Intellia Therapeutics at BofA Conference: Strategic Gene Editing Insights

On Tuesday, 13 May 2025, Intellia Therapeutics (NASDAQ:NTLA) presented at the BofA Securities 2025 Healthcare Conference. The discussion, led by CFO Ed Dulak, highlighted the company’s strategic focus on advancing its in vivo gene editing programs. Intellia is making notable progress, especially with its ATTR program, despite facing a competitive landscape. The company’s financial restructuring and robust cash position were also emphasized as critical to its future success.

Key Takeaways

• Intellia is advancing two Phase 3 studies in its ATTR program, targeting polyneuropathy and cardiomyopathy.
• The company has over $700 million in cash, expected to fund operations through the first half of 2027.
• Enrollment for the Phase 3 MAGNETUDE study in ATTR-CM is ahead of schedule, with completion expected by the end of 2026.
• Intellia is running "gold standard" randomized, placebo-controlled studies to ensure regulatory compliance.
• Numerous catalysts are anticipated over the next 12 to 18 months, including significant data releases and potential regulatory filings.

Financial Results

• Cash Balance: Intellia holds over $700 million, sufficient to support operations and key milestones through mid-2027.
• Restructuring: The company refocused its resources on late-stage clinical development, scaling back on early research to align with strategic goals.

Operational Updates

• ATTR Program:

- Two Phase 3 studies are ongoing, with a focus on deep and durable TTR reduction.

- Enrollment for the MAGNETUDE study is progressing well, with no impact from recent competitive approvals.

• HAE Program:

- Rapid enrollment in the Phase 3 study is expected to conclude by Q3 2025, with top-line data anticipated in a year.

• Regulatory Interactions:

- Intellia maintains strong FDA relations and is conducting rigorous studies to address any regulatory concerns.

Future Outlook

• Catalysts:

- Key data releases and a potential BLA filing are expected within the next 18 months.

• Commercialization:

- The company plans to build its commercial infrastructure, starting with HAE, followed by PN, and eventually targeting the larger ATTR-CM market.

• Financing Strategy:

- Intellia’s current cash position negates immediate financing needs, allowing strategic flexibility.

Q&A Highlights

• ATTR-CM Competition:

- Intellia’s differentiated approach focuses on deep and durable TTR knockdown, potentially enhancing existing therapies like tafamidis.

• HAE Market:

- The goal is a paradigm shift towards "no attacks, no therapy," with a single treatment providing lasting effects.

• PN Study Design:

- The study employs a co-primary endpoint strategy, targeting regions with limited access to silencer therapies.

• Commercial Strategy:

- Intellia aims to capitalize on the profitability of HAE and PN before expanding its reach in the ATTR-CM market.

For a detailed account, readers are encouraged to refer to the full transcript below.

Full transcript - BofA Securities 2025 Healthcare Conference:

Alec Stranahan, Senior Biotech Analyst, Bank of America: Let’s get started. Hello, everyone. Thanks for joining this session with Intellia Therapeutics on day one of the twenty twenty five Bank of America Healthcare Conference. My name is Alec Stranahan. I’m senior biotech analyst covering Intellia here at BofA, and I have the pleasure of being joined by Ed Dulak, the Chief Financial Officer of Intellia.

Ed, thanks for being here.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Really excited. We got a lot going on. Happy to talk about it.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Yeah. Yeah. Maybe we can just dive right in if you wanna tee up the conversation with sort of the the main assets, you know, and any sort of upcoming events that that, you know, you’re excited for and then and then we can get into the specific programs from there.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, of course. So we’re basically a gene editing company focused on in vivo applications. We’ve got a broad toolkit that we’re working on in research, but really the focus for the company has been squarely on the late stage program. So we have two assets, three phase three studies, and a couple of different very interesting indications. And so we’ve made really good progress on the operational side and we sort of restructured the company early in the year to map the financial plan to that.

