Precigen, Inc.

Good afternoon, ladies and gentlemen, and welcome to the President's Second 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 Tuesday, August 4, 2026. and I would now like to turn the conference over to Steve Harasym. Please go ahead.

Thank you, operator, and thank you to everyone joining us for Presagen's second quarter 2026 update call. We are pleased to be speaking with you today as we continue to see strong momentum across the commercial launch of Pepsimios. Joining me on today's call 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 an overview of the launch and key strategic updates. Phil will provide additional details on the commercial execution. Harry will review our financial results, and Rutul will be available for the Q&A section. Before we begin our prepared remarks, I remind everyone that we will be making various forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation and 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. Sabzevari.

Thank you, Steve, and thank you to everyone joining us for our G2 2026 business update call. As we approach the one-year anniversary of Papremius' approval in August 2025, it is worth reflecting on what a meaningful milestone this has been for adults with RRP. Papremius brought the first and the only approved therapy and the new first line of standard of care to the RRP community. Nearly one year after approval, we continued to see a strong commercial momentum with broadening patient access, growing physician adoption, and increasing utilization across both major medical centers and community practices. I'll begin with a high-level overview of what you're seeing across the launch before turning the call over to Phil for additional commercial detail. Q2 represented exceptional growth from Q1. I'm proud to say that we generated $53.1 million in Paximius revenue compared to $21.6 million in Q1, representing more than 145% revenue growth and marks a significant financial milestone for President. Paximius revenue in Q2 propelled the company to a quarterly net profit even before we reached the first anniversary of FDA approval. These results reinforced the significant enthusiasm we continue to see among patients, physicians, and institutions. What is particularly encouraging as we move through Q2 and continuing to Q3 is that momentum is building across several dimensions of the launch at the same time. We believe we now have the commercial foundation for durable multi-year growth for Paximius. We are seeing a strong demand, broader access, expanding use across care settings, and continued physician adoption. These indicators give us increased confidence in the breadth and durability of pap smear's early commercial trajectory. We are seeing the benefit of launching with full approval and a broad FDA label translate into a real-world prescribing behavior. Importantly, the label does not impose a minimum number of prior surgeries before a patient can be treated with pap smear. As a result, physicians are able to consider Paximius based on the individual patient's clinical need. We are seeing use across a broad range of RRP patients, not just the severe cases. This supports our view that Paximius is being embedded earlier in the treatment paradigm. The clinical profile continues to resonate strongly with physicians and patients at the newest standard of care. Coptimus is not another intervention in a cycle of repeated surgical intervention. It is designed to address the underlying HPV 6 or 11 driver of the disease through a targeted immune response. Coptimus durability data continues to strengthen as the long-term follow-up matures. As we presented at ASCO, as of the April 30th cutoff, the ongoing durability of complete responses continues to increase with 83% of patients in ongoing complete response beyond three years, with the number of them I would like to emphasize that these durable, complete responders have not received any treatment for RRP after receiving Paximia. We believe this combination of transformative efficacy, durability, and ongoing responses and a favorable safety profile remains were all highly differentiated. Finally, the FDA granted Papimia's seven-year market exclusivity for adult RRP patients. This exclusivity into August 2032 adds an important layer of protection against prospective competition and supports the value of the commercial opportunity as we continue to expand access and adoption. Collectively, these factors have helped build a strong commercial foundation leading to a strong performance in Q2 and momentum for what we anticipate to be a continued growth. As we have said before, we believe the RRP indication has a blockbuster potential. With that, I will now turn the call over to Phil for more detail on our commercial launch. Phil?

