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ArvinasB
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Investor releaseQuarter not tagged2026-08-11

Arvinas (ARVN) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 8 a.m. ET President and Chief Executive Officer - Randy Teel Chief Scientific Officer - Angela Cacace Chief Financial Officer - Andrew Saik Investor Relations - Jeff Boyle Operator: Hello, and welcome to Arvinas’ Second Quarter 2026 Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to Jeff Boyle. Sir, you may begin. Jeff Boyle: Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our second quarter 2026 financial results, which is available in the Investor and Media section of our website at arvinas.com. Joining us on the call today, we have Randy Teel, our President and Chief Executive Officer; Angela Cacace, our Chief Scientific Officer; and Andrew Saik our Chief Financial Officer. Before we begin, I'll remind you that today's discussions contain forward-looking statements that involve risks, uncertainties and assumptions. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which I urge you to read. Our actual results may differ materially from what is discussed on today's call. A replay of this call as well as today's press release and an updated corporate deck will be available on the Investor and Media section of our website. Now I'll turn the call over to Randy Teel. Randy? Randy Teel: Thanks, Jeff, and good morning, everyone. As a company, we've made significant progress over the past several months. Our focus has been on positioning Arvinas for our next phase of growth, guided by a clear strategic vision. Central to that vision is a relentless focus on advancing transformational improvements for patients. Through continued innovation and disciplined execution, we are focused on unlocking the full potential of our pipeline for patients and shareholders. We've reached 3 significant strategic milestones since the start of the year, beginning with the first-ever FDA approval of a PROTAC degrader, VEPPANU. Second, we completed an out-licensing of VEPPANU to Rigel Pharmaceuticals, who anticipate making VEPPANU available to patients in the very near future. And third, we made the strategic decision that our KRAS G12D program, ARV-806, will only move forward in the hands of a partner. While we believe 806 has the pote…Read full document

Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 8 a.m. ET President and Chief Executive Officer - Randy Teel Chief Scientific Officer - Angela Cacace Chief Financial Officer - Andrew Saik Investor Relations - Jeff Boyle Operator: Hello, and welcome to Arvinas’ Second Quarter 2026 Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to Jeff Boyle. Sir, you may begin. Jeff Boyle: Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our second quarter 2026 financial results, which is available in the Investor and Media section of our website at arvinas.com. Joining us on the call today, we have Randy Teel, our President and Chief Executive Officer; Angela Cacace, our Chief Scientific Officer; and Andrew Saik our Chief Financial Officer. Before we begin, I'll remind you that today's discussions contain forward-looking statements that involve risks, uncertainties and assumptions. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which I urge you to read. Our actual results may differ materially from what is discussed on today's call. A replay of this call as well as today's press release and an updated corporate deck will be available on the Investor and Media section of our website. Now I'll turn the call over to Randy Teel. Randy? Randy Teel: Thanks, Jeff, and good morning, everyone. As a company, we've made significant progress over the past several months. Our focus has been on positioning Arvinas for our next phase of growth, guided by a clear strategic vision. Central to that vision is a relentless focus on advancing transformational improvements for patients. Through continued innovation and disciplined execution, we are focused on unlocking the full potential of our pipeline for patients and shareholders. We've reached 3 significant strategic milestones since the start of the year, beginning with the first-ever FDA approval of a PROTAC degrader, VEPPANU. Second, we completed an out-licensing of VEPPANU to Rigel Pharmaceuticals, who anticipate making VEPPANU available to patients in the very near future. And third, we made the strategic decision that our KRAS G12D program, ARV-806, will only move forward in the hands of a partner. While we believe 806 has the potential to become a meaningful treatment option for patients, it will require investment that is inconsistent with our current capital allocation strategy. Taken together, our progress and decisions in the first half of 2026 have positioned Arvinas to fully capitalize on the promise of our platform in oncology and neurology. We fully shifted our focus to our Phase I clinical programs, and we are confident about the opportunity ahead to create important therapies for patients. With that, I'll spend a few moments diving into our 3 assets with significant clinical data catalysts in the next 12 months. I'll review their differentiated profiles and compelling value propositions. I'll start with ARV-393, our BCL6 degrader. I'll explain why BCL6 is an attractive target, share where we are in the progress of the trial and let you know what to expect in our data release later in 2026. BCL6 is an exciting therapeutic target with initial clinical validation. BCL6 is a previously undrugged transcription factor and a master regulator of multiple cellular processes during B-cell development, including proliferation, survival and apoptosis. Altered BCL6 activity has been implicated as an oncogenic driver in several subtypes of non-Hodgkin lymphoma. We believe that ARV-393 has the potential to become a foundational treatment option and pave the way as the first all-oral chemotherapy-free approach for patients with B or T-cell lymphomas. When we initiated our BCL6 program, no company had successfully demonstrated BCL6 degradation or advanced a degrader to the clinic. Based on feedback from the FDA, our trial began with doses well below our predicted efficacious exposure levels, leading to challenges with enrollment and extended enrollment time lines. However, we've seen a clear acceleration in the enrollment of the trial as we've dosed closer to the expected efficacious range. At the same time, enrollment in the glofi combo portion of the trial has been strong since it began in the past few months. And as we reported late last year, even at the doses we would not have expected to be efficacious, we've seen early responses in difficult-to-treat T-cell lymphomas like AITL as well as in patients with B-cell lymphomas. When it comes to upcoming data for ARV-393, we are on track to share initial Phase I data by the end of the year. Our safety profile has supported continued dose escalation, though the majority of the data in 2026 will be from the early cohorts dosed below the expected efficacious range. These early cohorts when compared with the overall lymphoma population include a higher-than-predicted proportion of patients with T-cell lymphomas, likely reflecting the limited treatment options for these patients. But as I mentioned, as we've approached the predicted efficacious range, enrollment of patients, including those with B-cell lymphomas has increased. In 2027, we will plan a subsequent disclosure that will include more mature monotherapy data, including patients with DLBCL treated with ARV-393, both as monotherapy and in combination with glofi. We are optimistic about the potential of this program to benefit patients who have historically experienced poor clinical outcomes, especially given the positive feedback we've received from investigators over the past few months. I'll turn now to ARV-027, our degrader targeting polyglutamine repeat androgen receptor or polyQ-AR. What's immediately interesting about this program is that the polyQ-AR protein is well understood to be the driver of pathology for patients with spinal and bulbar muscular atrophy or SBMA, also known as Kennedy's disease. SBMA is a rare neuromuscular disorder with between 10,000 and 13,000 diagnosed patients in major markets. Genomic studies suggest that SBMA remains substantially underdiagnosed and ARV-027 has the potential to become the first therapy to target the primary driver of disease. SBMA is an X-linked disease caused by the toxic buildup of the polyQ-AR protein in skeletal muscle. This accumulation disrupts normal muscle function, drives muscular atrophy and over time, leaves patients with long-term physical disabilities and often unable to accomplish daily activities. As an oral therapy, ARV-027 could be uniquely suited as a convenient treatment option to degrade the protein known to cause the disease. In February, we presented preclinical data supporting the potential of ARV-027 in SBMA. Guided by published preclinical evidence, we had established a target of achieving greater than 50% polyQ-AR degradation in skeletal muscle, a level we believed would provide functional benefit. In an aggressive mouse model of SBMA, 027 showed meaningful improvements in grip strength, endurance and survival. Importantly, while we don't believe complete elimination of PolyQ is required to achieve therapeutic benefit, our preclinical studies did demonstrate that 027 could achieve AR degradation far exceeding the levels required for functional improvement. Today, I'm pleased to announce that in our ongoing Phase I trial in healthy volunteers, we completed the single ascending dose cohorts and have now initiated the multiple dose portion of the trial. 027 is our first degrader aimed at a target in muscle. With that in mind, our Phase I trial must demonstrate 2 measures that we've never demonstrated before in human muscle tissue. The first step is achieving adequate exposure and the second is to demonstrate AR degradation in muscle. Taken together, these healthy volunteer data would provide proof of mechanism for ARV-027 and meaningfully derisk the program. In the first half of next year, we intend to show data for both of these measures as well as initial safety data from the trial. Following the dosing in healthy volunteers, our plan is next to dose patients with SBMA. The Phase I trial design already includes a multiple dose cohort in patients with SBMA. We believe this design will accelerate our development plan with the potential to move to a registrational study following the conclusion of the Phase I trial. Finally, I'll move to ARV-102, our third program with upcoming clinical data and discuss plans for upcoming disclosures and provide a brief update on our regulatory interactions as we plan the next trials for our LR2 (sic) [ LRRK2 ]degrader. As a reminder, there are no approved disease-modifying treatment options available for patients with either PSP or PD, and we believe 102 has the potential to become a paradigm-shifting treatment for these patients. This is supported by biomarker data that we presented in March at AD/PD. These data were the first to show modulation of key biomarkers implicated in both PSP and PD, an outcome that has not been demonstrated by LRRK2 inhibitors. This reinforces the potential for 102 to provide a unique approach in neurodegenerative diseases. We will share additional biomarker data from the Phase I trial, including ocular motor measures and CSF proteomics at the MDS conference in October. When it comes to our regulatory interactions for 102, as you'll recall, we are currently working to initiate clinical trials for 102 in patients with PSP, both in the U.S. and globally. After successfully completing our Phase I trial in the Netherlands earlier this year, we submitted an IND to the FDA to support the initiation of the Phase Ib trial in the first half of the year. As previously communicated, prior to authorizing initiation of the trial, the FDA requested additional information as well as final data from our chronic tox studies, which we've now completed. During the quarter, we've also had productive engagement with both European and Japanese health authorities. Interactions with the agencies are ongoing, and we look forward to updating you on our timing for initiating our next clinical trials, which we now expect to begin in 2027. Stepping back, our accomplishments and decisive actions during the first half of 2026 demonstrate our ability to embrace change, capitalize on new opportunities and execute efficiently. I'm proud of the entire team at Arvinas and how we've assertively concentrated our resources on the most promising opportunities for Arvinas. With disciplined capital allocation, we are prioritizing programs that address high unmet need and have strong commercial potential. Our pipeline is designed to maximize both clinical impact and long-term shareholder value. With that, I'll turn the call over to Angela. Angela? Angela Cacace: Thank you, Randy. The Arvinas approach to breakthrough medicines begins with choosing the right biology. The most important decision is selecting targets where targeted protein degradation can fundamentally change the course of disease. We started with 2 highly validated targets, androgen and estrogen receptor to establish the clinical power of our degrader platform. Today, we're applying those same principles to build the next generation of differentiated disease-modifying medicines across oncology and neurology. Randy highlighted the progress of our clinical portfolio I'd like to spend a few minutes on 2 oncology research programs that illustrate where we believe protein degradation can deliver unique advantages. I'll begin with ARV-6723, our oral HPK1 degrader and our first immuno-oncology PROTAC. HPK1 acts as a natural break on the immune system. It limits T cell activation and suppresses antitumor immunity. What's particularly challenging is that HPK1 biology extends beyond its kinase activity. HPK1 also functions as a signaling scaffold. As a result, inhibitors of the kinase activity leave part of the biology intact. Instead, degradation eliminates both kinase and scaffolding functions. We believe that's why ARV-6723 has produced a differentiated preclinical profile compared with inhibitors. Across multiple tumor models, including tumors with both high and low immunogenicity, ARV-6723 produced robust antitumor activity. In these studies, degradation consistently outperformed both an HPK1 inhibitor and anti-PD-1 therapy alone. Perhaps most exciting is what we've observed in checkpoint-resistant tumors. In 7 preclinical models, ARV-6723 demonstrated meaningful single-agent activity where neither an HPK1 inhibitor nor anti-PD-1 therapy showed benefit. We also demonstrated preclinically that the biology extends well beyond T cell activation. HPK1 degradation may remodel the tumor microenvironment through enhanced interferon signaling and activation of the myeloid compartment. We believe this broader immune remodeling may be due to elimination of the scaffolding activity that contributes to the differentiated profile we've observed. And if it translates clinically, could support broader combination opportunities and activity in tumors that have historically responded poorly to immunotherapy. We're excited to begin translating these findings into the clinic. We remain on track to initiate enrollment in our Phase I study in the coming weeks. We look forward to sharing updates as the program advances. Finally, I'd like to highlight our first-in-class oral pan-KRAS degrader program. We recently presented preclinical data demonstrating the potential to overcome key limitations of current pan-RAS inhibitors. Our lead oral degrader showed potent activity across a broad spectrum of KRAS mutations. Importantly, our lead oral pan-KRAS degrader targets KRAS mutations found in more than 90% of patients with KRAS-altered cancers, including difficult-to-treat mutations such as G12R and Q61. It also demonstrated activity against KRAS amplification, a major mechanism of resistance. We also demonstrated superior antitumor activity in combination with immune checkpoint blockade, highlighting the potential to favorably remodel the tumor microenvironment in a way that inhibitors do not. Together, these findings support the potential for broad activity across KRAS-driven cancers, a differentiated therapeutic index and extensive combination opportunities. We will present these exciting combination data at an upcoming scientific conference. The team continues to make outstanding progress, and we look forward to sharing additional updates in the coming months. With that, I'll turn the call over to Andrew to review our quarterly financial results. Andrew? Andrew Saik: Thanks, Angela, and good morning, everyone. I'm pleased to provide financial highlights for the second quarter 2026. As a reminder, detailed financial results for the second quarter are included in the press release we issued this morning. Reiterating the team's sentiment, we have much to look forward to later this year and are pleased with our strong financial position that will allow us to continue to advance our pipeline into the second half of 2028. At the end of the second quarter, we had $567.9 million in cash, cash equivalents and marketable securities on the balance sheet compared with $685.4 million at the end of 2025. With our healthy balance sheet and focus on our early pipeline, we are well positioned to continue developing our promising oncology and neurology programs. Q2 is a very busy period for us as during the quarter, we received FDA approval of the first ever PROTAC degrader VEPPANU and regulatory approval for the Rigel license agreement. These events had a significant impact to our financial statements, which I will summarize now. First, as a result of the license agreement with Rigel, we recorded license revenue of $62.5 million, of which $35 million was received within the quarter. We have also concluded that the method by which we were recognizing revenue under the original Pfizer agreement is no longer applicable under ASC 606 as a result of the Rigel agreement. We, therefore, moved all deferred revenue to the P&L, which resulted in a net revenue of $126.4 million, and we recorded a liability of $52.7 million to cover our remaining obligation to complete ongoing development activities. Additionally, we recorded a $50 million milestone from Pfizer triggered by the VEPPANU approval. Separately, we recorded $3.5 million in revenue under a Pfizer research collaboration agreement where the research term has been completed. Total revenue for the quarter was $249.7 million. Turning to expenses. During the quarter, we introduced a new cost of license revenue line, which represents royalties and other amounts payable to third parties that are directly attributable to revenue under our licensing agreements. Cost of license revenue was $9 million in the second quarter. The $9 million is comprised of payments to Yale under the amended Yale agreement and were triggered by the FDA's approval of VEPPANU and the entry into the Rigel license agreement. General and administrative expenses were $24 million for the second quarter compared to $25.3 million for the same period of 2025. The decrease of $1.3 million was primarily due to decreases in personnel and infrastructure-related costs of $3.9 million and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, primarily due to the Rigel license agreement. Research and development expenses were $52.6 million in the second quarter compared to $68.6 million for the same period of 2025. The decrease of $16 million was primarily driven by a decrease in compensation and related personnel expenses of $11 million, which are not allocated by program and a decrease in program-specific expenses of $0.6 million and non-program-specific expenses of $2.6 million. Our cost reduction programs initiated last year were completed during the second quarter. Non-GAAP R&D was down $8.1 million compared to the same period last year, representing a reduction of 14%. Non-GAAP G&A increased by $0.3 million or 2% compared to the prior year. During the quarter, we recognized all remaining deferred revenue from the Pfizer collaboration agreement. So going forward, there will be no revenue recognition related to the original Pfizer collaboration. Additionally, we booked a liability of $52.7 million to cover estimated remaining liabilities related to the VEPPANU runout costs. So our future obligations under the collaboration agreement will be booked against the accrual and will not impact our P&L. We continue to maintain our cash runway guidance into the second half of 2028. And in doing so, we will be able to fund operations through key data milestones over the coming months and continue to support our highly differentiated pipeline programs that have the potential to meaningfully improve patients' lives. With that, I'll turn the call over to Randy for closing remarks. Randy Teel: Randy? Thanks, Andrew. We've entered the second half of 2026 with multiple opportunities to advance our mission of developing pioneering transformational therapies for patients. We have important catalysts in the coming months and a healthy balance sheet to reach critical milestones. I'll simply close by thanking the patients, investigators and the entire Arvinas team for their continued support and commitment to helping us achieve our mission. Jeff Boyle: Thanks, Randy. Operator, can you please open the queue? Operator: [Operator Instructions] Our first question comes from the line of Nick Lorusso with TD Cowen. Nicholas Lorusso: So on 393, can you discuss a little bit more what you're thinking about the development path, especially considering the data coming mid next year with the glofi combo. Could this catalyze like a potentially pivotal trial in an earlier line setting with bispecifics? Any insight there would be great. Yes. Randy Teel: The short answer is yes. The long answer is the NHL space has a lot of opportunities to pursue, right? And so as we've talked about over the years, we think that while there's a lot of therapies across the lines of therapy, across the different diseases now, there's plenty of chemo. There's plenty of CAR-T, there's plenty of bispecifics. What there's not a lot of is orally bioavailable, tolerable small molecules. And so we think that a BCL6 degrader could slot into multiple areas within the disease landscape. So at this point, as we're in the Phase I dose escalation, a bit early to talk about exactly where we plan to go, but definitely can talk about the options, right? So I think as early options, looking at later line monotherapy makes sense, think about fourth-line LBCL, maybe third-line LBCL, think about later line AITL T cell disease that we've been enrolling patients with already in our Phase I trial. As we move forward with combinations, that could open up further access to the third-line LBCL space, second-line LBCL and perhaps moving ahead in T cell disease as well. So there's a lot of different places that we could go. And I think that the common thread is that to get to any of them, we've got to get through the monotherapy dose escalation, show some efficacy, show some signals there. We've got to show we're combinable with other therapies, most immediately a bispecific like glofi. And once we've done that, I think it becomes a lot easier to talk about where we'll go next, especially as the landscape continues to evolve around us. Operator: Our next question comes from the line of Derek Archila with Wells Fargo. Jacob Goell: This is Jacob on for Derek. I was just wondering if you could comment on the path forward for ARV-102 in PSP. And what does the time line and registration path look like for it in light of some of your more recent regulatory interactions? Randy Teel: Yes. So just to rehash a little bit where we are, right? So we began the year with a couple of Phase I trials, one in healthy volunteers, one in patients with PD. And what we plan to do over the course of the year was to start 2 other trials, a Phase Ib in the U.S. and a registrational-oriented study globally. So what we announced a couple of months ago is that after submitting the IND to the FDA, they asked us to wait before starting that study. So that's technically a clinical hold before starting the studies in the U.S. And then this morning, we announced that with a number of ongoing regulatory interactions that we're currently pursuing and going back and forth on, we think it will take into 2027 to start those studies. So overall, the registrational path in PSP we would think about the 2-part study there, the Phase Ib and a registrational study, that continues to be where we aim. A registrational path for PSP where we haven't even dosed patients yet would more likely be a longer period study. The studies we've done so far are only 28 days. So dosing more like 6 months or a year in patients with PSP would be what we'd be aiming to start with a registrational study. Definitely worth saying that as we go back and forth with the different regulatory authorities, which actually is quite beneficial to be getting feedback from the 3 major agencies all right now, we'll be taking that to finalize the path that we will then set out on, as we've said in 2027. Operator: Our next question comes from the line of Li Watsek with Cantor Fitzgerald. Li Wang Watsek: Maybe a follow-up on ARV-393. What will be a good outcome from the Phase I monotherapy cohorts that you're going to present later this year. It sounds like these are going to be at the subtherapeutic levels. And as we think about combination with glofi, would you be able to share where you are with the dose levels right now? Did you start at the subtherapeutic levels as well and early trends on combinability? Randy Teel: Yes. The short answer on that second one is yes. And just as a recap, we've talked about this in other venues. We were the first company to start working on BCL6, at least to bring it into the clinic to our knowledge. And based on that and some other factors, we got some feedback to start with a very low starting dose for BCL6 as monotherapy. And as we talked about with some operational questions that enrollment has been certainly slower than we would have liked. On the flip side, as we've gotten closer now to the predicted efficacious exposures, we've seen a clear uptick in. And in the combination study, which started a couple of months ago, that enrollment there has been quite strong ever since the start. So when it comes to the data that we will have at the end of the year, you were right to highlight we will be still very much in the -- below the efficacious range for most of the patients. In the doses that we're at now, we're starting to get to the exposure that we would expect the efficacious. So we'll start to see some of that. We also mentioned that we have been enrolling a greater proportion of patients with T-cell lymphomas than we would have anticipated based on the overall population. So we think it will make sense to focus on that population and the disclosure that's coming up. And then also, as we talked about heading into next year, focusing on LBCL patients as both monotherapy and combo. The data at the end of this year will certainly be focused on mono. We do not anticipate sharing combo data. We didn't start quite as low for the combo as we did for the mono, but it certainly is starting -- it certainly did start at levels that in monotherapy were not predicted to be efficacious in patients with B-cell lymphomas. Operator: Our next question comes from the line of Edward Tinhoff with Piper Sandler. Edward Tenthoff: Looking forward to more data this year, and congrats on all the progress. So I'll ask about SBMA and 227, really interesting mechanism here. Just to confirm the IND cleared there and what are we waiting for to -- I'm sorry, the -- where are you in multiple ascending dosing? And can you kind of characterize -- you mentioned exposure and degradation. What are the clinical endpoints that we would ultimately be modeling or expecting in SBMA? Randy Teel: Maybe I'll pass to Angela in a moment on some of the path forward questions. To reiterate where we are on that question, right? So we have been dosing healthy volunteers with 027. We've now completed the single ascending dose portion of the study and have just begun the multiple dose portion of the study. That will continue. We're expecting to share some data at the beginning or in the first half rather of next year. We do anticipate including some patients with SBMA in the latter stages of that Phase I study. And just to reiterate for everyone, this program, well, SBMA is certainly a rare disease. We're talking 10,000, 13,000 patients in major markets or so. The great thing about this target is that we are hitting the actual driver of disease. So polyglutamine AR is what drives disease. That's what we're degrading. We're not degrading an upstream transcription factor or some other factor, we're degrading the actual cause of disease. When it comes to the next phases, we've talked about being able to move into registrational intended studies even after Phase I. But Angela I invite you to speak a bit more about plans there and endpoints and so on. Angela Cacace: Sure. As we move forward, the goal is to really demonstrate that we can target 50% reduction of the polyglutamine repeat androgen receptor. In our preclinical studies and in other preclinical studies, 50% reduction is the target that we aim to achieve in muscle. So that's our goal from a biomarker perspective, and we'll also look at some other endpoints as well. Those will be the early endpoints. We will not be able to demonstrate functional change until we go into those registrational studies that Randy mentioned. And there, we'll be looking at meaningful scales like the SBMA functional rating scale and those endpoints as well. Operator: Our next question comes from the line of Jonathan Miller with Evercore ISI. Jonathan Miller: Congrats on the progress this quarter, guys. I'd like to follow up first on the polyQ-AR. There'll be a couple of patients you said next year. Am I right to assume that we shouldn't expect to see good translation of degradation rates from healthy volunteers to patients that have different levels of protein at baseline? And if that's the case, are there particular measures from healthy volunteers that you think will translate well to eventual degradation efficiency in patients and thereby efficacy and functional endpoints? And then similarly, on the other data sets where we'll get early data from, I'm thinking of HPK1 where you're going to dose in healthy volunteers to start. Are there particular endpoints that we should be paying attention to when we eventually see that data that you think will translate well? Randy Teel: All right. So on 027, the short answer on translating the degradation of 027 in polyglutamine AR, which the patients may have versus wild-type AR, which healthy volunteers will have, is that it's the same. We effectively degrade wild-type AR and polyQ-AR the same. So that will be really helpful to see, as I mentioned, that as we share the healthy volunteer data in the first half of next year, just to reiterate, there's a couple of pieces there that we have not done before, and we're looking forward to see if we can do. One is getting an orally available PROTAC in muscle. So that alone we haven't been looking for before. And second of all, getting degradation there. And we think that if we can see degradation of the wild-type AR in healthy volunteers, that will bode very well for our ability to degrade the disease-causing polyQ-AR in patients. So I think the translatability there will be quite good. I can move on to HPK1 question, but Angela, anything to add on the polyQ question? Angela Cacace: Just to add, John, that we did look at iPSC-derived skeletal muscle from both healthy volunteers and SBMA patients and the pharmacology was exactly intact, which is exactly what Randy was saying we would translate. And so that's our goal, and that's our reason to believe. Randy Teel: And on the HPK1 program, 6723. So again, as we said this morning, that's going to start dosing patients here in the quite near future. The thinking there is that this is our first IO therapy. So the first couple of trials will look very similar to other oncology trials, right? These will be in patients, not healthy volunteers, just to clarify that. It's an escalation design. We'll be looking at monotherapy. The Phase I also includes combination setting as well. And we think it's really important there to show some initial signs of efficacy and, of course, safety, tolerability and combinability as well. The HPK1 program is interesting, right? So the first IO therapy, it's got quite a large opportunity. We've certainly got to show, as we're very aware, something that the HPK1 inhibitors have not shown, which is good response rates and so on in patients, but we are really confident that we'll be able to do that based on the preclinical data we have which really goes a long way to show, including some recent preclinical data this year that we can have differential effects in getting responses, get inhibition and affect the tumor microenvironment in ways that HPK1 inhibitors have been unable to do, PD-1 therapies have been unable to do. And so for that reason, we have some good confidence moving into Phase I, but look forward to sharing those data. Operator: Our next question comes from the line of Yigal Nochomovitz with Citigroup. Yigal Nochomovitz: I had 2, one on BCL6. I think you mentioned, Randy, that the enrollment was a bit slow at the subtherapeutic doses, but you also mentioned that you saw some effective responses at the lower doses. So I was just trying to square those 2 things. I guess I would have thought that if you saw responses below therapeutic doses that would catalyze the enrollment curve. And then secondly, on LRK (sic) [LRRK2 ], could you just comment on the -- obviously, since the last earnings, Biogen and Denali had the Phase IIb for their inhibitor, which, as you know, didn't work, but I'd just love to get your thoughts on that and why the degrader may be a more promising approach? Randy Teel: Yes. So on BCL6, what you said is correct, and you did point out a bit of a contradiction, which we're certainly aware of. So yes, we started pretty far below the predicted efficacious range. And the other feedback that we gotten was around the design and the escalation of it. So not only do we start low -- sorry, not only do we start low, we've also escalated pretty slowly. Seeing the responses that we have has certainly helped. But I think especially where we're doing the trial in the U.S., especially in LBCL patients, there are quite a number of other options that patients can take before they get on to a clinical trial. And I think there's quite some natural hesitance by physicians to put patients on a dose that they might not expect to be efficacious when there are other options out there. So I do recognize that it has certainly picked up as we've gotten closer. The responses have helped. And it's another reason that we're excited to get some of these data out by the end of the year and especially with respect to T cell patients where we think we'll be the first to share data for BCL6 degrader looking at that patient population. When it comes to the LRRK2 program in LUMA, I think that -- and Angela, try to chime in here as well. As we've gotten asked about that over the past couple of months, the questions have largely followed the same path, which is, look, LUMA Trial didn't work. We didn't expect it to work. Is there anything to learn? And I think that for us, what we've been really focused on since the beginning of this program really was the fact that we don't think that inhibiting the kinase function of LRRK2 is enough. We think there are other aspects of LRRK2. There's GTPase function, there's [ scaff ] function that we know drive activity, inflammation and the lysosomal capabilities by the cells. And we think that those are critical. So we didn't -- we weren't terribly surprised to see that a program that by their reporting gets something like 30% kinase inhibition, we weren't surprised to see it fail. It doesn't deter us in what we're doing. A LRRK2 degrader, we think can hit all 3 different factors and features of LRRK2. We think that matters. We think that degrading it will even clearly affect the kinase function even more. And it doesn't deter from where we're going, which as we've talked about is first in PSP, where there's really substantial unmet need in a very rapidly progressing neurodegenerative disorder versus PD anyway and then ultimately, PD as well. Angela Cacace: Just briefly to add, Yigal, Biologically, we understand why the inhibitors aren't ineffective, right? We saw greater than 50-fold enhanced target engagement and phosphoRab pathway engagement in the brain. And then we'll be talking about some exciting synaptic markers at MDS that will, in our minds, really prove that the degrader is different in Parkinson's disease patients with looking at eye tracking as well as CSF synaptic markers that are unprecedented changes in markers that are prognostic of progression in Parkinson's disease. Operator: Our next question comes from the line of Etzer Darout with Barclays. Etzer Darout: Just a couple, one on pipeline and maybe one for Andrew. First, on the pipeline, you would expect to enroll tumor types in the HPK1 degrader program similar to what we've seen from the HPK1 inhibitors like gastric, lung, anything there would be helpful. And is PD-1 the most likely initial combination partner initially? And then for Andrew, maybe if you could help us out on how we should think about maybe the modeling of the cost of licensing moving forward? And anything there would be helpful as well. Randy Teel: All right. Yes. So on the -- maybe I'll answer the easiest ones first. PD-1, yes, that is the likely combination partner first. I haven't said specifically which one, but we will certainly get into that as the months go by. Tumor types, not far off either. Things like lung is the right place to be thinking about. That trial will enroll patients that have had prior immunotherapy. And think of it as a traditional sort of escalation trial that we'll get into data. I haven't talked about when, but as that gets going, it gets easier to talk about data coming. Andrew, questions on modeling? Andrew Saik: Yes, sure. So yes, a lot of changes to the accounting at a high level, and I'm happy to take a follow-up if this doesn't clear up your question. At a high level, we've been deferring revenue from the original Pfizer collaboration agreement over the life of the collaboration. Due to the Rigel out-license, we deemed that our contributions to that collaboration are complete. And therefore, we took all of the residual collaboration revenue through the P&L. So going forward, you'll see no additional revenue recognition. We do have tail liabilities on the closeout costs of the VEPPANU development plan. We booked a liability on the balance sheet for that. When the Q comes out, you're going to see a current portion of that of $28.4 million, a long-term portion of $24.3 million for a total of $52.7 million. So additional payments that we make for that collaboration cost will go against that liability. So essentially, our P&L going forward is somewhat cleansed from the previous VEPPANU collaboration agreement. We will be booking milestones and royalties going forward, but those will be sort of traditional and that there'll be real royalties that we'll receive from Rigel on a go-forward basis. We then additionally, we added that cost of sales line. That was really just to segregate Yale payments from our normal G&A. So you'll see that cost of sales line. For the time being, that's going to be 100% payments to Yale. We have a small royalty that we paid to Yale on any royalties in, and they get a small portion also of milestones going forward. So you'll see those picked up on that collaboration -- cost of revenue line. Please let me know if that answered your question. I know that's a lot. Operator: Our next question comes from the line of Paul Choi with Goldman Sachs. Kyuwon Choi: My first question is on LRRK2, and you indicated you'll present additional biomarker data in October. Can you maybe frame for us what the sort of cadence over 2027 will be in terms of additional updates for that program and any additional clinical measures or potential advancements to the next stage? And then my second question on BCL6 is after you present the glofi combination data in mid-2027, as you think about clinical development, can you maybe outline for us how you're thinking about potential comparator arms versus the monotherapy trial and just how you think about that down the road? Randy Teel: All right. Yes. So on LRRK2, I'll reiterate what I said before on where we are with 102, which is really focused on the regulatory approach, right? So what we're focused on right now is incorporating feedback and developing that plan for how we move forward with the trials that we've talked about before while incorporating that feedback. So when it comes to the cadence of trials, really the cadence will be we'd like to start. That's the case. When it comes to providing a bit more clarity on where we're going, as we begin those trials, as we get close or even before, we'll certainly talk about how those are shaping up. But the cadence following the biomarker data that we plan to show at MDS will really be dictated on those trial starts. When it comes to for BCL6, look, as we move, as I said, all roads lead through the monotherapy and the combination right now with glofi, and we'll talk a bit more about where we go after that. There's a lot of options, right? The bispecifics, there's more than one. Those are potential combinations. There's chemo, there's other things as well. I think that we will really have to watch the landscape evolve to see a bit of where the puck is going to see where it makes most sense for us to combine. I'll reiterate what I said around the opportunity to move earlier and faster with monotherapy approaches and then the ability to follow up with combination approaches that have the opportunity to reach bigger patient populations in earlier lines of therapy. So beyond that, a bit hard to specify what the details will be. But as we've started talking about this program, as we've shared the progress that we've made, certainly, lots of companies that are interested in the space, including strategic that clearly are following the traditional path in the NHL space, which is to identify ways to build out the treatment combinations that we're able to get to patients to extend responses and get responses to more patients. Operator: Our next question comes from the line of Jit [ Mukerjee ] with U.S. Bancorp BTIG. Blake Gitler: It's Blake on for Jit. A quick question on ARV-102. Do you still have an intended PSP population that you're targeting? Or is it going to be an all-comers trial, thinking more on the lines of Richardson syndrome patients or specific LRRK2 variants? Randy Teel: And maybe I'll have Angela give some more color here. The shortest answer is you're not -- you're thinking about it right, right, which is that we could look at all the PSP. Richardson is the largest subtype. When it comes to narrowing more than that, I think it's less likely. But maybe Angela, a little bit more detail on how we think about the population there. Angela Cacace: Right. I think that we would not restrict further. Richardson syndrome is really a very uniform progressing population, which is why we like it. and we like the focus there, but this does not restrict us from expanding to all PSP. I hope that helps. Operator: Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Randy for closing remarks. Randy Teel: Thanks, operator, and thanks, everybody, for joining this morning. We look forward to providing further updates as we move forward, and thanks again. Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Arvinas, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Arvinas wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $411,427!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,252!* That performance is why people listen. 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Arvinas (ARVN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-04

