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Earnings documents stored for PGEN.
Investor releaseQuarter not tagged2026-05-16Earnings Beat: Precigen, Inc. (NASDAQ:PGEN) Just Beat Analyst Forecasts, And Analysts Have Been Lifting Their Forecasts
Simply Wall St.
Earnings Beat: Precigen, Inc. (NASDAQ:PGEN) Just Beat Analyst Forecasts, And Analysts Have Been Lifting Their Forecasts
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 bus...
Investor releaseQuarter not tagged2026-05-153 Growth Companies With High Insider Ownership And Up To 71% Earnings Growth
Simply Wall St.
3 Growth Companies With High Insider Ownership And Up To 71% Earnings Growth
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 n...
Investor releaseQuarter not tagged2026-05-14Precigen, Inc. Q1 2026 Earnings Call Summary
Moby
Precigen, Inc. Q1 2026 Earnings Call Summary
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. The significant revenue jump from $3.4 million to $21.6 million in Q1 2026 reflects the first full quarter of PAPZIMEOS availability and accelerating prescriber momentum. Management attributes rapid adoption to a broad FDA label that lacks surgical pre-requisites, allowing treatment across all disease severities. Strategic expansion into community practices now accounts for 25% of hub registrations, demonstrating the therapy's ease of administration beyond major academic centers. The launch is supported by a landmark expert position paper designating PAPZIMEOS as the preferred first-line standard of care over repeated surgical interventions. The therapy's mechanism of action, targeting the root cause of RRP via HPV-6 and HPV-11 immune response, provides a unique competitive advantage in a historically surgery-dependent market. Operational efficiency is driven by an established distribution infrastructure that allows for rapid integration into routine clinical workflows. Management expects to reach cash flow breakeven by the end of 2026, supported by PAPZIMEOS revenue growth and current cash reserves without seeking additional capital. The implementation of a permanent J-code on April 1, 2026, is expected to simplify claims processing and further accelerate patient access in Q2 and beyond. Clinical expansion plans include initiating a pediatric trial for PAPZIMEOS in Q4 2026 and pursuing European market entry via an ongoing EMA review. The company anticipates providing Phase II data updates for PRGN-2009 in HPV-driven cancers during the second half of 2026. R&D expenses are projected to increase as the year progresses, following a temporary dip caused by the transition of PAPZIMEOS manufacturing costs from R&D to inventory. Q1 cash used in operations included $13 million in non-recurring outflows, with significantly lower cash burn expected in Q2. The reported net loss of $7.9 million was mitigated by strong product sales, resulting in an operating loss of only $6 million for the quarter. Exceptional payer coverage has been secured, reaching an estimated 297 million lives or over 90% of insured individuals in the U.S. Management noted that current hub registration figures (approximately 400 patients) understa...
Investor releaseQuarter not tagged2026-05-14Precigen (PGEN) Q1 2026 Earnings Transcript
Motley Fool
Precigen (PGEN) Q1 2026 Earnings Transcript
Image source: The Motley Fool. Wednesday, May 13, 2026 at 4:30 p.m. ET President and Chief Executive Officer — Helen Sabzevari Chief Commercial Officer — Phil Tennant Chief Financial Officer — Harry Thomasian Jr. Need a quote from a Motley Fool analyst? Email [email protected] Helen Sabzevari: Thank you, Steven. And thank you to all those joining us for our Q1 update call. The approval of Papzimias in August 2025 has brought a novel first-line standard-of-care treatment for adults with RRT. In 9 short months, we have witnessed tremendous progress with the first commercial therapeutic launch in the disease's history. Since last reporting in March, the launch has continued to show accelerating momentum. The early success and trajectory continues to build on this landmark achievement for the patients families, healthcare providers, the RRP Foundation, and all of those impacted by this devastating disease. I will begin by providing you with some general color around what we are seeing, and then turn the call over to Phil who will provide more specifics around commercialization. The accelerating trajectory we are seeing in revenue growth is robust. As reported in our quarterly report, Papzimias net product revenue for Q1 2026 the first full quarter of availability was $21.6 million as compared to $3.4 million in Q4 2025. Prescribers continue to add Papzimias to their practices at both major medical centers and community practices alike. Which has been a strong tailwind as we are seeing this increasing momentum continue into Q2. This is a clear signal of the high level of enthusiasm among patients and physicians resulting in significant uptake of the therapy. Why we believe we are seeing such a significant launch trajectory? First, the full approval and broad label from the FDA. There are no restrictions on the number of surgeries a patient must undergo prior to treatment with Papzimias. We are seeing this as patients are being dosed across all severities and in the extensive payer coverage we have secured. Second, the transformative clinical data based on significant efficacy durable and ongoing responses with a median duration of follow-up of 3 years. Importantly, we look forward to updating the ongoing durability data at ASCO next month. Third, the ease of administration of the drug has enabled broad and rapid uptake at not just the major medical institution, but inc...
