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Precigen Reports Multi-Year PAPZIMEOS Durability With FDA Exclusivity in Rare Disease Market Precigen reported updated long-term follow-up data for PAPZIMEOS in adults with recurrent respiratory papillomatosis, showing that 83% of complete responders maintained complete responses for at least 36 months.
Some patients on PAPZIMEOS maintained complete responses beyond four years, indicating extended durability in this treated group.
PAPZIMEOS has been granted seven years of orphan drug market exclusivity by the US FDA, making it the only approved therapy for adults with recurrent respiratory papillomatosis in the US.
The combination of durable response data and orphan drug exclusivity points to a more defined commercial opportunity for PAPZIMEOS within a rare disease setting where it currently faces no approved direct competitors for adults in the US.
Investors may want to watch how quickly Precigen can translate this exclusivity and long-term data into physician adoption and payer coverage, and also consider typical rare disease risks such as market size constraints and potential future competing therapies. Reported Earnings • May 14
First quarter 2026 earnings: EPS and revenues exceed analyst expectations First quarter 2026 results: US$0.022 loss per share (improved from US$0.18 loss in 1Q 2025). Revenue: US$23.3m (up US$21.9m from 1Q 2025). Net loss: US$7.93m (loss narrowed 85% from 1Q 2025). Revenue exceeded analyst estimates by 12%. Earnings per share (EPS) also surpassed analyst estimates by 50%. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 50% per year but the company’s share price has increased by 54% per year, which means it is well ahead of earnings. Announcement • May 08
Precigen, Inc. to Report Q1, 2026 Results on May 13, 2026 Precigen, Inc. announced that they will report Q1, 2026 results on May 13, 2026 Announcement • May 02
Precigen, Inc., Annual General Meeting, Jun 18, 2026 Precigen, Inc., Annual General Meeting, Jun 18, 2026. Recent Insider Transactions • Apr 07
Executive Chairman recently sold US$7.7m worth of stock On the 30th of March, Randal Kirk sold around 2m shares on-market at roughly US$3.30 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Randal has been a net seller over the last 12 months, reducing personal holdings by US$14m. Major Estimate Revision • Apr 01
Consensus revenue estimates increase by 17% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from US$98.6m to US$115.4m. Forecast losses expected to reduce from -US$0.18 to -US$0.047 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target up from US$8.50 to US$9.50. Share price rose 27% to US$3.93 over the past week. New Risk • Mar 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Reported Earnings • Mar 26
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: US$1.37 loss per share (further deteriorated from US$0.47 loss in FY 2024). Net loss: US$429.6m (loss widened 240% from FY 2024). Revenue missed analyst estimates by 28%. Earnings per share (EPS) also missed analyst estimates by 56%. Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 47% per year but the company’s share price has increased by 57% per year, which means it is well ahead of earnings. Announcement • Mar 12
Precigen, Inc. to Report Fiscal Year 2025 Results on Mar 25, 2026 Precigen, Inc. announced that they will report fiscal year 2025 results on Mar 25, 2026 Announcement • Jan 20
Precigen, Inc. Announces the Publication for The Laryngoscope Recommends PAPZIMEOS (zopapogene imadenovec) as the New Standard of Care First-Line Treatment for Adults with Recurrent Respiratory Papillomatosis Precigen, Inc. announced the publication of a new expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of recurrent respiratory papillomatosis (RRP) has been published in The Laryngoscope, one of the field's most respected peer-reviewed journals. The paper recommends PAPZIMEOS™? (zopapogene imadenovec) as the new standard of care first-line treatment for adults with RRP. This independent, expert-authored consensus paper represents a landmark moment for the RRP community, formalizing a shift away from surgery toward a new standard of care that treats the underlying HPV infection. The recommendations position HPV-specific immunotherapy, PAPZIMEOS, as the preferred first-line treatment for adults With RRP and are grounded in the collective clinical experience of the authors, a comprehensive review of the published literature, and the availability of PAPZIMEOS, the first and only FDA-approved HPV-specific immunotherapy. The consensus paper was developed with direct input from RRP leadership, including patients and caregivers, and reflects a shared commitment to advancing patient-centered care in RRP. The authors note that the availability of an FDA-approved HPV-specific Immunotherapy, PAPZIME OS, makes it possible for the first time to establish a modern management algorithm focused on durable disease control rather than repeated surgical interventions to achieve symptoms. Announcement • Jan 13
Precigen Showcases Rapid Commercialization Momentum and Growing Market Adoption of First-And-Only Fda-Approved Therapy for RRP Precigen, Inc. provided an update on the rapid commercialization momentum and growing market adoption of PAPZIMEOSTM (zopapogene imadenovec-drba), the first-and-only US Food and Drug Administration (FDA)-approved therapy for recurrent respiratory papillomatosis (RRP). Precigen's company presentation at the 44th Annual J.P. Morgan Healthcare Conference will be on January 15, 2026 at 7:30 AM PT. Importantly, PAPZIMEOS remains the only FDA-approved therapy for adults with RRP, providing an exclusive window to execute commercial strategy. PAPZIMEOS: Establishing a New Standard of Care for the Treatment of Adults with RRP; PAPZIMEOS full approval with broad label: In August 2025, the FDA granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with RRP. About PAPZIMEOS (zopapogene imadadogene imadenovec- Drba), for subcutaneous injection only; PAPZIMEOS is the first-and-only FDA-approved therapy for the treatment of adults withRRP and the first-and-only approved therapy to address the root cause of RRP. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP. 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 im adadenovec-drba) for the treatment of recurrent respiratory papillomATosis (RRP) in adults, 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, and the Company's ability to commence clinical studies or complete ongoing clinical studies for the Company's clinical and pre-clinical stage candidates. Recent Insider Transactions Derivative • Dec 24
Executive Chairman notifies of intention to sell stock Randal Kirk intends to sell 2m shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of December. If the sale is conducted around the recent share price of US$4.32, it would amount to US$8.2m. Since December 2024, Randal's direct individual holding has decreased from 17.55m shares to 15.74m. Company insiders have collectively sold US$8.4m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Dec 19