Arvinas Reports Second Quarter 2026 Financial Results and Provides Corporate Update

GlobeNewswire
– Secured the first-ever regulatory approval of a PROTAC (a type of heterobifunctional protein degrader), VEPPANU, and successfully completed out-licensing to Rigel Pharmaceuticals – – Anticipates sharing clinical data from three Phase 1 programs - ARV-393, ARV-102 and ARV-027 - over the next 12 months – – Presented promising preclinical data for HPK1 degrader program (ARV-6723) demonstrating the potential to overcome immune checkpoint inhibitor resistance in solid tumors – – Company to host conference call today at 8:00 a.m. ET – NEW HAVEN, Conn., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter 2026, and provided a corporate update. “Our progress during the quarter has helped position us to fully capitalize on the promise of our platform in oncology and neurology,” said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. “The approval of VEPPANU, the first ever for a PROTAC degrader, was a significant achievement for the Company, and our subsequent licensing of VEPPANU to Rigel Pharmaceuticals promises to unlock its commercial potential and provide access to patients as efficiently as possible.” “As we move into the second half of the year, enrollment in our ongoing Phase 1 trials is strong and we have important data milestones planned over the next 12 months for ARV-393, ARV-102, and ARV-027,” continued Dr. Teel. “In addition, we are initiating our first immuno-oncology Phase 1 trial with ARV-6723 – an HPK1 degrader that has shown meaningful single-agent activity in preclinical models where neither an inhibitor nor an anti-PD1 therapy has shown benefit. Altogether, our pipeline has the potential to address high unmet medical needs and maximize both clinical impact and long-term shareholder value.” Second Quarter 2026 Business Highlights and Recent Developments Approved Product VEPPANU™ (vepdegestrant): Oral PROTAC ER degraderAs part of Arvinas global collaboration with Pfizer, the companies: Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with…Read full document

– Secured the first-ever regulatory approval of a PROTAC (a type of heterobifunctional protein degrader), VEPPANU, and successfully completed out-licensing to Rigel Pharmaceuticals – – Anticipates sharing clinical data from three Phase 1 programs - ARV-393, ARV-102 and ARV-027 - over the next 12 months – – Presented promising preclinical data for HPK1 degrader program (ARV-6723) demonstrating the potential to overcome immune checkpoint inhibitor resistance in solid tumors – – Company to host conference call today at 8:00 a.m. ET – NEW HAVEN, Conn., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter 2026, and provided a corporate update. “Our progress during the quarter has helped position us to fully capitalize on the promise of our platform in oncology and neurology,” said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. “The approval of VEPPANU, the first ever for a PROTAC degrader, was a significant achievement for the Company, and our subsequent licensing of VEPPANU to Rigel Pharmaceuticals promises to unlock its commercial potential and provide access to patients as efficiently as possible.” “As we move into the second half of the year, enrollment in our ongoing Phase 1 trials is strong and we have important data milestones planned over the next 12 months for ARV-393, ARV-102, and ARV-027,” continued Dr. Teel. “In addition, we are initiating our first immuno-oncology Phase 1 trial with ARV-6723 – an HPK1 degrader that has shown meaningful single-agent activity in preclinical models where neither an inhibitor nor an anti-PD1 therapy has shown benefit. Altogether, our pipeline has the potential to address high unmet medical needs and maximize both clinical impact and long-term shareholder value.” Second Quarter 2026 Business Highlights and Recent Developments Approved Product VEPPANU™ (vepdegestrant): Oral PROTAC ER degraderAs part of Arvinas global collaboration with Pfizer, the companies: Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. Announced that the National Comprehensive Cancer Network® (NCCN®) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.* Pipeline ARV-393: Oral PROTAC BCL6 degrader Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin lymphoma (NHL). Continued enrollment in the Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL). ARV-102: Oral PROTAC LRRK2 degrader Joined the LRRK2 Investigative Therapeutics Exchange (LITE) program and the Parkinson’s Precision Medicine Initiative (PPMI), both supported by The Michael J. Fox Foundation for Parkinson’s Research (MJFF). ARV-027: Oral PROTAC polyQ-AR degrader Completed the single-ascending dose cohorts of the first-in-human Phase 1 clinical trial in healthy volunteers and initiated enrollment in the multiple dose cohorts in healthy volunteers. ARV-6723: Oral PROTAC HPK1 degrader Arvinas’ first immuno-oncology clinical candidate Presented preclinical data at the AACR Annual Meeting demonstrating greater antitumor activity than standard-of-care immune checkpoint inhibitors (ICIs) or an investigational HPK1 inhibitor. Novel pan-KRAS degrader Presented preclinical data at the AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics. ARV-806: Novel PROTAC KRAS G12D degrader Completed dose escalation enrollment in the Phase 1 clinical trial in patients with solid tumors harboring KRAS G12D mutations. Announced plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials. Anticipated Upcoming Milestones and Expectations ARV-393: Oral PROTAC BCL6 degrader Share data from early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial in patients with relapsed/refractory NHL(ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026). ARV-102: Oral PROTAC LRRK2 degrader Share additional biomarker data from the Phase 1 clinical trial in patients with Parkinson’s disease at the International Congress on Parkinson’s Disease and Movement Disorders (October 2026). Continue discussions with global health authorities on plans to initiate clinical trials in patients with progressive supranuclear palsy (2027). ARV-027: Oral PROTAC polyQ-AR degrader Continue enrollment in the multiple dose cohort of the Phase 1 clinical trial in healthy volunteers and share initial data evaluating androgen receptor (AR)-degradation in muscle (1H 2027). ARV-6723: Oral PROTAC HPK1 degrader Initiate enrollment of the Phase 1 clinical trial in patients with advanced solid tumors (3Q 2026). Financial GuidanceBased on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of June 30, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028. Second Quarter 2026 Financial ResultsCash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2026, cash, cash equivalents, and marketable securities were $567.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $117.5 million for the six months ended June 30, 2026, was primarily related to cash used in operations of $114.3 million (net of $35.0 million received under the Rigel License Agreement), unrealized losses on marketable securities of $2.0 million, and the purchase of lab equipment and leasehold improvements of $1.5 million. Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $52.6 million for the quarter ended June 30, 2026, as compared with $68.6 million for the quarter ended June 30, 2025. The decrease in R&D expenses of $16.0 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $11.0 million, which are not allocated by program, and a decrease in external expenses of $3.2 million. External expenses include (i) program-specific expenses, which decreased by $0.6 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $10.6 million, partially offset by increases in our ARV-806, ARV-027, and ARV-393 programs of $3.9 million, $3.2 million, and $2.3 million, respectively. Non-GAAP R&D expenses were $51.4 million for the quarter ended June 30, 2026, as compared with $59.5 million for the quarter ended June 30, 2025, excluding $0.3 million and $0.6 million of restructuring expense for the quarters ended June 30, 2026, and 2025, respectively, and $0.9 million and $8.5 million of non-cash stock-based compensation expense for the quarters ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. General and Administrative Expenses: GAAP general and administrative (G&A) expenses were $24.0 million for the quarter ended June 30, 2026, as compared with $25.3 million for the quarter ended June 30, 2025. The decrease in G&A expenses of $1.3 million for the quarter was primarily due to decreases in personnel and infrastructure related costs of $3.9 million, and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, inclusive of an increase in the amortization of costs to obtain a contract related to the Pfizer Letter Agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement and professional fees related to the Rigel License Agreement. Non-GAAP G&A expenses were $18.4 million for the quarter ended June 30, 2026, as compared with $18.1 million for the quarter ended June 30, 2025, excluding $1.3 million and $0.4 million of restructuring expenses for the quarters ended June 30, 2026, and 2025, respectively, and $4.3 million and $6.8 million of non-cash stock-based compensation expense for the quarter ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. Cost of License Revenue: Cost of license revenue was $9.0 million for the quarter ended June 30, 2026, as compared with zero for the quarter ended June 30, 2025. The increase of $9.0 million was due to expenses under the Amended Yale License Agreement related to the FDA’s approval of VEPPANU and the entry into the Rigel License Agreement. Revenue: Revenue was $249.7 million for the quarter ended June 30, 2026, as compared with $22.4 million for the quarter ended June 30, 2025. Revenue for the quarter is related to the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the research collaboration agreement with Pfizer and the Rigel License Agreement. The increase of $227.3 million was primarily due to $112.6 million of revenue from the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by the recognition of the remaining deferred revenue upon entry into the Rigel License Agreement of $126.4 million, partially offset by a decrease in revenue of $13.8 million for the period prior to the Rigel License Agreement. In addition, we recognized $62.5 million of revenue from the Rigel License Agreement, and $50.0 million of revenue from a development milestone payment in connection with the FDA’s approval of VEPPANU. Investor Call & Webcast DetailsArvinas will host a conference call and webcast today, August 4, 2026, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas, with its partner Pfizer, developed the first U.S. Food and Drug Administration (FDA) approved PROTAC, a type of heterobifunctional protein degrader. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle for the treatment of Spinal-Bulbar Muscular Atrophy, also known as Kennedy’s disease; and ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. About ARV-393 ARV-393 is an investigational, orally bioavailable PROTAC designed to specifically target and degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6. ARV-393 is currently being evaluated in a Phase 1 clinical trial as a monotherapy in patients with relapsed/refractory non-Hodgkin lymphoma and in in combination with glofitamab as a chemotherapy-free combination approach in patients with DLBCL. About ARV-102 ARV-102 is an investigational, orally bioavailable PROTAC designed to cross the blood-brain barrier and specifically target and degrade leucine-rich repeat kinase (LRRK2), a large, multidomain scaffolding kinase with GTPase activity. Increased activity and over expression of LRRK2 have been implicated in the pathogenesis of neurological diseases, including LRRK2 genetic and idiopathic Parkinson’s disease and progressive supranuclear palsy (PSP). ARV-102 has been evaluated in a Phase 1 clinical trial in healthy volunteers and in patients with Parkinson’s disease. About ARV-027ARV-027 is an oral, peripherally restricted investigational PROTAC degrader designed to selectively target and eliminate the polyglutamine-expanded androgen receptor (polyQ-AR) in skeletal muscle. ARV-027 is a clinical candidate specifically selected for potent in vitro reduction of cytosolic and nuclear polyQ-AR and for favorable skeletal-muscle exposure following oral administration. The polyQ-AR protein is the pathogenic driver of spinal and bulbar muscular atrophy (SBMA), a rare, X-linked, genetically defined neuromuscular disease caused by a CAG trinucleotide repeat expansion in the androgen receptor (AR) gene. SBMA leads to progressive muscle weakness, dysphagia, and functional decline, and currently has no approved disease-modifying therapies approved by the FDA or EMA, representing a significant unmet medical need. ARV-027 is currently being evaluated in a fist-in-human Phase 1 clinical trial in healthy volunteers. About ARV-6723ARV-6723 is an oral investigational PROTAC designed to degrade hematopoietic progenitor kinase 1, or HPK1, and is Arvinas’ first clinical candidate in the immuno-oncology space. Preclinically, ARV-6723 has shown potent, selective HPK1 degradation and strong anti-tumor immune responses with superior tumor control in low- and high- immunogenic tumor models. HPK1 acts as a negative regulator in T-cell signaling. Degrading HPK1 and its scaffolding function has the potential to unleash an immune response with potent anti-tumor effects and minimum off-target toxicity. Arvinas plans to initiate a Phase 1 clinical trial of ARV-6723 in patients with advanced solid tumors in Q3 2026. About ARV-806 ARV-806 is a novel, investigational PROTAC designed to selectively target and degrade mutant Kirsten rat sarcoma (KRAS) G12D. KRAS is one of the most frequently mutated human oncogenes and G12D is the most common mutation of the KRAS protein. ARV-806 has demonstrated potent, selective degradation of KRAS G12D and robust anti-tumor activity in preclinical models. Arvinas believes ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer. ARV-806 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors harboring KRAS G12D mutations. About VEPPANUVEPPANU (vepdegestrant) is an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), estrogen receptor degrader approved in the U.S. for use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Arvinas and Pfizer Inc. entered into a license agreement with and Rigel Pharmaceuticals, Inc. for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. Non-GAAP Financial InformationThe results presented in this press release include both Generally Accepted Accounting Principles (GAAP) information and non-GAAP information. As used in this release, non-GAAP research and development (“R&D”) expense is defined by Arvinas as GAAP R&D expense excluding restructuring and stock-based compensation expense, and non-GAAP general and administrative (G&A) expense is defined by Arvinas as GAAP G&A expense excluding restructuring and stock-based compensation expense. Arvinas uses these non-GAAP financial measures to evaluate Arvinas’ ongoing operations and for internal planning and forecasting purposes. Arvinas believes that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in Arvinas’ industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of Arvinas’ non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate Arvinas’ business Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the promise of Arvinas’ platform in oncology and neurology, and the progress during the quarter positioning Arvinas to capitalize on that promise; the licensing of VEPPANU to Rigel Pharmaceuticals, Inc. (Rigel) unlocking VEPPANU’s commercial potential and providing access to patients as efficiently as possible; Arvinas’ plans to share clinical data from ARV-393, ARV-102 and ARV-027 over the next twelve months; ARV-6723 preclinical data demonstrating the potential to overcome immune checkpoint inhibitor resistance in solid tumors; the plans for initiation of Arvinas’ first immuno-oncology Phase 1 clinical trial with ARV-6723 and timing thereof; the therapeutic potential or potential benefits of Arvinas’ product candidates and potential of its pipeline to address high unmet medical needs and maximize both clinical impact and long-term shareholder value; Arvinas’ anticipated milestones, expectations and plans with respect to ARV-393, ARV-102, ARV-027 and ARV-6723, including timings related to anticipated enrollment or initiation of trials and sharing or presentation of data as well as forums for presenting any such data; Arvinas’ plans to share initial data from the ARV-806 Phase 1 monotherapy dose escalation clinical trial and the timing thereof; Arvinas’ plans to seek an out-license of ARV-806 for further development, including any dose expansion or combination clinical trials; statements regarding Arvinas’ cash, cash equivalents and marketable securities, including their sufficiency to fund planned operating expenses and capital expenditure requirements into the second half of 2028; and Arvinas’ belief that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas will be able to successfully conduct and complete development for its product candidates, including ARV-393, ARV-102, ARV-027, and its preclinical candidates, including ARV-6723, and including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials and preclinical studies on its expected timelines or at all; Rigel’s performance of its obligations under the license agreement with the Company, Pfizer Inc. and Rigel and whether Rigel will successfully commercialize VEPPANU on the current timeline expectations or at all; the potential demand and market potential and acceptance of, VEPPANU, including estimates regarding the potential market opportunity; the competitive landscape for VEPPANU; risks related to Arvinas’ expectations regarding the potential clinical benefit of VEPPANU, or its other product candidates; the uncertainties inherent in research and development, including preclinical study or clinical trial results; risks and uncertainties relating to regulatory applications and related approval timelines; the risk that any regulatory approval may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; regulatory actions or delays or government regulation generally; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; early termination of any of Arvinas’ collaborations; the impact of the previously announced workforce reductions on Arvinas’ business and reputation; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. *NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Contacts Investors: Jeff Boyle +1 (347) 247-5089 [email protected] Media: Alyssa Kuciunas+1 (331) [email protected] (*) Excludes restructuring related stock-based compensation.

