Antisense Therapeutics Limited initiates the process with Contract Research Organisation (CRO) Pharmaron to conduct a nine-month chronic monkey toxicology study to support the advancement of the ATL1102 program in the US for Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102. Successful completion of the toxicology study is expected to be the final requisite step for the lifting of the partial clinical hold in the US that presently limits the dosing of ATL1102 to 25mg per week for 6 months. Lifting of the partial clinical hold would also allow ANP to apply for expedited program status with the US Food and Drug Administration (FDA) including Fast Track or potential Breakthrough Therapy designation.

There has been a well-documented long-term shortage of monkeys of the appropriate type and age available to the CROs for the conduct of such studies, leading to significant uncertainty on the possible future timing for an ANP study start. An opportunity recently presented to the Company whereby Pharmaron is able to run a study much earlier than anticipated following the cancellation of a similar study by one of Pharmaron's customers. To take advantage of this opportunity, ANP has taken on the husbandry and housing costs of the pre-allocated animals while completing the necessary arrangements with the CRO*.

This enables Pharmaron to initiate the Company's chronic toxicology study with dosing of all animals to commence before the end of this calendar year with the reporting of key study findings expected in 1H'24, around the same time as six-month dosing results from the ATL1102 in DMD Phase IIb clinical study.