Precigen, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Precision Third Quarter 2025 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 Thursday, November 13, 2025. I would now like to turn the conference over to Steve Harasim. Please go ahead.

Thank you, Operator, and thank you to all those joining us for our third quarter 2025 update call. Joining me today are Helen Sabzabari, our President and CEO, Phil Tennant, our Chief Commercial Officer, Ritul Shah, our Chief Operating Officer, and Harry Tomasi, our CFO. Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation and in 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 Helen. Helen?

Thank you, Steve, and thank you to all those joining us for our third quarterly update call. The approval of Paximius in August marked a monumental turning point for all those impacted by recurrent respiratory papillomatosis, or RRP. Patients, families, physicians, and the RRP Foundation alike. We would like to welcome you to the new era of RRP treatment with Pepsimus poised to become the standard of care. Pepsimus is the first and only available treatment for adults with RRP, and it represents the best data, and that's by a wide margin, ever generated in adults with RRP. Why is pap smear a groundbreaking therapy? Let's look at the facts. First, pap smear addresses underlying root cause of RRP by generating an immune response against HPV6 and 11-infected papilloma cells. Secondly, pap smear has demonstrated transformative clinical benefit. What do I mean by that? 51% of patients achieved complete response requiring no surgery for 12 months post-treatment, with the durability shown in 15 of 18 complete responders remaining surgery-free at medium duration of three years without any additional treatment. Also, Overall, 86% of our patients had reduction in their surgical burden after Pepsimus treatment. Pepsimus has a very favorable safety profile with nothing greater than grade 2 TRAs, which are similar to those of all receiving a flu vaccine, for instance. Also, the ease of administration of pap smear, it's given as a subcutaneous administration that can be administered at any clinic or any of the physician offices. Furthermore, pap smear is not associated with a painful device necessary for administration. Let me be very clear here. We have treated the most severe RRP patients and demonstrated unmatched complete response rate, which has been durable with excellent safety profile. Based on the RRP pathology, it is easy to extrapolate pap smear results to a less severe patient population, which has been reflected in FDA's review and subsequent grant of a broad label for all adult RRP patients, irrespective of severity of their disease. In contrast, it is very difficult to extrapolate the results achieved in a less severe patient population to a more severe RRP population, as is the case with the competitor. I would like to emphasize that PAP-semias pivotal study is the first and today the only clinical trial in RRP conducted with this robust, prospectively defined statistical primary endpoint. PAP-semias clinical data not only beat the high statistical bar set for the pivotal study using the most robust clinical efficacy endpoints ever evaluated in RRP, It furthermore demonstrated the strongest data shown to date for RRP. In summary, Papsinias was granted full approval by the FDA with a broad label of adult RRP that does not include restriction on a number of prior surgeries. This is a testament to the transformative clinical data. that include unmatched efficacy and a strong, ongoing, durable responses from a pivotal study with a prospectively defined statistical primary efficacy endpoints of complete response rate. In addition, due to the mechanism of action of Papzimius, there is an opportunity for redosing of Papzimius. And with full approval, we have significantly raised the bar for clinical data for any competitor to enter the adult RRPA space in the future. This approval also marks a pivotal transition for Precision, propelling the company into a commercial stage, delivering this transformative therapy to market with exceptional speed and agility is a remarkable achievement. In the short time since approval, we have made great strides toward recognizing the robust commercial opportunity and building this strong foundation for pap smear to be the newest standard of care treatment. As always, our dialogue with the FDA continues to be very productive. including the completion of a successful post-approval meeting. We are currently working toward initiation of Paximius clinical trial for the pediatric RRP population. In addition, we have initiated our efforts for geographic expansion of Paximius. With that in mind, I'm pleased to announce that we have submitted marketing authorization application with the EMA. I will now turn the call over to our Chief Commercial Officer, Phil, to walk us through our commercial development. Phil?

