Fadra (Fadraciclib) Development - Cyclacel is developing fadraciclib, a next-generation CDK2/9 inhibitor, with a precision medicine strategy in Phase 2 trials[3] - Phase 2 cohorts are enrolling patients with solid tumors with CDKN2A/CDKN2B abnormalities and T-cell lymphoma, with readouts expected in 2H 2024 and 2H 2024-1H 2025, respectively[3] - In a Phase 1 dose escalation study, 11 patients had CDKN2A/B abnormalities[12] - One endometrial cancer patient with CDKN2A, CDKN2B, and MTAP loss achieved a complete response (CR) with fadraciclib at 213mg QD[13] - In an oral Phase 1 dose escalation study (065-101), out of 32 patients, 2 achieved partial responses (PR), 21 had stable disease (SD), and 9 had progressive disease (PD)[17, 18] - In an expansion cohort of 12 patients, 7 (58.3%) experienced at least one related treatment-emergent adverse event (TEAE) of any grade, with most being Grade 1 or 2[34] - In the expansion cohorts, the overall response rate (ORR) was 8%, with a disease control rate (DCR) of 67%[35] Plogosertib (CYC140) Development - Plogosertib (CYC140) is a next-generation PLK1 inhibitor with a novel mechanism of action targeting ARID1A and TP53 mutated cancers[42, 44] - Preclinical data shows anti-cancer activity in 5 out of 13 solid tumors[43] - A Phase 1/2 clinical study (140-101) is ongoing in solid tumors and lymphoma, with dose escalation up to Dose Level 5 showing good tolerability and no dose-limiting toxicities observed to date[55, 57] - In vitro studies of 16 CRC PDX models showed that 5 models had an EC50 < 30 nM to plogosertib[65, 67] Financial Status - As of June 30, 2024, Cyclacel had $6.0 million in cash equivalents[82]

Core Points - Cyclacel Pharmaceuticals has regained compliance with Nasdaq Listing Rule 5550(a)(2) regarding the Minimum Bid Price Requirement as of June 3, 2025 [1][2] - The company had previously received a notification from Nasdaq on December 6, 2024, indicating non-compliance due to its shares trading below $1.00 for 30 consecutive business days [2] - Following the notification, Cyclacel's shares closed at or above $1.00 for 15 consecutive business days from May 12, 2025, to June 2, 2025, leading to the closure of the compliance matter [2] Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, transcriptional regulation, and mitosis biology [3] - The company's key program includes plogosertib, a PLK1 inhibitor targeting both solid tumors and hematological malignancies [3] - Cyclacel aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates addressing oncology and hematology indications [3]

Core Viewpoint - Cyclacel Pharmaceuticals is focusing on the development of its plogosertib clinical program while undergoing significant operational changes due to the liquidation of its UK subsidiary, Cyclacel Limited, which has impacted its financial results and strategic direction [2][4][7]. Financial Highlights - As of March 31, 2025, cash and cash equivalents increased to $3.5 million from $3.2 million as of December 31, 2024 [3]. - Net cash used in operating activities for the first quarter of 2025 was $3.3 million, with current cash resources expected to fund planned programs into the second quarter of 2025 [3]. - Research and development expenses for the first quarter of 2025 were $0.8 million, a decrease from $2.8 million in the same period of 2024, primarily due to the cessation of expenditures related to the transcriptional regulation program following the liquidation of Cyclacel Limited [4]. - General and administrative expenses rose to $4.2 million in the first quarter of 2025 from $1.6 million in the same period of 2024, attributed to one-time costs associated with the change of control [5]. - The company reported a net loss of $0.1 million for the first quarter of 2025, a significant improvement compared to a net loss of $2.9 million in the same period of 2024 [7]. Strategic Developments - The company has repurchased certain assets related to plogosertib for approximately $0.3 million to enhance the development of an alternative salt, oral formulation with improved bioavailability [2]. - Following the liquidation of Cyclacel Limited, the company anticipates a significant decrease in research and development expenses for the year ending December 31, 2025 [2][4]. - The company is exploring strategic alternatives to continue as a going concern, including raising additional debt or equity financing or pursuing a merger or acquisition [2]. Other Financial Metrics - Total other income for the first quarter of 2025 was $5.0 million, primarily due to a gain on deconsolidation of the UK subsidiary [6]. - The company lost eligibility for research and development tax credits following the liquidation of Cyclacel Limited, resulting in no tax credits for the first quarter of 2025 compared to $1.4 million in the same period of 2024 [6][7].