Independent Director recently sold US$856k worth of stock On the 12th of December, Jeffrey Kindler sold around 235k shares on-market at roughly US$3.63 per share. This transaction amounted to 68% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$6.2m. Insiders have been net sellers, collectively disposing of US$7.4m more than they bought in the last 12 months. Recent Insider Transactions • Dec 18
Independent Director recently sold US$856k worth of stock On the 12th of December, Jeffrey Kindler sold around 235k shares on-market at roughly US$3.63 per share. This transaction amounted to 68% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$6.2m. Insiders have been net sellers, collectively disposing of US$7.4m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Dec 15
Independent Director notifies of intention to sell stock Jeffrey Kindler intends to sell 235k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of December. If the sale is conducted around the recent share price of US$3.69, it would amount to US$869k. Since March 2025, Jeffrey's direct individual holding has decreased from 520.43k shares to 346.07k. Company insiders have collectively sold US$7.6m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Nov 20
Executive Chairman notifies of intention to sell stock Randal Kirk intends to sell 1m shares in the next 90 days after lodging an Intent To Sell Form on the 19th of November. If the sale is conducted around the recent share price of US$4.22, it would amount to US$4.6m. Since December 2024, Randal's direct individual holding has decreased from 17.55m shares to 15.74m. Company insiders have collectively sold US$7.6m more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Nov 20
Consensus EPS estimates fall by 124%, revenue upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$12.4m to US$13.5m. Forecast EPS reduced from -US$0.392 to -US$0.877 per share. Biotechs industry in the US expected to see average net income decline 7.4% next year. Consensus price target of US$8.50 unchanged from last update. Share price rose 5.0% to US$4.22 over the past week. Reported Earnings • Nov 14
Third quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2025 results: US$0.48 loss per share (further deteriorated from US$0.087 loss in 3Q 2024). Net loss: US$146.3m (loss widened US$122.4m from 3Q 2024). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) missed analyst estimates significantly. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has increased by 35% per year, which means it is well ahead of earnings. New Risk • Nov 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (20% average weekly change). Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Significant insider selling over the past 3 months (US$6.8m sold). Announcement • Nov 07
Precigen, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Precigen, Inc. announced that they will report Q3, 2025 results on Nov 13, 2025 Announcement • Oct 13
Precigen, Inc. Announces Long-Term Follow-Up Results Highlighting Ongoing Durable Complete Responses After Treatment with Papzimeos Precigen, Inc. announced long-term follow-up data demonstrating durable responses to PAPZIMEOS™? (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). These data were presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting. PAPZIMEOS was granted full approval by the United States Food and Drug Administration (FDA) in August 2025, becoming the first and only approved therapy for the treatment of adults with RRP. PAPZIMEOS approval was supported by results from the pivotal study, which successfully met its primary safety and pre-specified primary efficacy endpoints. PAPZimeOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% (18 out of 35) of study patients achieved complete response (95% CI: 34-69%), requiring no surgeries in the 12-month period after treatment with PAPZIMEOS. Results from the pivotal clinical study of PAPZIMEOS were published in The Lancet Respiratory Medicine. Key data highlights from the AAO-HNSF presentation: 15 out of the 18 complete responders (83%) in the pivotal study demonstrated ongoing complete responses as of the September 19, 2025 data cutoff, with: Median duration of follow-up of 36 months (range: 27-37 months); Median duration of complete response yet to be reached; and No new safety events observed during long-term follow-up. And for the healthcare system, durable responses translate into fewer procedures, reduced complications, and lower long-term burden of care. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adult with RRP and the first and only approved therapy to address the root cause of RRP. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP. Recent Insider Transactions • Oct 02
Executive Chairman recently sold US$6.2m worth of stock On the 30th of September, Randal Kirk sold around 2m shares on-market at roughly US$3.41 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Randal's only on-market trade for the last 12 months. New Risk • Oct 01
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$0 This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-US$5.9m). Minor Risks Significant insider selling over the past 3 months (US$0 sold). Revenue is less than US$5m (US$4.3m revenue). Recent Insider Transactions Derivative • Sep 30
Independent Director notifies of intention to sell stock Jeffrey Kindler intends to sell 68k shares in the next 90 days after lodging an Intent To Sell Form on the 29th of September. If the sale is conducted around the recent share price of US$3.63, it would amount to US$245k. Since March 2025, Jeffrey has owned 520.43k shares directly. Company insiders have collectively sold US$820k more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Sep 19
Executive Chairman notifies of intention to sell stock Randal Kirk intends to sell 5m shares in the next 90 days after lodging an Intent To Sell Form on the 18th of September. If the sale is conducted around the recent share price of US$3.93, it would amount to US$20m. Since December 2024, Randal has owned 17.55m shares directly. Company insiders have collectively sold US$860k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Sep 03
Precigen, Inc. announced that it expects to receive $125 million in funding Precigen, Inc. entered into a credit facility agreement for gross proceeds of $125 million on September 3, 2025. The transaction included participation from funds managed by new lender Pharmakon Advisors, LP. The transaction will be raised in two tranches. The first tranche of $100 million will be funded at closing and a second tranche of $25 million can be drawn at the company’s discretion through March 31, 2027, subject to certain conditions. The credit facility bears interest at a variable rate per year equal to 6.50% plus three-month secured overnight financing rate (SOFR) with a SOFR floor of 3.75%. Major Estimate Revision • Aug 19
Consensus EPS estimates fall by 13%, revenue upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$13.7m to US$14.1m. Forecast EPS reduced from -US$0.352 to -US$0.397 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target up from US$6.00 to US$8.25. Share price rose 79% to US$3.22 over the past week. Price Target Changed • Aug 15
