C4 Therapeutics, Inc. (CCCC) came out with a quarterly loss of $0.68 per share versus the Zacks Consensus Estimate of a loss of $0.67. This compares to loss of $0.76 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -1.49%. A quarter ago, it was expected that this company would post a loss of $0.65 per share when it actually produced a loss of $0.55, delivering a surprise of 15.38%.Over the last four quarters, the company has su ...

Financial Performance - The net loss for the fiscal year ended December 31, 2023, was $132.5 million, compared to $128.2 million for the previous year[83]. - The company has not generated any revenue from product sales to date and expects to incur significant expenses and operating losses for the foreseeable future[83]. - Total revenue from collaboration agreements decreased to $20.8 million in 2023 from $31.1 million in 2022, with Biogen contributing $10.6 million, Roche $9.1 million, and Calico $1.1 million[168]. - The company reported a net loss of $132.49 million for the year ended December 31, 2023, compared to a net loss of $128.18 million for the previous year[256]. - The company has an accumulated deficit of $528.4 million, reflecting ongoing financial challenges[260]. - The company expects to continue incurring operating losses for the foreseeable future, indicating a challenging path ahead[260]. - Cash, cash equivalents, and marketable securities totaled $281.7 million as of December 31, 2023, which the company believes will be sufficient to fund operations for at least the next twelve months[260]. Clinical Development - The company has initiated a first-in-human Phase 1/2 clinical trial for its product candidate CFT7455, which targets IKZF1 and IKZF3, in June 2021[87]. - CFT7455 has received orphan drug designation from the FDA for the treatment of multiple myeloma (MM) in August 2021[87]. - Positive clinical data from the dose escalation portion of the CFT7455 Phase 1/2 trial was presented in December 2023, showing efficacy as a monotherapy and in combination with dexamethasone in MM[87]. - CFT1946, an orally bioavailable BiDAC degrader, shows superior efficacy compared to standard therapies in preclinical studies for CRC and NSCLC, with ongoing Phase 1/2 trials initiated in January 2023[89]. - CFT8919, another orally bioavailable BiDAC degrader targeting EGFR mutations, has demonstrated equipotent antiproliferation activity in preclinical studies and received FDA IND clearance in June 2023[89]. - CFT7455 demonstrated anti-myeloma activity and International Myeloma Working Group (IMWG) responses in patients with multiple prior therapies, indicating potential for improved clinical outcomes[121]. - The company is advancing its clinical oral oncology degrader programs using the proprietary TORPEDO platform, aiming for expedited development and accelerated approval pathways with the FDA[90]. Research and Development - The company has a proprietary TORPEDO platform that enables the design of small molecule protein degraders, including MonoDAC and BiDAC degraders[61]. - The clinical pipeline includes several protein degraders targeting various cancers and other indications, focusing primarily on oncology[61]. - The company is developing new degraders for both clinically validated and undruggable targets, with a focus on therapeutic areas such as oncology and neurodegenerative diseases[89]. - The company focuses on Cereblon as the E3 ligase target due to its extensive clinical experience and ability to impact human disease through degradation of specific targets[119]. - The company has invested in a proprietary TORPEDO platform to design, analyze, and predict degrader performance, enhancing potency and selectivity[119]. - The platform includes high-throughput cellular degradation assays that provide quantitative data on the relationship between degrader concentration and target protein degradation, allowing for rapid optimization of candidates[120]. Collaborations and Agreements - The company has ongoing collaboration agreements with Roche, Betta Pharma, and Merck, and may seek additional collaborations in the future[83]. - The collaboration with Betta Pharma includes an upfront payment of $10 million and potential milestone payments of up to $357 million, along with tiered royalties on net sales in Greater China[104]. - The Biogen Agreement includes an upfront payment of $45 million for candidate development activities, with potential milestone payments ranging from $2 million to $5 million per target[123]. - The Roche Agreement includes an upfront payment of $40.0 million and potential milestone payments up to $273 million for each target upon achieving specific research, development, and commercial milestones[126]. - The company entered into a stock purchase agreement with Betta Investment for the purchase of 5,567,928 shares at $4.49 per share, totaling approximately $25.0 million[173]. - The Company entered into an exclusive license and collaboration agreement with Merck on December 11, 2023, receiving a $10.0 million upfront payment and potential milestone payments totaling approximately $600 million[248]. Regulatory and Compliance - The company is subject to rigorous regulatory requirements imposed by the FDA and other agencies regarding the clinical development and marketing of its pharmaceutical products[156]. - The FDA requires substantial user fees for NDA submissions, which must be paid at the time of the first application submission[146]. - The FDA's Project Optimus initiative aims to reform dose selection in oncology drug development, emphasizing safety and tolerability alongside efficacy[160]. - The FDA's expansion cohort trials may streamline the clinical trial process, potentially reducing costs and time for drug development[160]. Financial Position - As of December 31, 2023, the company reported cash and cash equivalents of $126.6 million, an increase from $29.8 million in 2022[221]. - The total current assets decreased to $271.2 million in 2023 from $287.6 million in 2022, primarily due to a reduction in marketable securities[221]. - Total liabilities decreased to $130.3 million in 2023 from $141.6 million in 2022, reflecting a reduction in long-term debt and operating lease liabilities[221]. - Stockholders' equity decreased to $246.1 million in 2023 from $289.2 million in 2022, driven by an increase in accumulated deficit to $528.4 million[221]. - The company has no long-term debt as of December 31, 2023, compared to $9.2 million in 2022, indicating a shift in financial strategy[221]. - The company’s interest income is sensitive to changes in U.S. interest rates, but historical fluctuations have not been significant[182].

