CLNN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• In August 2026, we announced the results from new biomarker analyses examining clinical outcomes among CNM-Au8®-treated patients in our two completed Phase 2 ALS trials. Patients whose neurofilament light chain (“NfL”) biomarker levels declined or stabilized lived significantly longer than concurren…

• We intend to submit our NDA in early fourth quarter of 2026, which will remain a matter of FDA review. The planned NDA submission will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and…

• We met with the FDA in a Type B end of Phase 2 meeting during the third quarter of 2025 to review results from the Phase 2 VISIONARY-MS trial and discuss a planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies, addressing a critical unmet medical need…

• an increase in unallocated expenses during the three months ended June 30, 2026, primarily due to (A) an increase in manufacturing expenses primarily due to use of gold lots purchased at higher commodity prices to manufacture CNM-Au8, and (B) an increase in equipment-related expenses, partially offs…

• a decrease in unallocated expenses during the six months ended June 30, 2026, primarily due to (A) an offset to manufacturing expense due to reprocessing multiple gold lots by our supplier when the commodity price of gold increased compared to the original purchase prices, and (B) a decrease in othe…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• We had a Type C in-person meeting with the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2026 to discuss the statistically significant reductions in neurofilament light (“NfL”) and glial fibrillary acidic protein (“GFAP”), the strong associations of biomarker improvements with lo…

• The FDA also noted that “NfL could potentially serve as a reasonably likely surrogate endpoint to support (an) accelerated approval.” This submission would occur under the Subpart H accelerated approval pathway (21 CFR 314.510) in ALS. The FDA has also requested that we provide additional informatio…

• The planned NDA submission will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and the National Institutes of Health-sponsored expanded access protocol for CNM-Au8. Supporting data incl…

• We met with the FDA in a Type B end of Phase 2 meeting during the third quarter of 2025 to review results from the Phase 2 VISIONARY-MS trial and discuss a planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies, addressing a critical unmet medical need…

• a decrease in unallocated expenses, primarily due to an offset to manufacturing expenses due to reprocessing multiple gold lots by our supplier when the commodity price of gold increased compared to the original purchase prices, partially offset by an increase in equipment-related expenses;