RIGL

Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Raul Rodriguez Chief Commercial Officer - David Santos Chief Financial Officer - Dean Schorno Chief Medical Officer - Alison Hannah Need a quote from a Motley Fool analyst? Email [email protected] Ray J. Furey: Welcome to our Q2 2026 Financial Results and Business Update Conference Call. The financial press release for the Q2 2026 was issued earlier today and can be viewed along with the slides for this presentation in the News and Events section of our investor relations site on rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for commercial regulatory product development and other business activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Description of those risks can be found in our most recent annual report on Form 10-K for the year ended December 31st, 2025, on file with the SEC, and subsequent filings with the SEC, including our Q2 quarterly report on Form 10-Q with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances, except as required by law. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul? Raul R. Rodriguez: Thank you, Ray, and thank you all for joining us today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Schorno, our Chief Financial Officer. I would also like to welcome Dr. Alison Hannah, our newly appointed Chief Medical Officer, who is with us today and will discuss our development pipeline. To begin, I will provide an overview of Rigel's business, our accomplishments for the Q2, and the strategic initiatives that positions us for continued growth in the coming years. Moving to slide four. The Q2 was an excellent one and marked an important step in Rigel's transformation into a diversified commercial oncology and hematology company. During the quarter, we continued to grow our current products. We completed the in-license of VEPPANU or vepdegestrant, adding a significant near-term growth driver. We delivered another quarter of strong profits, and we continued advancing R289 in lower-risk MDS in our dose expansion trial with a readout at year-end. We believe these actions positions Rigel for sustainable near-term and long-term growth. On the slide, you see the strategic framework that has guided Rigel's transformation and will continue to drive our growth. Our strategy is centered on four core strategic objectives: grow our commercial business, expand our product portfolio and pipeline through in-licensing or acquisition, advance our development pipeline in the clinic, and maintain financial discipline. Together, these four pillars support a durable long-term growth strategy. Our May announcement of the exclusive global license of VEPPANU demonstrates our execution of this strategy. It expands our portfolio with an important new commercial opportunity and furthers our long-term growth trajectory. Moving to slide five. VEPPANU significantly expands Rigel's commercial oncology platform into breast cancer and provides the opportunity to leverage our commercial capabilities across this very substantially larger market. VEPPANU is the first and only FDA-approved proteolysis targeting chimera, or PROTAC, for the patients with second-line or later ER-positive, HER2-negative, advanced or metastatic breast cancer with an ESR1 mutation. There is a critical unmet need in this patient population, and we believe VEPPANU is an important new treatment option. With the novel mechanism and differentiated data, we believe VEPPANU has potential to become a market-leading treatment. When the transaction was closed in June, our team across the organization began actively preparing for the commercial launch, and we are on track for VEPPANU to be available in mid-August. Dave and Alison will provide more information on our launch preparations and the clinical data supporting the FDA approval. Moving to slide six. Since 2020, we have transformed Rigel from a single-product company with a limited development pipeline and significant cash burn into the profitable multi-product company with a promising pipeline that we are today. In 2026, we expect to grow a compound annual growth rate of approximately 35% since 2022 using the midpoint of our 2026 net product sales guidance, which excludes any contribution from VEPPANU. We view this performance as a foundation of our next phase of growth. Our in-license of VEPPANU marks the next major step in Rigel's evolution. We believe it has potential to become Rigel's largest commercial product and meaningfully drive growth through the end of the decade and beyond. Looking towards the 2030s, we plan to build on the momentum of our commercial portfolio. We will also continue to evaluate late-stage in-licensing or acquisition opportunities that address areas of significant need, offer substantial growth potential, and continue to further expand our portfolio. Subject to positive clinical data and regulatory approval, R289 could become a new treatment option for patients with lower risk MDS and potentially other indications. Several of the possible R289 indications represent potentially billion-dollar market opportunities. If successful, this could significantly expand our commercial portfolio in the 2030s and beyond. Together, these opportunities can drive sustained growth and long-term shareholder creation with the potential to transform Rigel once again. With that, I will turn the call over to Dave to discuss our commercial business and VEPPANU and our progress towards commercial availability. Dave? David A. Santos: Thank you, Raul. On slide eight, you'll see our three commercial products, TAVALISSE, GAVRETO, and REZLIDHIA. Moving to slide nine, which shows our product revenue for the Q2 of 2026. We generated $67 million in U.S. net product sales, an increase of $8.1 million over the Q2 of 2025, representing a 14% increase year-over-year. For TAVALISSE, we reported another strong quarter in which we generated a record, $47.4 million in net product sales, an increase of 18% compared to the Q2 of 2025, which was aided by favorable gross to net and inventory dynamics. TAVALISSE was launched in our portfolio. And finally, for REZLIDHIA, we reported $8.9 million in net product sales, an increase of 27% compared. We believe emerging frontline VENCLEXTA data may further reinforce the relevance of REZLIDHIA in the post-VENCLEXTA setting and improve adoption in the community. We believe that these efforts and data can be elements to continued REZLIDHIA growth into the future. Overall, we're pleased with our Q2 results. While VEPPANU will become our lead focus upon commercial availability, we remain committed to supporting TAVALISSE, REZLIDHIA, and GAVRETO. Moving to slide 10, we generated $11.7 million in revenues from collaborations in the Q2, driven by the availability of TAVALISSE in global markets and a regulatory milestone payment for elacestrant. Our partners continue to pursue regulatory approvals for both TAVALISSE and REZLIDHIA in new markets. In May, our partner, Knight, commercially launched TAVALISSE in Mexico, and they achieved regulatory approval of TAVALISSE in Brazil, with plans to commercially launch there in the second half of 2026. Also in May, Kissei announced they submitted a new drug application for elacestrant for marketing approval in Japan. We are delighted that access to our products is expanding outside the U.S. With that, I'll now turn attention to the newest addition to our commercial portfolio, VEPPANU. One line of endocrine therapy. Moving to slide 13, we believe VEPPANU has the potential to transform our commercial portfolio. Importantly, VEPPANU is the first and only approved PROTAC, a new class of targeted agents. It has a novel mechanism of action and potential to be an important new treatment option for patients. We believe our proven commercial and medical expertise and organization enable us to successfully commercialize VEPPANU. We integrated both REZLIDHIA and GAVRETO into our portfolio over the last four years, and that experience served us well as we needed to quickly integrate VEPPANU to ensure readiness in such a short amount of time. Lastly, importantly, we believe moving forward that VEPPANU has the potential to become Rigel's largest revenue producer. On slide 14, I'll take you through the unique biology of proteolysis targeting chimeras, or PROTACs, which are bifunctional small molecules that destroy specific disease-causing proteins rather than just inhibiting them. The VEPPANU PROTAC design consists of three parts. A targeting ligand that binds to the estrogen receptor, or ER, a recruiting ligand that binds to the E3 ligase complex, and a linker connecting them. This unique design represents a major innovation in ER degradation. First, VEPPANU binds to an ER and recruits an E3 ligase complex to tag the receptor with a chain of ubiquitin