Financial Performance - Total revenue for the year ended December 31, 2023, was $20.8 million, a decrease from $31.1 million in 2022, primarily due to the end of a collaboration agreement with Calico[20] - Revenue from collaboration agreements decreased to $20.8 million in 2023 from $31.1 million in 2022, representing a decline of approximately 33.5%[41] - Net loss for the year ended December 31, 2023, was $132.5 million, compared to $128.2 million in 2022, with a net loss per share of $2.67[32] - Net loss increased to $132.5 million in 2023 compared to a net loss of $128.2 million in 2022, reflecting a rise of approximately 3.0%[41] - Total operating expenses slightly decreased to $159.8 million in 2023 from $160.6 million in 2022, a reduction of about 0.5%[41] - Interest and other income increased significantly to $9.8 million in 2023 from $3.6 million in 2022, an increase of approximately 173.2%[41] - Cash, cash equivalents, and marketable securities decreased to $281.7 million as of December 31, 2023, down from $337.1 million in 2022, a decline of about 16.4%[44] - Total assets decreased to $376.5 million in 2023 from $430.8 million in 2022, a reduction of approximately 12.6%[48] - Total stockholders' equity decreased to $246.1 million in 2023 from $289.2 million in 2022, a decline of about 14.9%[48] Expenses - General and Administrative (G&A) expenses for 2023 were $42.1 million, down from $42.8 million in 2022, mainly due to reduced professional fees[5] - Research and Development (R&D) expenses for 2023 were $117.7 million, relatively flat compared to $117.8 million in 2022, as preclinical costs decreased while clinical costs increased[31] Capital and Funding - C4 Therapeutics is well-capitalized with a cash runway expected to extend into 2027, with a proforma balance of approximately $330 million as of January 2024[33] - In January 2024, C4T sold approximately 13.7 million shares at an average price of $5.42 per share, raising approximately $72 million in new equity capital[28] Product Development - CFT7455 is in a Phase 1 dose escalation study, with initial clinical data showing anti-myeloma activity and well-tolerated results[6] - CFT1946 is also in a Phase 1 dose escalation study, with encouraging initial pharmacokinetic and pharmacodynamic data shared in January 2024[25] - The company received approval for the Clinical Trial Application of CFT8919 in December 2023, indicating progress in its product pipeline[42] Strategic Initiatives - C4T and Merck entered into a collaboration for degrader antibody conjugates, with an upfront payment of $10 million and potential milestone payments totaling approximately $600 million[27] - C4T announced strategic priorities for 2024, focusing on advancing product candidates CFT7455 and CFT1946, while reducing the workforce by approximately 30%[17] - The company plans to participate in a fireside chat at the Leerink Partners Global Biopharma Conference on March 11, 2024, highlighting upcoming milestones for CFT1946[43] Deferred Revenue - Deferred revenue increased to $37.3 million in 2023 from $33.5 million in 2022, an increase of about 11.4%[48]

