NTLA

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:00 a.m. ET Chief Executive Officer - John Leonard Chief Financial Officer - Edward Dulac Vice President of Investor Relations and Corporate Communications - Jason Fredette Operator: Hello, and welcome to Intellia Therapeutics Second Quarter Conference Call. My name is Chloe, and I will be your conference operator today. Please be advised that today's call is being recorded. I would now like to turn the call over to Jason Fredette, Vice President of Investor Relations and Corporate Communications at Intellia. Please proceed. Jason Fredette: Thank you, operator, and hello, everyone. Earlier this morning, we issued a press release outlining recent business updates in our second quarter financial results. This document can be found on the Investors and Media section of Intellia's website at intelliatx.com. At this time, I would like to take a minute to remind listeners that during this call, Intellia management may make certain forward-looking statements. We ask that you refer to our SEC filings available at sec.gov for a discussion of potential risks and uncertainties. All information presented on this call is current as of today, and Intellia undertakes no duty to update this information unless required by law. Joining me on the call are John Leonard, our Chief Executive Officer; and Ed Dulac, our Chief Financial Officer. With that, I'll now turn the call over to John to begin our business discussion. John Leonard: Thank you, Jason, and good morning, everyone. We're excited to be speaking with you to recap the tremendous progress we made in our Phase III development programs of lonvo-z in hereditary angioedema or HAE, and nex-z in transthyretin amyloidosis or ATTR. The full results of our Phase III HAELO trial in HAE position us very well for a potential approval and launch of the world's first in vivo gene editing product in the first half of next year. We also have gained important new genomic insights that further our understanding of nex-z's profile and could help position us even more favorably within a large and dynamic ATTR market. Let's begin with lonvo-z. Simply put, the second quarter was a momentous period for this program. In April, we reported positive top line results from HAELO and got our rolling BLA submission underway with the FDA. This was followed by our late-breaking oral presentation at EAACI and a concurrent publication in the New England Journal of Medicine, Intellia's sixth manuscript in this prestigious journal. HAELO was an unequivocal success as we achieved statistical significance for the primary and all key secondary endpoints. More specifically, during the 6-month primary observation period, we reported an 87% reduction in mean monthly attacks for lonvo-z versus placebo. 62% of patients were entirely attack-free and therapy-free in the lonvo-z arm. A 23-point improvement was observed for the lonvo-z arm in the total angioedema quality of life score from baseline. For context, a change of just 6 points is considered to be clinically meaningful. The New England Journal manuscript also contained compelling figures and analyses underscoring the unique value proposition that could be afforded by this onetime therapy if it's approved. For instance, patient-level data demonstrated that all patients in the lonvo-z arm experienced attack rate reductions from baseline for weeks 5 to 28. In other words, every single patient received a clinical benefit, including those who are not yet fully attack-free during that 6-month period. A subgroup analysis demonstrated meaningful attack rate reductions in the lonvo-z arm regardless of age, sex, race, weight, geography, baseline attack rate or prior therapy. The publication also included a figure depicting the mean number of HAE attacks over time. It traced patients from when they were on prior therapies before screening through the entire efficacy evaluation period and into crossover. And it showed that mean attack rates for the lonvo-z arm dropped well below the prescreening attack rates by week 4. Attacks continued to decline in the months that followed and approached 0 in the crossover period after week 28. In the placebo arm, not surprisingly, mean attack rates didn't drop below prescreening levels until patients crossed over to lonvo-z. At that point, they dropped steeply and approached 0 within a few months. Also, notably, all patients who received lonvo-z at baseline or in crossover remained free from long-term prophylaxis therapy as of the data cutoff. And finally, favorable safety and tolerability data were observed. The most common treatment-emergent adverse events were infusion-related reactions, headache and fatigue. All treatment-emergent adverse events were Grade 1 or Grade 2, and there were no serious adverse events observed in the lonvo-z arm as of the data cutoff. These results are unsurpassed by chronic long-term prophylaxis therapies or LTPs. We believe it is clear moreover that they truly stand alone in the HAE space given that this is a onetime treatment. Most patients were attack-free and therapy-free for the entire 6-month efficacy observation period following a single lonvo-z dose. Based on our preclinical work and observations from our Phase I/II trial, our expectation is that this percentage will increase further over time as patients who have lived with HAE their entire lives adjust to their new normal. So what's next for us? Well, we expect to be in a position to announce the FDA's acceptance of a BLA filing for lonvo-z by the end of this year. In the meantime, our pre-commercial readiness efforts are advancing well as we prepare for a potential U.S. launch in the first half of next year. Most of these efforts are well underway, including work streams across medical engagement, payer outreach, treatment center readiness, distribution planning and access strategy. We completed hiring for our field medical, reimbursement and strategic accounts teams, and they're now engaging with treatment centers around the country to ensure they are well prepared to address patient needs shortly after approval. We're also building awareness of the many burdens associated with HAE. During the second quarter, we launched haereframed.com, a disease awareness initiative designed to elevate understanding of the challenges patients face, including those related to lifelong chronic therapy. Together, these efforts reflect meaningful progress in building the infrastructure, awareness and access pathways needed to support our planned launch. So, let's turn to the progress we made with nex-z, our potential onetime treatment for patients with ATTR cardiomyopathy and polyneuropathy. We were pleased to have resolved the clinical holds in our Phase III trials quite rapidly earlier this year, and I'm excited to report today that we were able to resume enrollment and dosing in both trials in Q2. Investigator engagement and enthusiasm remain high and our screening rate is rapidly increasing globally once again. ATTR is a large, growing and highly underdiagnosed market with significant unmet needs. Today, patients are predominantly served by stabilizers, silencers or a combination of the 2. About a month ago, disappointing top line results were shared from CARDIO-TTRansform, the pivotal trial of eplontersen, a TTR silencer for patients with ATTR cardiomyopathy. Since then, there's been some debate about whether a silencer can work on top of a stabilizer. We and others believe the negative outcome is specific to eplontersen in this particular trial, and it does not speak to combination outcomes in general. We remain firm believers that combination therapy will work, but only with the right agent. This belief is based empirically on clinical evidence. First, we would point to the fact that another chronically dosed silencer, Vutrisiran, has already shown a directional benefit on top of stabilizers in a well-controlled trial. But even more importantly, we would point to what was observed in the monotherapy data for each of the chronically dosed stabilizers and silencers. If you go back and look at the readouts for approved stabilizers like tafamidis and acoramidis and approved silencers like eplontersen and patisiran, you'll see that patients continue to progress while they're on those therapies. Why is that? Well, we and others are convinced it's because they adequately reduce or control TTR protein. Focusing in on the approved silencers, you'll see that mean TTR reductions for each of them are about 80%. However, the details behind that number matter. For instance, it takes many months for those silencers to achieve their 80% of reduction. There's significant variability in TTR from patient to patient with some achieving a 90% knockdown and many others receiving reductions of only 50% or 60% and even within an individual patient, the knockdown fluctuates due to issues with PK and issues with dose interruptions and adherence, whether due to patient behavior or toxicity. Simply put, it appears today's silencers and stabilizers are leaving efficacy on the table and a progressive disease with high mortality like ATTR-CM every day and every microgram per milliliter of TTR counts. Nex-z has demonstrated its ability to deliver an unsurpassed knockdown of TTR protein for patients in both relative and absolute terms. Our Phase I data demonstrated a mean TTR reduction of 90%. While that percentage is impressive, we believe the absolute TTR reduction is even more clinically relevant. When nex-z is provided as monotherapy, mean serum TTR was less than 20 micrograms per milliliter, about 1/3 of the absolute level seen with leading chronic silencer. That knockdown was achieved rapidly within 1 month of the infusion, and it was extremely consistent across all patients. Best of all, patients began receiving therapeutic doses of nex-z in 2021. And as of our latest data cutoff, intra-patient TTR control was constant and was maintained across all patients following the onetime nex-z treatment. We look forward to presenting updated long-term durability data at future congresses. We believe nex-z's distinct TTR knockdown is why disease stabilization or reversal is observed in most patients in our Phase I, while our would-be competitors have observed disease progression. Additionally, the response has been consistent across patients of all New York Heart Association classes, those with either variant or wild-type disease, and it also includes patients who have progressed on past silencers. And so we continue to have significant confidence in our ability to show a benefit on top of tafamidis and MAGNITUDE. Additionally, unlike CARDIO-TTRansform, which was a time-bound study, MAGNITUDE's primary endpoint is strictly event-based. We've enrolled well over 650 patients in MAGNITUDE. We've been accruing events for quite some time, and those events continued unabated through the clinical hold. While still premature for us to guide us to data timing, what I can say today is that the blinded event rate in the trial remains within the range we had projected internally. We're looking forward to reviewing the detailed CARDIO-TTRansform data later this month at ESC. And of course, we have the opportunity to consider changes that further optimize MAGNITUDE's design based on what we learned. Now let's move on to one other encouraging update we're able to share today related to nex-z. As we reported late last year, Grade 4 liver transaminase elevations have been observed in less than 1% of patients enrolled in MAGNITUDE. These were transient and in most cases, they resolved without any intervention. Based in part on the fact that the observations consistently occurred 2 to 5 weeks after dosing, we hypothesized they were caused by an adaptive immune response. As a result, we implemented mitigation measures to enhance monitoring for transaminase elevations and intervene if they are observed. These measures are very straightforward and could easily be implemented in a real-world commercial setting if required. We also went further, working with Regeneron and other external experts, we sequenced and analyzed data from over 600 patient samples across all nex-z clinical trials to date. Our goal was to understand if there were subpopulations that might be most susceptible to higher-grade transaminase elevations. This work focused on HLAs, which are proteins on the surface of cells that play a key role in regulating the immune system and helping to distinguish native and foreign peptides. This blinded analysis revealed one statistically significant finding. Patients carrying specific HLA allele that's known as C*05:01 had a significantly higher rate of Grade 3 or greater transaminase elevations than the broader population. In fact, each of the 5 highest elevations observed following dosing occurred in patients carrying this allele. Now some important context on what this does and doesn't mean. Only 12% of the 600-plus samples we analyzed carry this allele and the strong majority of C*05:01 positive patients did not experience severe transaminase elevations. So we continue to see the potential for a favorable benefit risk profile even in the subgroup, particularly with the mitigation strategy that is now in place. What the finding gives us is valuable, a mechanistic explanation for a general signal we had already flagged and a way to identify patients who are more likely to be affected before it happens. In doing so, it further increases our confidence in nex-z's ability to deliver on its long recognized potential. So here are our next steps. We're engaging with FDA to review the findings. In the meantime, we already have updated our protocols, investigators' brochures and informed consents to incorporate HLA typing for all patients in the Phase III trials. These documents are in the process of being rolled out to regulatory authorities, IRBs and sites globally. Following the reviews, investigators and patients will be informed about the HLA results during screening or prior to crossover so they can make more informed treatment decisions. And so to close, I'm exceedingly proud of all the team continues to accomplish here at Intellia. We're marching towards the world's first potential launch of an in vivo gene editing therapy with lonvo-z. We're on track to complete enrollment in MAGNITUDE-2 later this year, and we're demonstrating precision medicine at its finest with our HLA work on nex-z. These achievements layer on top of all the other pioneering work we've undertaken as we seek to harness the power of gene editing to deliver optimal treatment outcomes for patients with just one dose. So with that, let's now turn the call over to Ed to share some financial color. Edward Dulac: Thank you, John, and hello, everyone. In addition to the tremendous clinical, pre-commercial and scientific progress we made in the second quarter, we also kept the company on sound financial footing. In April, we completed an equity financing that yielded approximately $195 million in net proceeds for the company. Cash, cash equivalents and marketable securities were $628.4 million as of June 30, 2026, compared to $605.1 million on December 31, 2025. We believe this cash balance will be sufficient to get us at least into 2028. Importantly, while we expect to obtain approval and launch lonvo-z in the U.S, in the first half of 2027, our cash runway guidance is conservative in that it excludes all product revenues. Collaboration revenue was $7.7 million for the second quarter of 2026 compared to $14.2 million for the prior year quarter. This change is primarily due to a reduction in revenue from Regeneron. R&D expenses were $82.6 million for the second quarter of 2026 compared to $97 million during the prior year quarter. The decrease was primarily driven by lower external costs related to lonvo-z and nex-z and reduced stock-based compensation, partially offset by higher employee-related expenses due to increased headcount. Stock-based compensation expense included in R&D was $9.4 million for the second quarter of 2026. G&A expenses were $37.8 million during the second quarter of 2026 compared to $27.2 million for the prior year quarter. This increase was primarily driven by costs associated with the ongoing build-out of our commercial infrastructure, higher legal expenses and stock-based compensation. Stock-based compensation expense included in G&A was $8.6 million for the second quarter of 2026. And finally, net loss for the second quarter of this year was $106.6 million, which compared with the $101.3 million for the prior year quarter. With that, we are ready to begin our question-and-answer session. Operator, would you please open the line for questions? Operator: [Operator Instructions] The first question today comes from Maurice Raycroft with Jefferies. Maurice Raycroft: Congrats on the progress. I'll ask one on the allele finding, which is interesting for that C*05:01 allele, can you talk about the implications for the 12% of patients where there could be some added risk? And is there another parameter that you could use to help fine-tune patient selection? And lastly, is there more you can share on the biologic relationship for what exactly is triggering the immune response? John Leonard: Thanks, Maurice, for your question. So we think that the finding confirms our initial thinking about an adaptive immune response as many will know, HLAs are deeply implicated in cell-mediated immunity. And this would be an important part of understanding what we saw with our early observations with timing of the immune response. So it gives us significant confidence that the mitigation measures that we put in place are appropriate and are on target for what seems to be going on. With respect to the patients that carry C*05:01, as I said in my comments during the earlier portion of the call here, we're making that information available to all investigators and patients. There's a relationship that's significant, but many of the patients that carry C*05:01 do not have LT elevations. So the first order of business is to make sure that if patients have that, they're aware of it, and they can discuss the elevated risk with their physicians and make a determination of what's appropriate for them. Our expectation just based on conferring with our steering committee members and people, the experts that we've been working on this during the course of our findings is that many of the patients may choose to self-exclude and that's appropriate for them. But for those who believe that the state of their disease and the other opportunities available to them were continuing to receive the therapy and advancing the trial, we're making the drug available for them. As we continue to learn during the course of our trial, we discussed with the FDA these findings and any further implications. But in the meanwhile, we think that this will give enhanced confidence to the physicians and patients who are entering that they can drive the best possible outcome, all things considered. Operator: The next question comes from Joseph Thome with TD Cowen. Unknown Analyst: This is Jacob on for Joe. Just sticking with the HLA allele. I wanted to confirm that this is something specific to nex-z and not lonvo-z. And then also, you said, I believe that it was 12% of the 600 samples that carried the allele, but only a fraction of that 12% actually had elevations. Is that correct? John Leonard: Yes. In my comments, I said that across the study, there's about 12% of patients who carry the C*05:01. And that broadly reflects what's seen in a North American, Western European population. There will be some variance across different ethnic groups with numbers sometimes lower than that, but that's what we've observed in the study. With respect to specificity, almost certainly, this would be specific to nex-z and not have any implications for lonvo-z. And there's a couple of reasons for that. When you think about what an HLA molecule is, it binds to a very, very specific short peptide, and we wouldn't expect those peptides to be implicated in any way with the lonvo-z treatment effect. So that's further supported by the fact that as shown in the New England Journal publication that was recently released, there's no signal in patients with lonvo-z. And at this point, we think that this is just a finding that's going to be limited to nex-z. Edward Dulac: And I'll just add one thing, John. I think there's a comment about just the vast majority of those patients that had C*05:01 did not experience severe transaminase elevations. So 12% of the samples do represent those that are carrying the allele, but only a small subset have had these higher grade elevations. Operator: The next question comes from Luca Issi with RBC Capital Markets. Luca Issi: Congrats obviously on all the progress. Obviously, we have yet to see the full CARDIO-TTRansform trial. I was looking forward to that data, European Society of Cardiology. But I think, John, you already mentioned potential to maybe optimizing your trial to maximize the probability of the success. Can you just talk about what are the options that you're contemplating at this point? Can you enroll more patients? Can you extend the minimum follow-up longer than 18 months? I don't know, can you limit the use of SGLT2? Like just walk us through big picture, how you're thinking about potentially tweaking your trial. John Leonard: Thanks for the question, Luca. I mean the first order of business is really understanding the data that comes from the CARDIO-TTRansform study. As I said in the prepared comments, we believe, based on everything we know thus far, that the findings are likely specific to eplontersen and not generally applicable to how we think about treatment of patients with TTR disease or patients with receiving combination therapy. What we think is going to be the most important information is the degree to which TTR is reduced. The variability or lack thereof as we see in our own patients, the speed with which treatment effect is achieved and then obviously, the durability as patients go through the many, many months of observation that -- where variability may be attributable to pharmacokinetics or interruptions for toxicity, for example. All of those elements will erode the overall treatment effect. And it's important, I think, to really understand that before we jump to conclusions about combination therapy and how best to use it. But with an understanding in hand, and we will, of course, work with experts who are deep in the data. We'll consider if there's anything that we need to change, we remain open-minded. We adapt as necessary, and we certainly try to learn at a prodigious rate as information becomes available. The factors that you mentioned are possible to change, but we don't start with a thesis in mind until we have a really good understanding of the data. And like you all on this call and many others, we're very, very anxious to see what that information is before we make any changes. Operator: The next question comes from Salveen Richter with Goldman Sachs. Salveen Richter: Can you remind us of the background stabilizer used in the study? And if you expect that to change given recent CARDIO-TTRansform results? Also on the HLA filing finding, do you see enrollment changes just given screening for HLA? John Leonard: Thanks for the question, Salveen. Background stabilizer use is running around 80%, which is what we projected when we set out and what we've been confirming on various data releases along the way. And so that does not appear to be changing one way or the other. I think it reflects how stabilizers are broadly used around the world and obviously, in sites where we're doing the investigation. With respect to HLA, as we talk to investigators and people who are working with in this trial, most of them view this as confidence building in terms of how to think about patients and who to enter and potentially who to exclude should the patient or the doctor think that, that's the most appropriate course of action for any particular patient. But across the board, as we've gone through the data with people who are practicing cardiologists and experts in the field to a person, all of them have viewed this as a very, very favorable finding that enhances overall confidence. And our job now is to make that information available to those doctors and physicians in the trial and patients in the trial as quickly as possible, and that's well underway. Operator: The next question comes from Silvan Tuerkcan with Citizens. Silvan Tuerkcan: Maybe can you talk a little bit about the patient gateway that you're building with HAE reframe? And kind of is that more to get data points to you for potentially their marketing? Or is that to kind of push your message out around some of these endpoints where onetime treatment could be helpful? And if so, what are those? And maybe related to that, what can we see as the driving symposium data that's coming up here? John Leonard: Let me speak first to the symposium that you referenced. You'll remember that across the entire HAE program, virtually every single patient at some point gets to something that resembles no attacks and no therapy. It takes some patients longer to get there than others. But virtually everybody ceases to use long-term prophylaxis and almost all the patients no longer require on-demand therapy. They may carry it with them, but the overall utilization for these patients really plummets, which we think is exciting for the patients, for the doctors and certainly for the payers who are supporting these patients. At the symposium, we'll go through what we think is very important information for -- how the drug behaves from a molecular level and how you can trace that with respect to a high molecular weight kininogen. And that has specific reference to one particular patient who had a significant benefit from the drug but did not reach an attack-free status. And the long and short of it is the patient probably has a second process unrelated HAE and we'll speak to that. So I think that's really exciting information that speaks to one particular patient who stood out from the vast majority of patients who have all done very, very well. With respect to the website, we're trying to make sure that people have a good understanding of what the burden of HAE really is. We typically talk about disease attacks and the efficacy and safety of drugs that they receive. But what's left out of the discussion many times is what patients have to go through just to get that and stay on their therapy and still how HAE continues to affect their lives because for all practical purposes, they continue to suffer from the disease. So by having a better understanding of what patients need to do to get the drug on a recurring basis, sometimes requiring prior authorizations even twice in a year, we want to make sure that payers, patients and doctors have a really good understanding of what that burden is. And then when they see the profile of lonvo-z, they will be -- the contrast will be very, very apparent. Operator: The next question comes from Leah Cann with Brookline Capital Markets. Leah Rush Cann: My question has been answered. Operator: The next question comes from Jonathan Miller with Evercore ISI. Unknown Analyst: This [Ginger] is on for John. And I'd like to double-click on allele analysis. So 2 questions. First, how many patients with Grade 3 liver signals do not carry the allele? And are there any patients with lower grade signals that actually carry the allele? And the second question is, are you considering additional prophy for patients carrying the C*05:01 allele? And then what are the additional risks to consider for those carriers? And any particular like antigens on the cell surface that has caught your attention that may be relevant for the liver injuries? John Leonard: Yes. So thank you for the question. With respect to the full data set and the analysis, we'll release that information at the appropriate time. And go through the molecular findings, the statistics that support that, et cetera. And that's not something that we're in a position to do today. You asked, are we doing something different for patients who choose to participate in the study if they're all C*05:01 positive. And at this point, the answer to that is no. We believe the mitigation measures that are put in place are entirely appropriate for a cell-mediated immune adaptive response, which now we have some increased confidence that, that's exactly what's occurring in these patients with these high LFT elevations. But what we have found is that we can identify patients before the event occurs and give them the opportunity not to participate, recognizing that the likelihood of their having one of these increases is higher, substantially higher than the broader patient population. If you flip it around, I think a helpful way to think about this is for the approximately 90% of people who don't carry C*05:01, the likelihood of a high LFT elevation is extremely low. And that is confidence building for anyone who may wonder about what the likelihood might be for them given the general data that's been released previously. And as was stated earlier, even for the C*05:01s, most patients will not have the elevations, but we do know that when they do occur, these tend to be the ones that are most severe. Operator: The next question comes from Terence Flynn with Morgan Stanley. Unknown Analyst: Great. This is Chris on for Terence. Maybe just double-click on the HLA genotyping finding. Just kind of looking ahead, do you expect that to be potentially on the label if approved? And then in the commercial setting, do you expect every patient to get genotyped? John Leonard: I think it's too early to say. Oftentimes, as you well know, labels reflect many of the aspects of how clinical trials are done and the data that they accumulate. But that's a bridge that we'll pass when we get to that point. I think in the meanwhile, what we're excited about and what our investigators are excited about is that this will give really good information with respect to how to focus in the best possible way, the benefit risk on those patients who can most benefit from it. So we will collect information during the screening process in the study. We don't think that it will slow down screening at all. This is a relatively straightforward process. And many of our investigators believe that this will actually pick up the pace of screening, which is already rapidly accelerating. So we are very, very excited about this finding and the very, very positive things it can do for us. Operator: The next question comes from Myles Minter with William Blair. Myles Minter: I've been getting a few inbounds since you published in the New England Journal on lonvo-z in HAE in the supplement. You showed the ALT ASTs over time. I think in the ASTs like week 30 to 32 in patients that got lonvo-z first up at randomization. There -- it looks pretty benign to me, but there are 3 patients that have