Thank you, Helen, and welcome to everyone joining us today. I'm pleased to provide an update on the continued progress of our commercial launch. Q2 represented a meaningful acceleration across the business with strong demand, expanding patient access, and increasing engagement from physicians, and institutions as Papsimeas continues to establish itself as the new standard of care for adults with RRP. Importantly, the commercial indicators we are seeing that this is the beginning of a durable growth story. As Alan mentioned in Q2, Papsimeas generated $53.1 billion in revenue compared with $21.6 million in Q1, reflecting continued strong launch performance since the first full quarter of sales in Q1. Launch-to-date Absymia's revenue exceeded $78 million at the end of Q2, underscoring the continued strong momentum we are seeing across all aspects of our launch effort. As per my commentary in previous quarters, there are a number of factors and leading indicators continuing to support the impressive launch performance. Patient engagement through the Presagen Hub continues to grow. As of today, the total Hub number is well over 500 patients. This reflects steady patient identification and continued interest from both major academic centers and community settings. Importantly, Presagen Hub data did not capture all patients, so the meaningful proportion of treated patients are coming through non-Hub using institutions. sites are becoming increasingly confident in their own processes for securing patient access, which could mean more patients in the future receiving Pepsineus without necessarily requiring precision hub intervention. We believe the current picture reinforces the breadth of demand for the brand, irrespective of our hub utilization. AIA coverage remains exceptional and continues to provide a strong foundation for access. With the addition of approximately 18 million covered lives in Q2, total commercial and government coverage is now approximately 315 million lives representing nearly all potential covered lives in the U.S. market. In my experience, this compares extremely favorably to the typical speed and breadth of coverage for newly approved treatments in the U.S. As expected, we also continue to see activation across both major medical centers and community practices. We feel the permanent J-code, which became effective April 1st, has been particularly important as accounts move from initial engagement to routine use. It provides a standard pathway for reimbursement, it helps institutions process claims more efficiently, and it reduces uncertainty for sites that are still building Papsimius into their workflows. Together with our field reimbursement support and favorable payer coverage, this has helped bring forward additional accounts and supported continued adoption across both academic centers and community practices. Taken together, the Q2 numbers show clear and continued acceleration across leading indicators, including hub registrations, new patient starts, payer coverage and account activation, on top of the FDA-granted market exclusivity and robust quarter-over-quarter revenue growth. We are extremely pleased with the launch performance to date and believe these trends provide a strong foundation for continued growth. The key point is that Papsinias remains early in its launch curve with a substantial continued opportunity in RRP. I'll now turn the call over to Harry for an overview of our Q2 financials. Harry.

Thank you, Phil, and good afternoon to all of you participating in our call today. You've heard Helen and Phil talk about the exciting second quarter of Capsule Meals revenue that we've reported today. That revenue has propelled Crescigen to profitability for both the quarter and the six months ended June 30th. This is a significant milestone and somewhat rare for a company to have achieved this prior to the first anniversary of an FDA-approved drug. With that said, let me provide some further color on our overall financial results for the quarter. Total revenues were $55 million, which included $53.1 million related to Pepsimios. Our second quarter Pepsimios revenue grew from the first quarter at $31.5 million as we saw demand for Pepsimios continue to build as the second quarter progressed. Cost of products and services for the second quarter total $2.8 million, resulting in a gross margin of $52.2 million per 95%. After the sale of our remaining pre-launch inventory, which we anticipate to be in the third quarter of this year, we expect gross margins related to Pepsimios to stabilize between the high 80% and low 90%. Research and development costs for the quarter was $7.3 million, which compared to the prior year second quarter decreased by $4.2 million. The majority of this change is explained by the fact that Pepsimios manufacturing costs were expensed as R&D costs prior to the FDA approval, and that amount was $5.7 million in the prior year quarter. We expect that R&D expenses will increase as the year progresses and we continue to advance our pipeline. Selling, general, and administrative expenses for the quarter were $22.2 million, having increased by $6.1 million from the prior year's second quarter. This increase was significantly driven by increased commercial activities related to Papsimidos. Moving down the statement of operations, Operating income for the quarter was $22.6 million. Other expense net totaled $2.6 million for the second quarter, representing interest expense of $3 million on our $100 million outstanding debt, offset by interest income on investments of approximately $400,000. Net income for the quarter was $20.1 million, or 5 cents per diluted share. Turning to the balance sheet, We ended the quarter with $38.7 million in cash, cash equivalents, and investments. Q2 represented the first quarter where we saw cash proceeds from the collection of accounts receivable related to Patsy Neos. We ended the quarter with $71.9 million in trade accounts receivable on the balance sheet, which based on customer payment terms, we expect to collect over the four months following the quarter end. We continue to reiterate that based on our current financial forecast, our cash, cash equivalents, and investments, along with the collection of Pepsimio's receivables, will fund operations through cash flow breakeven by the end of 2026. Thank you again for participating in today's call. I'd like to now turn it back to Helen for some closing remarks. Helen?