When C4 Therapeutics, Inc. (CCCC) reports fourth-quarter and full-year 2023 results, investors will primarily focus on pipeline updates.The company has a decent track record of beating on earnings in three of the trailing four quarters and missing in one, delivering an average surprise of 5.04%. In the last reported quarter, it delivered an earnings surprise of 15.38%.Factors to NoteC4 Therapeutics is a clinical-stage biopharmaceutical company, advancing targeted protein degradation science to develop a new ...

Wall Street expects a year-over-year increase in earnings on higher revenues when C4 Therapeutics, Inc. (CCCC) reports results for the quarter ended December 2023. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss ...

Table of Contents Table of Contents NOTE REGARDING COMPANY REFERENCES Table of Contents Table of Contents C4 Therapeutics, Inc. See accompanying notes to unaudited condensed consolidated financial statements. Table of Contents | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------------------------|--------------------------------|----------------------|-------|-------|----------------------------------------|-------------- ...

Financial Performance - For the six months ended June 30, 2023, the company reported a net loss of $70.7 million, compared to a net loss of $59.0 million for the same period in 2022[41]. - The company reported a comprehensive loss of $35.2 million for the quarter, compared to a comprehensive loss of $28.3 million in the previous quarter[30]. - The company reported a net loss of $35.922 million for the three months ended June 30, 2023, compared to a net loss of $27.412 million for the same period in 2022, reflecting an increase in losses of approximately 31.5%[124]. - The net cash used in operating activities was $52.1 million for the six months ended June 30, 2023, compared to $48.8 million for the same period in 2022[35]. - The company expects to continue incurring operating losses for the foreseeable future[41]. Cash and Securities - Cash, cash equivalents, and marketable securities totaled $286.7 million as of June 30, 2023, expected to fund operations for at least the next twelve months[41]. - The company reported cash equivalents and marketable securities totaling $286.450 million as of June 30, 2023, compared to $39.009 million at the end of 2022[46]. - The company’s total marketable securities, current and non-current, were valued at $241.819 million as of June 30, 2023[74]. - Total marketable securities as of June 30, 2023, amounted to $307.361 million, with gross unrealized losses of $4.141 million[104]. Research and Development - The company is focused on advancing its TORPEDO platform for developing small-molecule medicines targeting protein degradation[40]. - Research and development expenses for the first half of 2023 were $58.968 million, slightly up from $57.526 million in the same period of 2022[57]. - The company expects research and development expenses to continue to increase substantially in connection with planned preclinical and clinical development activities[103]. - The company has commenced clinical trials for three advanced product candidates: CFT7455, CFT8634, and CFT1946, initiated in June 2021, May 2022, and December 2022, respectively[215]. Collaboration Agreements - The company has a collaboration agreement with Roche, which includes potential milestone payments ranging from $260 million to $275 million for product development achievements[78]. - The Company entered into a collaboration and license agreement with Betta Pharma, receiving an upfront cash payment of $10.0 million and potential milestone payments of up to $357.0 million[81]. - Revenue from collaboration agreements for Q2 2023 was $2.664 million, a decrease of 80.7% compared to $13.834 million in Q2 2022[57]. - Revenue from the Biogen Agreement was $2.504 million for the three months ended June 30, 2023, down from $9.534 million in the same period of 2022, indicating a decline of about 73.8%[117]. Risks and Challenges - The company is subject to risks typical of early-stage life science companies, including the uncertainty of raising additional financing and the market acceptance of products[68]. - The company acknowledges the high risk of failure in product development, particularly for early-stage candidates[209]. - The company may need substantial additional funding to continue operations and pursue business objectives[203]. - The company faces significant risks in clinical development, including potential harmful side effects and market acceptance issues, which could hinder revenue generation[217]. Intellectual Property - Patent protection is crucial for competitive positioning; failure to secure patents could impair commercialization efforts[229]. - The company may become involved in expensive and time-consuming lawsuits to protect its intellectual property, which could adversely affect its financial condition[263]. - The company may need to license intellectual property from third parties, which may not be available on commercially reasonable terms, potentially adversely affecting its business and financial condition[265]. - The company filed a petition with the USPTO on May 1, 2023, seeking a post-grant review of U.S. patent number 11,414,416, which relates to compounds for the treatment of BRD9-related disorders[266]. Regulatory Environment - The FDA's approval process for product candidates is lengthy and unpredictable, potentially harming the company's business if marketing approval is not obtained[272]. - The company plans to seek Orphan Drug Designations for its product candidates, which could provide exclusivity but may not guarantee marketing rights if broader indications are pursued[278]. - The company must comply with extensive regulatory requirements for marketing, labeling, and promotion, with potential penalties for non-compliance[275]. - The company may face claims from third parties regarding intellectual property misappropriation, which could lead to litigation and loss of valuable rights[269]. Market and Commercialization - The market acceptance of the company's product candidates will depend on factors such as efficacy, side effects, pricing, and insurance coverage[224]. - The company may need to establish strategic partnerships to enhance its product development efforts, but faces competition and complexity in negotiations[223]. - The company’s ability to commercialize products may be affected by unfavorable pricing regulations and reimbursement practices in various countries[257]. - The successful commercialization of product candidates depends on third-party payors providing coverage and adequate reimbursement levels[281]. Financial Strategy - The company may raise additional capital in the future through the sale of shares or convertible securities, which could lead to stockholder dilution[293]. - There is uncertainty regarding the sustainability of an active trading market for the company's common stock, which may affect liquidity[293]. - The trading price of the company's common stock may be influenced by the research and reports published by industry or securities analysts[293]. - The company has broad discretion in the use of the capital raised, which may not be utilized effectively[295].

