Krystal Biotech at TD Cowen Conference: Strategic Pipeline Progress

On Tuesday, 04 March 2025, Krystal Biotech (NASDAQ: KRYS) participated in the TD Cowen 45th Annual Healthcare Conference. CEO Krish Krishnan outlined the company’s strategic plans, focusing on the upcoming EU launch of Vyjavec and regulatory progress in Japan. The discussion highlighted both the potential market opportunities and the challenges faced in pricing and patient education.

Key Takeaways

• Positive CHMP opinion received for Vyjavec in Europe, with a focus on pricing and market access.
• Regulatory interactions ongoing in Japan and the US, with submissions planned for the UK.
• The Cristal Connect program emphasizes patient education and support.
• Data readouts for cystic fibrosis, oncology, and Alpha-1 Antitrypsin Deficiency expected soon.
• Conservative pricing strategy in Europe, aiming for 60-70% of US pricing.

Vyjavec EU Launch and Pricing

The European launch of Vyjavec is a pivotal step for Krystal Biotech, following a positive CHMP opinion. The label allows for dosing from birth and at-home administration, offering an advantage over the US label. The company estimates around 1,000 diagnosed patients in Germany and France are ready for treatment. Initial visits must occur in healthcare settings, which could slow early prescription rates. The pricing strategy is conservative, with hopes to achieve 60-70% of US prices, varying by country. Commercial operations will be supported by approximately 10 employees per country, with headquarters in Zug, Switzerland.

Japan and Other Regulatory Submissions

In Japan, Krystal Biotech is collaborating with the PMDA, with an inspection scheduled soon. The market strategy targets 350-500 patients, supported by a team of 15 employees. The company plans to submit regulatory applications in the UK mid-year, anticipating pricing challenges. Distributor relationships are being explored in the Middle East and North Africa.

Vyjavec US Market and Patient Support

In the US, over 65% of prescribers are new to Vyjavec. A significant barrier is the lack of DEB knowledge among community dermatologists. The Cristal Connect program aims to address this through patient education on disease management and expectations. Drug holidays are common, with patients typically resuming treatment within 90 days, aligning with the collagen seven half-life.

Pipeline Updates

The Phase 3 IOLITE trial for ocular DEB is set to start in the first half of the year, aiming to reduce lesion severity and frequency. For cystic fibrosis, data from cohort three is expected mid-year, focusing on molecular data. Updated data for the oncology program will be presented at ASCO, with early monotherapy results showing a 30% ORR in NSCLC. The Alpha-1 Antitrypsin Deficiency program will provide updates in the second half of the year, with initial data indicating a 50% reduction in neutrophil elastase levels.

Conclusion

For a detailed overview of Krystal Biotech’s strategic plans and pipeline progress, readers are encouraged to refer to the full conference transcript.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Ritu Baral, Analyst, TD Cowen: We’re going to go ahead and get started. Thank you very much for joining us for the Cristal Biotech Fireside Chat here at the forty fifth Annual TD Cowen Healthcare Conference. I’m covering analyst, Ritu Baral. And with us from, from Cristal, we have CEO, Krish Krishnan. Krish, thank you for joining us today.

Krish Krishnan, CEO, Cristal Biotech: Thanks for having me.

Ritu Baral, Analyst, TD Cowen: So let’s start with Vyjavec. Late last week, you guys got the positive CHMP opinion, and Christel previously guided to a second half EU launch in Germany followed by France. What should we expect from an investor perspective about the initial EU launch as far as pricing and pace of prescriptions?

Krish Krishnan, CEO, Cristal Biotech: Yeah. We were pretty pleased with the label we got from the EMA. We expect there are about 1,000 diagnosed patients between Germany and France that are in registries and ready to go. The label was incrementally positive to an already good U. S.

Label with respect to being able to dose from birth? Yes. Giving the patient the optionality at home to be dosed by a caregiver or by themselves. So it’s definitely incrementally better label, which is remarkably good for the patients in the long term. That said, the one thing we have to be careful about with respect to the EU launch is the first visit by has to be by a HCP by a patient in a healthcare setting.

So to start, you have to go to a doctor’s office to initiate treatment. And that, depending on the country we’re talking about, whether it’s France or Germany, could take a certain amount of time to get an appointment and go to a physician.

Ritu Baral, Analyst, TD Cowen: Do you know what the capacity of the clinics in Germany and France are? Like, how many and how many sort of clinic day visits there are?

