Precigen, Inc. (PGEN) Q3 2026 Earnings Report, Transcript and Summary

Good afternoon, ladies and gentlemen, and welcome to the Precigen Third Quarter 2026 Financial Results and Business Update Conference Call. [Operator Instructions] This call is being recorded on Wednesday, November 4, 2026. I would now like to turn the conference over to Steven Harasym. Please go ahead.

Thank you, operator, and thank you to everyone joining us for Precigen's Third Quarter 2026 Financial Results and Business Update Call. Joining me today are Helen Sabzevari, our President and Chief Executive Officer; Phil Tennant, our Chief Commercial Officer; Harry Thomasian, our Chief Financial Officer; and Rutul Shah, our Chief Operating Officer. Helen will begin with our business highlights. Phil will review commercial progress, and Harry will discuss our financial results for the quarter. Rutul will be available for Q&A as well. Before we begin, I remind everyone that today's discussion will include forward-looking statements based on our current expectations and beliefs. Actual results could differ materially because of risks and uncertainties described in the forward-looking statement slide of this presentation and our most recent SEC filings. With that, I will turn the call over to Dr. Sabzevari, Helen?

Thank you, Steve, and thank you to everyone joining us today. The third quarter of 2026 represents another defining milestone for Precigen. Just over 1 year ago, we made the history with the FDA approval of PAPZIMEOS, the first approved treatment for adults with recurrent respiratory papillomatosis or RRP, in more than a century of this disease. Today, we are demonstrating what that achievement means for patients, physicians and our business. We have moved rapidly from regulatory approval to commercial success, delivering 3 consecutive quarters of significant revenue growth bringing PAPZIMEOS to major medical centers, infusion centers and community practices across the country, achieving profitability in both the second and third quarters and generating positive cash flow in the third quarter, ahead of our guidance, bringing in net product revenue in Q3 of $72.9 million and a launch to date of $151 million. This is the definition of execution excellence. These accomplishments reflect our paradigm-shifting approach to drug development. combining differentiated science, a smart indication selection and innovative clinical and regulatory strategies to accelerate the delivery of transformative therapies to patients. With the recent conditional approval of a competitor therapy for RRP treatment, I want to provide a perspective on Precigen's position and the continued opportunity ahead. We have always anticipated competition and incorporated it into our strategic planning, commercial modeling and investment decisions from the outset. Our strategy was built not simply to be first, but to establish enduring leadership in RRP. -- and that is exactly what we have accomplished. Our leadership is built on 4 pillars: the first-line product defined by its efficacy, safety, durability and the ease of administration, a strong regulatory foundation and established commercial infrastructure and a demonstrated ability to execute. Together, these attributes have already established our position in the market, and they continue to strengthen our value proposition. First, our product. The true measure of any successful therapy is the benefit it delivers to patients. The pivotal clinical study of PAPZIMEOS demonstrated an unmatched 51% complete response rate with 18 of 35 patients requiring no surgeries during the 12 months following treatment conclusion. The 51% complete response primary efficacy endpoint, which is reflected in the PAPZIMEOS FDA-approved prescribing information sets a new clinical benchmark in RRP. Similarly, PAPZIMEOS is unmatched in establishing a meaningful standard of durable complete responses for up to 5 years without the need for any additional treatment. Being free of surgeries for a sustained period speaks for itself and its groundbreaking clinical benefit, which differentiates PAPZIMEOS by a wide margin. In the pivotal clinical study PAPZIMEOS demonstrated a well-characterized safety profile with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2, which is another point of differentiation. Equally important is the practicality of treatment. PAPZIMEOS is administered through a defined regimen of subcutaneous injections without the need for an external specialized device, which could also introduce device-related adverse events. Importantly, leading RRP experts continue to recognize and adopt PAPZIMEOS as the first-line standard of care treatment for adults with RRP. Second, our regulatory foundation. One of the most achievements in our development of PAPZIMEOS was securing full FDA approval in August 2025 based on the strength of the efficacy and the safety evidence presented in our BLA. This was full approval without the requirement for a post-approval confirmatory clinical trial to verify the clinical benefit. That is a significant achievement. Confirmatory clinical trials can require years of additional development, substantial financial investment and continued regulatory uncertainty, including the risk of FDA revocation. Our approved indication, the treatment of all adults with RRP is broad without the requirement for a minimum number of prior surgeries, enabling physicians to consider treatment based on each patient's clinical needs. This full regulatory approval, combined with our clinical evidence and broad label indication creates a secure regulatory foundation for PAPZIMEOS. Third, our commercial leadership. Being first to market gave us an important opportunity. Our commercial strategy and execution have transformed that opportunity into a significant first-mover advantage. And the results speaks for itself. As of today's call, well over 500 patients have begun treatment of PAPZIMEOS and well over 300 of them have completed treatment. This rapid adoption in a rare disease is a powerful demonstration of the demand for PAPZIMEOS and the effectiveness of our commercial strategy. Phil will provide more details on these subjects, but we have established our leadership position in RRP, and we continue to rapidly scale our commercial business. Finally, our ability to execute. Precigen achieved full FDA approval of PAPZIMEOS in less than 5 years from IND, demonstrating our ability to translate innovative science into an approved medicine with remarkable speed. We have demonstrated our ability to execute across the entire development and commercialization continuum from innovative science to regulatory approval to a growing profitable commercial business. Today, with more than a year of commercial experience, a strong physician adoption and enthusiastic market reception, we have substantially strengthened that position to sustain and grow our significant first-mover advantage. With that, I will turn the call over to Phil for a closer look at our commercial progress. Phil?

