Clene (CLNN) Emerging Growth Virtual Conference summary

Key clinical and regulatory updates

• Presented compelling survival and biomarker data for CNM-Au8 in ALS, including statistically significant reductions in neurofilament and GFAP, both linked to improved survival outcomes.

• Ongoing dialogue with the FDA, with a Type C meeting expected by the end of Q1 and meeting minutes anticipated in early Q2, to discuss potential accelerated approval based on biomarker and survival data.

• If timelines proceed as planned, NDA filing is targeted for the end of Q2, with a possible PDUFA date in Q3 and commercialization as early as Q1 2027.

• Confirmatory Phase III trial is planned as part of the accelerated approval pathway, with the goal of providing early patient access to CNM-Au8.

• The company has engaged with the FDA four times over the past 14 months and is preparing to present additional data and opinion leader support at the upcoming meeting.

Financial position and funding strategy

• Recently secured $6 million in structured financing, with two additional tranches contingent on regulatory milestones, potentially extending runway into 2027.

• Current funding is sufficient to support operations through the FDA Type C meeting and NDA filing.

• Additional tranches of $7 million and $13 million will be triggered by NDA acceptance and approval, respectively.

• Financial strategy is designed to align capital inflows with key regulatory and commercialization milestones.

Pipeline and future development plans

• Plans to advance CNM-Au8 into Phase III for multiple sclerosis (MS), focusing on cognition improvement as a primary endpoint, pending funding from ALS commercialization or partnerships.

• Demonstrated sustained vision and cognition improvements in MS patients over three years, with ongoing discussions with the FDA to adjust precedent endpoints.

• The asset is positioned as a pipeline-in-a-product, with potential applications in both ALS and MS.