Krish Krishnan, CEO, Cristal Biotech: Not completely. But I do know France is in general much more it’s a much more concentrated patient base than The U. S, which means a majority of patients are tied to a center of excellence. And one area we are trying since we got the opinion, we have started to work on is to try and figure out what these centers of excellence do in France.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: And if there’s anything we could help between now and then, for example, we do you know, how they have EB clinics in The US. Mhmm. Maybe simulator creates such opportunities for the center of excellence to bring in a bunch of patients, get them all trained at the same time as opposed to one at a time.

Ritu Baral, Analyst, TD Cowen: Oh, right. Because they can they can dose themselves. So you have

Krish Krishnan, CEO, Cristal Biotech: Or by FDA. They’re trained. Yeah. And Germany is less concentrated than France’s, but more than The US. Mhmm.

And again, on the COEs, we’re trying to think about ways to help patients get on drug faster than the normal process would allow.

Ritu Baral, Analyst, TD Cowen: What about pricing?

Krish Krishnan, CEO, Cristal Biotech: Look, from an so pricing, there are two aspects to pricing in our opinion. One is the accrual. We’re going to be very conservative in the way we accrue for the eventual price. But I want people to understand what we accrue is not doesn’t point to where we think we’re gonna end up. We’re hoping to end up at a higher price than what we are accruing for when we accrue.

And, you know

Ritu Baral, Analyst, TD Cowen: So you’re gonna accrue at a aggressive discount, which is which would be the worst case scenario?

Krish Krishnan, CEO, Cristal Biotech: Correct.

Ritu Baral, Analyst, TD Cowen: Okay. And that’s, what, 40%, fifty %? What’s a good proxy in the orphan drug space for how you think Europe will approach VITUVAX?

Krish Krishnan, CEO, Cristal Biotech: There have been enzyme replacements in the past, that have done that that have gotten up to 60 to 70% of The US price. Mhmm. It does vary by country, and there are also macroeconomic factors that contribute budgets and change the government. So but we do believe Vazovec has a very strong value proposition in Europe. It is a loud disease.

It is a highly What do you

Ritu Baral, Analyst, TD Cowen: mean by loud disease?

Krish Krishnan, CEO, Cristal Biotech: That the patient is vocal. Everyone can see it. Like, you don’t it’s not you don’t have to it doesn’t take much to help people understand how debilitating the disease is, and it’s an ultra rare disease.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: So there are a lot of things going for it. And if you look at our pivotal trial, it was a double blinded separation from placebo has been great. The patient experience to date in The US has been great. So we do believe we have a strong dossier to present to the HDA or the agency.

Ritu Baral, Analyst, TD Cowen: All of the things that you mentioned, you know, the fact that it’s a allowed disease and a motivated patient population, Are those things I can’t believe I have to ask this, but are those things even considered as part of the health technology assessment in Europe? Does it matter to the plan authorities?

Krish Krishnan, CEO, Cristal Biotech: I I believe they’re important and relevant. At the end of the day, you’re making a case of benefit.

Ritu Baral, Analyst, TD Cowen: But on what endpoint? I’m I’m trying to figure out, like Yeah. It’s it’s almost hard to figure out what matters to them. I mean, at the end of the day, they want to save money. But the different proxies and different diseases that in that analysis equates to saving money can be varied.

So I’m just wondering, like, for EB, what is it?

Krish Krishnan, CEO, Cristal Biotech: And I think, look, it’s ultra rare. If you tally up all the patients in a particular country times the price of the drug, it doesn’t blow the budget, relatively speaking compared to some of the bigger indications. No, but you make a good point. Like we actually believe we have enough to make a to connect all the dots. Yep.

We have a strong case to make, and we’ll see how it

Ritu Baral, Analyst, TD Cowen: And you already have insight into the levers in the health technology assessments right now. Correct?

Krish Krishnan, CEO, Cristal Biotech: Yeah. We have a pretty good understanding of how it works and how we have to get prepared for negotiations.

Ritu Baral, Analyst, TD Cowen: Got it. And so with that in mind, what is the investment in commercial infrastructure going to look like and the timing of the investment?

Krish Krishnan, CEO, Cristal Biotech: Roughly about 10 patient there are 10 employees per country.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: We also have HQ headquarters in Switzerland.

Ritu Baral, Analyst, TD Cowen: Zug. Right?

