On February 23, 2023 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 business highlights and financial results for the year ended December 31, 2022 (Press release, C4 Therapeutics, FEB 23, 2023, View Source [SID1234627600]).

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"2022 was a year of execution that has laid the groundwork for 2023 as we work to progress three clinical programs, with a fourth expected to enter the clinic by year end," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "With cash runway through the end of 2024, we look forward to having two clinical readouts in the second half of the year, which have the potential to validate our TORPEDO platform to develop both BiDAC and MonoDAC degraders for patients with difficult-to-treat diseases."

FOURTH QUARTER 2022 AND RECENT HIGHLIGHTS

CFT7455: CFT7455 is an oral degrader of IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL).

Progressed the Phase 1/2 Clinical Trial: In January 2023, opened Arm B2 of the ongoing Phase 1/2 clinical trial, evaluating CFT7455 in combination with dexamethasone for the treatment of MM.
CFT8634: CFT8634 is an oral degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Encouraging Initial Pharmacokinetic (PK) and Pharmacodynamic (PD) Data: In January 2023, shared PK and PD data from the initial escalation cohorts of the ongoing CFT8634 Phase 1/2 clinical trial demonstrating dose proportional exposure, strong oral bioavailability and deep BRD9 degradation.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the treatment of solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and melanoma.

Dosed First Patient in Phase 1/2 Clinical Trial: In January 2023, dosed the first patient in the CFT1946 Phase 1/2 clinical trial. Trial sites are open and enrolling patients with BRAF V600 mutant cancers including NSCLC, CRC and melanoma.
New Preclinical Data Accepted for Presentation at AACR (Free AACR Whitepaper): Accepted to present new preclinical data on the discovery and characterization of CFT1946 at 2023 AACR (Free AACR Whitepaper) Annual Meeting.
KEY UPCOMING MILESTONES

CFT7455: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial of Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second half of 2023.
CFT8634: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial in the second half of 2023 in synovial sarcoma and SMARCB1-null solid tumors.
CFT1946: Continue site activation and patient enrollment of the dose escalation portion of the CFT1946 Phase 1/2 clinical trial in BRAF V600 mutant solid tumors. Present new preclinical data on the discovery and characterization of CFT1946 at 2023 AACR (Free AACR Whitepaper) Annual Meeting in April.
CFT8919: Submit an Investigational New Drug (IND) application for CFT8919 for the treatment of NSCLC in the first half of 2023.
UPCOMING INVESTOR EVENTS

March 6, 2023: Management will participate in the Cowen & Co. 43rd Annual Health Care Conference.
FULL YEAR 2022 FINANCIAL RESULTS

Revenue: Total revenue for the year ended December 31, 2022 was $31.1 million, compared to $45.8 million for the year ended December 31, 2021. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The decrease in revenue is primarily due to a one-time cumulative recognition during the year ended December 31, 2021 for all of the previously unrecognized revenue allocated to the BRAF program upon the termination of the Roche agreement related to that target.

Research and Development (R&D) Expense: R&D expense for the year ended December 31, 2022 was $117.8 million, compared to $94.7 million for the year ended December 31, 2021. The increase in R&D expense was primarily attributable to clinical costs for CFT7455 and CFT8634, increased external costs, and internal workforce expenses to support the increased level of clinical trial activity.

General and Administrative (G&A) Expense: G&A expense for the year ended December 31, 2022 was $42.8 million, compared to $33.3 million for the year ended December 31, 2021. The increase in G&A expense was primarily attributable to the full-year 2022 impact of the build-out of our general and administrative team to support business growth.

Net Loss and Net Loss per Share: Net loss for the year ended December 31, 2022 was $128.2 million, compared to $83.9 million for the year ended December 31, 2021. Net loss per share for the year ended December 31, 2022 was $2.62, compared to $1.82 for the year ended December 31, 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2022 was $337.1 million, compared to $451.5 million as of December 31, 2021. C4T expects that its cash, cash equivalents and marketable securities as of December 31, 2022, together with anticipated collaboration expense reimbursements, but excluding any collaboration option or milestone payments, will enable the company to fund its operating plan to the end of 2024.