Precigen, Inc.

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Good afternoon, ladies and gentlemen, and welcome to the President's First Quarter 2026 Financial Results and Business Updates Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, May 13, 2026. And I would now like to turn the conference over to Mr. Steven Karasim. Please go ahead, sir.

Thank you, operator, and thank you for all those joining us today for our Q1 2026 update call. Joining me today are Dr. Helen Sabzabari, our president and CEO, Phil Tennant, our chief commercial officer, Harry Tomasi, our CFO, and Ritul Shah, our COO. Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements during this call. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation, as well as our SEC filings, which include risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that, I will now turn the call over to Dr. Sabzabari.

Thank you, Steve, and thank you to all those joining us for our Q1 update call. The approval of Paximius in August of 2025 has brought a novel first-line standard of care treatment for adults with RRP. In nine short months, we have witnessed tremendous progress with the first commercial therapeutic launch in the disease's history. Since last reporting in March, the launch has continued to show accelerating momentum. The early success and trajectory continues to build on this landmark achievement for the patients, families, healthcare providers, the RRP Foundation, and all of those impacted by this devastating disease. I will begin by providing you with some general color around what we are seeing, and then turn the call over to Phil, who will provide more specifics around commercialization. The accelerating trajectory we are seeing in revenue growth is robust. As reported in our quarterly report, Paximius net product revenue for Q1 2026, the first full quarter of availability was $21.6 million as compared to $3.4 million in Q4 2025. Prescribers continue to add Pepsimus to their practices at both major medical centers and community practices alike, which has been a strong tailwind as we are seeing this increasing momentum continue into Q2. This is a clear signal of the high level of enthusiasm among patients and physicians, resulting in significant uptake of the therapy. Why we believe we are seeing such a significant launch trajectory. First, the full approval and broad label from the FDA. There are no restrictions on the number of surgeries a patient must undergo prior to treatment with Pepsimus. We are seeing this as patients are being dosed across all severities and in the extensive payer coverage we have secured. the transformative clinical data based on significant efficacy, durable and ongoing responses with the median duration of follow-up of three years. Importantly, we look forward to updating the ongoing durability data at ASCO next month. Third, the ease of administration of the drug has enabled broad and rapid uptake at not just the major medical institution, but increasingly at community practices. Specifically, the ease of dosing as well as the efficient distribution infrastructure we have in place across the country allow rapid and effective integration into routine clinical practices. Finally, the power of this therapy is strongly supported by a landmark expert position paper released earlier this year. The paper, sponsored by the RRP Foundation and authored by 16 leading U.S. physicians specializing in RRP, was published in the Laryngoscope, the premier peer-reviewed journal in otolaryngology. The paper recommends Paximius as the new standard of care and the preferred first-line therapy. Collectively, these factors mean that Paximius has set a new benchmark for this space, prioritizing medical therapy over repeated surgical interventions to improve patients' outcomes. As a reminder, this therapy directly addresses the root cause of RRP by eliciting a targeted immune response against HPV611. Popsimus also offers the potential for redosing due to its mechanism of action and favorable safety profile. We are evaluating this in an ongoing clinical trial, which is enrolling patients as we speak. I will now turn the call over to Phil for details around our commercial launch. Phil?

Thank you, Helen, and a warm welcome to all those listening. I'm delighted to share the most recent progress of our launch efforts with details around the completion of Q1 and the sharp momentum we continue to see with Pepsimios launch in Q2 of this year. As seen in our filings, we showed strong quarter-over-quarter product revenue growth in Q1, 2026, clearly demonstrating the expected acceleration of product uptake from 3.4 million to 21.6 million. As we report today, we continue to see comprehensive payer coverage and further activation of accounts across the country. I will now present some of the leading indicators we are observing as of today, translating to the launch acceleration. Registrations in the Pap Simios patient hub continue to grow. As of today, we have approximately 400 patients registered, of which 25% are in the community setting, underscoring the broad reach of Pap Simios beyond academic and major centers and reinforcing that Pap Simios can be effectively integrated into routine clinical practice beyond major centers. As previously mentioned, this does not account for non-HERB patients directly enrolled by institutions. This continues to support the fact that there is expected pent-up demand for the new standard of care for adults with RRP. Payer coverage has been exceptional and provides a solid platform for patient access to pap simios. Total lives covered through commercial Medicare and Medicaid stands at an estimated 297 million. All-inclusive, this equates to more than 90% of insured lives covered in the U.S. As expected, we continue to see activation of accounts who are prescribing and ordering pap simios across both major medical centers and community practices. We are seeing this trend continue into Q2, further fueled by the permanent J-code and the dedicated field reimbursement resources we have implemented. As Helen mentioned earlier, the expert position paper continues to solidify Papazemios as the first choice for adult patients and treating physicians. We continue to have a significant presence at major scientific congresses in the U.S. and beyond, both through publications and presentations and interactions with thought leaders and the broader treatment community. This, again, reinforces the strong receptivity to Papazemios that we are seeing from the market. These congresses will continue to be a significant part of our commercial and scientific strategy moving forward. The assignment of the permanent JCODE on April 1st, coupled with the durability of response that we are seeing in patients, is helping this impetus continue. The permanent JCODE designation will further simplify claims processing and facilitate broader patient access through both medical centers and community practices. The significant quarter-over-quarter revenue growth is a clear sign that the healthcare community is embracing Pepsimios. We are thrilled with launch performance in Q1 and expect these positive trends to continue into Q2 and beyond. I look forward to sharing those Q2 results in August. I'll now turn the call over to Harry for an overview of our Q1 financials. Harry.

