Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology,
announced today second quarter financial results and provided a
business update.
“Following oral fadraciclib data presented at the
2024 American Society of Clinical Oncology (ASCO) Annual Meeting,
the Phase 2 stage of our 065-101 study is enrolling well,” said
Spiro Rombotis, President and Chief Executive Officer. “We are on
track to report in the fourth quarter of 2024 initial data from the
precision medicine cohort of 065-101 with our CDK2/9 inhibitor as
monotherapy in patients with advanced solid tumors and later on in
patients with T-cell lymphoma.”
“We are enrolling patients prospectively selected
for CDKN2A/CDKN2B alterations in the Phase 2, proof of concept
(PoC) stage of 065-101,” said Brian Schwartz, M.D., interim Chief
Medical Officer. “We are pleased with strong investigator interest
and are nearing completion of recruitment in the precision medicine
cohort. There are no approved medicines for patients with
CDKN2A/CDKN2B alterations. A second cohort to evaluate fadraciclib
in patients with T-cell lymphoma is open for enrollment. We are
encouraged about fadraciclib’s prospects and look forward to
presenting emerging data from the 065-101 study later in the
year.“
Financial Highlights
As of June 30, 2024, cash equivalents totalled $6.0
million, compared to $3.4 million as of December 31, 2023. Net cash
used in operating activities was $3.6 million for the six months
ended June 30, 2024 compared to $8.2 million for the same period of
2023. Net cash provided by financing activities was approximately
$6.3 million, net of expenses, for the six months ended June 30,
2024 from the issuance of common stock and warrants. The Company
estimates that its current cash resources will fund planned
programs into the fourth quarter of 2024.
Research and development (R&D) expenses were
$2.0 million for the three months ended June 30, 2024, as compared
to $4.7 million for the same period in 2023. R&D expenses
relating to fadraciclib were $1.5 million for the three months
ended June 30, 2024, as compared to $3.0 million for the same
period in 2023 due to a decrease in clinical trial and other
non-clinical expenditures. R&D expenses related to plogosertib
were $0.5 million for the three months ended June 30, 2024, as
compared to $1.4 million for the same period in 2023 due to a
decrease in manufacturing costs and other non-clinical
expenditures.
General and administrative expenses remained flat
at approximately $1.6 million for each of the three months ended
June 30, 2024 and 2023.
Total other expenses, net, for the three months and
year ended June 30, 2024 were $0.1 million for each of the three
months ended June 30, 2024 and 2023.
United Kingdom research & development tax
credits for the three months ended June 30, 2024 were $0.4 million,
compared to $0.6 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 June 30, 2024,
was $3.3 million (including stock-based compensation expense of
$0.2 million), compared to $5.5 million (including stock-based
compensation expense of $0.4 million) for the same period in
2023.
Conference call information:
Call: (800) 225-9448 / international call: (203)
518-9708Archive: (800) 934-7884 / international archive: (402)
220-6987 Code for live and archived conference call is
CYCCQ224. 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 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, among other things, statements related to Cyclacel’s
future plans and prospects, Cyclacel’s anticipated cash runway and
the planned timing of data results and continued development of
fadraciclib. Factors that may cause actual results to differ
materially include market and other conditions, 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 risks associated with
reliance on collaborative partners for further clinical trials,
development and commercialization of product candidates and
Cyclacel’s ability to regain and maintain compliance with Nasdaq’s
continued listing requirements. 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 2024 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 $000s, except share and
per share amounts) |
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Three Months Ended |
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June 30, |
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2024 |
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2023 |
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Revenues |
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$ |
4 |
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$ |
373 |
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Operating
expenses: |
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Research and development |
|
|
2,023 |
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|
|
4,727 |
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General and administrative |
|
|
1,625 |
|
|
|
1,575 |
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|
Total
operating expenses |
|
|
3,648 |
|
|
|
6,302 |
|
|
Operating
loss |
|
|
(3,644 |
) |
|
|
(5,929 |
) |
|
Other income
(expense): |
|
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|
|
Foreign exchange gains (losses) |
|
|
3 |
|
|
|
(76 |
) |
|
Interest income |
|
|
(28 |
) |
|
|
77 |
|
|
Other income, net |
|
|
- |
|
|
|
(106 |
) |
|
Total other income (expense), net |
|
|
(25 |
) |
|
|
(105 |
) |
|
Loss
before taxes |
|
|
(3,669 |
) |
|
|
(6,034 |
) |
|
Income tax
benefit |
|
|
412 |
|
|
|
586 |
|
|
Net
loss |
|
|
|
|
(3,257 |
) |
|
|
(5,448 |
) |
|
Dividend on
convertible exchangeable preferred shares |
|
|
- |
|
|
|
(50 |
) |
|
Net loss
applicable to common shareholders |
|
$ |
(3,257 |
) |
|
$ |
(5,498 |
) |
|
Basic and
diluted earnings per common share: |
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|
|
|
|
Net loss per share
– basic and diluted (common shareholders) |
|
$ |
(0.72 |
) |
|
$ |
(6.57 |
) |
|
Net loss per share
– basic and diluted (redeemable common shareholders) |
|
$ |
- |
|
|
$ |
(6.57 |
) |
CYCLACEL PHARMACEUTICALS,
INC. CONSOLIDATED BALANCE
SHEET (In $000s, except share, per share, and
liquidation preference amounts) |
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June 30, |
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December 31, |
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2024 |
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2023 |
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ASSETS |
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Current
assets: |
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Cash and cash equivalents |
|
|
$ |
6,000 |
|
$ |
3,378 |
|
Prepaid expenses and other current assets |
|
|
|
1,707 |
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|
4,066 |
|
Total current assets |
|
|
|
7,707 |
|
|
7,444 |
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|
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Property and equipment, net |
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|
|
5 |
|
|
9 |
|
Right-of-use lease asset |
|
|
|
65 |
|
|
93 |
|
Non-current deposits |
|
|
|
413 |
|
|
1,259 |
|
Total assets |
|
|
$ |
8,190 |
|
$ |
8,805 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
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Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
|
$ |
4,741 |
|
$ |
3,543 |
|
Accrued and other current liabilities |
|
|
|
2,445 |
|
|
4,618 |
|
Total current liabilities |
|
|
|
7,186 |
|
|
8,161 |
|
Lease
liability |
|
|
|
5 |
|
|
37 |
|
Total liabilities |
|
|
|
7,191 |
|
|
8,198 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Stockholders’
equity |
|
|
|
999 |
|
|
607 |
|
Total liabilities and stockholders’ equity |
|
|
$ |
8,190 |
|
$ |
8,805 |
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