Financial Performance - Net cash used in operating activities for the three months ended March 31, 2023, was $(33,125) thousand, compared to $(26,596) thousand for the same period in 2022, indicating an increase in cash outflow [87] - Total net change in cash, cash equivalents, and restricted cash for the three months ended March 31, 2023, was $19,722 thousand, a significant improvement from $(30,120) thousand in the prior year [87] Marketable Securities - As of March 31, 2023, the company had marketable securities totaling $255.6 million, consisting of corporate debt securities, U.S. government debt securities, and U.S. Treasury securities [208] - The weighted-average maturity date of the company's marketable securities is 0.6 years, indicating a short-term investment strategy [208] Research and Development - The company is currently engaged in research and development programs, with ongoing clinical trials and preclinical studies, although specific timelines and results were not disclosed [86] - Future agreements with third parties for the manufacturing, development, and commercialization of product candidates are anticipated, contingent on regulatory approvals [86] - The company is focused on expanding its product candidates to address additional disease indications, although specific candidates were not mentioned [86] - The company is actively working on its TORPEDO technology platform, which is aimed at optimizing protein degradation [86] Risks and Challenges - The company faces risks related to the ongoing COVID-19 pandemic, which may impact its business operations and clinical trials [86] - The company acknowledges potential pricing and reimbursement challenges for its product candidates if they receive regulatory approval, particularly under the Inflation Reduction Act of 2022 [86]

