Clinical Trial to Evaluate BO-112 in Patients with Basal Cell Carcinoma (BCC)

Inclusion Criteria:

1. Participant must be ≥ 18 years old [or the legal age of consent in the jurisdictionin which the study is taking place], at the time of signing the informed consent. Type of Participant and Disease Condition

2. Has primary resectable low or high risk basal cell carcinoma according to theprotocol definition

3. Has diagnostic punch biopsy of all lesions intended for injection available prior tothe first dose of BO-112.

4. Has adequate organ function defined as defined per protocol

5. Women of childbearing potential (WOCBP) must have a negative serum or urinepregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionicgonadotropin [HCG]) within 24 hours prior to the start of study drug.

6. Women of childbearing potential must be willing to use two effective methods ofbirth control while treated with BO-112 and for 4 weeks after the last treatment.The two forms of birth control authorized are defined as the use of a barrier methodof contraception (condom with spermicide) in association with one of the followingmethods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives from the timeof informed consent.

7. Male patients with female partners of childbearing potential must be willing to usetwo adequate contraception methods while treated with BO-112 and for 4 weeks aftertreatment completion. Informed Consent

8. Capable of giving signed informed consent as described in Appendix 1 which includescompliance with the requirements and restrictions listed in the informed consentform (ICF) and in this protocol.

9. Able and willing to comply with all study requirements, including surgical removalof lesion/lesion site at completion of study.

Exclusion Criteria:

1. Has history of hypersensitivity to BO-112 or its excipients/vehicle. 2. Has any BCClesion(s) in site of prior radiation and/or any BCC lesion(s) within 2 cm of theopen eyelid margins 4. Has Gorlin's syndrome 5. Has clinically active oruncontrolled skin disease or tattoos that would interfere with evaluation of thearea surrounding the target lesion 6. Has another malignant disease requiringtreatment 7. Has a history of immunological disorder, severe allergic reaction,moderate or severe asthma or known history of anaphylaxis or any other seriousadverse reactions to the investigational products.

2. Female participants: lactating or pregnant. 9. Has received a live vaccine ormessenger ribonucleic acid (mRNA) Corona virus disease (COVID) vaccine within 7 daysprior to the first dose of study drug or has a vaccination planned during treatmentwith BO-112 and within 7 days after the last study drug administration.

3. Is immunocompromised. Systemic corticosteroids at >10 mg/day prednisone orequivalent within 1 week prior to the first dose of BO-112.

4. Has any prior systemic anti-lesion therapy or local treatment for study lesionsprior to first dose; any chemotherapy or immunotherapy for any other malignancywithin 24 months prior to the first dose of BO-112.

5. Has any experimental or investigational agents within one month of first BO-112injection.

6. Has received or is expected to receive treatment with psoralen plus ultraviolet A (UVA) or ultraviolet B (UVB) therapy within 6 months prior to the first dose ofBO-112.

7. Requires / or has used topical products within 5 cm of a treatment-targeted BCClesion or systemic therapies that might interfere with the evaluation of the studymedication during the study.

8. Has any other concurrent anti-cancer therapy (chemotherapy, immunotherapy,radiotherapy, or any ancillary therapy considered investigational [used for a notapproved indication and in the context of a research investigation]) within 28 daysof first study drug administration; or plans to participate in an experimental drugstudy while enrolled in this study.

9. Has any medical contraindications to surgery