Thank you, Helen. What an extraordinary year it has been for PAPZIMEOS. Just over 1 year after FDA approval, we have moved beyond the foundational phase of our launch and established PAPZIMEOS as the first-line standard of care for adults with RRP. We have activated treatment centers across the country, secured broad payer coverage and established the infrastructure to support treatment in major academic centers, infusion centers and community practices. Our commercial strategy is delivering results and the pace of adoption demonstrates the strong demand for PAPZIMEOS. Third quarter PAPZIMEOS net product revenue reached $72.9 million, bringing launch to date revenues through the end of Q3 to approximately $151 million. These results demonstrate the strength of our launch and the significant momentum we are carrying into the fourth quarter. I want to highlight 4 areas that illustrate the scale of our achievement and the opportunity ahead. First, patient adoption. I mentioned earlier, well over 500 patients have begun treatment with PAs PAPZIMEOS and well over 300 of them have completed treatment. Having spent decades leading oncology and specialty product launches around the world, I believe the speed of adoption we have achieved in just over 1 year is exceptional, particularly in a rare disease historically managed through repeated surgeries. Importantly, PAPZIMEOS is being prescribed across the spectrum of disease severity. A significant proportion of patients treated to date have fewer than 3 surgeries in the preceding 12 months. This demonstrates that physicians are embracing the broad PAPZIMEOS label and integrating treatment into their approach to managing RRP rather than waiting until patients have undergone repeated surgical interventions. We now also have well over 600 patients registered in our hub, reflecting continued patient engagement and demand. And importantly, as I've said previously, hub registrations do not capture all patients receiving treatment. Increasingly, experienced institutions are independently managing patient access and reimbursement through their own established processes. This reflects the success of our efforts to integrate PAPZIMEOS into their clinical workflows without the need for specialized administration equipment or device-specific training. Treatment centers are not simply adopting PAPZIMEOS. They have built the capabilities to support ongoing prescribing and administration independently. Second, broad market access. We have secured coverage representing over 315 million U.S. lives across commercial plans, Medicare and Medicaid, establishing broad access to nearly 100% of insured lives nationwide. Our permanent J-code effective from April 1, 2026, combined with the experienced field reimbursement support and patient assistance resources provides established pathways from prescription to treatment. We started early to remove many of the traditional access barriers encountered during a specialty product launch, and this helped establish the infrastructure to support continued expansion. In my experience, investing ahead of the launch was critical to securing the trajectory we are now seeing. Thirdly, the expansion of our treatment network. We have brought PAPZIMEOS to where patients live. With our established distribution network, we are supplying PAPZIMEOS to treatment sites across the entire country within 24 hours. And importantly, cold chain storage and distribution requirements have not been an impediment to our ability to support broad treatment access. The community uptake we are already seeing is testament to that. Together, our distribution capabilities, expanding treatment network and simple administration regimen have enabled us to scale rapidly across the entire United States. Finally, our first-mover advantage. Over the past year, we have built far more than the distribution network. We have established deep physician relationships, real-world prescribing experience, payer access, reimbursement processes and operational capabilities across the country. And importantly, hundreds of patients have benefited from this work. As the RRP market evolves, any new market entrant must establish physician confidence, secure payer access, build treatment site capabilities and navigate the complexities of commercial adoption. We have already successfully executed each of these critical steps, which reinforces our confidence in our leadership position. We are not building a commercial business from the ground up. We are expanding an established, growing and highly functioning nationwide treatment network. With an estimated 27,000 adults living with RRP in the United States, we believe we are still in the early stages of realizing the blockbuster potential of PAPZIMEOS. Our priority is clear: accelerate the breadth and depth of adoption, capitalize on our established competitive advantage and continue delivering strong, sustainable commercial growth. With that, I'll turn the call over to Harry to review our third quarter financials. Harry?