proteins. Next, the ubiquitin tagged ER is then recognized and eliminated by the proteasome, the cell's natural waste, allowing a single PROTAC to degrade many ERs. Because of VEPPANU's unique design and mechanism of action, it is the first in a novel pharmacologic class of heterobifunctional protein degraders, which is differentiated from other estrogen receptor antagonists, which only bind to the estrogen receptors. Moving on to slide 15. I'd like to review the significant patient opportunity for VEPPANU. There are an estimated 170,000 patients in the U.S. living with metastatic breast cancer, and approximately 70%, or 119,000 patients, have ER-positive, HER2-negative disease. The standard of care typically includes endocrine therapy and a CDK4/6 inhibitor, and over time, up to 50% of patients may develop an ESR1 mutation. In VERITAC-2, all patients had received endocrine therapy and a CDK4/6 inhibitor, and 43% had an ESR1 mutation. Using approximately 40% as a benchmark, more than 47,000 ER-positive, HER2-negative patients could have the ESR1 mutated disease. Based on our internal market research, we assume that approximately 60% of these patients are diagnosed and treated annually. Because ESR1 mutations generally emerge after exposure to endocrine therapy and CDK4/6 inhibitors, most of these patients are in the second-line or later setting. This results in an estimated 20,000 U.S. patients diagnosed and treated annually with second-line or later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Overall, we believe this represents a U.S. market opportunity of more than $1 billion. Moving to slide 16, I wanted to provide some background on current treatments for second-line and later ESR1-mutated metastatic breast cancer. First, and importantly, in the blue portions of the bars, you can see how oral SERDs have rapidly become the treatment of choice in the second-line setting, garnering nearly 60% share since they've been introduced. Even in the third-line setting, oral SERDs make up nearly 30% of treatment. This demonstrates how eager clinicians have been to find new options versus older treatments like fulvestrant, chemotherapy, and other therapies. That said, those options still make up more than 40% of treatment in the second-line setting and most of the treatment in the third-line setting. The adoption of oral SERDs has been the strongest in academic centers, where ESR1 testing and awareness of new therapies are higher. However, approximately 80% of metastatic breast cancer patients are treated in community practice as a new oral treatment option. Moving to slide 17, we believe that VEPPANU has the potential to become a market-leading treatment. First, vepdegestrant demonstrated impressive efficacy in the phase III VERITAC-2 clinical trial with a significant improvement in median PFS, a 2.4-fold improvement, and meaningful responses. Alison will walk you through the data from the trial in a few minutes. Second, vepdegestrant demonstrated tolerability in the phase III VERITAC-2 study with a manageable safety profile and low rates and severity of GI-related events, mainly vomiting and diarrhea, which can be challenging for patients on other metastatic breast cancer treatments. Indeed, as a marker of being well-tolerated, just 3% of patients discontinued, and only 2% required dose reductions. These are important differentiators in this market. Last, we believe that the real-world applicability of the patient population in VERITAC-2 is meaningful to clinicians. The standard of care for ER-positive, HER2-negative metastatic breast cancer patients is to use endocrine therapy and a CDK4/6 inhibitor. Vepdegestrant demonstrated efficacy, safety, and tolerability in exactly this setting in VERITAC-2, where 100% of patients received a CDK4/6 inhibitor and endocrine therapy as previous treatment for their disease. Based on these data, the NCCN, or National Comprehensive Cancer Network, added vepdegestrant to the NCCN Clinical Practice Guidelines for breast cancer as a Category 2A targeted therapy treatment option for HR-positive, HER2-negative ESR1 mutation for recurrent, unresectable, or stage four disease. Overall, we see significant potential for VEPPANU as a valuable new option in the treatment armamentarium for both academic and community physicians as they treat second-line and later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Now, let's turn to commercialization planning, which you'll see on slide 18. First, thanks to close coordination and the strong partnerships we have, we are on track to make VEPPANU available in mid-August, which is ahead of schedule compared to our initial expectations. Second, we've prepared key stakeholders for commercial availability, including distributors, patient services providers, payers, and GPOs. Further, we engaged with breast cancer key opinion leaders and identified key accounts in advance of commercial availability based on our market research, launch forums, and other activation initiatives. Third, our teams fully leveraged our experience to immediately deploy critical promotional activities. After the transaction closed, veppanu.com went live. Importantly, our sales team was fully trained in record time and began enthusiastically driving awareness of VEPPANU's approval and near-term commercial availability. In addition, RIGEL ONECARE, our patient services hub, is now live and ready to serve healthcare providers and patients. We launched veppanu.com, added VEPPANU to the RIGEL ONECARE and medical information websites, and provided initial materials to our sales force. With commercial availability this month, we're launching the next phase of materials to support customer engagement and patient starts. These include a VERITAC-2 publication overview, dosing and administration guidance, a distribution guide, and patient resources. In the Q4, we expect to begin our branded campaign using an omni-channel approach to expand awareness and adoption among healthcare providers and patients. Our organization has moved quickly to put our patient services, the field team, and promotional resources in place as quickly as possible. We're proud of what the organization has accomplished since closing and are fully ready to make VEPPANU available to patients and drive rapid awareness and adoption. My sincere thanks to the entire Rigel team for all their hard work and commitment. With that, I'll turn the call over to Alison for a review of the data from the phase III VERITAC-2 clinical trial and ongoing development of vepdegestrant, and to update you on our development pipeline. Alison? Alison L. Hannah: Thank you, Dave. I'm very excited to join Rigel at this important stage in the company's evolution. Having served on Rigel's board since 2021, I've seen firsthand the strength of this team, the scientific rationale behind our programs, and the opportunity we have to advance meaningful new therapies for patients with hematological disorders and other cancers. I'm happy to tell you about the continued development of R289 and Rigel's broader clinical strategy, including the recent addition of vepdegestrant. With that, let me walk you through Rigel's plans to advance our development pipeline. First, I'd like to start with the clinical data from vepdegestrant, which underlies its approval by the FDA and gives us confidence in its potential to help patients. I'm now on slide 22, which shows the design of the VERITAC-2 clinical trial in patients with ER-positive, HER2-negative, ESR1 mutated, advanced or metastatic breast cancer. Patients were at least 18 years old and had ER-positive, HER2-negative, advanced or metastatic breast cancer, and all patients had already received endocrine therapy on their most recent line of endocrine therapy for at least six months. They were not allowed to have had a prior SERD, whether that was fulvestrant or elacestrant, and they could not have had prior cytotoxic chemotherapy for metastatic disease. Patients were randomized in a one-to-one fashion to receive either fulvestrant given at its approved dosing or vepdegestrant, 200 milligrams orally once daily. The primary efficacy endpoint was progression-free survival by blinded independent central review. Initially, in those patients with ESR1 mutations, if positive, then we would subsequently test progression-free survival among all patients, the ITT population. Secondary endpoints included overall survival, clinical benefit rate, objective response rate, as well as adverse events and tolerability. Moving to slide 23, we show the primary endpoint, PFS by blinded independent central review among the patients with the ESR1 mutations. Median PFS was 5.0 months for those patients receiving vepdegestrant, where it was only 2.1 months for those patients receiving fulvestrant. This was