PGEN

Biotech in the News: The Longview The Company's New Drug, the First FDA-Approved Therapy for Recurrent Respiratory Papillomatosis (RRP), is Delivering Strong Commercial Traction While Highlighting the Broader Potential of Its Proprietary AdenoVerse Therapeutic Platform in HPV-Associated Cancers GERMANTOWN, MD / ACCESS Newswire / August 25, 2026 / For Germantown, MD-based Precigen Inc. (NASDAQ:PGEN), the second quarter marked a commercial inflection. PAPZIMEOS (zopapogene imadenovec-drba) generated $53.1 million in net product revenue-more than double the prior quarter-and helped the company achieve quarterly profitability. Validated Platform President and CEO Helen Sabzevari, PhD, framed the quarter as platform validation. "PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers," she said. PRGN-2009: Same Platform, Oncogenic HPV Targets PRGN-2009 uses the identical adenovirus backbone as PAPZIMEOS but is engineered to target high-risk oncogenic types HPV 16 and HPV 18. AdenoVerse vectors offer practical advantages: very low seroprevalence in humans, large genetic payload capacity, and the ability to be administered repeatedly without generating neutralizing antibodies that blunt subsequent doses. It is administered as a simple subcutaneous injection-an off-the-shelf product rather than a patient-specific cell therapy. HPV-related cancers account for roughly 5% of all cancers worldwide and approximately 690,000 new cases annually. They include cervical, oropharyngeal (head and neck), anal, penile, vaginal, and vulvar cancers. Many patients still progress after receiving current standards of care, and there is growing interest in neoadjuvant approaches that could reduce the need for radiation or intensive surgery. Phase 1 Signal and Ongoing Phase 2 Program In a first-in-human Phase 1 study conducted with the National Cancer Institute, PRGN-2009 was well tolerated as monotherapy and in combination with a checkpoint inhibitor. In the combination arm (mostly checkpoint-resistant patients), the objective response rate was 20% to 30% and median overall survival reached 24.6 months. Precigen is now conducting multiple Phase 2 trials: The first trial in newly diagnosed HPV-positive oropharyngeal cancer evaluates PRGN-2009 in combination with pembrolizumab, a PD1 checkpoint inhibitor in a neoadjuvant setting. A second multicenter study is evaluating PRGN-2009 plus pembrolizumab in recurrent or metastatic cervical cancer. The company is looking forward to providing a data update in the head and neck program in the Fourth Quarter of this year. Commercial Foundation and Next Milestones PAPZIMEOS' rapid uptake - driven by field engagement, a permanent J-code, broad payer coverage, and Precigen Hub patient-support services - has given the company both cash flow and proof that an AdenoVerse product can achieve commercial success. The FDA granted PAPZIMEOS seven-year market exclusivity through August 2032. A marketing authorization application is under review by the EMA, which has also granted orphan designation, and Precigen is pursuing a U.S. pediatric label expansion. PRGN-2009 now carries the broader potential of the AdenoVerse platform into HPV-associated cancers. If Phase 2 data confirm the immune and clinical signals observed in Phase 1, the same platform that dramatically reduced surgeries in a rare HPV-driven disease could have significant potential across the much larger oncology market. Contact: Steven [email protected] Click here for more information on Precigen Featured image from Shutterstock This post contains sponsored content and was created with a third-party partner. The author is a publisher and does not provide investment advice or act as a broker or dealer. The content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security. SOURCE: Precigen, Inc. View the original press release on ACCESS Newswire

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Precigen (PGEN) drew fresh attention after its second quarter 2026 earnings, where revenue reached US$54.98 million and net income came in at US$20.07 million, following the commercial launch of PAPZIMEOS. See our latest analysis for Precigen. Precigen’s latest earnings arrived alongside strong share price momentum, with a 30 day share price return of 28.95% and a 90 day share price return of 65.30%. The 1 year total shareholder return of 281.11% highlights how sentiment has shifted over a longer window despite some short term pullback, including a 1 day share price decline of 2.00% to US$6.86. If PAPZIMEOS has put Precigen on your radar, you might also want to see which other healthcare AI related opportunities are moving right now through our 43 healthcare AI stocks. The surge in Precigen’s share price reflects a sharp reset in expectations after PAPZIMEOS and the first profitable quarter. The next step is to assess whether the current valuation still offers sufficient potential return given the risks involved. Precigen’s most followed narrative points to a fair value of $14.50 per share compared with the latest close at $6.86, which frames the recent earnings beat and PAPZIMEOS launch in a different light. Read the complete narrative. Curious what sits behind that revenue ramp story. The narrative leans on aggressive growth, sharply higher margins, and a richer earnings multiple than most biotechs. The mix of these assumptions is what drives the $14.50 figure. Result: Fair Value of $14.50 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the Precigen story can shift quickly if PAPZIMEOS uptake slows relative to expectations or if real world safety and durability data disappoints physicians and payers. Find out about the key risks to this Precigen narrative. The fair value narrative around Precigen focuses on future earnings and cash flows, yet today the stock trades on a P/S ratio of 28.7x. That is far above the US Biotechs industry at 11.5x, the peer average at 9.7x, and the fair ratio of 10.2x that the market could move towards. This gap points to meaningful valuation risk if expectations ease or PAPZIMEOS growth normalizes, so it is worth considering how much optimism to incorporate into any valuation view. See what the numbers say about this price — find out in our valuation breakdown. If this mix of optimism and concern around Precigen feels familiar, consider taking action and evaluating the assumptions for yourself using our 1 key reward and 3 important warning signs. Precigen is just one opportunity. If you stop here, you risk missing other stocks that might fit your goals even better using the Simply Wall St Screener. Spot potential mispricings early by checking out 49 high quality undervalued stocks that combine quality fundamentals with prices that may not fully reflect their strengths. Strengthen your income stream by reviewing 8 dividend fortresses that offer higher yields while still focusing on stability. Prioritise resilience by scanning 85 resilient stocks with low risk scores that score well on balance sheet strength and lower overall risk. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include PGEN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Helen Sabzevari Chief Commercial Officer - Phil Tennant Chief Financial Officer - Harry Thomasian Chief Operating Officer - Rutul Shah Operator: Good afternoon, ladies and gentlemen, and welcome to the Precigen's Second Quarter 2026 Financial Results and Business Update Conference Call. [Operator Instructions] 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. Steven Harasym: Thank you, operator, and thank you to everyone joining us for Precigen'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 PAPZIMEOS. 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. Helen Sabzevari: Thank you, Steve, and thank you to everyone joining us for our Q2 2026 business update call. As we approach the 1-year anniversary of PAPZIMEOS approval in August 2025, it is worth reflecting on what a meaningful milestone this has been for adults with RRP. PAPZIMEOS brought the first and the only approved therapy and the new first-line standard of care to the RRP community. Nearly 1 year after approval, we continue 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 we are 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 state that we generated $53.1 million in PAPZIMEOS revenue compared to $21.6 million in Q1, representing more than 145% revenue growth and marks a significant financial milestone for Precigen. PAPZIMEOS revenue in Q2 propelled the company to a quarterly net profit even before we reached the first anniversary of FDA approval. These results reinforce the significant enthusiasm we continue to see among patients, physicians and institutions. What is particularly encouraging as we move through Q2 and continue into 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 multiyear growth for PAPZIMEOS. 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 PAPZIMEOS' 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 PAPZIMEOS. As a result, physicians are able to consider PAPZIMEOS 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 PAPZIMEOS is being embedded earlier in the treatment paradigm. The clinical profile continues to resonate strongly with physicians and patients as the new standard of care. PAPZIMEOS is not another intervention in a cycle of repeated surgical interventions. It is designed to address the underlying HPV-6 or 11 driver of the disease through a targeted immune response. PAPZIMEOS durability data continues to strengthen as the long-term follow-up matures. As we presented at ASCO, as of the April 30 cutoff, the ongoing durability of complete responses continues to increase with 83% of patients in ongoing complete response beyond 3 years with a number of them beyond 4 years of being surgery-free. I would like to emphasize that these durable complete responders have not received any treatment for RRP after receiving PAPZIMEOS. We believe this combination of transformative efficacy, durability and ongoing responses and a favorable safety profile remains highly differentiated. Finally, the FDA granted PAPZIMEOS 7-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? Phil Tennant: Thank you, Helen, and welcome to everyone joining us today. I am 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 PAPZIMEOS 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 Helen mentioned, in Q2, PAPZIMEOS generated $53.1 million 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 PAPZIMEOS 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 Precigen 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, Precigen Hub data do not capture all patients as a 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 PAPZIMEOS without necessarily requiring Precigen Hub intervention. We believe the current picture reinforces the breadth of demand for the brand, irrespective of our hub utilization. Payer 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 1, 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 PAPZIMEOS 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 PAPZIMEOS 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? Harry Thomasian: 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 PAPZIMEOS revenue that we've reported today. That revenue has propelled Precigen for profitability for both the quarter and the 6 months ended June 30. 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 PAPZIMEOS. Our second quarter PAPZIMEOS revenue grew from the first quarter by $31.5 million as we saw demand for PAPZIMEOS continue to build as the second quarter progressed. Cost of products and services for the second quarter totaled $2.8 million, resulting in a gross margin of $52.2 million or 95%. After the sale of our remaining prelaunch inventory, which we anticipate to be in the third quarter of this year, we expect gross margins related to PAPZIMEOS to stabilize between the high 80 percentages and low 90 percentages. Research and development costs for the quarter were $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 PAPZIMEOS 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 second quarter. This increase was significantly driven by increased commercial activities related to PAPZIMEOS. 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 $0.05 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 PAPZIMEOS. 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 4 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 PAPZIMEOS 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? Helen Sabzevari: Thank you, Harry. I will now provide an update on our broader portfolio, beginning with Thank you, Harry. I will now provide an update on our broader portfolio, beginning with PAPZIMEOS clinical and regulatory progress in the U.S. and abroad. PAPZIMEOS 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 PAPZIMEOS this year. In addition, our marketing authorization application for PAPZIMEOS is under review by the EMA. PAPZIMEOS has been granted orphan drug designation from the European Commission. Now turning to PRGN-2009, which uses the same AdenoVerse platform backbone as our approved therapy, PAPZIMEOS, and underscores the broader potential of this technology. PRGN-2009 is an investigational immunotherapy designed to train the immune system to recognize and eliminate tumor cells associated with HPV16 and HPV18, which are the underlying drivers of several major HPV-related cancers, including certain head and neck and cervical cancers. Together, HPV-related malignancies represents nearly 5% of all cancer cases worldwide. PRGN-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 PAPZIMEOS 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? Operator: [Operator Instructions] And your first question comes from the line of Jason Butler from Citizens. Jason Butler: Congrats on an exceptional quarter. Obvious first question, can you give us any color into -- 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? Phil Tennant: 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. Physicians and so on, I mean we're seeing activations of accounts 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. Helen Sabzevari: And maybe, Jason, this is Helen, and thank you for your question. Maybe we can also add further. Obviously, a tremendous growth rate from Q1 to Q2, which we expect to continue. As Phil mentioned, I think the prework that was done by the commercial group in