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1月前
C4 Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Planning Activities Are Ongoing for Next Phase of Cemsidomide Clinical Development in Multiple Myeloma and Non-Hodgkin’s Lymphoma; Trials Expected to Initiate in Early 2026
CFT1946 Phase 1/2 Trial Continues to Progress Across Multiple Cohorts; Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025
Cash, Cash Equivalents and Marketable Securities of $267.3 million as of December 31, 2024; Expected to Provide Runway into 2027
WATERTOWN, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today reported financial results for the year ended December 31, 2024, as well as business updates.
“In 2024, C4T made significant progress across our degrader portfolio and our discovery collaborations. We shared clinical data from our two lead programs, where cemsidomide demonstrated a potential best-in-class profile, and CFT1946 demonstrated proof of mechanism and early signs of anti-tumor activity, and a third program, CFT8919, entered clinical development in Greater China. We also delivered two development candidates to Biogen and initiated a new discovery collaboration with Merck KGaA, Darmstadt, Germany,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Entering 2025, we continue to advance these clinical programs and operationalize the next phase of cemsidomide development to enable patient dosing in early 2026. We remain focused on unlocking value of cemsidomide and generating data from the Phase 1 trials of CFT1946 and CFT8919 to inform future development strategies for these programs.”
FOURTH QUARTER 2024 HIGHLIGHTS AND RECENT ACHIEVEMENTS
Cemsidomide:
Multiple Myeloma (MM)
In December 2024, at the Annual Society of Hematology (ASH) meeting, presented data from the ongoing dose escalation trial with cemsidomide in combination with dexamethasone. As of the data cutoff date of October 11, 2024, the 75 µg once daily (QD) dose level achieved an overall response rate (ORR) of 36 percent. Cemsidomide was well-tolerated across all dose levels.
The maximum tolerated dose has not yet been reached. Patients are enrolling at the 100 µg QD dose level.
Non-Hodgkin’s Lymphoma (NHL)
In December 2024, at ASH, presented data from the ongoing cemsidomide monotherapy dose escalation trial. As of the data cutoff date of October 11, 2024, cemsidomide demonstrated an ORR of 38 percent across all subtypes and doses studied. In peripheral T-cell lymphoma (PTCL), cemsidomide achieved an ORR of 44 percent and a 25 percent complete metabolic response rate.
The maximum tolerated dose has not yet been reached. Patients are enrolling at the 87.5 µg QD dose level.
CFT1946:
In October 2024, at the Targeted Protein Degradation Summit, presented new preclinical data demonstrating CFT1946 crosses the blood-brain barrier, with Kpuu values of 0.34-0.88, an important feature as a portion of patients with BRAF V600 mutant solid tumors develop brain metastases.
Continued to enroll patients with BRAF V600 mutations in the ongoing Phase 1/2 trial across multiple cohorts including monotherapy in melanoma, in combination with trametinib in melanoma and in combination with cetuximab in colorectal cancer (CRC).
CFT8919:
In November 2024, Betta Pharmaceuticals, with C4T support, initiated the Phase 1 clinical trial of CFT8919 in Greater China.
CORPORATE UPDATE:
Continued to evolve the Board of Directors with the appointment of biotechnology executive, Steve Hoerter, who has over three decades of executive management, commercial and board experience in oncology.
KEY UPCOMING MILESTONES
Cemsidomide:
Complete Phase 1 dose escalation and present data in MM and NHL in the second half of 2025.
Open expansion cohort(s) in PTCL as part of the current Phase 1/2 trial in the second half of 2025.
Enable initiation of the next phase of clinical development for MM and PTCL, with new studies expected to initiate in early 2026.
CFT1946:
Complete monotherapy Phase 1 dose escalation in BRAF V600 mutant solid tumors in the first half of 2025.
Present Phase 1 data in the second half of 2025, which will include: (1) CFT1946 monotherapy in BRAF V600 mutant solid tumors, (2) CFT1946 monotherapy expansion in melanoma and (3) CFT1946 in combination with cetuximab in CRC.
UPCOMING INVESTOR EVENTS
March 3, 2025 at 9:10 am ET: Management will be present at TD Cowen 44th Annual Healthcare Conference taking place March 3 – 5, 2025 in Boston, MA.
March 10, 2025: Management will participate in the Leerink Partners Global Healthcare Conference taking place March 9 – 12, 2025 in Miami, FL.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
Revenue: Total revenue for the fourth quarter and full year ended December 31, 2024 was $5.2 million and $35.6 million, respectively, compared to $3.3 million and $20.8 million for the prior year periods. The increase in revenue was primarily due to new collaborations with Merck KGaA, Darmstadt, Germany (MKDG) and Merck, as well as revenue related to our ongoing collaboration with Betta Pharmaceuticals. Total revenue for the full year 2024 reflects revenue recognized under our collaborations with Biogen, Betta Pharmaceuticals, Merck, MKDG and Roche, and total revenue recognized for the full year 2023 reflects revenue recognized under collaboration agreements with Biogen, Roche and Calico.
Research and Development (R&D) Expense: R&D expense for the fourth quarter and full year ended December 31, 2024 was $32.5 million and $110.6 million, respectively, compared to $30.4 million and $117.7 million for the prior year periods. The increase in R&D expense for the fourth quarter was primarily related to clinical trial expense as cemsidomide and CFT1946 continue to advance. The decrease in R&D expense for the full year was primarily due to reduced headcount and external services resulting from restructuring activities that occurred in January 2024.