Krish Krishnan, CEO, Cristal Biotech: You said Zug. Yep. Where some some areas like medical affairs and pricing are centralized even though there could be some decentralization. Mhmm. So about 10 per country, so the investment would be 10 in France and in Germany, and we are close to six or seven already who are employed.

So we have one or two more reps to fill out the gaps. Mhmm. And we’ll be ready for the launch in the second half.

Ritu Baral, Analyst, TD Cowen: How is Japan progressing, the timelines? Can you walk us through that?

Krish Krishnan, CEO, Cristal Biotech: We’re in the middle of going back and forth with the PMDA as we speak. We have an inspection scheduled in the upcoming weeks from the Japanese authorities.

Ritu Baral, Analyst, TD Cowen: We’ll be going back and forth on the application.

Krish Krishnan, CEO, Cristal Biotech: On the application.

Ritu Baral, Analyst, TD Cowen: The application is in, so you’re in the Q and A portion. I’m in the application. Got it. So what is the go to market strategy for Japan? What is the how should we think about commercial investment?

Krish Krishnan, CEO, Cristal Biotech: About three fifty to 500 patients, a total Japanese employment size of 15 or so.

Ritu Baral, Analyst, TD Cowen: Mhmm. How many, centers of excellence are there in Japan? It must be small.

Krish Krishnan, CEO, Cristal Biotech: I’m not. It’s less than 10, but I can’t recall the exact.

Ritu Baral, Analyst, TD Cowen: Are there any other countries or regions where we should expect regulatory submissions near term that would be meaningful?

Krish Krishnan, CEO, Cristal Biotech: Yeah. We’re looking to submit in The UK in the middle of this year.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: That that that is Now

Ritu Baral, Analyst, TD Cowen: you have EC approval because you said EC approval makes it easy.

Krish Krishnan, CEO, Cristal Biotech: Relatively easy. They have a lot of patients, DEB. I’ve heard pricing can be more challenging in The UK, so we have to go through that process. Mhmm. And Japan by the end of the year.

And along the way, we are thinking about establishing distributor relationships in areas like one or two of these, like in MENA. MENA is in Middle East or Israel. Like, we’re working through a few conversations with distributors for some of the other countries.

Ritu Baral, Analyst, TD Cowen: With other rare diseases, the Japanese prices come between Europe and US. Is that a fair statement?

Krish Krishnan, CEO, Cristal Biotech: Yes.

Ritu Baral, Analyst, TD Cowen: Okay. And then there are definitely some therapies that have walked from The U. K. Because pricing was not a reasonable pricing could not be set. Given the disease and the unmet need, is this something within the realm of possibility?

And isn’t there pressure on you to make the drug available as well? Or is there, like, reimportation or something like that?

Krish Krishnan, CEO, Cristal Biotech: Clearly from the foundational reasons, our objective is to get Vazirbect to as many patients in as many countries as possible. With that, we’re hopeful that we’re able to convince these pricing authorities in different countries on the value that BaiserVac brings. So I hope we don’t get to one of those situations where we have to walk away from a country on some But would you? I’m inclined not to at the moment, but it will be a bigger conversation with my forward and the other management team. It’s not a sole decision.

Ritu Baral, Analyst, TD Cowen: So on the Q4 earnings, you mentioned that over 65% of total prescribers are new prescribers. What are you seeing the largest barrier to new community dermatologists prescribing and dosing VIGERVAC? Is it still that sort of scheduling of the outpatient nurse? Or is there some other aspect?

Krish Krishnan, CEO, Cristal Biotech: No. What happens, out in the community is a lot of is a general lack of knowledge of DEP among a lot of derms and P derms. So patient education is a very important aspect of community physicians, not just in the nature of the disease, but in all the experiences in the types of bandages to use, how frequent should they be looking at, which wounds to start treatment, expectations in terms of wound healing, chronic versus recurring, there’s a place to start. And obviously, with respect to gene therapy and gene delivery and repeat administration, a lot of patients have either not worried about or don’t have the genetic information or have lost it or have access and we gotta find a way to make sure they’re genetically tested for DEB prior to putting them on Bijovec.

Ritu Baral, Analyst, TD Cowen: And you’re still running that free genetic screening?

Krish Krishnan, CEO, Cristal Biotech: We’re not. We have a partner.

Ritu Baral, Analyst, TD Cowen: Okay.

Krish Krishnan, CEO, Cristal Biotech: When was that? But it’s a hands off type. Okay.