Investor releaseQuarter not tagged2026-05-14Precigen Q1 Earnings Call Highlights
MarketBeat
Precigen Q1 Earnings Call Highlights
Interested in Precigen, Inc.? Here are five stocks we like better. PAPZIMEOS drove a sharp revenue jump in Precigen’s first quarter, generating $21.6 million in net product revenue in its first full quarter of availability and lifting total company revenue to $23.3 million. The company said the launch is gaining traction with strong payer coverage and broad adoption, with more than 90% of insured lives covered and roughly 400 patients registered in its hub as of the call. Precigen reported a narrower operating loss and said it expects cash use to decline later this year, with management reiterating a path to cash flow break-even by the end of 2026 without needing to raise capital. Precigen (NASDAQ:PGEN) reported a sharp increase in first-quarter 2026 revenue as the company’s first commercial product, PAPZIMEOS, continued its U.S. launch following FDA approval in August 2025. On the company’s earnings call, President and CEO Dr. Helen Sabzevari said PAPZIMEOS generated net product revenue of $21.6 million in the first quarter, its first full quarter of availability, compared with $3.4 million in the fourth quarter of 2025. Total company revenue for the quarter was $23.3 million. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? PAPZIMEOS is approved as a first-line treatment for adults with recurrent respiratory papillomatosis, or RRP. Sabzevari said the launch has shown “accelerating momentum” across both major medical centers and community practices. “The early success and trajectory continues to build on this landmark achievement for the patients, families, healthcare providers, the Recurrent Respiratory Papillomatosis Foundation, and all of those impacted by this devastating disease,” Sabzevari said. → MP Materials Is Quietly Building a Rare Earth Powerhouse Sabzevari attributed the uptake to several factors, including the FDA’s full approval and broad label, which does not restrict treatment based on the number of surgeries a patient has previously undergone. She also cited clinical data showing efficacy and durability, ease of administration and distribution, and a recent expert position paper published in The Laryngoscope. The paper, sponsored by the RRP Foundation and authored by 16 U.S. physicians specializing in RRP, recommended PAPZIMEOS as the new standard of care and preferred first-line therapy, according to Sabzevari. → M...
Investor releaseQuarter not tagged2026-05-14Transcript: Precigen Q1 2026 Earnings Conference Call
Benzinga
Transcript: Precigen Q1 2026 Earnings Conference Call
On Wednesday, Precigen (NASDAQ:PGEN) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. The full earnings call is available at https://app.webinar.net/gM6Ljy5jKN3 Precigen Inc reported strong financial performance with Q1 2026 net product revenue of $21.6 million from Papcemios, up from $3.4 million in Q4 2025. The company highlighted the successful commercial launch of Papcemios, supported by FDA approval, broad payer coverage, and strong adoption in both major medical centers and community practices. Management expressed optimism about continued growth, with plans to initiate a pediatric trial for Papcemios in Q4 2026 and updates on their PRGN 2009 immunotherapy program expected later in the year. The company reported an operating loss of $6 million for the quarter, with a net loss of $7.9 million, and ended the quarter with $56.7 million in cash and equivalents. Precigen Inc anticipates achieving cash flow breakeven by the end of 2026 without needing to access additional capital markets. OPERATOR Good afternoon ladies and gentlemen and welcome to the President's first quarter 2026 financial results and Business Updates Conference Call at this time all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, May 13, 2026 and I would now like to turn the conference over to Mr. Steven Karasim. Please go ahead sir. Steven Karasim (Moderator) Thank you Operator and thank you for all those joining us today for our Q1 2026 update call. Joining me today are Dr. Helen Sabzavari, our President and CEO, Phil Tennant, our Chief Commercial Officer, Harry Temassian, our CFO and Ratul Shah, our coo. Before we begin our prepared remarks, I remind everyone that we will be making certain forward looking statements during this call. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation as well as our SEC filings which include risks and uncertainties that could cause actual results to differ materially from today's forward look...
Investor releaseQuarter not tagged2026-05-14Precigen Inc (PGEN) Q1 2026 Earnings Call Highlights: Strong Revenue Growth Amid Operational ...
