On August 9, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, reported its financial results and business highlights for the second quarter ended June 30, 2017 (Press release, Cyclacel, AUG 9, 2017, View Source [SID1234520114]). Schedule your 30 min Free 1stOncology Demo! The Company’s net loss applicable to common shareholders for the three months ended June 30, 2017 was $2.2 million or $0.50 per share, compared to net loss applicable to common shareholders of $3.0 million, or $1.01 per share for the second quarter of 2016. As of June 30, 2017, cash and cash equivalents totaled $13.6 million. Pro forma cash and cash equivalents as of June 30, 2017 totaled $27.4 million after including $13.8 million in proceeds, net of expenses, received in the Company’s underwritten offering completed on July 21, 2017.
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"As a result of the completion of our recent offering, in which existing and new investors participated, we are able to advance the clinical investigation of CYC065, our Cyclin Dependent Kinase (CDK) 2/9 inhibitor, in selected, molecularly-defined patient populations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We have selected a recommended Phase 2 dose for CYC065 from part 1 of a dose-escalating, Phase 1, first-in-human, study of CYC065. Data from this study evidenced durable target engagement and Mcl-1 biomarker suppression at well tolerated doses with initial evidence of anticancer activity in patients with Mcl-1 and/or cyclin E overexpression or amplification. Our top priority is to finalize designs for a Phase 1/2 study testing CYC065 in combination with venetoclax, a Bcl-2 inhibitor approved for chronic lymphocytic leukemia, an indication in which we believe Mcl-1 suppression may be beneficial. In parallel, we will enroll a new part 2 of the Phase 1 study in patients with advanced solid tumors testing additional dosing schedules. We look forward to reporting our progress, commencement of these studies and data, as they arise."
Business Highlights
Transcriptional Regulation Program: CYC065 CDK inhibitor
Selected a recommended Phase 2 dose (RP2D) from part 1 of a dose-escalating, Phase 1, first-in-human, clinical study. RP2D was determined at dosing level 6, which enrolled 10 patients with advanced cancers. Prolonged reduction of the Mcl-1 biomarker was observed in 7 out of 9 evaluable patients for at least 24 hours following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in three patients with Mcl-1, MYC and Mcl-1/cyclin E amplified cancers. The trial is being conducted at the Dana Farber Cancer Institute in Boston.
Part 2 of the study will enroll patients with advanced solid tumors, in particular cyclin E amplified tumors. Such tumors include subsets of high grade serous ovarian and uterine cancers. Part 2 will evaluate CYC065 in a more intensive schedule for 2 days per week, for 2 weeks of a three-week cycle. Biospecimens will be collected for assessment of biomarkers related to CYC065’s mechanism of action.
SEAMLESS Study
An abstract of the results of the Phase 3 study of oral sapacitabine in elderly patients with acute myeloid leukemia (AML) has been submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper), and if accepted, will be the subject of an oral or poster presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting to be held December 9 – 12, 2017.
July Underwritten Offering
On July 21, 2017, the Company announced the closing of an underwritten offering, with net proceeds of approximately $13.8 million after deducting underwriting discounts and commissions and other estimated offering expenses, including full exercise of the underwriters’ overallotment option. The Company issued and sold in the offering (i) 3,154,000 Class A Units, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock, and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock convertible into 500 shares of common stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000 divided by the conversion price. The price to the public in the offering was $2.00 per Class A Unit and $1,000 per Class B Unit.
Subsequent to the closing of the offering, holders of 7,613 (86%) shares out of 8,872 shares outstanding of Series A Preferred Stock elected to convert their shares into 3,806,500 shares of common stock. Following such conversions, 11,400,447 shares of common stock and 1,259 (14%) shares of Series A Preferred Stock remain outstanding as of August 8, 2017.
Financial Highlights
As of June 30, 2017, cash and cash equivalents totaled $13.6 million, compared to $16.5 million on December 31, 2016. After the July offering, pro forma cash and cash equivalents are $27.4 million.
Revenue for the three months ended June 30, 2017 were $0 compared to $0.2 million for the same period of the previous year. Revenue is primarily related to previously awarded grants from the UK government being recognized over the period to progress IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November 2016.
Research and development expenses were $1.2 million compared to $2.6 million for the same period in 2016. The decrease was primarily due to reduced study and clinical supply costs associated with completion of the SEAMLESS study and completion of preclinical development of CYC140.
General and administrative expenses for the three months ended June 30, 2016 and 2017 remained flat at $1.3 million.
Other income (expense), net for the three months ended June 30, 2017 was $34,000, compared to $0.2 million for the same period of the previous year. The decrease in other income (expense) is primarily related to foreign exchange movements.
The UK government research & development tax credit for the quarter was $0.3 million, compared to $0.6 million for the same period of the previous year. During the quarter, we also recognized cash received for the 2016 tax credit of $1.8 million.
Net loss for the three months June 30, 2017 was $2.2 million compared to $3.0 million for the same period in 2016.