PER 4.65% 9.0¢ percheron therapeutics limited

Ann: ATL1102 DMD Paediatric Investigation Plan submitted to EMA, page-25

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    Antisense Therapeutics (ANP) PDF

    Still flying under the radar


    SPECULATIVE BUY (maintained) | current price:A$0.17 | target price: A$0.38 (previous: A$0.38)

    §ANP reported 1H results with a small increase in underlying net losses with higher staffing costs as regulatory preparations commence.

    §With the recent capital raise completed in the half, the company is well funded to commence drug manufacture and trial preparation work in 2H21.

    §The Company has made strong progress recently but we view the next 12 months as particularly important with a large number of catalysts and events unfolding giving further clarity on costs, trial design, new indications, and potential for partnering discussions to commence.

    §We retain our A$0.38 price target and Speculative Buy recommendation.


    1H21 results in line – expenses weighted to 2H for trial prep
    ANP reported its 1H results showing a net reported loss for the period of A$2.0m (53% improvement in the pcp). General expenses (staff / R&D / patent) were broadly similar with the main driver of the variance being A$2.4m in non-cash share based payments cycling through pcp results. Operating cash outflow increased 28% to A$1.8m. We expect a significant increase in R&D expenses with drug formulation and trial preparatory work and submissions to roll through in 2H. With A$8.5m in capital raised over the half, ANP closed the period with A$10.0m in cash, sufficient to fund all preparatory work ahead of its pivotal Ph2b trials.

    PIP submission to EMA – feedback and lodgment in 2Q
    ANP has submitted its Paediatric Investigation Plan (PIP) for DMD trial to the European Medicines Agency. These plans are designed to ensure all necessary data is obtained in studies involving children, and that the data (if successful) will support the authorisation plans for approval. The process is designed to inform both the regulatory bodies and the Company of all facets of the trial, with feedback providing further clarity around regulatory expectations finalising design and subsequent trial registration. While the submission was expected, it nonetheless confirms expected timelines with feedback expected in Q2CY21 and formal trial application submission shortly after (Q2CY21). Given this timeline, and if trial submission is approved, the Company expects first site initiation in Q4CY21 which is in-line with our forecast by late 1H22.

    1H achievements / CY21 milestones ahead
    Achieved: 1) Sep '20 – inclusion into FDA Rare Pediatric Disease Priority Review Voucher Program; 2) Oct '20 – post study analysis on Ph2a results; 3) US FDA Orphan Drug Designation; and 4) EMA orphan Drug Designation. Ahead: 1) data on new indications (3Q/4Q21); 2) EMA PIP feedback (3Q21); 3) EMA trial submission; 4) Type-C FDA feedback (May '21); 5) Trial recruitment (2Q22); and 6) EU trial commencement (2Q22).

    Investment view – no change to positive view
    With no changes to forecasts, our valuation range remains at A$0.38 to A$1.82 per share with our near-term target price set at the bottom end of our range. While considerable trial risk and hurdles remain, we view ANP as one of the best risk/reward plays in the healthcare space given the data produced to date and heading into a catalyst rich 36 month period. Downside risk to our price target is failure in the DMD Ph2b program (value is 2 cps) and prolonged delays in trial recruitment and commencement.


 
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