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Chemomab Therapeutics (CMMB) FY Conference Transcript
2025-09-05 12:00
Summary of Chemomab Therapeutics (CMMB) FY Conference Company Overview - **Company**: Chemomab Therapeutics - **Focus**: Development of novel treatments for inflammatory and fibrotic diseases - **Lead Asset**: First-in-class monoclonal antibody targeting CCL24, involved in inflammation and fibrosis [2][4] Industry Context - **Target Disease**: Primary sclerosing cholangitis (PSC) - **Characteristics**: Significant inflammation and fibrosis in the bile duct, no approved treatments available [3][5] - **Patient Demographics**: Approximately 70,000 patients in major markets, primarily young men around their 40s [6] Clinical Development - **Phase II Study**: Successfully completed with positive results - **Participants**: 76 patients, treated with Nebucadnezar at doses of 10 mg/kg, 20 mg/kg, and placebo [9] - **Endpoints**: Safety, tolerability, and various markers of disease progression [10] - **Results**: - Met primary safety endpoint and secondary endpoints showing anti-inflammatory and anti-fibrotic activity [11] - Identified 20 mg/kg as the effective dose for further studies [11] Efficacy and Safety Data - **Biomarker Improvements**: - Significant reduction in liver stiffness and ELF score, indicating disease progression [12][13] - Dose-dependent improvements in inflammatory markers such as IL-6 and IL-18 [14] - **Long-term Safety**: - 93% of eligible patients continued in open-label extension, showing sustained reduction in biomarkers after 48 weeks [16] - Nebucadnezar remained safe and well-tolerated [16] Competitive Landscape - **Unique Positioning**: - Nebucadnezar is the only drug suggesting disease modification in PSC, unlike competitors focusing on symptom management [6][7] - Potential to become the first approved drug for PSC, addressing a significant unmet medical need [8] Market Opportunity - **Commercial Potential**: - Estimated annual commercial opportunity exceeding $1 billion under conservative assumptions [9] - Premium pricing expected due to first-in-class mechanism and significant unmet need [9] Regulatory Engagement - **FDA Interaction**: - Clear alignment with FDA on a single pivotal study for full approval of Nebucadnezar in PSC [20][21] - Study design will evaluate multiple clinical events beyond just liver transplant and death [21] Future Plans - **Phase III Study**: - Preparations underway to initiate Phase III clinical study as soon as possible [22] - Ongoing discussions with potential partners to facilitate market entry [22] Conclusion - **Transformative Potential**: - Nebucadnezar represents a breakthrough in PSC and potentially other fibrotic diseases, with strong data supporting its efficacy [23] - Chemomab Therapeutics is positioned to lead in addressing this rare disease with significant unmet needs [23]
Chemomab Therapeutics to Present at H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-08-21 12:00
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro- inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been gene ...
CMMB, with P&G Support, Responds to Deadly Cholera and Hunger Crisis in South Sudan
GlobeNewswire News Room· 2025-08-14 20:05
Core Insights - Catholic Medical Mission Board (CMMB) is launching an emergency response in South Sudan due to a cholera outbreak and a deepening hunger crisis affecting thousands of lives in Upper Nile and Central Equatoria State [1] - The cholera outbreak has infected over 85,700 individuals, primarily children under 14, with case fatality rates exceeding WHO emergency thresholds [1] Group 1: Emergency Response - CMMB is distributing P&G Purifier of Water sachets to families in the most affected areas to curb the cholera spread [2] - The partnership with P&G has been crucial in enabling CMMB to respond quickly to the crisis [2] - Additional resources are urgently needed to address the complex health threats faced by the population [3] Group 2: Collaborative Efforts - CMMB supports a consortium of local and international actors to implement a multisectoral response to the emergency [4] - The organization is involved in supporting oral cholera vaccination campaigns led by the Ministry of Health, with logistical support from UNICEF and WHO [7] - CMMB is running mobile clinics to provide treatment for childhood illnesses and nutrition services for displaced populations [7] Group 3: Call to Action - CMMB has launched an emergency campaign to expand its lifesaving response, emphasizing the urgency of contributions to prevent further deaths [5] - The organization has a long history of providing medical and development aid, focusing on women's and children's health in various countries [6] - In 2024, CMMB's Access to Medicines program delivered $278.9 million worth of medicines and medical supplies to 32 countries [6]
Chemomab Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2025-08-14 12:00