General and Administrative (G&A) Expense: G&A expense for the fourth quarter and full year ended December 31, 2024 was $10.4 million and $42.1 million, respectively, remaining relatively flat compared to $10.3 million and $42.1 million for the prior year periods.
Net Loss and Net Loss per Share: Net loss for the fourth quarter and full year ended December 31, 2024 was $34.6 million and $105.3 million, respectively, compared to $34.8 million and $132.5 million for the prior year periods. Net loss per share for the fourth quarter and full year ended December 31, 2024 was $0.49 and $1.52, respectively, compared to $0.68 and $2.67 for the prior year periods.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2024 were $267.3 million, compared to $281.7 million as of December 31, 2023. The reduction in cash, cash equivalents and marketable securities during 2024 was primarily the result of $65.2 million of cash used in operating activities (net of $16 million received in milestone payments from Biogen), partially offset by $24.4 million in proceeds from the sale of shares of our common stock through our “at-the-market” offering arrangement and $20 million received under the Betta stock purchase agreement, all of which were previously disclosed. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2024 will enable the company to fund its operating plan into 2027.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable small-molecule degrader designed to be a more potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), with unique pharmacokinetic properties. Clinical data has shown that cemsidomide is well-tolerated. In MM, cemsidomide displays evidence of anti-myeloma activity and immunomodulatory effects. In NHL, cemsidomide displays evidence of anti-lymphoma
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4月前
C4 Therapeutics Presents Cemsidomide Phase 1 Data at the American Society for Hematology (ASH) Annual Meeting that Demonstrated Potential to Become Best-in-Class IKZF1/3 Degrader
In Multiple Myeloma, Cemsidomide in Combination with Dexamethasone at Highest Dose Level Explored to Date Achieved 36 Percent Overall Response Rate (ORR) and 45 Percent Clinical Benefit Rate (CBR); Responses Seen Across All Dose Levels
Multiple Myeloma Arm Demonstrated Well-Tolerated Safety Profile; On-Target Neutropenia Was Manageable With Low Rates of Febrile Neutropenia and Infections; No Treatment Emergent Adverse Events Leading to Dose Reduction
In Non-Hodgkin’s Lymphoma, Cemsidomide Monotherapy Demonstrated a 38 Percent ORR and 19 Percent Complete Metabolic Response (CMR) Rate Across All Subtypes; In Peripheral T-Cell Lymphoma (PTCL), Cemsidomide Achieved a 44 Percent ORR and 25 Percent CMR Rate
Cemsidomide is Well Positioned for Future Development in Multiple Myeloma Combination Regimens and Various Non-Hodgkin’s Lymphoma Subtypes and Therapeutic Regimens to Unlock Potential in Growing Markets
C4T To Host Webcast Today at 5 pm EST; Webcast Link Available Here
WATERTOWN, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today presented clinical data from the ongoing Phase 1 trial of cemsidomide, an orally bioavailable small molecule degrader of IKZF1/3, at the ASH Annual Meeting. Presentations included a poster highlighting results for cemsidomide in combination with dexamethasone in multiple myeloma, and an oral presentation delivering initial results for cemsidomide as a monotherapy for non-Hodgkin’s lymphoma. These presentations reinforce the potential of cemsidomide to become a backbone therapy of choice in both multiple myeloma and non-Hodgkin’s lymphoma where IKZF1/3 degradation is warranted.
C4T designed cemsidomide to be a more potent and selective degrader of IKZF1/3 with unique pharmacokinetic properties, with the goal to improve the therapeutic index to treat multiple myeloma and non-Hodgkin’s lymphoma—both alone and in combination with other therapeutic agents in these therapeutic areas.
“Cemsidomide continues to deliver clinical data demonstrating its potential to be used in both multi-refractory patients and as part of combination therapies across all lines of treatment for a significant number of patients with multiple myeloma or non-Hodgkin’s lymphoma,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We look forward to leveraging today’s data to inform clinical development strategies in both multiple myeloma and non-Hodgkin’s lymphoma that has the potential to unlock the value of cemsidomide for patients in need of innovative therapies across treatment lines.”
Multiple Myeloma (MM)
At the ASH Annual Meeting, C4T presented safety and anti-myeloma data demonstrating cemsidomide has the potential to become a best-in-class IKZF1/3 degrader used as a backbone therapy of choice for patients with multiple myeloma where IKZF1/3 degradation is warranted. These data support the future development of cemsidomide across treatment lines in combination with other anti-myeloma agents.
As of the data cutoff date of October 11, 2024, a total of 47 patients received cemsidomide in combination with dexamethasone across four dose levels (50 µg dosed Monday, Wednesday, Friday (MWF); 37.5 µg dosed once daily (QD); 62.5 µg QD; 75 µg QD). Patients were heavily pretreated, receiving a median of six prior therapies. All patients (100 percent) were triple-class exposed, defined as exposure to one or more immunomodulatory agents, one or more proteasome inhibitors, and one anti-CD38 antibody. Thirty-three patients (70 percent) received prior BCMA directed therapy. Thirty-one patients (66 percent) received prior CAR-T or T-cell engager therapy.
Safety: Cemsidomide in combination with dexamethasone was well tolerated.
As of the data cutoff date, 47 patients were evaluable for safety.