Things are working really well, judging from the first quarter. And so we’ve got a number of catalysts over the next twelve to eighteen months, we’re going to continue to do more of the same, but we’re really excited about the prospects ahead.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Well, maybe we can jump into the ATTR program. Maybe just we can talk about how the space is evolving overall. How do you see the recent approvals from Atruby and Vutra? How does that sort of change the commercial makeup as you’re thinking about going to launch?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, so we have two phase three studies in our TTR program, one focused on PN and one focused on Centimeters. We can talk about both. As it relates to Centimeters, you’re referencing a more recent approval in the competitive space. And I think, look, they’ve read a good Phase III study, they have a label that reflects that Phase III study, and we’ll see how that commercial opportunity unfolds. I think generally speaking, most of us look at cardiomyopathy as an already large and increasingly larger market opportunity.

More diagnosis in this space, and we’re continuing to see that although there’s options for patients, there’s still a high level of unmet need. Our hypothesis and our approach has always been one of lower TTR really matters, right? So, a pathogenic protein causes these manifestations. And so the extent that you can quickly reduce TTR levels, do that very deeply, very consistently, and very durably, that will benefit patients. And I think we’ve seen our phase one data that we presented in November of last year.

It’s a very encouraging profile that we’re hoping to replicate in our Phase III MAGNETUDE study. So, overall, we like the trajectory of the Centimeters opportunity, and I think we’re well positioned to execute our clinical studies. We have guided that we will complete enrollment by the end of twenty twenty six for that seven sixty five patient study, and we’re excited about the investigator enthusiasm we’ve seen. The patients have shown up and the momentum has been very strong, so we continue to execute ahead of our estimates and we haven’t seen a deviation since we started that study in March of last year.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay, okay. So no real impact at all, it sounds like, from the pace of enrollment from the recent approval?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: No, and I think we can look at the data in more detail, but the attributes that I mentioned for our NextSeq program, that deep, fast reduction, we just don’t see that profile on the market today. And so, in a world where there may be combination therapies, right, increasingly patients are on tafamidis as a background therapy. And so, there hasn’t been a lot of incremental effect with the addition of some of these more recent therapies in development. We suspect that might change with our next C program. A lot of the patients will be on background tafamidis, and so we think that combination could really be a game changer.

We think there’s still significant unmet need, and we’re running a really good study. We’ve been comfortable with the design, but we see no inflection. If anything, we see momentum kind of increase after our November disclosures at So we’re very excited about that.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Yeah, and it’s a pretty differentiated drug profile, right, being a potential one time treatment, pretty differentiated from what’s currently out there. Do you think durability of response is maybe a key focal point for the study and through the profile?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Most definitely. Yeah. I think that the therapy we’re providing will give benefit to the patient, but also to the healthcare system. We’re mindful of all the stakeholders and we think gene editing is uniquely positioned to deliver on all those.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Is there a particular, durability threshold that would be sort of a value unlocking event for the program in terms of just physician buy in to the the one time nature? Is it two years, three years?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: I don’t know the exact number. It’s depending on who you talk to. I do think, as you think about in the case of Centimeters, for example, it’s an elderly patient population. I think all of us would acknowledge that background therapy has improved, right? Thyretics, SGLT2 use, new novel therapies that are available.

And so I think patients are living longer, and for us as a one time intervention, I do think the ability to give patients a significant benefit over time in a matter of years is the goal. As I mentioned before, if we’re able to knock out these genes, that does reduce the pathogenic toxic protein that should give these patients a longer term durable benefit. So this year, we’ll present two years worth of data, but as you think about where the company will be in two or three years’ time, as we’re thinking about launching our first program, which will be directed at HAE, we’ll have patients that are on our earliest programs from six, seven years out. So, it’ll be a substantial safety database, but a lot of information around the durability of effect. So, we continue to accumulate data as we add more patients, and so far we really like the profile.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. I definitely want to ask about HAE. Maybe we can split the last part on that program. Maybe just another one on ATTR. I think you’ve said in the past that an interim analysis could maybe be possible depending on the magnitude of the TTR knockdown.

I guess what’s sort of the gating around this and any reason to expect different knockdown from what you saw in the phase one?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, as it relates to TTR, I think we’re running the gold standard randomized placebo controlled study, multinational. And so it’s a very well considered study. And I don’t see any differences. The patient population, if anything, will be a more contemporary population. Just reminding folks that our phase one study was almost enriched for the variant type.