establishing all the fundamentals that is needed to sustain the growth and promote it as we go forward has paid off and continue 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-Precigen hubs, clearly, this speaks to the uptake of PAPZIMEOS as a standard of care by physicians, the request of the patients. And what we are seeing, which is also extremely exciting, it's 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. Operator: And your next question comes from the line of Swayampakula Ramakanth from Wainwright. Swayampakula Ramakanth: Excellent quarter. Congratulations from my end as well. So PAPZIMEOS is a 4 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 how should we think about that as a tailwind as we go into third quarter? That's the first question. I have a couple more. Can I go one by one? Helen Sabzevari: Sure, 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 1 dose of PAPZIMEOS. And as you are seeing, the number of the patients in the hubs has continued 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 hubs as we go. So we are very excited about this. And Phil... Phil Tennant: Yes. RK, 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 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 demand. There's definitely a carryover factor quarter-over-quarter, but it's new demand that is driving the business. Swayampakula Ramakanth: Okay. A couple of more questions that I have is 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 your pre-approval manufacturing costs that got expensed through the R&D line. What could be the real steady-state COGS once that inventory is consumed? Harry Thomasian: RK, it's Harry. The first question, remind me again the first question? Swayampakula Ramakanth: So out of that $53.1 million that you recorded in the second quarter, is there any true-up from the prior quarter? Harry Thomasian: Yes. Any true-up that would have been recorded as part of reserves would have been very insignificant. So the answer is no. Swayampakula Ramakanth: Okay. And then on the COGS, what could be the steady-state COGS once you use up all your pre-approval manufacturing reserves? Harry Thomasian: Yes. 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. Operator: And your next question comes from the line of Brian Cheng from JPMorgan Chase. Lut Ming Cheng: Maybe just 2 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 update? Phil Tennant: Brian, it's Phil here. I'll take the first question. So 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, and you can -- we 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. Helen Sabzevari: Yes. Brian, in regard to PRGN-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. Lut Ming Cheng: Great. And maybe just a quick follow-up here. Can you talk about just the cadence of patients are incoming? I mean, you've seen your permanent J-code 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 J-code in place. Phil Tennant: Yes. Thanks, Brian. I mean we've seen from other launch analogs that the J-code can have an impact. And I think it's safe to say that it definitely has helped us since April 1. 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, it's -- the momentum is definitely with us, particularly after the J-code. Operator: And your next question comes from the line of Michael DiFiore from Evercore ISI. Michael DiFiore: Congrats on the stellar quarter. A few for 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 I have a follow-up. Phil Tennant: No, great question. Thanks for that. Yes, there are a lot of patients out there, 27,000. And in any 1 year, you would expect a number of -- several thousand of those are actually very evident to the health care system because they're they have multiple surgeries, and they're using a lot of resources of the health care system. So 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 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 PAPZIMEOS, 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. Michael DiFiore: I'm sorry. I was going to say a related question is regarding if there's any bolus or pent-up demand/warehouse patients, how big is that? And how long might it take you to work through? Phil Tennant: Yes. Well, I'd refer you to my previous answer really because there are several thousand in any 1 year, and that's just say count over the past 12 months. But in any 1 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 we haven't worked our way through that, and there are more -- many more patients consistent with our broad label. So again, we reiterate there's an ongoing growth story here. Helen Sabzevari: And maybe I can also add, Michael. From a perspective of the patient population for 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, basically 611, whereas PAPZIMEOS does that and addresses exactly the underlying issue. So for that reason, as Phil mentioned, not only we have the 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 PAPZIMEOS 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 we have not only passed 3 years and some of our patients in 4 years post receiving PAPZIMEOS 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 receive 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 PAPZIMEOS. Operator: And your last question comes from the line of Yuan Zhi from B. Riley. Yuan Zhi: 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 registrations in the hub? Phil Tennant: 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've targeted accordingly. But as I also mentioned before, we've seen the community come on board quickly. And so that's -- 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, 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 PAPZIMEOS and the user-friendliness of that experience is all going to drive the continued wave of growth that we expect. Operator: Thank you. And that concludes our question-and-answer session. I will now hand the call back to Helen Sabzevari for any closing remarks. Helen Sabzevari: 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 PAPZIMEOS and the important foundation we are building for a long-term growth. As we approach the 1-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 Precigen team, thank you for joining us today and for your continued support. We look forward to keeping you updated as the year progresses. Operator: That concludes our call for today. Thank you for participating. You may all disconnect. Before you buy stock in Precigen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Precigen wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $411,427!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,252!