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Cyclacel Pharmaceuticals, Inc. Cyclacel Pharmaceuticals Reports fourth quarter and full year 2022 financial results and provides business update - On Track to Start Oral Fadraciclib Phase 2 Proof of Concept in 1H 2023 an

Key Takeaway: Pharmaceuticals Reports fourth quarter and full year 2022 financial results and provides business update On Track to Start Oral Fadraciclib Phase 2 Proof of Concept in 1H 2023 and Report Interim data in 2H 2023 - Expect to Report Final Data from Fadraciclib 065-101 Dose Escalat

Full Press Release Details

Pharmaceuticals Reports fourth quarter and full year 2022 financial results and provides business update
On Track to Start Oral Fadraciclib Phase 2 Proof of Concept in 1H 2023 and Report Interim data in 2H 2023 -
Expect to Report Final Data from Fadraciclib 065-101 Dose Escalation -
Expect to Report Initial Data from Oral Plogosertib 140-101 Dose Escalation -
Management to Host Conference Call at 4:30 pm ET Today -
NJ, March 6, 2023 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"),
a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced fourth quarter and full year
2022 financial results and provided a business update.
2022, we anticipate that 2023 will be even more exciting for Cyclacel. We plan to advance oral fadraciclib, our CDK2/9 inhibitor, into
Phase 2 proof-of-concept evaluating multiple cancer cohorts, and also further explore the anti-cancer potential of our oral PLK1 inhibitor
plogosertib," said Spiro Rombotis, President and Chief Executive Officer. "We expect three key data readouts this year, including
pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of our fadraciclib 065-101 Phase 1/2
study, initial clinical activity data from the Phase 2 proof of concept stage of the study and PK, PD, safety and activity data from
the dose escalation part of our 140-101 Phase 1/2 study of plogosertib. These data have the potential to further demonstrate that fadraciclib
and plogosertib are differentiated from other molecules in their respective classes."
with our pipeline's progress in 2022 and believe that we have the opportunity to demonstrate promising results for our two drug
candidates, fadraciclib and plogosertib, in the year ahead," said Mark Kirschbaum, M.D., Chief Medical Officer. "At the recent
ENA 2022 Symposium we reported fadraciclib's good tolerability profile and clear anti-cancer signals. We are currently recruiting
patients at dose level 6a of 125mg administered orally twice daily for four out of four weeks. We plan to optimize the dosing schedule
and move into Phase 2 testing of the tumor types that should be most sensitive to fadraciclib treatment. We are also advancing plogosertib
through dose escalation and are now recruiting patients at dose level 4 in our Phase 1/2 solid tumor study. We have observed efficacy
at lower dose levels with three patients on treatment for three to eight cycles. We expect to report additional data of our mechanistically
differentiated PLK1 inhibitor from this trial later this year. We remain enthusiastic about Cyclacel's advancing clinical-stage
pipeline and look forward to presenting emerging data from these two programs during the year."
Key Business Objectives
Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
Report interim Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
Report interim data from dose escalation stage of 065-102 study with oral fadraciclib in patients with advanced leukemia
Report final data from dose escalation stage of 140-101 study with oral plogosertib in advanced solid tumors and lymphoma
of December 31, 2022, cash and cash equivalents totaled $18.3 million, compared to $36.6 million as of December 31, 2021. Net cash used
in operating activities was $20.8 million for the twelve months ended December 31, 2022 compared to $18.5 million for the same period
of 2021. The Company estimates that its available cash, including the United Kingdom research & development tax credit receivable
of $4.7 million, will fund currently planned programs into the fourth quarter of 2023.
and development (R&D) expenses were $6.7 million and $20.3 million for the three months and year ended December 31, 2022, as compared