So although cardiomyopathy is a disease of aging, it’s really a wild type patient population. Ninety percent are wild type patients. About a third, almost about thirty one percent of our phase one data were invariant, more difficult to treat patient populations. Still, we saw a great effect, very consistent TTR knockdown. We get to nadir in twenty eight days.

The error bars around that are extremely narrow, it’s very impressive, and that’s a very long lasting durable effect. We’ve shown the twelve month data, but again, we’ll have two years. So that is the goal for the phase three data, and if we’re successful there, I think that positions us really well in

Alec Stranahan, Senior Biotech Analyst, Bank of America: a competitive marketplace. Okay. And, you know, it’s probably the right way to be thinking of Centimeters and PN as separate markets here. Maybe starting with Centimeters, any functional endpoints that either clinicians or patients you think could be focusing on? Like what’s most meaningful for these groups?

So we have a

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: lot of endpoints. We’re running a traditional study in the sense that we’re looking at Mortality and hospitalization. We are looking at TTR levels. It does matter.

There’s a clear correlation between your ability to knock down TTR and the ultimate clinical effects. We do think that’s important. We’re doing things like the Kansas City Cardiomyopathy Questionnaire, and then we’ve got functional endpoints, some of the more traditional like six minute walk tests. We do New York Heart Association classification, and then maybe things that I was less familiar with, but there’s SPPB, which is a sort of a short physical performance assessment, a battery test that sort of mimics the everyday daily activities for patients. So there’s a number of things that we’re tracking that we hope in addition to the hard clinical out points, we will demonstrate very important improvements on some of these functional considerations as well.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay, and I imagine even just directional benefit, just given how the breadth of the metrics that you could potentially show a benefit on, it doesn’t necessarily, and the study wouldn’t be powered to show stat signal on many of those, right?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, we’ll see where it goes. Showed early trends. The treatment effect on the phase one population was not insubstantial, and so, for the first time, we thought about the possibility of can we actually halt progression of the disease, right? Patients are well served today, but they invariably progress. The thought of more deeply and maybe early intervention that could lead to disease stabilization or even regression in certain patients, that’s a very exciting prospect.

So, in a dynamic disease like this one, we can’t roll up that possibility, and we’ll be looking to all these metrics to see, is there a clear signal, and do we have some very interesting data that we can share more holistically?

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Okay. And then for PN, I guess, why pursue two endpoints here? Do you need to hit on both, the TTR for filing, or how is this designed?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, so it’s a co primary endpoint, and we talk to our internal colleagues that are experts in this space. We talk to physicians or KOLs, talk to regulators. They see the value in TTR reduction. I think the data is pretty clear. When you intervene and TTR comes down meaningfully, you get the neurological benefits to follow.

So, in our case, the TTR reduction we hit at day 28 already, sort of that low level, that nadir of serum TTR, so it’s easy for us to capture. In addition, we’ll be following the MS endpoints that are traditional for study in PN, but that combination will serve to support the filing.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. And maybe you could touch on sort of the choice to screen silencers and wash out for stabilizers in the study. Could there be a compounding or could there be influence from that that you’re trying to minimize in terms of how clear the efficacy signal is?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, so this is quite a bit different than the Centimeters population, so I think it’s important to talk through this. There isn’t a lot of use of stabilizers. Tafamidis, for example, isn’t really approved. So there’s not a lot of use of a product like Tafamidis in PN. There are other products that are in this space that honestly would be unethical to wash them out of an effective therapy.

We are running a randomized, blinded, placebo controlled study, and so the prospect of them going on placebo and coming off a therapy that patients still can progress on but does have a good treatment effect would be a really almost impossible study to run by definition. So we’re looking at geographies where those therapies aren’t available, so we’re outside of The United States for this particular program. But it’s the rationale for why we are not running it on top of a silencer.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. And then maybe last question on ATTR before we flip to HAE. As you think about pursuing in tandem both of these markets, is the go to market strategy maybe different the way that you would approach? It would be a great problem to have approvals in both, but maybe walk us through sort of the commercial approach that you would take and anything that’s being done proactively along those lines? So I’ll take

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: a big step back for this one. We’re a pretty small company, and we have three phase three programs, which is an embarrassment of riches in some sense, but it’s a real operational challenge that we want to make sure that we don’t fumble on and misstep. So we’re going to start to build the company through a launch of HAE. It’s important to recognize that’s a relatively small opportunity. It doesn’t require a lot of infrastructure as I think about what’s needed commercially to be successful.

