On August 11, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the second quarter ended June 30, 2015 (Filing, 8-K, Cyclacel, AUG 11, 2015, View Source [SID:1234507208]).

The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2015 was $3.4 million, or $0.10 per basic and diluted share, compared to a net loss income applicable to common shareholders of $4.9 million, or $0.22 per basic and diluted share for the second quarter ended June 30, 2014. As of June 30, 2015, cash and cash equivalents totaled $26.9 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 13% of events remaining to occur and we expect to report top-line data during the second half of 2015 through the first half of 2016. Following unblinding and analysis of the SEAMLESS data, we will determine their suitability for submission to regulators in the U.S. and Europe. Additionally, in the Phase 1 study of our all-oral combination of sapacitabine with our first-generation CDK2/9 inhibitor, seliciclib, we reported updated data in heavily pretreated cancer patients with BRCA mutations. The data showed a 55% overall response rate with patients achieving durable benefit after multiple cycles of therapy, including a breast cancer patient who has received to date over 60 cycles. These promising data are encouraging us to explore this regimen further. Our next generation CDK2/9 inhibitor, CYC065, received institutional review board approval for a first-in-human, Phase 1 study in advanced solid tumors and we expect to start treating patients shortly. CYC065 has demonstrated increased potency compared to seliciclib. Based on published preclinical efficacy data, we plan to develop CYC065 as a targeted anticancer agent in both hematological and solid cancers. In addition to our focus on SEAMLESS, we have continued to make progress with our other programs, while ensuring we have sufficient resources to deliver on our key milestones and execute on our business strategy."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

· Continued to follow-up patients as 13% of events remain to occur before analyzing the data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.

Sapacitabine and seliciclib, all-oral combination in Phase 1 study in patients with advanced solid tumors

· Observed an overall response rate of 55% in breast, ovarian and pancreatic patients with BRCA mutations in updated data from this study of heavily pre-treated patients.

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Cyclin Dependent Kinase (CDK) Inhibitor Programs

· Received institutional review board approval to start a first-in-human Phase 1 trial of CYC065, the Company’s second generation CDK2/9 inhibitor, in solid tumor patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065.
· Presented preclinical data demonstrating therapeutic potential of CYC065 as a targeted anticancer agent at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2015. The data show that CYC065 may reverse drug resistance associated with addiction of cancer cells to cyclin E, the partner protein of CDK2. CYC065 may also inhibit CDK9-dependent oncogenic and leukemogenic pathways, including malignancies driven by certain oncogene and MLL rearrangements. MLL gene status and levels of Bcl-2 family proteins correlated with sensitivity of AML cell lines to CYC065. CYC065’s anticancer activity presents an opportunity for patient stratification and combinations with anti-leukemic agents. CYC065 was also effective against uterine cancer cells including those resistant to chemotherapy and was especially potent in uterine cancer cells in which cyclin E was amplified or overexpressed.
· Entered into a license and supply agreement with ManRos Therapeutics regarding the development of seliciclib, the Company’s first generation CDK inhibitor, in cystic fibrosis.
· Dosed first patient in Phase 2 investigator sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

Other Events

· Entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., as sales agent ("Cantor"), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor.
· Transferred the listing of the Company’s common stock from the NASDAQ Global Market to the NASDAQ Capital Market effective at the opening of business on August 6, 2015. The Company’s common stock will continue to trade under the symbol "CYCC." The Company currently meets the NASDAQ Capital Market initial listing criteria, except for the bid price requirement. With the transfer to the NASDAQ Capital Market, the Company is being afforded an additional 180-day grace period to regain compliance with NASDAQ’s minimum bid price requirement of a stock price of at least $1.00 for at least ten consecutive business days during this grace period ending on February 2, 2016 or be delisted.

Second Quarter 2015 Financial Results

Grant Revenue

Revenue for the three months ended June 30, 2015, was $0.3 million compared to $0.4 million for the same period of the previous year. The revenue is related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2015, compared to $4.5 million for the same period in the previous year. The decrease was primarily a result of reduced expenditure in the SEAMLESS Phase 3 study this quarter compared to the same period last year.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2015 remained relatively flat at $1.3 million compared to $1.4 million for the same period in 2014.