C4 Therapeutics' Strategy and Pipeline - C4 Therapeutics' mission is to deliver on the promise of targeted protein degradation science to create a new generation of medicines that transform patients' lives[20, 114] - The company is focused on progressing multiple small molecule oncology degrader programs in the clinic to improve upon the standard of care[12, 40] - C4 Therapeutics is expanding the application of the TORPEDO platform through existing and new collaboration partners[13, 40] - C4 Therapeutics has a robust clinical pipeline with 4 oncology degraders against targets of high unmet need[20, 114] - An additional program is expected to enter the clinic by the end of 2023[21] CFT7455 (IKZF1/3 Degrader) - The approved IKZF1/3 degrader market is valued at $13 billion[30] - CFT7455 has the potential to become a backbone therapy for multiple myeloma due to its class-leading catalytic activity, selectivity, and high binding affinity[4, 45] - Phase 1 dose escalation data from the Phase 1/2 trials of CFT7455 is expected to be presented in the second half of 2023[40, 115] CFT8634 (BRD9 Degrader) - CFT8634 targets BRD9 for Synovial Sarcoma & SMARCB1-Null Solid Tumors[26, 60] - Phase 1 dose escalation data from the Phase 1/2 trials of CFT8634 is expected in the second half of 2023[40, 88, 115] - In front-line Synovial Sarcoma setting, Progression Free Survival (PFS) is ~7 months, and in relapsed refractory setting, PFS is ~5 months[61] CFT1946 (BRAF V600 Degrader) - CFT1946 targets BRAF-V600 Melanoma, Colorectal (CRC) & Non-Small Cell Lung Cancer (NSCLC)[26, 100] - The approved BRAF inhibitor market is approximately $2 billion[102] - Approximately 70-90% of BRAF mutations are V600[109] - C4 Therapeutics will advance the dose escalation portion of the Phase 1/2 trial and present new preclinical data in the first half of 2023[40, 115] CFT8919 (EGFR L858R Degrader) - CFT8919 targets EGFR L858R for Non-Small Cell Lung Cancer (NSCLC)[26, 111] - The approved EGFR inhibitor market is approximately $6 billion[112] - Osimertinib provides a PFS of 14.4 months for L858R mutations[73, 112] - C4 Therapeutics plans to submit an IND application for CFT8919 in the first half of 2023[113, 115]

Regulatory Compliance - The company is subject to various healthcare laws and regulations that may impact its business operations and financial arrangements, including the federal Anti-Kickback Statute and the False Claims Act [187]. - The company may face significant civil, criminal, and administrative penalties if found in violation of healthcare laws, which could include exclusion from government-funded healthcare programs [191]. - The company must ensure compliance with various state and federal consumer protection laws, which regulate marketplace activities and may impact its operations [189]. - The company may be subject to increased scrutiny from federal and state enforcement bodies regarding its interactions with healthcare providers [189]. Clinical Trials and Research - The Drug Administration Law of the PRC has adopted an implied approval system for clinical trials, allowing trials to proceed if no objections are received within 60 business days [186]. - The company is required to register and publish clinical trials conducted in China, ensuring transparency in its research activities [186]. - The NMPA's guidelines encourage the development of innovative oncology drugs, which may influence the company's research and development strategies [186]. Market Access and Pricing - The company must navigate complex reimbursement landscapes in both the U.S. and foreign jurisdictions, which may affect its product pricing and market access strategies [192]. - The centralized procedure for marketing authorization in the EU is mandatory for certain medicinal products, impacting the company's product launch strategies in Europe [185]. - Individual states in the U.S. are implementing regulations to control pharmaceutical pricing, which may affect competition and pricing strategies [1]. - Pricing negotiations for patented medicines in Canada are undergoing significant changes that may impact profitability for companies selling products there [2]. - Regional healthcare authorities are increasingly using bidding procedures to determine pharmaceutical product inclusion, potentially reducing demand for product candidates [1]. Legislative Changes - Legislative changes, such as the Affordable Care Act, have expanded Medicaid eligibility, potentially increasing the company's Medicaid rebate liability [193]. - The Inflation Reduction Act of 2022 (IRA) includes provisions that reduce the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025 [1]. - The IRA allows the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition [1]. - The removal of safe harbor protections for price reductions from pharmaceutical manufacturers under Part D has been delayed until January 1, 2027 [1]. - Legislation allowing drug reimportation could decrease prices received for developed products, adversely affecting future revenues [1]. Communication and Reporting - The company will make its Annual Report and other filings available on its website and intends to use various platforms for disclosing material non-public information [3].