Thank you, Phil, and hello to all of you participating in our call this afternoon. As Helen and Phil discussed, this was an exciting quarter. PAPZIMEOS revenue of $72.9 million for Q3 drove Precigen to profitability for both the third quarter and the 9-month period ended September 30, 2026, reporting net income of $35.8 million for the quarter and $47.9 million for the 9-month period. We also achieved another significant milestone this quarter, that being the generation of positive cash flow for the quarter. This milestone was achieved ahead of our prior guidance. Our cash and investment balance increased from $38.7 million at the end of June to $51 million at the end of September. That increase was supported in part by $11.9 million in cash generated from operating activities. In my experience, few, if any, companies have achieved similar financial results this quickly after approval of their first drug. Now let me turn to a more detailed discussion of our financial results for the quarter. Total revenues were $74.1 million, which included $72.9 million related to PAPZIMEOS. Our third quarter PAPZIMEOS revenue grew from the second quarter by approximately $20 million or 37% as we saw demand for PAPZIMEOS os continue to build throughout the third quarter. Cost of products and services for the quarter totaled $6.5 million, resulting in a gross margin of $67.6 million or 91%. We continue to expect gross margins related to U.S. PAPZIMEOS sales to stabilize between the high 80 percentages and low 90 percentages going forward. Research and development costs for the quarter was $6.6 million, which compared to the prior year third quarter decreased by $5.7 million. The majority of this change is explained by the fact that PAPZIMEOS manufacturing costs were expensed as R&D costs prior to the FDA approval. Selling, general and administrative expenses for the quarter were $22.4 million, having decreased by $1.6 million from the prior year's third quarter. This decrease was primarily driven by lower performance-based compensation in the current year period, offset by higher compensation and benefit expense related to workforce expansion as well as higher marketing and freight expenses, both of which were driven by the commercial launch of PAPZIMEOS. Other expense net totaled $2.7 million for the third quarter, representing interest expense of $3 million on our $100 million outstanding debt, offset by interest income on investments of approximately $300,000. Turning to the balance sheet. We ended the quarter with $51 million in cash, cash equivalents and investments. In addition, we had $96.5 million in trade accounts receivable on the balance sheet, which based on customer payment terms, we expect to collect over the 4 months following the quarter end. As I noted earlier, we delivered positive cash flow for the quarter with cash provided by operating activities of $11.9 million. This milestone was achieved sooner than we have previously guided. In regards to the company's capital structure, we believe we are well capitalized, taking into account our aforementioned cash and receivable balances along with the availability of an additional $25 million under our debt facility. Based on these factors and in consideration of expanding our portfolio, we do not currently anticipate a need to raise additional capital. Having achieved these strong financial results, we will not rest on our laurels. We will continue to drive PAPZIMEOS revenue growth, allowing us to progress our pipeline in a rapid fashion with the goal of bringing our next drug candidate to market. Before turning it back to Helen, I'd be remiss in not saying that although we are excited about the company's financial results, what makes every Precigen employee proud is the hope we have given the RRP community in fighting this terrible HPV-related disease. I'd like to now turn it back to Helen for a clinical, regulatory and strategic update. Helen?

