Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-130

From Taylor Collision Research report:

7 June 2021
Speculative Investment
Recommendation: Outperform

https://www.antisense.com.au/wp-content/uploads/2021/06/ANP-20210607-FDA-feedback.pdf

Antisense Therapeutics (ANP)
Positive FDA feedback on pivotal trial design
Our View
ANP has received formal minutes from the type C meeting with the FDA held on 19 April. The FDA feedback noted that the design of the proposed Phase IIb/III trial of ATL1102 in non-ambulant DMD patients (including the PUL 2.0 primaryendpoint) appears to be acceptable and that it would consider the exploration of higher doses subject to adequate justification. The FDA expects the company to conduct a 9-month monkey toxicology study to support dosing for 12 months vs 6 months in the earlier Phase IIa trial, but in a positive surprise would allow the Phase IIb/III trial to commence before the monkey study is completed. While the FDA feedback is positive for the US development plans for ATL1102, ANP’s
main focus continues to be on the planned European Phase IIb trial, which aims to commence recruitment in Q421. The company expects to receive feedback from European Medicines Agency (EMA) on its Paediatric Investigation Plan (PIP) for ATL1102 in the coming weeks, which will allow it to finalise the trial design. Our valuation is unchanged at $154m, $0.27/sh (undiluted), or $0.25/sh fully diluted for a potential capital raise to fund the est. $25m European trial.