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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

DC 20549

FORM

8-K

CURRENT

REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

May 14, 2025

Date of Report (date of earliest event reported)

Cyclacel Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

0-50626

91-1707622

(State or other jurisdiction of

incorporation or organization)

(Commission

File Number)

(I.R.S.

Employer

Identification Number)

Level 10, Tower 11, Avenue 5, No. 8

Jalan Kerinchi, Kuala Lumpur, Malaysia 592000

(Address of principal executive offices) (Zip code)

(908) 517-7330

(Registrant’s telephone number, including area code)

Not Applicable

(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 Operation and Financial Condition.

On May 14, 2025, Cyclacel Pharmaceuticals, Inc. announced in a news release its financial performance for the first quarter ended March 31, 2025 and other related material information (the “Earnings Release”). A copy of the Earnings Release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished under Item 2.02 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The below exhibit is furnished as part of this Current Report on Form 8-K.

Exhibit No.

Description

99.1

News release for Cyclacel Pharmaceuticals, Inc., dated May 14, 2025, announcing financial performance for the first quarter ended March 31, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

Date: May 15, 2025 Cyclacel Pharmaceuticals, Inc.

By: /s/ Datuk Dr. Doris Wong Sing Ee

Name: Datuk Dr. Doris Wong Sing Ee

Title: Chief Executive Officer

EX-99.1

2 cyclacel_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals Reports FOURTH quarter

financial results and provides business update

BERKELEY HEIGHTS, NJ, April 2, 2025 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines, today announced fourth quarter financial results and provided a business update.

“As part of Cyclacel’s efforts to reduce operating costs, it has determined to focus on the development of plogosertib, a polo-like kinase 1 (PLK 1) inhibitor for treatment of advanced cancers and hematological malignancies, which we acquired on March 10, 2025, from Cyclacel Limited, our wholly-owned subsidiary that is currently in liquidation,” said Datuk Dr. Doris Wong Sing Ee, Chief Executive Officer and Executive Director. “Our new, alternative salt, oral formulation of plogosertib with improved bioavailability is under development.”

“The commencement of the liquidation of Cyclacel Limited means that the Company will no longer have control over Cyclacel Limited and its financial results will be deconsolidated from those of the Company; as a result, the Company anticipates a significant decrease to research and development expenses for the year ended December 31, 2025 as we focus on our plogosertib clinical program and have no expenditures related to fadraciclib,” said Kiu Cu Seng, Chief Financial Officer. “The deconsolidation of Cyclacel Limited, which is anticipated to increase stockholders’ equity by approximately $5.0 million, will be reported in the Company’s Form 10-Q for the three months ended March 31, 2025.”

Financial Highlights

As of December 31, 2024, pro forma cash and cash equivalents totaled $7.2 million, including $4.1 million of equity financing received after the end of the year. Cash and cash equivalents as of December 31, 2024, totaled $3.1 million, compared to $3.4 million as of December 31, 2023. Net cash used in operating activities was $8.0 million for the twelve months ended December 31, 2024 compared to $16.1 million for the same period of 2023. The Company estimates that its available cash, including the equity financing of $4.1 million, will fund currently planned activities into the second quarter of 2025.

Research and development (R&D) expenses were $0.9 million and $6.7 million for the three months and year ended December 31, 2024, as compared to $3.5 million and $19.2 million for the same period in 2023. R&D expenses relating to fadraciclib were $0.8 million and $5.0 million for the three months and year ended December 31, 2024, as compared to $2.7 million and $13.4 million for the same period in 2023 due to decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $0.1 million and $1.6 million for the three months and year ended December 31, 2024, as compared to $0.7 million and $5.0 million for the same period in 2023 due to decrease in clinical trial and other non-clinical expenditures.

General and administrative expenses for the three months and year ended December 31, 2024, were $0.9 million and $5.4 million, compared to $1.9 million and $6.7 million for the same period of the previous year due to a decrease in stock compensation and professional and corporate fees.

Total other income, net, for the three months and year ended December 31, 2024, were an expense of $30,000 and income of $10,000, compared to an expense of $333,000 and $98,000 for the same period of the previous year, due to foreign exchange movements.