Thank you, Harry. As we close today's prepared remarks, I want to focus on what comes next for Precigen and how we intend to build on the extraordinary progress we have achieved. PAPZIMEOS has fundamentally changed the treatment paradigm for adults with RRP. It has also transformed Precigen into a growing profitable commercial stage company with the resources, capabilities and a proven strategy to pursue a much broader opportunity, and we are just getting started. Our first priority is to maximize the potential of PAPZIMEOS. In the United States, we have established PAPZIMEOS as the first-line standard of care for adults with RRP. With an estimated 27,000 adult patients in the United States, significant opportunity remains to expand adoption and bring this treatment to more patients. But our vision extends well beyond the currently approved adult indication. We are actively advancing 3 important opportunities to expand the reach and potential of PAPZIMEOS: redosing, pediatric population and global expansion. While we are tremendously pleased with the efficacy with a single course of PAPZIMEOS, we want to give an opportunity for the partial responders to become complete responders through our redosing study. We are also advancing pediatric development. RRP can be particularly devastating in children who may face repeated surgeries beginning early in life with profound consequences for their voice, breathing and quality of life. Our objective is to extend the potential benefits of HPV-specific immunotherapy to the underserved population. Beyond the United States, we are working to bring PAPZIMEOS to patients around the world. Our marketing authorization application is under review by the European Medicines Agency, and PAPZIMEOS has received orphan drug designation from the European Commission. The interest we are seeing from European physicians and the RRP community reinforces the significant unmet need for new treatment options outside of the United States. Our second priority is to unlock the broader potential of AdenoVerse platform. In September, the FDA granted platform technology designation to our AdenoVerse platform, an important achievement made possible by the approval of PAPZIMEOS. Precigen is 1 of 2 companies with an active FDA platform technology designation. This is a defining milestone for Precigen. PAPZIMEOS did more than establish a new treatment for RRP. It provided the foundation for a platform that we believe has the potential to transform how therapies are developed across multiple diseases. The designation creates opportunities to leverage manufacturing and preclinical knowledge generated through the PAPZIMEOS, reduce duplicative development work and engage earlier and more frequently with the FDA as we advance additional AdenoVerse-based therapies. In a practical terms, this means we have an opportunity to build rapidly on what we have already proven rather than starting from the beginning with each new clinical program. We intend to be highly selective in where we invest focusing on programs with compelling scientific rationale, clear unmet medical needs and opportunities to create meaningful value for patients and shareholders. This is not simply about advancing more programs. It is about advancing the right programs with a greater speed, efficiency and the potential for lasting impact. And that brings me to PRGN-2009, our next important opportunity to demonstrate the power of AdenoVerse platform. PRGN-2009 is designed to generate immune responses against HPV-16 and 18, which are associated with several serious diseases, including head and neck and cervical cancers. Importantly, PRGN-2009 is built on the same AdenoVerse backbone as PAPZIMEOS, allowing us to leverage the scientific and development knowledge established through our approved therapy and the FDA platform technology designation. And importantly, at the forthcoming R&D Day, we plan to share new clinical data from our Phase II program in HPV-associated head and neck cancers along with a comprehensive update on PRGN-2009 and our broader AdenoVerse development strategy. As I reflect on where Precigen stands today, I'm incredibly proud of what our team has accomplished. We have brought the first approved therapy to adults with RRP and treated hundreds of patients and counting, established a growing and profitable commercial business and secured an FDA designation that creates new opportunities to accelerate development across our AdenoVerse platform. We have demonstrated our ability to translate innovative science into meaningful therapies with the speed, strategic discipline and exceptional execution. Now we are building on that success. I will now turn the call over to the operator for questions. Operator?