Core Insights - Chemomab Therapeutics is advancing its Phase 3 program for nebokitug, a treatment for primary sclerosing cholangitis (PSC), and is actively seeking strategic partnerships to optimize development resources and accelerate the program [3][4][11] - The company has received positive feedback from the FDA regarding the Chemistry, Manufacturing, and Controls (CMC) strategy and the timeline for nonclinical toxicology testing, which supports the timely advancement of the Phase 3 program [7][11] - Chemomab plans to adjust the ratio of its American Depositary Shares (ADSs) from 1:20 to 1:80, effective August 26, 2025, which will serve as a reverse split for ADS holders [3][10] Company Developments - The Phase 2 SPRING trial data for nebokitug was presented at major scientific meetings, highlighting its anti-fibrotic, anti-inflammatory, and anti-cholestatic effects [2][4][5] - Chemomab has expanded its patent protections for nebokitug in China and Russia, extending coverage until 2041, which is crucial for future commercialization [7][9] - The company reported a net loss of $2.1 million for Q2 2025, a decrease from $3.6 million in Q2 2024, reflecting reduced R&D expenses due to the completion of the Phase 2 trial [6][15] Financial Highlights - As of June 30, 2025, Chemomab had cash and cash equivalents of $9.5 million, expected to fund operations through the second quarter of 2026 [6][10] - R&D expenses for Q2 2025 were $1.3 million, down from $2.9 million in Q2 2024, while G&A expenses increased to approximately $1.0 million from $0.8 million in the same period [6][15] - The total number of ordinary shares issued and outstanding increased to 413,851,140 as of June 30, 2025, compared to 377,132,220 as of December 31, 2024 [10][14]
Chemomab Announces Oral Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis at BSG Live'25
Globenewswire· 2025-06-30 12:00
Core Insights - The SPRING trial data indicates that nebokitug is a promising first-in-class treatment for primary sclerosing cholangitis (PSC), showing substantial improvements in multiple biomarkers associated with disease progression [1][2][3] - Nebokitug has demonstrated a favorable safety profile, being well-tolerated over 48 weeks of treatment, and is advancing towards a Phase 3 registration trial [2][3][4] Company Overview - Chemomab Therapeutics is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug (CM-101) being a dual activity monoclonal antibody targeting CCL24 [7] - The company has received FDA and EMA Orphan Drug designations and FDA Fast Track designation for nebokitug in the treatment of PSC, indicating its potential significance in addressing unmet medical needs [7] Clinical Trial Details - The Phase 2 SPRING trial was a double-blind, placebo-controlled study that showed nebokitug's dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects in patients with PSC [2][3] - In a prespecified subgroup of patients with moderate to advanced disease, those treated with nebokitug exhibited broad and consistent improvements in biomarkers linked to better clinical outcomes [2] Future Prospects - The company is preparing to initiate a Phase 3 trial for nebokitug, which is designed to provide a clear pathway to potential full regulatory approval [4][7] - The positive results from the SPRING trial support the advancement of nebokitug as a potential first approved therapy for PSC, a condition currently lacking effective treatments [2][4]
Chemomab Reports Positive Feedback From Two Recent FDA Meetings Supporting Phase 3 Advancement of Nebokitug in Primary Sclerosing Cholangitis
Globenewswire· 2025-06-11 12:00
Core Insights - Chemomab Therapeutics has achieved significant milestones with the FDA regarding the development of nebokitug for primary sclerosing cholangitis (PSC) [1][4] - The FDA has agreed on the Chemistry, Manufacturing, and Controls (CMC) strategy and the non-clinical toxicology testing pathway for nebokitug, allowing for parallel testing during the Phase 3 clinical trial [2][3] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics for fibro-inflammatory diseases, particularly targeting the soluble protein CCL24 [8] - Nebokitug (CM-101) is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, showing potential in treating severe fibro-inflammatory diseases [5][8] Clinical Development - The company is preparing for a Phase 3 clinical trial of nebokitug, building on positive results from the Phase 2 SPRING trial, which met its primary safety endpoint and showed improvements in secondary endpoints [5][8] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track status for PSC treatment, indicating its potential significance in addressing unmet medical needs [5][8]
Chemomab Announces New Patent Awards for Its First-in-Class Agent Nebokitug that is Positioned to Potentially Become the First Approved Drug for Primary Sclerosing Cholangitis
Globenewswire· 2025-06-03 12:00
Core Viewpoint - Chemomab Therapeutics has secured new patent protections for its lead product nebokitug in China and Russia, enhancing its intellectual property portfolio and positioning for future commercialization in the treatment of primary sclerosing cholangitis (PSC) [1][2][3] Patent Protections - The State Intellectual Property Office of China issued Patent No. ZL 2018 8 0018207.8, which protects the use of nebokitug in hepatic diseases, including PSC, with coverage extending to 2038 [2] - The Federal Service for Intellectual Property of Russia granted RU Patent 2022125176, which covers various formulations and doses of nebokitug, providing protection until 2041 [3] Clinical Development and Regulatory Pathway - Positive data from the Phase 2 SPRING trial of nebokitug has established a promising clinical profile for treating PSC, which is a debilitating disease with no effective treatments [2] - The FDA has outlined a clear pathway for regulatory approval of nebokitug in PSC, which is significant for the company's future plans [2] - Chemomab is preparing for a potential Phase 3 registrational trial for nebokitug in PSC, following the positive results from earlier trials [6] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug being a first-in-class dual activity monoclonal antibody targeting CCL24 [6] - The company has reported positive results from four clinical trials of nebokitug, demonstrating a favorable safety profile and potential for treating severe fibro-inflammatory diseases [6]
Chemomab Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-15 12:00