Investor releaseQuarter not tagged2026-08-04

Arvinas, Inc. (ARVN) Beats Q2 Earnings and Revenue Estimates

Zacks
Arvinas, Inc. (ARVN) came out with quarterly earnings of $2.58 per share, beating the Zacks Consensus Estimate of a loss of $0.24 per share. This compares to a loss of $0.84 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +1,175.00%. A quarter ago, it was expected that this company would post a loss of $0.95 per share when it actually produced a loss of $0.9, delivering a surprise of +5.26%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Arvinas, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $249.7 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 562.56%. This compares to year-ago revenues of $22.4 million. The company has topped consensus revenue estimates two times 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. Arvinas shares have lost about 32% since the beginning of the year versus the S&P 500's gain of 11%. While Arvinas has underperformed 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 Arvinas was mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy)…Read full document

Arvinas, Inc. (ARVN) came out with quarterly earnings of $2.58 per share, beating the Zacks Consensus Estimate of a loss of $0.24 per share. This compares to a loss of $0.84 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +1,175.00%. A quarter ago, it was expected that this company would post a loss of $0.95 per share when it actually produced a loss of $0.9, delivering a surprise of +5.26%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Arvinas, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $249.7 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 562.56%. This compares to year-ago revenues of $22.4 million. The company has topped consensus revenue estimates two times 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. Arvinas shares have lost about 32% since the beginning of the year versus the S&P 500's gain of 11%. While Arvinas has underperformed 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 Arvinas was mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 -$0.78 on $25.51 million in revenues for the coming quarter and -$2.82 on $103.17 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 42% 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. Iovance Biotherapeutics (IOVA), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This biotechnology company is expected to post quarterly loss of $0.17 per share in its upcoming report, which represents a year-over-year change of +48.5%. The consensus EPS estimate for the quarter has been revised 6.1% higher over the last 30 days to the current level. Iovance Biotherapeutics' revenues are expected to be $87.33 million, up 45.7% 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 Arvinas, Inc. (ARVN) : Free Stock Analysis Report Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-04

Arvinas Q2 Earnings Call Highlights

MarketBeat
Interested in Arvinas, Inc.? Here are five stocks we like better. Arvinas is shifting resources to early-stage oncology and neurology programs after the FDA approved VEPPANU, the first PROTAC degrader, and the company licensed it to Rigel. Its KRAS G12D program, ARV-806, will advance only through a partner. The company expects key clinical catalysts from ARV-393 in lymphoma by year-end 2026, ARV-027 in spinal and bulbar muscular atrophy in the first half of 2027, and ARV-102 trials in neurodegenerative disease to begin in 2027. Arvinas reported $249.7 million in second-quarter revenue, including license and milestone payments tied to VEPPANU. Cash and marketable securities totaled $567.9 million at June 30, with management maintaining a cash runway into the second half of 2028. 3 Small-Cap Biopharma Stocks that Could See Big Growth in 2023 Arvinas (NASDAQ:ARVN) said it is concentrating resources on its early-stage oncology and neurology pipeline after reaching several strategic milestones in the first half of 2026, including FDA approval of VEPPANU, the first approved PROTAC degrader, and an out-licensing agreement for the product with Rigel Pharmaceuticals. President and Chief Executive Officer Randy Teel said Rigel expects to make VEPPANU available to patients “in the very near future.” Arvinas also decided that its KRAS G12D program, ARV-806, will advance only through a partner, citing investment needs that do not align with its current capital-allocation strategy. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “We’ve fully shifted our focus to our phase I clinical programs,” Teel said, highlighting three assets with clinical data catalysts expected over the next 12 months: ARV-393 in lymphoma, ARV-027 in spinal and bulbar muscular atrophy, and ARV-102 in neurodegenerative disease. Arvinas remains on track to report initial phase I data for ARV-393, its BCL-6 degrader, by the end of 2026. BCL-6 is a transcription factor involved in B-cell development, and altered activity has been associated with several non-Hodgkin lymphoma subtypes. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? Teel said the study initially began at doses below the company’s predicted efficacious exposure range following FDA feedback, contributing to enrollment challenges and longer timelines. Enrollment has accelerated…Read full document

Interested in Arvinas, Inc.? Here are five stocks we like better. Arvinas is shifting resources to early-stage oncology and neurology programs after the FDA approved VEPPANU, the first PROTAC degrader, and the company licensed it to Rigel. Its KRAS G12D program, ARV-806, will advance only through a partner. The company expects key clinical catalysts from ARV-393 in lymphoma by year-end 2026, ARV-027 in spinal and bulbar muscular atrophy in the first half of 2027, and ARV-102 trials in neurodegenerative disease to begin in 2027. Arvinas reported $249.7 million in second-quarter revenue, including license and milestone payments tied to VEPPANU. Cash and marketable securities totaled $567.9 million at June 30, with management maintaining a cash runway into the second half of 2028. 3 Small-Cap Biopharma Stocks that Could See Big Growth in 2023 Arvinas (NASDAQ:ARVN) said it is concentrating resources on its early-stage oncology and neurology pipeline after reaching several strategic milestones in the first half of 2026, including FDA approval of VEPPANU, the first approved PROTAC degrader, and an out-licensing agreement for the product with Rigel Pharmaceuticals. President and Chief Executive Officer Randy Teel said Rigel expects to make VEPPANU available to patients “in the very near future.” Arvinas also decided that its KRAS G12D program, ARV-806, will advance only through a partner, citing investment needs that do not align with its current capital-allocation strategy. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “We’ve fully shifted our focus to our phase I clinical programs,” Teel said, highlighting three assets with clinical data catalysts expected over the next 12 months: ARV-393 in lymphoma, ARV-027 in spinal and bulbar muscular atrophy, and ARV-102 in neurodegenerative disease. Arvinas remains on track to report initial phase I data for ARV-393, its BCL-6 degrader, by the end of 2026. BCL-6 is a transcription factor involved in B-cell development, and altered activity has been associated with several non-Hodgkin lymphoma subtypes. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? Teel said the study initially began at doses below the company’s predicted efficacious exposure range following FDA feedback, contributing to enrollment challenges and longer timelines. Enrollment has accelerated as dosing has approached the expected efficacious range, while enrollment in the combination portion of the study with glofitamab, or glofi, has been strong since it started several months ago. The company previously observed early responses at low doses in difficult-to-treat T-cell lymphomas, including angioimmunoblastic T-cell lymphoma, as well as in B-cell lymphomas. However, Teel said most data reported in 2026 will come from early cohorts dosed below the anticipated efficacious range. Those early cohorts included a higher-than-expected proportion of T-cell lymphoma patients. → Why Rare Earth Processing Could Be the Real 2027 Opportunity Arvinas plans a further disclosure in 2027 with more mature monotherapy data, including diffuse large B-cell lymphoma, or DLBCL, patients treated with ARV-393 alone and in combination with glofi. Teel said the company sees potential opportunities for the program in later-line monotherapy and, if combination data support it, potentially earlier treatment settings. Arvinas completed single-ascending-dose cohorts in healthy volunteers for ARV-027 and initiated the multiple-dose portion of the phase I trial. ARV-027 targets polyglutamine-expanded androgen receptor, or polyQ-AR, the protein that drives spinal and bulbar muscular atrophy, also known as Kennedy’s disease. The company estimates that between 10,000 and 13,000 patients have been diagnosed with the rare neuromuscular disorder in major markets, while noting that the condition may be substantially underdiagnosed. Teel said ARV-027 is designed as an oral therapy that could degrade the disease-causing protein in skeletal muscle. Arvinas intends to report exposure, muscle androgen-receptor degradation and initial safety data from healthy volunteers in the first half of 2027. The company said these measures could provide proof of mechanism for the program. The trial design also includes a multiple-dose cohort in patients with spinal and bulbar muscular atrophy. Chief Scientific Officer Angela Cacace said the company aims to demonstrate a 50% reduction of polyQ-AR in muscle, based on its preclinical work and other published preclinical studies. Functional changes would be assessed in subsequent registrational-intended studies, including through measures such as the SBMA Functional Rating Scale, she said. Arvinas is working with regulators on plans to begin patient trials of ARV-102, its LRRK2 degrader for progressive supranuclear palsy, or PSP, and Parkinson’s disease. The company completed a phase I trial in the Netherlands earlier this year and submitted an investigational new drug application to the FDA to support a U.S. phase Ib study. Teel said the FDA requested additional information and final chronic toxicology data before authorizing the U.S. study. Those toxicology studies have now been completed, but ongoing discussions with U.S., European and Japanese health authorities have pushed the anticipated start of next trials into 2027. The company expects to present additional phase I biomarker data, including oculomotor measures and cerebrospinal-fluid proteomics, at the MDS conference in October. In discussing future PSP studies, Teel said Arvinas is considering a two-part approach involving a phase Ib trial and a registrational-oriented study that could involve treatment periods of six months or a year. Cacace said the company expects to focus initially on Richardson syndrome, the largest PSP subtype, without further restricting the population. Management said ARV-102’s degradation approach could address multiple aspects of LRRK2 biology, including kinase, GTPase and scaffolding functions. The company said it believes this may differentiate the program from LRRK2 inhibitors. Arvinas also said it remains on track to begin enrollment in a phase I study of ARV-6723, an oral HPK1 degrader and its first immuno-oncology PROTAC, in the coming weeks. Cacace said preclinical studies showed antitumor activity across multiple models, including checkpoint-resistant tumors. Teel said the early clinical program is expected to include monotherapy dose escalation and a combination component, with PD-1 therapy viewed as the likely initial combination partner. The company also highlighted preclinical work on an oral pan-KRAS degrader, which it said showed activity across a range of KRAS mutations and KRAS amplification. Arvinas plans to present additional combination data at an upcoming scientific conference. For the second quarter, Chief Financial Officer Andrew Saik reported $567.9 million in cash equivalents and marketable securities as of June 30, down from $685.4 million at the end of 2025. The company maintained guidance that its cash runway extends into the second half of 2028. Total revenue was $249.7 million for the quarter. Arvinas recorded $62.5 million in license revenue from the Rigel agreement, with $35 million received during the quarter. The company recorded a $50 million milestone payment from Pfizer triggered by VEPPANU’s FDA approval. Research and development expense was $52.6 million, compared with $68.6 million in the prior-year period. General and administrative expense was $24 million, compared with $25.3 million a year earlier. Saik said Arvinas recognized all remaining deferred revenue from its original Pfizer collaboration during the quarter and expects no further revenue recognition from that agreement. The company also recorded a $52.7 million liability for estimated remaining VEPPANU development closeout costs. Arvinas, Inc (NASDAQ: ARVN) is a biopharmaceutical company focused on the development of therapies based on targeted protein degradation. Utilizing its proprietary proteolysis-targeting chimera (PROTAC®) platform, Arvinas aims to selectively eliminate disease-causing proteins rather than merely inhibit their activity. This novel approach has the potential to address a range of diseases, including oncology, neurodegeneration and inflammation, by harnessing the body's natural protein-recycling systems. The company's most advanced clinical candidates address hormone-driven cancers. 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 "Arvinas Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-04

Arvinas, Inc. Q2 2026 Earnings Call Summary

Moby
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. Achieved a foundational milestone with the first-ever FDA approval of a PROTAC degrader, VEPPANU, validating the company's protein degradation platform. Shifted strategic focus to Phase I clinical programs in oncology and neurology following the out-licensing of VEPPANU to Rigel Pharmaceuticals. Prioritized capital allocation by deciding to only advance the KRAS G12D program (ARV-806) through a partnership, citing investment requirements inconsistent with current strategy. Accelerated ARV-393 (BCL6) enrollment by reaching predicted efficacious exposure levels after initial delays caused by FDA-mandated low starting doses. Positioned ARV-027 as a potential first-in-class therapy for SBMA by targeting the primary disease driver, polyQ-AR, rather than secondary symptoms. Differentiated the LRRK2 program (ARV-102) from failed competitor inhibitors by targeting kinase, GTPase, and scaffolding functions simultaneously. Maintained a disciplined financial position with a cash runway extending into the second half of 2028 to support upcoming clinical catalysts. Initial Phase I monotherapy data for ARV-393 (BCL6) is expected by year-end 2026, with mature combination data with glofitamab slated for 2027. Proof-of-mechanism data for ARV-027 in healthy volunteers, including first-ever human muscle degradation measures, is anticipated in the first half of 2027. Initiation of Phase Ib and registrational trials for ARV-102 (LRRK2) in PSP is now projected for 2027 following ongoing regulatory feedback from FDA, EMA, and PMDA. Enrollment for the Phase I study of ARV-6723 (HPK1) is on track to begin in the coming weeks, targeting checkpoint-resistant tumors. Future development of ARV-393 aims to establish the first all-oral, chemotherapy-free regimen for B-cell and T-cell lymphomas. Recorded a one-time revenue surge of $249.7 million driven by the Rigel licensing agreement and the recognition of all remaining deferred Pfizer revenue. Established a $52.7 million liability to cover remaining VEPPANU development obligations, effectively removing these costs from future P&L statements. Acknowledged a 'technical' clinical hold on ARV-102 in the U.S. as the FDA requested additional chronic toxicology data and information prior to tr…Read full document