Thank you, Harry. I will now provide an update on our broader portfolio beginning with Papsinias clinical and regulatory progress in the U.S. and abroad. Papsinias has the potential for redosing, supported by its mechanism of action and favorable safety profile. We are currently evaluating this in an ongoing clinical trial, which is actively enrolling patients. We remain on track to initiate a pediatric clinical trial of Popsinius this year. In addition, our marketing authorization application for Popsinius is under review by the EMA. Popsinius had been granted open drug designation from the European Commission. Now turning to PRGN 2009, which uses the same Adenovir platform backbone as our approved therapy, Papsineers, and underscores the broader potential of this technology. ERGN 2009 is an investigational immunotherapy designed to train the immune system to recognize and eliminate tumor cells associated with HPV 16 and HPV 18 which are the underlying drivers of several major HPV-related cancers, including certain head and neck and cervical cancers. Together, HPV-related malignancies represent nearly 5% of all cancer cases worldwide. CRGN 2009 is currently advancing in multiple Phase II clinical trials in combination with PEMBRO in both head and neck cancer and cervical cancer. We remain very enthusiastic about the potential of this program, particularly given the scale of HPV-related cancers globally. We look forward to providing updated data on head and neck cancer later this year. More broadly, the success of Papzinius and the progress of PRGN 2009 has established proof of principle for the Adenoverse platform. As commercial and clinical evidence continues to build, we believe the platform has a strategic value across various indications and we are extremely excited to advance the platform to maximize its potential. We expect to continue evaluating opportunities to advance this platform. 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 followed by the one on the telephone keypad. You will hear a prompt that your hand has been raised. and if you wish to cancel your request, please press star followed by the view. I would like to advise everyone to have a limit of one question and one follow-up. If anyone have an additional question, you can put yourself back in the queue by pressing star 1. If you are 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 Sierra Defense. Please go ahead.

Hi. Thanks for taking the questions and congrats on an exceptional quarter. Obvious first question, can you give us any color into, you know, or insight into the growth rate we should expect from 2Q to 3Q? Can you maintain the growth rate you saw from 1Q to 2Q or at least just in broad level help us understand the trajectory we should expect here? and then the follow-up is can you give us a sense of the number of physicians and institutions that have used the drug so far and if the majority of patients are coming from your hub or outside of the hub? Thank you.

Hey, Jason. Thank you for the question. It's Phil here. Let me address the first one first. Obviously, the growth rate is critical. We definitely have a very exciting growth story. on our hands, and as you've seen, we've grown significantly from Q1 into Q2. The growth story will continue. The level at which we continue to grow will be determined when we get to the end of Q3. But all of the things that we've spoken about in terms of the leading indicators, the payer coverage, the account activation, the patients that are coming into play, the permanent J-code, All of these things are leading to a continued growth story. Now, mathematically, obviously, when you launch, the growth rate tends to diminish over time, but it's still a growth story, and we're very encouraged by what we're seeing as we head into Q3. And the physicians and so on, I mean, we're seeing activations of accounts, you know, consistently. So it's a high proportion of our targeted accounts and others that are actually using. And importantly, that's both at the IDN level and in the community setting. So we expect that to continue to grow as we go forward.

And maybe, Jason, this is Helen, and thank you for your question. Maybe we can also add further questions. Obviously, a tremendous growth rate from Q1 to Q2, which we expect to continue. As Phil mentioned, I think the pre-work that was done by the commercial group in establishing all the fundamentals that is needed to sustain the growth and promote this as we go forward has paid off and continues to pay off. We are really looking forward as we move as we have mentioned previously, with 27,000 patients at hand in the United States alone. And as you are seeing with the continuous increase in the number of the patients in our hub and also ex-precision hubs, clearly this speaks to the uptake of pap smear as a standard of care by physicians, the request of the patient. And what we are seeing, which is also extremely exciting, is not just on a severe patient population. We see this across a broad label that we have. And all of that are indicators for us that we are looking at really a very, very exciting trajectory.

Thank you, Helen.

Thanks for taking questions. Thanks, Chase.

Thank you. And your next question comes from the line of Swayam Pakola from Ramakant from Wainwright. Please go ahead.

Thank you. Good afternoon, team. Excellent quarter. Congratulations from my end as well. So PAP-CMEOS is a four injection course over 12 weeks. So what portion of the second quarter revenues is later cycle doses in these patients who initiated in the first quarter. And, you know, how should we think about that as a tail end as we go into third quarter? That's the first question. I have a couple more. Can I go one by one?