Thank you, Helen, and I am delighted to share with you all today the exciting progress we are making with the launch of Pepsimios. We've achieved a lot in a relatively short space of time. As a reminder, the approval in mid-August was the trigger to bring the full sales team of 18 key account managers on, who were hired, onboarded, and deployed in September. In the few weeks since full team deployment, we have made great progress towards our goal of quickly establishing Papazinos as the new standard of care for adults with RRP. So, let me highlight the key achievements to date. Firstly, the drug is available and has started shipping to prescribers in the U.S. for the treatment of all adults with RRP. Our field team has now engaged with 90% of our target institutions, which cover a significant portion of the 27,000 adult patients with RRP. These engagements are focused on supporting and expediting the formulary inclusion process. And we have been very impressed by the enthusiasm of the HCPs in accelerating that process. We have already seen multiple formulary approvals nationally. We're also working with HCPs in those institutions to enroll patients who are waiting for treatment. To that end, we have over 100 patients registered in our Precision Patient Services Hub. And a significantly larger number also being processed through institutions' own patient services teams. In line with our expectations, there is clearly pent-up demand that these hospital systems that is now being processed for treatment with PrEPzimios. It's not just the large academic sites or IDNs that are expressing an interest in PrEPzimios. We're also making good progress with a number of community practices to expedite product uptake. including some of the supergroups affiliated to ENT and oncology networks around the country. This clearly reinforces what we heard in our market research ahead of launch, and we're now seeing in practice. There is strong preference for papzimios due to its efficacy, durability, safety, and mode of administration. The drug can be shipped anywhere, as well as stored and forward easily. No device needed, no training on device needed, just a simple subcutaneous injection, and as Helen said, no need for painful electroporation. Payer coverage is advancing rapidly. As of last week, over 80 million lives are covered, and a number of other policy updates are expected to be announced in the near future. Importantly, pap smear is also covered through Medicare and Medicaid. Suffice it to say we're extremely pleased with this momentum, which is in line with our expectations. Finally, we're seeing strong support from physicians, whether from a large institution or a community practice, again reflective of the speed at which our teams have engaged with our target customers. We continue to see strong support and advocacy from the RRP Foundation. We have published important new data regarding the significant burden of RRP both at the individual level and to the healthcare system, including the data released this week at the ISFOR meeting in Europe. These data, coupled with the impressive and evolving durability profile of Pepsineos, is helping to propel us forward as we look to establish a new treatment paradigm. In summary, we are extremely pleased with the progress being made. The market is embracing Pepsineos as expected, And we also expect to further build on this momentum throughout the rest of Q4 and into Q1 2026. I look forward to continuing to share further progress across key indicators of success as we complete Q4 and move into the new year. I will now turn the call over to our Chief Operating Officer, Ritul Shah, to give a brief update on manufacturing. Ritul.

Thank you, Phil, and good afternoon, everyone. I'm excited to share Pepsimio's manufacturing operations updates today. As part of our strategic commitment to long-term value creation, we have made significant investments to have control over our CGMP manufacturing operations. We operate a dedicated in-house CGMP facility for commercial Pepsimio's drug substance manufacturing. Our facility has been fully operational, had a successful pre-approval inspection by the FDA and has been manufacturing Pepsimus drug substance since prior to approval. With significant in-house expertise in the production of adenoviral vectors, we are executing on our operational plan to supply Pepsimus to both current and anticipated future demand. I'd like to take the opportunity today to briefly address the cold chain requirement of Pepsimus. We have done our homework in detail regarding this topic, and our interactions indicate no impact on the adoption of Pepsimus. In fact, post-COVID, the significant majority of our target IDNs and community centers are equipped to handle frozen drug products like Pepsimus. We have end-to-end validated logistics in place to distribute Pepsimus efficiently, and as Phil mentioned, drug product is available, on the shelf, is being ordered, and shipped to our customers. With that, I'd like to turn the call over to Harry, our Chief Financial Officer, for a financial update. Harry?