very much in line with what we expected of how a fulvestrant control arm would perform in this population. The hazard ratio was 0.57 for a statistically significant P value of less than 0.001. You can see the landmark analyses at six months progression-free survival, approximately double the percentage of patients remaining progression-free at six months who are receiving vepdegestrant compared to those patients receiving fulvestrant. Slide 24 shows important secondary endpoints, clinical benefit rate and objective response rate by blinded independent central review. In patients with ESR1 mutations, the clinical benefit rate more than doubled with vepdegestrant at 42% compared to 20% with fulvestrant. In terms of objective response rate, vepdegestrant more than quadrupled the ORR observed with fulvestrant in a breast cancer population known to have a relatively low objective response rate. Only 4% of patients receiving single agent fulvestrant had an objective response, compared to 18.6% of patients who received vepdegestrant. Turning to safety and tolerability on slide 25, grade three or higher treatment emergent adverse events occurred in 23% of patients receiving vepdegestrant and 18% of patients receiving fulvestrant. Treatment discontinuations and dose reductions due to adverse events were low, with vepdegestrant at 3% and 2% respectively. The most common treatment-emergent adverse event was fatigue, reported in 27% of patients receiving vepdegestrant. ALT and AST increases occurred in approximately 14%, with grade three or four events in only 1%. Nausea occurred in 13% with no grade three or four cases. I'd note you do not see diarrhea on this slide because it did not meet the 10% threshold to be included. Any grade diarrhea was only 6% for patients receiving vepdegestrant. Although QT prolongation of any grade was reported in the VERITAC-2 trial, which led to its inclusion in the warning and precaution section of the U.S. package insert, no clinical sequelae were reported. A dedicated QT sub-study in 88 patients showed a mean QTcF increase from baseline of 11.1 milliseconds, with the upper bound of the 90% confidence interval below 20 milliseconds, indicating no large QT-prolonging effect. Overall, the efficacy and manageable safety profile demonstrated in VERITAC-2 supported FDA approval of vepdegestrant for patients with second-line or later ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. As we think about studying vepdegestrant further, on the left side of slide 26, you will see the ongoing studies for which Arvinas and Pfizer will continue to maintain responsibility. As a reminder, all of the studies listed are active but no longer enrolling patients, with the exception of the hepatic impairment study. These studies include the completion of the VERITAC-2 trial for its time to event and disposition endpoints. In addition, there are four studies focused on studying vepdegestrant in combination with other agents. We believe these studies will provide additional safety and efficacy data that will be helpful as we evaluate future development opportunities. Now let's move on to our development focus areas. I'm on slide 27. Our hematology and oncology pipeline focus is around the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor in lower-risk myelodysplastic syndrome, referred to as MDS, and potentially other indications. I'll spend time providing an update on R289 in a minute. On the right side of the slide, you can see we are evaluating olutasidenib beyond relapsed or refractory IDH1-mutated AML in collaboration with academic partners. MD Anderson is evaluating olutasidenib in multiple clinical studies in IDH1-mutated AML and other hematologic malignancies where IDH1 plays a role. Olutasidenib is also being evaluated as maintenance therapy in IDH1 mutation-positive high-grade glioma by the CONNECT Cancer Consortium. Lastly, we are partnering with MyeloMATCH for a planned study in first-line AML and MDS. We look forward to seeing the data that these studies generate in the future. I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor. You can review the R289 slides in full in our corporate presentation that's posted in the investor section of our website. I'll provide a brief update on the program today. I'm now on slide 29. I'd first like to remind you about the treatment landscape for lower-risk MDS. Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESA, if patients are eligible, or luspatercept. Luspatercept, and more recently, imetelstat, are also approved for ESA-failure, transfusion-dependent, lower-risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients receiving transfusion independence is low. With eight-week transfusion independence rates approaching 40% with luspatercept and imetelstat, there is still a need for safe, effective therapies for transfusion-dependent, lower-risk MDS patients that are relapsed or refractory or ineligible for ESAs. On slide 30 is the value proposition of R289 in lower-risk MDS. There are about 12,000 previously treated lower-risk MDS patients in the U.S. As I mentioned, there's a high unmet need for therapies, including transfusion-dependent patients. R289 has a novel mechanism of action as a dual IRAK1 and IRAK4 inhibitor. Blocking both IRAK one and four may suppress marrow inflammation and leukemic stem progenitor cell function. Restore normal hematopoiesis. Clinical proof of concept came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo. As a reminder, R289 is the oral prodrug that is rapidly converted to R835 in the gut. From the FDA, R289 has Fast Track designation for the treatment of patients with previously treated transfusion-dependent lower-risk MDS and Orphan Drug Designation for MDS, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval. R289 has thus far demonstrated a promising clinical profile with both encouraging preliminary safety and efficacy data in our phase I-B study. On slide 31, you can see the design of our multicenter open-label phase I-B study in patients with relapsed or refractory lower-risk MDS. The phase I-B study evaluates the safety, tolerability, PK, and preliminary efficacy of R289 in patients with lower-risk MDS and is also designed to select a dose for future studies. In the dose expansion part of the study, which we are enrolling now, up to 40 transfusion-dependent relapsed/refractory lower-risk MDS patients will be randomized to receive R289 doses of either 500 milligrams once or 500 milligrams twice daily in order to select the recommended phase II dose for future clinical studies. On slide 32, you see highlights from the dose escalation phase data presented at ASH meeting in 2025. I encourage you to review the R289 ASH 2025 data slides in full in our corporate presentation. R289 was generally well-tolerated. Of the 18 evaluable patients receiving doses of 500 milligrams daily or higher, six patients or 33% achieved red blood cell transfusion independence, or RBCTI, lasting for eight weeks or longer. In four patients, RBCTI lasted for more than 16 weeks, and for three patients, more than six months. The median duration of RBCTI was approximately 23 weeks, ranging from nine weeks to more than 24 months. Median time to onset of RBCTI was about two months. In summary, R289 was generally well-tolerated with an encouraging safety profile and promising efficacy in an elderly, heavily pretreated, transfusion-dependent, lower-risk MDS population. While this is a small dataset, we are encouraged by the dose-dependent positive results given the highly refractory nature of these patients. On slide 33 are the next steps for R289. In lower-risk MDS, we plan to complete enrollment of the dose escalation phase of the phase I-B study and select the recommended phase II dose for future studies in the second half of this year. We anticipate sharing top-line data from the dose expansion phase by the end of the year. Once the recommended phase II dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed or refractory to or ineligible for ESAs in the same study. Upon completion of the phase I-B study, we plan to follow up with the FDA to discuss a potential registration trial. In addition, we are continuing to progress with our evaluation of R289 and other potential indications that align with its mechanism of action and plan to provide an update later this year. I will now pass the call to Dean to discuss our financial results for the quarter. Dean? Dean Schorno: Thank you, Alison. I am on slide 35. We reported net product sales of $67 million for the Q2, a growth of 14% year-over-year, including TAVALISSE net product sales of $47.4 million, a growth of 18% year-over-year. GAVRETO net product sales of $10.7 million, a modest decline year-over-year, and REZLIDHIA net product sales of $8.9 million, a growth of 27% year-over-year. Our net product sales were recorded net of estimated discounts, chargebacks, rebates, returns, co-pay assistance, and other allowances of $21.4 million. We also reported $11.7 million in contract revenues for the Q2, primarily consisting of $5.8 million of revenue from Kissei, which included a $4 million regulatory milestone payment in connection with the marketing authorization application submission for olutasidenib in Japan and the delivery of drug supplies. $5 million of revenue from Grifols related to earned royalties and delivery of drug supplies, and $300,000 of revenue from Medison related to delivery of drug supply and earned royalties. Our total revenues for the Q2 was $78.7 million. Moving to slide 36. For the Q2 of 2026, our cost of product sales was approximately $8.5 million. Total costs and expenses were $55.1 million compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289 and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer, as well as an increased cost of product sales and higher personnel-related costs. Income before income taxes was $23.6 million. We reported net income of $17.3 million for the Q2 compared to net income of $59.6 million in the same period in 2025. As a reminder, the Q2 of 2025 included $40 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. We ended the quarter with cash equivalents, and short-term investments of $95.3 million compared to $155 million as of the end of 2025. Turning to our financial outlook for 2026. We've raised and narrowed our guidance range and expect total revenues in the range of approximately $285 million-$295 million. Our guidance range includes our expectation of approximately $255 million-$265 million in net product sales, excluding VEPPANU, and approximately $30 million in contract revenues. We also anticipate reported positive net income for the full year while funding existing and new clinical development programs. On slide 37, I'll review the key transaction terms of our VEPPANU licensing agreement. Rigel paid the upfront payment of $70 million following the close of the transaction. Beyond that, there are $15 million in milestones owed to Arvinas and Pfizer tied to the successful completion of transition activities. Arvinas and Pfizer are also eligible to receive potential regulatory and commercial payments totaling up to $320 million. The tiered royalties on cumulative net sales owed to Arvinas and Pfizer range from the mid-teens to the mid-20s. As Alison mentioned, Pfizer and Arvinas remain responsible for the current ongoing development activities for vepdegestrant. Rigel will contribute up to $40 million over the next four years in support of these activities. With that, I'd like to turn the call back over to Raul. Raul? Raul R. Rodriguez: Thank you, Dean. Moving on to slide 38. The first half of 2026 marked significant progress across each of our strategic priorities. Most notably, we closed the VEPPANU transaction, adding a fourth FDA-approved product to our portfolio and creating an important new long-term growth opportunity. We remain on track for commercial availability in mid-August. Our priorities for the second half of the year are clear. Successfully launch VEPPANU and grow our commercial portfolio, complete R289 dose expansion enrollment, select the recommended phase II dose, evaluate additional indications for R289, and finally, maintain financial discipline while delivering top-line growth and positive net income. With a broader commercial portfolio, a promising pipeline, and a strong financial foundation, we believe Rigel is well-positioned for its next phase of growth and long-term shareholder value creation. We appreciate your time today. With that, I'll turn the call back to the operator for your questions. Operator? Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please for the first question. Our first question comes from the line of Joseph Pantginis with H.C. Wainwright. Please proceed with your question. Joseph Pantginis: Hey, everybody. Good afternoon. Thanks for taking the question. Wanted to go back to one of your comments on the commercial assets that you have here. Obviously, VEPPANU is, as you said, the largest potential financial opportunity. I wanted to focus on the comment that this would be the lead focus on availability. Obviously, you can't have the accelerator pushed, I guess, 100% on all your assets and what's sort of on autopilot, what gives you the confidence to say it will be the lead focus and how that impacts or potentially impacts your efforts on TAVALISSE and REZLIDHIA? Raul R. Rodriguez: Thank you, Joe. I'll ask Dave to comment. David A. Santos: That's a great question, Joe. Over the years, we have gotten very, very good at really understanding what impacts our business, particularly with TAVALISSE, and certainly more recently over the last four years with REZLIDHIA. With TAVALISSE, I think we understand that market quite well. We know where there are potential new prescribers as well as existing prescribers, and I think you have to understand that the majority of that comes from the community, and our team is going to be in those community offices. What I mean by support in terms of TAVALISSE is we're calling on them, bringing a VEPPANU message, and we're making sure that they're completely supported in their desire to prescribe TAVALISSE. With REZLIDHIA, one of the things we've really done well, the team has done a lot of work on this, even incorporated AI as well as a lot of looking at diagnostic data, is we've really helped to have the team target potentially when an IDH1 patient occurs, particularly in the community. We get a lot of these, what we call them, our alerts for the team, and they can focus on that when the opportunity arises. We don't have to spend a whole bunch of time going around and talking about AML and REZLIDHIA in the community when there's no patients there. That's not what we want to do. We want to selectively find when we think there's going to be an opportunity and present that message, and that'll continue. What we have here is an opportunity to go in, really talk about VEPPANU a lot. The team has already been doing that, as I said, since close. Actually, what's been interesting is they're getting more access to accounts because of that. That enables them to support TAVALISSE, support REZLIDHIA when there are patients available. Joseph Pantginis: That's very, very helpful. I appreciate that color. Maybe a question for Alison, if you don't mind. Welcome to the full-time position off of the board as well. With regard to R289 and the different strategic collaborations, is there one that may or may not be your personal favorite, with other hemes or even the glioma indication, based on the drug's mechanism of action or other factors that might contribute? Alison L. Hannah: Thank you for the question. Is there one favorite of when our corporate collaborations, we have the MD Anderson Alliance, which is moving forward very well with multiple clinical trials at this time. We have the CONNECT study. We have MyeloMATCH. In terms of favorite collaboration, I dare say it would have to be MD Anderson. I have personally worked with the hematological division of MD Anderson for nearly 30 years, so I'm very familiar with all the important scientific collaborations that they can bring. They are attacking hematological malignancies in various different subgroups that I find very attractive, including a maintenance trial, an upfront trial. Honestly, if I had to pick one favorite, it would probably be the MD Anderson collaboration. Thank you for the question. Joseph Pantginis: I appreciate that. Maybe not favorite because I don't want you to have a favorite child. Alison L. Hannah: I feel like I may have gotten into trouble. Raul R. Rodriguez: No. Joseph Pantginis: You have great infrastructure relationships there, so thanks for the questions and the answers. Thank you. Raul R. Rodriguez: Thank you, Joe. Operator: Thank you. Our next question comes from the line of Farzin Haque with Jefferies. Please proceed with your question. Unknown Analyst: Hi. Thank you for taking our questions. This is Amin on for Farzin. A couple of questions from us. First, you increased the upper bound of guidance by $5 million, which doesn't include VEPPANU. The question is, what are you seeing to date for the commercial portfolio that are underpinning this assumption, and what's your expectation for the VEPPANU launch this year? Raul R. Rodriguez: Well, I'll ask Dave, I can comment. By the way, the change to the guidance, before I turn it over to Dave, was we increased the contract revenue from $20 million-$30 million range to approximately $30 million, as we've seen strong contract revenue come in the first half of the year. We left intact