C4 Therapeutics(CCCC)

Search documents
C4 Therapeutics, Inc. (CCCC) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-02-27 14:20
C4 Therapeutics, Inc. (CCCC) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.68 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.36%. A quarter ago, it was expected that this company would post a loss of $0.40 per share when it actually produced a loss of $0.35, delivering a surprise of 12.50%.Over the last four quarters, the company has s ...
C4 Therapeutics(CCCC) - 2024 Q4 - Annual Report
2025-02-27 12:15
Product Development and Pipeline - The company is focused on developing targeted protein degradation (TPD) therapies, leveraging its proprietary TORPEDO platform to create small-molecule medicines[22]. - The most advanced product candidate, cemsidomide, is in clinical development for multiple myeloma and non-Hodgkin lymphoma, with promising data shared in December 2023 showing a well-tolerated profile and compelling anti-lymphoma activity[24]. - CFT1946, another advanced candidate, targets BRAF V600 mutant proteins and has shown the ability to cross the blood-brain barrier, with initial signs of anti-tumor activity presented in September 2024[25]. - The company has entered a collaboration with Betta Pharma for the development of CFT8919 in Greater China, with a Phase 1 clinical trial initiated in November 2024[26]. - The ongoing clinical trials for cemsidomide and CFT1946 are part of the company's strategy to advance oral oncology degrader programs and seek expedited development pathways with the FDA[28]. - The company is diversifying its pipeline by developing new degraders in collaboration with partners like MKDG, Merck, and Roche, focusing on multiple therapeutic areas[27]. - The company aims to leverage its TPD approach to address significant unmet medical needs in oncology and other disease areas[28]. - Cemsidomide targets IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL), showing robust activity in preclinical studies[50]. - CFT1946 is being developed for BRAF V600 mutant solid tumors, with BRAF mutations occurring in approximately 6% of all cancers, translating to over 100,000 patients annually in the US[61]. - CFT8919 is designed to target EGFR L858R mutations, which account for approximately 25-45% of EGFR-mutant NSCLC, and aims to overcome resistance mechanisms[76][79]. Clinical Trials and Regulatory Pathways - The company is conducting first-in-human Phase 1/2 clinical trials for cemsidomide and CFT1946, with a partner conducting a Phase 1 trial for CFT8919 in Greater China[49]. - In December 2024, data from the ongoing Phase 1/2 trial indicated a well-tolerated safety profile for cemsidomide, with compelling anti-myeloma activity across a broad range of doses[51]. - CFT1946 demonstrated dose-dependent bioavailability and degradation of BRAF V600E protein, with initial signs of anti-tumor activity across all dose levels in the ongoing Phase 1/2 trial[68]. - The FDA's testing and approval process for product candidates requires substantial time, effort, and financial resources[132]. - The IND submission becomes effective 30 days after receipt by the FDA unless safety concerns arise[133]. - Clinical trials are conducted in three phases, with Phase 1 focusing on safety and dosage, Phase 2 on preliminary efficacy, and Phase 3 on statistically significant evidence of efficacy[136][144]. - The FDA has implemented initiatives like Project Optimus to reform dose selection in oncology drug development[139]. - The FDA's accelerated approval pathway allows drugs to be approved based on surrogate endpoints that predict clinical benefit[149]. - Priority review designation by the FDA reduces the review goal to six months for drugs providing significant safety or effectiveness improvements[150]. Financial Performance and Funding - The company reported a net loss of $105.3 million for the year ended December 31, 2024, compared to a net loss of $132.5 million for 2023, resulting in an accumulated deficit of $633.7 million[211]. - The company has not generated any revenue from product sales to date and has financed operations primarily through equity sales and collaborations[211]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it prepares for clinical trials and expands its research and development activities[212]. - The company anticipates substantial additional funding will be required to pursue its business objectives and continue operations, particularly for ongoing clinical trials and commercialization efforts[217]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of approximately $267.3 million, which is expected to fund planned operating expenses into 2027[218]. - The company anticipates needing to raise substantial