Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

Inclusion Criteria:

• Adult males or females aged 18 years through 78 years (have not had their 79thbirthday)

• Patient or Legally Acceptable Representative (LAR) willing to give informed consentbefore study procedure.

• Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT)scan or diagnostic magnetic resonance imaging (MRI) before enrolment. No hemorrhageas proved by cerebral CT/MRI scan.

• Cerebral ischemic stroke patients presenting within 24 hours after onset of symptomswith mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score >5 (NIHSSLevel of Consciousness (1A) score must be < 2). This includes cerebral ischemicstroke patients who completely recovered from earlier episodes before having a newor fresh stroke.

• The patient is <24 hours from the time of stroke onset when the first dose ofSovateltide therapy is administered. Time of onset is when symptoms began; forstroke that occurred during sleep, time of onset is when the patient was last seenor was self-reported to be normal.

• Reasonable expectation of availability to receive the full Sovateltide course oftherapy and to be available for subsequent follow-up visits.

Exclusion Criteria:

• Patients receiving endovascular therapy or is a candidate for any surgicalintervention for the treatment of stroke, which may include but not limited toendovascular techniques.

• Patients classified as comatose are defined as a patient who requires repeatedstimulation to attend or is obtunded and requires strong or painful stimulation tomake movements (NIHSS Level of Consciousness (1A) score ≥ 2).

• Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricularhemorrhage, subarachnoid hemorrhage, epidural hemorrhage, an acute or chronicsubdural hematoma on the baseline CT or MRI scan 4. Known pregnancy.

• Confounding pre-existing neurological or psychiatric disease.

• Concurrent participation in any other therapeutic clinical trial.

• Evidence of any other major life-threatening or serious medical condition that wouldprevent completion of the study protocol, impair the assessment of outcome, or inwhich Sovateltide therapy would be contraindicated or might cause harm to thepatient.