We have some already in house expertise here, and so we’ve got a really clear plan. We’ve already begun to implement at the end of last year. That general framework applies to PN, where it’s still a relatively small patient population. For a company our size to operationalize that financially and otherwise, I think is still very doable. The goal, quite frankly,

Alec Stranahan, Senior Biotech Analyst, Bank of America: is to build the company on

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: the back of those types of indications. These are gonna be highly profitable businesses for us, and that allows us to think about the company differently and how we invest behind the company. But the bigger nut to crack is gonna be Centimeters. There’s just that much more patients. It’s gonna require a larger footprint.

So we’ve got a clear plan that we’ve been working against, and we would like to be able to sequence these in a way that allows us to capture as many patients as we can, but also make sure that we successfully build the company. So, that’s the plan. We’ll see how things go, but so far it seems to be working out as we expected.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. And obviously, you’d wanna retain as much of the economics as as you possibly can from from both of these programs.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Without question. I mean, it’s been a tough biotech market. I will say the company I’ve only been with the company ten months, but the company has worked really hard. We’ve had dedicated people for a long time working on these programs. I love the setup of the data, the whole setup for the next twelve to eighteen months.

And we are gonna try to find a way to make sure that we can capture the value for the company, but also for patients, payers, the whole ecosystem. It’s going be a lot of firsts that we’ve done at Intellia. We’ve got a lot of New England Journal of Medicine publications. We would love to add to the list the ability to launch these products successfully. That is the task and we want to make sure that whether it’s a financing strategy or partnership strategy that we are doing so in a way that reflects the fair value of the programs that we have.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. That’s very well said. Maybe flipping to HAE, sort of walk us through the stage of development for this asset and then we can get into the data.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: So we just gave a pretty good update, as in first quarter results that we reported last week. We’ve been saying for quite some time that there’s been a lot of engagement from investigators and patients. We’ve been saying it, the better judge is to see how people are actually acting in the marketplace, and we’ve been enrolling very aggressively. And so the update that we provide is we previously said we will enroll the study by the end of this year. We brought that into the third quarter, and we feel really comfortable about that.

We threw in a little one liner that I’m sure I’m not sure many people picked up, but from first patient enrolled to last patient will be less than nine months. It’s a very fast enrollment for an HAE study that’s a pivotal phase three program. So, we see a lot of US interest, a lot of ex US interest, a lot of enthusiasm for investigators, and a lot of enthusiasm for patients, more so when they gain the experience of the program itself. And so, we’ll be in a position to give updates on the clinical side, both mid year and probably later the year on HAE. And you’ll begin to see us lean more forward into the market research that we’ve done.

We’ve got a commercial team that’s now in place on the leadership side, so we’ve done a lot of work on the patient perspective. This is a switch market, a patient driven market, so that patient perspective is super important. We’ll begin to share that more clearly. We obviously talk to physicians. That perspective is important as well.

And so we’ve done some interesting market research there. And payers are gonna be super important as they always are. And so we’ve got a lot of expertise and we’re doing a lot of work. So there’ll be a steady stream of clinical updates and some more of the commercial side of what we’re doing. We’re not that far from the top line phase three data.

We’re roughly a year away. So there’s a lot going on here in just HAE alone, but we’ll be talking about that very soon.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. I guess from your market research or what you’ve seen in the literature, what kind of attack rate reduction do you think you’ll need to show to be competitive versus other options?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: So I love this question. We fundamentally think about HAE very differently. So attack rate reductions is what a lot of our peers are looking at, and we obviously have that data. When we’re working with a gene editing technology, and again, we can get at the root cause of the disease and you see the Kallikai reduction sort of the implications for patients, we have the opportunity to change a narrative substantially. So the goal for this program is no attacks, and no therapy.

