Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone

Inclusion Criteria:

• Age ≥ 18 years at time of signing Informed Consent.

• Has a diagnosis of hepatocellular carcinoma (HCC) documented radiologically byAmerican Association for the Study of Liver Diseases (AASLD) criteria and/orhistopathologically from a tumor biopsy.

• Has a treatment plan to receive either a curative ablation (RFA or MWA) or acurative surgical resection and ablation.

• Has HCC with intermediate, high or very high risk of recurrence.

• Has hepatic only HCC (disease confined to the liver only), defined by noextra-hepatic lesions greater than 1 cm in size.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Patient with past or ongoing hepatitis C virus (HCV) infection will be eligible ifthe patient has completed HCV treatment at least 1 month prior to Day 1.

• Patient with controlled hepatitis B will be eligible if the patients meets thefollowing criteria:

1. Antiviral therapy for hepatitis B virus (HBV) must be given for at least 4weeks and HBV viral load must be less than 500 IU/mL prior to treatment.Patients on active HBV therapy with viral loads under 00 IU/mL should stay onthe same therapy throughout study treatment.

2. Patients who are hepatitis B core antibody (anti-HBc) positive, negative forHBsAg, and negative or positive for anti- HBs, and who have an HBV viral loadunder 500 IU/mL do not require HBV anti-viral prophylaxis.

• Has adequate organ function as specified in the Adequate Organ Function LaboratoryValues Table. Specimens must be collected within 14 days prior to Day 1.

Exclusion Criteria:

• Known allergic reaction to shellfish, crabs, crustacean, or any trial components.

• Has an active infection requiring systemic therapy.

• Has a diagnosis of immunodeficiency or currently receiving chronic systemic steroidtherapy (in dosing exceeding 10 mg daily of prednisone equivalent), or any otherform of immunosuppressive therapy within 7 days prior to treatment day (Day 1), orhas plans to start treatment including >10 mg daily of prednisone equivalent or anyimmunotherapy.

• Has an active autoimmune disease that has required systemic treatment in the past 2years (i.e., with use of disease modifying agents or immunosuppressive drugs). NOTE:replacement therapy (e.g., thyroxine or insulin) is not considered a form ofsystemic treatment and is allowed.

• Has had an allogenic tissue/solid organ transplant.

• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitisobliterans), drug-induced pneumonitis, active tuberculosis, or idiopathicpneumonitis.

• Has received local therapy to liver, ablation other than radiofrequency or microwaveablation (i.e., alcohol ablation, transcatheter chemoembolization, transcatheterembolization, hepatic arterial infusion, local radiation/Stereotactic Body RadiationTherapy or radioembolization) less than 3 months prior to treatment.

• Is receiving any of the following prohibited concomitant therapies less than 21 daysfrom treatment or 5 drug elimination half-lives, whichever is shorter prior torandomization:

1. Antineoplastic systemic chemotherapy or biological therapy.

2. Immunotherapy not specified in this protocol.

3. Systemic glucocorticoids for any purpose other than to modulate symptoms froman adverse event (AE) that is suspected to have an immunologic etiology.Inhaled or topical steroids are allowed, and systemic steroids at doses ≤10mg/day prednisone or equivalent are allowed. Exception: steroids may be usedfor premedication prior to imaging.

• Has received a live vaccine within 28 days prior to treatment Day 1.