Financial Performance - The company reported revenue of $0 for the three months ended March 31, 2025, compared to $29,000 for the same period in 2024, and does not expect significant revenue in the foreseeable future[137] - Revenue for the three months ended March 31, 2025 was $0, compared to $29,000 for the same period in 2024, related to clinical manufacturing cost recovery[162] - The accumulated deficit as of March 31, 2025, was $440.5 million, indicating significant financial losses since inception[151] - The company anticipates no revenue for the foreseeable future[163] Cash Flow and Liquidity - The company used net cash of $8.2 million to fund operating activities for the three months ended March 31, 2025, with cash and cash equivalents of $3.5 million remaining[143] - Net cash used in operating activities increased by $2.8 million, from $0.5 million for the three months ended March 31, 2024, to $3.2 million for the same period in 2025[153] - As of March 31, 2025, the company had a total working capital deficit of $3.051 million, compared to a deficit of $3.515 million in 2024[151] - The company plans to finance future cash needs primarily through public or private equity offerings, debt financings, or strategic collaborations[158] Research and Development - Research and development expenses decreased by $2.0 million from $2.8 million in Q1 2024 to $0.8 million in Q1 2025, representing a 71% reduction[166] - Total research and development expenses accounted for 16% of operating expenses in Q1 2025, down from 64% in Q1 2024[165] - Following the liquidation of the UK subsidiary, overall research and development expenses for the year ending December 31, 2025 are expected to decrease significantly compared to 2024[167] - The Phase 1/2 study of plogosertib has treated fifteen patients with no dose-limiting toxicities observed, and stable disease was noted in patients with gastrointestinal, lung, and ovarian cancers[142] General and Administrative Expenses - General and administrative expenses increased by approximately $2.6 million from $1.6 million in Q1 2024 to $4.2 million in Q1 2025, a 166% increase[171] - Total general and administrative expenses represented 84% of operating expenses in Q1 2025, up from 36% in Q1 2024[170] Other Income and Tax Benefits - Total other income increased by $4.9 million from $55,000 in Q1 2024 to $5.0 million in Q1 2025, primarily due to a gain on deconsolidation of a subsidiary[173] - The total income tax benefit decreased from $1.4 million in Q1 2024 to $0 in Q1 2025, a 100% decline, following the liquidation of the UK subsidiary[177] Strategic Alternatives - The company is exploring strategic alternatives, including raising additional capital or pursuing mergers and acquisitions, due to substantial doubt about its ability to continue as a going concern[145] - The company is currently investigating ways to raise additional capital through private equity financing or strategic transactions[161] - The company repurchased certain assets related to the plogosertib clinical program for approximately $0.3 million in cash on March 10, 2025[138] - The company has retained all marketing rights worldwide to its drug programs[139]

BERKELEY HEIGHTS, NJ, May 07, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, today announced that it expects to implement a 1-for-16 reverse stock split on its shares of common stock effective May 12, 2025, with trading to begin on a split-adjusted basis at the market open on that day. Trading in the shares of common stock will continue on The Nasdaq Capital Market under the symb ...

KUALA LUMPUR, MALAYSIA, May 06, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") today announced that it entered into an Exchange Agreement with FITTERS Diversified Berhad (9318.KL; "FITTERS"), an investment holding company engaged, through its subsidiaries, in the business of the sale of fire safety materials, equipment and fire prevention systems, "Waste-To-Resource" services and real estate development and construction. Pursuant to the Exc ...

Financial Performance - 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, representing a 50.4% decrease[5] - Net loss for the three months and year ended December 31, 2024, was $3.0 million and $11.2 million, compared to $5.3 million and $22.6 million for the same period in 2023, showing a 43.4% and 50.5% reduction respectively[10] - 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, reflecting a 52.6% and 19.4% decrease respectively[7] - Research and development (R&D) expenses were $0.9 million and $6.7 million for the three months and year ended December 31, 2024, compared to $3.5 million and $19.2 million for the same period in 2023, indicating a 74.3% and 65.1% decrease respectively[6] Cash Position - 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[5] - The company estimates that its available cash will fund currently planned activities into the second quarter of 2025[5] Corporate Governance - The company appointed two new independent directors to its board on April 2, 2025, enhancing its governance structure[11] Strategic Development - The new oral formulation of plogosertib with improved bioavailability is under development[4] - The company has focused on the development of plogosertib, a PLK1 inhibitor for advanced cancers and hematological malignancies[4] Equity Impact - The deconsolidation of Cyclacel Limited is anticipated to increase stockholders' equity by approximately $5.0 million[4]