So we’re not talking about attack rate reductions, we’re talking about getting to no tax zero, and no requirement, Today, you have an option to choose long term prophylaxis, which could be oral or injectable. But these patients are young at diagnosis, on average about 20. That could be decades long of chronic therapy. It’s a chronic disease. There’s on demand therapy for some patients, but we see this market really transitioning into potentially a one in time paradigm.

So, for otherwise healthy 20 year old patient, the prospect of having a single four hour infusion, this is a very simple administration for gene editing. It’s not like anything else that investors and others maybe have experience with. So it’s a very simple profile, it has a very profound effect. And to the extent that we replicate the early data, the vast majority of patients could be in a position to have no attacks and have no therapy.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Yeah. Maybe talk to the reductions you’ve seen in the phase one and phase two. Were there any differences between these patient groups that maybe led to at least percent differences? They’re both pretty impressive, but maybe just talk us through the attack rate data that we’ve seen so far.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, the data are good. They’re at the very high end of the range. There are some important differences to the point of your question. The phase one study was not blinded. So unblinded study, there was no placebo control, and patients were not required to wash off their existing therapy.

So a very different paradigm, they can come on study with their existing therapy, get the addition of NTLA-two thousand two. And that’s where we sold the ninety plus ninety eight percent attack rate reduction. Very, very good outcome. The phase two study is very different. It was randomized, it is placebo controlled, and patients were required to wash off their long term prophylaxis or any other therapy that they were on.

So it’s a very different test than the phase one, but it happens to represent the phase three study very well. So it’ll be a very similar set of circumstances. Patients require the wash off. They’re readily willing to do so, including on some of the leading therapies today, but it does change the primary observation period. And for a patient that has HAE, their entire life is to make sure that they’re surveilling their body, they’re looking for attacks, and they want to prevent what could be a life threatening attack.

And so they use on demand therapy readily to ask them to wash off therapy, potentially go on to a placebo arm is not comforting. And so they’re hypervigilant. If they feel like they’re having an attack, particularly if it’s not external swelling and it’s obvious, then we use on demand therapy. Where they get very interesting though is after the primary observation period, where the study is unblinded, the patient now has the comfort of knowing that they’ve received therapy. And when they know that, they can think about their disease different.

And so the data we shared in October was from the primary observation period, eight out of eleven patients had no attacks and no therapy, but there were three that responded. So they had attack rate reductions, but they didn’t have complete elimination of attacks. The data that we will present later in the year will be longer term follow-up, and we’ll see how those patients now behave knowing that they’ve received active therapy. These patients can continue to evolve in a favorable way. So some very interesting data coming up in the second half of this year and I think that will be a very good read into the Phase III program that’s going follow shortly thereafter.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Do you think that washout period is something that would be, required in the commercial setting or is that just exclusively a clinical trial aspect where you want

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: to really see what the drug effect is? It’s a clinical trial aspect. I think this market, for the benefit and good of patients, there have been a lot more treatment options, so a lot of physicians are comfortable with switching. There are quite a few switches. I think in the real world, I think physicians will contemplate half life and they’ll think about the overlap.

There isn’t anything inherently concerning from a safety perspective as you would think about transitioning from one or the other, so a degree of overlap is probably not problematic, but it’s sort of required to have a true test of investigational agent in a phase two or phase three study in our case, but that doesn’t necessarily reflect. Clearly there won’t be a blinding of experience. Patients will know that they’ve received therapy and they can immediately start thinking about their disease differently as a result.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Okay. It seems like speaking with physicians that twenty eight weeks is kind of the common treatment durability that folks would want to see. Does this sort of resonate with what you’ve heard or do you think maybe longer durability could maybe be additive to the profile?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: It’s definitely additive, right? To go back to what we talked about before, the promise of gene editing is really fixing the root cause and having a prolonged therapeutic effect. We see that in our early data, very likely to see that in our phase two, or the two year data follow-up that we present across our programs this year. I do think that’s important for us to have that durable effect. People ask, have we redosed?

