Ann: Change of Director's Interest Notice GP, page-26

Antisense TherapeuticsThe next Neuren?Ambitious, but we see the potential for a Neuren-esque (Neuren Pharmaceuticals:NEU.ASX) rally (from $2 to $12 over two years) pending clinical success over thenext 18 months followed by favourable regulatory outcomes.

Following a successful placement and proceeds from the current SPP, ANP hasenough funds to deliver the potentially pivotal Ph2b trial in DMD in Aus and Europe- with top-line results due mid CY24.New CEO, board refresh, and a number of recent hires including ex-CSL staffers,we’re backing the management and clinical team and its ability to extract an answeras efficiently and with the greatest regulatory bang-for-buck as possible.Of course, success is far from a foregone conclusion as clinical results often showcause for question and require further investigation or clarification – which is whya basket approach is often required.

We see ANP as one of those stocks whichshould be in the basket as risk tolerance allows.We have updated our model to include the new shares on issue and assume fulltake-up of the SPP offer. Our risked-DCF valuation reduces to A$0.23 (fromA$0.26) and retain a Speculative Buy recommendation.Event▪ ANP has successfully raised A$8.35m via institutional placement (the maximumavailable under placement capacity), followed by an SPP which is expected to raise~ A$1.5m. With A$11m as at the end of 4Q23, this will leave ANP with ~A$21m incash + R&D rebates to bring the company through to the key results in its Ph2btrial for DMD.▪ In further news, results from the mouse model in combination of ATL1102 anddystrophin restoration drug was positive. The study showed small but presentdystrophin levels in the muscle both in monotherapy and combination arms versusnone in the controls. The data supports its potential use both as a monotherapy aswell as in combination (see p.4) and will support IP protections out to 2044.Analysis▪ With the funding overhang now resolved and a clear line of site to top-line results,we expect to see increasing interest in the name in the lead-up to the readouts.▪ The risks ahead are of course the trial results (clinical risk) and recruitment rates(timeline risk), particularly given the rarity of the condition. Recruitment to date hasbeen positive, with 5 of 45 boys having already received first dose, five inscreening, and further site activations imminent.▪ Our views on Ph2b results remain positive, with replication of the Ph2a efficacyand safety data on higher patient numbers we view as sufficient to show clinicalbenefit and garner regulatory favour.Forecast and valuation update▪ We have maintained our broader assumptions which includes clinical progressionrisk, further Ph3 EU trials, as well as smaller confirmatory trials required for USregistration. We see this as our base-case scenario, with significant upside onpositive data readouts and confirmation of the pathway to regulatory clearance.▪ We roll through an additional 200m shares from the recent capital raising initiativesand based on small delays to site initiations and trial commencement, roll R&Dexpenses from FY23 into subsequent years.Investment view▪ We view ANP as a strong proposition in the burgeoning rare disease space with astrong scientific foundation for success, multiple near-term catalysts, and potentialfor accelerated approval.

There aren’t many micro-cap biotech opportunities withthe scale of near-term upside that ANP has, combined with the board andmanagement pedigree it has been able to attract. We have a Speculative Buyrating and risk-adjusted DCF based target price of $0.23 per share on the stock.Price catalysts▪ Limb Girdle R2 Dystrophy study results (Aug-23) / full recruitment (Dec-23) /monkey tox (May-24) / Ph2b primary endpoint readout (Jul-24).Risks▪ Delays in trial recruitment and commencement / Failure of DMD in Ph2b program.


The above from Morgan’s
They see requirement as a hurdle so any news re enrolling DMD patients in all x4 countries could be a trigger for the sp..imo