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 treatment regions 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 of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.
* Must be willing to comply with sun avoidance measures for all exposed areas including use of Investigator-approved sunscreen and/or hats, have limited sun exposure 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 effective contraception from screening until 90 days after discontinuing study treatment.
* Female participants who had a menstrual cycle within 2 years prior to screening must have a negative serum pregnancy test at screening and a negative urine pregnancy test 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 the treatment 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 selected treatment area.
* Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to the Baseline 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 the Baseline 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 cell carcinoma not in the treatment area that were treated with curative intent and are without recurrence.
* Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation