Cyclacel Pharmaceuticals Reports First Quarter 2021 Financial Results
May 12 2021
- Announces IND Authorization by FDA for Fadraciclib, a CDK2/9 Inhibitor, in Solid Tumors -
- Recent Publication Reported that Overactive KRAS Mutants are Impeded by CDK9 Inhibition -
- Following Recent Financing, Cash Runway Extended to Early 2023 -
- Conference Call Scheduled
“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
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 Franciscoand NCI’s Frederick National Lab for Cancer Researchreported 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 millionin the quarter through warrant exercises.
Key Near-Term Business Objectives and Expected Timeline
- First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor study
- 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
- 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
Research and development expenses were
General and administrative expenses for the three months ended
Total other income, net, for the three months ended
Net loss for the three months ended
The Company raised net proceeds of approximately
The Company estimates that cash resources of
Conference call information:
Conference ID 2763358 Webcast link
US/Canada call: (877) 493-9121 / international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.
2 Somarelli JA, et al, Mol Cancer Ther, 2020 19 2516. DOI: 10.1158/1535-7163.MCT-20-0454.
3 Blake DR, et al, Science Signalling, 2019, https://pubmed.ncbi.nlm.nih.gov/31311847/.
4 Kawakami M, et al J Natl Cancer Inst, 2017 109, https://pubmed.ncbi.nlm.nih.gov/28376145/.
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of
© Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
|Three Months Ended|
|Research and development||1,106||2,566|
|General and administrative||1,318||1,739|
|Total operating expenses||2,424||4,305|
|Other income (expense):|
|Foreign exchange gains (losses)||69||10|
|Other income, net||817||126|
|Total other income (expense), net||914||140|
|Loss before taxes||(1,510||)||(4,165||)|
|Income tax benefit||290||687|
|Dividend on convertible exchangeable preferred shares||(50||)||(50||)|
|Beneficial conversion feature of Series B preferred stock||-||-|
|Net loss applicable to common shareholders||$||(1,270||)||$||(3,528||)|
|Basic and diluted earnings per common share:|
|Net loss per share – basic and diluted||$||(1.48||)||$||(0.50||)|
|Weighted average common shares outstanding||859,998||7,099,037|
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|Cash and cash equivalents||$||33,406||$||47,777|
|Prepaid expenses and other current assets||2,063||2,686|
|Total current assets||35,469||50,463|
|Property and equipment, net||106||173|
|Right-of-use lease asset||1,227||1,181|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other current liabilities||1,972||1,901|
|Total current liabilities||2,486||2,772|
|Total liabilities and stockholders’ equity||$||36,802||$||51,817|