- The stock price of Cyclacel Pharmaceuticals (CYCC) surged by over 30% pre-market today. This is why.
The stock price of Cyclacel Pharmaceuticals (CYCC) surged by over 30% pre-market today. Investors are responding to the company’s second-quarter results. Cyclacel had reported a Q2 EPS of ($0.46), which was $0.08 higher than analyst estimates of ($0.54).
— As of June 30, 2022, cash and cash equivalents totaled $29.1 million, compared to $36.6 million as of December 31, 2021. Net cash used in operating activities was $8.7 million for the six months ended June 30, 2022 compared to $7.8 million for the same period of 2021. The Company estimates that its available cash will fund currently planned programs into the second half of 2023.
— Research and development (R&D) expenses were $4.2 million for the three months ended June 30, 2022, as compared to $4.1 million for the same period in 2021. R&D expenses relating to fadraciclib were $2.6 million for the three months ended June 30, 2022, as compared to $2.8 million for the same period in 2021 due to increased clinical trial costs of $0.5 million associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies offset by a reduction of $0.7 million in non-clinical expenditures. R&D expenses related to CYC140 were $1.5 million for the three months ended June 30, 2022, as compared to $1.1 million for the same period in 2021 due to clinical trial costs associated with the start of the CYC140 Phase 1/2 study.
— General and administrative expenses for the three months ended June 30, 2022, were $1.6 million, compared to $2.0 million for the same period of the previous year due to a decrease in facilities, professional and recruitment costs
— Total other income, net, for the three months ended June 30, 2022, was $0.2 million, compared to $9,000 for the same period of the previous year. The increase of $0.2 million for the three months ended June 30, 2022, is primarily related to foreign exchange gains.
— United Kingdom research & development tax credits were $1.0 million for each of the three months ended June 30, 2022 and June 30, 2021 and are directly correlated to qualifying research and development expenditure. Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were received in April 2022.
— Net loss for the three months ended June 30, 2022, was $4.6 million, compared to $5.1 million for the same period in 2021.
“In the first half of 2022 we have established that oral fadraciclib, our CDK2 and CDK9 inhibitor, is well-tolerated and demonstrated single-agent, anticancer activity across multiple solid tumor and lymphoma patients in our 065-101 study. In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2 dose (RP2D). We then anticipate advancing into Phase 2 proof of concept stage of 065-101. We believe that daily dosing of oral fadraciclib targeting both CDK2 and CDK9 at efficacious doses without dose limiting toxicities may represent best-in-class properties. We look forward to reporting additional clinical and preclinical data at our upcoming R&D Day for both fadraciclib and CYC140, our differentiated PLK1 inhibitor, also in a Phase 1/2 study.”
— Spiro Rombotis, President and Chief Executive Officer of Cyclacel
“We are excited with the progress of oral fadraciclib in our Phase 1/2 solid tumor and lymphoma study because of the promising safety and early efficacy results we are seeing in a challenging Phase 1 population. As fadraciclib has been relatively well tolerated, 065-101 principal investigators agreed to continue dose escalation with the current 4-week schedule. Following Food and Drug Administration (FDA) clearance of a protocol amendment, we are recruiting patients at the sixth dose level of 065-101. We have previously observed partial response and anticancer activity including tumor shrinkage in endometrial, lymphoma and pancreatic cancer patients. In parallel we are determining which tumor types to prioritize for the Phase 2 stage of 065-101 informed by preclinical modeling and data from our clinical collaborators. The 065-102 study of fadraciclib in advanced leukemias continues to enroll at the 100mg twice a day dose level after clearance of a protocol amendment that allowed us to skip two dose levels. We are also encouraged that the 140-101 dose escalation study of CYC140 is now recruiting patients with solid tumors and lymphomas for the second dose level.”
— Mark Kirschbaum, M.D., Chief Medical Officer of Cyclacel