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. Achieved a foundational milestone with the first-ever FDA approval of a PROTAC degrader, VEPPANU, validating the company's protein degradation platform. Shifted strategic focus to Phase I clinical programs in oncology and neurology following the out-licensing of VEPPANU to Rigel Pharmaceuticals. Prioritized capital allocation by deciding to only advance the KRAS G12D program (ARV-806) through a partnership, citing investment requirements inconsistent with current strategy. Accelerated ARV-393 (BCL6) enrollment by reaching predicted efficacious exposure levels after initial delays caused by FDA-mandated low starting doses. Positioned ARV-027 as a potential first-in-class therapy for SBMA by targeting the primary disease driver, polyQ-AR, rather than secondary symptoms. Differentiated the LRRK2 program (ARV-102) from failed competitor inhibitors by targeting kinase, GTPase, and scaffolding functions simultaneously. Maintained a disciplined financial position with a cash runway extending into the second half of 2028 to support upcoming clinical catalysts. Initial Phase I monotherapy data for ARV-393 (BCL6) is expected by year-end 2026, with mature combination data with glofitamab slated for 2027. Proof-of-mechanism data for ARV-027 in healthy volunteers, including first-ever human muscle degradation measures, is anticipated in the first half of 2027. Initiation of Phase Ib and registrational trials for ARV-102 (LRRK2) in PSP is now projected for 2027 following ongoing regulatory feedback from FDA, EMA, and PMDA. Enrollment for the Phase I study of ARV-6723 (HPK1) is on track to begin in the coming weeks, targeting checkpoint-resistant tumors. Future development of ARV-393 aims to establish the first all-oral, chemotherapy-free regimen for B-cell and T-cell lymphomas. Recorded a one-time revenue surge of $249.7 million driven by the Rigel licensing agreement and the recognition of all remaining deferred Pfizer revenue. Established a $52.7 million liability to cover remaining VEPPANU development obligations, effectively removing these costs from future P&L statements. Acknowledged a 'technical' clinical hold on ARV-102 in the U.S. as the FDA requested additional chronic toxicology data and information prior to trial initiation. Reported a 14% year-over-year reduction in non-GAAP R&D expenses following the completion of cost-reduction programs initiated in 2025. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management views BCL6 as a foundational oral small molecule that can slot into multiple lines of therapy where CAR-T or bispecifics are currently used. Confirmed that while monotherapy is the immediate focus, combination with bispecifics like glofitamab is the key to moving into earlier treatment lines. Management argued that competitor failures (Biogen/Denali) were expected due to insufficient kinase inhibition and a failure to address non-kinase functions. Claimed ARV-102 provides 50-fold enhanced target engagement and addresses scaffolding functions that inhibitors leave intact. Confirmed that degradation of wild-type AR in healthy volunteers is expected to translate directly to polyQ-AR degradation in SBMA patients. Preclinical iPSC models showed identical pharmacology between healthy and patient-derived muscle cells, derisking the upcoming Phase I readout.

TranscriptFY2026 Q22026-08-04

FY2026 Q2 earnings call transcript

Earnings source - 86 paragraphs
Operator

Hello, and welcome to Arvinas' second quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. I would now like to hand the conference over to Jeff Boyle. Sir, you may begin.

Jeff Boyle

Good morning, everyone. Thank you for joining us. Earlier today, we issued a press release with our second quarter 2026 financial results, which is available in the investor and media section of our website at arvinas.com. Joining us on the call today, we have Randy Teel, our President and Chief Executive Officer, Angela Cacace, our Chief Scientific Officer, and Andrew Saik, our Chief Financial Officer. Before we begin, I'll remind you that today's discussions contain forward-looking statements that involve risks, uncertainties, and assumptions. These risks and uncertainties are outlined in today's press release and in the company's recent filing with the Securities and Exchange Commission, which I urge you to read. Our actual results may differ materially from what is discussed on today's call.

Jeff Boyle

A replay of this call, as well as today's press release and an updated corporate deck, will be available on the investor and media section of our website. Now I'll turn the call over to Randy Teel. Randy?

Randy Teel

Thanks, Jeff. Good morning, everyone. As a company, we've made significant progress over the past several months. Our focus has been on positioning Arvinas for our next phase of growth, guided by a clear strategic vision. Central to that vision is a relentless focus on advancing transformational improvements for patients. Through continued innovation and disciplined execution, we are focused on unlocking the full potential of our pipeline for patients and shareholders. We've reached three significant strategic milestones since the start of the year, beginning with the first-ever FDA approval of a PROTAC degrader, VEPPANU. Second, we completed an out-licensing of VEPPANU to Rigel Pharmaceuticals, who anticipate making VEPPANU available to patients in the very near future. Third, we made the strategic decision that our KRAS G12D program, ARV-806, will only move forward in the hands of a partner.

Randy Teel

While we believe ARV-806 has the potential to become a meaningful treatment option for patients, it will require investment that is inconsistent with our current capital allocation strategy. Taken together, our progress and decisions in the first half of 2026 have positioned Arvinas to fully capitalize on the promise of our platform in oncology and neurology. We've fully shifted our focus to our phase I clinical programs. We are confident about the opportunity ahead to create important therapies for patients. With that, I'll spend a few moments diving into our three assets with significant clinical data catalysts in the next 12 months. I'll review their differentiating profiles and compelling value propositions. I'll start with ARV-393, our BCL-6 degrader.

Randy Teel

I'll explain why BCL-6 is an attractive target, share where we are in the progress of the trial. Let you know what to expect in our data release later in 2026. BCL-6 is an exciting therapeutic target with initial clinical validation. BCL-6 is a previously undrugged transcription factor, a master regulator of multiple cellular processes during B-cell development, including proliferation, survival, and apoptosis. Altered BCL-6 activity has been implicated as an oncogenic driver in several subtypes of non-Hodgkin lymphoma. We believe that ARV-393 has the potential to become a foundational treatment option and pave the way as the first all-oral chemotherapy-free approach for patients with B or T-cell lymphomas. When we initiated our BCL-6 program, no company had successfully demonstrated BCL-6 degradation or advanced a degrader to the clinic.

Randy Teel

Based on feedback from the FDA, our trial began with doses well below our predicted efficacious exposure levels, leading to challenges with enrollment and extended enrollment timelines. However, we've seen a clear acceleration in the enrollment of the trial as we've dosed closer to the expected efficacious range. At the same time, enrollment in the glofitamab combo portion of the trial has been strong since it began in the past few months. As we reported late last year, even at the doses we would not have expected to be efficacious, we've seen early responses in difficult-to-treat T-cell lymphomas like AITL, as well as in patients with B-cell lymphomas. When it comes to upcoming data for ARV-393, we are on track to share initial phase I data by the end of the year.

Randy Teel

Our safety profile has supported continued dose escalation, though the majority of the data in 2026 will be from the early cohorts dosed below the expected efficacious range. These early cohorts, when compared with the overall lymphoma population, include a higher-than-predicted proportion of patients with T-cell lymphomas, likely reflecting the limited treatment options for these patients. As I mentioned, as we've approached the predicted efficacious range, enrollment of patients, including those with B-cell lymphomas, has increased. In 2027, we will plan a subsequent disclosure that will include more mature monotherapy data, including patients with DLBCL treated with ARV-393, both as monotherapy and in combination with glofitamab. We are optimistic about the potential of this program to benefit patients who have historically experienced poor clinical outcomes, especially given the positive feedback we've received from investigators over the past few months.

Randy Teel

I'll turn now to ARV-027, our degrader targeting polyglutamine-expanded androgen receptor, or polyQ-AR. What's immediately interesting about this program is that the polyQ-AR protein is well understood to be the driver of pathology for patients with Spinal and Bulbar Muscular Atrophy, or SBMA, also known as Kennedy's disease. SBMA is a rare neuromuscular disorder with between 10,000 and 13,000 diagnosed patients in major markets. Genomic studies suggest that SBMA remains substantially underdiagnosed, and ARV-027 has the potential to become the first therapy to target the primary driver of disease. SBMA is an X-linked disease caused by the toxic buildup of the polyQ-AR protein in skeletal muscle. This accumulation disrupts normal muscle function, drives muscular atrophy, and over time, leaves patients with long-term physical disabilities, and often unable to accomplish daily activities.

Randy Teel

As an oral therapy, ARV-027 could be uniquely suited as a convenient treatment option to degrade the protein known to cause the disease. In February, we presented preclinical data supporting the potential of ARV-027 in SBMA. Guided by published preclinical evidence, we had established a target of achieving greater than 50% polyQ-AR degradation in skeletal muscle, a level we believed would provide functional benefit. In an aggressive mouse model of SBMA, 027 showed meaningful improvements in grip strength, endurance, and survival. Importantly, while we don't believe complete elimination of polyQ-AR is required to achieve therapeutic benefit, our preclinical studies did demonstrate that 027 could achieve AR degradation far exceeding the levels required for functional improvement. Today, I'm pleased to announce that in our ongoing phase I trial in healthy volunteers, we completed the single ascending dose cohorts and have now initiated the multiple dose portion of the trial.

Randy Teel

027 is our first degrader aimed at a target in muscle. With that in mind, our phase I trial must demonstrate two measures that we've never demonstrated before in human muscle tissue. The first step is achieving adequate exposure, and the second is to demonstrate AR degradation in muscle. Taken together, these healthy volunteer data would provide proof of mechanism for ARV-027 and meaningfully de-risk the program. In the first half of next year, we intend to show data for both of these measures, as well as initial safety data from the trial. Following the dosing in healthy volunteers, our plan is next to dose patients with SBMA. The phase I trial design already includes a multiple dose cohort in patients with SBMA. We believe this design will accelerate our development plan with the potential to move to a registrational study following the conclusion of the phase I trial.

Randy Teel

I'll move to ARV-102, our third program with upcoming clinical data, and discuss plans for upcoming disclosures and provide a brief update on our regulatory interactions as we plan the next trials for our LRRK2 degrader. As a reminder, there are no approved disease-modifying treatment options available for patients with either PSP or PD, and we believe 102 has the potential to become a paradigm shift in treatment for these patients. This is supported by biomarker data that we presented in March at ADPD. These data were the first to show modulation of key biomarkers implicated in both PSP and PD, an outcome that has not been demonstrated by LRRK2 inhibitors. This reinforces the potential for 102 to provide a unique approach in neurodegenerative diseases. We will share additional biomarker data from the phase I trial, including oculomotor measures and CSF proteomics at the MDS conference in October.

Randy Teel

When it comes to our regulatory interactions for 102, as you'll recall, we are currently working to initiate clinical trials for 102 in patients with PSP, both in the U.S. and globally. After successfully completing our phase I trial in the Netherlands earlier this year, we submitted an IND to the FDA to support the initiation of the phase I-B trial in the first half of the year. As previously communicated, prior to authorizing initiation of the trial, the FDA requested additional information as well as final data from our chronic tox studies, which we've now completed. During the quarter, we've also had productive engagement with both European and Japanese health authorities. Interactions with the agencies are ongoing, and we look forward to updating you on our timing for initiating our next clinical trials, which we now expect to begin in 2027.

Randy Teel

Stepping back, our accomplishments and decisive actions during the first half of 2026 demonstrate our ability to embrace change, capitalize on new opportunities, and execute efficiently. I'm proud of the entire team at Arvinas and how we've assertively concentrated our resources on the most promising opportunities for Arvinas. With disciplined capital allocation, we are prioritizing programs that address high unmet need and have strong commercial potential. Our pipeline is designed to maximize both clinical impact and long-term shareholder value. With that, I'll turn the call over to Angela. Angela?

Angela Cacace

Thank you, Randy. The Arvinas approach to breakthrough medicines begins with choosing the right biology. The most important decision is selecting targets where targeted protein degradation can fundamentally change the course of disease. We started with two highly validated targets, androgen and estrogen receptor, to establish the clinical power of our degrader platform. Today, we're applying those same principles to build the next generation of differentiated disease-modifying medicines across oncology and neurology. Randy highlighted the progress of our clinical portfolio. I'd like to spend a few minutes on two oncology research programs that illustrate where we believe protein degradation can deliver unique advantages. I'll begin with ARV-6723, our oral HPK1 degrader and our first immuno-oncology PROTAC. HPK1 acts as a natural brake on the immune system. It limits T cell activation and suppresses antitumor immunity. What's particularly challenging is that HPK1 biology extends beyond its kinase activity.

Angela Cacace

HPK1 also functions as a signaling scaffold. As a result, inhibitors of the kinase activity leave part of the biology intact. Instead, degradation eliminates both kinase and scaffolding functions. We believe that's why ARV-6723 has produced a differentiated preclinical profile compared with inhibitors. Across multiple tumor models, including tumors with both high and low immunogenicity, ARV-6723 produced robust antitumor activity. In these studies, degradation consistently outperformed both an HPK1 inhibitor and anti-PD-1 therapy alone. Perhaps most exciting is what we've observed in checkpoint-resistant tumors. In seven preclinical models, ARV-6723 demonstrated meaningful single-agent activity where neither an HPK1 inhibitor nor anti-PD-1 therapy showed benefit. We also demonstrated preclinically that the biology extends well beyond T cell activation. HPK1 degradation may remodel the tumor microenvironment through enhanced interferon signaling and activation of the myeloid compartment.

Angela Cacace

We believe this broader immune remodeling may be due to elimination of the scaffolding activity that contributes to the differentiated profile we've observed, and if it translates clinically, could support broader combination opportunities and activity in tumors that have historically responded poorly to immunotherapy. We're excited to begin translating these findings into the clinic. We remain on track to initiate enrollment in our phase I study in the coming weeks. We look forward to sharing updates as the program advances. Finally, I'd like to highlight our first in class oral pan-KRAS degrader program. We recently presented preclinical data demonstrating the potential to overcome key limitations of current pan-RAS inhibitors. Our lead oral degrader showed potent activity across a broad spectrum of KRAS mutations.

Angela Cacace

Importantly, our lead oral pan-KRAS degrader targets KRAS mutations found in more than 90% of patients with KRAS altered cancers, including difficult to treat mutations such as G12R and Q61. It also demonstrated activity against KRAS amplification, a major mechanism of resistance. We also demonstrated superior antitumor activity in combination with immune checkpoint blockade, highlighting the potential to favorably remodel the tumor microenvironment in a way that inhibitors do not. Together, these findings support the potential for broad activity across KRAS-driven cancers, a differentiated therapeutic index, and extensive combination opportunities. We will present these exciting combination data at an upcoming scientific conference. The team continues to make outstanding progress, and we look forward to sharing additional updates in the coming months. With that, I'll turn the call over to Andrew to review our quarterly financial results. Andrew?