Core Insights - Cyclacel Pharmaceuticals is focusing on the development of plogosertib, a PLK1 inhibitor for advanced cancers, following the liquidation of its subsidiary Cyclacel Limited [2] - The company anticipates a significant decrease in research and development expenses for 2025 due to the deconsolidation of Cyclacel Limited, which is expected to increase stockholders' equity by approximately $5.0 million [2] - Financial results indicate a net loss of $11.2 million for the year ended December 31, 2024, a reduction from $22.6 million in 2023 [8] Financial Highlights - As of December 31, 2024, pro forma cash and cash equivalents totaled $7.2 million, including $4.1 million from equity financing received after the year-end [3] - Cash and cash equivalents decreased to $3.1 million as of December 31, 2024, from $3.4 million in 2023 [3] - Net cash used in operating activities was $8.0 million for the year ended December 31, 2024, down from $16.1 million in 2023 [3] Research and Development Expenses - R&D expenses for the year ended December 31, 2024, were $6.7 million, a decrease from $19.2 million in 2023 [4] - R&D expenses related to fadraciclib were $5.0 million for 2024, down from $13.4 million in 2023 [4] - R&D expenses for plogosertib were $1.6 million for 2024, compared to $5.0 million in 2023 [4] General and Administrative Expenses - General and administrative expenses for the year ended December 31, 2024, were $5.4 million, down from $6.7 million in 2023 [5] Other Income and Tax Credits - Total other income for the year ended December 31, 2024, was an income of $10,000, compared to an expense of $98,000 in 2023 [6] - UK R&D tax credits for the year ended December 31, 2024, were a credit of $0.8 million, compared to $3.0 million in 2023 [7] Board and Committee Appointments - On April 2, 2025, Cyclacel appointed Ms. Inigo Angel Laurduraj and Dr. Satis Waran Nair Krishnan as independent directors [9][10] - The board also approved committee appointments for the new directors [13] Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [14] - The company aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates targeting oncology and hematology indications [14]

Core Viewpoint - Cyclacel Pharmaceuticals has successfully completed a private placement of its convertible Series E Preferred Stock, raising gross proceeds of $1.0 million to support its working capital and extend its cash runway into the third quarter of 2025 [1][2]. Group 1: Financing Details - The private placement of Preferred Stock closed on March 21, 2025, and the net proceeds will be utilized for working capital and general corporate purposes [2]. - Each share of Preferred Stock is convertible into 110 shares of common stock, subject to stockholder approval as per Nasdaq listing rules [3]. - The securities were sold in reliance on Regulation S of the Securities Act and have not been registered under the Securities Act or any state securities laws [4]. Group 2: Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines, particularly through its anti-mitotic program plogosertib, a PLK1 inhibitor targeting solid tumors and hematological malignancies [7]. - The company aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates addressing oncology and hematology indications [7]. Group 3: Advisory Information - Arc Group Ltd. acted as a financial advisor for Cyclacel during the private placement, while Rimon P.C. served as legal counsel [6].

Core Viewpoint - Cyclacel Pharmaceuticals has undergone a significant change in control and leadership, with Datuk Dr. Doris Wong Sing Ee acquiring a controlling stake and being appointed as the new CEO [1][5]. Company Control and Leadership Change - Datuk Dr. Doris Wong Sing Ee purchased 1,000,000 shares of Series C Convertible Preferred Stock and 1,745,262 shares of Series D Convertible Preferred Stock, resulting in her owning 70% of Cyclacel's issued shares [2][4]. - The total consideration for the acquisition was $6,300,000, which included an $800,000 cash brokerage fee and a holdback amount of $100,000 [3]. - Following the acquisition, Datuk Dr. Doris Wong Sing Ee was elected as CEO, and Kiu Cu Seng was appointed as CFO [5][7]. Resignations and Board Changes - David Lazar resigned as interim CEO and secretary, and several other directors also resigned, including Dr. Samuel L. Barker and Paul McBarron [5][6]. - Chong Kwang Fock was appointed as an Independent Director to the Board [7]. Background of New Leadership - Datuk Dr. Doris Wong Sing Ee has over 20 years of management experience across various industries, including oil and gas and property development, and has held executive roles in multiple companies [8][10]. - Kiu Cu Seng has significant accounting and audit experience, having served as CFO for Energem Corp and worked with various publicly listed companies [11]. - Chong Kwang Fock is a Chartered Accountant with nearly 20 years of experience in auditing and has served as an Independent Director for Energem Corp [12][13]. Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle and transcriptional regulation [15][16].