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C4 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights
Updated Cemsidomide Multiple Myeloma Data Further Demonstrate Compelling Response Rates at Multiple Doses and Potential for Best-in-Class Profile; 50% ORR Observed at the Highest Dose Level of 100 µg, Including One Patient With a Minimal Residual Disease Negative Complete Response; 40% ORR Achieved at the 75 µg Dose Level
Cemsidomide Multiple Myeloma Dose Escalation is Complete; FDA Feedback Expected by Mid-Year 2025 to Support Initiation of Next Phase of Development in Early 2026
Portfolio Decision to Prioritize Cemsidomide Development; C4T to Seek Partnership Opportunities to Advance BRAF Program
CFT8919 Phase 1 Trial Continues to Advance in Partnership with Betta Pharmaceuticals; Discovery Platform Achieves Two Preclinical Milestones Under the Roche Collaboration
Cash, Cash Equivalents and Marketable Securities of $234.7 Million as of March 31, 2025 Expected to Provide Runway Into 2027
WATERTOWN, Mass., May 07, 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 first quarter ended March 31, 2025, as well as business updates.
“2025 has been marked by focused execution across C4T to generate key data to optimize development plans across our clinical portfolio. With cemsidomide demonstrating compelling overall response rates at multiple dose levels, including one multiple myeloma patient at 100 µg who achieved a minimal residual disease negative complete response, we are prioritizing progressing cemsidomide to the next phase of development to realize its potential to be a best-in-class IKZF1/3 degrader,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “With the achievement of two preclinical milestones in our Roche collaboration, we continue to demonstrate the productivity of our TORPEDO platform to discover highly catalytic, orally bioavailable, and brain penetrant degraders. We remain focused on maximizing our cash runway, which includes advancing cemsidomide and pursuing our internal discovery pipeline focused on targets with a clear degrader rationale and compelling biology applicable to a broad range of therapeutic areas.”
FIRST QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS
Cemsidomide:
Phase 1 dose escalation is complete in multiple myeloma (MM) with the 100 µg once daily (QD) dose level declared safe for expansion; 10 additional patients will be treated in a 100 µg QD expansion cohort to further characterize cemsidomide’s safety and efficacy profile at this dose level.
Cemsidomide MM topline data demonstrate compelling responses rates at multiple doses: As of the data cutoff date of April 30, 2025, 10 patients have been treated at the 100 µg QD dose level, achieving an overall response rate (ORR) of 50 percent. Notably, one patient who previously progressed on two prior T-cell engager therapies achieved a minimal residual disease (MRD) negative complete response (measured by flow cytometry). Eight patients (80 percent) treated at this dose level received prior CAR-T or T-cell engager therapy.Since October 11, 2024, six additional patients have been treated for a total of 20 patients treated at the 75 µg QD dose level. As of the data cutoff date of April 30, 2025, the 75 µg QD dose level achieved an ORR of 40 percent.Cemsidomide remains well-tolerated with manageable neutropenia.
For the non-Hodgkin’s lymphoma (NHL) arm, the Phase 1 dose escalation is ongoing at the 87.5 µg QD dose level and the maximum tolerated dose has not yet been reached.
C4T expects to receive regulatory feedback on registrational development by mid-year 2025.
CFT1946:
Phase 1 dose escalation is complete with 640 mg BID declared as the maximum administered dose. Across the trial, which includes the dose escalation, melanoma and colorectal cancer cohorts, 89 patients were treated.
The pharmacodynamic and safety data, including the data presented at the European Society for Medical Oncology (ESMO) Congress 2024, supports proof of mechanism and the therapeutic potential of degrading the BRAF V600 mutant protein.
Given emerging clinical data and the company’s focus on strategic capital allocation, C4T will not advance CFT1946 beyond the ongoing Phase 1 trial. C4T has made the decision to seek partnership opportunities to advance the BRAF program given the high unmet need and strong degrader rationale for treating BRAF V600 mutant solid tumors.
The CFT1946 Phase 1 data will be presented at a future medical meeting.
CFT8919:
Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery Collaborations:
Advanced Roche collaboration to preclinical milestones. In March 2025, C4T earned a total of $4 million in payments upon achieving certain preclinical milestones for two programs. C4T and Roche continue to advance these programs.
C4T continues to advance its internal research pipeline focused on targets in therapeutic areas in and beyond oncology with a strong degrader rationale and genetic link to disease.
KEY UPCOMING MILESTONES
Present data from completed cemsidomide Phase 1 dose escalation in MM in Q3 2025.
Complete cemsidomide Phase 1 dose escalation in NHL and present data in Q4 2025.
Open expansion cohort(s) in PTCL as part of the current cemsidomide Phase 1/2 trial in the second half of 2025.