GuruFocus.com
Precigen Inc (PGEN) Q1 2026 Earnings Call Highlights: Strong Revenue Growth Amid Operational ...
This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Precigen Inc (NASDAQ:PGEN) reported strong revenue growth with Q1 2026 net product revenue for Papcimius reaching $21.6 million, up from $3.4 million in Q4 2025. The launch of Papcimius has been well-received, with significant uptake among both major medical centers and community practices. The FDA's full approval and broad label for Papcimius, without restrictions on the number of surgeries prior to treatment, has facilitated its rapid adoption. Comprehensive payer coverage has been achieved, with more than 90% of insured lives in the U.S. covered, supporting patient access to Papcimius. The company has a strong financial position, with $56.7 million in cash equivalents and investments, and expects to reach cash flow breakeven by the end of 2026 without needing additional funding. Despite strong revenue growth, Precigen Inc (NASDAQ:PGEN) reported an operating loss of $6 million for Q1 2026. Research and development expenses are expected to increase as the year progresses, potentially impacting future profitability. Selling, general, and administrative expenses increased by $8.7 million from the prior year's first quarter, driven by commercial activities related to Papcimius. Cash used in operations for Q1 was $43.8 million, which included $13 million of non-recurring cash outflows, indicating high operational costs. The company is not providing specific guidance for future quarters, creating uncertainty about the pace of revenue growth and financial performance. Warning! GuruFocus has detected 8 Warning Signs with PGEN. Is PGEN fairly valued? Test your thesis with our free DCF calculator. Q: Can you speak to the number of patients that have now received at least the first dose, and if you're now also seeing patients complete the full course of therapy? Also, can you provide details on the redosing trial and when we might see initial data? A: (Dr. Helen Sabzivari, CEO) We are not commenting on the specific number of patients initiated on treatment, but we are seeing progress with patients completing the full course. For the redosing trial, we have started with partial responders from previous trials and are gathering data to report later. Regarding PRGN-2009, we will report data from ongoing...
Investor releaseQuarter not tagged2026-05-133 Growth Companies With High Insider Ownership Expect Earnings Growth Up To 63%
Simply Wall St.
3 Growth Companies With High Insider Ownership Expect Earnings Growth Up To 63%
Over the last 7 days, the United States market has risen by 1.5%, contributing to a remarkable 26% climb over the past year, with earnings forecasted to grow by 17% annually. In this flourishing environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business and potential for substantial earnings expansion. Click here to see the full list of 185 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's explore several standout options from the results in the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing chimeric antigen receptor cell therapy for light chain amyloidosis and immune-mediated diseases, with a market cap of $525.88 million. Operations: Revenue Segments (in millions of $): null Insider Ownership: 12.8% Earnings Growth Forecast: 63.4% p.a. Immix Biopharma is a growth-focused company with high insider ownership, currently navigating financial challenges with a reported net loss of US$10.09 million for Q1 2026. Despite this, its revenue is forecasted to grow significantly faster than the US market at 56.6% annually, driven by promising developments like NXC-201 for AL Amyloidosis. The company anticipates profitability within three years, although it has experienced substantial shareholder dilution and share price volatility recently. Get an in-depth perspective on Immix Biopharma's performance by reading our analyst estimates report here. Our valuation report here indicates Immix Biopharma may be overvalued. Simply Wall St Growth Rating: ★★★★★☆ Overview: Rumble Inc. operates a video sharing and cloud services platform across the United States, Canada, and internationally, with a market cap of approximately $2.77 billion. Operations: The company's revenue is generated from its Internet Software & Services segment, amounting to $100.62 million. Insider Ownership: 35.9% Earnings Growth Forecast: 56.8% p.a. Rumble Inc. exhibits high insider ownership and is positioned for substantial growth, with revenue forecasted to expand at 42.5% annually, outpacing the US market. Recent initiatives like the OpenClaw Starter package on Rumble Cloud highlight its innovative approach in AI infrastructure. Despite a history of volatility and fin...
TranscriptFY2026 Q12026-05-13FY2026 Q1 earnings call transcript
Earnings source - 51 paragraphs
FY2026 Q1 earnings call transcript
Good afternoon, ladies and gentlemen, and welcome to the Precigen First Quarter 2026 financial results and business updates conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, May 13, 2026. I would now like to turn the conference over to Mr. Steven Harasym. Please go ahead, sir.
Thank you, operator, and thank you for all those joining us today for our Q1 2026 update call. Joining me today are Dr. Helen Sabzevari, our President and CEO; Phil Tennant, our Chief Commercial Officer; Harry Thomasian, our CFO; and Rutul R. Shah, our COO. Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements during this call. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation as well as our SEC filings, which include risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that, I will now turn the call over to Dr. Sabzevari.
Thank you, Steve, and thank you to all those joining us for our Q1 update call. The approval of PAPZIMEOS in August of 2025 has brought a novel first-line standard of care treatment for adults with RRP. In nine short months, we have witnessed tremendous progress with the first commercial therapeutic launch in the disease's history. Since last reporting in March, the launch has continued to show accelerating momentum. The early success and trajectory continues to build on this landmark achievement for the patients, families, healthcare providers, the RRP Foundation, and all of those impacted by this devastating disease. I will begin by providing you with some general color around what we are seeing and then turn the call over to Phil, who will provide more specifics around commercialization. The accelerating trajectory we are seeing in revenue growth is robust.
As reported in our quarterly report, PAPZIMEOS' net product revenue for Q1 2026, the first full quarter of availability, was $21.6 million as compared to $3.4 million in Q4 2025. Prescribers continue to add PAPZIMEOS to their practices at both major medical centers and community practices alike, which has been a strong tailwind as we are seeing this increasing momentum continue into Q2. This is a clear signal of the high level of enthusiasm among patients and physicians, resulting in significant uptake of the therapy. Why we believe we are seeing such a significant launch trajectory? First, the full approval and broad label from the FDA. There are no restriction on the number of surgeries a patient must undergo prior to treatment with PAPZIMEOS.
We are seeing this as patients are being dosed across all severities and in the extensive payer coverage we have secured. Second, the transformative clinical data based on significant efficacy, durable and ongoing responses with a median duration of follow-up of three years. Importantly, we look forward to updating the ongoing durability data at ASCO next month. Third, the ease of administration of the drug has enabled broad and rapid uptake at not just the major medical institution, but increasingly at community practices. Specifically, the ease of dosing as well as the efficient distribution infrastructure we have in place across the country allow rapid and effective integration into routine clinical practices. Finally, the power of this therapy is strongly supported by a landmark expert position paper released earlier this year.
The paper is sponsored by the RRP Foundation and authored by 16 leading U.S. physicians specializing in RRP, was published in The Laryngoscope, the premier peer-reviewed journal in otolaryngology. The paper recommends PAPZIMEOS as the new standard of care and the preferred first-line therapy. Collectively, these factors mean that PAPZIMEOS has set a new benchmark for this space, prioritizing medical therapy over repeated surgical interventions to improve patients' outcome. As a reminder, this therapy directly addresses the root cause of RRP by eliciting a targeted immune response against HPV 6 and 11. PAPZIMEOS also offers the potential for redosing due to its mechanism of action and favorable safety profile. We are evaluating this in an ongoing clinical trial, which is enrolling patients as we speak. I will now turn the call over to Phil for details around our commercial launch. Phil?
Thank you, Helen, and a warm welcome to all those listening. I'm delighted to share the most recent progress of our launch efforts with details around the completion of Q1 and the sharp momentum we continue to see with PAPZIMEOS' launch in Q2 of this year. As seen in our filings, we showed strong quarter-over-quarter product revenue growth in Q1 2026, clearly demonstrating the expected acceleration of product uptake from $3.4 million-$21.6 million. As we report today, we continue to see comprehensive payer coverage and further activation of accounts across the country. I will now present some of the leading indicators we are observing as of today translating to the launch acceleration. Registrations in the PAPZIMEOS' patient hub continue to grow.
As of today, we have approximately 400 patients registered, of which 25% are in the community setting, underscoring the broad reach of PAPZIMEOS beyond academic and major centers and reinforcing that PAPZIMEOS can be effectively integrated into routine clinical practice beyond major centers. As previously mentioned, this does not account for non-hub patients directly enrolled by institutions. This continues to support the fact that there is expected pent-up demand for the new standard of care for adults with RRP. Payer coverage has been exceptional and provides a solid platform for patient access to PAPZIMEOS. Total lives covered through commercial Medicare and Medicaid stands at an estimated $297 million. All inclusive, this equates to more than 90% of insured lives covered in the U.S.
As expected, we continue to see activation of accounts who are prescribing and ordering PAPZIMEOS across both major medical centers and community practices. We are seeing this trend continue into Q2, further fueled by the permanent J-code and a dedicated field reimbursement resources we have implemented. As Helen mentioned earlier, the expert position paper continues to solidify PAPZIMEOS as the first choice for adult patients and treating physicians. We continue to have a significant presence at major scientific congresses in the U.S. and beyond, both through publications and presentations and interactions with thought leaders and the broader treatment community. This, again, reinforces the strong receptivity to PAPZIMEOS that we are seeing from the market. These congresses will continue to be a significant part of our commercial and scientific strategy moving forward.
The assignment of the permanent J-code on April first, coupled with the durability of response that we are seeing in patients, is helping this impetus continue. The permanent J-code designation will further simplify claims processing and facilitate broader patient access through both medical centers and community practices. The significant quarter-over-quarter revenue growth is a clear sign that the healthcare community is embracing PAPZIMEOS. We are thrilled with launch performance in Q1 and expect these positive trends to continue into Q2 and beyond. I look forward to sharing those Q2 results in August. I'll now turn the call over to Harry. for an overview of our Q1 financials. Harry?
Thank you, Phil, and good afternoon to all of the participants on today's call. As you've already heard, we're extremely pleased with our top-line financial results for the first quarter. I also want to add that not only do we surpass $21 million in PAPZIMEOS' revenue, but our operating loss for the quarter was only $6 million. Let me provide some further color on our overall financial results for the quarter. Total revenue was $23.3 million, which included $21.6 million related to PAPZIMEOS sales. We saw demand for PAPZIMEOS continue to build as the first quarter progressed, and we're continuing to see that demand increase as we enter the second quarter. Research and development costs for the quarter were $5.6 million, which compared to the prior year first quarter, decreased by $4.8 million.
The majority of this change is explained by the fact that PAPZIMEOS' manufacturing costs were expensed prior to the FDA approval. As we look forward, we anticipate R&D expense will increase as the year progresses. Selling, general, and administrative expenses for the quarter were $21 million, having increased by $8.7 million from the prior year's first quarter. The increase was significantly driven by increased commercial activities related to PAPZIMEOS. Moving down the statement of operations, as I noted earlier, our operating loss for the quarter was $6 million. Our net loss for the quarter was $7.9 million or $0.02 per basic and diluted share. Turning to the balance sheet, we ended the quarter with $56.7 million in cash equivalents, and investments.
I do wanna point out that our cash used in operations for the quarter was $43.8 million and included $13 million of cash outflows that we do not expect to recur in future quarters this year. The first quarter cash used also did not include any cash receipts from PAPZIMEOS sales based on customer payment terms. With that said, we expect cash used in operations in the second quarter to be significantly lower than what we saw in Q1. We continue to reiterate that based on our current financial forecast, our cash equivalents, and investments, along with the collection of PAPZIMEOS' receivables, will fund operations through cash flow break even by the end of 2026. We currently do not see a need to access capital markets for additional funding. I'd like to now turn it back to Helen for some closing remarks. Helen?
Thank you, Harry. I will now provide updates on the portfolio, starting with PAPZIMEOS' clinical and regulatory updates. We intend on initiating a pediatric trial in PAPZIMEOS in Q4 of this year, as previously mentioned. In addition, our marketing authorization application continues under the review path by EMA for PAPZIMEOS. We are also pleased to announce our sponsorship of a third annual RRP Awareness Day in June. This event provides another excellent platform to raise global awareness of RRP and the new standard of care for its treatment in the U.S. Now turning to PRGN-2009. This is the same backbone as our approved therapy, PAPZIMEOS, expanding the proven AdenoVerse platform. Our PRGN-2009 immunotherapy is designed to train the immune system to recognize and eliminate tumor cells infected with HPV-16 and HPV-18, the root cause of major HPV-driven cancers such as head and neck and cervical cancers.
These malignancies together represents nearly five percent of all cancer cases worldwide. PRGN-2009 is advancing in multiple phase II clinical trials in combination with pembro in both head and neck and cervical cancers. I am very enthusiastic about the prospects of this program. We plan to provide updates on the program later in the year. With that, I will now turn the call over to the operator for Q&A. Operator?
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Thank you. Your first question comes on the line of Jason Butler from Citizens. Please go ahead.
Hi. Thanks for taking the questions, congrats on the quarter and the progress with PAPZIMEOS. A couple from me. First of all, can you speak to the number of patients that have now received at least the first dose, and if you're now also seeing patients complete the full course of therapy? Second question on the redosing trial, can you just maybe hit a couple of the design highlights for the trial and when we may see initial cuts of data? Last one from me on PRGN-2009, for the update that you'll give later this year, can we expect to see any results from the ongoing phase II trials in that update? Thank you.
Thank you, Jason, for the question. In regards to the first question, I'm gonna hand it over to Phil, and then I will take the last two questions.
Hey, Jason. Thanks for the question. Yeah, we're not commenting on the specific number of patients who have actually been initiated on treatment, but as you can see from the revenue number, we're obviously making some very good progress there. Yes, given that we started our dosing in November and it's a 12-week regimen, yes, absolutely, we are starting to see patients who have completed treatment.
Yeah. Maybe I can also add that very clearly as patients are being dosed and finishing, all of the patients have received their doses. This is again going back to the regional data that we have presented on the safety and efficacy and durability of PAPZIMEOS, which again points to that factor and ease of administration. In regard to the second question on redosing, we have currently started the redosing of the patients, especially the patients that they had a partial responses in our previous treatments, in our previous trials, in Tivicay trials, and we are have started with that. Clearly, our patients that are being dosed right now commercially, obviously, we are very much excited.
From what we are hearing from the field, the physicians are extremely excited about some of the results that are seeing currently. For now, we are focusing on the partial responders that were in our original trials, and we are gathering the information on that, and we will be reporting from that perspective. In regard to the PRGN-2009, the answer is absolutely. We will be reporting data, and actually, we are looking forward to that. This is, as we have mentioned, in our phase II trials, both in especially on the head and neck, that is in combination with pembrolizumab.
I think what is very important, these are open label trials, so we obviously have had and have a continuous opportunity to follow the data. We are looking forward to be sharing this in the second half of this year.
Great. Thanks again, and congrats again on the quarter.
Thank you.
Thanks, Jason.
Thank you. Your next question comes from the line of Brian Cheng from JP Morgan. Please go ahead.
Hey, guys. Thanks for taking our questions this afternoon and congrats on the quarter. Maybe just first, out of the 400 patients that you currently in the hub, can you talk about the pace of conversion that you're seeing to commercial products? Just curious if you can talk a little bit about just the pace of also recruitment seen through the hub. Are you seeing any uptick since you launched? Just curious if you can talk about the pace there, then we have a follow-up. Thank you.
Sure. Hey, Brian. Thanks for the question. Phil here. I think the revenue is probably the first thing that speaks to the pace of conversion of the patients. It's a little early to go into definitive details on that. We are looking at that, of course, and I think with the advent of the J-code, the permanent J-code, that's something that over the next couple of quarters we'll do a deep dive on to understand exactly how quickly and how many of these patients are being converted and how we can help. We've implemented dedicated field resources to assist in that conversion and, you know, the momentum that we're seeing coming into Q2 suggests that we're making great progress there.
In terms of the pace of recruitment into the hub, I mean, you've seen the numbers steadily increase as we started to report on hub numbers. Remember, this is only the Precigen hub that we are commenting on, and there's a significant number of patients who are not using our hub who are being identified and treated. That's another dynamic that is important.
Yeah. Perhaps, Brian, I can also add this to tell it. I think what is very important, and Phil pointed that out, is also the number of the patients that are coming through the community centers, because this is extremely important. As we reported, now we have 25% of the patients are coming from community. This really points out not only the large or expanded efforts on medical centers, but now the community docs and the centers are participating. Again, a lot of those are not necessarily in the hubs and they are treating the patients as we speak. Also another important point is this is not basically in regard of doesn't matter the severity of the patient, which is very important again.
We are very excited about this out the reach and the way that PAPZIMEOS has been basically embraced by physicians and patients.
Thank you, Helen. Maybe just a follow-up here. As we think about, you know, as we think about how to model second quarter, and, you know, obviously moving into the rest of the year, are there any specific consideration that we should really think through, as we, you know, run through our modeling exercise on 2Q, 3Q, and so on? You know, just like you did for the first quarter number, are you able to provide some guardrail in terms of what we could see numerically for the second quarter number? Thank you.
Okay. Yeah. Thank you, Brian, for the question. Clearly, we have said we are not at this moment providing the guidance. However, as you saw from Q4 to Q1, we have gone to over $21.5 million. Also, we have a acceleration, as you have seen in really treatment and expansion of the treatment both at medical centers and community centers. I think we are looking forward definitely to our Q2 and the results that we will be sharing as far as revenue is concerned. As Phil said, I think the revenue will speak for itself as it gets presented, which really shows the bringing in the number of the patients continuously and the treatment as we are expanding.
One of the good indicators you can see that just from our hub, again, which is limited because it's only our hub and doesn't include patients from the others necessarily, you can see a continued expansion in the number of the patients or increase in the number of patients, which is, again, it speaks to the fact that this therapy is very much, it's in accelerated fashion, is taken up by the field. One other thing that maybe I can speak to and Phil can add is from a perspective of what we are seeing at the conferences. The fact that how the physicians are speaking and basically putting the patients on these treatments and It's really amazing, and it's quite encouraging in regard to what we have. Phil?
I would just add, Brian Cheng, that, you know, there's a few things that we're very confident about and looking forward to reporting on more. Obviously, the strong payer position we cemented quite early and, you know, that gives us a firm foundation for what's to come. I would say, as Helen mentioned, we expect the continued activation of accounts who are ordering and using PAPZIMEOS, and not only in the IDNs but in the community. We would expect that community trend to continue to strengthen and ultimately the patient identification in line with our broad label to continue as we go through Q2 and beyond. Ultimately, all of that is laying the firm foundation for the long-term success of the product over multiple quarters and years, and not just over a single quarter.
Great. Thank you, Phil. Thanks for the color. Congratulations for it again.
Thank you. [crosstalk]
Thank you once again. That is star one to ask a question. Your next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.
Thank you. Good afternoon, Helen, Phil, Rutul, and team. obviously a fantastic quarter, with $21.6 million in revenues. Phil, if you can help us understand that number a little bit more, in terms of, you know, what portion of that was either part of pent-up demand or flow from Q4 to Q1, in terms of getting the payer policies processes set up, versus patients who were treated. In the same vein, you know, you disclosed 400 patients in the hub with 25%, you know, coming from the community. How many of these 400 or so patients that you have in the hub have been infused at this point?
You know, what's the average time somebody takes from enrollment to getting dosed? The last question from me is on the data itself, that's expected at the ASCO conference in terms of the durability data. You know, how should we think about that data? Would that be helpful and supportive of any label expansions? How should we think about that in terms of the current studies, whether it is pediatric or redosing? You know, will that give us some sort of a feel for how these studies should, you know, eventually read out? Thanks for taking my questions.
Thank you very much, RK, for the questions. This is Helen. Maybe I take the last question first, then I will give the rest to Phil. In regards to the ASCO presentation, we are actually very excited about the durability response and the data that is going to be presented at ASCO. Clearly, we continue seeing the same kind of a momentum, and as far as both safety, durability of response and the efficacy that we have reported, and we are now building further on that at ASCO. This is all going to be quite exciting for us. Yes, that data will be helping in further really adding toward the durability of the response and expansion of the indication. We are looking forward to that.
That data further adds to the really the robustness of the platform, which is simply this is something that we are very excited about, the AdenoVerse platform to be used across a number of the indication and specifically on HPV-related indication, both in the rare diseases but also in oncology. We think that that data is another feather in the cap of AdenoVerse platform, which we are moving towards the platform designation with. With that, I'm gonna hand it to Phil to answer the other questions.
Hey, RK. Thanks for the question. Let me tackle your hub question first. I did refer to this a little earlier. I think we'd like to see another couple of quarters before we communicate details of exactly the hub conversion and time to conversion and so on. I mean, what I would say is that it's pretty much as expected at the moment. I think we do need another quarter or two to really understand the meaningful trends there. Your first question was about carryover revenue. Yes, absolutely. Given that we've got a three-month or 12-week regimen, at the end of each quarter, you will see some revenue spill over into the next quarter. I would say from Q4 into Q1, that was pretty minimal given the level of revenue that we had in Q4.
You would expect that to be more as we go forward. You know, the key thing there is that it's new patients that are fueling the business opportunity that we've seen in Q1.
Yeah. Maybe I can add to that what, especially with what achievement with the J-code, that has been also extremely helpful in not only for institutes to be able to process the patients through much more rapidly, and I think we are seeing that trajectory going up, and we are seeing the same thing actually in Q2. We are very excited about that.
Thank you. Thanks for taking all my questions.
Sure. Thank you.
Thanks, RK.
Thank you. There are no further questions at this time. I'll now hand the call back to Dr. Helen Sabzevari for any closing remarks.
Thank you, operator, and thank you for all of the thoughtful questions. We appreciate the opportunity to provide you with this update on this historic product launch. I believe we are building the foundation of a meaningful portfolio for Precigen and for the community of our patients. We look forward to updating you as the launch continues and specifically also further on our portfolio progress. With that, I wish everyone a wonderful evening. Thank you.
Thank you. This concludes today's call. Thank you for participating. You may all disconnect.
Investor releaseQuarter not tagged2026-05-08Precigen to Announce First Quarter 2026 Financial Results and Provide Business Updates on May 13
PR Newswire
Precigen to Announce First Quarter 2026 Financial Results and Provide Business Updates on May 13
GERMANTOWN, Md., May 7, 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 first quarter 2026 financial results and provide business updates on Wednesday, May 13, 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 Statements This 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 inclu...
Investor releaseQuarter not tagged2026-04-213 Growth Companies With High Insider Ownership Growing Earnings Up To 63%
Simply Wall St.
3 Growth Companies With High Insider Ownership Growing Earnings Up To 63%
The United States market has recently experienced a notable upswing, climbing 3.6% in the last week and showing a robust 39% increase over the past year, with earnings projected to grow by 16% annually in the coming years. In this favorable environment, growth companies with high insider ownership can be particularly appealing as they often demonstrate strong confidence from those who know the business best and have vested interests in its success. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's take a closer look at a couple of our picks from the screened companies. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Clearfield, Inc. designs, manufactures, and distributes fiber management, protection, and delivery products globally with a market cap of $415.12 million. Operations: The company's revenue segment is primarily derived from its fiber management, protection, and delivery products, totaling $154.78 million. Insider Ownership: 18.3% Earnings Growth Forecast: 61.1% p.a. Clearfield's insider ownership aligns with its growth prospects, as earnings are forecast to grow significantly at 61.1% annually, outpacing the US market. Despite recent losses, Clearfield became profitable this year and expects net sales between US$160 million and US$170 million for fiscal 2026. Substantial insider buying occurred over the past three months, reflecting confidence in future performance. Recent presentations at major industry events highlight ongoing efforts to strengthen market presence and investor relations. Unlock comprehensive insights into our analysis of Clearfield stock in this growth report. In light of our recent valuation report, it seems possible that Clearfield is trading beyond its estimated value. Simply Wall St Growth Rating: ★★★★★☆ Overview: Alphatec Holdings, Inc. is a medical technology company that focuses on designing and developing technologies for the surgical treatment of spinal disorders, with a market cap of approximately $1.68 billion. Operations: The company generates revenue primarily from its Medical Products segment, which accounted for $764.16 million. Insider Ownership: 10.4% Earnings Growth Forecast: 56.9% p.a. Alphatec Holdings' insider ownership supports its growth trajectory, with earnings projected to grow significantly at 56.89% annually and revenue expected...
Investor releaseQuarter not tagged2026-04-153 Growth Stocks With High Insider Ownership And 43% Earnings Growth
Simply Wall St.
3 Growth Stocks With High Insider Ownership And 43% Earnings Growth
The United States market has experienced a notable upswing, climbing 4.4% in the last week and showing a robust 32% increase over the past year, with earnings forecasted to grow by 16% annually. In this thriving environment, identifying growth companies with high insider ownership can be particularly appealing as they often signal confidence from those closest to the business and potential alignment with shareholder interests. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. We're going to check out a few of the best picks from our screener tool. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Loar Holdings Inc. designs, manufactures, and sells aerospace and defense components for aircraft and systems both in the United States and internationally, with a market cap of $6.19 billion. Operations: The company generates revenue of $496.28 million from its aerospace and defense segments, focusing on components for aircraft and related systems in both domestic and international markets. Insider Ownership: 17.6% Earnings Growth Forecast: 24.4% p.a. Loar Holdings exhibits strong growth potential with earnings forecasted to grow significantly at 24.4% annually, outpacing the US market. Recent results show a substantial increase in net income and sales for both the fourth quarter and full year 2025, reflecting robust performance. Insider confidence is evident as more shares were bought than sold recently. However, challenges persist with low future return on equity and debt not well covered by operating cash flow. Navigate through the intricacies of Loar Holdings with our comprehensive analyst estimates report here. The valuation report we've compiled suggests that Loar Holdings' current price could be inflated. Simply Wall St Growth Rating: ★★★★★☆ Overview: Paymentus Holdings, Inc. offers cloud-based bill payment technology and solutions both in the United States and internationally, with a market cap of approximately $3.22 billion. Operations: The company generates revenue from its cloud-based bill payment technology and solutions, with services to financial companies amounting to $1.20 billion. Insider Ownership: 30.6% Earnings Growth Forecast: 24.6% p.a. Paymentus Holdings demonstrates strong growth potential with earnings expected to rise significantly at 24.6% annually, exceeding the US market...