[Operator Instructions] Your first question comes from Jason Butler with Citizens.

Congrats on a strong quarter. Helen, understanding that you're not giving guidance for the fourth quarter, can you help us understand the growth dynamics that you're seeing right now? I mean is the growth you achieved quarter-over-quarter in third quarter sustainable into the fourth quarter? Or just any color you can give us about the trajectory for the rest of the year? And then the follow-up for me is just can you give us any color on the number of patients that -- in your hub, the 600 that have already been treated? Or I guess, looking from a different perspective of the 500 patients that have been treated or started treatment, how many of them are coming from your hub versus other hubs?

Jason, thank you so much. And in regard to the path and what we have seen, it's really extraordinary. For those of us who have been in drug development for a long time, such an uptake of PAPZIMEOS, especially in the past 3 quarters as we go from $21.5 million to 53 million to 73 a continuous expansion. And what we are seeing is the number of patients really having started their treatment and also completing the treatment. This is really an outstanding result that we are seeing, and it has to do directly with what we have said, the unmatched efficacy of this drug at 51% complete response going to safety grade 1 and 2 only, durability of the response, which now these patients have done more than some of them 5 years, and they have continued to be in response. And then finally, the very ease of administration that doesn't require any kind of device or anything else. Having said that, I think from that perspective, we are very confident in our teams as they are moving and with the preparation and the original preparation that they made to make sure that we have a very, very solid commercial path with the agility that you have seen, and we continue to be basically building further more on that and continue with that. But Phil is also -- I'm going to pass it to him and give his opinion as the Chief Commercial Officer of the company and what he thinks.

Yes. Thanks, Helen. Jason. Look, we feel very good about Q4 and the growth prospects based on all the lead indicators that we've seen, whether it's hub, whether it's activation of accounts, new accounts ordering, new patients being treated, they're all heading in the direction that we feel very good about. So we feel good about our growth prospects moving forward. Regarding your second question on the hub, we expect to continue to convert a significant proportion of patients that are in the hub on to treatment. But as you said, we are getting a significant contribution also from patients that never touch our hub because the institutions have built up their own infrastructure to do so. And both of those will be significant contributors to our future growth story.

Your next question comes from Michael DiFiore. Please go ahead.

Two questions for me. I think in the past, you reported coverage across about 350 million lives and attributed additional site activation to getting a permanent J-code. But you also described prior auth as a new workflow for many of these sites or practices. So could you provide any color on what the average time is from prescription to first dose at this juncture in the launch as well as what the authorization approval rates and even abandoned rates are? And separately, my last question is, what are the next decision points for EU, I guess, partnering? And what capabilities or even economics would make a regional partner preferable versus going at it yourselves?

Michael, thank you for the question. First part, I'm going to hand over to Phil, and I will answer the second portion in regard to EU and partnership.

Michael, Phil here. So you're right, 315 million-plus lives covered. We got there in very quick time. We've done a lot of good work before the permanent J-code, but the permanent J-code did help us and has made an impact. I would say that in terms of time from conversion of prescription intent to patient being treated is standard for what you see in a rare disease or oncology. We're settled into that sort of steady-state period. And there's nothing different to what we've seen in oncology or rare disease drug launch. And abandonment rates relatively low. Again, we're having -- our access story, I think, is one of the success stories that we've had in terms of the detailed reimbursement support, prior authorization support and helping these institutions who haven't had that experience get up to speed very quickly so that each and every patient can be supported through that journey.

