuing to execute
on our clinical development plan. We look forward to presenting initial fadraciclib clinical data in solid tumors and lymphomas, in the
coming weeks, determining the recommended Phase 2 dose and entering proof of concept stage in the second half of 2022."
publication confirming fadraciclib suppresses MCL1 and synergizes with venetoclax in chronic lymphocytic leukemia. Results
from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived, anti-apoptotic protein
MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of
MCL1 protein levels. Furthermore, fadraciclib was shown to combine synergistically with the BCL2 antagonist, venetoclax, and demonstrated
even greater synergy when targeted against 17p deleted CLL cells which were not sensitive to either agent alone.
on our clinical trials can be found here.
Financial Highlights
of March 31, 2022, cash and cash equivalents totaled $29.6 million, compared to $36.6 million as of December 31, 2021. Subsequent
to the end of the first quarter, the Company received $3.6 million of United Kingdom research & development tax credits and
$1.3 million in royalty receipts providing pro forma March 31, 2022, cash and cash equivalents of $34.5 million. The Company
estimates that its available cash will fund currently planned programs through June 2023.
and development (R&D) expenses were $5.0 million for the three months ended March 31, 2022, as compared to $2.6 million for
the same period in 2021. R&D expenses relating to fadraciclib were $3.6 million for the three months ended March 31, 2022, as
compared to $1.7 million for the same period in 2021 due to increase in clinical trial costs associated with ongoing clinical
trials evaluating fadraciclib in Phase 1/2 studies along with an increase in non-clinical expenditures. R&D expenses related to CYC140
were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period in 2021 due to clinical
trial costs associated with the opening of clinical sites for CYC140 Phase 1/2 studies.
General and administrative expenses for the three
months ended March 31, 2022, were $1.6 million, compared to $1.7 million for the same period of the previous year due to a decrease
in professional and recruitment costs.
other income, net, for the three months ended March 31, 2022, was $1.3 million, compared to $0.1 million for the same period of
the previous year. The increase of $1.2 million for the three months ended March 31, 2022, is primarily related to royalty
income received from Thermo Fisher Scientific Corporation.
United Kingdom research &
development tax credits were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period
in 2021 as a direct consequence of increased qualifying research and development expenditure. Tax credit receipts of $3.6 million in
respect of the financial year ended December 31, 2021, were received in May 2022.
Net loss for the three
months ended March 31, 2022, was $4.1 million, compared to $3.5 million for the same period in 2021.
US/Canada call: (866)
342-8591 / international call: (203) 518-9713
US/Canada archive: (800)
839-6136 / international archive: (402) 220-2572
for live and archived conference call is CYCCQ122. Webcast link
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. All Rights
Reserved. The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.
PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
Three Months Ended
March 31,
2022 2021
Revenues:
Total revenues $ - $ -
Operating expenses:
Research and development 4,954 2,566
General and administrative 1,605 1,739
Total operating expenses 6,559 4,305
Operating loss (6,559 ) (4,305 )
Other income (expense):
Foreign exchange gains (losses) 29 10
Interest income 4 4
Other income, net 1,280 126
Total other income (expense), net 1,313 140
Loss before taxes (5,246 ) (4,165 )
Income tax benefit 1,138 687
Net loss (4,108 ) (3,478 )
Dividend on convertible exchangeable preferred shares (50 ) (50 )
Net loss applicable to common shareholders $ (4,158 ) $ (3,528 )
Net loss per share - basic and diluted $ (0.42 ) $ (0.50 )
Weighted average common shares outstanding 9,993,135 7,009,037
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE
(In $000s, except share,
per share, and liquidation preference amounts)
March 31, December 31,
2022 2021
ASSETS
Current assets:
Cash and cash equivalents $ 29,639 $ 36,559
Prepaid expenses and other current assets 6,759 4,383
Total current assets 36,398 40,942
Property and equipment, net 57 64
Right-of-use lease asset 15 30
Non-current deposits 2,980 1,551
Total assets $ 39,450 $ 42,587
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,850 $ 2,117
Accrued and other current liabilities 3,354 3,177
Total current liabilities 6,204 5,294
Lease liability 15 30
Total liabilities 6,219 5,324
Stockholders' equity 33,231 37,263
Total liabilities and stockholders' equity $ 39,450 $ 42,587
Last updated: May 11, 2022