Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical leader in cell
cycle checkpoint control developing innovative medicines based on
cancer cell biology, announced today first quarter financial
results and provided a business update.
“We are on track to deliver on key readouts this
year. For fadraciclib, our oral CDK2/9 inhibitor, we plan to report
pharmacokinetic (PK), pharmacodynamic (PD), safety and activity
data from the dose escalation stage of our 065-101 study followed
by initial clinical activity data from the Phase 2 proof of concept
(PoC) stage. We also expect to report PK, PD, safety and activity
data from the dose escalation part of our 140-101 Phase 1/2 study
of plogosertib, our oral PLK1 inhibitor,” said Spiro Rombotis,
President and Chief Executive Officer. “Data collected to date
suggest that fadraciclib and plogosertib are differentiated from
other molecules in their respective classes. Furthermore, the
receipt of $4.7 million in non-dilutive capital from the R&D
tax credit along with existing resources supports our ongoing
clinical programs.”
“Both clinical programs with fadraciclib and
plogosertib are progressing well and are approaching important data
readouts,” said Mark Kirschbaum, M.D., Chief Medical Officer. “In
065-101, we are currently recruiting patients at dose level 6A of
fadraciclib with the aim of optimizing the recommended Phase 2
dosing schedule before opening the PoC stage. Our Phase 2 clinical
sites are ready to enroll patients with the tumor types that appear
to be most sensitive to fadraciclib treatment. With plogosertib we
are recruiting patients at dose level 4. After observing unexpected
efficacy at lower dose levels with three patients on treatment for
three to eight cycles, we are investigating the biological
rationale for this effect and how we could exploit these findings
in subsequent studies. We remain enthusiastic about our clinical
stage pipeline and look forward to presenting emerging data from
these two programs during the year.“
Key Upcoming Milestones for
2023
- 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 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
Financial Highlights
As of March 31, 2023, pro forma cash and cash
equivalents totaled $16.1 million, including the $4.7 million of
United Kingdom research & development tax credits received
after the end of the quarter. Cash and cash equivalents as of March
31, 2023 was $11.4 million, compared to $18.3 million as of
December 31, 2022. Net cash used in operating activities was $6.9
million for the three months ended March 31, 2023 compared to $6.8
million for the same period of 2022. The Company estimates that its
available cash will fund currently planned programs into the first
quarter of 2024.
Research and development (R&D) expenses were
$5.7 million for the three months ended March 31, 2023, as compared
to $5.0 million for the same period in 2022. R&D expenses
relating to fadraciclib were $4.1 million for the three months
ended March 31, 2023, as compared to $3.6 million for the same
period in 2022 due to increased non-clinical expenditures. R&D
expenses related to plogosertib were $1.4 million for the three
months ended March 31, 2023, as compared to $1.1 million for the
same period in 2022 due to clinical trial costs associated with the
progression of the Phase 1/2 study.
General and administrative expenses for the three
months ended March 31, 2023 and 2022, remained relatively flat at
$1.6 million.
Total other income, net, for the three months ended
March 31, 2023, was $0.2 million compared to an income of $1.3
million for the same period of the previous year. The decrease of
$1.1 million for the three months ended March 31, 2023, is
primarily related to royalty income received in the previous
year.
United Kingdom research & development tax
credits for the three months ended March 31, 2023 were $1.3 million
compared to $1.1 million for the same period of the previous year
and are directly correlated to qualifying research and development
expenditure.
Net loss for the three months ended March 31, 2023,
was $5.8 million, compared to $4.1 million for the same period in
2022.
Conference call information:
US/Canada call: (800) 274-8461 / international
call: (203) 518-9783
US/Canada archive: (800) 839-6975 /
international archive: (402) 220-6061
Code for live and archived conference call is
CYCCQ123. Webcast link
For 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. 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.
Forward-looking StatementsThis
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.
Contacts
Company: |
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
Investor Relations: |
Grace Kim, IR@cyclacel.com |
|
|
© Copyright 2023 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
SOURCE: Cyclacel Pharmaceuticals, Inc.
|
CYCLACEL
PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS (LOSS)(In $000s, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
March 31, |
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
Revenues |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
5,674 |
|
|
|
4,954 |
|
|
General and administrative |
|
|
1,645 |
|
|
|
1,605 |
|
Total operating expenses |
|
|
7,319 |
|
|
|
6,559 |
|
Operating loss |
|
|
(7,319 |
) |
|
|
(6,559 |
) |
Other income (expense): |
|
|
|
|
|
Foreign exchange gains (losses) |
|
|
(87 |
) |
|
|
29 |
|
|
Interest income |
|
|
116 |
|
|
|
4 |
|
|
Other income, net |
|
|
166 |
|
|
|
1,280 |
|
|
|
Total other income (expense), net |
|
|
195 |
|
|
|
1,313 |
|
Loss before taxes |
|
|
(7,124 |
) |
|
|
(5,246 |
) |
Income tax benefit |
|
|
1,320 |
|
|
|
1,138 |
|
Net loss |
|
|
(5,804 |
) |
|
|
(4,108 |
) |
Dividend on convertible exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
Net loss applicable to common shareholders |
|
$ |
(5,854 |
) |
|
$ |
(4,158 |
) |
Basic and diluted earnings per common share: |
|
|
|
|
Net loss per share – basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.42 |
) |
Weighted average common shares outstanding |
|
|
12,539,189 |
|
|
|
9,993,135 |
|
|
|
|
|
|
|
|
|
CYCLACEL
PHARMACEUTICALS, INC.CONSOLIDATED BALANCE
SHEET(In $000s, except share, per share, and liquidation
preference amounts) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,435 |
|
|
$ |
18,345 |
|
|
Prepaid expenses and other current assets |
|
|
7,539 |
|
|
|
6,066 |
|
|
|
Total current assets |
|
|
18,974 |
|
|
|
24,411 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
31 |
|
|
|
32 |
|
|
Right-of-use lease asset |
|
|
139 |
|
|
|
142 |
|
|
Non-current deposits |
|
|
2,916 |
|
|
|
2,916 |
|
|
|
Total
assets |
|
$ |
22,060 |
|
|
$ |
27,501 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
2,509 |
|
|
$ |
2,561 |
|
|
Accrued and other current liabilities |
|
|
4,829 |
|
|
|
4,831 |
|
|
|
Total
current liabilities |
|
|
7,338 |
|
|
|
7,392 |
|
Lease liability |
|
|
80 |
|
|
|
106 |
|
|
|
Total
liabilities |
|
|
7,418 |
|
|
|
7,498 |
|
|
|
|
|
|
|
|
Redeemable common stock |
|
|
4,494 |
|
|
|
4,494 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
10,148 |
|
|
|
15,509 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
22,060 |
|
|
$ |
27,501 |
|
|
|
|
|
|
|
|
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