TEL AVIV - Chemomab Therapeutics Ltd. (NASDAQ:CMMB), a biotech firm focusing on therapies for fibro-inflammatory diseases, has announced that its Phase 2 SPRING trial results for primary sclerosing cholangitis (PSC) will be presented at the upcoming American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024 in San Diego, California, scheduled for November 15-19.
The data, which will be discussed in an oral presentation by Professor Christopher Bowlus from the University of California Davis School of Medicine, pertains to the trial's double-blinded segment that evaluated CM-101's effects on individuals with PSC. The presentation, titled "CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING Study," is set for November 18.
CM-101, Chemomab's leading drug candidate, is a monoclonal antibody targeting CCL24, a protein implicated in fibrosis and inflammation. The drug has been generally well-tolerated in clinical and preclinical studies, showing a favorable safety profile. Chemomab has garnered FDA and EMA Orphan Drug designations, as well as FDA Fast Track designation for CM-101 in the treatment of PSC.
The company is eyeing two significant milestones in early 2025, including receiving feedback from the FDA on the design of its planned Phase 3 registrational trial for PSC. Additionally, Chemomab's CM-101 program for systemic sclerosis treatment is ready to enter Phase 2 trials.
Members of Chemomab's senior leadership team will be present at the AASLD conference to discuss the company's developments. The information in this article is based on a press release statement.
In other recent news, Chemomab Therapeutics Ltd. has successfully regained compliance with Nasdaq's minimum bid price requirement, following a challenging period where its shares traded below $1.00 for over 30 consecutive business days. The biotech firm, specializing in fibro-inflammatory diseases, has also secured approximately $10 million through a private investment in public equity (PIPE) deal, extending its operational runway through early 2026.
The funds raised in the PIPE deal will support the development of Chemomab's lead drug candidate, CM-101, amongst other general corporate purposes. CM-101, a monoclonal antibody, has shown promise in recent clinical trials. The company reported positive results from a Phase 2 trial showing significant improvements in liver stiffness, a marker of disease progression.
However, Chemomab has cautioned stakeholders that there are substantial risks and uncertainties in drug development. The company has plans to engage with the FDA for an end-of-Phase 2 meeting and aims to initiate a Phase 3 trial in 2025.
In addition, Chemomab has been granted a new patent from the European Patent Office for CM-101, enhancing its intellectual property portfolio. These are among the recent developments at Chemomab Therapeutics Ltd.
InvestingPro Insights
As Chemomab Therapeutics Ltd. (NASDAQ:CMMB) prepares to present its Phase 2 SPRING trial results at the upcoming AASLD conference, investors may find additional context from recent financial data and expert insights valuable.
According to InvestingPro data, Chemomab's market capitalization stands at $17.23 million, reflecting its current position as a small-cap biotech company. This valuation aligns with the company's developmental stage, focusing on novel therapies like CM-101 for fibro-inflammatory diseases.
InvestingPro Tips highlight that Chemomab holds more cash than debt on its balance sheet, which is crucial for a biotech firm in the research and development phase. This financial cushion could provide some runway as the company advances its clinical programs, particularly the anticipated Phase 3 trial for PSC and the upcoming Phase 2 trials for systemic sclerosis.
However, it's important to note that Chemomab is currently not profitable, with an adjusted operating income of -$16.03 million over the last twelve months as of Q2 2023. This is typical for biotech companies in the development stage, as they invest heavily in research and clinical trials before generating revenue from approved products.
The stock has shown significant volatility, with a 64.38% price increase over the past six months, contrasted by a 32.77% decline in the last month. This volatility may reflect investor reactions to clinical trial developments and broader market sentiment towards biotech stocks.
For investors considering Chemomab's potential, it's worth noting that InvestingPro lists 11 additional tips for this stock, offering a more comprehensive analysis of the company's financial health and market position.
As Chemomab approaches key milestones in early 2025, including FDA feedback on its Phase 3 trial design, investors will likely be watching closely for updates that could impact the company's valuation and future prospects in the competitive biotech landscape.
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