Study of COYA 302 for the Treatment of ALS

Key Inclusion Criteria:

1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable,or definite ALS according to the revised El Escorial criteria

2. Male or female participants aged 18 to 80

3. Time since onset of ALS symptoms ≤28 months from Screening.

4. ALSFRS-R total score ≥35 at Screening

5. Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-Rtotal score.

6. SVC ≥70% of predicted capacity.

7. Participants receiving riluzole must be on a stable dose for at least 30 days priorto Screening, with intent to stay on stable dosage throughout the study. If not on astable dose of riluzole for at least 30 days prior to Screening, willing to refrainfrom initiation of the agent for the duration of the trial.

8. Participants receiving edaravone (intravenous [IV] or oral, RADICAVA®) must havecompleted at least one treatment cycle prior to Screening, with intent to remain onstable dosage throughout the study. If participant has not completed at least onetreatment cycle of edaravone at the time of Screening, willing to refrain frominitiation of the agent for the duration of the trial.

9. Participants receiving tofersen (QALSODY®) must have completed 90 days of treatmentprior to Screening, with intent to remain on stable dosage throughout the study. Ifparticipant has not completed at least 90 days of tofersen at the time of Screening,willing to refrain from initiation of the agent for the duration of the trial.

Key Exclusion Criteria:

1. Any clinically significant and/or unstable medical (including active systemicinfections requiring treatment), surgical, or psychiatric condition or laboratoryabnormality other than ALS, in the judgement of the Investigator.

2. Active suicidality (e.g., any suicide attempts within the past 12 months or anycurrent suicidal intent, including a plan, as assessed by the C-SSRS, score of "YES"on questions 4 or 5; and/or based on clinical evaluation by the Investigator).

3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greaterthan 3 times the upper limit of normal (ULN).

4. Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of <60 mL/min.

5. Pre-existing chronic obstructive pulmonary disease or significant pulmonaryimpairment including those with an FEV1 ≤ 2 liters or < 75% predicted for height andage, in the judgement of the Investigator.

6. Clinically significant history of cardiac function impairment including cardiacejection fraction below 40%, ventricular wall motion abnormalities, or coronaryartery disease.

7. Any organ allografts.

8. A positive tuberculosis (TB) test indicating a latent TB infection or a positivetest for viral hepatitis.

9. Currently receiving or have received abatacept treatment within 75 days prior toScreening.

10. Currently receiving or have received interleukin-2 (IL-2) treatment within 30 daysprior to Screening.

11. Currently receiving or expected to receive immunosuppressant therapy (e.g.,cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) overthe course of the study.

12. Planning to receive a live vaccine during the study or within 3 months ofdiscontinuation.

13. Current participation in another interventional clinical trial and/or participationin any investigational medication or device clinical trial within 30 days prior toScreening or 5 half-lives of elimination of the investigational medication,whichever is longer.

14. Previous participation in any COYA 302 (LD rhIL-2 and DRL_AB) study.

15. Uncontrolled autoimmune condition.

16. Presence of an indwelling central catheter.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.