Price target increased by 18% to US$7.25 Up from US$6.13, the current price target is an average from 2 analysts. New target price is 147% above last closing price of US$2.94. Stock is up 170% over the past year. The company is forecast to post a net loss per share of US$0.38 next year compared to a net loss per share of US$0.47 last year. Announcement • Aug 15
Precigen, Inc. Announces Full FDA Approval of PAPZIMEOS (Zopapogene Imadenovec-Drba) Precigen, Inc. announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS(zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. PAPZIMEOS is delivered via four subcutaneous injections over a 12-week interval. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Management of RRP has primarily consisted of repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. The approval is supported by data from the open-label, single-arm, pivotal study in adult patients with RRP: The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. 51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with PAPZIMEOS. These Complete Responses remained durable for over 12 months. Of the 18 patients with a Complete Response in the ongoing study, 15 patients evaluated at 24 months demonstrated continued Complete Response. PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. PAPZIMEOS induced HPV 6/11-specific T cell responses in RRP study patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders. Reported Earnings • Aug 13
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.09 loss per share (improved from US$0.23 loss in 2Q 2024). Net loss: US$26.6m (loss narrowed 55% from 2Q 2024). Revenue exceeded analyst estimates by 28%. Earnings per share (EPS) missed analyst estimates by 8.0%. Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year whereas the company’s share price has fallen by 6% per year. Major Estimate Revision • May 21
Consensus revenue estimates increase by 24%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$11.1m to US$13.7m. EPS estimate fell from -US$0.271 to -US$0.352 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target broadly unchanged at US$6.13. Share price rose 3.1% to US$1.32 over the past week. Recent Insider Transactions Derivative • May 18
President exercised options and sold US$756k worth of stock On the 16th of May, Helen Sabzevari exercised options to acquire 521k shares at no cost and sold these for an average price of US$1.45 per share. This trade did not impact their existing holding. For the year to December 2018, Helen's total compensation was 18% salary and 82% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, Helen has owned 2.76m shares directly. Company insiders have collectively sold US$944k more than they bought, via options and on-market transactions in the last 12 months. Breakeven Date Change • May 16
Forecast breakeven date pushed back to 2027 The 3 analysts covering Precigen previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 72% per year to 2026. The company is expected to make a profit of US$90.3m in 2027. Average annual earnings growth of 67% is required to achieve expected profit on schedule. Reported Earnings • May 15
First quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2025 results: US$0.18 loss per share (further deteriorated from US$0.095 loss in 1Q 2024). Net loss: US$54.2m (loss widened 128% from 1Q 2024). Revenue exceeded analyst estimates by 168%. Earnings per share (EPS) missed analyst estimates by 125%. Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has increased by 2% per year, which means it is well ahead of earnings. Announcement • May 08
Precigen, Inc., Annual General Meeting, Jun 26, 2025 Precigen, Inc., Annual General Meeting, Jun 26, 2025. Major Estimate Revision • Mar 26
Consensus revenue estimates fall by 25% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$21.5m to US$16.1m. Forecast losses increased from -US$0.203 to -US$0.269 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target broadly unchanged at US$6.39. Share price fell 10% to US$1.61 over the past week. Reported Earnings • Mar 20
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: US$0.47 loss per share (further deteriorated from US$0.39 loss in FY 2023). Net loss: US$126.2m (loss widened 32% from FY 2023). Revenue missed analyst estimates by 31%. Earnings per share (EPS) also missed analyst estimates by 2.0%. Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Announcement • Mar 13
Precigen, Inc. to Report Fiscal Year 2024 Results on Mar 19, 2025 Precigen, Inc. announced that they will report fiscal year 2024 results on Mar 19, 2025 Major Estimate Revision • Mar 03
Consensus revenue estimates increase by 42% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$4.00m to US$5.70m. Forecast losses expected to reduce from -US$0.467 to -US$0.461 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target up from US$6.00 to US$6.33. Share price fell 4.6% to US$1.67 over the past week. Announcement • Feb 26
Precigen, Inc. Announces FDA Grants Priority Review to its BLA for PRGN-2012 for Treatment of Adults with Recurrent Respiratory Papillomatosis with PDUFA Target Action Date Set for August 27, 2025 Precigen, Inc. announced the US Food and Drug Administration (FDA) has accepted the company's biologics license application (BLA) for PRGN-2012 (nonproprietary name: zopapogene imadenovec), an investigational AdenoVerse gene therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP). The FDA granted priority review to the BLA and set a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2025. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss this application. PRGN-2012 is designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11. PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the FDA, and Orphan Drug Designation from the European Commission. If approved, PRGN-2012 would be the first and only FDA-approved therapeutic for the treatment of adults with RRP. RRP is a rare, difficult-to-treat, lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal. Currently, there is no cure for RRP and the current standard-of-care is repeated surgeries, which do not address the underlying cause of disease and are associated with significant morbidity. As a result, the cycle of recurrence and surgery continues and patients can require hundreds of lifetime surgeries. The cumulative risk of laryngeal injury increases with each RRP surgery, particularly with patients requiring five or more lifetime surgeries. There is high unmet need for a therapeutic alternative to prevent these irreversible surgery-related injuries. The BLA is supported by data from the pivotal Phase 1/2 clinical study (NCT04724980), which were presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting and published in The Lancet Respiratory Medicine. The pivotal study met its primary safety and efficacy endpoints, with more than 50% of patients achieving Complete Response and more than 85% of patients experiencing a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment. PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. Primary endpoints included safety and Complete Response rate defined as the percentage of patients who require no RRP surgeries in the 12-month period after PRGN-2012 treatment completion. Key secondary endpoints included HPV-specific immune responses, extent of papilloma growth as measured by Derkay scoring, and quality of life as measured by Vocal Handicap Index-10 (VHI-10). Announcement • Jan 01
Precigen, Inc. announced that it has received $79 million in funding On December 30, 2024. Precigen, Inc. has closed the transaction. New Risk • Dec 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (US$4.0m revenue). Announcement • Dec 30
Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis Precigen, Inc. announced the completion of the rolling submission for a biologics license application (BLA) to the US Food and Drug Administration (FDA) for PRGN-2012 (INN: zopapogene imadenovec†) for the treatment of adult patients with recurrent respiratory papillomatosis (RRP). The submission is in the initial 60 day review period, during which time the FDA will decide whether to accept the BLA for further review and set the Prescription Drug User Fee Act (PDUFA) action date. The BLA included a request for priority review, which, if granted, would reduce the review timeline from the standard 10-month to a priority 6-month review from the date the submission is accepted by the FDA. PRGN-2012 is an investigational AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11. PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the US Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission. PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of adults with RRP. RRP is a rare, difficult-to-treat, lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal. Currently, there is no cure for RRP and the current standard-of-care is repeated surgeries, which do not address the underlying cause of disease and are associated with significant morbidity. As a result, the cycle of recurrences and surgeries continues and patients can require hundreds of lifetime surgeries. The BLA is supported by data from the pivotal Phase 1/2 clinical study of PRGN-2012 for the treatment of RRP (NCT04724980), which evaluated the safety and efficacy of PRGN-2012 in adult RRP patients. Of the 38 total patients enrolled in the study, three patients received four administrations of PRGN-2012 at 1x 1011 particle units (PU)/dose and 35 patients received four administrations of PRGN-2012 at the recommended phase 2 dose (RP2D) of 5 x 1011 PU/dose over a 12 week treatment period via subcutaneous injection. Primary endpoints included safety and Complete Response rate defined as the percentage of patients who require no RRP surgeries in the 12-month period after PRGN-2012 treatment completion. Key secondary endpoints included HPV-specific immune responses, extent of papilloma growth as measured by Derkay scoring, and quality of life as measured by Vocal Handicap Index-10 (VHI-10). As reported in the results from the pivotal study presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, the primary safety and efficacy endpoints were met. Announcement • Dec 29
Precigen, Inc. announced that it expects to receive $79 million in funding Precigen, Inc. entered into a securities purchase agreement to issue 8% Series A Convertible Perpetual Preferred Stock for gross proceeds of $79.0 million on December 27, 2024. In addition, the investors will have rights to exercise warrants to purchase 52,666,669 shares of Precigen's common stock at an exercise price of $0.75 per share. The offering is expected to close on or before December 30, 2024, subject to customary closing conditions. The private placement was led by affiliates of Patient Capital Management, with participation from Bill Miller, Randal J. Kirk, executive chairman of the board of directors of Precigen, and certain other investors. Reported Earnings • Nov 15
Third quarter 2024 earnings: EPS and revenues miss analyst expectations Third quarter 2024 results: US$0.087 loss per share (further deteriorated from US$0.08 loss in 3Q 2023). Net loss: US$24.0m (loss widened 21% from 3Q 2023). Revenue missed analyst estimates by 26%. Earnings per share (EPS) also missed analyst estimates by 9.4%. Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 40% per year, which means it is significantly lagging earnings. Announcement • Nov 09
Precigen Receives Non-Compliance Letter from Nasdaq Regarding Bid Price Rule On November 1, 2024, Precigen, Inc. (the Company"), received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1) (the Bid Price Rule"), as the minimum bid price for the Company's listed securities was less than $1 for the previous 30 consecutive business days. The Company has a period of 180 calendar days, or until April 30, 2025 (the Compliance Date"), to regain compliance with the Bid Price Rule. To regain compliance, the bid price of the Company's common stock must close at $1 or more for a minimum of ten consecutive business days before the Compliance Date. The deficiency letter does not result in the immediate delisting of the Company's common stock from the Nasdaq Global Select Market. If the Company does not regain compliance by the Compliance Date, the Company may be eligible for an additional 180 calendar-day compliance period. To qualify, the Company would be required to transfer the listing of its common stock to the Nasdaq Capital Market, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement in Nasdaq Listing Rule 5550(a)(2) and notifies Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. If the Company does not regain compliance with the Bid Price Rule by the Compliance Date and it appears to the Staff that the Company will not be able to regain compliance with the Bid Price Rule during the additional compliance period, or if the Company is otherwise not eligible for an additional compliance period at that time, the Staff will provide written notification to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Listing Qualifications Panel. The Company intends to actively monitor the closing bid price of its common stock and will consider available options to resolve the deficiency and regain compliance with the Bid Price Rule, which could include seeking to effect a reverse stock split. However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Rule. Major Estimate Revision • Aug 21
Consensus revenue estimates fall by 12% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$5.02m to US$4.43m. Forecast losses increased from -US$0.377 to -US$0.455 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target down from US$10.12 to US$6.00. Share price rose 6.3% to US$1.19 over the past week. Price Target Changed • Aug 16
Price target decreased by 41% to US$6.00 Down from US$10.12, the current price target is an average from 3 analysts. New target price is 450% above last closing price of US$1.09. Stock is down 32% over the past year. The company is forecast to post a net loss per share of US$0.46 next year compared to a net loss per share of US$0.39 last year. Reported Earnings • Aug 15