Thank you, Phil, and good afternoon to all of the participants on today's call. As you've already heard, we're extremely pleased with our top line financial results for the first quarter. I also want to add that not only do we surpass $21 million in Pepsimios revenue, but our operating loss for the quarter is only $6 million. Let me provide some further color on our overall financial results for the quarter. Total revenue was $23.3 million, which included $21.6 million related to PEP CMEOS sales. We saw demand for PEP CMEOS continue to build as the first quarter progressed, and we're continuing to see that demand increase as we enter the second quarter. Research and development costs for the quarter were $5.6 million, which compared to the prior year first quarter decreased by $4.8 million. The majority of this change is explained by the fact that Pepsimeo's manufacturing costs were expensed prior to the FDA approval. As we look forward, we anticipate R&D expense will increase as the year progresses. Selling, general, and administrative expenses for the quarter were $21 million, having increased by $8.7 million from the prior year's first quarter. The increase was significantly driven by increased commercial activities related to Pepsimios. Moving down the statement of operations, as I noted earlier, our operating loss for the quarter was $6 million. Our net loss for the quarter was $7.9 million, or two cents per basic and diluted share. Turning to the balance sheet, we ended the quarter with $56.7 million in cash, cash equivalents, and investments. I do want to point out that our cash used in operations for the quarter was $43.8 million and included $13 million of cash outflows that we do not expect to recur in future quarters this year. The first quarter cash used also did not include any cash receipts from Pepsimeo sales based on customer payment terms. With that said, we expect cash used in operations in the second quarter to be significantly lower than what we saw in Q1. We continue to reiterate that, based on our current financial forecast, our cash, cash equivalents, and investments, along with a collection of PEP CMEOS receivables, will fund operations through cash flow breakeven by the end of 2026. and we currently do not see a need to access capital markets for additional funding. I'd like to now turn it back to Helen for some closing remarks. Helen?

Thank you, Harry. I will now provide updates on the portfolio, starting with Papzimius clinical and regulatory updates. We intend on initiating a pediatric trial in Papzimius in Q4 of this year, as previously mentioned. In addition, our marketing authorization application continues under the review path by EMA for Proxima. We are also pleased to announce our sponsorship of a third annual RRP Awareness Day in June. This event provides another excellent platform to raise global awareness of RRP and the newest standard of care for its treatment in the U.S. Now turning to PRGN-2009. This is the same backbone as our approved therapy PAP-semias, expanding the proven adenovirus platform. Our PRGN-2009 immunotherapy is designed to train the immune system to recognize and eliminate tumor cells infected with HPV-16 and HPV-18. the root cause of major HPV-driven cancers such as head and neck and cervical cancers. These malignancies together represent nearly 5% of all cancer cases worldwide. TRGN 2009 is advancing in multiple Phase II clinical trials in combination with PEMBRO in both head and neck and cervical cancers. I am very enthusiastic about the prospects of this program. We plan to provide updates on the program later in the year. With that, I will now turn the call over to the operator for Q&A.

Operator?

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star four by the one on your telephone keypad. You will hear a prompt that your hand has been raised. And should you wish to cancel your request, please press star followed by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question.

Thank you.

And your first question comes from the line of Jason Butler from Citizens. Please go ahead.

Hi, thanks for taking the questions, and congrats on the quarter and the progress with pap simios. A couple from me. First of all, can you speak to the number of patients that have now received at least the first dose, and if you're now also seeing patients complete the full course of therapy? Second question, on the redosing trial, can you just maybe hit a couple of the design highlights for the trial and when we may see initial cuts of data? And then last one from me on PRGM 2009. So the update that you'll give later this year, can we expect to see any results from the ongoing phase two trials in that update? Thank you.

