20-F: Chemomab Therapeutics Reports Positive Data, Aligns with FDA on Phase 3 Trial for PSC Treatment

Chemomab Therapeutics announces positive clinical data from its PSC SPRING study and alignment with the FDA on a Phase 3 registration study for nebokitug, a potential treatment for Primary Sclerosing Cholangitis.

Summary

• Chemomab Therapeutics Ltd. has reported positive clinical data from the open label (OLE) part of the PSC SPRING study.
• Treatment with nebokitug for up to 48 weeks was well-tolerated and reinforced the positive results seen in the 15-week double-blinded portion of the Phase 2 SPRING trial.
• Treatment in PSC patients with moderate/advanced disease for up to 48 weeks resulted in continued substantial improvements across key biomarkers of liver injury/inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C.
• OLE patients treated with nebokitug showed stabilization of liver stiffness and a significantly lower number of clinical events compared to historical controls.
• Chemomab announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with the FDA on the design of a Phase 3 registration study for nebokitug for the treatment of PSC.
• The FDA and Chemomab agreed on the design for a single Phase 3 pivotal PSC trial that could result in full regulatory approval of nebokitug for patients with PSC.
• The primary endpoint measures time-to-first clinical event and encompasses multiple clinical events associated with disease progression.
• Approximately 350 PSC patients will be enrolled in the trial, and the study population will be enriched for patients with moderate to advanced disease.
• Chemomab expects to leverage the strong relationships with global clinical investigators it developed during its successful Phase 2 SPRING study to facilitate enrollment in the nebokitug pivotal trial.
• As of December 31, 2024, the registrant had outstanding 377,132,220 ordinary shares, no par value.
• As of December 31, 2024, our cash, cash equivalents and deposits were approximately $14.3 million.
• We believe our cash and cash equivalents and bank deposits as of December 31, 2024, will be sufficient to fund our operations through the first quarter of 2026.
• This excludes capital losses of approximately $14,224 thousands for which the company will create a full valuation allowance.

Sentiment

Score: 6

Explanation: The document presents a mixed sentiment. Positive clinical trial results and FDA alignment are encouraging, but concerns about ongoing losses and the need for additional funding temper the outlook.

Positives

• Nebokitug treatment for up to 48 weeks was well-tolerated and reinforced the positive results seen in the 15-week double-blinded portion of the Phase 2 SPRING trial.
• Treatment in PSC patients with moderate/advanced disease for up to 48 weeks resulted in continued substantial improvements across key biomarkers of liver injury/inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C.
• OLE patients treated with nebokitug showed stabilization of liver stiffness and a significantly lower number of clinical events compared to historical controls.
• Chemomab and the FDA aligned on a clinical events-driven Phase 3 trial design for nebokitug for the treatment of PSC.
• We believe our cash and cash equivalents and bank deposits as of December 31, 2024, will be sufficient to fund our operations through the first quarter of 2026.

Negatives

• The Company has incurred recurring losses from operations as of December 31, 2024 of approximately $103 million and negative cash flows from operating activities in 2024 of $15.4 million with currently no products approved for sale.
• These indicators raising substantial doubt about its ability to continue as a going concern.
• The Company will be required to raise additional funds to support its operations and continue as a going concern.
• This excludes capital losses of approximately $14,224 thousands for which the company will create a full valuation allowance.

Risks

• The Company has incurred recurring losses from operations as of December 31, 2024 of approximately $103 million and negative cash flows from operating activities in 2024 of $15.4 million with currently no products approved for sale.
• These indicators raising substantial doubt about its ability to continue as a going concern.
• The Company will be required to raise additional funds to support its operations and continue as a going concern.
• There can be no assurance that these efforts will be successful or sufficient.
• The Company relies on one supplier for the production of the CM-101 used in its product development.
• If this supplier fails to deliver or experiences production delays, the Company will be required to seek an alternative solution.
• Switching suppliers may cause manufacturing delays and higher costs, potentially delaying the product's development and impacting the Company's operational results and financial position.

Future Outlook

The company plans to initiate a Phase 3 trial for nebokitug in PSC, contingent on securing a strategic partnership or financing.

Industry Context

The announcement highlights the competitive landscape of drug development for fibrotic/inflammatory diseases, noting that Chemomab is unique in having a monoclonal antibody targeting CCL24 in clinical development.

Comparison to Industry Standards

• The document mentions that in 2024 Gilead acquired Cymabay for its PPAR agonist in Primary biliary cirrhosis.
• In 2019 Novartis completed two transactions related to the treatment of MASH, a liver metabolic fibrotic disease.
• It acquired IFM Tre for NLRP3 antagonists for a $310 million upfront payment and total potential consideration of $1.5 billion and licensed an integrin inhibitor from Pliant Therapeutics for an $80 million upfront payment.
• Additionally, Gilead Sciences licensed two preclinical programs, one in MASH for a $15 million upfront payment (total potential consideration of $785 million) and the other for TGFinhibitors in fibrosis for an $80 million upfront payment and total potential consideration of $1.4 billion.
• In 2020, Roche acquired Promedior for a $390 million upfront payment and total potential consideration of $1 billion in milestones for its Phase 2 product in pulmonary fibrosis, and Bayer partnered with Recursion Pharmaceuticals to develop and commercialize preclinical-stage small molecule treatments for fibrotic conditions for a $30 million upfront payment and total potential consideration of $1 billion.

Stakeholder Impact

• Positive clinical results and potential FDA approval could benefit patients with PSC.
• The need for additional funding may dilute shareholder value.
• Successful commercialization of nebokitug could create value for shareholders.

Next Steps

• Initiate a Phase 3 pivotal trial in PSC, contingent on securing a strategic partnership or financing.

Key Dates

Keywords

Chemomab Therapeutics, nebokitug, Primary Sclerosing Cholangitis, PSC, FDA, Phase 3 Trial, Clinical Data, Biomarkers, Clinical Events, Drug Development