On August 11, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported business highlights and financial results for the second quarter of 2021 (Press release, C4 Therapeutics, AUG 11, 2021, View Source [SID1234586329]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Andrew Hirsch, chief executive officer at C4 Therapeutics. "We believe C4T’s differentiated approach to targeted protein degradation can alter existing paradigms for cancer treatment. With a focus on advancing our research portfolio, we initiated IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R, the driver mutation in more than a third of mutant EGFR lung cancer tumors. Backed by a strong balance sheet, following a successful follow-on offering, we remain on track to deliver four clinical-stage programs by the end of 2022."

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, the Food 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: In June 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: In May 2021, C4T appointed Lauren 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 at Novartis 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 $9.8 million, compared to $9.7 million for the second quarter of 2020. 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 targets under collaboration agreements.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2021 was $23.3 million, compared to $17.8 million for the second quarter of 2020. The increase in R&D expense was primarily attributable to higher pre-clinical costs related to our lead programs, and increased workforce expenses to support continued clinical development activities for CFT7455.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2021 was $8.6 million, compared to $2.8 million for the second quarter of 2020. The increase in G&A expense was primarily attributable to workforce expenses related to our growing G&A functions, principally stock-based compensation expense related to new stock option grants and an increase in the fair value of C4T’s common stock, and higher professional fees and insurance costs resulting from the transition to a public company.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2021 was $22.6 million, compared to $10.8 million for the second quarter of 2020. Net loss per share for the second quarter of 2021 was $0.51, compared to $9.28 for the second quarter of 2020. The decrease in net loss per share despite the increase in net loss was driven by a significant increase in the weighted-average shares outstanding caused by our initial public offering of 11,040,000 common shares in October 2020 and the resultant conversion of then outstanding shares of redeemable convertible preferred stock into 30,355,379 shares of common stock, and 4,887,500 shares of common stock issued upon closing of our follow-on offering in June 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2021 were $498.7 million, compared to $371.7 million as of December 31, 2020. The change in cash was primarily driven by net proceeds from the June 2021 follow-on offering of $169.5 million, offset by expenditures to fund operations. C4T expects that cash, cash equivalents and marketable securities as of June 30, 2021, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures for at least the next 24 months.