On August 8, 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 financial results for the second quarter ended June 30, 2023, as well as recent business highlights (Press release, C4 Therapeutics, AUG 8, 2023, View Source [SID1234633958]).

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"In the first half of 2023, we achieved important objectives to support the continued advancement of our degrader medicine portfolio. We completed an exclusive licensing agreement with Betta Pharmaceuticals to develop CFT8919, our EGFR-L858R degrader, in Greater China, strengthened our leadership team, and progressed three clinical studies across multiple cancer indications," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "In the second half of the year, we expect to share clinical updates from the dose escalation portion of the ongoing Phase 1/2 trials for our two lead programs, CFT7455 in multiple myeloma and CFT8634 in synovial sarcoma and SMARCB1-null cancers."

SECOND QUARTER 2023 AND RECENT ACHIEVEMENTS

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: The dose escalation portion of the CFT7455 Phase 1/2 clinical trial continues in MM and NHL. The three arms of the trial are evaluating CFT7455 as a monotherapy for MM, in combination with dexamethasone for MM and as a monotherapy for NHL.
Presented New Preclinical Data at the International Conference on Malignant Lymphoma (ICML): In June 2023, C4T presented preclinical CFT7455 data in NHL demonstrating potent anti-tumor activity in peripheral and CNS models of NHL as a single agent or in combination with clinically approved agents.
CFT8634: CFT8634 is an oral degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Progressed the Phase 1/2 Clinical Trial: The dose escalation portion of the CFT8634 Phase 1/2 clinical trial continues in synovial sarcoma and SMARCB1-null solid tumors.
Initiated the first enrichment cohort: In August, C4T initiated the first enrichment cohort to further assess pharmacodynamic and safety data. This planned additional cohort further helps support enrollment demand for the ongoing dose escalation portion of the CFT8634 Phase 1/2 clinical trial.
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.

Progressed the Phase 1/2 Clinical Trial: The dose escalation portion of the CFT1946 Phase 1/2 clinical trial continues in V600 solid tumors, including NSCLC, CRC and melanoma. Trial sites are now open and enrolling patients in the U.S. and Europe.
Presented Trial in Progress Poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: In June 2023, C4T presented a trial in progress poster titled "A Phase 1/2 Study of CFT1946, A Novel Bifunctional Degradation Activating Compound, or BiDAC Degrader, of Mutant BRAF V600 as Monotherapy and in Combination with Trametinib, in Mutant BRAF V600 Solid Tumors."
CFT8919: CFT8919 is an oral degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC).

Exclusive Licensing Agreement with Betta Pharmaceuticals in Greater China: In May 2023, C4T entered into an exclusive license and collaboration agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. C4T expects to receive a total of $35.0 million, which includes $10.0 million in upfront cash paid in June 2023 under the collaboration agreement and a $25.0 million one-time equity investment under the stock purchase agreement. Additionally, C4T is eligible for up to $357.0 million in potential milestones and low to mid-double-digit percent royalties on net sales in the licensed territories.
Investigational New Drug (IND) Application Clearance Achieved: In June 2023, the U.S. Food and Drug Administration (FDA) cleared C4T’s IND application for CFT8919. C4T expects to initiate clinical trial activities outside Greater China following the completion of Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China.
CORPORATE UPDATES

In July 2023, C4T appointed two new senior leaders. Leonard (Len) Reyno, M.D., joined C4T as chief medical officer with nearly 30 years of clinical development experience, spanning first-in-human studies to Phase IV clinical trials. Mary Christian, Pharm.D. joined C4T as senior vice president, regulatory with more than two decades of experience in regulatory and drug development.
UPCOMING KEY 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 for synovial sarcoma and SMARCB1-null solid tumors in the second half of 2023.
SECOND QUARTER 2023 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2023 was $2.7 million, compared to $13.8 million for the second quarter of 2022. The decrease in revenue was due to a reduction of revenue recognized for research activities under the Biogen and Calico collaborations. Total revenue for the second quarter of 2023 reflects revenue recognized under collaboration agreements with Roche and Biogen, and total revenue recognized in the second quarter of 2022 reflects revenue recognized under collaborations agreements with Roche, Biogen, and Calico.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2023 was $29.9 million, compared to $31.3 million for the second quarter of 2022. The reduction in R&D expense was primarily attributable to a decrease in IND-enabling activities as programs transition to the clinic.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2023 was $10.3 million, compared to $9.9 million for the second quarter of 2022. The higher G&A expense was attributable to a slight increase in professional fees.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2023 was $35.9 million, compared to $27.4 million for the second quarter of 2022. Net loss per share for the second quarter of 2023 was $0.73 compared to $0.56 for the second quarter of 2022.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2023, were $286.7 million, compared to $337.1 million as of December 31, 2022. The decrease in cash was primarily driven by expenditures to fund operations, partially offset by the $10.0 million upfront payment received from Betta Pharmaceuticals. C4T expects that its cash, cash equivalents and marketable securities as of June 30, 2023, along with the anticipated equity investment from an affiliate of Betta Pharmaceuticals, will be sufficient to fund planned operating expenses and capital expenditures into the second half of 2025.