Second quarter 2024 earnings: EPS and revenues miss analyst expectations Second quarter 2024 results: US$0.23 loss per share (further deteriorated from US$0.082 loss in 2Q 2023). Net loss: US$58.8m (loss widened 189% from 2Q 2023). Revenue missed analyst estimates by 44%. Earnings per share (EPS) also missed analyst estimates by 140%. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings. New Risk • Aug 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (13% increase in shares outstanding). New Risk • Aug 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$68m free cash flow). Minor Risk Share price has been volatile over the past 3 months (9.9% average weekly change). Announcement • Jul 23
Precigen, Inc. Announces the Appointment of Phil Tennant as Chief Commercial Officer Precigen, Inc. announced the appointment of Phil Tennant as the Company's chief commercial officer. Mr. Tennant will be responsible for commercial strategy and execution across US and global markets. His initial focus will be on driving commercial readiness activities for the potential launch of the first- and best-in-class PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Mr. Tennant will report to Precigen's President and CEO, Helen Sabzevari, PhD, and will join Precigen's executive leadership team. Mr. Tennant's 30-plus year career has spanned numerous leading biotech and pharmaceutical companies, including Merck, Sharp & Dohme, AstraZeneca, Bristol Myers Squibb and, most recently, Astellas Pharma. He has worked in multiple therapeutic areas across the globe, including in the United Kingdom, Europe, Japan, Australia, and the US. For the past 13 years, his career has focused mainly on oncology, initially driving commercial success at Bristol Myers Squibb in new markets for the first wave of immuno-oncology agents, including launching YERVOY (ipilimumab) in Australia and supporting subsequent launches in Europe for both YERVOY and OPDIVO (nivolumab), and orchestrating commercial growth across several hematological cancers with SPRYCEL (dasatinib) and EMPLICITI (elotuzumab). Most recently at Astellas, Mr. Tennant drove double-digit growth for the $5 Billion global oncology portfolio, including driving commercial expansion for the androgen receptor inhibitor, XTANDI (enzalutamide), leading US commercial growth in two new indications for the antibody drug conjugate, PADCEV (enfortumab vedotin), expanding the ex-US footprint for the tyrosine kinase inhibitor, XOSPATA (gilteritinib), and adding commercial momentum to the targeted monoclonal antibody, VYLOY (zolbetuximab). At Astellas, he served as a core member of the joint steering committees for two successful alliances: with Seagen/Pfizer for PADCEV and with Pfizer for XTANDI. Mr. Tennant has also been a board member for the Illinois Biotechnology Innovation Organization (iBIO) and the global startup incubator, MATTER. Price Target Changed • Jun 16
Price target increased by 11% to US$10.12 Up from US$9.12, the current price target is an average from 3 analysts. New target price is 521% above last closing price of US$1.63. Stock is up 34% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$0.39 last year. Announcement • Jun 05
Precigen, Inc. Announces Groundbreaking Pivotal Study Data for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis in Which More Than Half of Patients Achieved Complete Response Precigen, Inc. released positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse gene therapy in patients with recurrent respiratory papillomatosis (RRP). Results were presented in a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Scott M. Norberg, DO, Associate Research Physician, Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute and a lead investigator for the PRGN-2012 clinical study. The Company will host a webcast event on June 3, 2024 at 6:00 PM CT /7:00 PM ET to detail the results presented at ASCO. Pivotal Study Design and Endpoints: The Phase 1/2 clinical study (clinical trial identifier: NCT04724980) evaluated safety and efficacy of PRGN-2012. The study design included an initial 3+3 dose escalation cohort to identify the recommended Phase 2 dose (RP2D). Adult RRP patients who had three or more surgeries in the prior 12 months were eligible for the study. The Phase 1/2 study enrolled a total of 38 patients. Of these, 3 patients received four administrations of PRGN-2012 at 1x 1011 particle units (PU)/dose and 35 patients received four administrations of PRGN-2012 at RP2D (5 x 1011 PU/dose) over a 12 week treatment period via subcutaneous injection. Primary endpoints included safety and Complete Response rate defined as the percentage of patients who require no RRP surgeries in the 12-month period after PRGN-2012 treatment completion. Key secondary endpoints included HPV-specific immune responses, extent of papilloma growth as measured by Derkay scoring, and quality of life measurement as measured by Vocal Handicap Index-10 (VHI-10). Patient Characteristics: Baseline patient characteristics of the 35 adult patients included a median age of 49 years (range: 20-88); 20 of the patients were male and 15 were female. Patients had a median of 4 surgeries (range: 3-10) in the 12 months before PRGN-2012 treatment initiation. Average years since RRP diagnosis was 20 (range: 1-65) with 12 and 23 patients with juvenile and adult onset RRP, respectively. Clinical Efficacy: Primary efficacy endpoint analysis demonstrated that 51% (18 out of 35) (95% CI: 34-69) patients achieved Complete Response, defined as no need for RRP surgeries in the 12-month period following completion of PRGN-2012 treatment. The Complete Response rate was 50% (6 out of 12) and 52% (12 out of 23) in the Phase 1 and Phase 2 portions of the study, respectively (TABLE 1). Complete Responses were durable. Median durability of response has not yet been reached with median follow up of 20 months as of the data cutoff date of May 20, 2024. PRGN-2012 treatment significantly (p < 0.0001) reduced the need for surgeries in RRP patients compared to pre-treatment history (FIGURE 1). PRGN-2012 treatment reduced the need for RRP surgeries in 86% (30 out of 35) of patients compared to their pre-treatment history. RRP surgeries were reduced from a median of 4 (range: 3-10) in the 12 months pre-treatment to 0 (range: 0-7) in the 12 months post PRGN-2012 treatment completion. PRGN-2012 treatment showed significant (p < 0.0001) improvement in anatomical Derkay scores, a tool used for research purposes to quantify RRP severity based on involvement of laryngeal structures, with mean Derkay scores reducing from 9 (range: 5-19) at baseline to 1 (range: 0-5) at 24 weeks post-treatment in patients with Complete Response. Quality of life, as evaluated using the validated VHI-10, significantly (p < 0.0001) improved from a mean of 25 (range: 12-38) at baseline to 7 (range: 0-30) at 24 weeks post PRGN-2012 treatment in patients with Complete Response. PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells observed in responders compared with non-responders. Safety: PRGN-2012 treatment was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events (TRAEs) greater than Grade 2 (TABLE 2). All patients received four administrations of PRGN-2012 at the intended dose levels. TRAEs were mostly mild with no treatment-related serious adverse events reported. The most common TRAE was injection site reaction. Other common TRAEs occurring in more than one subject were fatigue, chills, and fever. There was no meaningful anti-drug antibody response with repeat administrations of PRGN-2012. Price Target Changed • Jun 04
