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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date
of earliest event reported): May 14,
2024
CYCLACEL
PHARMACEUTICALS, INC.
(Exact name of registrant
as specified in its charter)
Delaware |
|
0-50626 |
|
91-1707622 |
(State
or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS
Employer
Identification No.) |
200
Connell Drive, Suite 1500
Berkeley
Heights, NJ 07922
(Address of principal
executive offices and zip code)
Registrant’s telephone
number, including area code: (908) 517-7330
(Former Name or Former
Address, if Changed Since Last Report)
Check the appropriate
box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered
|
Common
Stock, par value $0.001 per share |
CYCC |
The Nasdaq
Capital Market |
Preferred
Stock, $0.001 par value |
CYCCP |
The Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results
of Operations and Financial Condition.
The information set forth
under this “Item 2.02. Results of Operations and Financial Condition,” including the exhibit attached hereto, shall not be
deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated
by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference
in such filing.
Attached as Exhibit 99.1 is
a copy of a press release of Cyclacel Pharmaceuticals, Inc. (the “Company”), dated May 14, 2024, announcing certain
financial results for the first quarter ended March 31, 2024.
The Company will conduct a
conference call to review its financial results on May 14, 2024, at 4:30 p.m., Eastern Time.
Item 9.01. Financial
Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
CYCLACEL PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Paul McBarron |
|
Name: |
Paul McBarron |
|
Title: |
Executive Vice President-Finance, |
|
|
Chief Financial Officer and Chief Operating Officer |
|
Date: May 14, 2024
Exhibit 99.1
| | Cyclacel
Pharmaceuticals, Inc. |
|
Cyclacel
Pharmaceuticals Reports first quarter financial results
and
provides business update
-
New Clinical Data to be Presented at ASCO Annual Meeting
Highlighting
Potential Precision Medicine Strategy with Oral Fadraciclib -
-
First Patients Enrolled in Oral Fadraciclib Phase 2 Proof of Concept Study -
-
Balance Sheet Bolstered with $8.0 million Private Placement
Priced
At-The-Market Under Nasdaq Rules -
- Management
to Host Conference Call at 4:30 pm EDT Today -
BERKELEY HEIGHTS,
NJ, May 14, 2024 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"),
a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today first quarter financial results
and provided a business update.
“We are excited
to report that we have begun enrolling patients in the Phase 2, proof of concept (PoC) stage of our 065-101 study of fadraciclib, our
oral CDK2/9 inhibitor, and are on track to deliver key readouts this year,” said Spiro Rombotis, President and Chief Executive
Officer. “Receipt of $8.0 million gross proceeds in a private placement together with existing resources support our ongoing clinical
program. Pharmacokinetic, pharmacodynamic, safety and anticancer activity data from the Phase 1, dose escalation stage of 065-101 in
patients with advanced solid tumors and lymphoma will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting. Data to date suggest that fadraciclib is differentiated from other next generation CDK inhibitors.”
“Having
determined the recommended Phase 2 dose for fadraciclib we are now enrolling patients in the Phase 2 PoC stage of 065-101”
said Brian Schwartz, M.D., interim Chief Medical Officer. “We are initially concentrating on the biomarker cohort which is
enrolling patients prospectively selected for CDKN2A/CDKN2B alterations to be followed by patients with T-cell lymphoma. There are
no approved medicines for patients with CDKN2A/CDKN2B alterations. Including currently opened trial sites, we expect a total of up
to seven sites will participate with the majority in the United States. We are encouraged about fadra’s prospects and look
forward to presenting emerging data from the 065-101 study later in the year.“
Key Upcoming Milestones
for 2024
| · | 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 at the ASCO 2024 Annual Meeting |
| · | 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, 2024, pro forma cash and cash equivalents totalled $9.9 million, including proceeds from this month’s private placement and
$0.8 million received for the United Kingdom research & development tax credit. Cash and cash equivalents as of March 31, 2024, totalled
$2.8 million, compared to $3.4 million as of December 31, 2023.
