Welcome to our dedicated page for Chemomab Therapeutics news (Ticker: CMMB), a resource for investors and traders seeking the latest updates and insights on Chemomab Therapeutics stock.
About Chemomab Therapeutics Ltd.
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) is a clinical-stage biotechnology company pioneering the development of innovative therapies for fibro-inflammatory diseases with significant unmet medical needs. Based in Tel Aviv, Israel, Chemomab's research focuses on addressing the underlying mechanisms of fibrosis and inflammation, conditions that contribute to a range of severe and life-threatening diseases. The company's lead therapeutic candidate, nebokitug (CM-101), is a first-in-class monoclonal antibody designed to neutralize the soluble protein CCL24, a key regulator of inflammatory and fibrotic pathways.
Core Therapeutic Focus and Mechanism of Action
Nebokitug (CM-101) operates through a unique dual mechanism of action, targeting both immune cell recruitment and fibroblast activation. By inhibiting CCL24, nebokitug disrupts the self-perpetuating fibro-inflammatory cycle that drives fibrosis. This approach has shown promise in addressing a variety of fibro-inflammatory diseases, including primary sclerosing cholangitis (PSC), a rare and progressive liver disease, and systemic sclerosis (SSc), a debilitating autoimmune condition affecting the skin, lungs, and other organs.
Clinical Development and Regulatory Milestones
Chemomab has advanced nebokitug through multiple clinical trials, demonstrating its safety, tolerability, and efficacy. The company's Phase 2 SPRING trial in PSC established clinical proof-of-concept, showing improvements across a range of disease biomarkers, including liver stiffness, Enhanced Liver Fibrosis (ELF) scores, and pruritus severity. These results have positioned nebokitug as the first investigative therapy for PSC with broad activity across all major disease components.
In collaboration with the U.S. Food and Drug Administration (FDA), Chemomab recently secured alignment on the design of a single Phase 3 registration trial for nebokitug in PSC. This pivotal trial will evaluate clinically meaningful endpoints, such as time-to-first-event of disease progression, without requiring invasive liver biopsies. This streamlined pathway offers a significant acceleration toward potential full regulatory approval.
Market Position and Competitive Advantages
Chemomab's focus on fibro-inflammatory diseases with high unmet needs provides a strategic advantage in the biotechnology sector. Nebokitug has received Orphan Drug and Fast Track designations from both the FDA and the European Medicines Agency (EMA), underscoring its potential to address critical gaps in treatment. The company's robust intellectual property portfolio, including patents extending to 2038, further strengthens its market position.
With an estimated 30,000 PSC patients in the U.S. and 80,000 worldwide, as well as significant unmet needs in related conditions like systemic sclerosis, Chemomab is well-positioned to capture a substantial share of these markets. Additionally, the company's ongoing discussions with strategic partners could accelerate the development and commercialization of nebokitug across multiple indications.
Future Outlook
Chemomab is preparing to launch its Phase 3 PSC trial in late 2025, with results from the open-label extension of the Phase 2 SPRING trial expected in early 2025. These milestones, coupled with the company's proactive engagement with regulatory authorities and potential biopharma partners, highlight its commitment to delivering transformative therapies. By addressing the root causes of fibro-inflammatory diseases, Chemomab aims to improve patient outcomes and establish itself as a leader in this specialized therapeutic domain.
Key Takeaways
- Innovative Science: First-in-class monoclonal antibody targeting CCL24, a novel driver of fibrosis and inflammation.
- Clinical Progress: Positive Phase 2 data in PSC, with Phase 3 trial design aligned with FDA guidance.
- Regulatory Advantages: Orphan Drug and Fast Track designations for nebokitug in PSC.
- Market Potential: Addressing high unmet needs in rare fibro-inflammatory diseases.
- Strategic Partnerships: Active discussions with biopharma companies to accelerate development timelines.
Chemomab Therapeutics (Nasdaq: CMMB) announced that its late-breaking abstract on the Phase 2 SPRING trial results for CM-101 in primary sclerosing cholangitis (PSC) has been selected for an oral presentation at the AASLD The Liver Meeting® 2024. The conference will be held in San Diego from November 15-19, 2024.
Professor Christopher Bowlus, MD, FAASLD, from the University of California Davis School of Medicine, will present the data from the double-blinded portion of the trial. The presentation, titled 'CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING Study', is scheduled for November 18, 2024, from 2:45-3:00pm PT during the Late Breaking Abstract Parallel Session 1.
Chemomab Therapeutics (Nasdaq: CMMB), a clinical stage biotechnology company focused on fibro-inflammatory diseases, has announced its participation in two upcoming investor conferences. The company will attend the Third Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York City, where management will meet with investors. Additionally, CEO Dr. Adi Mor will participate in a fireside chat at the Maxim Healthcare Virtual Summit on October 16, 2024, at 9:00 am ET.
The ROTH conference will feature one-on-one meetings with investors, while the Maxim Healthcare Summit will include a virtual fireside chat. A recording of the Maxim Summit fireside chat will be made available on Chemomab's investor relations website after the event. Both conferences are invitation-only events.