Price target increased by 11% to US$10.12 Up from US$9.12, the current price target is an average from 3 analysts. New target price is 514% above last closing price of US$1.65. Stock is up 27% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$0.39 last year. Announcement • May 31
Precigen, Inc., Annual General Meeting, Jul 05, 2024 Precigen, Inc., Annual General Meeting, Jul 05, 2024. Major Estimate Revision • May 21
Consensus revenue estimates fall by 10% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$5.59m to US$5.02m. Forecast losses increased from -US$0.336 to -US$0.36 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target broadly unchanged at US$9.12. Share price rose 3.0% to US$1.39 over the past week. Price Target Changed • May 17
Price target increased by 40% to US$9.12 Up from US$6.50, the current price target is an average from 3 analysts. New target price is 561% above last closing price of US$1.38. Stock is up 7.0% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$0.39 last year. Reported Earnings • May 15
First quarter 2024 earnings: EPS and revenues miss analyst expectations First quarter 2024 results: US$0.095 loss per share. Net loss: US$23.7m (loss widened 4.4% from 1Q 2023). Revenue missed analyst estimates by 28%. Earnings per share (EPS) also missed analyst estimates by 14%. Revenue is forecast to grow 55% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Announcement • May 10
Precigen, Inc. to Report Q1, 2024 Results on May 14, 2024 Precigen, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 14, 2024 Price Target Changed • May 09
Price target decreased by 27% to US$6.50 Down from US$8.95, the current price target is an average from 2 analysts. New target price is 404% above last closing price of US$1.29. Stock is up 13% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.39 last year. Announcement • Apr 25
Precigen, Inc. to Present Late-Breaking Abstract for Pivotal Phase 2 Study Data for PRGN- 2012 AdenoVerse Immunotherapy Precigen, Inc. announced clinical data from the pivotal Phase 2 study of PRGN-2012 AdenoVerse immunotherapy for the treatment of patients with recurrent respiratory papillomatosis (RRP) will be presented in a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 31 to June 4, 2024 at McCormick Place in Chicago, Illinois. Recent Insider Transactions Derivative • Apr 11
President exercised options and sold US$575k worth of stock On the 5th of April, Helen Sabzevari exercised options to acquire 410k shares at no cost and sold these for an average price of US$1.40 per share. This trade did not impact their existing holding. For the year to December 2018, Helen's total compensation was 29% salary and 71% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2023, Helen's direct individual holding has increased from 1.56m shares to 2.22m. Company insiders have collectively bought US$206k more than they sold, via options and on-market transactions, in the last 12 months. Reported Earnings • Mar 20
Full year 2023 earnings: EPS and revenues miss analyst expectations Full year 2023 results: US$0.39 loss per share. Net loss: US$95.9m (loss widened 20% from FY 2022). Products in clinical trials Phase I: 3 Phase II: 4 Revenue missed analyst estimates by 6.2%. Earnings per share (EPS) also missed analyst estimates by 9.3%. Revenue is forecast to grow 51% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Announcement • Mar 06
Precigen, Inc. to Report Q4, 2023 Results on Mar 19, 2024 Precigen, Inc. announced that they will report Q4, 2023 results on Mar 19, 2024 Announcement • Jan 17
Precigen, Inc. Receives Orphan Drug Designation for PRGN- 2012 for the Treatment of Recurrent Respiratory Papillomatosis from the European Commission Precigen, Inc. announced that the European Commission (EC) has granted Orphan Drug Designation for the Company's first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). PRGN-2012 received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and Precigen was the first company to receive Breakthrough Therapy Designation and an accelerated approval pathway from the FDA for an RRP treatment. PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses gorilla adenovector technology, part of Precigen's proprietary AdenoVersetm platform, to elicit immune responses directed against cells infected with HPV 6 or HPV 11. Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, and the ability to deliver a large genetic payload. Orphan Drug Designation in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. Medicines intended for the treatment, diagnosis or prevention of seriously debilitating or life-threatening conditions that affect fewer than five in 10,000 people in the European Union (EU). The Orphan Drug Designation allows companies certain regulatory, financial and commercial incentives to develop medicines for rare diseases where there are no satisfactory treatment options. PRGN-2012 is currently under investigation in a Phase 1/2 pivotal single-arm study in adult patients with RRP in the United States (clinical trial identifier: NCT04724980). A Phase 2 data presentation is anticipated in the second quarter of 2024 and a planned Biologics License Application (BLA) submission under an accelerated approval pathway with the FDA is anticipated in the second half of 2024. Commercial readiness preparations are underway for a potential launch in the United States in 2025. Recent Insider Transactions • Dec 31
Independent Director recently sold US$136k worth of stock On the 28th of December, Jeffrey Kindler sold around 97k shares on-market at roughly US$1.41 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought US$1.6m more than they sold in the last 12 months. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 5 analysts covering Precigen expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$30.1m in 2026. Average annual earnings growth of 53% is required to achieve expected profit on schedule. Major Estimate Revision • Nov 16
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$7.50m to US$6.71m. Forecast losses increased from -US$0.342 to -US$0.351 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target broadly unchanged at US$9.46. Share price fell 16% to US$1.06 over the past week. Reported Earnings • Nov 10
Third quarter 2023 earnings: EPS and revenues miss analyst expectations Third quarter 2023 results: US$0.08 loss per share (further deteriorated from US$0.038 loss in 3Q 2022). Net loss: US$19.8m (loss widened 159% from 3Q 2022). Revenue missed analyst estimates by 30%. Earnings per share (EPS) also missed analyst estimates by 3.2%. Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Recent Insider Transactions • Aug 17