Sure. Okay. Hi. And thank you for the question. So in regards to the patients, that we have up to this point have treated more than 200 patients, at least have received one dose of pacemius. and as you are seeing the number of the patients in the hubs is continue to grow as well as in ex-hubs and patients that are coming in from a community center. So this is quite exciting. As far as the number of the patients that have completed, they are over 100 patients have gone through all the basically for treatment. and obviously new patients are joining the hub as we go. So we are very excited about this.

Okay, you're right though. There is a sort of a mini annuity, right, with these patients depending on when they start during the quarter. And, you know, some of those doses are carried over into the following quarter. But I would say that certainly for the next few quarters the bulk of the revenue that we will win is going to be new patients. New demand. There's definitely a carryover factor, quarter over quarter, but it's new demand that is driving the business.

Okay. There's a couple more questions that I have. One is, of the $53.1 million that you recorded in the second quarter, is there any true-up from prior period revenue reserves? And the third question is, on the gross margin, you recorded 95%. Obviously, quite a bit of that is from . What could be the real steady state COGS once that inventory is consumed?

Hey, RK. It's Harry. How are you? Great. The first question, remind me again the first question.

So out of that $53.1 million that you recorded in the second quarter, is there any true-up from the prior quarter?

Yeah, any true-up that would have been recorded as part of reserves would have been very insignificant, so the answer is no.

Okay. And then on the COGS, you know, what could be the steady-state COGS once you, you know, once you use up all your pre-approval manufacturing reserves?

Yeah, we've guided that we anticipate the gross margin will be in the high 80 percentages to low 90 percentages, so in the 10% range for COGS. Perfect.

Thank you very much, folks. Thanks.

Thanks, Rocky.

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

Hey, guys. Thanks for taking our questions this afternoon. Maybe just two from us. First, can you talk about the trajectory that we're seeing here just based on the patients at your own patient hub? Are you seeing more patients onboarding from the Center of Excellence versus your own patient hub in the recent quarter? And the second question is, just looking into the update later this year, what will you be looking for from the head and neck and cervical updates? Thank you.

Hey, Bryan, Phil here. I'll take the first question. So, you know, I think the revenue speaks to a very exciting trajectory in terms of patient identification and treatment, regardless of whether it's patients in our hub or patients that have come from outside of our hub. And there's a significant contribution of treated patients from institutions who don't use our hub, who haven't used our hub. So I think what we're seeing, you know, we've reported the hub numbers, which are now well over 500 You see that steady and ongoing patient identification, but that is not the only source of patient identification, and we're excited by both trends.

Yeah. Hi, Bryan. In regard to TRGN 2009 and head and neck, as we had mentioned previously, our head and neck trial is an open-label trial, so clearly we have the We are seeing the data as we move and we will be presenting not only all of the science-based data that will be there, but also the clinical efficacy as well as safety. and especially it's quite interesting as obviously the arms of the trial are continuing and we are following those but definitely the clinical data as well as the scientific data of the mechanism of action and everything else will be presented and we are very excited about this in the coming very near future by the end of the year we will be presenting.

Great. And maybe just a quick follow-up here. Can you talk about just the cadence of patients are incoming? I mean, you know, you've seen your permanent JCO in place in April. Has that changed in a meaningful way in terms of patients that are onboarding? Just curious if you can provide a little bit more color since the JCO is in place. Thank you.

Yeah, thanks, Brian. I mean, we've seen from other launch Analogues that the J-code can have an impact and I think it's safe to say that it definitely has helped us since April 1st. You know, tangibly we've seen some institutions that we knew were holding back and waiting for the permanent J-code and as you would imagine they've now come on board and are starting to identify patients. and just in general across the board this J-code which does give more certainty for providers of being reimbursed by payers is quite an important factor and I think across the board that has sort of lifted all boats in terms of identification of patients and their treatment. So yes, the momentum is definitely with us particularly after the J-code.

Great, thank you guys.

Thank you. And your next question comes from the line of Michael DeFior from Evercore ISI. Please go ahead.

Hi, guys. Thanks so much for taking my question, and congrats on the stellar quarter. A few from me. You frequently referenced that the, I guess, prevalent patient pool in the U.S. is 27,000. So I guess my question is how many of those patients are actively managed, identifiable, and realistically addressable? by your commercial infrastructure at this point and have a follow-up.

Great question. Thanks for that. Yes, there are a lot of patients out there, 27,000, and in any one year you would expect a number of several thousand of those are actually very evident to the healthcare system because they have multiple surgeries and they're using a lot of resources of the healthcare system. so you know there are thousands of what you might call severe patients but then beyond that particularly as you then go into the community setting there are many patients who are earlier in their journey and so you know the good thing from our perspective is that we have a very broad label and patients right from the beginning of that journey can be treated with pausinias and that's obviously our goal we are seeing patients across all severities as Helen mentioned starting to be treated But as we also said, we feel we're at the beginning of our journey, and there are a lot more patients, and there's a lot more runway ahead for us.

Yeah. Go ahead. I'm sorry. Go ahead. No, no, no.

I'm sorry. I was going to say a related question is regarding if there's any bolus or pent-up demand slash warehouse patient, how big is that, and how long might it take you to work through? Thank you.

Yeah, well, I'd refer you to my previous answer, really, because there are several thousand, you know, in any one year, and that's just to say a count over the past 12 months, but in any one year, you're going to have, from our numbers, several thousand patients who fall into that more severe category, which is an obvious place to start for some physicians as they get experience with the drug. But, you know, we haven't worked our way through that, and there are many more patients consistent with our broad label. So, Again, we reiterate there's an ongoing growth story here.

And maybe I can also add, Michael, from a perspective of the patient population for the RRP, unfortunately patients that are diagnosed with RRP or they have been diagnosed over the years, the tendency of this disease is just it becomes worse. As we have mentioned, these patients, just by doing a surgery, this disease does not go away because surgeries never address the underlying issues, which is infection by HPV and basically 6-11, whereas taptenias does that and addresses exactly the underlying issues. So for that reason, as Phil mentioned, not only we have these severe patient populations that exist, we have a patient population that they unfortunately, they are infected and start and then eventually as the year go by, it becomes worse. But also what is very, for us is very important and what we are seeing across is the uptake of pap smear by physicians and also patients that because the physician at this point based on the broad label, the safety, the efficacy and especially the durability that we see and we reported at ASCO that now where we have not only passed three years and some of our patients in four years post receiving pap smear have not required any treatment for RRP. This has added to the excitement for treating the patients as early as possible so they do not received irreversible damages. So, as you can see, not only we have the thousands of patients that are at the severe position, but also patients that are in their journey with RRP with the less severe, and definitely the physicians do not want them to become more severe and therefore prescribing the Paximis.

Very helpful. Thank you.

Thank you, and your last question comes from the line of Phil Wenzhai from Bee Valley. Please go ahead.

Thank you for taking our questions, and congrats for a strong quarter. Since you had in-person engagement with initial target accounts, can you remind us how many accounts were on the initial list, and how many have actually ordered your drug so far? and then maybe a quick follow-up there. What is the second wave expansion plan now you have 500 registration in the hub? Thank you.

Great. Thanks for the question. So just going back to the initial footprint and target number of institutions we identified, There were about 500 institutions that we identified that looked at over 90% or covered 90% of the patient population. And within that, it was about 100 large hospital systems that were responsible for over 80%. So obviously, we targeted accordingly. But as I also mentioned before, we've seen the community come on board quickly. And so we've embraced the community side of things into our targeting as well. I won't give a specific number on the number that are using but as you can see from our revenue and all of the leading indicators that we've spoken about you know we're making great progress on activating those accounts and the accounts that are activated are becoming repeat users so in terms of the outlook I mean all of the things that we've spoken about the continued account activation with the support of the permanent J-code, our broad label, the continued durability results that we have, the safety profile of the drug, and the early experience of treating patients with pap smear and the user friendliness of that experience is all going to drive the continued wave of growth that we expect.

Got it. Thank you for taking our questions.

Thank you, and that concludes our question and answer session. I'm going to hand the call back to Helen Sabzevari for any closing remarks.

Thank you, Operator, and thank you to everyone who joined us today. We are very pleased with the strong results we delivered in the second quarter, particularly the continued momentum behind capillaries and the important foundation we are building for long-term growth. As we approach the one-year anniversary of approval, we remain focused on expanding access, supporting adoption, advancing our clinical and regulatory priorities, and continuing to execute across the business. On behalf of the entire President team, thank you for joining us today and for your continued support. We look forward to keeping you updated as the year progresses.

That concludes our call for today. Thank you for participating. You may all disconnect.