Andrew Saik

Thanks, Angela, and good morning, everyone. I'm pleased to provide financial highlights for the second quarter 2026. As a reminder, detailed financial results for the second quarter are included in the press release we issued this morning. Reiterating the team's sentiment, we have much to look forward to later this year and are pleased with our strong financial position that will allow us to continue to advance our pipeline into the second half of 2028. At the end of the second quarter, we had $567.9 million in cash equivalents, and marketable securities on the balance sheet, compared with $685.4 million at the end of 2025. With our healthy balance sheet and focus on our early pipeline, we are well positioned to continue developing our promising oncology and neurology programs.

Andrew Saik

Q2 was a very busy period for us as during the quarter, we received FDA approval of the first ever PROTAC degrader, VEPPANU, and regulatory approval for the Rigel license agreement. These events had a significant impact to our financial statements, which I will summarize now. As a result of the license agreement with Rigel, we recorded license revenue of $62.5 million, of which $35 million was received within the quarter. We have also concluded that the method by which we were recognizing revenue under the original Pfizer agreement is no longer applicable under ASC 606 as a result of the Rigel agreement. We therefore moved all deferred revenue to the P&L, which resulted in a net revenue of $126.4 million, and we've recorded a liability of $52.7 million to cover our remaining obligation to complete ongoing development activities.

Andrew Saik

Additionally, we recorded a $50 million milestone from Pfizer, triggered by the VEPPANU approval. Separately, we recorded $3.5 million in revenue under a Pfizer research collaboration agreement, where the research term has been completed. Total revenue for the quarter was $249.7 million. Turning to expenses. During the quarter, we introduced a new cost of license revenue line, which represents royalties and other amounts payable to third parties that are directly attributable to revenue under our licensing agreements. Cost of license revenue was $9 million in the second quarter. The $9 million is comprised of payments to Yale under the amended Yale agreement and were triggered by the FDA's approval of VEPPANU and the entry into the Rigel license agreement. General and administrative expenses were $24 million for the second quarter, compared to $25.3 million for the same period of 2025.

Andrew Saik

The decrease of $1.3 million was primarily due to decreases in personnel and infrastructure-related costs of $3.9 million and costs related to developing our commercial operations of $1.4 million. Partially offset by an increase in professional fees of $4.2 million, primarily due to the Rigel license agreement. Research and development expenses were $52.6 million in the second quarter, compared to $68.6 million for the same period in 2025. The decrease of $16 million was primarily driven by a decrease in compensation and related personnel expenses of $11 million, which are not allocated by program, and a decrease in program-specific expenses of $0.6 million and non-program-specific expenses of $2.6 million. Our cost reduction programs initiated last year were completed during the second quarter. Non-GAAP R&D was down $8.1 million compared to the same period last year, representing a reduction of 14%.

Andrew Saik

Non-GAAP G&A increased by $0.3 million, or 2% compared to the prior year. During the quarter, we recognized all remaining deferred revenue from the Pfizer collaboration agreement. Going forward, there will be no revenue recognition related to the original Pfizer collaboration. Additionally, we booked a liability of $52.7 million to cover estimated remaining liabilities related to the VEPPANU run-out cost. Our future obligations under the collaboration agreement will be booked against the accrual and will not impact our P&L. We continue to maintain our cash runway guidance into the second half of 2028, and in doing so, we will be able to fund operations through key data milestones over the coming months and continue to support our highly differentiated pipeline programs that have the potential to meaningfully improve patients' lives. With that, I'll turn the call over to Randy for closing remarks. Randy?

Randy Teel

Thanks, Andrew. We've entered the second half of 2026 with multiple opportunities to advance our mission of developing pioneering transformational therapies for patients. We have important catalysts in the coming months and a healthy balance sheet to reach critical milestones. I'll simply close by thanking the patients, investigators, and the entire Arvinas team for their continued support and commitment to helping us achieve our mission.

Andrew Saik

Thanks, Randy. Operator, can you please open the queue?

Operator

Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star one one on your telephone, wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Nick Lorusso with TD Cowen. Your line is open.

Nick Lorusso

Great. Thanks very much for taking our question. On 393, can you discuss a little bit more what you're thinking about the development path, especially considering the data coming mid-next year with the glofitamab combo? Could this catalyze a potentially pivotal trial in an earlier line setting with bispecifics? Any insight there would be great. Thanks.

Randy Teel

Yeah, thanks for the question, Nick. The short answer is yes. The long answer is the NHL space has a lot of opportunities to pursue, right? As we've talked about over the years, we think that while there's a lot of therapies across the lines of therapy, across the different diseases now, there's plenty of chemo, there's plenty of CAR T, there's plenty of bispecifics. What there's not a lot of is orally bioavailable, tolerable small molecules. We think that a BCL-6 degrader could slot into multiple areas within the disease landscape. At this point, as we're in the phase I dose escalation, a bit early to talk about exactly where we plan to go, definitely can talk about the options, right? I think as early options, looking at later line monotherapy makes sense. Think about fourth line LBCL, maybe third line LBCL.

Randy Teel

Think about later line AITL, a T-cell disease that we've been enrolling patients with already in our phase I trial. As we move forward with combinations, that could open up further access to the third-line LBCL space, second-line LBCL, and perhaps moving ahead in T-cell disease as well. There's a lot of different places that we could go, and I think that the common thread is just to get to any of them, we've got to get through the monotherapy dose escalation, show some efficacy, show some signals there. We've got to show we're combinable with other therapies, most immediately a bispecific like glofitamab. Once we've done that, I think it becomes a lot easier to talk about where we'll go next, especially as the landscape continues to evolve around us.

Nick Lorusso

Great. Thanks very much.

Operator

Please stand by for our next question. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is open.

Jacob Goell

Morning. This is Jacob, on for Derek. Thanks for taking our question. I was just wondering if you could comment on the path forward for ARV-102 and PSP, and what does the timeline and registrational path look like for it in light of some of your more recent regulatory interactions?

Randy Teel

Yeah, thanks for the question, Jacob. Just to rehash a little bit where we are, right? We began the year with a couple of phase I trials, one in healthy volunteers, one in patients with PD. What we planned to do over the course of the year was to start two other trials, a phase I-B in the U.S. and a registrational-oriented study globally. What we had announced a couple of months ago is that after submitting the IND to the FDA, they asked us to wait before starting that study, that's technically a clinical hold before starting the studies in the U.S. This morning we announced that with a number of ongoing regulatory interactions that we're currently pursuing and going back and forth on, we think it'll take into 2027 to start those studies.

Randy Teel

Overall, the registrational path in PSP, we would think about the two-part study there, the phase I-B and a registrational study. That continues to be where we aim. A registrational path for PSP where we haven't even dosed patients yet would more likely be a longer period study. The studies we've done so far are only 28 days. Dosing more like six months or a year in patients with PSP would be what we'd be aiming to start with a registrational study. Definitely worth saying, though, that as we go back and forth with the different regulatory authorities, which actually is quite beneficial to be getting feedback from the three major agencies all right now, we'll be taking that to finalize the path that we will then set out on, as we've said, in 2027.

Jacob Goell

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Li Watsek with Cantor Fitzgerald. Your line is open.

Li Watsek

Hey, good morning. Thanks for taking our question. Maybe a follow-up on ARV-393. What would be a good outcome from the phase I monotherapy cohorts that you're going to present later this year? It sounds like these are going to be at the subtherapeutic levels. As we think about combination with glofitamab, would you be able to share where you are with the dose levels right now? Did you start at the subtherapeutic levels as well, and early trends on combinability?

Randy Teel

Yeah. Thanks, Li. The short answer on that second one is yes. Just as a rehash, and we've talked about this in other venues, we were the first company to start working on BCL-6, at least to bring it into the clinic to our knowledge. Based on that and some other factors, we got some feedback to start with a very low starting dose for BCL-6 as monotherapy. As we talked about with some operational questions, that enrollment has been certainly slower than we would have liked. On the flip side, as we've gotten close now to the predicted efficacious exposures, we've seen a clear uptick in enrollment. In the combination study, which started a couple of months ago, that enrollment there has been quite strong ever since the start.

Randy Teel

When it comes to the data that we will have at the end of the year, you were right to highlight we will be still very much below the efficacious range for most of the patients. In the doses that we're at now, we're starting to get to the exposure that we would expect the efficacious, so we'll start to see some of that. We also mentioned that we have been enrolling a greater proportion of patients with T-cell lymphomas than we would have anticipated based on the overall population. We think it'll make sense to focus on that population and the disclosure that's coming up. Then also, as we talked about heading into next year, focusing on LBCL patients as both monotherapy and combo. The data at the end of this year will certainly be focused on mono. We do not anticipate sharing combo data.

Randy Teel

We didn't start quite as low for the combo as we did for the mono, but it certainly did start at levels that in monotherapy were not predicted to be efficacious in patients with B-cell lymphomas.

Operator

Thank you. Our next question comes from the line of Edward Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff

Great. Thank you very much. Looking forward to more data this year, and congrats on all the progress. I'll ask about SBMA and ARV-027. Really interesting mechanism here. Just to confirm, the IND cleared there. Where are you in multiple ascending dosing, and can you kind of characterize, you mentioned exposure and degradation. What are the clinical endpoints that we would ultimately be modeling or expecting in SBMA? Thanks.

Randy Teel

Thanks, Ted. Maybe I'll pass to Angela in a moment on some of the path forward questions. To reiterate where we are on that question, right? We have been dosing healthy volunteers with 027. We've now completed the single ascending dose portion of the study and have just begun the multiple dose portion of the study. That will continue. We're expecting to share some data at the beginning or in the first half rather of next year. We do anticipate including some patients with SBMA in the latter stages of that phase I study. Just to reiterate for everyone, this program, well, SBMA is certainly a rare disease. We're talking 10,000, 13,000 patients in major markets or so. The great thing about this target is that we are hitting the actual driver of disease. Polyglutamine AR is what drives disease. That's what we're degrading.

Randy Teel

We're not degrading an upstream transcription factor or some other factor. We're degrading the actual cause of disease. When it comes to the next phases, we've talked about being able to move into registrational intended studies even after Phase I. Angela, I'd invite you to speak a bit more about plans there and endpoints and so on.

Angela Cacace

Sure. As we move forward, the goal is to really demonstrate that we can target 50% reduction of the polyglutamine repeat androgen receptor. In our preclinical studies and in other preclinical studies, 50% reduction is the target that we aim to achieve in muscle. That's our goal from a biomarker perspective, and we'll also look at some other endpoints as well. Those will be the early endpoints. We will not be able to demonstrate functional change until we go into those registrational studies that Randy mentioned. There, we'll be looking at meaningful scales like the SBMA Functional Rating Scale, and those endpoints as well.

Edward Tenthoff

Great. That's helpful, Angela. Thank you.

Operator

Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is open.

Jonathan Miller

Thanks. I'll take the question, and congrats on the progress this quarter, guys. I'd like to follow up first on the polyQ-AR. There'll be a couple of patients you said next year. Am I right to assume that we shouldn't expect to see good translation of degradation rates from healthy volunteers to patients that have different levels of protein at baseline? If that's the case, are there particular measures from healthy volunteers that you think will translate well to eventual degradation efficiency in patients and thereby efficacy and functional endpoints? Similarly, on the other data sets where we'll get early data from, I'm thinking of HPK1, where you're going to dose in healthy volunteers to start. Are there particular endpoints that we should be paying attention to when we eventually see that data that you think will translate well?

Randy Teel

All right. Thanks for the questions. That's good. On 027, the short answer on translating the degradation of 027 in polyglutamine AR, which the patients with SBMA have, versus wild type AR, which healthy volunteers will have, is that it's the same. We effectively degrade wild type AR and polyQ-AR the same. That will be really helpful to see, as I mentioned, that as we share the healthy volunteer data in the first half of next year, just to reiterate, there's a couple pieces there that we have not done before, and we're looking forward to see if we can do. One is getting an orally available PROTAC into muscle. That alone, we haven't been looking for before. Second of all, getting degradation there.

Randy Teel

We think that if we can see degradation of the wild type AR in healthy volunteers, that will bode very well for our ability to degrade the disease-causing polyQ-AR in patients. I think the translatability there will be quite good. I can move on to HPK1 question, but Angela, anything to add on the polyQ question?

Angela Cacace

Just to add, Jon, that we did look at iPSC-derived skeletal muscle from both healthy volunteers and SBMA patients, and the pharmacology was exactly intact, which is exactly what Randy was saying we would translate. That's our goal, and that's our reason to believe.

Randy Teel

On the HPK1 program 6723, again, as we said this morning, that's going to start dosing patients here in the quite near future. The thinking there, look, this is our first IO therapy. The first couple of trials will look very similar to other oncology trials, right? These will be in patients, not healthy volunteers, just to clarify that. It's an escalation design. We'll be looking at monotherapy. The phase I also includes combination setting as well, and we think it's really important there to show some initial signs of efficacy and of course safety, tolerability, and combinability as well. The HPK1 program's interesting, right? As a first IO therapy, it's got quite a large opportunity. We've certainly got to show as we're very aware, something that the HPK1 inhibitors have not shown, which is good response rates and so on in patients.

Randy Teel

We are really confident that we'll be able to do that based on the preclinical data that we have, which really goes a long way to show, including some recent preclinical data this year, that we can have differential effects in getting responses, get inhibition, and affect the tumor microenvironment in ways that HPK1 inhibitors have been unable to do, PD-1 therapies have been unable to do, and so for that reason, we have some good confidence moving into phase I, but look forward to sharing those data.

Jonathan Miller

Great. Thanks so much.

Operator

Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open.

Yigal Nochomovitz

Hi. Great. Thank you very much for taking the questions. I had two, one on BCL6. I think you mentioned, Randy, that the enrollment was a bit slow at the subtherapeutic doses, but you also mentioned that you saw some effective responses at the lower doses. I was just trying to square those two things. I guess I would've thought that if you saw responses below therapeutic doses, that would catalyze the enrollment curve. And then secondly, on LRRK, could you just comment on the-- obviously since the last earnings, Biogen and Denali had the phase II-B for their inhibitor, which as you know, didn't work. I'd just love to get your thoughts on that and why a degrader may be a more promising approach. Thank you.

Randy Teel

Thanks for the questions, Yigal. On BCL-6, what you said is correct, and you did point out a bit of a contradiction, which we're certainly aware of. We started pretty far below the predicted efficacious range. The other feedback that we got was around the design and the escalation of it. Not only do we start low, we've also escalated pretty slowly. Seeing the responses that we have has certainly helped. I think especially in where we're doing the trial in the U.S., especially in LBCL patients, there are quite a number of other options that patients can take before they get onto a clinical trial. I think there's quite some natural hesitance by physicians to put patients on a dose that they might not expect to be efficacious when there are other options out there.

Randy Teel

Do recognize that it has certainly picked up as we've gotten closer. The responses have helped. It's another reason that we're excited to get some of these data out by the end of the year, and especially with respect to T-cell patients, where we think we'll be the first to share data for BCL-6 degrader, looking at that patient population. When it comes to the LRRK2 program and ARV-102, I think that, and Angela, I'll invite you to chime in here as well. As we've gotten asked about that over the past couple of months, the questions have largely followed the same path, which is, look, ARV-102 trial didn't work. We didn't expect it to work. Is there anything to learn?

Randy Teel

I think that for us, what we've been really focused on since the beginning of this program really was the fact that we don't think that inhibiting the kinase function of LRRK2 is enough. We think there are other aspects of LRRK2, there's GTPase function, there's scaffoldin function that we know drive activity, inflammation, and the lysosomal capabilities by itself, and we think that those are critical. We weren't terribly surprised to see that a program that by their reporting gets something like 30% kinase inhibition, we weren't surprised to see it fail. It doesn't deter us in what we're doing. A LRRK2 degrader, we think can hit all three different factors and features of LRRK2. We think that matters.