United Kingdom research & development tax credits for the three months and year ended December 31, 2024 were a debit of $1.2 million and a credit of 0.8 million compared to credits $0.4 million and $3.0 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 and year ended December 31, 2024, was $3.0 million and $11.2 million (including stock based compensation expense of $0.1 million and $0.6 million respectively), compared to $5.3 million and $22.6 million (including stock based compensation expense of $0.3 million and $1.5 million respectively) for the same period in 2023.

Board and Committee Appointments

On April 2, 2025, coinciding with the effective time of the previously announced resignations of Avraham Ben-Tzvi and David Natan, as independent directors, the Company appointed Ms. Inigo Angel Laurduraj and Dr. Satis Waran Nair Krishnan, as independent directors, on the Company’s board of directors (the “Board”) to fill the vacancies.

Dr. Satis Waran Nair Krishnan (age 39) is a Medical Doctor at Centric Health in Drogheda, County Louth, Ireland. Dr. Krishnan is a highly experienced practitioner originally from Malaysia. Dr. Krishnan joined Centric Health in Ireland September 2023. Prior to that, from 2010 to August 2023, Dr. Krishnan was a Doct

EX-99.1

2 tm2428051d2_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals Reports THIRD quarter financial results

and provides business update

BERKELEY HEIGHTS, NJ, November 12, 2024 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, today announced third quarter financial results and provided a business update.

“We were pleased to report initial safety and efficacy data from twelve patients with advanced solid tumors enrolled in the Phase 2 part of the 065-101, proof of concept, clinical study of fadraciclib as a single agent as a poster presentation at the 2024 EORTC-NCI-AACR 36th Symposium on Molecular Targets and Cancer Therapeutics (“Triple Meeting”), in Barcelona, Spain. The patients were enrolled in the biomarker-enriched, Cohort 8 of the study and were preselected for CDKN2A and/or CDKN2B abnormalities,” said Spiro Rombotis, President and Chief Executive Officer. “Nasdaq has granted the Company an extension until December 24, 2024, to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and we continue to pursue opportunities to obtain additional funding for our programs. If we do not secure such additional funding in an amount that allows us to meet or exceed Nasdaq’s minimum stockholders’ equity requirement, our securities will be delisted from Nasdaq.”

Financial Highlights

As of September 30, 2024, cash equivalents totaled $3.0 million, compared to $3.4 million as of December 31, 2023. Net cash used in operating activities was $6.6 million for the nine months ended September 30, 2024 compared to $12.2 million for the same period of 2023. The Company estimates that its available cash will fund currently planned programs into the fourth quarter of 2024.

Although the Company has made substantial reductions in its expenses, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction. In the event that we are not able to secure such additional funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy. In such events, our stockholders may lose their entire investment in the Company.

Research and development (R&D) expenses were $1.0 million for the three months ended September 30, 2024, as compared to $5.2 million for the same period in 2023. R&D expenses relating to fadraciclib were $0.9 million for the three months ended September 30, 2024, as compared to $3.6 million for the same period in 2023 due to manufacturing costs not recurring in 2024. R&D expenses related to plogosertib were $0.1 million for the three months ended September 30, 2024, as compared to $1.5 million for the same period in 2023 also due to manufacturing costs not recurring in 2024.

General and administrative expenses for the three months ended September 30, 2024 were $1.2 million, as compared to $1.6 million for the same period in 2023 due largely to reduction in stock compensation costs.

Total other income, net, for the three months ended September 30, 2024 was $10,000 compared to an income of $145,000 for the same period of the previous year.

2

United Kingdom research & development tax credits for the three months ended September 30, 2024 were $0.2 million compared to $0.7 million for the same period of the previous year. Research & development tax credits are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended September 30, 2024 was $2.0 million, compared to $6.0 million for the same period in 2023.

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 the efficacy and safety profile of fadraciclib in an incomplete clinical trial, Cyclacel’s future plans and prospects, Cyclacel’s anticipated cash ru

EX-99.1

2 tm2421702d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals Reports SECOND quarter financial results

and provides business update

- Oral Fadraciclib Phase 2 Proof of Concept Study Enrolling Well -

- 065-101 PoC Interim Data Anticipated in the Fourth Quarter of 2024 -

- Management to Host Conference Call at 4:30 pm EDT Today -

BERKELEY HEIGHTS, NJ, August 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 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.

2

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) 518-9708

Archive: (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

EX-99.1

2 tm2414455d1_ex99-1.htm

EXHIBIT 99.1

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.

2

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 mill