Enable initiation of the next phase of clinical development for cemsidomide with new studies expected to initiate in early 2026.
UPCOMING INVESTOR EVENTS
June 4, 2025: Management will participate in the Jefferies Global Healthcare Conference taking place from June 3 – June 5, 2025 in New York, New York.
FIRST QUARTER 2025 FINANCIAL RESULTS
Revenue: Total revenue for the first quarter of 2025 was $7.2 million, compared to $3.0 million for the first quarter of 2024. The increase in revenue was primarily due to our collaborations with Merck KGaA, Darmstadt, Germany (MKDG), which commenced in March 2024, as well as our achievement of two preclinical milestones under our Roche collaboration.
Research and Development (R&D) Expense: R&D expense for the first quarter of 2025 was $27.1 million compared to $22.5 million for the first quarter of 2024. The increase in R&D expense was primarily related to clinical trial expenses for cemsidomide and CFT1946, in addition to increased preclinical spend as our research collaborations continue to advance.
General and Administrative (G&A) Expense: G&A expense for the first quarter of 2025 was $9.3 million compared to $10.3 million for the first quarter of 2024. The decrease was primarily a result of reduced personnel costs related to our 2024 restructuring activities.
Net Loss and Net Loss per Share: Net loss for the first quarter of 2025 was $26.3 million, compared to $28.4 million for the first quarter of 2024. Net loss per share for the first quarter of 2025 was $0.37 compared to $0.41 for the first quarter of 2024.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2025 were $234.7 million, compared to $267.3 million as of December 31, 2024. The decrease was primarily the result of cash used in operating activities. The balance as of March 31, 2025 is exclusive of the $4.0 million in milestones earned under our Roche collaboration, which the company expects to receive in the second quarter of 2025. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 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 activity. More information may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946
C4T has advanced preclinical and clinical research to explore how targeted protein degradation may offer improvement over approved therapies that inhibit mutant BRAF V600. C4T advanced CFT1946, an investigationa
C4 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights
Updated Cemsidomide Multiple Myeloma Data Further Demonstrate Compelling Response Rates at Multiple Doses and Potential for Best-in-Class Profile; 50% ORR Observed at the Highest Dose Level of 100 µg, Including One Patient With a Minimal Residual Disease Negative Complete Response; 40% ORR Achieved at the 75 µg Dose Level
Cemsidomide Multiple Myeloma Dose Escalation is Complete; FDA Feedback Expected by Mid-Year 2025 to Support Initiation of Next Phase of Development in Early 2026
Portfolio Decision to Prioritize Cemsidomide Development; C4T to Seek Partnership Opportunities to Advance BRAF Program
CFT8919 Phase 1 Trial Continues to Advance in Partnership with Betta Pharmaceuticals; Discovery Platform Achieves Two Preclinical Milestones Under the Roche Collaboration
Cash, Cash Equivalents and Marketable Securities of $234.7 Million as of March 31, 2025 Expected to Provide Runway Into 2027
WATERTOWN, Mass., May 07, 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 first quarter ended March 31, 2025, as well as business updates.
“2025 has been marked by focused execution across C4T to generate key data to optimize development plans across our clinical portfolio. With cemsidomide demonstrating compelling overall response rates at multiple dose levels, including one multiple myeloma patient at 100 µg who achieved a minimal residual disease negative complete response, we are prioritizing progressing cemsidomide to the next phase of development to realize its potential to be a best-in-class IKZF1/3 degrader,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “With the achievement of two preclinical milestones in our Roche collaboration, we continue to demonstrate the productivity of our TORPEDO platform to discover highly catalytic, orally bioavailable, and brain penetrant degraders. We remain focused on maximizing our cash runway, which includes advancing cemsidomide and pursuing our internal discovery pipeline focused on targets with a clear degrader rationale and compelling biology applicable to a broad range of therapeutic areas.”
FIRST QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS
Cemsidomide:
Phase 1 dose escalation is complete in multiple myeloma (MM) with the 100 µg once daily (QD) dose level declared safe for expansion; 10 additional patients will be treated in a 100 µg QD expansion cohort to further characterize cemsidomide’s safety and efficacy profile at this dose level.
Cemsidomide MM topline data demonstrate compelling responses rates at multiple doses: As of the data cutoff date of April 30, 2025, 10 patients have been treated at the 100 µg QD dose level, achieving an overall response rate (ORR) of 50 percent. Notably, one patient who previously progressed on two prior T-cell engager therapies achieved a minimal residual disease (MRD) negative complete response (measured by flow cytometry). Eight patients (80 percent) treated at this dose level received prior CAR-T or T-cell engager therapy.Since October 11, 2024, six additional patients have been treated for a total of 20 patients treated at the 75 µg QD dose level. As of the data cutoff date of April 30, 2025, the 75 µg QD dose level achieved an ORR of 40 percent.Cemsidomide remains well-tolerated with manageable neutropenia.