The most common adverse events (AEs) Grade 3 or above were neutropenia (n=18), anemia (n=10) and infections (n=8). No patients discontinued therapy due to neutropenia.
No patients experienced a treatment emergent adverse event that led to dose reduction.
The maximum tolerated dose has not yet been identified. Enrollment is currently ongoing at the 100 µg QD dose level.
Anti-myeloma activity: Cemsidomide in combination with dexamethasone demonstrated anti-myeloma activity across a broad range of doses, highlighting a wide therapeutic range.
As of the data cutoff, 42 patients were evaluable for anti-myeloma activity.
Across all dose levels, cemsidomide in combination with dexamethasone achieved a 26 percent ORR and a 40 percent clinical benefit rate (CBR).
At the highest dose level explored to date (75 µg QD), cemsidomide achieved a 36 percent ORR and a 45 percent CBR.
At the two highest dose levels evaluated to date (62.5 µg QD and 75 µg QD), 62 percent of patients remained on therapy as of the data cutoff date.
Binod Dhakal, M.D., M.S., associate professor of medicine, Medical College of Wisconsin, Division of Hematology, presented a poster highlighting the MM results. He commented: “The data presented at the ASH Annual Meeting demonstrate cemsidomide in combination with dexamethasone is active and well-tolerated over a range of doses in a heavily pretreated, relapsed/refractory multiple myeloma patient population—including a majority of patients who have received T-cell directed therapies who are challenging to treat. I look forward to cemsidomide’s continued development as a potential new treatment option for patients in the evolving myeloma landscape.”
C4T has identified 75 µg QD as a target dose for various dexamethasone combination regimens; as dose escalation continues, higher doses may also be considered. For immune-based combination strategies, C4T believes doses lower than 75 µg QD will be optimal based on anti-myeloma activity and immune activation observed in the previously disclosed monotherapy data set.
C4T has identified the following next steps in cemsidomide MM development:
Complete Phase 1 dose escalation trial in MM to establish go forward doses
Initiate initial combination trials
Engage regulatory authorities on registrational path
Non-Hodgkin’s Lymphoma (NHL)
At the ASH Annual Meeting, C4T also presented safety and anti-lymphoma data that reinforce C4T’s belief that IKZF1/3 degradation remains relevant in lymphoma. Based on the emerging anti-lymphoma signal demonstrated in patients with PTCL, C4T believes cemsidomide could be further developed in areas of high unmet need.
As of the data cutoff date of October 11, 2024, a total of 23 patients received cemsidomide monotherapy across five dose levels (25 µg MWF; 50 µg MWF QD; 37.5 µg QD; 62.5 µg QD; 100 µg QD). Patients were heavily pretreated, receiving a median of three prior therapies. Seventeen patients had refractory progressive PTCL and six patients had refractory progressive B-cell lymphoma.
Safety: Cemsidomide monotherapy was well tolerated and additional dose finding is ongoing.
As of the data cutoff, 23 patients were evaluable for safety.
The most common AEs Grade 3 or above were neutropenia (n=11), infections (n=6), febrile neutropenia (n=4) and anemia (n=4). No patients discontinued therapy due to neutropenia.
At this time, the maximum tolerated dose has not been defined. Two dose-limiting toxicities occurred at the 100 µg QD dose level. As a result, a 75 µg QD cohort was opened to refine the understanding of dose and safety in the NHL population; this cohort is currently enrolling patients. Escalation above 75 µg QD may be explored pending the outcome of the cohort.
Anti-lymphoma activity: Cemsidomide monotherapy demonstrated anti-lymphoma activity across a broad range of doses.
As of the data cutoff, 21 patients were evaluable for efficacy, 16 of which had PTCL.
Cemsidomide displays a differentiated pharmacokinetic profile with an approximate two-day half-life and an ability to induce rapid and potent degradation of IKZF1/3.
Across all dose levels explored, cemsidomide achieved a 38 percent ORR and 19 percent CMR rate.
In patients with PTCL, cemsidomide achieved a 44 percent ORR and 25 percent CMR rate.
Steve Horwitz, M.D., lymphoma specialist and cellular therapist, Memorial Sloan Kettering Cancer Center, delivered an oral presentation highlighting the NHL results at the ASH Annual Meeting. He commented: “I am pleased to share the first clinical data on monotherapy cemsidomide in non-Hodgkin’s lymphoma, which demonstrated its well-tolerated safety profile and compelling anti-lymphoma activity. These initial data are encouraging, particularly in PTCL where relapsed/refractory patients lack effective targeted therapies. We believe these Phase 1 monotherapy data demonstrate that cemsidomide is well suited for further development in earlier lines of treatment and in combination with other anti-lymphoma agents.”
