Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness

Inclusion Criteria:

• Sex: male or female

• Age 60 to 80 years of age at the time of signing the informed consent.

• Race/nationality: all races and ethnicities accepted for which there are validatedreference values for obesity and sarcopenia diagnostic criteria

• Disease characteristics: To be eligible, the participant must meet at least onecriterion for obesity and at least one criterion for sarcopenia, as defined below:

Obesity:

Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for women (World Health Organization)

Sarcopenia:

Grip strength women: < 16 kg, men: < 27 kg in the dominant hand Gait speed < 0.8 m/s (men and women)

Acceptable stages:

STAGE I: No complications attributable to altered body composition and skeletal muscle functional parameters STAGE II: Presence of up to two complications attributable to altered body composition and skeletal muscle functional parameters (e.g. metabolic syndrome components, disabilities resulting from high fat mass and/or low muscle mass, cardiovascular and respiratory disease). Limitations apply (see exclusion criteria).

• Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in theSTEM-META clinical protocol

• In order to understand the nature of this study it is expected that mostparticipants will be able to speak, read, and understand English, or Spanishhowever, additional translations of the informed consent may be made available afterstudy initiation to include additional languages for participants

• Study participant is willing and able to comply with all study requirements,according to the judgment of the Investigator.

• To be eligible for enrollment and for each treatment administration, the vital signspre-dose, should be in the following ranges. If the vitals are outside of the range,will be reassessed 3 times at 10 minutes resting intervals.

Heart rate >50 and <100 bpm Systolic pressure >100 and <170 mmHg Diastolic pressure >50 and <100 mmHg Blood oxygenation (by pulse-oximetry) >95%

Exclusion Criteria:

• Unmanaged/uncontrolled comorbidities (examples include high blood pressure,hyperglycemia, unstable angina, deep vein thrombosis, hepatic cirrhosis, pepticulcers, complicated GERD, COPD, asthma etc.) as judged by the investigator.

• Type 1 Diabetes Mellitus, insulin-dependent Type 2 Diabetes mellitus, or hemoglobinA1C level >7.0%

• Severe obesity, or class III obesity (CDC criteria, BMI >40)

• Current diagnosis of major psychiatric disorders that may impact participation, asjudged by the investigator.

• Conditions that interfere with gait balance or mobility, such as severe arthritis oflumbo-sacral area, hip or lower extremities if gait speed is used for inclusioncriteria

• Conditions that interfere with ability to measure grip strength including handarthritis, carpal tunnel syndrome and elbow tendinitis if hand grip criteria is usedfor inclusion

• Study participant has current or past history of invasive malignancy (5 years)excluding non-melanoma skin cancer.

• Inflammatory conditions requiring regular use of oral or parenteral corticosteroids (Raynaud phenomenon, scleroderma, rheumatoid arthritis, LED etc.).

• Cushing's syndrome, Graves disease (hyperthyroidism), or other condition of hormoneimbalance caused by genetic or auto-immune disorder. Exceptions include controlledhypothyroidism and polycystic ovarian syndrome.

• Severe cardiovascular disease (including New York Heart Association [NYHA] class IIIor IV congestive heart failure, clinically significant valvular disease, history ofcardiac arrest, presence of an implantable defibrillator)

• Parkinson's disease, multiple sclerosis or other progressive neurological disorders

• Renal disease requiring dialysis, or known renal insufficiency (moderate or severereduction in GFR≤30 ml/min/1.73 m2)

• Chest pain, severe shortness of breath, or occurrence of other safety concernsduring the baseline functional tests

• Study participant is taking or has taken a prohibited medication as defined inSection 6.8.2 of the clinical protocol.

• Participant has had a change in medication to manage comorbid condition(s) (including diabetes, hypertension, asthma, and cardiovascular disease) within 1month of the Screening visit.

• Weight loss (bariatric) surgery of any type including biliopancreatic diversion withduodenal switch, gastric bypass, sleeve gastrectomy, adjustable gastric banding, 1year prior enrollment.

• Study participant has previously participated in this study or participant haspreviously been assigned to treatment in a study of the medication underinvestigation in this study.

• Study participant has been exposed to an investigational drug or device within 1year, prior to the first dose of IMP, or is currently participating or planning toparticipate in another study of an investigational drug.

• Woman of Childbearing Potential (WOCBP) (defined as women with less than 12 monthsof amenorrhea).

• Unable to understand and/or perform the functional tests, as judged by theInvestigator.

• Current physical/rehabilitation therapy (except for passive physical therapy)

• Substance abuse (including but not limited to alcohol, cannabis, narcotics, painmedication) as judged by the investigator.

• Smoking or vaping of products containing nicotine, tobacco or any other products,currently and in the past 1 year.

• Study participant is known positive for hepatitis B surface antigen (HBsAg),hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (humanimmunovirus 1/2Ab)

• All participants will be encouraged to follow a healthy diet. Caloric restrictionwill not be pursued.

• Smoking of tobacco, marijuana or any other inhaled products (vaping) are prohibitedduring treatment and during the follow-up period

• There is no restriction on caffeine consumption

• Occasional alcohol consumption is acceptable, however the participants will beprohibited to consume alcohol 72 hours (3 days) prior medical and laboratory visits

• All participants in the trial (including placebo group) will be encouraged toincrease daily physical activities. The participants can follow any preferredphysical activity (walking, running, swimming, bicycle, treadmill, etc.), it can beevaluated by summed duration of a variety of activities, such as household work. Theactivity is measured by the sensors of the wearable activity tracker; thus, thenature of the activity is not critical.

• Activities that are conductive to falls and accidents are discouraged. Examplesinclude horse riding, skiing, skydiving, scuba diving, mountain biking, bungeejumping, etc.

• Participant must be able to wear an activity tracker device daily, optional duringsleep, and must be aware of the requirements to charge the tracker or transfer thedata.