Company Overview - Cyclacel Pharmaceuticals, Inc. (CYCC) stock is experiencing a significant increase, trading at $13.85, up 318.43% with a session volume of 21.9 million compared to an average volume of 206.9K [1][5] - The company recently amended its Exchange Agreement with FITTERS Diversified Berhad, which is involved in fire safety materials, "Waste-To-Resource" services, and real estate development [2] Research and Development - A publication in the journal Gut highlighted a study indicating that DNAJ-PKAc, a fusion oncoprotein, enhances the sensitivity of FLC (focal liver cancer) to treatment with plogosertib [3] - The study found that PLK1 is crucial for FLC cells, making them particularly sensitive to PLK1 loss, with a direct interaction between DNAJ-PKAc fusions and PLK1 promoting mitotic progression [3] Clinical Findings - Pharmacologic inhibitors of PLK1, such as plogosertib, have shown to significantly reduce FLC growth while sparing normal liver cells in both patient-derived in vitro and in vivo xenograft models [4] - Cyclacel has conducted two reverse stock splits, a 1-for-15 in July and a 1-for-16 in May, indicating a strategic move to manage stock price [4] Financial Activities - In June, Cyclacel completed a private placement that generated gross proceeds of $3.0 million, issuing series A, B, and C warrants for the purchase of 3.27 million shares at exercise prices of 51 cents, 60 cents, and 68 cents per share respectively [5]

Core Viewpoint - Cyclacel Pharmaceuticals has amended its Exchange Agreement with FITTERS Diversified Berhad to facilitate the acquisition of Fitters Sdn. Bhd., a subsidiary of FITTERS, through the exchange of shares and a cash payment [1][2][3]. Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [6]. - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies, aiming to build a diversified biopharmaceutical business [6]. Transaction Details - Under the amended Exchange Agreement, Cyclacel will exchange all ordinary shares of Fitters Sdn. Bhd. for common stock, representing 19.99% of Cyclacel's issued and outstanding shares at closing [2]. - Cyclacel will also pay USD 1,000,000 or a mutually agreed amount to FITTERS as part of the transaction [2]. - The final date for the transaction has been extended to September 30, 2025 [2]. Approval and Governance - The transaction is subject to approval from the stockholders of both Cyclacel and FITTERS, and has been unanimously approved by the Boards of Directors of Cyclacel, FITTERS, and Fitters Sub [3]. Fitters Sdn. Bhd. Overview - Fitters Sdn. Bhd. specializes in distributing, trading, and installing fire safety materials and equipment, with a strong reputation for reliability and compliance with regulatory standards [4][8]. - The company offers a wide range of fire safety products, including fire extinguishers, fire-resistant doors, and personal protective equipment [8].

Core Insights - Cyclacel Pharmaceuticals is developing plogosertib, a PLK1 inhibitor, as a potential treatment for fibrolamellar hepatocellular carcinoma (FLC), a rare liver cancer with no approved therapies [1][2][5] Group 1: Disease Overview - FLC primarily affects adolescents and young adults, with an estimated annual incidence in the US of 0.02 per 100,000 [3] - The five-year survival rate for FLC patients is approximately 30%, and the disease is often misdiagnosed as hepatocellular carcinoma (HCC) [3] - FLC is characterized by the presence of a unique DNAJB1-PKAc gene fusion, which is a common driver of the disease [4] Group 2: Research Findings - A recent study published in the journal Gut indicates that the DNAJ-PKAc fusion oncoprotein increases sensitivity to PLK1 inhibitors like plogosertib in FLC cells [1][2] - PLK1 is essential for the growth of FLC cells, and its inhibition leads to significant reduction in FLC growth while sparing normal liver cells [2] - The study suggests further evaluation of plogosertib in preclinical and clinical studies for FLC treatment [2] Group 3: Drug Development - Plogosertib is a selective and potent PLK1 inhibitor that has shown efficacy in human tumor xenografts at non-toxic doses [7] - Initial Phase 1 clinical study data indicate that plogosertib is well tolerated with no dose-limiting toxicity observed [8] - Cyclacel's strategy includes developing plogosertib for various solid tumors and hematological malignancies, with a focus on cancers associated with DNAJ-PKAc fusions [10]

Core Viewpoint - Cyclacel Pharmaceuticals, Inc. is implementing a 1-for-15 reverse stock split effective July 7, 2025, to enhance its stock price and maintain compliance with Nasdaq listing requirements [1][3]. Company Overview - Cyclacel is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [4]. - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies as part of its epigenetic/anti-mitotic program [4]. - Cyclacel aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates targeting oncology and hematology indications [4]. Reverse Stock Split Details - The reverse stock split will convert every 15 shares of common stock into one share, with no fractional shares issued; any fractions will be rounded to the nearest whole number [2]. - The board of directors and stockholders approved the reverse stock split, which will reduce the number of shares from 23,759,475 to 1,583,965 [3]. - The new CUSIP number for the shares post-split will be 23254L876, and trading will continue under the symbol "CYCC" on The Nasdaq Capital Market [1][3].

Core Viewpoint - Cyclacel Pharmaceuticals has successfully completed a private placement of its convertible Series F Preferred Stock, raising gross proceeds of $3.0 million, which will be utilized for working capital and general corporate purposes [1][2]. Group 1: Financing Details - The private placement involved the issuance of convertible Series F Preferred Stock and warrants to purchase a total of 9,810,000 shares of common stock at varying exercise prices of $0.51, $0.60, and $0.68 per share [1]. - The offering closed on June 20, 2025, and the warrants will expire five years from the date of issuance [1]. - Each share of Preferred Stock is convertible into 3.27 shares of Common Stock, subject to stockholder approval as per Nasdaq listing rules [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and general corporate purposes, which, along with existing cash, is expected to extend the company's cash runway into the third quarter of 2025 [2]. Group 3: Regulatory and Legal Aspects - The securities issued in the private placement have not been registered under the Securities Act of 1933 and were sold in reliance on Regulation S [4]. - The offering was conducted directly to investors without the involvement of a placement agent, underwriter, broker, or dealer [4]. Group 4: Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines, particularly through its anti-mitotic program, plogosertib, which targets PLK1 in various cancer types [7].

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]

Core Viewpoint - Cyclacel Pharmaceuticals, Inc. will implement a 1-for-16 reverse stock split effective May 12, 2025, with trading to begin on a split-adjusted basis on that day [1][2][3] Group 1: Reverse Stock Split Details - The reverse stock split will convert every 16 shares of common stock into one share, with no fractional shares issued; any resulting fractions will be rounded to the nearest whole number [2] - The board of directors and stockholders approved the reverse stock split, and a Certificate of Amendment will be filed with the Delaware Secretary of State [3] - The number of shares issued and outstanding will decrease from 356,357,531 to 22,272,346 post-split [3] Group 2: Company Overview - Cyclacel is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [4] - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies as part of its epigenetic/anti-mitotic program [4] - Cyclacel aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates targeting oncology and hematology indications [4]