Intermediate Expanded Access Protocol CNMAu8.EAP04

Exclusion Criteria

• •1. Participant is eligible for participation in any double-blind placebo-controlled study the treatment of ALS at the same research site.
• •2. Participant has a history of any clinically significant or unstable medical condition (other than ALS) that may interfere with assessment of safety or compromise the study objectives.
• •3. Based on the investigator's judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
• •4. Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays, including but not limited to: (i) ALT or AST ≥ 3 times upper limits of normal, (ii) direct (conjugated) with bilirubin ≥2 times upper limits of normal, (iii) low platelet counts (\< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), (iv) serum creatinine \>1.2 mg/dL, or (v) eGFR \< 45 ml/min per 1.73 m2.
• •5. Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions-see concomitant medications below).
• •6. Females who are pregnant or nursing or who plan to get pregnant during the EAP, or within 6 months of the end of this trial.
• •7. Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
• •8. History of gold allergy.