Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

Key Inclusion Criteria:

• Must be of at least 50 years of age, at the time of signing the informed consent.

• Have a clinical diagnosis of stable, clinically typical actinic keratosis.

• Have at least 3 actinic keratosis lesions contained within contiguous treatmentregions of face and/or scalp and/or back of hands.

• Must agree not to use any product on the treatment area during the entire course ofstudy except for Investigator-approved cleanser, sunscreen, wash, and non-medicatedmakeup.

• Must be willing to comply with sun avoidance measures for all exposed areasincluding use of Investigator-approved sunscreen and/or hats, have limited sunexposure time, and have no tanning bed use.

• Must be in good general health (ECOG 0-1)

• Participants of reproductive potential must agree to use double effectivecontraception from screening until 90 days after discontinuing study treatment.

• Female participants who had a menstrual cycle within 2 years prior to screening musthave a negative serum pregnancy test at screening and a negative urine pregnancytest on their first treatment day.

• Must be capable of giving signed informed consent

Key Exclusion Criteria:

• Known or suspected hypersensitivity to any of the excipients of bimiralisib gel.

• Clinically atypical and/or rapidly changing actinic keratosis lesions in thetreatment area.

• Clinical evidence of severe, uncontrolled autoimmune, cardiovascular,gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.

• Participation in any clinical research study within 30 days of the Baseline Visit.

• Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy,cryotherapy) within 4 weeks of the Baseline visit and within 2 cm of the selectedtreatment area.

• Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to theBaseline Visit or planned use during the study.

• Use of any retinoids within 90 days of the Baseline Visit, or glucocorticosteroids,methotrexate or other anti-metabolites or nicotinamide within 28 days of theBaseline Visit.

• Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.

• Any other malignancy within 5 years prior to Screening except basal or squamous cellcarcinoma not in the treatment area that were treated with curative intent and arewithout recurrence.

• Other significant uncontrolled or unstable medical diseases or conditions that, inthe opinion of the Investigator, would expose the participant to unacceptable riskby study participation