kind of got an excursion outside of the reference range. Is that just variability? Or is there something else going on there at the later stages? John Leonard: Yes. Yes. Thanks for the question, Myles. It's -- the data is laid out in the New England Journal for anybody who wants to see it. Across the entire program, there's never been an LFT elevation greater than Grade 2. And of those, there are other confounding reasons to consider them. In one case, as you're referring to is somebody late many, many months after receiving the drug, and this is almost certainly related to another thing that was occurring for the patient, and that's what his investigator thought. The elevation was benign. Nothing was done with respect to it, and it was low grade. For other patients that we've reported in the various stages of active clinical observation, patients either were compounded by the ongoing use of alcohol, but one patient had a Grade 2 that resolved rapidly. And in a second case, again, reported in the Phase III study here, patient had LFT elevations during the screening phase and had a Grade 2 elevation with a concomitant viral infection. Across the board, we see no signal. There is variability, as we all know, about patients, how they live their lives. And we're very, very excited about the efficacy and the safety profile of the drug as we move towards what we hope will be BLA approval. Operator: The next question comes from Yanan Zhu with Wells Fargo. Unknown Analyst: This is Jeff on for Yanan. For the lonvo-z BLA, can you mention if the final BLA has been submitted to the FDA? And if not, which remaining modules need to be completed? And based on your conversations with clinical sites for lonvo-z, are you expecting a bolus of patients at launch if approved? John Leonard: So, we are far into the BLA filing. And I would anticipate that the next time you'll hear from us will be announcing what we hope will be the acceptance of the BLA. And with that, we'll all gain a lot more information with respect to PDUFA dates, priority review and things like that. So we've been excited with the team's preparation, the very rapid and efficient way that they've been able to work with the FDA. And we're very, very excited about the progress that we've made. Operator: [Operator Instructions] The next question comes from Andy Chen with Wolfe Research. Unknown Analyst: This is Jason taking in for Andy. I just wanted to ask really quickly about the HLA genotyping, if this is specific for ATTR-CM? Or do we see this in other indications like maybe in PN maybe? And do we see any sort of genotyping for maybe some of your other trials coming up? John Leonard: We're not currently doing genotyping on a standard basis for any program that we begin. We don't think that, that would be necessary. It would be hard to know what to look for as we believe that we're finding here is a very, very specific finding. And could you repeat your first question? Maybe, Ed, if you heard it, I didn't hear that. Unknown Analyst: I just wanted to ask if this genotyping was unique for ATTR-CM and maybe if it is usable in polyneuropathy. Yes. John Leonard: No, the genotyping is done across the entire program irrespective of the indication. And we're treating it as a relevant finding for both polyneuropathy and for cardiomyopathy and are applying the same rules and the same -- providing the same information for both studies. Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Jason Fredette for any closing remarks. Jason Fredette: Thanks, operator, and thanks, everyone, for joining us. We hope you have a great end to the summer, and we look forward to seeing many of you at the upcoming conferences in September. That concludes the call. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Lonvo-z Phase III HAELO trial achieved statistical significance across all endpoints, demonstrating an 87% reduction in mean monthly HAE attacks and a 62% attack-free rate. Management attributes lonvo-z's success to its unique onetime treatment profile, which surpassed results typically seen with chronic long-term prophylaxis therapies. Nex-z enrollment has resumed globally following the resolution of clinical holds, with screening rates reportedly increasing rapidly across both cardiomyopathy and polyneuropathy trials. Management remains confident in nex-z's ability to show benefit on top of stabilizers, arguing that current silencers leave efficacy 'on the table' due to slow onset and TTR protein variability. A genomic analysis of over 600 samples identified the HLA allele C*05:01 as a specific marker for increased risk of Grade 3 or higher transaminase elevations in nex-z patients. The company is pivoting toward a precision medicine approach for nex-z, implementing HLA typing to identify higher-risk patients and applying straightforward mitigation measures. Anticipates FDA acceptance of the lonvo-z BLA filing by the end of 2026, targeting a potential U.S. launch in the first half of 2027. Cash runway is projected to extend at least into 2028, a conservative estimate that excludes any potential product revenue from the lonvo-z launch. The MAGNITUDE trial for nex-z remains event-based rather than time-bound, with blinded event rates currently tracking within internal projections. Management intends to review detailed competitor data from the CARDIO-TTRansform trial to determine if any design optimizations are necessary for the MAGNITUDE study. Commercial infrastructure build-out is accelerating, with field medical, reimbursement, and strategic accounts teams already engaging with treatment centers. Identified that 12% of the population carries the C*05:01 allele, though the majority of these carriers do not experience severe liver enzyme elevations. Reported transient Grade 4 liver transaminase elevations in less than 1% of MAGNITUDE patients, which management believes are caused by an adaptive immune response. Lonvo-z safety data showed no serious adverse events, with the most common issues being low-grade infusion reactions, headache, and fatigue. Collaboration revenue decreased to $7.7 million from $14.2 million year-over-year, primarily due to reduced revenue from the Regeneron partnership. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management believes the finding confirms an adaptive immune response and validates their current mitigation measures. Investigators and patients will be informed of HLA status during screening; management expects some high-risk patients may choose to self-exclude. The finding is considered confidence-building for the 90% of patients who do not carry the allele, as their risk for high LFT elevations is extremely low. Management is open to trial tweaks but will wait for full CARDIO-TTRansform data before making changes to enrollment or follow-up duration. They maintain that negative competitor outcomes are likely specific to the drug eplontersen rather than the combination therapy approach itself. The HLA finding is almost certainly specific to nex-z because HLA molecules bind to specific short peptides not implicated in lonvo-z's mechanism. Clinical data for lonvo-z has shown no similar liver signal to date, supporting the indication-specific nature of the genomic finding. Management does not expect HLA typing to slow down screening; some investigators believe it may actually accelerate the process by increasing physician confidence. The genotyping process is described as relatively straightforward and is being applied across both polyneuropathy and cardiomyopathy indications.

Interested in Intellia Therapeutics, Inc.? Here are five stocks we like better. Lonvo-z delivered strong Phase III results in hereditary angioedema, reducing monthly attacks by 87% versus placebo; 62% of treated patients were attack-free and therapy-free. Intellia is preparing a rolling BLA, targeting FDA acceptance by the end of 2026 and a potential U.S. launch in the first half of 2027. Nex-z Phase III trials resumed for transthyretin amyloidosis after clinical holds were resolved, but Intellia identified an HLA allele linked to higher rates of severe liver-enzyme elevations. The company added HLA screening and enhanced monitoring while continuing discussions with the FDA. Intellia ended the quarter with $628.4 million in cash, cash equivalents and marketable securities, supported by $195 million in net financing proceeds, and expects its cash runway to extend into at least 2028. Second-quarter revenue fell to $7.7 million, while the net loss widened to $106.6 million. 3 Biotech Stocks That Could Benefit from the Patent Cliff Intellia Therapeutics (NASDAQ:NTLA) said it advanced its lead gene-editing programs during the second quarter, highlighting positive Phase III results for lonvo-z in hereditary angioedema and the resumption of enrollment in Phase III studies of nex-z for transthyretin amyloidosis. Chief Executive Officer John Leonard said the company is preparing a rolling biologics license application, or BLA, for lonvo-z, a one-time therapy intended to treat hereditary angioedema, or HAE. Intellia expects to be positioned to announce FDA acceptance of the filing by the end of 2026 and is preparing for a potential U.S. approval and launch in the first half of 2027. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Goldman Spotlights These 3 Stocks in Its Bullish S&P 500 Outlook Leonard pointed to results from the Phase III HALO trial, which were presented at the European Academy of Allergy and Clinical Immunology meeting and published in The New England Journal of Medicine. During the six-month primary observation period, lonvo-z reduced mean monthly HAE attacks by 87% compared with placebo, according to the company. Sixty-two percent of patients receiving lonvo-z were attack-free and therapy-free during the observation period. Patients in the lonvo-z arm recorded a 23-point improvement from baseline in the total angioedema quality-of-life score. Leonard said a six-point change is considered clinically meaningful. All patients in the lonvo-z arm experienced attack-rate reductions from baseline during weeks five through 28, according to patient-level data cited by the company. The most common treatment-emergent adverse events were infusion-related reactions, headache and fatigue. All reported events were Grade 1 or Grade 2, and no serious adverse events had been observed in the lonvo-z arm as of the data cutoff. Leonard said patients in both the original treatment arm and crossover group remained free of long-term prophylaxis therapy at the data cutoff. He also said the company believes some patients may continue to improve over time based on preclinical work and observations from its Phase I/II study. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Analysts Think These Stocks Could More Than Double in Value Intellia has completed hiring for field medical, reimbursement and strategic accounts teams as it builds its commercial infrastructure. The company said those teams are engaging treatment centers on readiness, while separate work continues on payer outreach, distribution planning and access strategy. During the quarter, Intellia launched the HAEreframed.com disease-awareness initiative. Leonard said the effort is intended to broaden understanding of the burdens associated with HAE, including the recurring requirements of chronic therapy and prior authorizations. → Ulta's Growth Is Real, But So Are the Risks Intellia said it resumed enrollment and dosing in both Phase III nex-z studies during the second quarter after resolving clinical holds earlier in the year. Nex-z is being evaluated as a one-time treatment for transthyretin amyloidosis, including cardiomyopathy and polyneuropathy. Leonard said more than 650 patients have been enrolled in the MAGNITUDE study in transthyretin amyloid cardiomyopathy, or ATTR-CM. The trial’s primary endpoint is event-based, rather than time-bound, and the company said its blinded event rate remains within its internally projected range. Intellia remains on track to complete enrollment in MAGNITUDE-2 later in 2026, though management said it was premature to provide data timing. The company also discussed a genetic analysis involving more than 600 patient samples across nex-z clinical trials. The blinded analysis identified an HLA allele known as C0501 that was associated with a significantly higher rate of Grade 3 or greater transaminase elevations. Each of the five highest elevations after dosing occurred in patients carrying the allele, Leonard said. About 12% of analyzed samples carried C0501, although the majority of those patients did not experience severe transaminase elevations. Intellia said the finding appears specific to nex-z and does not have implications for lonvo-z. The company has updated trial protocols, investigator brochures and informed-consent documents to incorporate HLA typing for patients in its Phase III nex-z studies. Patients and investigators will receive HLA results during screening or before crossover, allowing them to make treatment decisions with additional information. Leonard said Intellia is discussing the findings with the FDA and does not currently expect the screening process to slow enrollment. Management said it believes the liver-enzyme findings support its earlier hypothesis that the elevations may be related to an adaptive immune response. The company has implemented enhanced monitoring and intervention measures, which Leonard said could be used in a commercial setting if needed. Chief Financial Officer Ed Dulac said Intellia completed an equity financing in April that generated approximately $195 million in net proceeds. Cash, cash equivalents and marketable securities totaled $628.4 million as of June 30, 2026, up from $605.1 million at the end of 2025. The company said it expects its cash balance to fund operations into at least 2028. Dulac noted that this runway estimate excludes potential revenue from lonvo-z. Second-quarter collaboration revenue was $7.7 million, compared with $14.2 million a year earlier, primarily reflecting lower revenue from Regeneron. Research and development expense declined to $82.6 million from $97 million, driven by lower external costs for lonvo-z and nex-z and reduced stock-based compensation. General and administrative expense rose to $37.8 million from $27.2 million, reflecting commercial infrastructure buildout, legal costs and stock-based compensation. Net loss was $106.6 million for the quarter, compared with a net loss of $101.3 million in the prior-year period. Intellia said it will continue evaluating information from the CARDIO-TTRansform study of eplontersen as it considers whether any changes could further optimize the MAGNITUDE trial design. Intellia Therapeutics, Inc (NASDAQ: NTLA) is a clinical‐stage biotechnology company focused on developing potentially curative genome editing therapies using the CRISPR/Cas9 platform. The company's research spans both in vivo and ex vivo applications of CRISPR/Cas9, aiming to correct or disable disease‐causing genes with a single administration. Intellia's lead in vivo program targets transthyretin amyloidosis (ATTR) by delivering CRISPR/Cas9 machinery directly to the liver, while additional preclinical efforts pursue treatments for hemophilia A, hereditary angioedema and other genetic disorders. Beyond its in vivo pipeline, Intellia collaborates with strategic partners to extend the impact of its genome editing approach. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Intellia Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Intellia Therapeutics NTLA incurred a second-quarter 2026 loss of 80 cents per share, in line with the Zacks Consensus Estimate. The loss narrowed 18.4% from the loss of 98 cents per share in the year-ago quarter. Intellia’s total revenues currently comprise only collaboration revenues. The company reported revenues of $7.7 million, which missed the Zacks Consensus Estimate of $15 million. Revenues declined 46.2% year over year, reflecting lower collaboration revenues from Regeneron Pharmaceuticals REGN. Research and development expenses declined 14.9% year over year to $82.6 million. The decrease was due to lower external costs related to Intellia’s lead development programs, lonvo-z and nex-z, and lower stock-based compensation, partly offset by higher employee-related expenses due to increased headcount. General and administrative expenses increased 39% year over year to $37.8 million. The increase was primarily driven by costs associated with the ongoing buildout of Intellia's commercial infrastructure, higher legal expenses and stock-based compensation. As of June 30, 2026, Intellia had cash, cash equivalents and marketable securities worth $628.4 million compared with $517.2 million as of March 31, 2026. Following the completion of an underwritten public offering of common stock in April, which generated approximately $195 million in net proceeds, the company expects its existing cash resources to fund operations at least into 2028 and well beyond the anticipated U.S. commercial launch of lonvo-z for hereditary angioedema (HAE) in the first half of 2027. Year to date, shares of NTLA have surged 25% compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research Intellia continued to advance lonvoguran ziclumeran (lonvo-z) for HAE. The phase III HAELO study met its primary endpoint and all key secondary endpoints, with a one-time infusion reducing attacks by 87% compared with placebo over the six-month efficacy evaluation period. NTLA expects the FDA to accept its biologics license application for lonvo-z to treat HAE in the second half of 2026. If approved, Intellia plans a U.S. commercial launch in the first half of 2027 and has been building its field medical, reimbursement and strategic accounts teams ahead of that potential launch. Intellia is developing nexiguran ziclumeran (nex-z) with Regeneron for transthyretin (ATTR) amyloidosis. Both phase III studies of nex-z, MAGNITUDE in ATTR cardiomyopathy and MAGNITUDE-2 in hereditary ATTR amyloidosis with polyneuropathy, were previously placed on clinical hold by the FDA. Earlier this year, the FDA lifted the clinical holds on both studies, following which enrollment and dosing resumed in both studies in the first quarter of 2026. NTLA remains on track to complete enrollment in MAGNITUDE-2 in the second half of 2026. Management said screening activity is accelerating globally. The MAGNITUDE study has enrolled well over 650 patients. Working with Regeneron and external experts, Intellia analyzed more than 600 patient samples across nex-z clinical studies. The analysis found that the highest observed liver transaminase elevations occurred in patients carrying one specific HLA allele. About 12% of the analyzed samples carried the allele, while most carriers did not experience severe transaminase elevations. Intellia has incorporated HLA typing into both ongoing phase III nex-z studies and is providing the information to investigators and patients during screening or before crossover. Intellia Therapeutics, Inc. price-consensus-eps-surprise-chart | Intellia Therapeutics, Inc. Quote Intellia currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.92 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Positive Phase 3 HAELO clinical data for lonvo-z in HAE presented at EAACI and published in New England Journal of Medicine Anticipate FDA acceptance of BLA for lonvo-z in second half of 2026 and U.S. launch in first half of 2027 Enrollment successfully reinitiated in nex-z Phase 3 clinical trials; MAGNITUDE-2 enrollment in ATTRv-PN expected to be completed in second half of 2026 New genomic insights enhance understanding of nex-z’s profile and potential to deliver clinically meaningful outcomes for patients Ended second quarter with approximately $628 million in cash, cash equivalents and marketable securities; expected to fund operations at least into 2028 CAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today reported business updates and financial results for the second quarter ended June 30, 2026. “The second quarter was a momentous period for Intellia highlighted by the positive Phase 3 HAELO clinical trial results we reported for lonvo-z in hereditary angioedema,” said John Leonard, M.D., Intellia President and Chief Executive Officer. “These data serve as strong validation for in vivo gene editing and lonvo-z’s potential to transform the treatment paradigm for patients who are burdened by this disease.” “We also resumed enrollment in our Phase 3 clinical trials in ATTR during the second quarter and gained important new genomic insights that enhance our understanding of nex-z’s safety profile and its potential to deliver clinically meaningful outcomes for patients. Underpinned by a recent capital raise that strengthened our balance sheet, we are well positioned to deliver on our research, regulatory, clinical and commercial objectives,” Dr. Leonard concluded. Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE) Designed as a one-time treatment that is administered in an outpatient setting, lonvo-z is an in vivo CRISPR gene editing candidate that is intended to inactivate the kallikrein B1 (KLKB1) gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks. In April, Intellia announced positive topline results from the global Phase 3 HAELO clinical trial of lonvo-z in HAE. In June, additional data were reported in a late-breaking oral session at the European Academy of Allergy & Clinical Immunology Annual Congress 2026 and in a manuscript published in the New England Journal of Medicine. Highlights included: During the second quarter, the company launched www.HAEreframed.com. The campaign aims to raise awareness of the significant burden of HAE and patients’ top concerns, including the mental toll of the disease and the challenges of taking and maintaining access to chronic treatment. Intellia significantly advanced its launch readiness activities in recent months, including finalizing its field medical, reimbursement and strategic accounts teams and engaging with HAE treatment centers around the U.S. Intellia expects the U.S. Food and Drug Administration (FDA) to accept its submission of a biologics license application (BLA) for lonvo-z in the second half of 2026. If approved, Intellia plans to launch lonvo-z commercially in the first half of 2027. Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis Nex-z is an investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a rapid, deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. (Regeneron). Together with Regeneron and other external experts, Intellia recently conducted a comprehensive genomic analysis of more than 600 patient samples across nex-z clinical trials. The analysis revealed that the highest observed liver transaminase elevations were in patients carrying one specific human leukocyte antigen (HLA) allele. As Intellia engages with the FDA and global health authorities regarding this finding, the company will provide HLA genotyping results to investigators and patients enrolled or entering screening in the ongoing nex-z Phase 3 trials. During the second quarter, nex-z Phase 1 clinical data in ATTR were presented at the Peripheral Nerve Society Annual Meeting in Maastricht, the Netherlands and at the European Society of Cardiology Heart Failure Congress in Barcelona, Spain. Intellia has advanced enrollment in its MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z in ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively. Intellia remains on track to complete patient enrollment in MAGNITUDE-2 in the second half of 2026. Upcoming EventsThe company will participate in the following events during the third quarter of 2026: Bradykinin Symposium 2026, September 2-3, Berlin, Germany Wells Fargo 21st Annual Healthcare Conference, September 9, Boston Morgan Stanley 24th Annual Global Healthcare Conference, September 14, New York Second Quarter 2026 Financial Results Cash Position: In April 2026, the company completed an underwritten public offering of its common stock resulting in approximately $195 million in net proceeds. Cash, cash equivalents and marketable securities were $628.4 million as of June 30, 2026, compared to $605.1 million as of December 31, 2025. The company’s existing cash resources are expected to fund its operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. commercial launch for HAE in the first half of 2027. This guidance excludes all potential commercial revenues from lonvo-z. Collaboration Revenue: Collaboration revenue was $7.7 million for the second quarter of 2026, compared to $14.2 million for the second quarter of 2025. The decrease is primarily due to a reduction in revenue from Regeneron. R&D Expenses: Research and development (R&D) expenses were $82.6 million for the second quarter of 2026, compared to $97.0 million for the second quarter of 2025. The decrease was primarily driven by lower external costs related to the company’s lead development programs and reduced stock-based compensation, partially offset by higher employee-related expenses due to increased headcount. Stock-based compensation expense included in R&D expenses was $9.4 million for the second quarter of 2026. G&A Expenses: General and administrative (G&A) expenses were $37.8 million for the second quarter of 2026, compared to $27.2 million for the second quarter of 2025. The increase was primarily driven by costs associated with the ongoing buildout of the company’s commercial infrastructure, higher legal expenses and stock-based compensation. Stock-based compensation expense included in G&A expenses was $8.6 million for the second quarter of 2026. Net Loss: Net loss was $106.6 million for the second quarter of 2026, compared to $101.3 million for the second quarter of 2025. About Intellia TherapeuticsIntellia Therapeutics, Inc. (Nasdaq: NTLA) is a leading clinical-stage biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. The company’s mission is to transform the lives of people with severe diseases by developing and commercializing potentially curative treatments. With deep scientific, technical and clinical development experience, Intellia aims to reset the standard for medicine by durably treating the root causes of disease. Learn more at intelliatx.com and follow us @intelliatx. Forward-Looking Statements This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations concerning: the success and advancement of its clinical programs for lonvoguran ziclumeran or “lonvo-z” (previously referred to as NTLA-2002) for the treatment of hereditary angioedema (“HAE”) and nexiguran ziclumeran or “nex-z” (previously referred to as NTLA-2001) for transthyretin (“ATTR”) amyloidosis, including its expectations regarding the U.S. Food and Drug Administration’s acceptance of its biologics license application (“BLA”) for lonvo-z in the second half of 2026 and the subsequent review and approval of that BLA, its expectations regarding a planned U.S. launch of lonvo-z in the first half of 2027, and its plans to complete patient enrollment in MAGNITUDE-2 of nex-z for hereditary ATTR amyloidosis with polyneuropathy in the second half of 2026; the potential of lonvo-z to inactivate the KLKB1 gene to permanently lower kallikrein and bradykinin levels, to eliminate HAE attacks via a highly differentiated one-time treatment that is administered in an outpatient setting, and to transform the treatment paradigm for patients with this burdensome disease; the potential of nex-z to halt and reverse disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment and to deliver clinically meaningful outcomes for patients; its ability to optimize the impact of its collaborations on its development programs, including, but not limited to, its collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and their co-development program for ATTR amyloidosis; and its growth as a company and expectations regarding its uses of capital, expenses, future accumulated deficit and financial results, including its ability to fund operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. commercial launch for HAE in the first half of 2027. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the conduct of clinical studies and other development and commercialization requirements for its product candidates, including lonvo-z and nex-z, including risks related to the ability to develop and successfully commercialize lonvo-z, nex-z or any of Intellia’s product candidates; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to Intellia’s relationship with third parties, including its contract manufacturers, collaborators, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to the authorization, initiation and conduct of preclinical and clinical studies and other development requirements for its product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; risks related to the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the risk that clinical study results will not be positive; risks related to the potential delay of planned clinical trials due to regulatory feedback or other developments; and risks related to Intellia’s collaborations with Regeneron, or its other collaborations not continuing or not being successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission, including its recent quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Investor Contact:Jason FredetteVice President, Investor Relations and Corporate CommunicationsIntellia Therapeutics, [email protected] Media Contact:Mike TattoryVice PresidentLifeSci [email protected]

This article first appeared on GuruFocus. Cash Position: Cash, equivalents, and marketable securities totaled $628.4 million as of June 30, 2026, up from $605.1 million at the end of 2025. Cash Runway: Company expects current cash balance to fund operations at least into 2028, excluding all potential product revenues. Collaboration Revenue: $7.7 million for Q2 2026, down from $14.2 million in the prior-year quarter, primarily due to reduced revenue from Regeneron. R&D Expenses: $82.6 million for Q2 2026, down from $97.0 million in the prior-year quarter, driven by lower external costs and reduced stock-based compensation. G&A Expenses: $37.8 million for Q2 2026, up from $27.2 million in the prior-year quarter, due to commercial infrastructure build-out and higher legal expenses. Net Loss: $106.6 million for Q2 2026, compared to a net loss of $101.3 million in the prior-year quarter. Equity Financing: Completed an equity financing in April 2026, yielding approximately $195 million in net proceeds. Warning! GuruFocus has detected 5 Warning Signs with NTLA. Is NTLA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Intellia Therapeutics Inc (NASDAQ:NTLA) reported positive top-line results from the Phase III HALO trial for LONVOSI in hereditary angioedema (HAE), achieving statistical significance on the primary and all key secondary endpoints, including an 87% reduction in mean monthly attacks versus placebo. The company is advancing its rolling BLA submission for LONVOSI with the FDA and expects to announce acceptance by the end of 2026, positioning it for a potential U.S. launch in the first half of 2027 as the world's first in vivo gene editing product. Intellia Therapeutics Inc (NASDAQ:NTLA) resumed enrollment and dosing in both Phase III trials for NEXI in ATTR after resolving clinical holds, with screening rates rapidly increasing globally and over 650 patients enrolled in the Magnitude trial. The company identified a specific HLA allele (C0501) associated with higher-grade transaminase elevations in NEXI trials, enabling the implementation of HLA typing and mitigation strategies to enhance patient safety and informed decision-making. Intellia Therapeutics Inc (NASDAQ:NTLA) maintains a strong financial position with $628.4 million in cash, sufficient to fund operations into 2028, excluding any potential product revenues from a LONVOSI launch. Intellia Therapeutics Inc (NASDAQ:NTLA) faces uncertainty in the ATTR market following the disappointing top-line results from the CardioTransform trial of a competing TTR silencer, which has sparked debate about the efficacy of combination therapies. The company identified a statistically significant finding that patients carrying the C0501 HLA allele have a higher rate of grade 3 or greater transaminase elevations, potentially limiting the addressable patient population for NEXI. Intellia Therapeutics Inc (NASDAQ:NTLA) reported a decrease in collaboration revenue to $7.7 million in Q2 2026 from $14.2 million in the prior year quarter, primarily due to reduced revenue from Regeneron. The company's net loss widened to $106.6 million in Q2 2026 from $101.3 million in the prior year quarter, reflecting increased G&A expenses tied to commercial infrastructure build-out and higher legal costs. Intellia Therapeutics Inc (NASDAQ:NTLA) is still awaiting detailed data from the CardioTransform trial and has not yet guided on data timing for its Magnitude trial, leaving uncertainty around the potential need for trial design changes. Q: Can you discuss the implications of the C0501 HLA allele finding for the 12% of patients who carry it, and is there another parameter that could help fine-tune patient selection? What is the biologic relationship triggering the immune response?A: John Leonard, CEO, explained that the finding confirms the hypothesis of an adaptive immune response, as HLAs are deeply implicated in cell-mediated immunity. This validates the mitigation measures already in place. For patients carrying the C0501 allele, the information is being shared with investigators and patients so they can make informed decisions. While the relationship is statistically significant, many carriers do not experience liver enzyme elevations. The company expects some patients may choose to self-exclude, but for those who see a favorable benefit-risk profile, the therapy remains available. Intellia is engaging with the FDA on the findings and any further implications. Q: Given the disappointing CardioTransform results, what options are you contemplating to potentially optimize the Magnitude trial design to maximize the probability of success?A: John Leonard, CEO, stated that the first priority is understanding the CardioTransform data in detail. Intellia believes the negative outcome is specific to eplontersen and not applicable to combination therapy in general. The key factors to analyze include the degree of TTR reduction, variability, speed of treatment effect, and durability. The company remains open-minded and will consider changes to the trialsuch as enrollment size or follow-up durationonly after a thorough review of the data and consultation with experts. No changes will be made until the full picture is understood. Q: Can you confirm that the HLA allele finding is specific to NEXI and not LONVOSI? And is it correct that only a fraction of the 12% of patients carrying the allele actually experienced elevations?A: John Leonard, CEO, confirmed the finding is almost certainly specific to NEXI, as HLA molecules bind to very specific short peptides that would not be implicated in the LONVOSI treatment effect. This is supported by the New England Journal publication showing no signal in LONVOSI patients. Edward Dulac, CFO, added that while 12% of the 600+ samples carry the allele, only a small subset of those patients experienced higher-grade transaminase elevations, meaning the vast majority of carriers did not have severe elevations. Q: What is the background stabilizer use in the Magnitude trial, and do you expect that to change given the CardioTransform results? Also, do you see enrollment changes due to HLA screening?A: John Leonard, CEO, noted that background stabilizer use is running around 80%, consistent with projections and reflecting real-world usage patterns. Regarding HLA screening, investigators view the finding as confidence-building, as it allows for better patient selection. The company is rapidly rolling out the information to sites and patients. Rather than slowing enrollment, many investigators believe the HLA typing will actually accelerate the pace of screening, which is already increasing globally. Q: Can you provide more detail on the HLA analysis? How many patients with grade 3 liver signals do not carry the allele, and are you considering additional prophylaxis for C0501 carriers?A: John Leonard, CEO, declined to release the full data set at this time, stating it will be presented at an appropriate future date. For C0501-positive patients who choose to participate, no additional prophylaxis is planned, as the current mitigation measures are deemed appropriate for a cell-mediated immune response. The key value of the finding is identifying at-risk patients before an event occurs, allowing them to make informed decisions. For the ~90% of patients who do not carry the allele, the likelihood of a high-grade LFT elevation is extremely low, which is confidence-building. Q: Do you expect the HLA genotyping finding to be on the label if approved, and will every patient be genotyped in a commercial setting?A: John Leonard, CEO, stated it is too early to say whether this will be reflected on the label, as that will depend on the data accumulated and regulatory discussions. In the meantime, the company is excited about the finding's ability to focus benefit-risk on patients who can most benefit. HLA typing is being incorporated into the screening process for the Phase III trials, and it is not expected to slow down screening. In fact, investigators believe it may pick up the pace, as it provides valuable information for patient selection. Q: Regarding the LONVOSI BLA, has the final submission been completed, and are you expecting a bolus of patients at launch if approved?A: John Leonard, CEO, indicated the company is far into the BLA filing process and expects to announce FDA acceptance by the end of the year, which will provide more information on PDUFA dates and priority review. He expressed excitement about the team's preparation and the efficient collaboration with the FDA. While he did not provide specific launch projections, the company's pre-commercial readiness efforts are well underway, including hiring for field medical, reimbursement, and strategic accounts teams. Q: Is the HLA genotyping finding specific to ATTR cardiomyopathy, or does it also apply to polyneuropathy? And are you implementing genotyping in other trials?A: John Leonard, CEO, clarified that the genotyping is being applied across the entire NEXI program, irrespective of the indication. The same rules and information are being provided for both the cardiomyopathy and polyneuropathy studies. For other programs, the company is not currently doing genotyping on a standard basis, as the finding is believed to be very specific to NEXI, and it would be difficult to know what to look for in other programs. Q: Can you elaborate on the patient gateway being built with HAE Reframe, and what can we expect from the upcoming symposium data?A: John Leonard, CEO, explained that the HAE Reframe initiative is designed to elevate understanding of the burdens patients face with lifelong chronic therapy, including prior authorizations and the ongoing impact of the disease. The goal is to ensure payers, patients, and doctors understand the contrast between chronic therapy burdens and the one-time LONVOSI profile. At the upcoming symposium, the company will present molecular-level data on the drug's behavior, including a specific case of a patient who benefited significantly but did not achieve attack-free status, likely due to a second, unrelated process. Q: Regarding the LONVOSI NEJM publication, can you comment on the ALT/AST excursions seen at later time points in some patients?A: John Leonard, CEO, addressed For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Protagonist Therapeutics (PTGX) came out with quarterly earnings of $2.29 per share, beating the Zacks Consensus Estimate of $2.11 per share. This compares to a loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +8.53%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.65 per share when it actually produced earnings of $0.05, delivering a surprise of +107.69%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Protagonist Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $213.48 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 3.12%. This compares to year-ago revenues of $5.55 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Protagonist Therapeutics shares have added about 55.5% since the beginning of the year versus the S&P 500's gain of 13%. While Protagonist Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Protagonist Therapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.23 on $275.9 million in revenues for the coming quarter and $3.69 on $560.65 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Intellia Therapeutics, Inc. (NTLA), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.80 per share in its upcoming report, which represents a year-over-year change of +19.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Intellia Therapeutics, Inc.'s revenues are expected to be $14.51 million, up 1.