C4T has identified the following next steps in cemsidomide NHL development:
Complete Phase 1 dose escalation trial and identify go forward dose
Initiate expansion cohort for PTCL
Engage regulatory authorities on registrational path
C4T Webcast for Analysts and Investors
C4T will host an investor webcast today December 8, 2024, at 5 pm EST. To join the webcast, please visit this link or the “Events & Presentations” page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable small-molecule degrader designed to be a more potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), with unique pharmacokinetic properties. Clinical data has shown that cemsidomide is well-tolerated. In MM, cemsidomide displays evidence of anti-myeloma activity and immunomodulatory effects. In NHL, cemsidomide displays evidence of anti-lymphoma activity. More information may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
About IKZF1/3
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5月前
C4 Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Cemsidomide Phase 1/2 Trial in Multiple Myeloma and non-Hodgkin’s Lymphoma Continues to Progress: Data from Both Indications to be Presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, CA
Initial Monotherapy CFT1946 Phase 1 Data Demonstrated Well-Tolerated Safety Profile and Early Evidence of Anti-tumor Activity; Phase 1/2 Trial Continues to Progress with Multiple Data Readouts Expected in 2025
Appointed Paige Mahaney, Ph.D. as Chief Scientific Officer Bringing More than 25 Years of Pharmaceutical and Biotech Experience
Cash, Cash Equivalents and Marketable Securities of $284.4 million as of September 30, 2024; Expected to Provide Runway into 2027
WATERTOWN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results today for the third quarter ended September 30, 2024, as well as recent business highlights.
“2024 has been a successful year for C4T marked by strong execution across our entire portfolio, which has continued to position us as a leader in targeted protein degradation science. We recently shared initial clinical data on CFT1946 demonstrating a well-tolerated safety profile and evidence of monotherapy anti-tumor activity in BRAF inhibitor exposed patients, and we delivered our second development candidate to Biogen,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “We look forward to continuing this momentum with cemsidomide Phase 1 data in multiple myeloma and in non-Hodgkin’s lymphoma being presented at ASH, and multiple CFT1946 data readouts expected in 2025. Our continued focus on discovery research, clinical development and collaborations sets us up for an exciting future and for the potential to improve patients’ lives.”
THIRD QUARTER 2024 AND RECENT ACHIEVEMENTS
Cemsidomide: Cemsidomide is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphoma (NHL).
Advanced the Phase 1/2 Clinical Trial. The cemsidomide Phase 1/2 trial in combination with dexamethasone for R/R MM and as a monotherapy for R/R NHL continues to enroll patients. Dose escalation continues as the maximum tolerated dose has not yet been reached. For the combination with dexamethasone MM arm, patients are now enrolling at dose level 6 (100 µg once daily (QD)) and enrollment in the dose level 5 (75 µg QD) expansion cohort is complete. The monotherapy NHL arm continues to progress and dose level 5 (100 µg QD) is the highest dose level evaluated to date.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the potential treatment of solid tumors including colorectal cancer (CRC), melanoma and non-small cell lung cancer (NSCLC).
Presented New Preclinical Data at the 7th Annual Targeted Protein Degradation (TPD) Summit: In October 2024, C4T shared new in vivo data for CFT1946 describing Kpu,u (range: 0.34 - 0.88), experimentally determined using independent methods in two different species. These results demonstrate CFT1946’s ability to cross the blood brain barrier and highlight the potential for activity in primary and metastatic central nervous system (CNS) disease.
Presented Monotherapy Clinical Data Demonstrating Proof of Mechanism and Early Evidence of Proof of Concept from the Ongoing CFT1946 Phase 1 Trial at the European Society for Medical Oncology (ESMO) Congress 2024: CFT1946 demonstrated a well-tolerated safety profile and evidence of monotherapy anti-tumor activity, which supports further clinical development as monotherapy and in combination with MEK and EGFR targeted therapies.
Advanced the Phase 1/2 Clinical Trial. The CFT1946 Phase 1/2 trial for BRAF V600 mutant solid tumors continues to enroll patients across multiple arms of the trial: CFT1946 Monotherapy Dose Escalation in BRAF V600 Mutant Solid Tumors: Patients continue to enroll in the 640 mg twice daily (BID) pharmacodynamic (PD) backfill cohort.CFT1946 Monotherapy Melanoma Expansion Cohorts: Enrollment at the 320 mg BID dose level is complete and patients are enrolling at the 640 mg BID dose level.CFT1946 with Cetuximab Phase 1b Dose Escalation for CRC: The 160 mg BID dose level has been declared safe and patients are enrolling at the 320 mg BID dose level.
RESEARCH UPDATES:
Presented at the 7th Annual TPD Summit Highlighting C4T’s TORPEDO® Platform: In October 2024, at the 7th Annual TPD Summit, C4T presented kinetics-based pharmacokinetic (PK) and PD models, demonstrating the company’s ability to predict clinical PD responses across target classes.
COLLABORATIONS:
Delivered Second Development Candidate to Biogen. In September 2024, C4T earned an additional $8 million milestone payment after Biogen accepted delivery of a second development candidate in an undisclosed indication. Biogen is responsible for all future clinical development and commercialization for this program. This marks the final development candidate under this strategic collaboration.
CORPORATE UPDATES:
In October 2024, C4T appointed Paige Mahaney, Ph.D., as the company’s chief scientific officer, succeeding Stew Fisher, Ph.D., who is retiring to pursue personal interests. Dr. Mahaney brings over 25 years of pharmaceutical executive leadership with multidisciplinary expertise in discovery research and development along with successfully building clinical portfolios across a wide range of disease indications and treatment modalities.
In September 2024, C4T appointed Stephen Fawell, Ph.D., to the Board of Directors. Dr. Fawell brings decades of experience leading discovery and development strategies for global pharmaceutical companies.
KEY UPCOMING MILESTONES
Cemsidomide:
Present updated dose escalation and expansion cohort data from the 50 µg M/W/F, 37.5 µg QD, 62.5 µg QD, and 75 µg QD dose levels in approximately 40 patients from the ongoing Phase 1/2 clinical trial with dexamethasone in R/R MM at the ASH Annual Meeting in December 2024.