the product sales guidance of $255 million-$265 million. That sales guidance is only on TAVALISSE, GAVRETO, and REZLIDHIA. I'll ask Dave to comment on VEPPANU specifically, but we've maintained our guidance on the other products. David A. Santos: Thanks, Raul. Yeah. In terms of guidance for VEPPANU, we're not going to be issuing any guidance in the short term for VEPPANU. Obviously, we don't have any sales yet coming in, and you'll see that after the Q3. We'll update you to give you color and insights into how the VEPPANU launch is progressing. I'll just reiterate that we believe that VEPPANU can become a market-leading treatment in the second-line ESR1 mutated space. We believe we have a product with a differentiated mechanism, and it's a wholly different pharmacologic class, being a heterobifunctional protein degrader. We have the proven efficacy that Alison reviewed, and particularly not only a very strong treatment effect in PFS, but also higher response rates, both from a partial response rate or overall response rate and a clinical benefit rate, which includes stable disease, which is extremely important in metastatic breast cancer. We think we have a tolerable agent. For all these reasons, frankly, even now, I think as we talk to customers, there's a lot of interest in the product. I think the most frequent question we have is, "When is the product going to be available?" We get this pretty much from all corners of the field. I think we're really looking forward to this product gaining traction in the near future. At some point, we will be issuing guidance on it. Raul R. Rodriguez: We'll have to wait a little bit until we get some time under our belt, Farzin, so that we can feel comfortable with the trajectory of the thing is. I have to say, we're excited to see the product in the hands of clinicians and patients in the short order. Providing some revenue by the end of the year, what we've accomplished this shortened year. It's an exciting driver for us. We're happy with the performance of the other products. They're growing modestly. This, we expect to be the real driver underlying our commercial business. Unknown Analyst: Thanks. That's very helpful. Just one clarification question on VEPPANU market opportunity. Can you clarify the $1 billion figure you referenced? Does this represent the overall second-line ESR1 mutated opportunity available for oral SERDs, or this is an estimate specifically for VEPPANU potential peak sales? David A. Santos: That's the market opportunity. We're clear that we think that the second line and later ESR1 mutated patient population is about 20,000, which correlates to about a $1 billion market opportunity. Raul R. Rodriguez: It's higher than that, depending on what assumptions you take on pricing, et cetera. Unknown Analyst: Okay, thanks. Raul R. Rodriguez: Thank you, Farzin. Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question. Unknown Analyst: Hi, this is Jenny on Kristen's line. Thank you so much for taking my questions. I have two. While not giving any guidance on VEPPANU at this time, realistically, when should we start to model in for sales, and what factors should we take into consideration for cadence and penetration? Second, could you also provide some color on the ongoing studies that Pfizer's conducting, particularly those evaluating VEPPANU in combination regimens? Raul R. Rodriguez: Sure. In terms of the timing, we will be reporting the Q3 sales that we accomplished. That'll be in November, we'll actually have those. This will be a shortened quarter, August and then some in September. Again, we'll report a full quarter at the end of the year. At JPMorgan, we typically put out a press release before that call, that meeting, saying what our revenues were for the year, in which case we'll include VEPPANU sales for 2024-- sorry, 2025, 2026 in total. That'll be a quarter and about a little bit more than that. At that point, we'll figure out what we're giving in terms of guidance, but we haven't decided that yet. It may not include VEPPANU at the time. On collaborations. Alison L. Hannah: Certainly, I can provide where we have been in terms of public distribution of data. The vepdegestrant plus palbociclib, the data was initially presented as ESMO Breast Cancer 2024. The vepdegestrant plus abemaciclib was presented at ASCO 2026. Finally, the vepdegestrant plus atirmociclib was also presented at that same meeting, ASCO 2026. The data for ribociclib and samuraciclib have not yet been publicly presented. We would anticipate seeing those data in the future, in the not-too-distant future. Raul R. Rodriguez: As you know- Unknown Analyst: Thank you so much Raul R. Rodriguez: The importance of this data is that it'll provide context for clinicians using this product in combo. As you probably heard, the product has a tolerability profile that's quite attractive, and therefore may be a good partner in terms of combining with other agents. Thank you, Kristen. Unknown Analyst: Thank you. Operator: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Raul R. Rodriguez: Thank you, everyone, for joining us today. We are pleased with our Q2 performance and really look forward to VEPPANU becoming commercially available later this month, in the middle of it, as well as several other important milestones with R289 that we are expected to achieve this year. We appreciate your continued interest and support, and we'll keep you updated throughout the year. Thank you, and have a good evening. Operator: This concludes today's teleconference. You may disconnect your line at this time. Thank you for your participation. Before you buy stock in Rigel Pharmaceuticals, 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 Rigel Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut 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!* Now, it’s worth noting Stock Advisor’s total average return is 965% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 11, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Rigel (RIGL) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in Rigel Pharmaceuticals, Inc.? Here are five stocks we like better. Strong Q2 performance: Rigel reported $78.7 million in revenue and $17.3 million in net income, with U.S. net product sales up 14% year over year. The company raised and narrowed its full-year revenue outlook to approximately $285 million–$295 million and expects to remain profitable while funding its clinical programs. VEPPANU launch approaching: Rigel plans to make its newly licensed, FDA-approved breast cancer therapy commercially available in mid-August. Management estimates the eligible U.S. market exceeds $1 billion but did not provide near-term product sales guidance. Pipeline investment weighs on cash: Rigel is advancing R289 in a Phase Ib study for lower-risk myelodysplastic syndrome and expects top-line data by year-end. Cash and investments fell to $95.3 million after the company paid a $70 million upfront VEPPANU licensing fee, with additional milestone and development obligations ahead. Rigel Pharmaceuticals (NASDAQ:RIGL) reported second-quarter 2026 total revenue of $78.7 million and net income of $17.3 million, while outlining plans to launch newly licensed breast cancer therapy VEPPANU in mid-August. The company generated $67 million in U.S. net product sales during the quarter, up 14% from the prior-year period. Contract revenue added $11.7 million, driven by international product availability, royalties, drug-supply deliveries and a regulatory milestone payment. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Rigel raised and narrowed its full-year total revenue outlook to approximately $285 million to $295 million. The guidance includes expected net product sales of $255 million to $265 million, excluding any contribution from VEPPANU, and roughly $30 million in contract revenue. The company said it expects to report positive net income for the full year while funding its clinical programs. TAVALISSE recorded quarterly net product sales of $47.4 million, a year-over-year increase of 18%. Chief Commercial Officer David Santos said the result was aided by favorable gross-to-net and inventory dynamics. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? REZLIDHIA net product sales rose 27% to $8.9 million. GAVRETO generated $10.7 million in sales, representing a modest decline from the prior year, according to Chief Financial Officer Dean Schorno. Rigel said it remains committed to supporting its existing products even as VEPPANU becomes the company’s primary commercial focus. During the question-and-answer session, Santos said the company has developed targeted approaches for TAVALISSE and REZLIDHIA, including identifying potential IDH1-mutated patients for REZLIDHIA through diagnostic data and other tools. → Why Rare Earth Processing Could Be the Real 2027 Opportunity Contract revenue included $5.8 million from Kissei, including a $4 million regulatory milestone associated with a Japanese marketing authorization application for olutasidenib, as well as drug supplies. Rigel also reported $5 million from Grifols and $300,000 from Medison, primarily related to royalties and drug supply. Internationally, partner Knight launched TAVALISSE in Mexico in May and received Brazilian regulatory approval, with a commercial launch planned for the second half of 2026. Kissei also submitted a Japanese new drug application for elacestrant in May. Rigel completed its exclusive global license for VEPPANU, or vepdegestrant, in June. The therapy is FDA approved for patients with second-line or later ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Company executives described VEPPANU as the first and only FDA-approved proteolysis-targeting chimera, or PROTAC, in the indication. Rigel expects the product to be commercially available in mid-August, ahead of its earlier expectations. Santos said the company has prepared distributors, patient-service providers, payers, group purchasing organizations and targeted accounts for the launch. Rigel’s sales force has completed training, and its RIGEL ONECARE patient-services hub is operational. The company expects to begin a branded omnichannel campaign in the fourth quarter. Rigel estimated that about 20,000 U.S. patients annually are diagnosed and treated for second-line or later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. The company characterized that as a market opportunity exceeding $1 billion, rather than a projection of VEPPANU-specific sales. Management did not provide near-term sales guidance for VEPPANU. Rodriguez said Rigel will report third-quarter sales results in November, reflecting a shortened launch period, and expects to provide additional information on the product’s trajectory after it has accumulated more commercial experience. Chief Medical Officer Alison Hannah reviewed data from the Phase III VERITAC-2 study that supported VEPPANU’s approval. Among patients with ESR1 mutations, median progression-free survival was 5.0 months for vepdegestrant, compared with 2.1 months for fulvestrant. The reported hazard ratio was 0.57, with a statistically significant p-value of less than 0.001. The clinical benefit rate was 42% with vepdegestrant and 20% with fulvestrant, while objective response rates were 18.6% and 4%, respectively. Grade 3 or higher treatment-emergent adverse events occurred in 23% of vepdegestrant patients and 18% of fulvestrant patients. Rigel said 3% of vepdegestrant patients discontinued treatment because of adverse events and 2% required dose reductions. Rigel is also advancing R289, an oral prodrug of a dual IRAK1 and IRAK4 inhibitor, for lower-risk myelodysplastic syndrome, or MDS. The company is enrolling the dose-expansion portion of its Phase Ib study, which will compare 500 milligrams once daily with 500 milligrams twice daily in up to 40 transfusion-dependent, relapsed or refractory lower-risk MDS patients. Rigel expects to complete dose-expansion enrollment, select a recommended Phase II dose and report top-line data by year-end. In earlier dose-escalation data presented at the 2025 American Society of Hematology meeting, six of 18 evaluable patients receiving 500 milligrams daily or higher achieved red blood cell transfusion independence lasting at least eight weeks. Second-quarter costs and expenses totaled $55.1 million, compared with $40.6 million a year earlier. Rigel attributed the increase primarily to R289 clinical activity, development work under its license agreement with Arvinas and Pfizer, higher product costs and personnel expenses. Net income declined from $59.6 million in the second quarter of 2025. Schorno noted that the prior-year result included $40 million of non-cash revenue related to Rigel’s collaboration agreement with Lilly. Cash, cash equivalents and short-term investments were $95.3 million at quarter-end, down from $155 million at the end of 2025. Rigel paid a $70 million upfront fee upon closing the VEPPANU transaction and may owe an additional $15 million upon successful transition activities. The agreement also includes up to $320 million in potential regulatory and commercial milestone payments, tiered royalties ranging from the mid-teens to mid-20s on cumulative net sales, and up to $40 million of Rigel support for ongoing development activities over four years. Rigel Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California. Founded in 2003, Rigel focuses on the discovery, development and commercialization of novel small molecule therapeutics targeting immune, hematologic and oncologic diseases. Leveraging a proprietary chemistry platform and expertise in signal transduction pathways, the company aims to address significant unmet medical needs in both rare and common disorders. Rigel's lead product, fostamatinib (commercially known as Tavalisse®), is an oral spleen tyrosine kinase (SYK) inhibitor approved in the United States for the treatment of adult patients with chronic immune thrombocytopenia (ITP). 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 "Rigel Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

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. The Q2 2026 results mark Rigel's evolution from a single-product company to a profitable, multi-product oncology and hematology platform. The in-license of VEPPANU (vepdegestrant) serves as a primary near-term growth driver, expanding the company's reach into the large breast cancer market. Management attributes the 14% year-over-year increase in net product sales to strong performance across TAVALISSE and REZLIDHIA, supported by favorable inventory dynamics. The strategic framework focuses on four pillars: growing the commercial business, expanding the portfolio via in-licensing, advancing the clinical pipeline, and maintaining financial discipline. VEPPANU is positioned as a market-leading treatment due to its novel PROTAC mechanism, which destroys rather than just inhibits disease-causing proteins. Operational readiness for VEPPANU was accelerated by leveraging existing commercial infrastructure and expertise gained from previous product integrations like GAVRETO. Management believes the company's 35% compound annual growth rate since 2022 provides a stable foundation for the next phase of expansion through the 2030s. VEPPANU is on track for commercial availability in mid-August 2026, ahead of initial management expectations. Management expects R289 to reach a significant milestone with top-line data from the dose expansion phase in lower-risk MDS by year-end 2026. The company raised its 2026 total revenue guidance to $285 million-$295 million, primarily driven by higher expected contract revenues of approximately $30 million. Future growth strategy includes evaluating R289 for additional billion-dollar market indications and pursuing further late-stage in-licensing opportunities. Financial guidance for 2026 anticipates positive net income while simultaneously funding new and existing clinical development programs. The VEPPANU licensing agreement involved a $70 million upfront payment, with Rigel contributing up to $40 million over four years for ongoing development. A warning and precaution for QT prolongation was included in the VEPPANU U.S. package insert, though management noted no clinical sequelae were reported in trials. The Q2 2026 net income of $17.3 million was lower than the prior year's $59.6 million, which had been inflated by a $40 million non-cash revenue item from the Lilly collaboration. Management flagged that approximately 80% of metastatic breast cancer patients are treated in community practices, necessitating a specific outreach strategy for VEPPANU. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while VEPPANU is the lead focus, they use AI and diagnostic data to target REZLIDHIA and TAVALISSE efforts efficiently. The team focuses on 'alerts' for specific patient occurrences in the community to avoid unnecessary broad-scale marketing where patients aren't present. Dr. Alison Hannah highlighted the MD Anderson collaboration as a priority due to their deep infrastructure and multi-pronged approach to hematological malignancies. The collaboration with MD Anderson includes maintenance and upfront trials for olutasidenib that align with the company's attractive subgroups for hematological malignancies. Management estimated a $1 billion U.S. market opportunity based on 20,000 diagnosed second-line ESR1-mutated patients annually. Specific sales guidance for VEPPANU will be withheld until the company has more 'time under its belt' to observe the launch trajectory, likely after Q3 results.