For the non-Hodgkin’s lymphoma (NHL) arm, the Phase 1 dose escalation is ongoing at the 87.5 µg QD dose level and the maximum tolerated dose has not yet been reached.
C4T expects to receive regulatory feedback on registrational development by mid-year 2025.
CFT1946:
Phase 1 dose escalation is complete with 640 mg BID declared as the maximum administered dose. Across the trial, which includes the dose escalation, melanoma and colorectal cancer cohorts, 89 patients were treated.
The pharmacodynamic and safety data, including the data presented at the European Society for Medical Oncology (ESMO) Congress 2024, supports proof of mechanism and the therapeutic potential of degrading the BRAF V600 mutant protein.
Given emerging clinical data and the company’s focus on strategic capital allocation, C4T will not advance CFT1946 beyond the ongoing Phase 1 trial. C4T has made the decision to seek partnership opportunities to advance the BRAF program given the high unmet need and strong degrader rationale for treating BRAF V600 mutant solid tumors.
The CFT1946 Phase 1 data will be presented at a future medical meeting.
CFT8919:
Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery Collaborations:
Advanced Roche collaboration to preclinical milestones. In March 2025, C4T earned a total of $4 million in payments upon achieving certain preclinical milestones for two programs. C4T and Roche continue to advance these programs.
C4T continues to advance its internal research pipeline focused on targets in therapeutic areas in and beyond oncology with a strong degrader rationale and genetic link to disease.
KEY UPCOMING MILESTONES
Present data from completed cemsidomide Phase 1 dose escalation in MM in Q3 2025.
Complete cemsidomide Phase 1 dose escalation in NHL and present data in Q4 2025.
Open expansion cohort(s) in PTCL as part of the current cemsidomide Phase 1/2 trial in the second half of 2025.
Enable initiation of the next phase of clinical development for cemsidomide with new studies expected to initiate in early 2026.
UPCOMING INVESTOR EVENTS
June 4, 2025: Management will participate in the Jefferies Global Healthcare Conference taking place from June 3 – June 5, 2025 in New York, New York.
FIRST QUARTER 2025 FINANCIAL RESULTS
Revenue: Total revenue for the first quarter of 2025 was $7.2 million, compared to $3.0 million for the first quarter of 2024. The increase in revenue was primarily due to our collaborations with Merck KGaA, Darmstadt, Germany (MKDG), which commenced in March 2024, as well as our achievement of two preclinical milestones under our Roche collaboration.
Research and Development (R&D) Expense: R&D expense for the first quarter of 2025 was $27.1 million compared to $22.5 million for the first quarter of 2024. The increase in R&D expense was primarily related to clinical trial expenses for cemsidomide and CFT1946, in addition to increased preclinical spend as our research collaborations continue to advance.
General and Administrative (G&A) Expense: G&A expense for the first quarter of 2025 was $9.3 million compared to $10.3 million for the first quarter of 2024. The decrease was primarily a result of reduced personnel costs related to our 2024 restructuring activities.
Net Loss and Net Loss per Share: Net loss for the first quarter of 2025 was $26.3 million, compared to $28.4 million for the first quarter of 2024. Net loss per share for the first quarter of 2025 was $0.37 compared to $0.41 for the first quarter of 2024.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2025 were $234.7 million, compared to $267.3 million as of December 31, 2024. The decrease was primarily the result of cash used in operating activities. The balance as of March 31, 2025 is exclusive of the $4.0 million in milestones earned under our Roche collaboration, which the company expects to receive in the second quarter of 2025. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 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 activity. More information may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946
C4T has advanced preclinical and clinical research to explore how targeted protein degradation may offer improvement over approved therapies that inhibit mutant BRAF V600. C4T advanced CFT1946, an investigationa
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CCCC, new 52 week low
Bounced up 8% from a new 52-week low of $1.08. Rediculously oversold!🙃
CCCC, new 52 week low
Way Oversold!
CCCC under $2.00
CCCC new 52 week low
Many of the biotech companies that I own and or follow got their asses kicked this past week. CCCC has been under severe pressure for months on end and yet my feeling about the Company continues to be extremely long-term bullish.
CCCC
Close to 100 tickers in the biomedical sector from Barchart are under $2
CCCC new 52-week low $2.47
CCCC new 52-week low $2.60
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
C4 Therapeutics announces that its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer, in Greater China
Wow great news Subs! I had to read between the lines of scientific lingo but it sounds like we're on the right path.
Thank you!
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).
CCCC under $6
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.
Well IMHO it went up in symphony with Biotechs having a bullish day.
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