Net cash used
in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in
respect of the United Kingdom research & development tax credit, compared to $6.9 million for the same period of 2023. 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 $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same
period in 2023. R&D expenses relating to fadraciclib were $1.8 million for the three months ended March 31, 2024, as compared to
$4.1 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 $1.0 million for the three months ended March 31, 2024, as compared to $1.4 million for the same period in 2023 due
to a decrease in manufacturing and other non-clinical expenditures.
General and
administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and
2023.
Total other
expenses, net, for the three months and year ended March 31, 2024, were $0.1 million, compared to $0.2 million for the same period of
the previous year.
United Kingdom
research & development tax credits for the three months March 31, 2024, were $1.4 million, which includes $0.8 million related to
the 2023 claim which was received in May 2024, compared to $1.3 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 March 31, 2024, was $2.9 million (including stock-based compensation expense of $0.2 million), compared to $5.8 million
(including stock-based compensation expense of $0.4 million) for the same period in 2023.
Conference
call information:
Call:
(888) 632-3384 / international call: (785) 424-1794
Archive:
(800) 938-1584 / international archive: (402) 220-1542
Code
for live and archived conference call is CYCCQ124. 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 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
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 the intended use of proceeds from the private placement, 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 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)
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Revenues | |
$ | 29 | | |
$ | - | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 2,802 | | |
| 5,674 | |
General and administrative | |
| 1,582 | | |
| 1,645 | |
Total operating expenses | |
| 4,384 | | |
| 7,319 | |
Operating loss | |
| (4,355 | ) | |
| (7,319 | ) |
Other income (expense): | |
| | | |
| | |
Foreign exchange gains (losses) | |
| 1 | | |
| (87 | ) |
Interest income | |
| 2 | | |
| 116 | |
Other income, net | |
| 52 | | |
| 166 | |
Total other income (expense), net | |
| 55 | | |
| 195 | |
Loss before taxes | |
| (4,300 | ) | |
| (7,124 | ) |
Income tax benefit | |
| 1,354 | | |
| 1,320 | |
Net loss | |
| (2,946 | ) | |
| (5,804 | ) |
Dividend on convertible exchangeable preferred shares | |
| - | | |
| (50 | ) |
Net loss applicable to common shareholders | |
$ | (2,946 | ) | |
$ | (5,854 | ) |
Basic and diluted earnings per common share: | |
| | | |
| | |
Net loss per share – basic and diluted (common shareholders) | |
$ | (2.27 | ) | |
$ | (7.00 | ) |
Net loss per share – basic and diluted (redeemable common shareholders) | |
$ | - | | |
$ | (7.00 | ) |
| |
| | | |
| | |
Weighted average common shares outstanding | |
| 1,296,547 | | |
| 835,946 | |
CYCLACEL PHARMACEUTICALS,
INC.
CONSOLIDATED
BALANCE SHEET
(In $000s, except
share, per share, and liquidation preference amounts)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 2,798 | | |
$ | 3,378 | |
Prepaid expenses
and other current assets | |
| 2,037 | | |
| 4,066 | |
Total current assets | |
| 4,835 | | |
| 7,444 | |
| |
| | | |
| | |
Property and equipment, net | |
| 7 | | |
| 9 | |
Right-of-use lease asset | |
| 79 | | |
| 93 | |
Non-current
deposits | |
| 1,244 | | |
| 1,259 | |
Total assets | |
$ | 6,165 | | |
$ | 8,805 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’
EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 5,200 | | |
$ | 3,543 | |
Accrued and other current liabilities | |
| 3,150 | | |
| 4,618 | |
Total current liabilities | |
| 8,350 | | |
| 8,161 | |
Lease liability | |
| 21 | | |
| 37 | |
Total liabilities | |
| 8,371 | | |
| 8,198 | |
| |
| | | |
| | |
Stockholders’ equity | |
| (2,206 | ) | |
| 607 | |
Total liabilities and stockholders’
equity | |
$ | 6,165 | | |
$ | 8,805 | |
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Cyclacel Pharmaceuticals (NASDAQ:CYCCP)
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