On August 10, 2016 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 financial results and business highlights for the second quarter ended June 30, 2016 (Press release, Cyclacel, AUG 10, 2016, View Source [SID:1234514462]).

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The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2016 was $3.0 million, or $1.01 per basic and diluted share, compared to net loss applicable to common shareholders of $3.4 million, or $1.19 per basic and diluted share for the second quarter ended June 30, 2015. As of June 30, 2016, cash and cash equivalents totaled $15.9 million.

"Subsequent to the end of the quarter, we achieved a key milestone in our acute myeloid leukemia (AML) SEAMLESS Phase 3 study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The required number of events has been reached and preparations for final analysis and reporting of SEAMLESS outcomes are underway. Over the next several weeks, we will complete data cleaning and validation operations after which the database will be transferred to our statistical analysis vendor. We will subsequently report outcomes for the primary (overall survival) and secondary endpoints and determination of submissibility of the SEAMLESS data set to regulatory authorities in Europe and the United States.

In our DNA damage response program, durable antitumor activity was reported at an oral presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting with a combination of sapacitabine and seliciclib, our CDK2/9 inhibitor, in heavily pretreated patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. A disease control rate of 35.6% was observed, with ongoing responding patients achieving treatment durations exceeding 1 and 4.7 years, respectively. We continue to enroll patients with solid tumors in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor."

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit or refused intensive chemotherapy, reached the number of events required for final analysis.
Preparations are underway for final analysis of study data.
DNA damage response program

Oral presentation of data at 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Phase 1 combination of sapacitabine and seliciclib as orally-administered treatment in 67 heavily-pretreated patients. Antitumor activity in subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. Disease control rate of 35.6% (1 CR, 5 PR and 10 SD). No CR or PR observed in BRCA negative patients.
Ongoing extension cohort in BRCA positive patients with breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors and lymphomas.
Corporate

Received notification from the Listing Qualifications Staff of NASDAQ that the Company regained compliance with the minimum bid price rule for continued listing on The NASDAQ Capital Market.
Effected a one-for-twelve reverse stock split of the Company’s outstanding shares of common stock.
Entered into an At Market Issuance Sales Agreement with FBR Capital Markets & Co. under which the Company may, from time to time, sell shares of the Company’s common stock.
Terminated Controlled Equity OfferingSM sales agreement with Cantor Fitzgerald & Co.
KEY UPCOMING MILESTONES

SEAMLESS study

Study database locked in preparation for final data analysis.
Report top-line data and determination of submissibility to regulatory authorities, anticipated in the fourth quarter 2016.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Plan to add Phase 1, part 3 to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS):

Plan a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
SECOND QUARTER 2016 FINANCIAL RESULTS

Grant Revenue

Revenue for the three months ended June 30, 2016 was $0.2 million, compared to $0.3 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2016 and $2.6 million for the three months ended June 30, 2015.

General and Administrative Expenses

General and administrative expenses were $1.3 million for the three months ended June 30, 2016 and $1.3 million for the three months ended June 30, 2015.

Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the first quarter of 2018.