Present dose escalation data from the 25 µg M/W/F, 50 µg M/W/F, 37.5 µg QD, 62.5 µg QD, and 100 µg QD dose levels in approximately 25 patients from the ongoing monotherapy Phase 1/2 clinical trial in R/R NHL at the ASH Annual Meeting in December 2024.
Complete Phase 1 dose exploration in R/R MM and R/R NHL by year-end.
CFT1946:
Initiate the Phase 1b dose escalation cohort evaluating CFT1946 in combination with trametinib in melanoma by year-end.
Present data from multiple anticipated readouts in 2025, including: Full monotherapy CFT1946 dose escalation cohorts in BRAF V600 mutant solid tumors.Expansion cohorts evaluating CFT1946 as a monotherapy in melanoma.Phase 1b dose escalation cohort evaluating CFT1946 in combination with cetuximab in CRC.
UPCOMING INVESTOR EVENTS:
November 20, 2024, at 8 am GT: Management will participate in a fireside chat at the Jefferies London Healthcare conference taking place in London, UK.
December 8, 2024: Management will host an investor call to discuss MM and NHL data from the ongoing Phase 1/2 trial of cemsidomide.
THIRD QUARTER 2024 FINANCIAL RESULTS
Revenue: Total revenue for the third quarter of 2024 was $15.4 million, compared to $11.1 million for the third quarter of 2023. The increase in revenue was primarily due to recognition of an $8.0 million milestone from Biogen as well as $2.9 million of revenue recognized under our license and supply agreement with Betta, partially offset by reduced revenue from our agreement with Roche due to the completion of research activities in the third quarter of 2023 for a nominated target. Total revenue for the third quarter of 2024 reflects revenue recognized under our collaborations with Biogen, Betta, Merck, Merck KGaA, Darmstadt, Germany (MKDG) and Roche, and total revenue recognized in the third quarter of 2023 reflects revenue recognized under collaboration agreements with Biogen and Roche.
Research and Development (R&D) Expense: R&D expense for the third quarter of 2024 was $31.8 million, compared to $28.3 million for the third quarter of 2023. The increase in R&D expense was primarily due to increased clinical trial expense as cemsidomide and CFT1946 continue to advance, partially offset by lower personnel costs.
General and Administrative (G&A) Expense: G&A expense was $11.8 million for the third quarter of 2024, compared to $10.5 million for the third quarter of 2023. The increase in G&A expense was primarily attributable to higher personnel expense related to stock-based compensation.
Net Loss and Net Loss per Share: Net loss for the third quarter of 2024 was $24.7 million, compared to $27.0 million for the third quarter of 2023. Net loss per share for the third quarter of 2024 was $0.35 compared to $0.55 for the third quarter of 2023.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of September 30, 2024 were $284.4 million, compared to $295.7 million as of June 30, 2024, and $281.7 million as of December 31, 2023. The reduction in cash, cash equivalents and marketable securities during the third quarter was primarily the result of cash used in operating activities, partially offset by $10.3 million in net proceeds raised through our at-the-market (ATM) facility. C4T expects that its cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund planned operating expenses and capital expenditures into 2027.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
About Cemsidomide
Cemsidomide is an orally bioavailable MonoDAC® degrader designed to be highly potent and selective against its intended targets of Ikaros (IKZF1) and Aiolos (IKZF3) and overcome shortcomings of currently approved therapies to treat multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). Cemsidomide is currently in a Phase 1 dose escalation study in MM and NHL. Initial clinical data show cemsidomide is well tolerated, demonstrates anti-myeloma activity and displays evidence of immunomodulatory effects. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
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6月前
C4 Therapeutics Appoints Paige Mahaney, Ph.D., as Chief Scientific Officer and Announces Retirement of Stewart Fisher, Ph.D.
Mahaney Brings More Than 25 Years of Pharmaceutical and Biotech Experience Overseeing Drug Discovery and Expansion of Leading Discovery and Clinical Portfolios
Fisher Will Serve as Senior Scientific Advisor Until December 31, 2024
WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the appointment of Paige Mahaney, Ph.D. as the company’s chief scientific officer (CSO), effective October 28, 2024, following the decision of Stewart (Stew) Fisher, Ph.D. to retire and pursue personal interests. Dr. Fisher will serve as senior scientific advisor through the end of 2024 and as a consultant to C4T through the end of 2025.
“We are excited to welcome Paige and look forward to utilizing her deep experience in expanding clinical portfolios at some of the world’s most prominent pharmaceutical organizations. Her expertise in leading innovation and pushing the boundaries of what’s possible with existing modalities, including degraders, will be instrumental as we look to further investigate the promise of targeted protein degradation,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “I would like to express profound gratitude to Stew for his contributions to both C4 Therapeutics and the entire targeted protein degradation field where he catalyzed research that is helping advance new therapies toward patients. Stew’s leadership over the past eight years has helped C4T build an exceptional platform that positions us to continue our evolution toward becoming a fully integrated biopharmaceutical company.”
“As I closely followed the targeted protein degradation field and its exciting advances in recent years, I was drawn to C4T because of the demonstrated ability of the TORPEDO® platform to consistently deliver highly catalytic, orally bioavailable degrader candidates across a wide range of target classes that have the potential to transform how medicine is practiced,” said Dr. Mahaney. “I am thrilled to join C4 Therapeutics at this exciting time as we focus on opportunities to leverage our innovative science and further extend our leadership in targeted protein degradation science.”