Thank you, Ratul, and good afternoon to those participating in this call. Before touching on the quarter, I want to thank our longstanding term shareholders for providing us the support necessary to the development and ultimate approval of Pepsimeos. It has been less than five years for this drug to go from the lab to approval, and we could not have achieved this momentous feat without your support. In addition, I'd like to say that I am proud to be part of the team that has provided patients with the first and only therapy targeting the root cause of RRP. Turning to our quarterly financial statements, specifically starting with our balance sheet, at September 30th, 2025, we had $123.6 million in cash, cash equivalents, and investments, following our recent drawdown of the first tranche of our credit facility, which was entered into during the quarter. We expect this balance, plus our projected revenues from PEP CMEOS, to fund our operations to cash breakeven, which includes continuing Pepsimeo's launch costs and further development of our pipeline. I want to pause and repeat this point. We expect that our cash and investment balance plus expected projected revenues from Pepsimeo's to fund our operations to cash breakeven. We remain confident in Precision's financial future as we continue to execute our upcoming milestones. Additionally, on the balance sheet, we ended the quarter with approximately $3 million in inventory, which represents the manufacturing costs that we have incurred subsequent to the approval of Pepsimeos. Costs incurred in manufacturing the product prior to the approval have been expensed as part of our R&D expenses. Lastly, during the quarter, all of our preferred shares were converted into common shares, providing a simplified capital structure going forward. In regard to our statement of operations, the one item to note within our operating expenses is the increase to our SG&A costs of approximately $14 million between the quarter ended September 30, 2025 versus the same quarter in the prior period. The majority of this increase was driven by increased commercialization spending related to the PEP CMEOS launch, and to a lesser extent, additional employee-related costs, most of which is attributable to the accounting for share-based awards. Additionally, our net loss attributable to common shareholders for the quarter ended September 30, 2025, includes two large accounting-related non-cash items. a change in the warrant liability, and a deemed dividend related to the conversion of our preferred shares. Those two items combined represent 95 cents per share of the $1.06 per share loss attributable to common shareholders. We do not expect these two items to recur in future periods. For more information on our financial statements, I refer you to today's press release and our 10-Q, which was filed with the SEC after market closed this afternoon. I do want to provide certain guidance relating to our gross-to-net revenue adjustment. We anticipate that this adjustment will be in the high teens to low 20%, which is consistent with peers in our industry. Lastly, it has been quite a year of precedent. As we prepared for the approval of PEP-CMEOS, we made a number of infrastructure investments, including the implementation of a new ERP system this past year. With these investments, we have positioned Precision with appropriate systems, personnel, and controls to manage the various processes of a commercial company.

With that, I'd like to turn it over to the operator for Q&A. Operator?

Ladies and gentlemen, we will now begin the question and answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. If you would like to withdraw from the polling process, please press star then the number two. If you are using a speakerphone, please lift your handset before pressing any case. Please be advised that we will only be taking one question and one follow-up per participant.

One moment while we prepare the Q&A roster. 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 launch. I'm wondering if you can give us any color on whether any patients have received reimbursement approvals yet or whether any patients have been dosed with the first dose of Pepsimios. And then the follow-up is how should we think about the cadence of the pull-through from patients that are now registered in the hub to getting reimbursed drug. Thank you.

Thank you, Jason. And I think for the first question, and I would refer to our chief commercial officer, Phil.

Sure. Hi, Jason. Yeah, Phil here. Good to speak to you. So, you know, as we mentioned, we've started shipping pap simios to institutions basically for patients who are being scheduled for treatment as we speak. And as I mentioned, we've got payer coverage coming through thick and fast. So those two things are coming together. And we're not going to go into details about specific patients being dosed at the moment. But I think in Q4, we'll see that come through. And we'll be, when we report our Q4 earnings, we'll be able to talk specifically to numbers of patients dosed and, of course, the earnings and the revenues that go along with that. Oh, the second question regarding patients in the hub. Again, you know, they're sitting there now ready for benefit verification and prior authorization. So, you know, and we're also seeing a whole load of those patients who are not necessarily in our hub but are going through the institution's own patient services systems. So, you know, that pull-through will be institution by institution, but we expect that to be starting to pick up the pace as we go through Q4 as these processes come together, both on the institution side and the payer side. But we're very pleased with the number of patients that we're seeing coming into the top of the funnel ready to be activated and treated.

Sorry, can I just squeeze in a quick clarification point there? Phil, do you expect the majority of patients that go into one of the hubs to actually become, to pull through into receiving drug?

