Binding Commitments Received for A$1.0 Million under Convertible Note

“The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin,” said Darin Messina , Ph.D., senior vice president, aesthetics R&D, AbbVie. “TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category.”

New patients wanting to experience the aesthetic benefits of a neurotoxin cite “fear of looking unnatural” as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic.

The BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the Phase 3 pivotal studies were previously shared .

“Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment,” said Cheryl Burgess , MD, FAAD, lead clinical investigator for one of the Phase 3 studies. “Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX® Cosmetic.”

BOTOX ^® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX ^® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING