BNO gets another shot at PTSD with lead drug BNC21020 February 2019
https://www.bellpotter.com.au/media/187945/bionomics.pdfUpcoming Key catalystsOver the course of the next 6-12 months we expect the following news flow to drive a rerating for BNO:
CLINICAL AND REGULATORY MILESTONES• Results from Phase 2 Agitation trial with BNC210 expected in 2QCY19:Results from the ongoing Agitation trial with BNC210 in elderly patients is expected to be available in 2QCY19. Further additional exposure-response analysis from this trial is likely to be available in 3QFY19. A positive result from this trial, along with the impressive results seen in the Phase 2 GAD trial and the data from the PTSD trial showing evidence of antidepressant and anxiolytic effect of BNC210 and exposure response analysis demonstrating potential benefit with adequate blood level exposure will further strengthen BNC210’s licensing package and improve its partnering prospects.
• FDA meeting/response on path forward for BNC210 for PTSD:BNO intends to submit the data package from the Pharmetheus exposure-response analysis of the PTSD trial within 3 months to the FDA. FDA’s response or meeting with the company providing input and guidance on potential path forward for the development of BNC210 for PTSD, in our view will be valuable in any partnering discussions for the drug.
COMMERCIAL AND OTHER MILESTONES• Additional milestone payments from partner Merck in 2QCY19 may providefurther tailwinds:We expect BNO to receive a second milestone payment of US$20m from Merck on first patient being dosed in a Phase 2 trial with the Alpha 7 Alzheimer’s asset in 2QCY19 (2HFY19). This would provide further validation and strengthen BNO’s cash position.
• Result of strategic review by Greenhill & Co:BNO intends to announce the result of the ongoing strategic review being conducted by Greenhill & Co. in 2QCY19 in parallel with the results from the Phase 2 Agitation trial.
• Licensing deal for BNC210 anxiety asset in 2HFY20:We expect partnering interest for the anxiety asset BNC210 to be rekindled after the latest findings on the exposure response relationship identified in the PTSD trial, which could translate into a deal in2HFY20 following completion of the ongoing Phase 2 agitation trial and FDA discussions on PTSD. This would represent a significant re-rating catalyst for the stock. We assume that BNC210 is licensed in 2HFY20 for a deal worth US$600m, including US$50m as upfront payments and double digit royalty on sales.
We note that in 2015, Allergan acquired Naurex for its injectable anti-depression drug while it was in a Phase 2b trial for an upfront payment of US$560m and undisclosed milestones and royalties on potential net sales.
