Freeline Therapeutics Holdings plc (NASDAQ:FRLN) Q4 2022 Earnings Call Transcript

Joe Hashmall: Hi, everybody. Thanks for the clarity. This is Joe Hashmall on for Patrick. Just one question regarding the GALILEO data. What might we look to see in the first cohort in terms of enzyme activity to give confidence bringing the molecule forward? And additionally, kind of on top of that from a safety perspective, are there any with the increased half-life adverse events that you will be looking out for, especially going forward as a result of it?

Michael Parini: Thanks for the question. Maybe the first part, I’ll ask Pam to comment on what we expect to share in the data. And obviously, we have modeling on dose translation from the preclinical work into humans. Pam, you want to give us some thoughts on that before maybe I ask Henning to take the second part?

Pam Foulds: Sure. Happy to. So, as you know, we’ll be dosing into the first cohort within GALILEO as he mentioned and Michael mentioned that . What we plan to be sharing in this first cohort, which would be two patients, would be any safety data, of course, as well as enzyme activity. That’s what we anticipate to be demonstrating in these patients. Importantly, as I mentioned earlier too, as Michael mentioned, we do expect to see based on our modeling a nice robust enzyme level that’s based at our modeling. So, we will see that data and share that data as that comes out in Q3.

Michael Parini: And then on the second part of the question, we certainly have done thorough safety assessments pre-clinically on the novel enzyme. Henning, do you want to talk a bit about that and why we’re confident that we understand that they will behave like a wild-type enzyme?

Henning Stennicke: Yes. I think in all practical aspects and we’ve dosed quite high in the preclinical experiments and studies in without seeing any adverse events. And we do not expect there to be any concerns about higher doses or higher exposures of the TCAs as there’s really no upper limit for the dosing of wild-type VPRIV observed other. So, it seems to be a fairly safe concept and this is still a replacement therapy. And even though we will have higher levels, we do not foresee any safety concerns from the payload itself. Obviously, we will have potential elements that we have observed previously with the AAVS3, which is sort of a separate issue. But overall, with the 19 patients, we have treated far events of ALT has been fairly well-tolerated.

Joe Hashmall: Thank you so much.

Operator: Thank you. We will now take the next question. It comes from the line of Dae Gon Ha from Stifel. Please go ahead. Your line is open.

Dae Gon Ha: Hey, good morning. Thanks for taking our questions. I’ve got three. First one on FLT190, if you can just remind us, have you dosed any additional patients beyond the first two, particularly interested in what you might have seen on the myocarditis front and the troponin level increase? Whether your immunosuppression strategy has worked on those? Second is, Pam, in your prepared remarks, you talked about facing some headwinds and I believe you’re referring to the one-half 2023 prior guidance for the GALILEO-1. If you can talk to maybe what happened there and why the data are now expected in 3Q 2023 speak to the confidence that you have towards that particular catalyst? And then third is, as we look toward your cash runway, 2Q 2024, GALILEO-1 cohort 1 data in the third quarter of this year, but any additional catalyst that we can expect before the cash runway? Thanks so much.