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Protagonist Therapeutics, Inc. (PTGX) : Free Stock Analysis Report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Data from HAELO Phase 3 clinical trial presented today in a late-breaking oral session at European Academy of Allergy & Clinical Immunology Annual Congress 2026 HAELO manuscript simultaneously published in the New England Journal of Medicine CAMBRIDGE, Mass., June 13, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today presented additional positive results from the global Phase 3 HAELO clinical trial of lonvo-z (formerly NTLA-2002) for hereditary angioedema (HAE) in a late-breaking oral presentation at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026 in Istanbul, Türkiye. Results from the trial were simultaneously published in the New England Journal of Medicine. The presentation and publication can be accessed from the Scientific Publications and Presentations section of intelliatx.com. As previously announced, HAELO met its primary endpoint with an 87% reduction (p<0.0001) in mean monthly attacks in the lonvo-z arm vs. the placebo arm during the efficacy evaluation period (weeks 5 to 28). In addition, 62% of patients in the lonvo-z arm were entirely attack free and therapy free for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm (p<0.0001), a key secondary endpoint. Today, Intellia reported data for the trial’s other key secondary endpoints: AE-QoL: Angioedema Quality of Life score, which is a validated, angioedema-specific patient-reported outcome measure with a lower score indicating improved quality of life. A 6-point reduction is considered to be a clinically important improvement in AE-QoL.CI: Confidence interval Favorable safety and tolerability data were observed for lonvo-z. The most common treatment emergent adverse events (TEAEs) during the primary observation period (infusion through week 28) that were higher in the lonvo-z group compared to placebo were infusion-related reaction, headache, fatigue, back pain, and upper respiratory tract infection. All reported TEAEs were mild or moderate and there were no serious adverse events observed in the lonvo-z arm. “These are the first Phase 3 results to deliver on the much-heralded promise of in vivo CRISPR gene editing,” said John Leonard, M.D., Intellia President and Chief Executive Officer. “Regardless of age or prior use of long-term prophylaxis therapies, it was observed that a single lonvo-z treatment significantly reduced HAE attacks for all patients during the efficacy evaluation period, with all patients remaining LTP free as of the data cutoff. We thank the many patients, physicians and caregivers who participated in HAELO and are excited to be advancing this highly differentiated candidate toward a potential approval.” Danny Cohn, M.D., Ph.D., Internist, Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, and a HAELO principal investigator, added, “As a clinician who has witnessed patients struggle with the unpredictability and emotional toll of HAE, the prospect of offering lasting freedom from attacks and chronic medication with a one-time treatment is incredibly exciting. These results give me confidence that many patients will soon have the potential to enjoy a normal life.” Today’s presentation and publication also included supplemental demographics, data and analyses, including: A time plot showing that the mean monthly attack rate for patients receiving lonvo-z through the data cutoff (February 10, 2026) was well below the reported rate in prescreening while patients were receiving standard-of-care therapy; Patient-level data demonstrating that all patients in the lonvo-z arm experienced attack-rate reductions from baseline during weeks 5 to 28; An analysis showing that meaningful attack-rate reductions were observed for all evaluated subgroups; A breakdown showing that 20% of the patients who enrolled in HAELO reported having complete disease control (no attacks) as their best response to prior long-term prophylaxis therapies; and A plasma kallikrein time plot showing that protein levels decreased substantially by the first measurement (day 15), reached a steady state by week 5 and remained stable through the data cutoff. A rolling biologics license application (BLA) submission for lonvo-z was initiated in April with the U.S. Food and Drug Administration (FDA). The company continues to anticipate regulatory approval and a U.S. launch in the first half of 2027. About Lonvo-zBased on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an in vivo CRISPR gene editing candidate that is intended to permanently lower kallikrein by inactivating the kallikrein B1 (KLKB1) gene with a single dose. Lonvo-z has received five notable regulatory designations: Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Hereditary AngioedemaHereditary angioedema (HAE) is a rare, genetic disease characterized by severe, recurring and unpredictable inflammatory attacks in various organs and tissues of the body, which can be painful, debilitating and life-threatening. It is estimated that one in 50,000 people are affected by HAE. There are preventative and on-demand treatment options to help manage the condition, including long- and short-term prophylaxis used to prevent swelling attacks. Current treatment options often include lifelong therapies, which may require chronic intravenous (IV) or subcutaneous (SC) administration as often as twice per week or daily oral administration to ensure constant pathway suppression for disease control. Despite chronic administration, breakthrough attacks still occur. Kallikrein inhibition is a clinically validated strategy for the preventive treatment of HAE attacks. About Intellia TherapeuticsIntellia Therapeutics, Inc. (Nasdaq: NTLA) is a leading clinical-stage biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. The company’s mission is to transform the lives of people with severe diseases by developing and commercializing potentially curative treatments. With deep scientific, technical and clinical development experience, Intellia aims to reset the standard for medicine by durably treating the root causes of disease. Learn more at intelliatx.com and follow us @intelliatx. Forward-Looking StatementsThis press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations concerning: the success and advancement of its program for lonvoguran ziclumeran or “lonvo-z” (formerly NTLA-2002) for the treatment of hereditary angioedema (“HAE”), including its plan to complete the submission of a biologics license application (“BLA”) for lonvo-z, its expectations regarding review and approval of that BLA, and its expectations regarding a potential U.S. launch of lonvo-z in the first half of 2027; and the potential of one dose of lonvo-z to become the first one-time treatment for HAE and to permanently lower kallikrein by inactivating the kallikrein B1 (KLKB1) gene with a single dose. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the conduct of clinical studies and other development and commercialization requirements for its product candidates, including lonvo-z, including risks related to the ability to develop and successfully commercialize lonvo-z or any of Intellia’s product candidates; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to Intellia’s relationship with third parties, including its contract manufacturers, collaborators, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the risk that clinical study results will not be positive; and risks related to the potential delay of planned clinical trials or regulatory filings due to regulatory feedback or other developments. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Investor Contact:Jason FredetteVice President, Investor Relations and Corporate CommunicationsIntellia Therapeutics, [email protected] Media Contact:Mike TattoryVice PresidentLifeSci [email protected]

A month has gone by since the last earnings report for Intellia Therapeutics, Inc. (NTLA). Shares have lost about 7.9% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Intellia Therapeutics due for a breakout? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent drivers for Intellia Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Intellia incurred a first-quarter 2026 loss of 81 cents per share, narrower than the Zacks Consensus Estimate of a loss of 92 cents. In the year-ago quarter, the company had incurred a loss of $1.10 per share. Intellia’s total revenues currently comprise only collaboration revenues. The company reported revenues of $15 million for the first quarter of 2026, which missed the Zacks Consensus Estimate of $16 million. Total revenues declined 9.5% year over year. Research and development expenses totaled $80.7 million, down 25.5% from the year-ago quarter’s figure. The decrease was due to lower employee-related expenses, stock-based compensation and reduced spending on research materials and contracted services. General and administrative expenses in the first quarter were $34.8 million, up 20.1% year over year, primarily due to continued investments in building the company’s commercial infrastructure and higher legal expenses, partially offset by lower stock-based compensation. As of March 31, 2026, Intellia had cash, cash equivalents and marketable securities worth $517.2 million compared with $605.1 million as of Dec. 31, 2025. Following an underwritten public offering of common stock, the company expects its cash runway to support operations into 2028. In the past month, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 7.62% due to these changes. At this time, Intellia Therapeutics has a average Growth Score of C, however its Momentum Score is doing a lot better with an A. However, the stock has a grade of F on the value side, putting it in the fifth quintile for value investors. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Intellia Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Intellia Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Incyte (INCY), has gained 4.1% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Incyte reported revenues of $1.27 billion in the last reported quarter, representing a year-over-year change of +20.9%. EPS of $1.81 for the same period compares with $1.16 a year ago. Incyte is expected to post earnings of $1.80 per share for the current quarter, representing a year-over-year change of +14.7%. Over the last 30 days, the Zacks Consensus Estimate has changed -3.3%. Incyte has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of B. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research