Ritu Baral, Analyst, TD Cowen: When was that moved When was that moved out of hands out? I think you It

Krish Krishnan, CEO, Cristal Biotech: was always that one.

Ritu Baral, Analyst, TD Cowen: Oh, CrystalConnect was always

Krish Krishnan, CEO, Cristal Biotech: No. No. No. No. CrystalConnect is not the genetic testing.

Ritu Baral, Analyst, TD Cowen: Oh, decode. Decode. Decode. Yeah. Somebody else always ran decode.

Yeah. Is that what you’re saying? Okay. Got it. And that provides free genetic testing.

Correct?

Krish Krishnan, CEO, Cristal Biotech: We help pay for the genetic testing. Got it. But that said, the relationship is hands it’s very arms length.

Ritu Baral, Analyst, TD Cowen: Okay. At 4Q earnings, you indicated conversion times for NRX to first treatment are now generally within forty five to sixty days. How does Cristal Connect help patients remain on drug and easily return after drug holidays to schedule home administration?

Krish Krishnan, CEO, Cristal Biotech: Yes. So, Crystal Connect is basically a patient supports team. It’s different than commercial. Commercial is primarily sales and marketing. Crystal Connect is a place where we help with reimbursement, educate families on what’s been working, like key learning lessons.

We stay close the PALS stay the patient liaison, they stay close to the patient. We one of the things about Vyjavec is it’s a in some ways, we’re gonna be connected with the patients for a very long time.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: So it’s important that we we we work very hard to ensure the patient experience on the drug is very positive. And to that extent, the the liaisons are very close to the patient if the wounds are healed and they wanna pause, we keep in touch and they are educated that when they see a new blister or an existing wound opens up, that it’s important to get back on drug. What’s more important is collagen seven. Like, absence of collagen seven has all kinds of negative issues from anemia to weight loss to osteoporosis to inflammation. So it’s important that all wounds, all parts of your body have college itself.

So those kind of reinforcements keep them on drug and stay out.

Ritu Baral, Analyst, TD Cowen: When a when a patient goes on a drug holiday and they want to return, is there I mean, is it as simple as calling their physician’s office and saying, I want to start back up again? Or is there some gating factor to finding another nurse and finding another schedule? You know, is it harder to do a restart after holiday than, you know, maintenance?

Krish Krishnan, CEO, Cristal Biotech: No. Not really.

Ritu Baral, Analyst, TD Cowen: Okay.

Krish Krishnan, CEO, Cristal Biotech: It depends on the length of the pause, and this is hypothetical. If you’ve been gone for more than six months, then your prescriptions probably expired, like, then it’s a different circumstance. But for the majority of the patients, taking a pause for a week or two weeks and getting back on drug is pretty easy and pretty smooth.

Ritu Baral, Analyst, TD Cowen: So on 4Q earnings, you also mentioned that compliance has been very good. Again, going to this concept of drug holidays, How frequent are patients going on drug holidays? And how does that differ from missed doses?

Krish Krishnan, CEO, Cristal Biotech: Holidays, look, Q2, we see some summer vacations. In Q3, we see a little bit of, you know, a lot of families have other kids who start school and they plan a few a couple days before in q four holidays. So holiday breaks are very predictable. Year over year, it kind of happens. As as you get more patients, there are gonna be more patients who take breaks.

But as a percentage, I think that is pretty consistent year over year. The other aspect is the wounds are healed, which is a very positive outcome for us. Sure. We actually appreciate the patients taking a pause, getting away from nurse fatigue because you are scheduling a nurse week after week over week over week. It gets to you.

So they take a breather and they are fully aware that when they see and they actually enjoy life a bit more than they ever did before, which is great to see. And then we’re pretty close to them to get back on drug. That is a little less predictable in terms of, you know, a good guiding principle is the half life of collagen seven. Like on average, wounds are healed for about ninety days.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: Now they all heal at different times and different locations and but it’s kind of a guiding principle that they’re back within ninety days. So

Ritu Baral, Analyst, TD Cowen: on 4Q earnings, you mentioned that your Phase three eight zero three, this is ocular.

Krish Krishnan, CEO, Cristal Biotech: Yeah.

Ritu Baral, Analyst, TD Cowen: IOLITE trial will start in first half with data a year later. Can you review for us the proposed design of IOLITE?

Krish Krishnan, CEO, Cristal Biotech: I will at a high level. But when we dose our first patient will be granular with respect to trial design and statistical analysis. A certain percentage of RDEB and DDEB population have lesions in the eye.

Ritu Baral, Analyst, TD Cowen: What percent?

Krish Krishnan, CEO, Cristal Biotech: I said, fifty percent of the RDEB and maybe ten percent, fifteen percent of DDEB. And you can think of them as very similar to lesions in the skin. Some are recurring, some are chronic, some stay for a long time, some come and go, you know, they heal and they come back. And we had in, earlier in the life of Visovac, we treated one patient who had very strong lesions in the eye. And within a certain amount of time, I believe three months, we kind of restored vision for this kid.

And that kid has been really without lesions for a long period of time. It was a great outcome. So the concept of this trial, in terms of trial design, is to have a natural history study of 50 patients, look at how many lesions they have, what is the frequency of the lesions, the duration of the lesion, kind of establish a baseline. And the whole point of the clinical trial is to show that if you potentially used ViseVac, you have reduced the severity and the frequency of the occurrence of lesions. That’s at a high level.

Whether we pick one or more of this as a primary endpoint and which one as a secondary, we’ll talk about that later.

Ritu Baral, Analyst, TD Cowen: What does good data look like with the top line? What are the most important efficacy measures in eye light? We were talking about this a little last night, like But this is

Krish Krishnan, CEO, Cristal Biotech: the BVAC for the eye, I think.

Ritu Baral, Analyst, TD Cowen: Yeah. Yes. Is it, you know, visual acuity? Or

Krish Krishnan, CEO, Cristal Biotech: No. We’re not we’re not looking at visual acuity as an endpoint. We’re thinking about it as reducing the number or the frequency of lesions in these patients.

Ritu Baral, Analyst, TD Cowen: So you’re still seeing it or arguing that this is a collagen disease, just manifesting in the eye, therefore, actual activity?

Krish Krishnan, CEO, Cristal Biotech: Look, there is a just similar to be VAC, there’s a range of severe severity in lesions in the eye. Some are really severe. Like, you saw that patient that one patient who was blind and could be restored lesion. Some of them have lesions that happen maybe once or twice a month and last for a few days and go away. Some have lesions that have that been persistent for a longer period.

Mhmm. And so what we’re trying to do is to find a way to keep the lesions healed, if you can call it that, for a longer period.

Ritu Baral, Analyst, TD Cowen: And how are you thinking about pricing? Because I struggle with potentially bundling it and giving a certain price or a separate? Because you said, I think, fifty percent of patients have ocular manifestations.

Krish Krishnan, CEO, Cristal Biotech: This drug, when approved, we’re looking to visit will have a new NDC number, its own label.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: So we’re not looking at it as any kind of bundle or an extension of bBAC, but as a separate drug for a separate communication. We do a lot about pricing. It’s still a bit premature to talk about pricing, and we should probably wait till the pivotal data comes out before we think about it.

Ritu Baral, Analyst, TD Cowen: 4 0 7 in cystic fibrosis, is next CF data still on track for midyear later this year? And what should we expect from the first cohort of Phase three?

Krish Krishnan, CEO, Cristal Biotech: Yeah. It’s on track for data reporting. Cohort three, is about six patients who are all bronced. We’re hoping to have three on modulator and three with the null mutation.

Ritu Baral, Analyst, TD Cowen: Three and three.

Krish Krishnan, CEO, Cristal Biotech: Okay. Three and three is what we’re shooting for. Predominantly molecular data is what one should expect. Molecular data involves extent of transduction in the airways, bronc data, very similar to the ALPHA-one data that you saw. You know, if you remember those images being able to see good expansion across.

And especially if we see that on null patients, it would give us a lot of confidence to move forward into a redosing type reg.

Ritu Baral, Analyst, TD Cowen: Right. Gotcha. Moving on to 707 in oncology, what next oncology data is on track for ASCO? And what’s going to be included?

Krish Krishnan, CEO, Cristal Biotech: We are I mean, I think we announced early data in NCLC towards the end of last year in about 11 patients. And if my recollection is right, in a monotherapy, ORR across all the different tumors was about thirty percent. It was a bit higher when talking about patients in the lung. Some of the scans were confirmed, some were not confirmed. Some of the data by the time we go to ASCO would be more mature.

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: So you should expect data to be incrementally built on the data we showed at the end of last year for the ASCO presentation on the monotherapy. But presently, with respect to NSCLC, there are also a handful of patients who do who are on the combo tariff. Mhmm. And for a delivery mechanism that is quite unique in lung cancer, which is it’s a nebulizer delivering a certain amount of cytokines locally to the tumor environment. So it’s a very innovative type delivery mechanism, pretty simple, at least in concept.

And the fact that the monotherapy read was directionally positive because a lot of companies quickly go into combo. We were really encouraged by what we saw in the mono data.

Ritu Baral, Analyst, TD Cowen: Got it. Alright. Well, for some reason, that just shut down. Sorry about that. We haven’t touched AT yet.

Krish Krishnan, CEO, Cristal Biotech: Yeah. You want me to talk about it?

Ritu Baral, Analyst, TD Cowen: Yeah. Can you talk about AT while I pull up my AT questions? Sorry. Yeah. When is our next update we’re gonna get?

Krish Krishnan, CEO, Cristal Biotech: The second half of this year. So just to go back to what we showed last year, we had two patients on which we tried to show Lavaage and bronch data. I think a couple of things were pretty interesting with respect to AAT. Within two days after dosing, we saw about a 50% reduction in neutrophil elastase levels, which is the best predictor of whether

Ritu Baral, Analyst, TD Cowen: the or activity.

Krish Krishnan, CEO, Cristal Biotech: Any activity. Obviously, it’s a best predictor of whether a drug is working or not.

Ritu Baral, Analyst, TD Cowen: Yep.

Krish Krishnan, CEO, Cristal Biotech: The other proxy, there is a general expectation that if you had alpha one levels of one micromolar in the lung, there’s a high

Ritu Baral, Analyst, TD Cowen: One micromolar in the lung. One micromolar. Yeah.

Krish Krishnan, CEO, Cristal Biotech: Also in the lung, it’s about 10% of the systemic levels. It kind of points towards an efficacious drug. We got to it we got to point seven five, but we are unique in that word redosing paradigm. And we actually believe we can if we safely redose, we could build on the levels in the lung over time. That said, what we plan to show in the second half of the early second half of this year is a few more patients with respect to the same cohort to prove out the thesis a bit more concretely.

Mhmm. And we’re also looking to enroll one or two patients in a higher cohort to see if from a baseline perspective, we could start maybe not at point seven five micromolar, but at one micromolar and build on that. That’s less of a conceptually, we’re just we’re just trying to see if a higher dose, assuming it’s safe

Ritu Baral, Analyst, TD Cowen: Mhmm.

Krish Krishnan, CEO, Cristal Biotech: Starts at a higher micromolar level. And if we establish that, our objective is to quickly transition the patients into a redosing paradigm to get some

Ritu Baral, Analyst, TD Cowen: Monthly. You’re assuming monthly Biweekly, monthly, something in that range. Okay. And how are your talks with FDA around what the approval path looks like, especially a serum biomarker for approval?

Krish Krishnan, CEO, Cristal Biotech: We have not had any serious conversations with the FDA besides, knowing that they are very open to thinking about an alpha one approval using biomarker. And with respect to biomarker approval, one way of demonstrating is to show alpha one levels in the lung, Reduction of neutrophil elastase activity. Mhmm. That’s one path. So you

Ritu Baral, Analyst, TD Cowen: In the lung. But you’d that would still require bronch. Correct?

Krish Krishnan, CEO, Cristal Biotech: Correct. That’s a great And

Ritu Baral, Analyst, TD Cowen: that’s terrible.

Krish Krishnan, CEO, Cristal Biotech: So the problem is bronch lavage is very burdensome on the patient. But one interesting thing we noticed which created some Wall Street confusion when we announced ALPHA1 data is we saw ALPHA1 seeping from the lung into systemic circulation through the interstitial. So So we saw Systemic levels of Alpha one go up incrementally. If we’re able to show correlation between the lung levels and the seepingly incremental levels and are able to make a case to the agency Right. Then we can avoid patients being tortured with lavage or bronch.

Ritu Baral, Analyst, TD Cowen: Is this something is this something that you have talked to the Alpha One Foundation

Krish Krishnan, CEO, Cristal Biotech: about? Not yeah. We would like to show that we do have a correlation between lung and systemic before we embark, but that initial thing.

Ritu Baral, Analyst, TD Cowen: Great. Well, we’re at time. Krish, thank you very much. This was very helpful.

Krish Krishnan, CEO, Cristal Biotech: Thanks for having me.

Ritu Baral, Analyst, TD Cowen: Yeah. Thanks everyone for coming.

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