And we have on certain occasions, but we don’t see that being required. Those are for patients that have had a lower dose or in some cases placebo that have gotten a higher dose, but we’ve had very consistent reductions in desired biomarkers. Those have not waned in the follow-up that we have seen to date, and so I do think longer follow-up will further support the profile. And I think that will only give confidence to physicians and patients that this is a very good and appropriate therapeutic intervention for them.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Yeah. I mean, maybe just on that last point about the re dosing. I was curious if there’s been any patients that maybe didn’t have as robust response as others that maybe deepened over time, or if this would even be anticipated

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: given the MOA. So we’re gonna have data towards the end of this year in HAE. The phase two portion of the study, there were six patients on placebo, so never had active therapy, and there were about 10 or 11 that were on the twenty five milligram lower dose. We selected the fifty milligram phase three dose. There was a clear dose effect in calacryl reduction, and we’ve seen clinical benefit as a result.

But for the first time, fifteen of those patients that had placebo or lower dose that have opted for the fifty milligram will be presented later this year. So it’ll give you a sense of how patients that have received a higher dose, what does that look like over time. And so that body of evidence is not trivial. So combine all the patients on our phase one and two portions of the study at fifty milligrams, it totals more than 30 patients. Our entire phase three exposure is 40 patients.

You’re gonna have a really good read into the clinical profile at the end of the year, and then we’re six months or less from top line data. So it’s gonna be a really important update for the company at year end.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Yeah. Very good, cadence of updates coming over the next twelve months. You know, maybe we could just touch on sort of the cash balance. I think over 700,000,000.

What does that sort of carry you through in terms of launch prep? Obviously this is well beyond sort of the upcoming readouts.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: Yeah, so we took a very hard look at the business at the end of last year. What resulted was the restructuring that we announced in January. And as painful as it was, it was very deliberate. And at the highest level, we essentially continue to do research, but we’ve dialed that down. We’re much more focused on research.

Alec Stranahan, Senior Biotech Analyst, Bank of America: And what we wanted to

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: make sure is that the existing balance sheet allows us to fully execute all the phase three programs that we’ve touched upon today, build the commercial infrastructure in The US to make sure we can capture the value starting with HAE, And in the process, allow the company to click through a lot of milestones. We just talked through a few of them. We have data coming this week on PN and Centimeters. There’s a lot of data second half of this year into 2026, and then it gets even more exciting as we file a BLA and think about approval in the first half of twenty seven. So my hope is that, you know, markets improve.

There’s better appreciation for the data that we’ve produced. These are pretty derisked. Apologies very clear. We feel like we have very winning products, So we’re well on our way, but we’re gonna click through a number of milestones. We’ll look to finance the company as we need to, but we don’t need to today, which is a good thing in today’s market.

But we’re really pleased with the operational performance. We’re pleased with the plan, and it’s very clear where we’re going through the first half of twenty seven.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Okay. I’m looking forward to the updates. I mean, maybe maybe just in the last minute, and appreciate there’s potentially not much you can say here, but we have seen gene editing companies catch a little bit of a bid following McCary’s comments that constructive on the space and rare diseases overall. Any changes with your FDA interactions, or if you could maybe talk about how your studies reflect today in the current and evolving dynamic there?

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: So I’ll say two things just for the sake of time. One, we are running gold standard studies, right? I mean, the fact that we’re running randomized placebo controlled studies, I think bodes really well. I think it may be more challenging if you’re trying to run a single arm study on a surrogate endpoint, but we’re using hard clinical endpoints, we’re not doing anything fancy, we’re doing exactly what they would expect us to do. And the second thing is there’s been a change at the top, but Nicole Verdon is the super director of OTP that we’ve been working with her and her team.

We’ve interacted with them very recently. There’s been no changes. There’s been a good relationship. So we expect that to continue, and we’ll leverage the RMAT designations that we have across all of it. So we’re buckled in and paying attention, but we’re cautiously optimistic that we’re running the right programs and we’ll get the right result.

Alec Stranahan, Senior Biotech Analyst, Bank of America: Okay. Okay. Very well said. But with that, I think we’ll have to leave it there for the sake of time. So please join me in thanking Ed for the really great discussion, and thanks for attending the conference, Ed.

Ed Dulak, Chief Financial Officer, Intellia Therapeutics: My pleasure. Thank you.

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