The Management is burst of confidence for sure …. It’s certainly...

The Management is burst of confidence for sure ….
It’s certainly building up momentum as we're one step closer to 2nd half the year…

Within the next 3-6 months, we should have the final data of the 9-months toxicology study of ATL1102, everything will unfold:
a) Discuss results with FDA, with a view to lifting clinical hold in the US.
b) Apply for expedited program status with the FDA including Fast Track or potential Breakthrough Therapy designation.
c) By end of the year, we will have Phase IIB Primary Endpoint PUL2.0 score result, if positive, will discuss with FDA on accelerated regulatory pathways to registration.
d) Combination therapy (potential use in ambulant boys – positive data in mdx mice: Have synergistic effect) under strategic consideration.
e) & LGMDR2 is also under strategic consideration (From annual report 2023)
f) Multiple Sclerosis & Acromegaly under Strategic Review (CY2024)
g) Undisclosed Indications under Strategic Review (CY2024)
h) Partnership with any of the above (c-g, hopefully). – Dr James Garner is looking to partner with 1 or more larger companies. (2 unlicenced products)

Key takeaways in today’s announcement (in my opinion):
1. The team is turning its attention to next steps, including potential engagement with regulatory agencies such as FDA
2. Prepare for the next chapter in the development of ATL1102
3. Cathryn’s extensive networks among clinicians and patient advocacy in the US
4. Momentum grows in the ATL1102 program

Looking forward to the NEXT big announcement…