Dr. Mahaney’s experience in pharmaceutical executive leadership spans more than 25 years, with multidisciplinary expertise in discovery research and development along with successfully building clinical portfolios across a wide range of disease indications and treatment modalities. Most recently, she served as senior vice president and corporate head of drug discovery at Exelixis, Inc., where she was responsible for the strategy and execution of the company’s drug discovery portfolio as well as advancing the early clinical pipeline. In just over three years at Exelixis, she built the discovery team and a state-of-the-art discovery platform while advancing multiple candidates toward investigational new drug applications and clinical trials, including a USP-1 inhibitor, XL309, and XL495, a PKMYT1 inhibitor. Prior to Exelixis, she spent over 10 years at Boehringer Ingelheim Pharmaceuticals, Inc. focused on pipeline expansion and discovery in positions including senior vice president, global head of biotherapeutics discovery and discovery research site head; senior vice president, head of small molecule discovery and discovery research site head; and vice president, head of small molecule discovery. While at Boehringer Ingelheim, Dr. Mahaney’s teams were responsible for delivering drug candidates to the company’s global clinical portfolio, including several investigational assets in oncology, immunology, cardiometabolic, inflammation and respiratory and orphan diseases, many of which have received FDA regulatory pathways including accelerated approval or breakthrough therapy designation. These include important contributions to the advancement of Spevigo®, a first-in-class IL36R blocking antibody for generalized pustular psoriasis; BI 764532, a first-in-class bi-specific T-Cell engager for neuroendocrine carcinomas and small cell lung carcinoma; and avenciguat, a small molecule activator of soluble guanyl cyclase for systemic sclerosis. Earlier in her career, she held scientist roles in medicinal chemistry at Hoffman-La Roche, Inc. and Wyeth Pharmaceuticals. She received her B.S. in chemistry from Guilford College and her Ph.D. in organic chemistry from the Massachusetts Institute of Technology (MIT).
Throughout his distinguished career, Dr. Fisher has dedicated himself, in academic and industry capacities, to identifying and discovering compounds to help advance treatments for patients. He joined C4T in 2016 and has served as the company’s CSO since 2018. While at C4T, he supported the development and evolution of the company’s TORPEDO® platform and led the development of a library of over 10,000 Cereblon ligands constructed from over 200 unique scaffolds. Dr. Fisher has spearheaded the identification, characterization and optimization of novel, selective, orally bioavailable BiDAC™ and MonoDAC™ degraders that have resulted in a total of six development candidates across a wide range of target classes delivered to C4T’s clinical pipeline or a collaboration partner. Under his leadership, C4T has advanced three novel degraders into the clinic and partnered with global pharmaceutical companies to further extend the reach of targeted protein degradation.
“It has been my honor to work alongside talented professionals at C4 Therapeutics to quickly advance the field of targeted protein degradation and bring several degraders into the clinic,” said Stew Fisher, Ph.D. “As I look forward to this exciting chapter of my personal life, I am also excited about the future of C4 Therapeutics with Paige’s leadership and innovation in place to help ensure our science will continue to push the boundaries of scientific discovery to positively impact patients.”
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.
subslover
7月前
More very nice news! The webcast is at noon EST. I'm not gonna listen will wait for the transcript
C4 Therapeutics Presents Monotherapy Data Demonstrating Proof of Mechanism and Early Evidence of Proof of Concept From Ongoing CFT1946 Phase 1 Trial in BRAF V600 Mutant Solid Tumors at the European Society for Medical Oncology (ESMO) Congress 2024
CFT1946 Is Well-Tolerated at All Dose Levels; No Dose-Limiting Toxicities
CFT1946 Achieves Dose Proportional Pharmacokinetic Exposure; Successfully Degrades BRAF V600 Mutant Protein
Early Evidence of CFT1946 Monotherapy Anti-Tumor Activity in Patients Who Have Progressed on or After BRAF Inhibitor Therapies; Majority of Patients Demonstrated Tumor Reduction Across V600 Mutation Types
CFT1946 Global Phase 1 Trial Continues to Enroll; Monotherapy and Combination Expansion Cohorts Advancing With Additional Data Expected in 2025
C4T To Host Webcast Today at 12:00 pm ET; Webcast Link Available Here
WATERTOWN, Mass., Sept. 13, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced initial clinical data from the ongoing clinical trial of CFT1946, an orally bioavailable small molecule degrader of BRAF V600 mutations in solid tumors. These data, the first clinical results for a BRAF V600X degrader, were shared as a proffered paper in an oral presentation by Maria Vieito, M.D., MSc, medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain, at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13 – 17 in Barcelona, Spain.
“We are thrilled to share initial CFT1946 monotherapy data and highlight how this molecule, the first and only clinical-stage degrader of BRAF V600 mutants, may disrupt the current treatment landscape as it quickly progresses through clinical development,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “In addition to addressing the needs of patients with BRAF V600 mutant solid tumors, we believe these clinical data further reinforce the potential of our TORPEDO® platform to design innovative small molecule degraders that excite the medical community and have the potential to improve patients’ lives.”
