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Cyclacel Pharmaceuticals Inc., located in London, UK, is a clinical-stage biopharmaceutical company focused on developing targeted medicines for cancer and other proliferative diseases. Specializing in CDK and PLK inhibitors, Cyclacel is dedicated to advancing pipeline programs like fadraciclib, Sapacitabine, and plogosertib to combat cancer effectively.
Cyclacel Pharmaceuticals (NASDAQ: CYCC) announced it is exploring strategic alternatives to preserve cash, including a potential transaction with investor David Lazar of Activist Investing, , subject to existing securityholder consent. The company's Board is reviewing strategies to realize value from assets and has directed management to reduce operating costs.
The company currently does not meet Nasdaq's continued listing requirements and faces potential delisting if compliance is not regained. Without securing a strategic transaction or additional funding, Cyclacel may be forced to cease operations, potentially resulting in stockholders losing part or all of their investment.
Cyclacel Pharmaceuticals announced the closing of a warrant exercise transaction, raising $2.1 million in gross proceeds. The company facilitated the exercise of existing warrants for 4,968,945 shares at a reduced price of $0.415 per share, down from the original $1.36. In exchange, Cyclacel issued new unregistered Series C and D warrants, each for 9,937,890 shares at $0.415 per share. The Series C warrants have a 5.5-year term, while Series D warrants expire in 18 months, both pending stockholder approval. The proceeds will be used for working capital and general corporate purposes.
Cyclacel Pharmaceuticals has entered into an agreement for the exercise of existing warrants to purchase 4,968,945 shares of common stock at a reduced price of $0.415 per share, down from the original $1.36. The company will issue new unregistered Series C and D warrants, each allowing purchase of up to 9,937,890 shares at $0.415 per share. The transaction is expected to generate $2.1 million in gross proceeds, which will be used for working capital and general corporate purposes. H.C. Wainwright & Co. serves as the exclusive placement agent.
Cyclacel Pharmaceuticals reported Q3 2024 financial results, highlighting initial safety and efficacy data from twelve patients in Phase 2 study of fadraciclib. Cash equivalents were $3.0 million as of September 30, 2024, down from $3.4 million at end-2023. Net loss decreased to $2.0 million from $6.0 million year-over-year. R&D expenses reduced to $1.0 million from $5.2 million in Q3 2023. The company faces potential Nasdaq delisting unless it meets minimum stockholders' equity requirement by December 24, 2024. Current cash is expected to fund operations into Q4 2024, with substantial doubt about continuing as a going concern.
Cyclacel Pharmaceuticals presented interim Phase 2 data for fadraciclib (fadra) monotherapy in advanced solid tumor patients with CDKN2A/B abnormalities at the 2024 EORTC-NCI-AACR Symposium. The study enrolled 12 patients in Cohort 8, with various cancer types including pancreatic, melanoma, and others. Out of six evaluable patients, two achieved stable disease: a melanoma patient (125 days treatment) and a squamous cell CUP patient with 11% tumor shrinkage (85+ days, ongoing). The drug showed good tolerability with no Grade 3 or higher adverse events. Two additional patients are ongoing but await first scans.
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) has announced that initial safety and efficacy data from its Phase 2 study of oral fadraciclib will be presented at the 2024 AACR-NCI-EORTC 36th Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain (October 23-25, 2024). The data comes from twelve patients with advanced solid tumors enrolled in Cohort 8 of the proof of concept study, who were preselected for CDKN2A and/or CDKN2B abnormalities.
The presentation, titled 'Fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma with CDKN2A and/or CDKN2B genetic alterations', will be displayed as a poster on October 23, 2024, from 12:00 p.m. to 7:00 p.m. CEST. This study is part of Cyclacel's efforts in developing innovative cancer medicines.
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) has completed enrollment of 12 patients in Cohort 8 of its Phase 2 study (065-101) of fadraciclib, a CDK2/9 inhibitor, for advanced solid tumors and lymphoma. This cohort focuses on patients with CDKN2A and/or CDKN2B abnormalities. Enrollment took approximately six months, highlighting the unmet medical need for this patient group.
The company reported stable disease and tumor shrinkage in a Phase 2 squamous cell cancer patient after two cycles of oral fadraciclib. Previously, a Phase 1 patient with squamous non-small cell lung cancer and CDKN2A/B abnormalities achieved a 22% reduction in tumor burden at 4 weeks.
Updated safety and efficacy data from the study will be presented at the upcoming 36th EORTC-NCI-AACR Symposium (ENA 2024, October 23-25, 2024). The Phase 2 study includes 8 cohorts, with Cohort 8 specifically targeting CDKN2A/B abnormalities, which occur frequently in various solid tumors.
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP), a biopharmaceutical company focused on developing innovative cancer medicines, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024, both virtually and in-person at the Lotte New York Palace Hotel in New York City.
Spiro Rombotis, President & CEO of Cyclacel, will present an overview of the company's business during the conference. Institutional investors can register for the event through the provided link or access the presentation via Cyclacel's investor relations website. The virtual presentations will be available on-demand starting September 9 at 7:00 A.M. (ET).
Cyclacel Pharmaceuticals (NASDAQ: CYCC) has filed an appeal against Nasdaq's delisting letter and requested a hearing before the Nasdaq Hearings Panel, scheduled for October 15, 2024. This action automatically stays any suspension or delisting pending the Panel's decision. The company was found non-compliant with Nasdaq Listing Rule 5550(b)(1) on August 26, 2024, as it reported stockholders' equity below $2.5 million as of June 30, 2024. At the hearing, Cyclacel will present its plan to regain and sustain compliance with the Equity Rule. However, there's no guarantee that the hearing will be successful or that the company will meet continued listing criteria if allowed to remain listed.
Cyclacel Pharmaceuticals (NASDAQ: CYCC) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. The Phase 2 stage of the 065-101 study for oral fadraciclib is enrolling well, with interim data expected in Q4 2024.
2. Cash equivalents totaled $6.0 million as of June 30, 2024.
3. R&D expenses decreased to $2.0 million in Q2 2024 from $4.7 million in Q2 2023.
4. Net loss for Q2 2024 was $3.3 million, compared to $5.5 million in Q2 2023.
5. The company estimates its current cash resources will fund planned programs into Q4 2024.
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