That would be our expectation, yes.

And Jason, maybe I can add on. These patients, both the ones that are being registered at the Tapsimius hub or at the centers that they have their own registration hubs, basically they are various adult RRP patients. that through their physicians have been identified for the treatment and will be joining to receive. So that's very exciting. And I think prior to approval of pap smear, our analysis had shown that there will be a large patient population and as you have seen it, The estimate is 27,000 in the United States. And it's really important to say that we are seeing that kind of a demand coming through from the various centers.

And just to reinforce, Jason, a lot of these centers, they prefer to use their own expertise and systems and patient services initially. Now, obviously, if they want to explore co-pay support or free drugs, support where, for appropriate patients, they would need to ultimately come into our hub. So we've, as you said, sort of got these two hub components that are coexisting at the moment, both of which suggest that the pent-up demand that we identified is absolutely there.

Your next question comes from the line of Soyam Pakula Ramakant from HC Wainwright.

Please go ahead.

Thank you. Congratulations, everybody, everyone on the team there. It's a great moment and it's a transitory quarter for you guys. Excellent. So for my one question, I want to check with Harry regarding the statement saying that you are funded to cash flow break-even. which is obviously a significant statement you're making. What sort of assumptions are you taking into this in terms of either revenue or patient penetration? How should we think to get there?

Yeah, okay, good to talk to you and appreciate the question. I would say at this point, we're not guiding on revenue. So it's kind of difficult to say, you know, when or how we get to cash flow breakeven, but I think we're willing to state that by the end of 2026 will be cash flow breakeven.

Okay. Okay. Thank you. Our next question comes from the line of Michael DeFure from Evercore ISI.

Please go ahead.

Hi, guys. Thanks so much for taking my question, and huge congrats on all the progress here. Number one, just given the obvious pent-up demand and bolus of patients that are expected to go on therapy soon, could you give us any color as to how long that bolus may last, just considering the reimbursement hurdles that any new therapy encounters during the first year?

And I have a follow-up.

Well, we've looked at analogs of rare diseases and the uptake, you know, where you do have pent-up demand. So we think that that's going to last for quite a while. The 27,000 adult patients that we've identified are already there in the system. Obviously, some more severe than others. Some see the healthcare practitioner more often than others. But those are the patients that are actually there in the treatment, and then you would have the incident population on top of that. So I think this bolus of patients is going to be there for quite a while to come.

And Michael, maybe I can also further add the importance of broad labels, which covers basically all adult RRP, which means anyone who is also going to be diagnosed immediately or they had for instance, even one surgery, and it will be continuously added to these hubs for the treatment. And it's very clear, at least from what we are seeing from the patients' enthusiasm, as well as the physicians'. that based on the data that has been published from Hopkins prior, that basically patients by fifth surgery, they have irreversible damages to their either trachea or vocal cords. Clearly, now the patients, as early as their diagnosis, they will be joining. So the pent-up demand obviously is All of the severe patients, but also now all of the patients that have been diagnosed or undergoing diagnosis, they are basically eligible to receive their pap smears and their physician. Actually, this is the importance. For instance, if you look at our press release today, Dr. Best, which is one of the renowned physicians for the treatment of RRP in the world, he refers to pap smear as nothing short of remarkable data for these patients' treatment of adult RRP. And then also positioning it, it's poised to become a standard of care, which then covers all that population. And I think that's very important.

Excellent. Thank you for that, Helen. And just my quick follow-up is, just for modeling purposes, how should we think about subsequent cycles of therapy? And would payers even allow subsequent cycles beyond the first four doses?

Yeah, I think this is an excellent question. First of all, it's very important, and this was one of the interesting concepts that FDA has encouraged us very much for the redosing of the pap smear. and for the expansion of that. And the reason has been based on the safety, obviously the efficacy, and the durability of the response and results that we have seen. And at the moment, of course, in the label, it's at the discretion of the physician in order to redose. So if they feel that the patient needs to be redosed, they can prescribe to that. And, of course, as we are moving forward, we are generating further data on redosing of the patients. So I think there is a huge expansion from that side. And one of the other things that we have mentioned is that our partial responders, as I mentioned, 86% of our patients, they reduce their number of surgeries. And it's very, very important. And that was part of the discussions along for our BLA that clearly they will benefit, it seems, from the redosing because their immune system is being enhanced to address the root cause of this disease, which is HPV 6 and 11. And I think this is one of the areas that we are also expanding besides our pediatric clinical trials. It's further generation of the data on the dosing of the patients, redosing of the patients, I should say, which is initiated in the next year.

