On May 12, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the first quarter 2021 and business highlights, including an update on its progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively (Press release, Cyclacel, MAY 12, 2021, View Source [SID1234579849]).
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"During the quarter, we have made significant progress in bringing our two oral targeted development candidates into mid-stage clinical development. Following recent FDA authorization of our IND for oral fadraciclib, we will finalize contract discussions with sites and open our multi-cohort Phase 1b/2 study in patients with solid tumors," said Spiro Rombotis, President and Chief Executive Officer. "We believe fadraciclib is establishing a strong position among compounds in clinical development that specifically address cancer resistance mechanisms, including suppression of MCL1, MYC and cyclin E. A recent publication identified potential utility of CDK9 inhibitors in KRAS mutant colorectal cancer, one of the tumor types in our study. Together with our oral CYC140 PLK1 inhibitor program, which has shown in preclinical models that KRAS mutant cancers are sensitive to CYC140 inhibition, we hope to provide valuable alternatives to patients with these difficult to treat malignancies. After strengthening our balance sheet in the quarter, we are executing a precision medicine strategy to achieve multiple milestones and data read outs over the next two years."
Key Corporate Highlights
CYC065-101 Phase 1b/2 oral fadraciclib in advanced solid tumors – announced that the U.S. Food & Drug Administration (FDA) has authorized Cyclacel’s Investigational New Drug (IND) application for oral fadraciclib to proceed. This Phase 1b/2 registration-directed trial includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and cyclin E amplified cancers. The cohorts include breast, colorectal (including KRAS mutant), endometrial/uterine, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology.
A recent publication by researchers led by Frank McCormick, PhD of University of California San Francisco and NCI’s Frederick National Lab for Cancer Research reported that overactive KRAS mutants are impeded by CDK9 inhibition1. These data expand on previous findings, which show that dual CDK2/9 inhibition is an optimal strategy to treat colorectal cancer2, that KRAS mutant pancreatic cancer is sensitive to CDK9 inhibition3, and that fadraciclib showed efficacy against KRAS mutant lung cancer in preclinical PDX models4. Collectively these publications suggest the potential for the therapeutic use of fadraciclib in KRAS-mutated cancers, including colorectal, lung and pancreatic.
CYC140 PLK1 inhibitor program – commenced IND-directed activities and manufacturing of clinical trial supplies for oral CYC140. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition.
Phase 1b/2 Investigator Sponsored Trial (IST) of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer – investigators reported that out of 9 patients enrolled, 5 have achieved partial response (PR), 3 stable disease (SD), and one patient has progressed.
Announced the closing of an underwritten public offering for net proceeds to the Company of approximately $13.5 million, after deducting placement agent fees and other offering expenses. Existing and new institutional investors participated in the offering. In addition, the Company received approximately $4.5 million in the quarter through warrant exercises.
Key Near-Term Business Objectives and Expected Timeline
1H 2021
First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor study
2H 2021
First patient dosed with oral fadraciclib in Phase 1b/2 leukemia study
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
1H 2022
First patient dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor study
Update data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
Financial Highlights
As of March 31, 2021, cash and cash equivalents totaled $47.8 million, compared to $33.4 million as of December 31, 2020. The increase of $14.4 million was primarily due to $18.0 million of net cash provided by financing activities, offset by net cash used in operating activities of $3.6 million. There were no revenues for each of the three months ended March 31, 2021 and 2020.
Research and development expenses were $2.6 million for the three months ended March 31, 2021 as compared to $1.1 million for the same period in 2020. Research and development expenses relating to the CDK inhibitor program increased by approximately $0.8 million for the three months ended March 31, 2021 as clinical evaluation of fadraciclib is progressing.
General and administrative expenses for the three months ended March 31, 2021 were $1.7 million, compared to $1.3 million for the same period of the previous year due to an increase in legal and professional expenses and recruitment costs.
Total other income, net, for the three months ended March 31, 2021 was $0.1 million, compared to $0.9 million for the same period of the previous year. The decrease of $0.8 million for the three months ended March 31, 2021 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.
United Kingdom research & development tax credits were $0.7 million for the three months ended March 31, 2021, as compared to $0.3 million for the same period in 2020 as a direct consequence of increased qualifying research and development expenditure.
Net loss for the three months ended March 31, 2021 was $3.5 million, compared to $1.2 million for the same period in 2020.
The Company raised net proceeds of approximately $13.5 million from an equity financing in March 2021. The Company also received an additional $4.5 million of proceeds from warrant exercises.
The Company estimates that cash resources of $47.8 million as of March 31, 2021 will fund currently planned programs through early 2023.