Thank you, Jason, for the question. So in regards to the first question, I'm going to hand it over to Phil, and then I will take the last two questions.

Hey, Jason. Thanks for the question. Yeah, we're not commenting on the specific number of patients who have actually been initiated on treatment, but it's As you can see from the revenue number, we're obviously making some very good progress there. And yes, given that we started our dosing in November and it's a 12-week regimen, then yes, absolutely, we are starting to see patients who have completed treatment.

Yeah. And maybe I can also add that very clearly as patients are being dosed and finishing, all of the patients have received their doses. So this is, again, going back to the original scenario. data that we have presented on the safety and efficacy and durability of pap smear, which again points to that factor and ease of administration. In regard to the second question on redosing, we have currently started the redosing of the patient, especially the patients that they had a partial responses in our previous treatment. in our previous trials, in Tevital trials, and we have started with that. And clearly, our patients that are being dosed right now commercially, obviously, we are very much excited. And from what we are hearing from the fields, the physicians are extremely excited about some of the results that are seen currently. So for now, we are focusing on the partial responders that were in our original trials, and we are gathering the information on that, and we will be reporting from that perspective. In regard to the PRG in 2009, the answer is absolutely. We will be reporting data. And actually, we are looking forward to that. This is, as we have mentioned, our phase two trials, both especially on the head and neck. That is in combination with PEMBRO. And I think what is very important, these are open-label trials. So we obviously have had and have continuous opportunity to follow the data, and we are looking forward to be sharing this in the second half of this year.

Great. Thanks again, and congrats again on the quarter.

Thank you. Thanks, Jason.

Thank you. And your next question comes from the line of Brian Chang from JPMorgan. Please go ahead.

Hey, guys. Thanks for taking our questions this afternoon, and congrats on the quarter. Maybe just first, out of the 400 patients that are currently in the hub, can you talk about the pace of conversion that you're seeing to commercial products? And just curious if you can talk a little bit about just the pace of also recruitment into the hub. Are you seeing any upticks since you launched? Just curious if you can talk about the pace there, and then we have a follow-up. Thank you.

Sure. Hey, Brian. Thanks for the question. So Phil here. So I think the revenue is probably the first thing that speaks to the pace of conversion of the patients. It's a little early to go into definitive details on that. We are looking at that, of course, and I think with the advent of the J-code, the permanent J-code, that's something that over the next couple of quarters we'll do a deep dive on to understand exactly how quickly and how many of these patients are being converted and how we can help. We've implemented dedicated field resources to assist in that conversion. And, you know, the momentum that we're seeing coming into Q2 suggests that we're making great progress there. In terms of the pace of recruitment into the hub, I mean, you've seen the numbers steadily increase as we've started to report on hub numbers. And remember, this is only the Presagen hub that we are commenting on. And there's a significant number of patients who are not using our hub who are being identified and treated. So that's another dynamic that is important.

Yeah. And perhaps, Brian, I can also add this to Talyn. I think what is very important, and Phil pointed that out, is also the number of the patients that are coming through the community centers, because this is extremely important. And as we reported, now we have 25% of the patients are coming from community. So this really points out not only the large or expanded efforts on medical centers, but now the community docs and the centers are participating. And again, a lot of those are not necessarily in the hubs and they are treating the patients as we speak. And also another important point This is not basically in regard of doesn't matter the severity of the patient, which is very, very important. Again, so we are very excited about the reach and the way that Paptenius has been basically embraced by physicians and patients.

Thank you, Helen. Maybe just a follow-up here. As we think about how to model second quarter and obviously moving into the rest of the year, are there any specific considerations that we should really think through as we run through our modeling exercise on 2Q, 3Q, and so on? And just like you did for the first quarter number, are you able to provide some guardrail in terms of what we could see numerically for the second quarter number? Thank you.

Okay. Yeah. Thank you, Brian, for the question. So clearly, we have said we are not at this moment providing the guidance. However, as you saw from Q4 to Q1, and we have gone to over 21.5 million And also we have acceleration, as you have seen, in really treatment and expansion of the treatment, both at medical centers and community centers. I think we are looking forward definitely to our Q2 and the results that we will be sharing as far as revenue is concerned. And as Phil said, I think the revenue will speak for itself as it gets presented, which really shows the bringing in the number of the patients continuously and the treatment as we are expanding. And one of the good indicators, you can see that just from our hub, again, which is limited because it's only our hub and doesn't include patients from the others necessarily, You can see a continuous expansion in the number of the patients or increase in the number of patients, which is, again, speaks to the fact that this therapy is very much in an accelerated fashion is taken up by the field. And one other thing that maybe I can speak to and Phil can add is from a perspective of what we are seeing at the conferences and the fact that how the physicians are speaking and basically putting the patients on these treatments. And it's really amazing and it's quite encouraging in regard to what they have to tell.