Chemomab Therapeutics (Nasdaq: CMMB), a clinical stage biotechnology company focused on fibro-inflammatory diseases, has announced upcoming investor conference presentations. CEO Dr. Adi Mor will deliver corporate presentations at two events:
1. H.C. Wainwright 26th Annual Global Investment Conference: A prerecorded webcast available from September 9, 2024, at 7:00 am ET for 90 days.
2. HBM Biopharma Summit 2024 in Zurich, Switzerland: A live in-person presentation scheduled for September 23, 2024, at 10:45 am CET at the Park Hyatt Zurich.
The H.C. Wainwright presentation will be accessible via webcast, while the HBM Summit presentation will not be webcast. These presentations offer investors insights into Chemomab's innovative therapeutics for high unmet need fibro-inflammatory diseases.
Chemomab Therapeutics (Nasdaq: CMMB) reported positive Phase 2 results for CM-101 in Primary Sclerosing Cholangitis (PSC), demonstrating safety and anti-fibrotic, anti-inflammatory, and anti-cholestatic activity. The company completed a $10 million PIPE financing, extending its cash runway through early 2026. Key highlights include:
- CM-101 met primary and secondary endpoints in the SPRING trial
- First therapy to show broad effects on PSC's main components
- Statistically significant reduction in liver stiffness after 15 weeks
- Planning for Phase 3 PSC trial and FDA discussions
- Q2 2024 financials: $12.8 million cash position, $2.9 million R&D expenses, $0.8 million G&A expenses
- Net loss of $3.6 million or $0.01 per share
Chemomab Therapeutics (Nasdaq: CMMB), a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, has announced that it will release its second quarter 2024 financial results on August 21, 2024, at 7:00 am Eastern Time. The company will also provide a business update along with the financial report. Investors interested in discussing the financial results or business update after the earnings release can contact the company at IR@chemomab.com.
Chemomab Therapeutics (Nasdaq: CMMB) has successfully closed a $10 million private placement, extending its cash runway potentially to early 2026. The financing, which involved both existing and new investors including HBM Healthcare Investments, OrbiMed, and Sphera Biotech Master Fund LP, positions the company to achieve key clinical milestones in Q1 2025 while advancing discussions with potential partners based on positive Phase 2 results.
The private placement involved the sale of 8,097,167 ADSs and pre-funded warrants at a price of $1.235 per ADS, without warrant coverage. Oppenheimer & Co. Inc. acted as Capital Markets Advisor, with LifeSci Capital and Maxim Group also advising. The company has agreed to file a registration statement with the SEC for the resale of the issued securities.
Chemomab Therapeutics (Nasdaq: CMMB), a clinical-stage biotech company focusing on fibro-inflammatory diseases, has regained compliance with Nasdaq's minimum bid price requirement. The company received a notification letter from Nasdaq confirming that it has met the closing bid price of $1.00 or greater for 10 consecutive business days from July 9 to July 22, 2024. This resolves the non-compliance issue initially reported on November 6, 2023, when Chemomab's American Depositary Shares (ADSs) had fallen below the $1.00 threshold for more than 30 consecutive business days. With this development, Nasdaq has closed the matter, affirming Chemomab's continued listing on the exchange.
Chemomab Therapeutics (Nasdaq: CMMB) has announced a $10 million private placement (PIPE) with participation from new and existing investors. The company is selling 4,188,867 American Depositary Shares at $1.235 per share and pre-funded warrants to purchase up to 3,908,300 ADSs. This funding is expected to extend Chemomab's cash runway through early 2026, supporting operations for about a year after two major milestones anticipated in early 2025.
The proceeds will be used to fund development programs for CM-101, their innovative therapeutic for fibro-inflammatory diseases, as well as general corporate purposes. The PIPE is set to close around July 26, 2024, subject to customary closing conditions. Oppenheimer & Co. Inc. is acting as Capital Markets Advisor for the transaction.
Chemomab Therapeutics (Nasdaq: CMMB) has reported positive topline results from its Phase 2 SPRING trial of CM-101, a first-in-class monoclonal antibody, in patients with primary sclerosing cholangitis (PSC). The trial met its primary endpoint of safety and tolerability and demonstrated anti-fibrotic, anti-inflammatory, and anti-cholestatic effects across multiple secondary efficacy endpoints.
Key findings include:
- Statistically significant improvement in liver stiffness, a important PSC disease marker
- Reduction in total bilirubin, an important marker of cholestasis and liver health
- Improvements in pruritis, a cholestatic indicator relevant to patients
- Favorable safety profile and general tolerability over the 15-week treatment period
The company plans to advance CM-101 to a Phase 3 PSC trial in 2025, following discussions with the FDA later this year.
Chemomab Therapeutics announced new publications reinforcing the clinical potential of its CCL24-neutralizing antibody, CM-101, in treating primary sclerosing cholangitis (PSC). A study published in the International Journal of Molecular Science used machine learning to analyze proteomic profiles from PSC patient sera, confirming that high levels of CCL24 are linked to PSC severity and cirrhosis. This highlights the possibility of CM-101 as an effective therapy. A second study in Drug Safety reported that CM-101 showed good tolerability and reduced biomarkers of inflammation and fibrosis in Phase 1 trials. Topline data from the Phase 2 PSC trial is expected mid-2024.
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