to $4.6 million and $15.5 million for the same period in 2021. R&D expenses relating to fadraciclib were $5.3 million and $14.0 million
for the three months and year ended December 31, 2022, as compared to $3.4 million and $11.1 million for the same period in 2021 due
to increased costs associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies and an increase in non-clinical
expenditures. R&D expenses related to plogosertib were $1.3 million and $5.5 million for the three months and year ended December
31, 2022, as compared to $1.1 million and $3.5 million for the same period in 2021 due to clinical trial costs associated with the plogosertib
and administrative expenses for the three months and year ended December 31, 2022, were $2.1 million and $7.4 million, compared to $1.9
million and $7.5 million for the same period of the previous year due to an increase in employment and professional costs.
other income, net, for the three months and year ended December 31, 2022, were an expense of $0.2 million and income of $1.7 million,
compared to an income of $43,000 and $0.2 million for the same period of the previous year. The increase of $1.5 million for the year
ended December 31, 2022, is primarily related to royalty income.
Kingdom research & development tax credits for the three months and year ended December 31, 2022 were $1.6 million and $4.7 million
compared to $1.2 million and $3.8 million for the same period of the previous year and are directly correlated to qualifying research
and development expenditure.
loss for the three months and year ended December 31, 2022, was $7.4 million and $21.2 million (including stock based compensation expense
of $0.4 million and $1.5 million respectively), compared to $5.3 million and $18.9 million (including stock based compensation expense
of $0.3 million and $1.2 million respectively) for the same period in 2021.
(800) 245-3047 / international call: (203) 518-9765
(800) 925-9627 / international archive: (402) 220-5390
for live and archived conference call is CYCCQ422. (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.
Cyclacel Pharmaceuticals, Inc.
Cyclacel 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 plogosertib, 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.
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
SOURCE: Cyclacel Pharmaceuticals,
CYCLACEL PHARMACEUTICALS,
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
share and per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2022 2021 2022 2021
Revenues:
Collaboration and research and development revenue - - - -
Total revenues - -
Operating expenses:
Research and development 6,702 4,593 20,274 15,477
General and administrative 2,143 1,941 7,382 7,461
Total operating expenses 8,845 6,534 27,656 22,938
Operating loss (8,845 ) (6,534 ) (27,656 ) (22,938 )
Other income (expense):
Foreign exchange gains (losses) (281 ) 39 233 44
Interest income 122 4 210 16
Other income, net 4 - 1,298 144
Total other income (expense), net (155 ) 43 1,741 204
Loss before taxes (9,000 ) (6,491 ) (25,915 ) (22,734 )
Income tax benefit 1,581 1,197 4,717 3,847
Corporation Tax - - - -
Net loss (7,419 ) (5,294 ) (21,198 ) (18,887 )
Dividend on convertible exchangeable preferred shares (50 ) (50 ) (201 ) (201 )
Net loss applicable to common shareholders $ (7,469 ) $ (5,344 ) $ (21,399 ) $ (19,088 )
Basic and diluted earnings per common share:
Net loss per share - basic and diluted $ (0.60 ) $ (0.54 ) $ (1.90 ) $ (2.14 )
Weighted average common shares outstanding 12,539,189 9,840,428 11,255,677 8,926,173
CYCLACEL PHARMACEUTICALS,
share, per share, and liquidation preference amounts)
December 31, December 31,
2022 2021
ASSETS
Current assets:
Cash and cash equivalents $ 18,345 $ 36,559
Prepaid expenses and other current assets 6,066 4,383
Total current assets 24,411 40,942
Property and equipment, net 32 64
Right-of-use lease asset 142 30
Non-current deposits 2,916 1,551
Total assets $ 27,501 $ 42,587
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,561 $ 2,117
Accrued and other current liabilities 4,831 3,177
Total current liabilities 7,392 5,294
Lease liability 106 30
Total liabilities 7,498 5,324
Redeemable common stock 4,494 -
Stockholders' equity 15,509 37,263
Total liabilities and stockholders' equity $ 27,501 $ 42,587
Last updated: Mar 6, 2023