On November 3, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported financial results for the third quarter ended September 30, 2022, as well as recent business highlights (Press release, C4 Therapeutics, NOV 3, 2022, View Source [SID1234622859]).

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"In the third quarter we remained focused on clinical execution as we continued to enroll patients in the dose escalation portions of the Phase 1/2 clinical trials of CFT7455 and CFT8634. Additionally, we received FDA clearance of the investigational new drug application for our Phase 1/2 clinical trial of CFT1946, which is expected to initiate by year-end, marking our third program cleared to enter the clinic," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Our recent progress demonstrates the power of our TORPEDO platform to create MonoDAC and BiDAC degrader medicines that have the potential to transform patients’ lives. We are well-financed to advance our clinical pipeline through key inflection points and leverage our discovery platform to progress our next wave of research programs focused on novel and historically undruggable targets."

THIRD QUARTER 2022 AND RECENT HIGHLIGHTS

CFT7455: CFT7455 is a novel degrader of IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), including peripheral T-cell lymphoma and mantle cell lymphoma.

Advanced Enrollment in Phase 1/2 Clinical Trial: C4T progressed the Phase 1/2 clinical trial of CFT7455. Cohort B1 is exploring CFT7455 as a monotherapy for relapsed or refractory MM, and Cohort C is exploring CFT7455 as a monotherapy for NHL.
CFT8634: CFT8634 is a degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Advanced Enrollment in Phase 1/2 Clinical Trial: C4T progressed the Phase 1/2 clinical trial of CFT8634. Cohort A is exploring CFT8634 as a monotherapy for synovial sarcoma and SMARCB1-null solid tumors.

Accepted to Present at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting: Brian A. Van Tine, MD, PhD, Professor of Medicine, Division of Oncology, Section of Medical Oncology, the Washington University School of Medicine, Siteman Cancer Center, will present a trial-in-progress poster titled "A Phase 1/2 Study of CFT8634, A Novel Bifunctional Degradation Activating Compound (BiDAC) Degrader of BRD9, in Synovial Sarcoma and SMARCB1-Null Tumors" at the 2022 CTOS Annual Meeting on November 17, 2022 at 5 pm PT.
CFT1946: CFT1946 is a degrader targeting BRAF-V600 mutations for the treatment of solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer and melanoma.

Investigational New Drug (IND) Application Clearance Achieved: In September 2022, C4T received a Study May Proceed Letter from the United States Food and Drug Administration (FDA) to begin a Phase 1/2 trial of CFT1946 for the treatment of BRAF-V600 mutant solid tumors.
Research Activities

Presented at Discovery on Target and the 5th Annual Targeted Protein Degradation Summit. In October 2022, C4T delivered presentations that highlighted how C4T’s platform has been built to enable rational and efficient discovery of MonoDAC degraders through the design and evolution of a diverse chemical library combined with various screening approaches.
UPCOMING 2022 MILESTONES

CFT1946: Initiate a Phase 1/2 clinical trial of CFT1946 for the treatment of BRAF V600-mutant solid tumors by year-end 2022.
CFT8919: Complete IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R, for the treatment of non-small cell lung cancer, by year-end 2022.
UPCOMING 2022 EVENTS

November 8, 2022: Management will participate in a fireside chat at the Credit Suisse 31st Annual Healthcare Conference.
November 17, 2022: An investigator will present C4T’s trial-in-progress poster for CFT8634 at the CTOS Annual Meeting.
December 1, 2022: Management will participate in a fireside chat at the Evercore ISI HealthCONx Conference.
THIRD QUARTER 2022 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2022 was $6.8 million, compared to $8.5 million for the third quarter of 2021. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen, and Calico.

Research and Development (R&D) Expense: R&D expense for the third quarter of 2022 was $29.7 million, compared to $24.3 million for the third quarter of 2021. The increase in R&D expense was primarily attributable to increased personnel expenses, and clinical expenses from the ongoing CFT7455 and CFT8634 Phase 1/2 clinical trials.

General and Administrative (G&A) Expense: G&A expense for the third quarter of 2022 was $9.6 million, compared to $8.5 million for the third quarter of 2021. The increase in G&A expense was primarily attributable to increased personnel expenses.

Net Loss and Net Loss per Share: Net loss for the third quarter of 2022 was $32.0 million, compared to $24.7 million for the third quarter of 2021. Net loss per share for the third quarter of 2022 was $0.65, compared to $0.51 for the third quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of September 30, 2022, were $366.0 million, compared to $451.5 million as of December 31, 2021. The decrease in cash was primarily driven by expenditures to fund operations. C4T expects that its cash, cash equivalents and marketable securities as of September 30, 2022, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures to the end of 2024.