Randy Teel

We think that degrading it will even clearly affect the kinase function even more. It doesn't deter from where we're going, which, as we've talked about, is first in PSP, where there's really substantial unmet need in a very rapidly progressing neurodegenerative disorder versus PD anyway, and then ultimately PD as well.

Angela Cacace

Yeah. Just to add.

Yigal Nochomovitz

Okay. Very helpful. Thanks.

Randy Teel

Yeah. Please, Angela. Go, yeah.

Angela Cacace

Just briefly to add, Yigal. Biologically, we understand why the inhibitors are ineffective, right? We saw greater than 50-fold enhanced target engagement and phospho-Rab pathway engagement in the brain. We'll be talking about some exciting synaptic markers at MDS that'll, in our minds, really prove that the degrader is different in Parkinson's disease patients with looking at eye tracking as well as CSF synaptic markers that are unprecedented changes in markers that are prognostic of progression in Parkinson's disease.

Yigal Nochomovitz

Got it. Thank you very much.

Operator

Thank you. Our next question comes from the line of Etzer Darout with Barclays. Your line is open.

Etzer Darout

Great. Thanks for. Just a couple, one on pipeline and maybe one for Andrew. First on the pipeline, if you would expect to enroll tumor types in the HPK1 degrader program similar to what we've seen from the HPK1 inhibitors like gastric, lung. Anything there would be helpful. Is PD-1 the most likely initial combination partner initially? For Andrew, maybe if you could help us out on how we should think about maybe the modeling of the cost of licensing moving forward and anything there would be helpful as well. Thank you.

Randy Teel

All right. Thanks, Etzer. Maybe I'll answer the easiest ones first. PD-1, yes. That is the likely combination partner first. Haven't said specifically which one, but we will certainly get into that as the months go by. Tumor types, not far off either. Things like lung is the right place to be thinking about. That trial will enroll patients that have had prior immunotherapy. Think of it as a traditional sort of escalation trial that we'll get into data. Haven't talked about when, but as that gets going, gets easier to talk about data coming out. Andrew, questions on modeling.

Andrew Saik

A lot of changes to the accounting at a high level, and I'm happy to take a follow-up if this doesn't clear up your question. At a high level, we've been deferring revenue from the original Pfizer collaboration agreement over the life of the collaboration. Due to the Rigel out-license, we deemed that our contributions to that collaboration are complete, and therefore, we took all of the residual collaboration revenue through the P&L. Going forward, you'll see no additional revenue recognition. We do have tail liabilities on the closeout costs of the Vepunu development plan. We booked a liability on the balance sheet for that. When the Q comes out, you're going to see a current portion of that of $28.4 million, a long-term portion of $24.3 for a total of $52.7.

Andrew Saik

Additional payments that we make for that collaboration cost will go against that liability. Essentially, our P&L going forward is somewhat cleansed from the previous Vepunu collaboration agreement. We will be booking milestones and royalties going forward, but those will be sort of traditional in that they'll be real royalties that we'll receive from Rigel on a go-forward basis. We additionally added that cost of sales line. That was really just to segregate Yale payments from our normal G&A. You'll see that cost of sales line. For the time being, that's going to be 100% payments to Yale. We have a small royalty that we pay to Yale on any royalties in, and they get a small portion also of milestones going forward. You'll see those picked up on that collaboration cost of revenue line. Please let me know if that answered your question.

Andrew Saik

I know that's a lot.

Etzer Darout

Yeah, no, great. Thank you. Thank you for that color.

Andrew Saik

Sure.

Operator

Thank you. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.

Paul Choi

Hi. Thanks. Good morning, and thank you for taking the questions. My first question is on LRRK2, and you indicated you'll present additional biomarker data in October. Can you maybe frame for us what the sort of cadence over 2027 will be in terms of additional updates for that program and any additional clinical measures or potential advancements to the next stage? My second question on BCL6 is, after you present the glofitamab combination data in mid-2027, as you think about clinical development, can you maybe outline for us how you're thinking about potential comparator arms versus a monotherapy trial and just how you think about that down the road? Thank you.

Randy Teel

All right. Thanks, Paul. Yeah. On LRRK2, I'll reiterate what I said before on where we are with 102, which is really focused on the regulatory approach, right? What we're focused on right now is incorporating feedback and developing that plan for how we move forward with the trials that we've talked about before while incorporating that feedback. When it comes to the cadence of trials, really the cadence will be, we'd like to start them. That's the cadence. When it comes to providing a bit more clarity on where we're going, as we begin those trials, as we get close or even before, we'll certainly talk about how those are shaping up. The cadence following the biomarker data that we plan to show at MDS will really be dictated on those trial starts.

Randy Teel

When it comes to BCL6, look, as I said, all roads lead through the monotherapy and the combination right now with glofitamab, and we'll talk a bit more about where we go after that. There's a lot of options, right? The bispecifics, there's more than one. Those are potential combinations. There's chemo, there's other things as well. I think that we will really have to watch the landscape evolve to see a bit of where the puck is going, to see where it makes most sense for us to combine. I'll reiterate what I said around the opportunity to move earlier and faster with monotherapy approaches, and then the ability to follow up with combination approaches that have the opportunity to reach bigger patient populations in earlier lines of therapy. Beyond that, a bit hard to specify what the details will be.

Randy Teel

As we've started talking about this program, as we've shared the progress that we've made, certainly lots of companies that are interested in the space, including strategic that clearly are following a traditional path in the NHL space, which is to identify ways to build out the treatment combinations that we're able to get to patients to extend responses and get responses to more patients.

Paul Choi

Great. Thank you.

Operator

Thank you. As a reminder, ladies and gentlemen, that's star 11 to ask the question. Our next question comes from the line of Jeet Mukherjee with US Bancorp BTIG. Your line is open.

Blake Gitler

Hi, it's Blake on for Jeet. Quick question on ARV-102. Do you feel there's an intended PSP population that you're targeting, or is it going to be an all-comers trial? Thinking more on the lines of Richardson syndrome patients or specific LRRK2 variants. Thanks for taking our question.

Randy Teel

Great question. Maybe I'll have Angela give some more color here. The shortest answer is you're thinking about it right, which is that we could look at all the PSP. Richardson is the largest subtype. When it comes to narrowing more than that, I think it's less likely. Maybe, Angela, a bit more detail on how we think about the population there.

Angela Cacace

Right. I think that we would not restrict further. Richardson syndrome is really a very uniform progressing population, which is why we like it. We like the focus there, this does not restrict us from expanding to all of PSP. I hope that helps.

Operator

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Randy for closing remarks.

Randy Teel

Thanks, operator. Thanks, everybody, for joining this morning. Look forward to providing further updates as we move forward, and thanks again.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Investor releaseQuarter not tagged2026-08-03

Earnings To Watch: Arvinas Inc (ARVN) Q2 2026 -- GF Value Sees 34% Upside

GuruFocus.com

This article first appeared on GuruFocus. Arvinas Inc (NASDAQ:ARVN) is set to release its Q2 2026 earnings on Aug 4, 2026. The consensus estimate for Q2 2026 revenue is 32.54 million, and the earnings are expected to come in at -0.44 per share. The full year 2026's revenue is expected to be $117.02 million and the earnings are expected to be $-2.87 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 6 Warning Signs with ARVN. Is ARVN fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Arvinas Inc (NASDAQ:ARVN) have increased from $95.50 million to $117.02 million for the full year 2026 and declined from $71.41 million to $66.83 million for 2027 over the past 90 days. Earnings estimates for Arvinas Inc (NASDAQ:ARVN) have increased from $-3.27 per share to $-2.87 per share for the full year 2026 and declined from $-3.45 per share to $-3.49 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, Arvinas Inc's (NASDAQ:ARVN) actual revenue was $15.60 million, which missed analysts' revenue expectations of $18.10 million by -13.80%. Arvinas Inc's (NASDAQ:ARVN) actual earnings were $-0.90 per share, which missed analysts' earnings expectations of $-0.87 per share by -3.81%. After releasing the results, Arvinas Inc (NASDAQ:ARVN) was down by -0.93% in one day. Based on the one-year price targets offered by 14 analysts, the average target price for Arvinas Inc (NASDAQ:ARVN) is $14.79 with a high estimate of $24.00 and a low estimate of $6.00. The average target implies an upside of 84.13% from the current price of $8.03. Based on GuruFocus estimates, the estimated GF Value for Arvinas Inc (NASDAQ:ARVN) in one year is $10.79, suggesting an upside of 34.37% from the current price of $8.03. Based on the consensus recommendation from 17 brokerage firms, Arvinas Inc's (NASDAQ:ARVN) average brokerage recommendation is currently 2.40, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-28

Arvinas to Report Second Quarter 2026 Financial Results on August 4, 2026

GlobeNewswire

NEW HAVEN, Conn., July 28, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that management will review second quarter 2026 financial results and provide a corporate update during a live webcast on Tuesday, August 4, 2026 at 8:00 a.m. ET. The webcast can be accessed under “Events and Presentations” on the investor page of the Arvinas website. A replay of the webcast will be available on the Arvinas website at www.arvinas.com following the completion of the event. About Arvinas Arvinas (Nasdaq: ARVN) is a biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas, with its partner Pfizer, developed the first U.S. Food and Drug Administration (FDA) approved PROTAC, a type of heterobifunctional protein degrader. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic, colorectal, and non-small cell lung cancers; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. ContactsInvestors:Jeff Boyle+1 (347) [email protected] Media:Alyssa Kuciunas+1 (331) [email protected]

Investor releaseQuarter not tagged2026-05-14

These Analysts Increase Their Forecasts On Arvinas After Q1 Results

Benzinga

Arvinas Inc (NASDAQ:ARVN) reported downbeat results for the first quarter on Tuesday. The company posted quarterly losses of 90 cents per share which missed the analyst consensus estimate of losses of 87 cents per share. The company reported quarterly sales of $15.600 million which missed the analyst consensus estimate of $18.097 million. Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) announced that it is entering an exclusive global licensing agreement with Arvinas and Pfizer Inc. (NYSE:PFE) for its oral PROTAC drug, VEPPANU (vepdegestrant). “The approval of VEPPANU is a defining achievement for Arvinas and reflects the culmination of more than a decade of focused work to translate our PROTAC science into our first approved therapy,” said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. “I’m proud to lead an organization advancing an industry-leading portfolio of degraders – one that has now joined the short list of those able to bring a new therapeutic modality from discovery to approval. As we move through the remainder of the year, our focus is on delivering key data and clinical milestones that we believe will further validate our approach and clearly distinguish our programs in an increasingly competitive environment.” Arvinas shares rose 1.7% to trade at $9.74 on Wednesday. These analysts made changes to their price targets on Arvinas following earnings announcement. BTIG analyst Jeet Mukherjee maintained Arvinas with a Buy and raised the price target from $16 to $18. Barclays analyst Etzer Darout maintained the stock with an Overweight rating and raised the price target from $18 to $20. Considering buying ARVN stock? Here’s what analysts think: Photo via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: APPLE (AAPL): Free Stock Analysis Report TESLA (TSLA): Free Stock Analysis Report This article These Analysts Increase Their Forecasts On Arvinas After Q1 Results originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Investor releaseQuarter not tagged2026-05-14

Earnings Beat: Arvinas, Inc. (NASDAQ:ARVN) Just Beat Analyst Forecasts, And Analysts Have Been Lifting Their Forecasts

Simply Wall St.
Arvinas, Inc. (NASDAQ:ARVN) shareholders are probably feeling a little disappointed, since its shares fell 3.8% to US$9.87 in the week after its latest first-quarter results. Despite revenues of US$16m falling 6.1% short of expectations, statutory losses of US$0.90 per share were well contained, and in line with analyst models. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Arvinas after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the 15 analysts covering Arvinas are now predicting revenues of US$125.9m in 2026. If met, this would reflect a sizeable 41% improvement in revenue compared to the last 12 months. Losses are supposed to decline, shrinking 17% from last year to US$2.85. Before this earnings announcement, the analysts had been modelling revenues of US$93.2m and losses of US$3.38 per share in 2026. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. View our latest analysis for Arvinas Despite these upgrades,the analysts have not made any major changes to their price target of US$15.00, implying that their latest estimates don't have a long term impact on what they think the stock is worth. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. There are some variant perceptions on Arvinas, with the most bullish analyst valuing it at US$24.00 and the most bearish at US$6.00 per share. So we wouldn't be assigning too much credibility to analyst price targets in this case, because there are clearly some widely different views on what kind of performance this business can generate. With this in mind, we wouldn'…Read full document

Arvinas, Inc. (NASDAQ:ARVN) shareholders are probably feeling a little disappointed, since its shares fell 3.8% to US$9.87 in the week after its latest first-quarter results. Despite revenues of US$16m falling 6.1% short of expectations, statutory losses of US$0.90 per share were well contained, and in line with analyst models. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Arvinas after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the 15 analysts covering Arvinas are now predicting revenues of US$125.9m in 2026. If met, this would reflect a sizeable 41% improvement in revenue compared to the last 12 months. Losses are supposed to decline, shrinking 17% from last year to US$2.85. Before this earnings announcement, the analysts had been modelling revenues of US$93.2m and losses of US$3.38 per share in 2026. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. View our latest analysis for Arvinas Despite these upgrades,the analysts have not made any major changes to their price target of US$15.00, implying that their latest estimates don't have a long term impact on what they think the stock is worth. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. There are some variant perceptions on Arvinas, with the most bullish analyst valuing it at US$24.00 and the most bearish at US$6.00 per share. So we wouldn't be assigning too much credibility to analyst price targets in this case, because there are clearly some widely different views on what kind of performance this business can generate. With this in mind, we wouldn't rely too heavily the consensus price target, as it is just an average and analysts clearly have some deeply divergent views on the business. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. It's clear from the latest estimates that Arvinas' rate of growth is expected to accelerate meaningfully, with the forecast 58% annualised revenue growth to the end of 2026 noticeably faster than its historical growth of 35% p.a. over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in a similar industry are forecast to grow their revenue at 8.7% per year. Factoring in the forecast acceleration in revenue, it's pretty clear that Arvinas is expected to grow much faster than its industry. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. Pleasantly, they also upgraded their revenue estimates, and their forecasts suggest the business is expected to grow faster than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. At Simply Wall St, we have a full range of analyst estimates for Arvinas going out to 2028, and you can see them free on our platform here.. That said, it's still necessary to consider the ever-present spectre of investment risk. We've identified 2 warning signs with Arvinas , and understanding them should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2026-05-13

Arvinas Inc (ARVN) Q1 2026 Earnings Call Highlights: Strategic Advances Amid Revenue Decline

