– Dosed First Patient in Phase 1/2 Clinical Trial of CFT7455, a novel IKZF1/3 Degrader, in Hematologic Malignancies; Data Expected in 2022 –
– Received Orphan Drug Designation for CFT7455 for the Treatment of Multiple Myeloma –
– Initiated Investigational New Drug (IND)-Enabling Activities for CFT8919, A Selective Degrader of EGFR L858R –
– Strengthened Balance Sheet with Public Offering Yielding Gross Proceeds of
“In the second quarter, C4T made meaningful progress on our ambitious goals and became a clinical-stage company with the initiation of the CFT7455 Phase 1/2 trial, which has the potential to deliver improved outcomes for patients with hematologic malignancies,” said
SECOND QUARTER 2021 AND RECENT BUSINESS HIGHLIGHTS
CFT7455: CFT7455 is an orally bioavailable MonoDAC™ degrader targeting IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), including peripheral T-cell lymphoma and mantle cell lymphoma.
- Received Orphan Drug Designation: In
August 2021 , theFood and Drug Administration (FDA) granted Orphan Drug Designation to CFT7455 for the treatment of multiple myeloma. - Dosed First Patient in Phase 1/2 Clinical Trial: In
June 2021 , C4T announced the dosing of the first patient in our Phase 1/2 clinical trial of CFT7455 in MM and NHL, including peripheral T-cell lymphoma and mantle cell lymphoma. - Presented at the 16th Annual
International Conference on Malignant Lymphoma : InJune 2021 , C4T presented pre-clinical data demonstrating CFT7455 binds to cereblon with high affinity, thereby inducing potent and deep degradation of IKZF1 in pre-clinical NHL models, and achieved improved in vivo potency and efficacy when compared to approved and investigational IKZF1/3 degraders.
CFT8919: CFT8919 is a potent and mutant-selective BiDAC™ degrader of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).
- Advanced CFT8919 towards Clinical Development: In
May 2021 , C4T announced its decision to advance CFT8919 toward IND-enabling studies. - Presented at the Keystone Symposium on Targeted Protein Degradation: In
June 2021 , C4T presented pre-clinical data showing single agent CFT8919 is active in both in vitro and in vivo models of EGFR L858R-driven NSCLC without resistance-causing secondary mutations in EGFR, as well as in similar models that harbor secondary resistance mutations such as EGFR T790M and C797S.
Corporate
- Completed Successful Public Offering: In
June 2021 , C4T announced the launch and closing of an underwritten public offering of 4,887,500 shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of common stock, at a public offering price of$37.00 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately$180.8 million . - Appointed
Lauren White as Chief Financial Officer: InMay 2021 , C4T appointedLauren White as chief financial officer.Ms. White joined C4T from Novartis, where she served most recently as vice president and global head of business planning and analysis atNovartis Institutes for BioMedical Research .
UPCOMING KEY MILESTONES
C4T continues to advance its portfolio and is on-track to achieve four clinical programs by year-end 2022.
Advance the CFT7455 Phase 1/2 program and share safety and efficacy data at a medical meeting in 2022.- Submit an IND application for CFT8634 in 2H-2021. CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
Advance IND -enabling activities for CFT8919 and submit an IND application by mid-2022.Advance the BRAF program into IND-enabling studies by YE 2021. The objective of the BRAF program, which is partnered with Roche, is to develop an orally bioavailable BiDAC degrader targeting BRAF V600E mutations for the treatment of genetically defined solid tumors, including locally advanced or metastatic melanoma and NSCLC.- Continue lead optimization activities for the RET program through 2021. The objective of the RET program is to develop an orally bioavailable BiDAC degrader targeting genetically altered RET for the treatment of solid tumors, including NSCLC and medullary thyroid cancers that are resistant to RET inhibitors.
SECOND QUARTER 2021 FINANCIAL RESULTS
Revenue: Total revenue for the second quarter of 2021 was
Research and Development (R&D) Expense: R&D expense for the second quarter of 2021 was
General and Administrative (G&A) Expense: G&A expense for the second quarter of 2021 was
Net Loss and Net Loss per Share: Net loss for the second quarter of 2021 was
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of
About
Forward-Looking Statements
This press release contains “forward-looking statements” of
Condensed Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
(unaudited) | ||||||||
2021 | 2020 | |||||||
Cash, cash equivalents and marketable securities | $ | 498,681 | $ | 371,689 | ||||
Total assets | 528,421 | 400,138 | ||||||
Deferred revenue | 74,884 | 81,220 | ||||||
Long-term debt − related party | 10,409 | 10,052 | ||||||
Total stockholders’ equity | 416,427 | 280,791 |
Condensed Consolidated Statement of Operations | ||||||||
(in thousands, except per share data) | ||||||||
(unaudited) | ||||||||
Three Months Ended | ||||||||
2021 | 2020 | |||||||
Revenue from collaboration agreements | $ | 9,781 | $ | 9,670 | ||||
Operating expenses: | ||||||||
Research and development | 23,286 | 17,760 | ||||||
General and administrative | 8,611 | 2,769 | ||||||
Total operating expenses | 31,897 | 20,529 | ||||||
Loss from operations | (22,116 | ) | (10,859 | ) | ||||
Other (expense) income, net: | ||||||||
Interest expense and amortization of long-term debt − related party | (533 | ) | (127 | ) | ||||
Interest and other income, net | 69 | 25 | ||||||
Total other (expense) income, net | (464 | ) | (102 | ) | ||||
Loss before income taxes | (22,580 | ) | (10,961 | ) | ||||
Income tax benefit | — | 168 | ||||||
Net loss | $ | (22,580 | ) | $ | (10,793 | ) | ||
Accrual of preferred stock dividends | — | (2,908 | ) | |||||
Net loss attributable to common stockholders | $ | (22,580 | ) | $ | (13,701 | ) | ||
Net loss per share attributable to common stockholders − basic and diluted | $ | (0.51 | ) | $ | (9.28 | ) | ||
Weighted-average number of shares used in computed net loss per share − basic and diluted | 43,855,420 | 1,476,378 |
Investor Contact:
Kendra Adams
SVP, Communications & Investor Relations
Kendra.Adams@c4therapeutics.com
Media Contact:
Loraine Spreen
Director, Corporate Communications & Patient Advocacy
LSpreen@c4therapeutics.com
Source:
2021 GlobeNewswire, Inc., source