And maybe I can just add one aspect to what Phil also mentioned. In regard to the number of lives that is covered, I think this is truly unprecedented for a rare disease to achieve almost close to 100% coverage for the adult RRP patients. And again, this, as you can imagine, with the payers, this speaks to the strength of the data and the strength of the efficacy of 51% complete response and the durability of response, which becomes very, very important in regard to the payers. And I think that is a sentiment of what we are seeing the coverage and they see moving. In regard to the expansion of the indication and absolutely in regard to Europe, we are -- of course, our application is under review. And this is, again, part of that strategy that we have spoken for a long period of time that we strategize, pair the strategy correctly with the indication and then we execute on it. And that speaks to -- we came right off the FDA full approval in last year in 2025. And you've seen that we submitted our basically application to EMA by November of 2025 and currently under basically review, which we are very excited about. At the same token, what in the process has happened to our DNA, we always prepare for executing ourselves. But as we have mentioned, we also look at the opportunities, and we have received a number of opportunities from ex U.S., and we are evaluating those partnerships currently. And then we will make a decision as a company, what would be best basically for the execution against that. And we are very excited about the -- basically the reception that we are receiving in regard to our data, the efficacy durability and the value of these drugs for the patient, both in U.S. and ex U.S.

[Operator Instructions] Your next question comes from Zhi Yuan with B. Riley.

Great to see this 30% quarter-over-quarter growth. Can you maybe talk about -- as a follow-up to Jason's question, can you maybe talk about the month-over-month growth that you observed in 3Q and momentum into October? That's my first question. And the second one is related to the redosing trial. Can you maybe talk about the time line there? What's the time interval between the last 4 doses of PAPZIMEOS and the new treatment?

Yes, I can add. Thank you, first of all, for the question. I just want to establish, obviously, we are not going to give any guidance month-to-month basis as we move forward. But clearly, what you have seen is a robust increase in our revenues quarter-over-quarter as we have been moving and really beating the expectation, especially in regard to the rare diseases and the launch for the past year. So with that, I can also add.

Yes, nothing really to add on that growth trajectory. I mean all the lead indicators, as I mentioned earlier, are very positive -- and I guess one of the most significant ones is the number of sites that continue to activate. And by activate, we mean order the drug. And that's been a steady growth story throughout Q3, and we expect to continue moving forward.

And also, what I can further add is in regard to our expansion of the indication with our redosing. Again, we very rapidly have established our redosing trial, which is currently enrolling. And this is -- will add on further in regard to making sure that the partial responders that already have benefited from PAPZIMEOS by reducing even their number of surgery, and they didn't go all the way like our 51% to surgeries, they will be also included in benefiting from the safety efficacy and durability of this drug. At the same token, as I mentioned, that trial has been already not only established, but it's enrolling, and we are anticipating that we will have the data and reporting on that in 2020.

Your next question comes from Charles Wallace with H.C. Wainwright.

This is Charles on for RK. So I think the first for me, so after the competitor got approved on their call, they stressed that there was no surgery needed during their dosing window. So I was just curious in the real-world use of PAPZIMEOS, is surgery required in the dosing window?

Thank you for the question. So first of all, let me be very clear. The surgery is not a requirement that is optional and depending on what the physician see if it's -- and by the way, this is not a surgery MRD. Maybe I should just address the elephant in the room. MRD done for minimum residual disease. And it is well established, not only now in RRP, but also across many other indications, including oncology that MRD is used to maximize also the responses and the immune activation for the patient. Again, it's not a requirement. It's something that is conditional. It's a procedural in RRP patients. And it is very, very important to differentiate that. And by the way, FDA has seen benefit in establishment of MRD across different indications. And for that reason, they have put it in both labels, by the way. And I think that's very important from that perspective. So there is no required surgery -- and for us, it's at the discretion and it's optional according to the. And not every patient that has received PAPZIMEOS or were receiving the PAPZIMEOS requires MRD, and that also has been shown in our pivotal study.