* Now, it’s worth noting Stock Advisor’s total average return is 965% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 11, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Precigen (PGEN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in Precigen, Inc.? Here are five stocks we like better. PAPZIMEOS drove a major commercial acceleration: Second-quarter revenue reached $53.1 million, up more than 145% from the first quarter, helping Precigen achieve $20.1 million in net income and $22.6 million in operating income. Adoption and reimbursement expanded: More than 200 patients had received treatment, over 100 completed the four-dose regimen, and payer coverage reached approximately 315 million U.S. lives. Precigen said the permanent J-code is helping additional institutions begin using the therapy. Management expects continued growth and pipeline expansion: PAPZIMEOS has FDA market exclusivity through August 2032, while trials are evaluating redosing and pediatric use. The company expects its cash, investments and receivables to fund operations through cash-flow breakeven by the end of 2026. Precigen (NASDAQ:PGEN) reported a sharp increase in second-quarter revenue from its PAPZIMEOS launch, with the company reaching quarterly profitability less than a year after the therapy’s August 2025 FDA approval for adults with recurrent respiratory papillomatosis, or RRP. PAPZIMEOS revenue totaled $53.1 million in the second quarter, up from $21.6 million in the first quarter. Total revenue was $55 million. Chief Executive Officer Helen Sabzevari said the result reflected broadening patient access, physician adoption and use at both major medical centers and community practices. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “Q2 represented exceptional growth from Q1,” Sabzevari said, adding that PAPZIMEOS revenue increased by more than 145% sequentially. She said the product’s launch-to-date revenue exceeded $78 million at the end of the quarter. The company said PAPZIMEOS is the first and only approved therapy for adult RRP and that its FDA label does not require patients to undergo a minimum number of prior surgeries before treatment. Sabzevari said physicians are using the drug across a broad range of patients, rather than only in the most severe cases. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? Precigen Chief Commercial Officer Phil Tennant said the company’s patient-support hub had registered well over 500 patients as of the call. However, he noted that hub data do not capture all treated patients because a meaningful number of patients are being treated at institutions that do not use the hub. The company said it had treated more than 200 patients with at least one PAPZIMEOS dose, while more than 100 patients had completed the four-treatment course. PAPZIMEOS is administered as a four-injection regimen over 12 weeks. Tennant said some patient doses carry into subsequent quarters, but that new demand is expected to drive the bulk of revenue over the next several quarters. → Why Rare Earth Processing Could Be the Real 2027 Opportunity Commercial and government payer coverage reached approximately 315 million lives after the addition of about 18 million covered lives during the quarter, according to Tennant. He said the coverage represents nearly all potential covered lives in the U.S. market. Management also cited the April 1 implementation of a permanent J-code as an important factor in adoption. Tennant said the code provides a standard reimbursement pathway and has helped bring additional institutions on board, including some that had been waiting for the code before beginning patient identification and treatment. Precigen initially identified approximately 500 institutions that it said cover more than 90% of the RRP patient population, including about 100 large hospital systems responsible for more than 80% of patients. Tennant did not disclose how many of those accounts have ordered PAPZIMEOS, but said activated accounts are becoming repeat users. Sabzevari highlighted long-term PAPZIMEOS data presented at ASCO, stating that as of an April 30 cutoff, 83% of patients in ongoing complete response remained surgery-free beyond three years. Some patients were beyond four years without surgery, she said. Sabzevari added that these complete responders had not received further RRP treatment after PAPZIMEOS. The FDA granted PAPZIMEOS seven years of market exclusivity for adult RRP, extending into August 2032, the company said. Precigen is also evaluating PAPZIMEOS redosing in an actively enrolling clinical trial and remains on track to begin a pediatric PAPZIMEOS trial this year. Its marketing authorization application is under review by the European Medicines Agency, and the therapy has received Orphan Drug Designation from the European Commission. In its broader pipeline, the company said PRGN-2009 is being studied in multiple Phase II trials in combination with pembrolizumab for head and neck cancer and cervical cancer. The investigational immunotherapy is designed to target tumor cells associated with HPV16 and HPV18. Sabzevari said Precigen expects to provide updated head and neck cancer data later this year. Precigen reported a gross margin of $52.2 million, or 95%, during the second quarter, as cost of products and services totaled $2.8 million. Chief Financial Officer Harry Thomasian said the margin reflected the sale of pre-launch inventory. Following the anticipated sale of the remaining pre-launch inventory in the third quarter, the company expects PAPZIMEOS gross margins to stabilize in the high-80% to low-90% range. Research and development expense was $7.3 million, down $4.2 million from the prior-year quarter. Selling, general and administrative expense was $22.2 million, up $6.1 million year over year, driven largely by PAPZIMEOS commercial activities. Operating income was $22.6 million. Net income was $20.1 million, or $0.05 per diluted share. At June 30, Precigen had $38.7 million in cash equivalents and investments, as well as $71.9 million in trade accounts receivable. Thomasian said the company expects to collect those receivables over the four months following quarter-end based on customer payment terms. Management reiterated that its cash equivalents and investments, together with expected collection of PAPZIMEOS receivables, are expected to fund operations through cash-flow breakeven by the end of 2026. While executives said PAPZIMEOS growth is continuing into the third quarter, they did not provide a specific revenue forecast, noting that growth rates typically diminish over time as a launch matures. Precigen, Inc (NASDAQ: PGEN) is a biotechnology company focused on the discovery, development and commercialization of genetic medicines. The company leverages proprietary gene and cell therapy platforms to design targeted therapies for oncology, infectious diseases and rare conditions. Precigen's approach combines synthetic biology, immuno-oncology and microbiome engineering to create precision treatments intended to enhance efficacy while minimizing off-target effects. The centerpiece of Precigen's technology is its OmniCAR platform, which enables the rapid generation of adaptable chimeric antigen receptor (CAR) T-cell products. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Precigen Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved quarterly net profit within one year of FDA approval, driven by $53.1 million in PAPZIMEOS revenue, representing 145% growth over the first quarter. Performance was bolstered by a broad FDA label that does not require a minimum number of prior surgeries, allowing for earlier intervention in the treatment paradigm. The launch benefited from the implementation of a permanent J-code on April 1, which standardized reimbursement pathways and reduced administrative uncertainty for medical institutions. Clinical durability data presented at ASCO showed 83% of patients remained surgery-free beyond three years, reinforcing the drug's position as a new standard of care over repeated surgical interventions. Management attributes the rapid uptake to a combination of high physician enthusiasm, broadening patient access across both academic and community settings, and exceptional payer coverage. The AdenoVerse platform's strategic value was reinforced by the commercial success of PAPZIMEOS, providing a validated framework for the company's oncology pipeline. Management expects to reach sustained cash flow breakeven by the end of 2026, supported by the collection of $71.9 million in current trade accounts receivable. Gross margins for PAPZIMEOS are projected to stabilize between the high 80% and low 90% range following the exhaustion of pre-launch inventory in the third quarter of 2026. Strategic expansion plans include the initiation of a pediatric clinical trial for PAPZIMEOS in 2026 and ongoing regulatory review by the EMA for European market entry. The company anticipates providing updated Phase II clinical data for PRGN-2009 in head and neck cancer by the end of the year, leveraging the same validated platform backbone. Future growth is expected to be driven by a 'mini annuity' effect as patients complete the four-dose treatment course, combined with new demand from an estimated 27,000 prevalent U.S. patients. The FDA granted 7-year market exclusivity for PAPZIMEOS in adult RRP through August 2032, providing a significant competitive moat against prospective entrants. R&D expenses are expected to increase in the second half of the year as the company advances its broader pipeline and shifts away from the benefit of previously expensed manufacturing costs. Precigen Hub data currently tracks over 500 patients, though management noted this underrepresents total demand as many institutions now secure access independently. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management acknowledged that while the percentage growth rate may naturally moderate as the launch matures, the absolute growth story remains robust due to leading indicators like account activation. The permanent J-code has acted as a catalyst, bringing onboard institutions that were previously hesitant due to reimbursement uncertainty. Over 200 patients have received at least one dose, with more than 100 having completed the full four-dose course. While there is a carryover 'annuity' effect from patients mid-cycle, the bulk of current revenue is being driven by new patient demand. Current 95% gross margins are temporarily elevated due to the sale of inventory previously expensed as R&D. Management guided to a long-term COGS of approximately 10% once pre-approval inventory is fully utilized. Physicians are increasingly prescribing the therapy for less severe cases to prevent irreversible damage, rather than waiting for patients to become 'severe'. The commercial team is successfully expanding beyond the initial 100 large hospital systems into community practices.

This article first appeared on GuruFocus. Total Revenue: $55 million for Q2 2026. Papsimios Revenue: $53.1 million in Q2, up from $21.6 million in Q1, representing over 145% growth. Launch-to-Date Revenue: Papsimios revenue exceeded $78 million at the end of Q2. Gross Margin: $52.2 million, or 95% for Q2. Research and Development Costs: $7.3 million for Q2, down $4.2 million year-over-year. Selling, General, and Administrative Expenses: $22.2 million for Q2, up $6.1 million year-over-year. Operating Income: $22.6 million for Q2. Net Income: $20.1 million, or $0.05 per diluted share for Q2. Cash and Investments: $38.7 million at the end of Q2. Trade Accounts Receivable: $71.9 million at the end of Q2. Warning! GuruFocus has detected 10 Warning Signs with PGEN. Is PGEN fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Precigen Inc (NASDAQ:PGEN) reported exceptional Q2 2026 revenue of $53.1 million for Tapsimius, a 145% increase from Q1, and achieved quarterly net profitability before the first anniversary of FDA approval. The company has established a strong commercial foundation with payer coverage expanding to approximately 315 million covered lives, nearly all potential US covered lives, and the permanent J-code effective April 1 has facilitated routine use and account activation. Clinical durability data continues to strengthen, with 83% of patients in ongoing complete response beyond three years and some beyond four years surgery-free, reinforcing the drug's transformative efficacy. The FDA granted Tapsimius seven-year market exclusivity for adult RRP patients, protecting against prospective competition until August 2032. The company is advancing its pipeline, including PRGN-2009 for HPV-related cancers, with multiple Phase II trials and expected data updates later this year, highlighting the broader potential of the Adenoverse platform. The company's cash position is relatively low at $38.7 million, and it relies on the collection of $71.9 million in accounts receivable to fund operations through cash flow breakeven by end of 2026. Gross margins are expected to decline from the current 95% to the high 80s to low 90s percentage range after the sale of prelaunch inventory, indicating a potential reduction in profitability. The growth rate from Q1 to Q2 may not be sustainable, as management acknowledged that growth rates typically diminish over time after a launch. The company faces uncertainty in the trajectory of patient onboarding, with a significant proportion of treated patients coming from non-hub institutions, making it difficult to accurately track and forecast demand. R&D expenses are expected to increase as the year progresses, which could pressure future profitability despite the strong commercial performance. Q: Can you provide insight into the expected growth rate from Q2 to Q3, and can you maintain the growth rate seen from Q1 to Q2? Also, can you give a sense of the number of physicians and institutions using the drug and whether the majority of patients come from your hub or outside of it? A: Phil Tennant (Chief Commercial Officer) stated that while the growth rate will continue, the specific level will be determined at the end of Q3. He noted that mathematically, growth rates tend to diminish over time post-launch, but leading indicators like payer coverage, account activation, and the permanent J-code support a continued growth story. He added that account activations are happening consistently across both IDNs and community settings. Helen Sabzevari (President and CEO) added that the pre-work by the commercial group has established the fundamentals to sustain growth, and with 27,000 patients in the US, the increasing number of patients in both hub and ex-hub settings speaks to the uptake of papsimias as a standard of care across a broad label. Q: Given that Papsimios is a full injection course over 12 weeks, what portion of Q2 revenue is from later-cycle doses for patients who initiated in Q1, and how should we think about this as a tailwind into Q3? A: Helen Sabzevari (President and CEO) noted that over 200 patients have received at least one dose, and over 100 patients have completed the full treatment course, with new patients continuously joining. Phil Tennant (Chief Commercial Officer) acknowledged there is a "mini annuity" effect with doses carrying over into the following quarter, but for the next few quarters, the bulk of revenue will be driven by new demand rather than the carryover factor. Q: Of the $53.1 million recorded in Q2, is there any true-up from prior period revenue reserves? And what could be the real steady-state COGS once the pre-approval manufacturing inventory is consumed? A: Harry Thomasian (Chief Financial Officer) confirmed that any true-up from prior period reserves would have been very insignificant, effectively answering no. Regarding COGS, he reiterated the guidance that gross margins are anticipated to stabilize in the high 80% to low 90% range, implying a COGS in the 10% range once the pre-launch inventory is sold. Q: Are you seeing more patients onboarding from Centers of Excellence versus your own patient hub in the recent quarter? And what will you be looking for from the head and neck cancer update later this year? A: Phil Tennant (Chief Commercial Officer) stated that the revenue reflects an exciting trajectory in patient identification and treatment regardless of the source, with a significant contribution of treated patients coming from institutions that do not use the Precigen Hub. Helen Sabzevari (President and CEO) added that for PRGN 2009 in head and neck cancer, the open-label trial will present both clinical efficacy and safety data, along with scientific data on the mechanism of action, by the end of the year. Q: Has the permanent J-code, effective April 1, changed the cadence of patient onboarding in a meaningful way? A: Phil Tennant (Chief Commercial Officer) confirmed that the J-code has definitely helped since April 1. He noted that some institutions that were holding back and waiting for the permanent J-code have now come on board and started identifying patients. The J-code provides more certainty for providers regarding reimbursement, which has "lifted all boats" in terms of patient identification and treatment, with momentum particularly strong after its implementation. Q: Of the 27,000 prevalent patient pool in the US, how many are actively managed, identifiable, and realistically addressable by your commercial infrastructure? And is there a bolus of pent-up demand, and how long might it take to work through? A: Phil Tennant (Chief Commercial Officer) explained that several thousand patients are very evident to the healthcare system each year due to multiple surgeries and high resource utilization. Beyond that, many patients earlier in their journey are addressable given the broad label. He noted that the company is at the beginning of its journey with a lot more runway ahead. Helen Sabzevari (President and CEO) added that RRP tends to worsen over time, and since surgeries do not address the underlying HPV6/11 infection, physicians are increasingly prescribing papsimias early to prevent irreversible damage, supported by durability data showing patients surgery-free for over three and four years. Q: How many accounts were on the initial target list, and how many have actually ordered the drug so far? What is the second wave expansion plan given the 500 registrations in the hub? A: Phil Tennant (Chief Commercial Officer) stated that the initial footprint identified about 500 institutions covering over 90% of the patient population, with about 100 large hospital systems responsible for over 80%. He did not provide a specific number of accounts using the drug but noted great progress in activating accounts, which are becoming repeat users. The continued growth will be driven by account activation supported by the permanent J-code, the broad label, durability results, safety profile, and the user-friendly treatment experience. Q: Can you provide color on the Q2 revenue growth and the key drivers behind the exceptional quarter-over-quarter performance? A: Helen Sabzevari (President and CEO) highlighted that Q2 revenue of $53.1 million represented over 145% growth from Q1's $21.6 million, propelling the company to a quarterly net profit before the first anniversary of FDA approval. She attributed the momentum to broadening patient access, growing physician adoption, and increasing utilization across major medical centers and community practices. The broad FDA label without a minimum number of prior surgeries allows physicians to treat patients based on individual clinical need, embedding papsimias earlier in the treatment paradigm. Q: What is the current status of payer coverage and how does it compare to typical launches? A: Phil Tennant (Chief Commercial Officer) reported that 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 US market. He noted that this compares extremely favorably to the typical speed and breadth of coverage for newly approved treatments in the US, providing a strong foundation for access. Q: Can you provide an update on the broader pipeline, specifically PRGN 2009 and the pediatric trial for papsimias? A: Helen Sabzevari (President and For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Precigen, Inc. (PGEN) came out with quarterly earnings of $0.05 per share, beating the Zacks Consensus Estimate of a loss of $0.02 per share. This compares to a loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +350.00%. A quarter ago, it was expected that this company would post a loss of $0.03 per share when it actually produced a loss of $0.02, delivering a surprise of +33.33%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Precigen, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $54.98 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 97.62%. This compares to year-ago revenues of $0.86 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Precigen shares have added about 58.1% since the beginning of the year versus the S&P 500's gain of 11%. While Precigen has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Precigen was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is breakeven on $34.64 million in revenues for the coming quarter and -$0.02 on $127.74 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Geron (GERN), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 5. This drugmaker is expected to post quarterly loss of $0.01 per share in its upcoming report, which represents a year-over-year change of +50%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Geron's revenues are expected to be $55.01 million, up 12.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Precigen, Inc. (PGEN) : Free Stock Analysis Report Geron Corporation (GERN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

PAPZIMEOS® net revenue of $53.1 million in the second quarter of 2026, more than double the prior quarter, reflects accelerating commercial momentum and broad US adoption PAPZIMEOS revenue propelled the Company to quarterly profitability Cash, cash equivalents, and investments totaled $38.7 million as of June 30, 2026, which together with proceeds from PAPZIMEOS revenue, is expected to support cash flow break-even by the end of 2026 PAPZIMEOS patient hub enrollment reached well over 500 patients across major centers and community practices, demonstrating expanding reach and ease of administration across treatment settings FDA granted PAPZIMEOS seven-year market exclusivity, providing long-term protection against prospective competition Conference call scheduled for 4:30 PM ET today GERMANTOWN, Md., Aug. 4, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced second quarter 2026 financial results and business updates. "We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy," said Helen Sabzevari, PhD, President and CEO of Precigen. "This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders." "We continue to see the key elements of the PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns, a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus reflected in a RRP position paper, and continued patient hub enrollments," said Phil Tennant, Chief Commercial Officer of Precigen. "This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into treated patients and further expanding access to PAPZIMEOS across the RRP community." KEY PROGRAM HIGHLIGHTS PAPZIMEOS®: First-line Standard of Care for the Treatment of Adults with RRP PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with RRP. Broad US adoption: Well over 500 patients have registered through Precigen's patient hub, with additional patients outside of the hub being identified and receiving treatment as institutions support patient access directly and independently. Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease. Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly 100% of insured lives nationwide. Permanent J-code: The Centers for Medicare and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS into their workflows. First-line standard of care: An expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States. Redosing study enrolling patients: The Company's open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480). MAA under review by the EMA: The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation from the European Commission. PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated CancersPRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers. PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing. The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year. FINANCIAL RESULTS "We are thrilled to report that Precigen achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Based upon our current revenue trajectory and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026." Second Quarter 2026 Financial Results Compared to Prior Year PeriodTotal revenues were $55.0 million for the three months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the three months ended June 30, 2026 were $53.1 million. Cost of products and services increased by $1.7 million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company's accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold. R&D expenses decreased by $4.2 million, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses. SG&A expenses increased by $6.1 million, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense. In the three months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026. Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long term debt that originated in the third quarter of 2025. Net income was $20.1 million, or $0.06 per basic and $0.05 per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic and diluted share, for the three months ended June 30, 2025. First Six Months 2026 Financial Results Compared to Prior Year PeriodTotal revenues were $78.2 million for the six months ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended June 30, 2026 were $74.7 million. Cost of products and services increased by $3.2 million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company's accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold. R&D expenses decreased by $9.0 million, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses. SG&A expenses increased by $14.8 million, compared to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense. In the six months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026. Total other expense, net decreased by $21.9 million, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025. Net income was $12.1 million, or $0.03 per basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic and diluted share, for the six months ended June 30, 2025. Precigen: Advancing Medicine with Precision®Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube. TrademarksPrecigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what the Company expects. Examples of forward-looking statements include, among others, information relating to the Company's business and business plans, the success of efforts to commercialize PAPZIMEOS® (zopapogene imadenovec-drba) for the treatment of recurrent respiratory papillomatosis (RRP) in adults including the revenue that the Company expects to realize from such efforts, the Company's ability to successfully obtain foreign regulatory approvals for PAPZIMEOS, expectations about the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat RRP, the Company's future financial and operational results including the Company's ability to reach quarterly profitability and cash flow break-even, and the Company's ability to commence clinical studies or complete ongoing clinical studies for the Company's clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. Investor Contact:Steven M. HarasymTel: +1 (202) [email protected] Media Contact:Donelle M. [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html

GERMANTOWN, Md., July 21, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced the Company will release second quarter 2026 financial results and provide business updates on Tuesday, August 4, 2026. The Company will host a conference call to discuss results that day at 4:30 PM ET. The conference call may be accessed by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call. Event details can be found on Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations. Precigen: Advancing Medicine with Precision®Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what the Company expects. Examples of forward-looking statements include, among others, information relating to the Company's business and business plans, the success of efforts to commercialize PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of recurrent respiratory papillomatosis (RRP) in adults including the revenue that the Company expects to realize from such efforts, the Company's ability to successfully obtain foreign regulatory approvals for PAPZIMEOS, expectations about the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat RRP, the Company's future financial and operational results including the Company's ability to reach cash flow break-even, and the Company's ability to commence clinical studies or complete ongoing clinical studies for the Company's clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. Investor Contact:Steven M. HarasymTel: +1 (202) [email protected] Media Contact:Donelle M. [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-to-announce-second-quarter-2026-financial-results-and-provide-business-updates-on-august-4-302830158.html

Precigen, Inc. (NASDAQ:PGEN) investors will be delighted, with the company turning in some strong numbers with its latest results. Precigen outperformed estimates, with revenues of US$23m beating estimates by 12%. Statutory losses were US$0.02, 50% smaller thanthe analysts expected. Earnings are an important time for investors, as they can track a company's performance, look at what the analysts are forecasting for next year, and see if there's been a change in sentiment towards the company. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Following the latest results, Precigen's three analysts are now forecasting revenues of US$124.6m in 2026. This would be a sizeable 295% improvement in revenue compared to the last 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 94% to US$0.06. Before this latest report, the consensus had been expecting revenues of US$115.4m and US$0.10 per share in losses. There's been a pretty noticeable increase in sentiment, with the analysts upgrading revenues and making a considerable decrease in loss per share in particular. See our latest analysis for Precigen The consensus price target rose 16% to US$11.00, with the analysts encouraged by the higher revenue and lower forecast losses for next year. Taking a look at the bigger picture now, one of the ways we can understand these forecasts is to see how they compare to both past performance and industry growth estimates. One thing stands out from these estimates, which is that Precigen is forecast to grow faster in the future than it has in the past, with revenues expected to display 5x annualised growth until the end of 2026. If achieved, this would be a much better result than the 40% annual decline over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in the industry are forecast to see their revenue grow 22% per year. So it looks like Precigen is expected to grow faster than its competitors, at least for a while. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. Pleasantly, they also upgraded their revenue estimates, and their forecasts suggest the business is expected to grow faster than the wider industry. There was also a nice increase in the price target, with the analysts clearly feeling that the intrinsic value of the business is improving. With that in mind, we wouldn't be too quick to come to a conclusion on Precigen. Long-term earnings power is much more important than next year's profits. At Simply Wall St, we have a full range of analyst estimates for Precigen going out to 2028, and you can see them free on our platform here.. Even so, be aware that Precigen is showing 4 warning signs in our investment analysis , you should know about... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

In the last week, the United States market has stayed flat, yet it has seen a remarkable 25% increase over the past year with earnings forecasted to grow by 17% annually. In this thriving environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business in its potential for continued success. Click here to see the full list of 187 stocks from our Fast Growing US Companies With High Insider Ownership screener. Below we spotlight a couple of our favorites from our exclusive screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Aeluma, Inc. develops optoelectronic and electronic devices for sensing, communication, and computing applications in the United States with a market cap of $488.06 million. Operations: The company's revenue is primarily derived from its Semiconductor Equipment and Services segment, which generated $5.23 million. Insider Ownership: 25.8% Earnings Growth Forecast: 68.6% p.a. Aeluma is positioned for significant growth with forecasted revenue expansion of 77% annually, outpacing the US market. Despite a volatile share price and recent net losses, its strategic focus on high-growth sectors like AI infrastructure and quantum technologies is bolstered by substantial U.S. government contracts exceeding US$4 million. The company's innovative quantum dot laser platform, supported by NASA awards, enhances its competitive edge in photonics integration. However, low projected return on equity remains a concern. Click to explore a detailed breakdown of our findings in Aeluma's earnings growth report. Our valuation report here indicates Aeluma may be overvalued. Simply Wall St Growth Rating: ★★★★☆☆ Overview: STAAR Surgical Company designs, develops, manufactures, and sells phakic implantable lenses and accessory delivery systems for the eye, with a market cap of approximately $1.40 billion. Operations: The company's revenue is primarily generated from its ophthalmic surgical products, totaling $239.44 million. Insider Ownership: 26.2% Earnings Growth Forecast: 71.6% p.a. STAAR Surgical's growth potential is underscored by its forecasted revenue increase of 11.8% annually, slightly above the US market average. Recent earnings showed significant improvement with sales reaching US$93.52 million, a substantial rise from the previous year, and a shift to net income of US$5.21 million from a prior loss. The recent FDA approval expanding age indications for its EVO ICL product enhances market reach, supporting long-term growth prospects despite past financial volatility. Dive into the specifics of STAAR Surgical here with our thorough growth forecast report. Insights from our recent valuation report point to the potential overvaluation of STAAR Surgical shares in the market. Simply Wall St Growth Rating: ★★★★★☆ Overview: Hyliion Holdings Corp. designs and develops power generators for stationary and mobile applications, with a market cap of approximately $477.92 million. Operations: Hyliion Holdings Corp. focuses on the design and development of power generators for both stationary and mobile applications, although specific revenue segments are not detailed in the provided information. Insider Ownership: 22.5% Earnings Growth Forecast: 54.3% p.a. Hyliion Holdings shows promising growth potential, with revenue expected to rise 75.2% annually, significantly outpacing the US market. Recent earnings reveal a substantial increase in revenue to US$2.83 million, though net losses persist at US$11.74 million. The successful demonstration of its KARNO reactor's multi-fuel capability highlights technological advancements that could drive future sales and market expansion. Despite financial volatility and limited cash runway, Hyliion's innovative approach supports its growth trajectory in diverse applications. Unlock comprehensive insights into our analysis of Hyliion Holdings stock in this growth report. Our comprehensive valuation report raises the possibility that Hyliion Holdings is priced higher than what may be justified by its financials. Navigate through the entire inventory of 187 Fast Growing US Companies With High Insider Ownership here. Contemplating Other Strategies? The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 16 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include ALMU STAA and HYLN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]