– 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.

Rigel Pharmaceuticals (RIGL) came out with quarterly earnings of $0.88 per share, missing the Zacks Consensus Estimate of $0.91 per share. This compares to earnings of $3.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -3.30%. A quarter ago, it was expected that this drug developer would post earnings of $0.74 per share when it actually produced earnings of $0.44, delivering a surprise of -40.54%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Rigel, which belongs to the Zacks Medical - Drugs industry, posted revenues of $78.7 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 14.58%. This compares to year-ago revenues of $101.68 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. Rigel shares have lost about 12.6% since the beginning of the year versus the S&P 500's gain of 11%. While Rigel 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 Rigel was unfavorable. 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 #4 (Sell) for the stock. So, the shares are expected to underperform 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 $1.05 on $73.74 million in revenues for the coming quarter and $3.51 on $280.61 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 - Drugs is currently in the bottom 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, electroCore, Inc. (ECOR), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.41 per share in its upcoming report, which represents a year-over-year change of -17.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. electroCore, Inc.'s revenues are expected to be $9.36 million, up 26.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Rigel Pharmaceuticals, Inc. (RIGL) : Free Stock Analysis Report electroCore, Inc. (ECOR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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.

Second quarter 2026 total revenues of $78.7 million, including net product sales of $67.0 million and contract revenues from collaborations of $11.7 million, and net income of $17.3 million Expanded commercial portfolio with the in-license of VEPPANU™ (vepdegestrant), with U.S. commercial availability expected in mid-August Advanced R289 development program; Phase 1b study in patients with lower-risk MDS remains on track to complete enrollment in the dose expansion portion and select the recommended Phase 2 dose in the second half of 2026 Updated 2026 Outlook: Total revenues of approximately $285 to $295 million, which includes net product sales, excluding VEPPANU, of $255 to $265 million and contract revenues from collaborations of approximately $30 million Conference call and webcast scheduled today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 4, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the second quarter ended June 30, 2026, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress, including the in-license of VEPPANU™ (vepdegestrant), a PRoteolysis TArgeting Chimera (PROTAC). "Rigel delivered a strong second quarter, highlighted by record net product sales, continued profitability and the in-license of VEPPANU, the first and only FDA-approved PROTAC for patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. We expect VEPPANU to be commercially available later this month, further expanding our commercial business in hematology and oncology," said Raul Rodriguez, Rigel's president and CEO. "We are also advancing the development of R289 in our ongoing Phase 1b study in patients with R/R lower-risk MDS, and remain on track to complete enrollment in the dose expansion phase of the study, select a recommended Phase 2 dose in the second half of 2026 and share preliminary data by year end." Second Quarter 2026 Business Update Corporate Rigel entered into an exclusive, global licensing agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer) to develop, manufacture and commercialize VEPPANU (vepdegestrant). VEPPANU is the first and only PROTAC approved by the U.S. Food and Drug Administration (FDA) 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 (mBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The agreement became effective on June 11, 2026, and Rigel paid the upfront payment of $70.0 million to Arvinas and Pfizer in the second quarter. Upon close of the transaction, Rigel immediately initiated launch activities and expects VEPPANU to be commercially available in the United States for the treatment of second line-plus (2L+) ER+/HER2-, ESR1-mutated mBC in mid-August 2026. In July, Rigel announced the appointment of Alison L. Hannah, M.D. to the role of Executive Vice President and Chief Medical Officer. Dr. Hannah has decades of oncology drug development experience and served on Rigel's Board of Directors since 2021. She resigned from Rigel's Board of Directors in connection with her appointment. Commercial Second quarter net product sales were $67.0 million, an increase of 14% from the same period of 2025. Rigel's partner Knight Therapeutics Inc. (Knight) received regulatory approval from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) in May for TAVALISSE for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Also in May, Knight commercially launched TAVALISSE in Mexico. Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) submitted a new drug application for manufacturing and marketing approval in Japan for olutasidenib in May. In connection with the submission, Rigel received a $4.0 million regulatory milestone payment from Kissei during the second quarter. Clinical Development Rigel continues to advance its Phase 1b clinical study of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS), with enrollment in the dose expansion phase ongoing and on track to be completed in the second half of 2026. The company expects to select the recommended Phase 2 dose in the second half of 2026 and share preliminary dose expansion data by year end. The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress featured an oral presentation and several poster presentations for pralsetinib and olutasidenib. The final data from the Phase 3 AcceleRET-Lung clinical trial of pralsetinib as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) were presented in an oral session at ASCO. In addition, ASCO and EHA featured poster presentations that included additional data for pralsetinib and data for olutasidenib for the treatment of R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML). Key Publication A paper titled "Preclinical Characterization and Early Development of R835, a Novel, Selective Dual IRAK1 and IRAK4 Inhibitor," was published in Scientific Reports in July. R835, the active metabolite of the prodrug R289, potently and selectively inhibited toll-like receptor (TLR) and interleukin-1 receptor (IL-1R)-dependent proinflammatory cytokine production in multiple preclinical models, demonstrating efficacy in both prophylactic and treatment preclinical settings. Additionally, in a placebo-controlled, double-blind, Phase 1, first-in-human study in 82 healthy participants, R835 was well tolerated with a favorable pharmacokinetic profile across all dose levels evaluated, and markedly inhibited lipopolysaccharide (LPS)-induced peak cytokine concentrations by approximately 40-80% compared to placebo. These data provided clinical proof of mechanism of a dual IRAK1/4 inhibitor suppressing proinflammatory cytokine release in humans. Second Quarter and Year-to-Date 2026 Financial UpdateFor the second quarter ended June 30, 2026, total revenues were $78.7 million, consisting of $67.0 million in net product sales and $11.7 million in contract revenues from collaborations. Net product sales increased 14% compared to $58.9 million in the same period of 2025. TAVALISSE net product sales were $47.4 million, an increase of 18% compared to $40.1 million in the same period of 2025. GAVRETO net product sales were $10.7 million, a decrease of 10% compared to $11.8 million in the same period of 2025. REZLIDHIA net product sales were $8.9 million, an increase of 27% compared to $7.0 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $5.8 million of revenue from Kissei, which included a $4.0 million regulatory milestone payment in connection with the marketing authorization application submission for olutasidenib in Japan and delivery of drug supplies; $5.0 million of revenue from Grifols S.A. (Grifols) related to earned royalties and delivery of drug supplies; and $0.3 million of revenue from Medison Pharma (Medison) related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel's collaboration agreement with Eli Lilly and Company (Lilly). Total costs and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs, cost of product sales, and research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer. Income before income taxes was $23.6 million, compared to $60.0 million for the same period of 2025. Rigel reported net income of $17.3 million, or $0.93 basic and $0.88 diluted per share, compared to $59.6 million, or $3.33 basic and $3.28 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. For the six months ended June 30, 2026, total revenues were $137.5 million, consisting of $121.9 million in net product sales and $15.6 million in contract revenues from collaborations. Net product sales increased 19% compared to $102.5 million in the same period of 2025. TAVALISSE net product sales were $84.7 million, an increase of 24% compared to $68.5 million in the same period of 2025. GAVRETO net product sales were $20.3 million, a decrease of 2% compared to $20.8 million in the same period of 2025. REZLIDHIA net product sales were $17.0 million, an increase of 29% compared to $13.