additional capital to complete the development and commercialization of its product candidates, as current resources are insufficient for regulatory approval[218]. Collaborations and Partnerships - The company has made significant investments in its proprietary TORPEDO platform, enhancing the design and optimization of protein degraders[44]. - The Merck License Agreement includes potential milestone payments totaling approximately $600 million and tiered royalties on net sales for degrader-antibody conjugates[84]. - The MKDG Agreement includes an upfront cash payment of $16 million and potential aggregate payments of approximately $740 million across the collaboration[82]. - Betta Pharma made an upfront cash payment of $10.0 million and the company is eligible to receive up to $357.0 million in milestone payments for CFT8919 in Greater China[86]. - The company received an upfront payment of $45.0 million from Biogen for the collaborative research and license agreement[98]. Market and Competitive Landscape - The company has identified potential competitors with greater financial resources and expertise, which could impact its market position[106]. - The company’s commercial success depends on securing and maintaining patent protection for its technologies, including the TORPEDO platform and product candidates[113]. - The company relies on trade secrets and technical know-how to maintain its competitive advantage, supported by confidentiality agreements with employees and partners[128]. - The company faces risks related to potential price controls and regulations that could adversely affect its business prospects and financial condition[200]. Regulatory Environment - The company is subject to substantial regulatory requirements imposed by the FDA and other agencies, which can affect the clinical development and marketing of its products[130]. - The FDA inspects manufacturing facilities and clinical trial sites to ensure compliance with cGMP and GCP requirements before approving an NDA[156]. - Regulatory approval may include limitations on indicated uses and may require Phase 4 post-marketing studies to monitor safety[161]. - The EU requires a marketing authorization (MA) for medicinal products, with centralized MAs valid throughout the EU[179]. - The China National Medical Products Administration (NMPA) allows clinical trials to proceed under an implied approval system if no objections are received within 60 business days, streamlining the process[184]. Employee and Workplace Culture - As of December 31, 2024, the company had 110 full-time employees, with 75 engaged in research and development activities[202]. - The company is committed to creating an inclusive workplace and has implemented various programs to support employee well-being and development[204].
C4 Therapeutics(CCCC) - 2024 Q4 - Annual Results
2025-02-27 12:07
Financial Performance - Total revenue for Q4 2024 was $5.2 million, and for the full year, it was $35.6 million, compared to $3.3 million and $20.8 million in the prior year periods, representing an increase of 58.8% and 71.8% respectively[9] - Revenue from collaboration agreements increased to $5,177 million in Q4 2024, up from $3,261 million in Q4 2023, representing a growth of 58.6%[25] - Total other income for the twelve months ended December 31, 2024, was $14,429 million, significantly higher than $7,818 million in 2023, an increase of 84%[25] Expenses - Research and Development (R&D) expenses for Q4 2024 were $32.5 million, and for the full year, they were $110.6 million, compared to $30.4 million and $117.7 million in the prior year periods[12] - Total operating expenses for Q4 2024 were $42,886 million, compared to $40,688 million in Q4 2023, reflecting an increase of 5.4%[25] - Research and development expenses for the twelve months ended December 31, 2024, totaled $110,637 million, down from $117,706 million in 2023, a decrease of 6%[25] - General and administrative expenses remained relatively stable at $10,373 million in Q4 2024 compared to $10,297 million in Q4 2023, a slight increase of 0.7%[25] Net Loss - Net loss for Q4 2024 was $34.6 million, with a net loss per share of $0.49, compared to a net loss of $34.8 million and a net loss per share of $0.68 in the prior year[14] - Net loss for Q4 2024 was $34,573 million, slightly improved from a net loss of $34,754 million in Q4 2023, indicating a reduction of 0.5%[25] - Net loss per share for Q4 2024 was $0.49, compared to $0.68 in Q4 2023, showing an improvement of 28%[25] - The company reported a total net loss of $105,316 million for the twelve months ended December 31, 2024, compared to $132,493 million in 2023, a decrease of 20.5%[25] - Loss before income taxes for the twelve months ended December 31, 2024, was $105,185 million, improved from $131,213 million in 2023, a reduction of 19.8%[25] Cash Position - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $267.3 million, down from $281.7 million as of December 31, 2023, providing a runway into 2027[15] - Weighted-average number of shares for basic and diluted was 70,606,156 in Q4 2024, up from 51,234,450 in Q4 2023, an increase of 37.8%[25] Clinical Development - Cemsidomide demonstrated an overall response rate (ORR) of 38% across all subtypes and doses studied in multiple myeloma and non-Hodgkin's lymphoma[4] - CFT1946 is expected to present data in melanoma and colorectal cancer in the second half of 2025, with ongoing trials across multiple cohorts[3] - The company initiated a new discovery collaboration with Merck KGaA, Darmstadt, Germany, and delivered two development candidates to Biogen[3] - The maximum tolerated dose for cemsidomide has not yet been reached, with patients currently enrolling at the 100 µg QD dose level[5] - The company expects to complete Phase 1 dose escalation and present data in multiple myeloma and non-Hodgkin's lymphoma in the second half of 2025[10] - CFT8919 entered clinical development in Greater China, with a Phase 1 trial initiated in November 2024[7]
C4 Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Globenewswire· 2025-02-27 12:00
Core Insights - C4 Therapeutics, Inc. is advancing its clinical development programs, particularly focusing on cemsidomide for multiple myeloma and non-Hodgkin's lymphoma, with trials expected to start in early 2026 [1][2] - The company reported a significant increase in total revenue for 2024, reaching $35.6 million, compared to $20.8 million in 2023, driven by new collaborations [9] - C4 Therapeutics has a strong cash position of $267.3 million as of December 31, 2024, which is expected to fund operations into 2027 [13][15] Cemsidomide Development - Cemsidomide is showing promising results in ongoing trials, with an overall response rate (ORR) of 36% in combination with dexamethasone and 38% in monotherapy across all subtypes studied [7] - The drug is well-tolerated, with the maximum tolerated dose not yet reached, and patient enrollment is ongoing at higher dose levels [7] - The company aims to complete Phase 1 dose escalation and present data in multiple myeloma and non-Hodgkin's lymphoma in the second half of 2025 [14] CFT1946 Progress - CFT1946 is in a Phase 1/2 trial, demonstrating a well-tolerated safety profile and evidence of anti-tumor activity in patients with BRAF V600 mutations [18] - The drug has shown the ability to cross the blood-brain barrier, which is significant for treating patients with brain metastases [7] - Data from melanoma and colorectal cancer trials are expected in the second half of 2025 [1][14] Financial Performance - Total revenue for Q4 2024 was $5.2 million, up from $3.3 million in Q4 2023, reflecting growth in collaboration agreements [9] - Research and development expenses for 2024 were $110.6 million, a decrease from $117.7 million in 2023, primarily due to restructuring [10] - The net loss for the full year 2024 was $105.3 million, an improvement from $132.5 million in 2023, with net loss per share decreasing from $2.67 to $1.52 [12] Upcoming Milestones - The company plans to initiate the next phase of clinical development for cemsidomide and CFT1946 in early 2026 [14] - Key presentations and investor events are scheduled for March 2025, including participation in the TD Cowen Annual Healthcare Conference [14]
C4 Therapeutics (CCCC) Loses -23.14% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2025-02-26 15:36
Core Viewpoint - C4 Therapeutics, Inc. (CCCC) has experienced a significant decline of 23.1% over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround as analysts expect better earnings than previously predicted [1][5][6]. Group 1: Stock Performance and Indicators - The stock has faced excessive selling pressure, leading to a decline of 23.1% in the last month [1]. - CCCC's Relative Strength Index (RSI) is currently at 21.84, indicating that the heavy selling may be exhausting itself, which could lead to a price rebound [5]. - A stock is generally considered oversold when its RSI falls below 30, and CCCC's current RSI suggests it is approaching this threshold [2][3]. Group 2: Earnings Estimates and Analyst Consensus - Over the past 30 days, the consensus EPS estimate for CCCC has increased by 0.3%, indicating a positive trend in earnings revisions [6]. - There is strong agreement among sell-side analysts regarding the potential for CCCC to report better earnings, which typically correlates with price appreciation [6]. - CCCC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7].
C4 Therapeutics to Participate in Upcoming March Investor Conferences
Newsfilter· 2025-02-24 12:00
Core Insights - C4 Therapeutics, Inc. (C4T) is a clinical-stage biopharmaceutical company focused on advancing targeted protein degradation science [4] - The company will participate in two investor conferences in March 2025, indicating active engagement with the investment community [1][2][3] Conference Participation - C4T management will present at the TD Cowen 45th Annual Healthcare Conference on March 3rd at 9:10 am ET in Boston, MA, with a live webcast available [2] - The company will also participate in the Leerink Partners Global Healthcare Conference on March 9th in Miami, FL [3] Company Overview - C4T is dedicated to creating a new generation of medicines through targeted protein degradation, aiming to transform patient outcomes [4] - The company utilizes its TORPEDO® platform to design and optimize small-molecule medicines for difficult-to-treat diseases [4] - C4T's degrader medicines aim to leverage the body's natural protein recycling system to degrade disease-causing proteins, potentially overcoming drug resistance and addressing undruggable targets [4]
C4 Therapeutics Announces 2025 Milestones Across Clinical Portfolio of Degrader Medicines Pursuing Targets of High Unmet Need in Oncology
Globenewswire· 2025-01-14 12:00
Core Insights - C4 Therapeutics is advancing its clinical programs, particularly focusing on cemsidomide, CFT1946, and CFT8919, with significant milestones anticipated in 2025 [2][3][4] Cemsidomide - Cemsidomide is an oral degrader targeting IKZF1/3 for treating relapsed/refractory multiple myeloma and non-Hodgkin's lymphoma, with data presented at the ASH Annual Meeting indicating a 36% overall response rate (ORR) at a dose of 75 µg once daily [4][13] - The company plans to initiate the next phase of clinical development for cemsidomide in combination with dexamethasone and other agents in early 2026 [6] CFT1946 - CFT1946 is an oral degrader targeting BRAF V600 mutations for solid tumors, with ongoing Phase 1/2 studies showing initial signs of anti-tumor activity [5][9] - Data from the Phase 1 dose escalation study is expected to be presented in the second half of 2025, including results from various cohorts [6][13] CFT8919 - CFT8919 targets EGFR with the L858R mutation for non-small cell lung cancer, with a Phase 1 trial ongoing in Greater China led by Betta Pharmaceuticals [7][10] - The data from this trial will inform future development plans for CFT8919 [6][7] Financial Outlook - C4 Therapeutics expects its cash reserves to fund operations into 2027, supported by anticipated collaboration reimbursements [14] Corporate Developments - The company has strengthened its leadership team and Board of Directors to support its evolution into a fully integrated biotechnology company [11][21]
C4 Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-08 12:00
Core Insights - C4 Therapeutics, Inc. (C4T) is a clinical-stage biopharmaceutical company focused on advancing targeted protein degradation science [1][3] - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [1] - C4T utilizes its TORPEDO platform to design small-molecule medicines that target disease-causing proteins, aiming to improve patient outcomes and address drug resistance [3] Company Overview - C4 Therapeutics is dedicated to creating a new generation of medicines that transform patients' lives through targeted protein degradation [3] - The company is advancing multiple targeted oncology programs and expanding its research platform for difficult-to-treat diseases [3] - C4T's approach leverages the body's natural protein recycling system to rapidly degrade harmful proteins [3]
C4 Therapeutics Appoints Accomplished Oncology Executive Steve Hoerter to Board of Directors
GlobeNewswire News Room· 2024-11-20 12:00
Core Insights - C4 Therapeutics, Inc. has appointed Steve Hoerter to its Board of Directors, emphasizing the company's commitment to enhancing its leadership as it advances its pipeline of targeted protein degraders [1][2] - Hoerter brings over three decades of experience in oncology commercialization, having previously led Deciphera Pharmaceuticals to a successful acquisition by ONO Pharmaceutical for $2.4 billion [2] - The company aims to leverage Hoerter's expertise to guide its transition into a fully integrated biotechnology firm focused on innovative small molecule degraders [2][3] Company Overview - C4 Therapeutics is a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, with a focus on creating new medicines that can transform patient lives [4] - The company utilizes its TORPEDO® platform to design and optimize small-molecule medicines aimed at addressing difficult-to-treat diseases, particularly in oncology [4] - C4T's degrader medicines are designed to exploit the body's natural protein recycling system, potentially overcoming drug resistance and improving patient outcomes [4]
C4 Therapeutics, Inc. (CCCC) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-10-31 13:20
Group 1 - C4 Therapeutics reported a quarterly loss of $0.35 per share, better than the Zacks Consensus Estimate of a loss of $0.40, and an improvement from a loss of $0.55 per share a year ago, resulting in an earnings surprise of 12.50% [1] - The company posted revenues of $15.36 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 158.10%, compared to revenues of $11.07 million in the same quarter last year [2] - C4 Therapeutics has surpassed consensus EPS estimates two times over the last four quarters, indicating a positive trend in performance [2] Group 2 - The stock has underperformed the market, losing about 2.1% since the beginning of the year, while the S&P 500 has gained 21.9% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates for the coming quarter at -$0.43 on revenues of $7.33 million, and for the current fiscal year at -$1.57 on revenues of $25.66 million [4][7] - The Medical - Biomedical and Genetics industry, to which C4 Therapeutics belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable industry outlook [8]