Key aspects of the Purchase Agreement include:
- Cyclacel will control the timing and amount of any sales of common stock to Aspire and will know the sales price before directing Aspire to purchase shares;
- Aspire has no right to require any sales by the Company, but is obligated to make purchases as the Company directs, in accordance with the terms of the Purchase Agreement;
- There are no limitations on use of proceeds, financial covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement;
- The Purchase Agreement may be terminated by Cyclacel at any time, at its discretion, without any additional cost or penalty; and
- Cyclacel has issued to Aspire Capital 74,548 common shares as consideration for entering into the purchase agreement.
Cyclacel will use the net proceeds from the sales of common stock to advance development of the Company's pipeline, including SEAMLESS, the ongoing Phase 3 trial evaluating sapacitabine as a potential treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML), and also Phase 2 trials in patients with myelodysplastic syndromes (MDS) and solid tumors. Cyclacel recently reported encouraging survival data from the pilot/lead-in stage of SEAMLESS and a Phase 2 trial of sapacitabine in patients with MDS failing front-line therapy.
A more complete and detailed description of the transaction is set forth in the Company's Current Report on Form 8-K, filed today with the U.S. Securities and Exchange Commission.
About Cyclacel Pharmaceuticals, Inc.Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. The Company's most advanced oral product candidate, sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment of acute myeloid leukemia (AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's pipeline includes seliciclib, a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1 in combination with sapacitabine; and CYC065, a second generation CDK inhibitor, in IND-directed development. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information. About Sapacitabine Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. Sapacitabine is also the subject of Phase 2 trials in patients with hematological malignancies, including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia and small lymphocytic lymphoma, and non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with seliciclib in patients with advanced solid tumors. Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination DNA repair (HRR) pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.
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