“The data presented at the ESMO Congress 2024 are impressive given the early stage of development of CFT1946 and the novel modality,” said Dr. Vieito. “I am especially encouraged by the safety and tolerability of CFT1946, which may allow for additional monotherapy exploration as well as combination approaches to better understand how this oral degrader medicine may support the needs of patients refractory to BRAF inhibitor therapies.”
“We are pleased with the safety profile CFT1946 has demonstrated over a range of doses, as well as its pharmacokinetics, pharmacodynamics and initial anti-tumor activity. Taken together, these data support our hypothesis that degradation may offer a new therapeutic option over inhibition for BRAF V600 mutant solid tumors,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We are deeply appreciative of the contributions from patients, caregivers and the oncology community that have enabled us to deliver this preliminary monotherapy data and we look forward to continuing these important relationships as we progress CFT1946 toward additional milestones in 2025 and beyond.”
At the ESMO Congress 2024, C4T reported initial monotherapy data from the ongoing dose escalation Phase 1 clinical trial evaluating twice daily oral dosing of CFT1946, a degrader of BRAF V600 mutants, in patients with BRAF V600X solid tumors who have received at least one prior standard of care therapy for unresectable locally advanced or metastatic disease. Prior therapy must include a BRAF inhibitor, unless access is limited by regional regulatory approvals or reimbursement. As of the data cutoff date of July 19, 2024, a total of 36 patients received CFT1946 monotherapy across five dose escalation cohorts (20 mg BID, 80 mg BID, 160 mg BID, 320 mg BID and 640 mg BID). Patients received a median of three prior therapies; 35 patients (97 percent) had received prior BRAF inhibitor therapy. Thirty-three patients (92 percent) had a BRAF V600E mutation, two patients (six percent) had a BRAF V600K mutation and one patient (two percent) had a BRAF V600R mutation. Fourteen patients (39 percent) had melanoma, 14 patients (39 percent) had colorectal cancer, two patients (six percent) had non-small cell lung cancer and six patients (17 percent) had other cancers. All patients had unresectable, locally advanced or metastatic disease, and 32 patients (89 percent) entered the study with Stage IV cancer.
Safety and Tolerability: CFT1946 has a well-tolerated safety profile that supports further clinical development as monotherapy and in combination with MEK and EGFR inhibitors.
There were no dose-limiting toxicities and no treatment-related serious adverse events.
Adverse events occurring in more than 10 percent of patients were all Grade 1 or Grade 2.
No patients discontinued therapy or experienced treatment interruptions due to treatment-related adverse events.
No patients receiving CFT1946 monotherapy experienced a Grade 3 or higher treatment-related cutaneous adverse event. These cutaneous adverse events, which are related to BRAF wild-type inhibition, are commonly seen with BRAF inhibitors.
Pharmacokinetics (PK) and Pharmacodynamics (PD): Initial data demonstrating dose-dependent bioavailability and degradation of BRAF V600E protein support CFT1946 proof of mechanism.
CFT1946 exhibits dose-dependent bioavailability in the five dose levels explored to date.
In all available post-treatment biopsies collected to date, degradation of BRAF V600E protein is observed.
Anti-Tumor Activity: CFT1946 demonstrates evidence of monotherapy anti-tumor activity, supportive of early proof of degrader concept.
At data cutoff, 27 patients were evaluable for anti-tumor activity, which is measured by RECIST 1.1 criteria. 16 patients demonstrated reduction of target metastatic lesions.Two patients achieved a confirmed Partial Response.
Reduction of target lesion tumors was observed across histologies. Of the 27 patients evaluable for anti-tumor activity: Eleven patients had melanoma, eight of whom had evidence of tumor reduction. One patient with Stage IV BRAF V600K melanoma enrolled in the 320 mg BID cohort achieved a 67 percent decrease in target lesions as measured by RECIST 1.1 criteria. This patient remains on CFT1946 treatment and in response.Nine patients had colorectal cancer, three of whom had evidence of tumor reduction.Seven patients have other tumor histologies, three of whom had evidence of tumor reduction. One patient with Stage IV BRAF V600E pancreatic cancer, who has liver metastases, enrolled in the 640 mg BID cohort achieved a 55 percent decrease in target lesion as measured by RECIST 1.1 criteria. This patient remains on CFT1946 treatment and in response.
As of data cutoff, 11 of the patients who were evaluable for anti-tumor activity remain on therapy.
Next Steps and Future Milestones for CFT1946
The CFT1946 Phase 1 trial is ongoing and multiple indication-specific cohorts are advancing. Next steps and related milestones for CFT1946 include:
Complete Phase 1 monotherapy dose escalation – This portion of the trial is enrolling patients with BRAF V600X mutations across solid tumor indications. Patients are currently enrolling in the 640 mg BID PD backfill cohort as this dose level was recently declared safe. The full monotherapy dose escalation data are expected in 2025.
Complete expansion cohort exploring CFT1946 monotherapy in melanoma – This Phase 1 exploratory expansion cohort is evaluating the potential of CFT1946 monotherapy for melanoma patients refractory to BRAF inhibitor therapies. Enrollment for the 320 mg BID dose level is complete, and enrollment is ongoing for the 640 mg BID dose level. Data from these dose levels are expected in 2025.
Complete dose escalation cohort exploring CFT1946 in combination with cetuximab in colorectal cancer – This Phase 1b dose escalation cohort is enrolling patients at the 160 mg BID dose level to explore safety and tolerability, PK, PD and anti-tumor activity of CFT1946 in combination with cetuximab. These data are expected in 2025.
