Key Developments For Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc. (CYCC.O) (Consolidated Issue listed on NASDAQ Global Market)
Cyclacel Pharmaceuticals, Inc. Announces Survival Data From Phase 2 Sapacitabine Study in Elderly Patients With Acute Myeloid Leukemia
Cyclacel Pharmaceuticals, Inc. announced topline survival data for the primary endpoint of the Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 or older with either newly diagnosed acute myeloid leukemia (AML) or AML in first relapse. The study was a three-arm randomized trial evaluating three dosing schedules of sapacitabine. The primary endpoint of 1-year survival is approximately 30% each on two out of the three schedules tested. Details of the results from this study will be presented at an upcoming medical conference. Survival in elderly patients aged 70 or older with newly diagnosed AML remains poor. A recent, randomized study comparing tipifarnib, an investigational drug with a different mechanism to sapacitabine, with best supportive care in this population reported 1-year survival of 15% for the tipifarnib arm and 18% for the best supportive care arm (Harousseau JL, et al, Blood, 2009 01:19:8093).
Cyclacel Pharmaceuticals, Inc. Completes Previously Announced Registered Direct Offering
Cyclacel Pharmaceuticals, Inc. announced that it completed its previously announced registered direct offering through the sale of shares of its common stock and warrants for gross proceeds of $3.4 million, before deducting placement agent fees and offering expenses, in a registered direct offering with select institutional investors led by Special Situations Fund. The offer included the sale and issuance of 4.0 million units, at a purchase price of $0.85 per unit, with each unit consisting of one share of the Company's common stock, a five-year warrant to purchase 0.18 shares of common stock, at an exercise price of $1.00 per share, exercisable beginning six months after the date of issuance, and a seven-month warrant to purchase 0.625 shares of common stock, at an exercise price of $1.00 per share, exercisable beginning six months after the date of issuance. If fully exercised, the seven-month warrants would produce additional gross proceeds of $2.5 million. In the aggregate, the warrants represent the right to acquire 3,235,522 shares of common stock, with 2,500,000 representing the seven-month warrants and the remaining 735,522 representing the five-year warrants. Lazard Capital Markets LLC served as the sole placement agent for the offering.
Cyclacel Pharmaceuticals, Inc. To Raise Up To $5.9 Million In Registered Direct Offering
Cyclacel Pharmaceuticals, Inc. announced that it has entered into definitive agreements to raise $3.4 million in gross proceeds, before deducting placement agent fees and other estimated offering expenses, and up to an additional $2.5 million, in a registered direct offering with select institutional investors led by Special Situations Fund. The offering includes the sale and issuance of 4.0 million units, each unit consisting of one share of the Company's common stock and a warrant to purchase 0.18 shares of common stock, at a purchase price of $0.85 per unit. The warrants, which represent the right to acquire an aggregate of 735,522 shares of common stock at an exercise price of $1.00 per share, have a five-year term from the date of issuance and are exercisable beginning six months after the date of issuance. The investors will also receive a second warrant giving them the option to purchase an additional 2,500,000 shares at a price per share of $1.00 during a period beginning six months after the date of issuance and ending seven months after the date of issuance. Lazard Capital Markets LLC served as the sole placement agent for the offering. Merriman Curhan Ford served as financial advisor. The sale is expected to close on or about July 29, 2009.
Cyclacel Pharmaceuticals, Inc. Announces Phase 2 Sapacitabine Data In Patients With Acute Myeloid Leukemia And Myelodysplastic Syndromes
Cyclacel Pharmaceuticals, Inc. announced interim data from a Phase 2 randomized clinical trial of oral sapacitabine (CYC682), a nucleoside analog, in elderly patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The data demonstrated that oral sapacitabine is active in AML across all three dosing schedules tested and that prolonged administration is feasible in the outpatient setting. Activity was also observed in the ongoing MDS stratum of the study. Based on the data, the Company intends to use the three day dosing schedule for further clinical development in elderly AML and will discuss with the FDA the design of a pivotal study in elderly patients with AML expected to commence in 2009. The Phase 2 study rapidly enrolled during 2008 a total of 60 patients aged 70 years or above with untreated or first relapse AML and randomized them to one of three dosing schedules. In the three-day dosing schedule, a response rate of 35% (7/20 patients) was observed of which 25% (5/20 patients) achieved CR. The median number of treatment cycles in responders currently exceeds nine with five of seven responders still on treatment. The majority of the responders had unfavorable cytogenetics. In the ongoing MDS stratum thus far 31 patients aged above 60 years have been treated with sapacitabine as second line therapy following treatment with hypomethylating agents. Complete remission and hematological improvement have been observed in 7 patients.
Cyclacel Pharmaceuticals, Inc. Announces Suspension Of Quarterly Dividend On 6% Convertible Exchangeable Preferred Stock
Cyclacel Pharmaceuticals, Inc. announced that its Board of Directors passed a resolution to suspend payment of but continue to accrue the quarterly cash dividend on the Company's 6% Convertible Exchangeable Preferred Stock. Following this measure, along with previously announced reductions in expenditure, the Company projects its cash resources are sufficient to fund operations into the second quarter of 2010. The Board of Directors will continue to evaluate the payment of a quarterly cash dividend on a quarterly basis.