Core Insights - Chemomab Therapeutics has achieved significant milestones in the development of nebokitug for the treatment of primary sclerosing cholangitis (PSC), including a clear regulatory pathway with the FDA for potential full approval and positive 48-week data from the Phase 2 SPRING trial [1][2][10] Company Developments - The company reported that nebokitug treatment in PSC patients with moderate/advanced disease resulted in continued improvements across key biomarkers of liver injury, inflammation, and fibrosis [1][2] - Chemomab has aligned with the FDA on a streamlined regulatory approval program for nebokitug, which will utilize a single pivotal Phase 3 trial based on clinical events associated with disease progression, eliminating the need for liver biopsies [2][10] - The positive results from the SPRING trial indicate that nebokitug-treated patients showed a significantly lower number of clinical events compared to historical controls, particularly in the 20 mg/kg dose group [2][4] Financial Highlights - As of March 31, 2025, Chemomab's cash position was $10.6 million, down from $14.3 million at the end of 2024, with a cash runway expected to last until the second quarter of 2026 [5][8] - The company reported a net loss of $3.3 million for the first quarter of 2025, compared to a net loss of $3.9 million in the same period of 2024 [8][14] Research and Development - R&D expenses for the first quarter of 2025 were $2.5 million, a decrease from $3.1 million in the first quarter of 2024, primarily due to the winding down of activities related to the Phase 2 SPRING trial [8][13] - The company is actively pursuing multiple partnering options to advance the nebokitug program and is in discussions with potential strategic partners [1][2] Clinical Trial Updates - Data from the Phase 2 SPRING trial was presented at major conferences, including Digestive Disease Week 2025 and EASL 2025, highlighting the drug's potential in treating PSC [3][4] - The Open Label Extension study confirmed that nebokitug was safe and well-tolerated over 12 months, with significant improvements in liver biomarkers and stabilization of cholestasis-related markers [6][10]
Chemomab Announces Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis in Distinguished Plenary Session at DDW 2025
GlobeNewswire News Room· 2025-05-05 12:00
Core Insights - The SPRING trial data presented at Digestive Disease Week 2025 indicates that nebokitug is well-tolerated and shows significant improvements in multiple biomarkers related to fibrotic and inflammatory diseases, suggesting its potential as a first-in-class treatment for primary sclerosing cholangitis (PSC) [1][2][4] Group 1: Clinical Trial Results - The Phase 2 SPRING trial data demonstrated that nebokitug was safe and well-tolerated over a 48-week treatment period, with a safety profile comparable to placebo [2][3] - Nebokitug exhibited dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects, particularly in patients with moderate to severe disease, showing sustained improvements in biomarkers associated with disease progression [2][3] - In the open-label extension of the study, patients receiving nebokitug for up to 48 weeks showed continual improvement in fibrosis markers and stabilization of liver stiffness, especially at the 20 mg/kg dose [3] Group 2: Company Overview and Future Plans - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug being a dual activity monoclonal antibody targeting CCL24 [8] - The company is preparing for a potential Phase 3 trial for nebokitug based on positive results from the Phase 2 SPRING trial, which has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC treatment [8] - The Phase 3 trial design aims for a single pivotal trial with a clinical event primary endpoint, providing a streamlined pathway to potential full regulatory approval [8]
Chemomab Reports New Positive Clinical Data at EASL 2025 Supporting Nebokitug's Impact in Primary Sclerosing Cholangitis and Related Diseases
GlobeNewswire News Room· 2025-04-28 12:00
Core Insights - The new clinical data confirms the potential of nebokitug (CM-101) as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases [2][8] - Comprehensive proteomic analyses indicate that treatment with nebokitug resulted in significant and dose-dependent improvements in various biomarkers related to fibro-inflammatory disease pathways [2][3] - The pharmacokinetic and pharmacodynamic data from the Phase 2 SPRING trial demonstrate effective and dose-dependent antibody-target engagement [4][8] Group 1: Clinical Data and Findings - Nebokitug-treated patients exhibited significant and dose-dependent changes in multiple proteins related to fibrosis, immune cell recruitment, and inflammation [2][3] - The treatment was linked to downregulation of disease-related proteins and pathways involved with leukocyte migration, cytokine activity, chemokine activity, and collagen binding [3] - The analysis provided new insights into PSC disease-related pathways and additional biological evidence of the clinical activity of nebokitug [2] Group 2: Pharmacokinetics and Pharmacodynamics - PK analyses indicated dose-proportional increases in the concentration of nebokitug, with steady-state levels achieved after the fourth dose [4] - Increased levels of nebokitug corresponded with increased levels of its CCL24 target, reflecting effective antibody-target engagement [4] - Linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of relevant PSC disease biomarkers, including liver enzyme and transient elastography scores [4] Group 3: Company Overview and Future Plans - Chemomab Therapeutics is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet need [8] - The company has reported positive results from four clinical trials of nebokitug and is preparing for a potential Phase 3 trial based on positive data from the Phase 2 SPRING trial [8] - Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC [8]