And I would just add from a payer perspective, you know, the one characteristic of the drug that really stands out for them and will support us in any redosing conversations is the durability. You know, so we started off with the one year from our clinical registrational studies. We then get the two-year follow-up in our label. We've just published our three-year data and All of this is very important data for the payers, and obviously we share that with them, build that into our value proposition so that we can support the concept of redosing.

Your last question is from the line of Brian Chang from JPMorgan. Please go ahead.

Hey, guys. Thanks for taking our questions, and congrats on your progress here. I just want to clarify how you record Pepsimil's revenue on your financial statements. Do you recognize revenue following each injection or at the end of the four injections and as a follow-up? Thank you.

Hey, Brian. This is Harry. Thanks for the question. Yeah, we recognize revenue when title transfers to, we're either shipping through a specialty pharmacy or directly to the IDN or the community hospital. And we recognize revenue upon receipt by those entities. So we don't wait until the injection occurs, which generally is going to be, you know, within a day of it being received.

And as we think about the registered patient population within your patient hub and also the institutional patient hub, I'm curious if you can help us think about, you know, the size and the trajectory of the registered patients And is it safe to assume that all of these registered patients will get Pepsimils within a defined period of time?

Yeah, I mean, look, our hub and the hubs that we are understanding are being set up and implemented at the institutions. They are recruiting patients rapidly. There's a lot of momentum there, and we would expect that to continue, obviously, with the bolus of patients that we know is out there. They'll be worked through, as we said earlier, you know, those patients are there for a reason because they've been identified for treatment with pap simios. And so we would expect the vast majority of those to ultimately then make it onto pap simios. The period of time is difficult to pin down, but there's a high sense of urgency. that we have picked up in our interactions with the physician community, whether it's at the IDNs, but actually also at the community level with physicians approaching us and wanting to expedite access at the community level. So I do think there will be an expedited uptake from the initial pool of patients that we're seeing, but that will continue for quite a while.

Yeah. And maybe, Brian, I can add really to what Phil said. I think what we are seeing, especially with the broad label that now we are going to be treating the patients as early as having one surgery or actually just being diagnosed, and they have to go through the surgery, plus all the other severe patient population that exists there, and they are being scheduled by their physicians. And as we have discussed, already knew prior to the approval but clearly have been seeing it post approval as well from the physicians physicians do not want to do these surgeries and they are trying to prevent having these surgeries as soon as possible for these patients because they know that with every surgery there is basically closer to that damage line of five surgeries that causes irreversible damage for this patient. So I think collectively, when you look at all of that, there is a continuous patient addition and with the understanding that, of course, these patients not only are identified and they will be getting a treatment, and they are enrolling as we speak, and actually the prescription is ongoing.

There are no further questions at this time, so I'll turn the call over back to Helen Sabzavary for closing comments. Please go ahead.

Thank you to all those participating in the call today. As you can see, times are very exciting for us at Presagen and for the RRP community as a whole. We look forward to providing you with further updates as our launch progresses. In closing, I would like to leave you with words from a pap smear patient who is one of the complete responders from the clinical study.

The sound of hope living with RRP the last 24 years has been the sound of my own voice when I have it. It's being heard even when this virus is trying to destroy my vocal cords. RRP not only took away my voice physically, but also emotionally. So hope for me has been the moments I've been able to speak and others been able to hear me. The power of voices is camaraderie and advocacy. being part of a community that refuses to be silenced. When my voice is weak, others are standing beside me and, if needed, speaking up for me. That's power and that's hope. Today, hope sounds different. It's a physician telling their long-time RRP patient, you don't need another surgery, there's something new. Today, the sound of hope is Pat Zemmios.