Independent Director recently bought US$688k worth of stock On the 14th of August, Steven Frank bought around 400k shares on-market at roughly US$1.72 per share. This transaction amounted to 83% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$739k more in shares than they have sold in the last 12 months. Major Estimate Revision • Aug 16
Consensus revenue estimates decrease by 12%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$8.51m to US$7.50m. EPS estimate increased from -US$0.424 to -US$0.342 per share. Biotechs industry in the US expected to see average net income decline 19% next year. Consensus price target up from US$9.08 to US$9.50. Share price rose 32% to US$1.53 over the past week. Reported Earnings • Aug 10
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.082 loss per share (improved from US$0.13 loss in 2Q 2022). Revenue: US$1.77m (down 39% from 2Q 2022). Net loss: US$20.3m (loss narrowed 22% from 2Q 2022). Revenue missed analyst estimates by 19%. Earnings per share (EPS) exceeded analyst estimates by 20%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 29% per year, which means it is significantly lagging earnings. Announcement • Aug 10
Precigen, Inc Announces FDA Confirmation that the Ongoing Phase 1/2 Study of PRGN-2012 AdenoVerse Immunotherapy Will Serve as the Pivotal Study to Support Accelerated Approval Precigen, Inc. announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in- class investigational PRGN-2012 AdenoVerse(TM) immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA. The FDA has confirmed that the current primary endpoint for the ongoing Phase 1/2 study, which is Complete Response rate (percentage of patients with no surgical interventions during the 12 months following treatment with PRGN-2012), along with an immunological surrogate marker demonstrating an induction of HPV-specific T cell responses following PRGN- 2012 treatment, is acceptable for the accelerated approval request. PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses Precigen's gorilla adenovector technology, part of Precigen's proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with HPV 6 or HPV 11. Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, which may improve safety, and the ability to deliver a large genetic payload. The FDA granted PRGN-2012 Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of RRP. Data from the Phase 1 portion of the study showed that 50% of adult RRP patients (who had >=3 surgeries to treat the disease in the year prior to treatment) were "surgery-free" (Complete Response) after PRGN-2012 treatment during the 12 month follow-up. All complete responders continue to be surgery-free with a minimum follow-up of 18 months post- treatment. Precigen has completed enrollment and dosing in the Phase 2 portion of the study (N=23) bringing the total number of enrolled patients to 35 at the recommended Phase 2 dose. Patient follow up is currently ongoing and data collection is anticipated to be completed by the second quarter of 2024. Recent Insider Transactions Derivative • Aug 06
President exercised options and sold US$58k worth of stock On the 4th of August, Helen Sabzevari exercised options to acquire 53k shares at no cost and sold these for an average price of US$1.10 per share. This trade did not impact their existing holding. For the year to December 2018, Helen's total compensation was 29% salary and 71% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Helen has owned 1.22m shares directly. Company insiders have collectively sold US$160k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Aug 04
Precigen, Inc. to Report Q2, 2023 Results on Aug 09, 2023 Precigen, Inc. announced that they will report Q2, 2023 results on Aug 09, 2023 Announcement • Jun 22
Precigen, Inc. Receives Breakthrough Therapy Designation for PRGN- 2012 Adenoverse Immunotherapy for the Treatment of Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).FDA's Breakthrough Therapy Designation expedites the development and review of medicines which are intended to treat serious or life-threatening diseases, and in which preliminary clinical evidence demonstrates substantial improvement on clinically significant endpoints over available therapies. PRGN-2012 incorporates optimized antigen design that uses gorilla adenovector technology, part of Precigen's proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, and the ability to deliver a large genetic payload. PRGN-2012 has previously been granted Orphan Drug Designation in patients with RRP by the FDA. The Breakthrough Therapy Designation was informed by the clinical evidence for PRGN-2012 generated in the Phase 1 study (NCT04724980), which was presented at Precigen's most recent R&D day, and showed strong response at the recommended phase 2 dose (RP2D) in patients who had an average of 5.8 RRP surgeries (range 3 -- 10) in the year prior to PRGN-2012 treatment. Patient follow up is ongoing as are discussions with the FDA regarding potential rapid development paths to enable a future submission of a Biologics License Application (BLA). Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Announcement • Jun 06
Precigen Announces Positive Phase 1 Data for PRGN-3005 Autologous UltraCAR-T Cells Manufactured Overnight for Infusion Next Day to Advanced Stage Platinum Resistant Ovarian Cancer Patients Precigen, Inc. presented positive data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase 1 portion of the Phase 1/1b clinical study evaluating safety and efficacy of PRGN-3005 UltraCAR-T® in advanced stage platinum resistant ovarian cancer patients (Abstract# 5590 [2]). The presentation was delivered by John B. Liao, MD, PhD, Cancer Vaccine Institute, University of Washington Medicine, and a lead investigator for the PRGN-3005 clinical trial. PRGN-3005 UltraCAR-T is an autologous chimeric antigen receptor T (CAR-T) cell therapy manufactured using non-viral gene delivery and is under investigation for the treatment of patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer. PRGN-3005 utilizes Precigen's transformative UltraCAR-T therapeutic platform, which eliminates ex vivo expansion and reduces manufacturing time to allow for rapid next day administration of UltraCAR-T cells following non-viral gene transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell investigational therapy utilizing Precigen's advanced non-viral gene delivery system to co-express a chimeric antigen receptor, membrane-bound interleukin-15 (mbIL15), and a kill switch for better precision and control. Conducted in collaboration with the University of Washington and Fred Hutchinson Cancer Research Center, the Phase 1 study has completed dose escalation, which evaluated the safety and efficacy of PRGN-3005 administered either via intraperitoneal (IP) or intravenous (IV) infusion, in the absence of lymphodepletion (LD) or IV following lymphodepletion with cyclophosphamide only (clinical trial identifier: NCT03907527). The study population includes patients with advanced stage (III/IV) recurrent ovarian, fallopian tube, and primary peritoneal cancer who are platinum resistant and have progressed after receiving standard-of-care therapies or are not eligible to receive available therapies with known clinical benefit (Table 1). The mean age of patients in the study was 57.4 in the IP arm without lymphodepletion, 67.3 in the IV arm without lymphodepletion and 62.7 in the IV arm with lymphodepletion. Patients were heavily pretreated with a median of greater than or equal to 8 prior lines of therapy across all arms. Patients had significantly advanced stage disease with a high baseline tumor burden with most patients having distant metastases, including liver, spleen, bladder and lung. Announcement • Jun 04