Yeah, I would just add, Brian, that there's a few things that we're very confident about and looking forward to reporting on more. Obviously, the strong payer position we cemented quite early and that gives us a firm foundation for what's to come. I would say, as Helen mentioned, we expect the continued activation of accounts who are ordering and using Pepsimios, and not only in the IDNs, but in the community, and we would expect that community trend to continue to strengthen. And ultimately, the patient identification in line with our broad label to continue as we go through Q2 and beyond. And ultimately, all of that is laying the firm foundation for the long-term success of the product over multiple quarters and years, and not just over a single quarter.

Great. Thank you, Phil. Thanks for the color. And congrats on the quarter again. Thank you.

Thank you. Once again, dotted star and one to ask a question. And your next question comes from the line of from H.C. Wainwright. Please go ahead.

Thank you. Good afternoon, Helen, Phil, and team. obviously a fantastic quarter with $21.6 million in revenues. Phil, if you can help us understand that number a little bit more in terms of what portion of that was either part of pent-up demand or flow from Q4 to Q1 in terms of getting the payer policies processes set up versus patients were who were treated in the same vein you know you disclosed 400 patients in the hub with 25% you know coming from the community so how much how many of these 400 or so patients that you have in the hub have been infused at this point and also you know, what's the average time somebody takes from enrollment to getting dosed? And the last question for me is on the data itself that's expected at the ASCO conference in terms of the durability data. You know, how should we think about that data? Would that be helpful and supportive of any label expansions? And also, how should we think about that in terms of the current studies, whether it is pediatric or re-dosing, will that give us some sort of a feel for how these studies should eventually read out? Thanks for taking my questions.

Thank you very much, RJ, for the questions. This is Ellen. And maybe I take the last question first, and then I will give the rest to Phil. In regard to the APCO presentation, we are actually very excited about the durability response and the data that is going to be presented at APCO. Clearly, we continue seeing the same kind of momentum as far as both safety, durability of response, and the efficacy that we have reported, and we are now building further on that at APCO. So this is all going to be quite exciting for us. And yes, that data will be helping in further really adding for the durability of the response and expansion of the indication. So we are looking forward to that. And also, that data further adds to really the robustness of the platform. which is simply this is something that we are very excited about, the Adenovirus platform to be used across a number of the indication, and specifically on HPV-related indication, both in rare diseases but also in oncology. And we think that that data is another feather in the cap of Adenovirus platform. which we are moving towards the platform designation with. So with that, I'm going to hand it to Phil to answer the other question.

Hey, RK, thanks for the question. So let me tackle your hub question first. I did refer to this a little earlier. I think we'd like to see another couple of quarters before we communicate details of exactly the hub conversion and time to conversion and so on. I mean, what I would say is that it's pretty much as expected at the moment. But I think we do need another quarter or two to really understand the meaningful trends there. Your first question was about carryover revenue. Yes, absolutely. Given that we've got a three-month or 12-week regimen, at the end of each quarter, you will see some revenue spill over into the next quarter. I would say from Q4 into Q1, that was pretty minimal, given the level of revenue that we had in Q4. But you would expect that to be more as we go forward. And, you know, the key thing there is that it's new patients that are fueling the business opportunity that we've seen in Q1.

Maybe I can add to that, that what, especially with what achievement with the J code, that has been also extremely helpful. in not only for institutes to be able to process the patient through much more rapidly, and I think we are seeing that trajectory going up, and we are seeing the same thing actually in Q2. So we are very excited about that.

Thank you. Thanks for taking all my questions.

Thank you.

Thank you, and there are no further questions at this time. I will now hand the call back to Dr. Helen Sabsevari for any closing remarks.

Thank you, operator, and thank you for all of the thoughtful questions. We appreciate the opportunity to provide you with this update on this historic product launch. I believe we are building the foundation of a meaningful full portfolio for Precision and for the community of our patients. We look forward to updating you as the launch continues and specifically also further on our portfolio progress. With that, I wish everyone a wonderful evening. Thank you.

Thank you, and this concludes today's call. Thank you for participating. You may all disconnect.