GuruFocus.com
This article first appeared on GuruFocus. Revenue: $15.6 million for Q1 2026, compared to $188.8 million for the same period in 2025. Cash and Marketable Securities: $614.9 million at the end of Q1 2026, down from $685.4 million at the end of 2025. General and Administrative Expenses: $19.1 million for Q1 2026, down from $26.6 million in Q1 2025. Research and Development Expenses: $60.3 million for Q1 2026, compared to $90.8 million for the same period in 2025. Non-GAAP R&D Expenses: Reduced by $25 million, a 32% decrease from the previous year. Non-GAAP G&A Expenses: Reduced by $10.1 million, a 44% decrease from the previous year. Total Non-GAAP Expenses: $67.3 million, down $35.1 million from the same period last year. Cash Runway Guidance: Maintained into the second half of 2028. Warning! GuruFocus has detected 4 Warning Signs with ARVN. Is ARVN fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FDA approval of VEPPANU for ESR1-mutant, ER-positive, HER2-negative advanced breast cancer, marking the first-ever approval of a heterobifunctional PROTAC degrader. Arvinas Inc (NASDAQ:ARVN) entered a global licensing agreement with Rigel Pharmaceuticals for the commercialization, development, and manufacturing of VEPPANU, ensuring its availability to patients. Strong preclinical and Phase 1 data for ARV-102, showing significant reductions in LRRK2 and associated biomarkers, supporting its advancement into PSP trials. Arvinas Inc (NASDAQ:ARVN) maintains a healthy balance sheet with $614.9 million in cash equivalents, allowing continued investment in their pipeline through 2028. Successful cost reduction initiatives have significantly decreased expenses, with non-GAAP R&D and G&A expenses down by 32% and 44%, respectively, compared to the previous year. Revenue for Q1 2026 decreased significantly to $15.6 million from $188.8 million in the same period of 2025, primarily due to changes in the Vega Strant collaborative agreement with Pfizer. The Phase 1b clinical trial for ARV-102 in PSP is on hold in the U.S. pending additional data, delaying its initiation until the end of 2026. Ongoing trials for VEPPANU are being run by Arvinas Inc (NASDAQ:ARVN) and Pfizer, with future development costs falling to Rigel, creating uncertainty i…Read full document

This article first appeared on GuruFocus. Revenue: $15.6 million for Q1 2026, compared to $188.8 million for the same period in 2025. Cash and Marketable Securities: $614.9 million at the end of Q1 2026, down from $685.4 million at the end of 2025. General and Administrative Expenses: $19.1 million for Q1 2026, down from $26.6 million in Q1 2025. Research and Development Expenses: $60.3 million for Q1 2026, compared to $90.8 million for the same period in 2025. Non-GAAP R&D Expenses: Reduced by $25 million, a 32% decrease from the previous year. Non-GAAP G&A Expenses: Reduced by $10.1 million, a 44% decrease from the previous year. Total Non-GAAP Expenses: $67.3 million, down $35.1 million from the same period last year. Cash Runway Guidance: Maintained into the second half of 2028. Warning! GuruFocus has detected 4 Warning Signs with ARVN. Is ARVN fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FDA approval of VEPPANU for ESR1-mutant, ER-positive, HER2-negative advanced breast cancer, marking the first-ever approval of a heterobifunctional PROTAC degrader. Arvinas Inc (NASDAQ:ARVN) entered a global licensing agreement with Rigel Pharmaceuticals for the commercialization, development, and manufacturing of VEPPANU, ensuring its availability to patients. Strong preclinical and Phase 1 data for ARV-102, showing significant reductions in LRRK2 and associated biomarkers, supporting its advancement into PSP trials. Arvinas Inc (NASDAQ:ARVN) maintains a healthy balance sheet with $614.9 million in cash equivalents, allowing continued investment in their pipeline through 2028. Successful cost reduction initiatives have significantly decreased expenses, with non-GAAP R&D and G&A expenses down by 32% and 44%, respectively, compared to the previous year. Revenue for Q1 2026 decreased significantly to $15.6 million from $188.8 million in the same period of 2025, primarily due to changes in the Vega Strant collaborative agreement with Pfizer. The Phase 1b clinical trial for ARV-102 in PSP is on hold in the U.S. pending additional data, delaying its initiation until the end of 2026. Ongoing trials for VEPPANU are being run by Arvinas Inc (NASDAQ:ARVN) and Pfizer, with future development costs falling to Rigel, creating uncertainty in future trial management. The competitive landscape for KRAS inhibitors/degraders is rapidly evolving, posing challenges for Arvinas Inc (NASDAQ:ARVN) to differentiate its ARV-806 program. The company faces potential challenges in translating preclinical success of ARV-027 in SBMA mouse models to clinical benefit in humans. Q: Could you talk about the economics associated with Rigel sub-licensing the drug outside of the U.S., and how Arvinas and Pfizer may split the percentage of the sub-licensing revenue? A: Randy Teel, President and CEO, explained that Arvinas and Pfizer have a 50-50 interest in the out-license deal, meaning they will split milestones and royalties equally. Andrew Saik, CFO, added that the economics disclosed pertain mainly to the U.S., where Rigel has global rights, and any international launch would involve a royalty back to Pfizer and Arvinas. Q: For ARV-806 and KRAS G12D, can you talk about the scope of the data that we'll get later this year and what you're viewing as the bar of success for advancement? A: Randy Teel, President and CEO, mentioned that data for ARV-806 will include safety, PK, PD, and initial response rates. The later the data is released, the more durability data will be available. Angela Cacace, Chief Scientific Officer, added that for ARV-027, the goal is to show pharmacodynamic impact on the target in muscle. Q: Can you tell us what are the average levels of LRRK2 in PSP patients, and would the 50% knockdown seen in Parkinson's be enough to bring PSP patients back into normal physiologic range? A: Randy Teel, President and CEO, confirmed that LRRK2 levels in Parkinson's patients are generally double those in healthy individuals, and the goal is to reduce these levels to normal. Noah Berkowitz, Chief Medical Officer, added that similar reductions are expected in PSP patients, which could lead to improvements in tau deposition. Q: For any future clinical trial developments or ongoing trial developments for VEPDEG, how will they be structured between Arvinas, Rigel, and Pfizer? A: Randy Teel, President and CEO, stated that ongoing trials are managed by Arvinas and Pfizer, with Rigel providing cost offsets. Future development work will fall to Rigel, but details will be discussed after the transaction is fully closed. Q: How do you view the patient population in the future for your KRAS programs, and do you think you'll be developing it in the same phase as PAN-RAS or PAN-K-RAS drugs? A: Randy Teel, President and CEO, emphasized the importance of first demonstrating that their drug works. He noted that there are many options for different indications and combinations, and the focus is on showing differentiation and competitiveness in the phase one trials. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-12

Arvinas Q1 Earnings Call Highlights

MarketBeat
Interested in Arvinas, Inc.? Here are five stocks we like better. VEPPANU’s FDA approval was the quarter’s biggest milestone, with CEO Randy Teel calling it the first approval of a heterobifunctional PROTAC degrader. Arvinas also struck a global licensing deal with Rigel Pharmaceuticals, shifting commercialization and much of the future development burden to Rigel. Arvinas’ pipeline remains active across oncology, neurodegeneration and neuromuscular disease, highlighted by encouraging Phase 1 data for ARV-102, completion of enrollment for KRAS G12D degrader ARV-806, and early responses seen with BCL6 degrader ARV-393. The company also expects ARV-6723 to enter the clinic later this year. Cash remains solid despite lower revenue: first-quarter revenue fell sharply to $15.6 million from $188.8 million a year earlier, but Arvinas ended the quarter with $614.9 million in cash and says its runway extends into the second half of 2028. Operating expenses also declined as cost-cutting measures continued. 3 Small-Cap Biopharma Stocks that Could See Big Growth in 2023 Arvinas (NASDAQ:ARVN) said its first quarter was marked by the FDA approval of VEPPANU, a new licensing agreement with Rigel Pharmaceuticals and continued progress across a clinical-stage pipeline focused on targeted protein degradation. President and Chief Executive Officer Randy Teel said the approval of VEPPANU for ESR1-mutant, ER-positive, HER2-negative advanced breast cancer represents “the first ever approval of the heterobifunctional PROTAC degrader” and validates the company’s targeted protein degradation platform. Teel said Arvinas and Pfizer have entered into a global licensing agreement with Rigel Pharmaceuticals for the commercialization, development and manufacturing of VEPPANU. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum Teel said Rigel has an established oncology sales team and infrastructure to make VEPPANU available to patients. He said the agreement allows Arvinas to focus capital on its next generation of degraders across oncology, neurodegenerative disorders and neuromuscular diseases. During the question-and-answer portion of the call, Chief Financial Officer Andrew Saik said Arvinas and Pfizer each have a 50% interest in the out-licensing arrangement, meaning milestones and royalties will be split equally between the two companies. Saik said the economics discus…Read full document

Interested in Arvinas, Inc.? Here are five stocks we like better. VEPPANU’s FDA approval was the quarter’s biggest milestone, with CEO Randy Teel calling it the first approval of a heterobifunctional PROTAC degrader. Arvinas also struck a global licensing deal with Rigel Pharmaceuticals, shifting commercialization and much of the future development burden to Rigel. Arvinas’ pipeline remains active across oncology, neurodegeneration and neuromuscular disease, highlighted by encouraging Phase 1 data for ARV-102, completion of enrollment for KRAS G12D degrader ARV-806, and early responses seen with BCL6 degrader ARV-393. The company also expects ARV-6723 to enter the clinic later this year. Cash remains solid despite lower revenue: first-quarter revenue fell sharply to $15.6 million from $188.8 million a year earlier, but Arvinas ended the quarter with $614.9 million in cash and says its runway extends into the second half of 2028. Operating expenses also declined as cost-cutting measures continued. 3 Small-Cap Biopharma Stocks that Could See Big Growth in 2023 Arvinas (NASDAQ:ARVN) said its first quarter was marked by the FDA approval of VEPPANU, a new licensing agreement with Rigel Pharmaceuticals and continued progress across a clinical-stage pipeline focused on targeted protein degradation. President and Chief Executive Officer Randy Teel said the approval of VEPPANU for ESR1-mutant, ER-positive, HER2-negative advanced breast cancer represents “the first ever approval of the heterobifunctional PROTAC degrader” and validates the company’s targeted protein degradation platform. Teel said Arvinas and Pfizer have entered into a global licensing agreement with Rigel Pharmaceuticals for the commercialization, development and manufacturing of VEPPANU. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum Teel said Rigel has an established oncology sales team and infrastructure to make VEPPANU available to patients. He said the agreement allows Arvinas to focus capital on its next generation of degraders across oncology, neurodegenerative disorders and neuromuscular diseases. During the question-and-answer portion of the call, Chief Financial Officer Andrew Saik said Arvinas and Pfizer each have a 50% interest in the out-licensing arrangement, meaning milestones and royalties will be split equally between the two companies. Saik said the economics discussed in the company’s press release largely relate to the U.S., where VEPPANU is currently approved, and that Rigel holds global rights. → MercadoLibre Boldly Invests in Growth: Discount Deepens Saik said Rigel is primarily focused in the U.S. and would need partners to launch internationally. He added that any international royalty back to Arvinas and Pfizer was not disclosed because the product currently has U.S. approval only. Teel said ongoing VEPPANU trials are being run by Arvinas and Pfizer, with Rigel providing some cost offsets for ongoing development plans. Future development economics would fall to Rigel after the transaction closes, he said. → 3 Ways to Target the Resources Powering AI and Data Centers Chief Medical Officer Noah Berkowitz highlighted recently presented Phase 1 data for ARV-102, an oral PROTAC designed to cross the blood-brain barrier and degrade LRRK2. Berkowitz said Phase 1 data in Parkinson’s disease patients showed approximately 50% or greater reductions in cerebrospinal fluid LRRK2 by day 14 across dose levels, sustained through day 28. He said ARV-102 also produced dose-dependent reductions in biomarkers of neuroinflammation and lysosomal stress, including CD68 and GPNMB, and was generally well tolerated with no serious adverse events through 28 days of dosing. Arvinas is focusing ARV-102 initially on progressive supranuclear palsy, or PSP, a rapidly progressive tauopathy with no disease-modifying therapies. Berkowitz said PSP affects about 25,000 patients in the U.S. and that elevated LRRK2 expression is associated with faster progression. The company disclosed that its planned U.S. Phase 1b trial in PSP is on clinical hold. Berkowitz said the FDA requested final data from chronic toxicology studies in non-human primates before authorizing the trial. Arvinas expects those data in mid-2026 and anticipates the U.S. trial could begin by the end of 2026. Berkowitz said the request is not expected to affect European trial plans or the company’s guidance for the start of a global Phase 2 study. Berkowitz said Arvinas completed enrollment of the dose-escalation portion for once-weekly ARV-806, its KRAS G12D degrader, ahead of schedule. He said the company expects initial data later this year, including safety, pharmacokinetic, pharmacodynamic and early response data. ARV-806 is designed to degrade both active and inactive forms of KRAS G12D. Berkowitz said preclinical data showed roughly 25- to 40-fold greater potency than clinical-stage KRAS G12D inhibitors and degraders, with more than 90% degradation lasting seven days after a single dose in preclinical testing. In response to analyst questions, Berkowitz said Arvinas is planning dose expansion to evaluate two doses, with dose selection to consider response, degradation data and safety. He said pancreatic cancer makes practical sense for expansion because it is a monotherapy setting with accessible patients and high unmet need. Arvinas also continues to advance ARV-393, its BCL6 degrader, in a Phase 1 monotherapy dose-escalation trial in relapsed or refractory B-cell and T-cell lymphomas. Berkowitz said the company has seen early responses in both populations, including at exposure levels below those predicted to be efficacious. The company has also initiated a combination trial with glofitamab in diffuse large B-cell lymphoma. Chief Scientific Officer Angela Cacace discussed ARV-027, an oral PROTAC degrader being developed for spinal and bulbar muscular atrophy, also known as SBMA or Kennedy’s disease. She said the therapy is designed to eliminate toxic polyglutamine-expanded androgen receptor protein from muscle cells. Arvinas has enrolled the first three cohorts in a Phase 1 single-ascending-dose study in healthy volunteers. Cacace said preclinical data in an aggressive SBMA mouse model showed ARV-027 degraded the toxic androgen receptor in muscle, improved functional measures and extended survival. Teel later said ARV-027 differs from prior Arvinas androgen receptor degraders because it was selected for activity in muscle. Cacace also reviewed ARV-6723, an oral immuno-oncology PROTAC targeting HPK1. She said the program is on track to enter the clinic later this year. In preclinical models, she said ARV-6723 showed single-agent antitumor activity, including in checkpoint-resistant models, and affected the myeloid compartment of the tumor microenvironment. The company also continues preclinical work on an oral pan-KRAS PROTAC program. Cacace said Arvinas has observed broad KRAS degradation across multiple alterations, including wild-type amplified KRAS, with selectivity over other RAS isoforms. Saik said Arvinas ended the first quarter with $614.9 million in cash, cash equivalents and marketable securities, down from $685.4 million at the end of 2025. He said the company continues to expect its cash runway to extend into the second half of 2028. First-quarter revenue totaled $15.6 million, compared with $188.8 million in the same period of 2025. Saik said the $173.2 million decrease was due to lower revenue recognized from the vepdegestrant collaboration with Pfizer, driven by changes to estimated remaining program costs. General and administrative expenses fell to $19.1 million from $26.6 million a year earlier, primarily due to lower professional fees. Research and development expenses declined to $60.3 million from $90.8 million, driven by lower compensation-related expenses and lower program-specific spending. Saik said cost reduction programs initiated last year and expected to finish in mid-2026 continue to reduce expenses. Teel said Arvinas is positioned for multiple clinical updates in 2026, including data from ARV-806 and ARV-393, and expects to move ARV-6723 into the clinic in the coming months. Arvinas, Inc (NASDAQ: ARVN) is a biopharmaceutical company focused on the development of therapies based on targeted protein degradation. Utilizing its proprietary proteolysis-targeting chimera (PROTAC®) platform, Arvinas aims to selectively eliminate disease-causing proteins rather than merely inhibit their activity. This novel approach has the potential to address a range of diseases, including oncology, neurodegeneration and inflammation, by harnessing the body's natural protein-recycling systems. The company's most advanced clinical candidates address hormone-driven cancers. 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 "Arvinas Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook