$15m cap raise Fresh Equities at 24c, page-534

Taylor Collison broker report out - outperform

Phase IIb/III trial designANP’s double blind, European Phase IIb/III study will recruit 114 non-ambulant DMD patients who will be randomised 1:1:1 to receive weekly doses of either placebo, 25mg or 50mg of ATL1102 for 52 weeks. The primary endpoint will be the change in the Performance of Upper Limb Module for DMD 2.0 (PUL 2.0) vs placebo. The trial is expected to commence recruitment in mid CY22 and will enrol at over 30 sites in 9 countries. A futility analysis will be conducted when ~48 patients have completed the week 24 interim PUL 2.0 assessment (mid CY23), leading to a go/no go decision whether to continue the treatment groups or the study itself. The primary endpoint is expected to read out in mid-CY24. At the completion of the 52-week treatment period participants will be invited to enter an open label extension (OLE) study – PDCO has advised that at least 60 participants should be followed for 6 months in the OLE before a marketing approval application is submitted (filing expected to be in H125).Raising $36.8m to fund the pivotal trial to interim analysisANP has raised $20m in a placement at $0.24/sh and is undertaking a non- underwritten 1 for 9.4 entitlement offer to raise a target amount of $16.8m. One free option exercisable at $0.48 will be issued for every 2 new shares. While the issue price of $0.24 was a ~19% discount to the previous closing price, the stock is trading around the issue price, increasing the uncertainty around the uptake of the entitlement offer. If the entitlement offer does not raise the full $16.8m the Phase IIb/III study may not be fully funded to the interim analysis, which may delay the trial or require the company to raise further capital.ATL1102 showed promise in Phase IIa DMD trialIn a Phase IIa trial in 9 non-ambulant DMD patients, subjects treated with 25mg ATL1102 per week for 24 weeks showed an improvement in PUL 2.0 scores, whereas PUL 2.0 scores declined in all 6 other studies of DMD patients that we examined. ATL1102 shows promise as a treatment to reduce inflammation and resultant muscle damage in DMD, which will be investigated in the upcoming pivotal trial at up to twice the dose used in the Phase IIa trial.Valuation per share remains $0.27/shWith funding secured to initiate the pivotal trial we increase our probability of success of ATLL1102 in Europe from 25% to 30%. Assuming 153m shares are issued to raise the targeted $36.8m, our valuation increases from $154m to $197m, but the increased share count sees our per share valuation unchanged at $0.27/sh (undiluted), although fully diluted valuation increases slightly to $0.26/sh.