Great. That's very helpful. And then for my follow-up question. So with -- you mentioned well over 500 patients have been treated with PAPZIMEOS and over 300 have completed the full course. So just curious, of these patients, can you maybe categorize how many of them were less severe or fewer prior surgeries? And then at what point do you expect to present the response data in terms of partial responders and complete responders?

So maybe the first part, Phil will take, and I answer the second part.

Yes, it's a great question, Charles. Thank you for that. We expected when we launched that there is potentially a propensity for more severe patients to be selected initially. They are more visible. They're using more health care resources, and there will be a natural unmet need. And I think that's certainly the case. But what we're seeing clearly in our claims data for patients who have been treated thus far is that patients with all surgical histories are being treated, 0 surgeries in the prior 12 months, 1, 2, 3 or more than 3. So it seems that the market is really embracing our broad label across the full spectrum of the disease.

Yes. So in regard to the second question that you had with the full data or complete responders, as you know, our endpoint to start with is having at least minimum of 1 year of a follow-up in order to get all of the data together. And that, obviously, we have followed our pivotal patients even further than that. And as we have reported just recently, which we are very excited, the durability of extending to 5 years and continue. So obviously, when we have a number of our patients that will be finishing the full 12 months and then the follow-up, we will be reporting also on that, and we are very excited about that. And the reason that I say that is very clear from what we are already hearing from the centers in regard to the responses and how the PAPZIMEOS currently, the patients that have been enrolled and treated with PAPZIMEOS, how they are responding to this and the kind of responses that they are seeing, we are really excited about showing that data in the upcoming future.

Your next call comes from Brian Cheng with JPMorgan.

Maybe just first, can you give a little bit more color on the hub conversion to commercial rates that you're seeing here? Has it changed? Has it improved? Is the hub still driving the majority of the new starts that we're seeing? And then I have a follow-up question.

Yes. Brian, Phil here. Hub conversion, we continue to see steady progress in converting patients in the hub. Obviously, we've got more to do as more patients come into the hub, but we're seeing a very healthy conversion rate. And I would say, as I said earlier, both hub and non-hub patients are significantly contributing to the growth that we're seeing.

Great. And then as we think about competitor launch in the near term, Inovio had guided that they will be launching in the new year. What is your commercial preparation to go up against that launch? How do you shore up the existing patient demand? How do you make sure that the demand will still continue to lean on your product to lean on PAPZIMEOS going forward into the new year?

Yes. Thanks, Brian. Great question. So obviously, as any good commercial team in the industry would do, we've always factored in a scenario where there would be competition. So it's no surprise to us, and we're obviously very well prepared. We stand by our assertion that PAPZIMEOS will be the clearly preferred drug in a competitive situation. We got a clear signal from the market even before we launched based upon our 51% complete response rate, our safety with no grade 3 or more adverse events. We -- our durability obviously has strengthened that position and our mode of administration, simple subcutaneous injection. All of those things factored in HCPs telling us that we were clearly the preferred choice. And since launch, our launch, nothing has really changed other than the durability has got more durable. And we've got well over 500 patients now of experience in the hands of physicians in the marketplace to reinforce that belief. And Helen mentioned the excellent reaction we're getting from patients who are currently being treated and the physicians who are treating them. So I think from what I understand from public messages that there's still several months away before the competition will be operationally up to speed. And as I said in my prepared remarks, we've moved beyond the critical foundational aspects of launch. We've won formularies. We've got payer policies. We've got -- we've had the permanent J-code in the rearview mirror for more than 6 months. And we're now in a consolidation and expansion mode. So any new competitor that comes into the market has to address all of those things to get up to speed and then to be in a position to compete. So we continue our momentum. We're very confident that all of those things mean that we will solidify our leadership position over the next few quarters.

Thank you. Ladies and gentlemen, that concludes today's Q&A session. I will turn the call back over to Dr. Helen Sabzevari for concluding remarks.

Thank you, operator. And I just want to thank you and thank everyone for joining us today. And I would say we are looking forward to our next quarter and also to our R&D Day. So please stay tuned.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.