Initiate dose escalation cohort exploring CFT1946 in combination with trametinib in melanoma – This Phase 1b dose escalation cohort will explore safety and tolerability, PK, PD and anti-tumor activity of CFT1946 in combination with trametinib. C4T expects to initiate this cohort by year-end 2024.
C4T Webcast for Analysts and Investors
C4T will host an investor webcast today, September 13, 2024, at 12:00 pm ET. To join the webcast, please visit this link or the “Events & Presentations” page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event.
About BRAF V600 Mutant Solid Tumors
BRAF mutations are found in approximately five percent of all cancers, including melanoma, colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and other malignancies. Of these BRAF mutation cancer diagnoses, up to 90 percent contain an activating BRAF V600 mutation. BRAF V600 mutations are observed in up to 50 percent of patients with melanoma, nearly 10 percent of patients with CRC and approximately five percent of patients with NSCLC. Resistance to FDA-approved BRAF inhibitors results in median progression-free survival rates of less than 15 months across all indications.
About CFT1946
CFT1946 is an investigational, orally bioavailable small molecule degrader of BRAF V600 mutations in solid tumors currently being evaluated in a Phase 1/2 global clinical trial in patients refractory to BRAF inhibitors. CFT1946 is designed to be potent and selective against the BRAF V600 mutant form. Initial clinical data from the Phase 1 trial demonstrate that CFT1946 has a well-tolerated safety profile, demonstrates dose-dependent bioavailability and degradation of BRAF V600E protein, and demonstrates evidence of monotherapy anti-tumor activity. CFT1946 is the only degrader of BRAF V600 mutant solid tumors in clinical trials. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT05668585).
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
subslover
7月前
C4 Therapeutics Announces Delivery of Second Development Candidate to Biogen
Milestone Results in $8 Million Payment to C4 Therapeutics
WATERTOWN, Mass., Sept. 10, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced it has successfully delivered a second development candidate to Biogen and earned an $8 million milestone payment. This marks the final development candidate under this strategic collaboration.
“We are thrilled to deliver a highly catalytic, brain penetrant orally bioavailable BiDAC™ degrader development candidate to Biogen in their pursuit of discovering, developing and delivering innovative therapies that improve the lives of patients,” said Andrew Hirsch, president and chief executive officer. “It is rare that discovery collaborations deliver one, much less two, development candidates to the partner. This result is a testament to the dedication of the Biogen and C4T teams and the productivity of our TORPEDO® platform, which has demonstrated its potential to design innovative degraders against a broad range of target classes. Since our founding in 2015, we have discovered and advanced four development candidates for our clinical pipeline and delivered two development candidates to Biogen, an impressive feat for a company of our size. We are proud to continue advancing the exciting field of targeted protein degradation and bring new medicines to patients.”
Under the terms of the strategic collaboration established in 2018, C4T provided expertise and research services in targeted protein degradation and Biogen provided scientific and drug development capabilities. Biogen is responsible for all future clinical development and commercialization for development candidates delivered under the collaboration. Previously, C4T earned an $8 million payment in April 2024 after Biogen accepted delivery of a first development candidate in an undisclosed indication as part of this collaboration.
subslover
7月前
C4 Therapeutics to Present Preliminary CFT1946 Monotherapy Phase 1 Clinical Data at the European Society for Medical Oncology (ESMO) Congress 2024
Abstract Released Today Highlights Favorable Safety Profile and Early Evidence of Monotherapy Anti-Tumor Activity
Investor Webcast to be Held Friday, September 13, 2024 at 12:00 pm ET
WATERTOWN, Mass., Sept. 08, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the abstract sharing clinical data from its ongoing Phase 1 clinical trial of CFT1946, a novel BiDAC™ degrader, in mutant BRAF V600 solid tumors, was released in conjunction with the ESMO Congress 2024 scheduled for September 13 – 17, 2024 in Barcelona, Spain. The full abstract, which includes results with a data cut-off of April 12, 2024, can be accessed on the ESMO Congress 2024 website.
Data on 36 patients, with a data cut-off date of July 19, 2024, will be presented as a proffered paper in an oral presentation scheduled for Friday, September 13, 2024 at 4:10 pm CEST (10:10 am ET) at the ESMO Congress 2024. This oral presentation will include patient demographics, safety, pharmacokinetic, pharmacodynamic and anti-tumor activity data as measured by RECIST 1.1 criteria.
ESMO Congress 2024 Presentation
Title: Preliminary Results from a Phase 1 Study of CFT1946, a Novel BiDAC™ Degrader in Mutant BRAF V600 Solid Tumors
Presentation Date and Time: Friday, September 13, 2024, 4:10 pm CEST (10:10 am ET)
Final Publication Number: 612O
Session Category: Proffered paper session 1
Session Title: Developmental therapeutics
Location: Santander Auditorium – Hall 5
Presenter: Maria Vieito, M.D., MSc (Barcelona, Spain)
C4T Webcast for Analysts and Investors
C4T will host a webcast on Friday, September 13, 2024 at 12:00 pm ET. To join the webcast, please visit this link or the “Events & Presentations” page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event. Additionally, following the proffered paper session at the ESMO Congress 2024, C4T will share that presentation on its website under the Scientific Presentations and Publications page.
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