On August 4, 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 second quarter ended June 30, 2022, as well as recent business highlights (Press release, C4 Therapeutics, AUG 4, 2022, View Source [SID1234617481]).

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"We have seen continued progress across our portfolio and governance initiatives that help us advance targeted protein degrader medicines towards patients," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "In the second quarter, we successfully initiated our Phase 1/2 clinical trial of CFT8634 in synovial sarcoma and SMARCB1-null solid tumors and continued to enroll patients in the dose escalation portion of our ongoing Phase 1/2 clinical trial of CFT7455 in multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL). As we prepare to submit the IND for CFT1946, a BRAF V600X degrader, in the second half of the year, our strong balance sheet allows us to execute on our clinical programs and further advance our research platform to develop the next wave of degrader medicines."

SECOND QUARTER 2022 AND RECENT HIGHLIGHTS

CFT7455: CFT7455 is a novel degrader targeting IKZF1/3 for the treatment of MM and 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 by enrolling patients in Cohort B1, exploring CFT7455 as a monotherapy for relapsed or refractory MM, and Cohort C, exploring CFT7455 as a monotherapy for NHL.
CFT8634: CFT8634 is a degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Dosed First Patient in Phase 1/2 Clinical Trial: In May 2022, C4T dosed the first patient in the Phase 1/2 clinical trial of CFT8634. The trial continues to progress, with sites open and enrolling patients in Cohort A, the Phase 1 dose escalation arm, to evaluate CFT8634 as an oral, single-agent therapy for patients with synovial sarcoma or SMARCB1-null solid tumors.
Corporate

Appointed Dr. Laura Bessen and Dr. Donna Grogan to Board of Directors: In August 2022, C4T appointed Dr. Laura Bessen and Dr. Donna Grogan to its board of directors. Dr. Bessen has more than two decades of experience across medical affairs and clinical development in support of successful product launches. Dr. Grogan is an accomplished drug development and regulatory strategy leader with more than 25 years of experience in developing novel therapeutics.
KEY UPCOMING MILESTONES

The company anticipates the following milestones:

CFT7455: Continue to enroll Cohorts B1 and C; data from these efforts will inform the identification of a recommended Phase 2 dose(s) and schedule(s) for single agent CFT7455 in MM and NHL.
CFT8634: Continue to enroll patients in the Phase 1/2 trial throughout 2022. Data from these efforts will inform the identification of a recommended Phase 2 dose for synovial sarcoma and SMARCB1-null solid tumors.
CFT1946: Submit an IND application and initiate a Phase 1 trial of CFT1946 in BRAF V600X-driven cancers including melanoma, colorectal and non-small cell lung cancer in 2H 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 EVENTS

Research & Development Presentations to Highlight MonoDACTM Degrader Platform and Library: C4T has been accepted to present at Discovery on Target, to be held October 17-20, 2022, and the 5th Annual Targeted Protein Degradation Summit, to be held October 25-28, 2022. These presentations will include research highlighting 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.

Investor Conference: C4T management is scheduled to participate in the Wells Fargo Healthcare Conference to be held September 7-8, 2022.

SECOND QUARTER 2022 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2022 was $13.8 million, compared to $9.8 million for the second quarter of 2021. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The increase in revenue was primarily due to additional progress made on our targets under the Biogen collaboration agreement, offset by the decrease in reimbursement for full-time employees recognized under our collaboration agreement with Calico.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2022 was $31.3 million, compared to $23.3 million for the second quarter of 2021. The increase in R&D expense was primarily attributable to increased personnel expenses including increases in stock compensation expenses, facility costs from additional leased space, and clinical expenses as a result of the ongoing Phase 1/2 clinical trial of CFT7455 and commencement of the CFT8634 Phase 1/2 trial.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2022 was $9.9 million, compared to $8.6 million for the second quarter of 2021. The increase in G&A expense was primarily attributable to increased personnel expenses, including an increase in stock compensation expense.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2022 was $27.4 million, compared to $22.6 million for the second quarter of 2021. Net loss per share for the second quarter of 2022 was $0.56, compared to $0.51 for the second quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2022, were $397.8 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 June 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.