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $7.6 million of revenue from Kissei, including a $4.0 million regulatory milestone and delivery of drug supplies; $6.8 million of revenue from Grifols related to earned royalties and delivery of drug supplies; and $0.5 million of revenue from Medison related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel's collaboration agreement with Lilly and a $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea. Total costs and expenses were $102.1 million, compared to $81.1 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher personnel-related costs; research and development costs, including the continued progress of the R289 program and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer; cost of product sales, and commercial-related expenses. Income before income taxes was $35.2 million, compared to $71.5 million for the same period of 2025. Rigel reported net income of $25.9 million, or $1.40 basic and $1.32 diluted per share, compared to $71.1 million, or $3.98 basic and $3.91 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. Cash, cash equivalents and short-term investments as of June 30, 2026 was $95.3 million, compared to $155.0 million as of December 31, 2025. 2026 OutlookRigel has increased its 2026 total revenues guidance to approximately $285 to $295 million, from the prior range of approximately $275 to $290 million, which includes: Net product sales of approximately $255 to $265 million. Contract revenues of approximately $30 million, an increase from the prior range of approximately $20 to $25 million. The above revenue guidance excludes VEPPANU. The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs. Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern TimeRigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and will be accessible from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website. About ITPIn patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP. About NSCLCIt is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3 About AMLAcute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4 Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. About ER+/HER2-, ESR1-mutated Metastatic Breast CancerBreast cancer is the most common cancer in women in the United States, except for skin cancers.8 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC). About TAVALISSE® TAVALISSE (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE. About GAVRETO® GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).* *Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO. About REZLIDHIA® REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA. About VEPPANU™ VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, 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. Please click here for Important Safety Information and Full Prescribing Information for VEPPANU. To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088). TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks and VEPPANU is a trademark of Rigel Pharmaceuticals, Inc. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com. R289 is an investigational compound not approved by the FDA. The American Cancer Society. Key Statistics for Lung Cancer. Revised January 13, 2026. Accessed June 30, 2026: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html Kato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679 The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised January 13, 2026. Accessed June 30, 2026: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html Patel, A, et al. Outcomes of Patients With Acute Myeloid Leukemia Who Relapse After 5 Years of Complete Remission. 2021 Sep 7;28(7):811-814. doi: https://doi.org/10.3727/096504020X15965357399750 Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia. Curr. Treat. Options on Oncol. (2020) 21: 66. doi: https://doi.org/10.1007/s11864-020-00765-5 Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. doi: https://doi.org/10.1182/blood-2014-10-551911 The American Cancer Society. Key Statistics for Breast Cancer. Revised June 24, 2026. Accessed June 30, 2026: https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html Forward Looking Statements This press release contains forward-looking statements relating to, among other things, expected commercial launches and commercial availability, commercial, financial and clinical results, projections of financial performance and outlook for 2026, expectations for growing our commercial business and successfully executing our commercial strategy, continued enrollment of our R289 study, presentation of study data, expectation of clinical outcomes, continued ability to develop and commercialize VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA, and R289 domestically and in certain international markets, the Company's ability to fund its existing and future clinical development programs, and expectations for our partnering, licensing, commercialization and collaboration efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. These forward-looking statements include, without limitation, anticipated financial performance and profitability for 2026; expected product sales and commercial growth; the anticipated timing, progress and results of clinical development activities for R289, including enrollment, dose selection and data readouts; the Company's ability to fund its existing and future development programs; the anticipated commercial launch and commercialization of VEPPANU; the Company's ability to execute its commercial strategy and its partnering, licensing, commercialization, collaboration and potential business development activities. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of VEPPANU, TAVALISSE, GAVRETO and REZLIDHIA, including uncertainties relating to physician adoption, patient demand, market acceptance, reimbursement and pricing; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA or R289; operational, regulatory or other risks that can affect the timing of enrollment and data availability for R289 clinical development; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that VEPPANU, TAVALISSE, GAVRETO, REZLIDHIA or R289 may have unintended side effects, adverse reactions or incidents of misuse; the availability of resources to develop or market Rigel's product candidates; market competition; product demand variability; pricing/reimbursement dynamics; unanticipated business needs and other developments, including potential partnering, licensing or other collaboration arrangements, which could impact Rigel's funding needs or other internal resource demands, as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors: Rigel Pharmaceuticals, [email protected] Media: David RosenArgot [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-reports-second-quarter-2026-financial-results-302842822.html

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Pfizer (NYSE:PFE) has entered a new alliance with Sarah Cannon Research Institute to accelerate oncology clinical trials and broaden patient access. The company has also granted Rigel Pharmaceuticals exclusive rights to commercialize VEPPANU, an FDA approved PROTAC based breast cancer therapy. These agreements reflect fresh moves in Pfizer's oncology R&D and commercialization approach that have not been covered in earlier updates. Pfizer's stock closed at $25.9, with the share price up 2.3% over the past week and 18.8% over the past year, while returns over 3 and 5 years show declines of 17.0% and 13.6%. In that context, the new SCRI partnership and VEPPANU licensing deal provide additional detail on how the company is positioning its oncology efforts beyond existing products. For investors tracking NYSE:PFE, these developments highlight how Pfizer is using external partnerships and out licensing to pursue breast cancer treatments and support its broader oncology pipeline. The impact of these moves will depend on clinical execution, regulatory outcomes and how effectively Rigel develops the VEPPANU opportunity over time. Stay updated on the most important news stories for Pfizer by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Pfizer. We've flagged 4 risks for Pfizer. See which could impact your investment. ✅ Price vs Analyst Target: At US$25.90, Pfizer trades about 11% below the US$29.19 analyst price target. ✅ Simply Wall St Valuation: The stock is flagged as undervalued, trading 57.9% below the platform's fair value estimate. ❌ Recent Momentum: The share price is down 4.1% over the past 30 days. There is only one way to know the right time to buy, sell or hold Pfizer. Head to Simply Wall St's company report for the latest analysis of Pfizer's Fair Value. 📊 The SCRI alliance and VEPPANU out licensing show Pfizer leaning on partnerships to progress oncology without taking on all the commercial execution alone. 📊 Watch uptake of VEPPANU under Rigel, the trajectory of Pfizer's oncology revenue, and how the P/E of 19.7 compares with the 14.7 industry average. ⚠️ Major flagged risks include forecast earnings decline, debt that is not well covered by operating cash flow, and a dividend that is not fully covered. For the full picture including more risks and rewards, check out the complete Pfizer analysis. Alternatively, you can visit the community page for Pfizer to see how other investors believe this latest news will impact the company's narrative. 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. Companies discussed in this article include PFE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]