Precigen Announces Positive Phase 1 Data for Off-the-Shelf PRGN-2009 AdenoVerse Immunotherapy Alone and in Combination with an Investigational Checkpoint Inhibitor in Patients with Recurrent/Metastatic HPV-associated Cancers Precigen, Inc. presented positive clinical data from the Phase 1 study of the off-the-shelf (OTS) PRGN-2009 AdenoVerse immunotherapy alone and in combination with an investigational anti-PDL1/TGF-Beta Trap checkpoint inhibitor (bintrafusp alfa) in patients with recurrent/metastatic (R/M) HPV-associated cancers (clinical trial identifier: NCT04432597) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# 2628). PRGN-2009 is an OTS investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV-positive (HPV+) solid tumors. PRGN-2009 is a novel, replication-incompetent gorilla adenovirus targeting HPV 16/18. PRGN-2009 can be administered repeatedly leading to enhancement of T-cells without increasing neutralizing antibodies. PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, within the Center for Immuno-Oncology (CIO), Center for Cancer Research (CCR), National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The Phase 1 trial is an open label, single-center study evaluating safety and response of PRGN-2009 as a monotherapy (Arm A) and in combination with bintrafusp alfa (Arm B) in previously treated adult patients with R/M HPV-associated cancers. In the monotherapy arm, patients (N = 6) enrolled in two sequential PRGN-2009 dose level cohorts, Dose Level 1 (1x1011 particle units (PU)) and Dose Level 2 (5x1011 PU) delivered via subcutaneous injection. In the combination arm, PRGN-2009 was administered at the recommended phase 2 dose (RP2D) in combination with bintrafusp alfa. The primary objective of the study was to evaluate safety and RP2D of PRGN-2009 and safety of PRGN-2009 in combination with a checkpoint inhibitor. Secondary objectives included Objective Response Rate (ORR) (per RECIST 1.1), and progression free survival (PFS). Seventeen adult patients were enrolled in the Phase 1 study. Patients received up to 20 doses of PRGN-2009 for a duration of 1.8 to 17.9 months in the monotherapy arm and 0.5 to 23.0 months in the combination arm. The median age in both arms was 61. The median number of prior lines of therapies in the metastatic setting was 2.5 for the monotherapy arm and 2 for the combination arm. All patients in the monotherapy arm (N=6) and 10 of 11 patients in the combination arm received prior immune checkpoint blockade (ICB) therapy. PRGN-2009 treatment in both monotherapy and combination arms was safe and well-tolerated. In both study arms, there was a low incidence of treatment-related adverse events (TRAEs) with only Grade 1 or 2 TRAEs in the monotherapy arm. The most common TRAEs in the monotherapy arm were injection site reactions, flu-like symptoms, fatigue and rash. In addition to these in the combination arm, patients also experienced Grade 1 or 2 epistaxis, headache, keratoacanthoma, fever, decreased lymphocyte count, anemia and oral hemorrhage. TRAEs reported in the combination arm were in line with the safety profile reported for bintrafusp alfa and only Grade 1 or 2 TRAEs were attributable to PRGN-2009 in the combination arm. Announcement • Jun 01
Precigen, Inc. Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer Precigen, Inc. announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase 2 study of the first-in-class PRGN-2009 Off-the-Shelf (OTS) AdenoVerse™ immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer. The Phase 2 randomized, open-label, two-arm, multicenter study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab versus pembrolizumab monotherapy in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. The study will enroll approximately 46 patients who previously have been treated with pembrolizumab for recurrent or metastatic disease. In the Phase 1 study, PRGN-2009 was evaluated as a monotherapy (N=6) and in combination with a checkpoint inhibitor (N=11) in patients with recurrent or metastatic human papillomavirus (HPV)-associated cancers. Interim Phase 1 data showed a favorable safety profile of repeated PRGN-2009 administrations in both the monotherapy and the combination arms with no dose limiting toxicities (DLTs). Interim Phase 1 data showed encouraging clinical activity with objective responses when combined with a checkpoint inhibitor in heavily pre-treated recurrent/metastatic cancer patients who had previously failed checkpoint inhibitor treatment. Full Phase 1 data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2023 from 8:00 to 11:00 AM CT (Abstract # 2628). Patients in the Phase 2 study will be randomized 1:1 to the combination of PRGN-2009 and pembrolizumab (cohort 1) or pembrolizumab monotherapy (cohort 2). Patients randomized to the PRGN-2009 plus pembrolizumab cohort will receive PRGN-2009 via subcutaneous (SC) injection (5 x 1011 PU every 3 weeks for three administrations followed by administration each 6 weeks thereafter). Patients in the PRGN-2009 plus pembrolizumab cohort and pembrolizumab monotherapy cohort will receive pembrolizumab via intravenous (IV) infusion (400 mg every 6 weeks). Patients randomized to the pembrolizumab monotherapy cohort will be offered the option to crossover to the PRGN-2009 plus pembrolizumab cohort if certain conditions are met. The primary objective of the Phase 2 study is to assess the objective response rate (ORR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab monotherapy. Secondary objectives include the evaluation of safety and tolerability, progression-free survival (PFS), overall survival (OS), best overall responses (BOR), Disease Control Rate (DCR), time to response and duration of response. Reported Earnings • May 11
First quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2023 results: US$0.099 loss per share (improved from US$0.12 loss in 1Q 2022). Revenue: US$1.85m (down 66% from 1Q 2022). Net loss: US$22.7m (loss narrowed 4.9% from 1Q 2022). Revenue missed analyst estimates by 38%. Earnings per share (EPS) exceeded analyst estimates by 3.2%. Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Announcement • May 04
Precigen, Inc. to Report Q1, 2023 Results on May 10, 2023 Precigen, Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 10, 2023