Rasmus H

Founder @ | 🧬 #biotech retail investor | 👀 $OCUL maxi | 🌎 Global citizen | 👋 always happy to connect

[Rasmus H @RazBioTech]

@bradloncar Welcome! Swedish summer is fantastic and Lund is great. Looking forward to seeing some biotech content from there. Random tip; get at least one Skagen toast.

[Rasmus H @RazBioTech]

@birgirm80 @moprocto @nalyticsatwork Even if they don’t the period between filing and decision is traditionally where most transactions take place

[Rasmus H @RazBioTech]

Important for expectation management ahead of $OCUL investor day in June

[Rasmus H @RazBioTech]

@nalyticsatwork Ah okay I am not sure - hope you are right!

[Rasmus H @RazBioTech]

@nalyticsatwork No because the 10 month clock starts ticking 60 days after submission. If they submit in July 2026 the decision likely July 2027.

[Rasmus H @RazBioTech]

@JeremyFalmouth Most likely is that the regulatory path is taking shape in a real way. Just me speculating. No idea on timing other than the investor day timing having something to do with it.

[Rasmus H @RazBioTech]

Felt that PD projected a deep calm and a different “aura” than previously - it’s clear to me something has been unblocked behind the scenes. Either on the regulatory side or a progressing courting process. Quite confident holding $OCUL

[Rasmus H @RazBioTech]

@AscendingBio None of those. It’s because they’ll have regulatory news by then and can provide guidance & explanation to the market. With this date anchored investors won’t speculate or get cold feet in May/June without news but instead simply wait for the investor day.

[Rasmus H @RazBioTech]

@Biotech_FC Good question, I actually don’t know, just sort of assumed it’d be made available and that it was for safety

[Rasmus H @RazBioTech]

$OCUL redosing data from SOL-1 is also not out of question though likely too early. Remember all patients got a second Axpaxli dose at 52 weeks…

[Rasmus H @RazBioTech]

@wallstlobo Would love data on how control group in SOL-1 performed with SOL-R rescue criteria applied. Would love “tap-out-data”, i.e is the BCVA data muted in Ax arm because vision maxed out? Would love other -relevant- subgroup analysis. $OCUL

[Rasmus H @RazBioTech]

$OCUL $EYPT $KOD https://t.co/w3mxsEkmrr

[Rasmus H @RazBioTech]

@wallstlobo Would love data on how control group in SOL-1 performed with SOL-R rescue criteria applied. Would love “tap-out-data”, i.e is the BCVA data muted in Ax arm because vision maxed out? Would love other -relevant- subgroup analysis. $OCUL

[Rasmus H @RazBioTech]

@Sjfms1Steven That HD is numerically inferior to Eylea 2mg is fine because it has (marginally) longer duration. The issue here is that HD isn’t dosed according to label in SOL-R, but at 6 months - the exact same cadence as Axpaxli. So if RFR Ax vs HD is the same, at the same 6m dosing…

[Rasmus H @RazBioTech]

My take; Eylea HD will do well in $OCUL SOL-R even when stretched to 24 weeks. Reason: inclusion criteria. Patients are stable. In this mild group the HD-arm will do better than in market. Study will hit, look optically/commercially questionable but Ax will still own the market.

[Rasmus H @RazBioTech]

@harvey_ramer We can call them well controlled. They are recruited to be as easy as possible to maintain. On top of that, rescue criteria is 5 ltrs AND 75um. More liberal than the Ph3 HD trials. Ultimately it doesn’t really matter if HD looks good though as everyone knows its true durability.

[Rasmus H @RazBioTech]

@harvey_ramer Yeah it’s a shit product, it’s just patient group is so mild in SOL-R that patients won’t be rescued to a large extent in any group.

[Rasmus H @RazBioTech]

@harvey_ramer I fear Axpaxli won’t have an edge on rescue free rate against HD in this population at 24 weeks. I worry that will look very bad optically. I am fairly confident Axpaxli meets non-inferiority against 2mg on protocol, so study will succeed.

[Rasmus H @RazBioTech]

@harvey_ramer Agree 100% that HD will only show marginal improvement vs 2mg - unfortunately marginal improvement is all it takes, as the delta between 2mg and Axpaxli groups at 24 weeks was just 8%

[Rasmus H @RazBioTech]

Thought about this in $OCUL SOL-R study, any thoughts?

[Rasmus H @RazBioTech]

@JeremyFalmouth @Sjfms1Steven @Biotech_FC @sububoston @AscendingBio @InvestorLatin One big unknown is redosing, and especially if HD will perform as well after redose 1 as after the first dose? Here ax might have a slight advantage as SOL-1 suggests it’ll be 30%+ drier at wk 24. HD enters 2nd phase wetter & without 6 months of recent loading doses to help it.

[Rasmus H @RazBioTech]

@Mikeptyg @JeremyFalmouth @TripESU89 Screenshot from FDA’s website.