On November 13, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the third quarter 2018 (Press release, Cyclacel, NOV 13, 2018, View Source [SID1234531427]). The Company’s net loss applicable to common shareholders for the three months ended September 30, 2018 was $2.1 million. As of September 30, 2018, cash and cash equivalents totaled $19.0 million.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We continue to execute on our strategy to rapidly develop CYC065 and CYC140 in hematological malignancies and CYC065 in advanced solid tumors," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The Phase 1 study evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and the CYC140 first-in-human study are open for enrollment. Two further protocols evaluating combinations of CYC065 and sapacitabine are in development. Our alliance with MD Anderson allows us to parallel track the development of our drugs in a cash-sparing manner while utilizing MD Anderson’s expertise to recruit patients across four studies. We estimate that our cash resources will be sufficient to fund operations until the second quarter of 2020. We are also pleased to report that the IST evaluating sapacitabine and olaparib in BRCA positive patients with breast cancer has started to enroll."
Key Company Highlights
·Announced a three-year strategic alliance agreement with The University of Texas MD Anderson Cancer Center enabling clinical evaluation of three Cyclacel medicines in patients with hematological malignancies. MD Anderson will conduct four clinical studies, with a total projected enrollment ofpatients, investigating CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs.
·Opened for enrollment the Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at AACR (Free AACR Whitepaper) 2018 showed enhanced activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination also demonstrated activity in two CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.
·First patient dosed in the Phase 1b/2 investigator-sponsored trial (IST) of sapacitabine with olaparib, an approved PARP inhibitor, in BRCA positive patients with breast cancer. Preclinical data support the hypothesis that dual targeting of the DNA damage response pathway by combining olaparib with sapacitabine may enhance the efficacy of standard of care treatment for BRCA positive patients with breast cancer.
·Activated the CYC140 first-in-human study in advanced leukemias. CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from other PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses.
þ 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466
¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067
www.cyclacel.com – [email protected]
·Progressed patient enrollment in part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced solid tumors including those with Mcl-1, MYC or cyclin E amplified cancers relevant to CYC065’s mechanism of action. Part 2 is evaluating increased dosing frequency of two days per week for two weeks of a three-week cycle.
·Completed meetings with three European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The regulators provided consistent guidance on next steps and Cyclacel is evaluating a potential request for a meeting with the Scientific Advice Working Party of the European Medicines Agency.
·Appointed Robert J. Spiegel, M.D. to the Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds.
·Entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to $5.0 million by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933 as amended.
Financial Highlights
As of September 30, 2018, cash and cash equivalents totaled $19.0 million compared to $23.9 million as of December 31, 2017. The decrease of $4.9 million in the nine-months was primarily due to net cash used in operating activities, including $1.2 million of R&D tax credit received from the United Kingdom government.
Research and development expenses were $1.2 million for the three months ended September 30, 2018 compared to $1.0 million for the same period in 2017.
General and administrative expenses were $1.3 million for the three months ended September 30, 2018 compared to $1.2 million for the same period in 2017.
Other income, net for the three months ended September 30, 2018 was $0.1 million compared to $36,000 for the same period of the previous year.
The United Kingdom R&D and tax credits were $0.3 million for the three months ended September 30, 2018 compared to $0.2 million for the same period in 2017.
Net loss for the three months ended September 30, 2018 was $2.1 million compared to $1.9 million for the same period in 2017. With the cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $19.0 million as of September 30, 2018, will be sufficient to finance operations until the second quarter of 2020.
Conference call information:
US/Canada call: (877) 493-9121 / international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
Code for live and archived conference call is 3775807
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.