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Xenetic Biosciences Reports First Quarter 2026 Financial Results and Highlights Continued Advancement of DNase Oncology Platform

On May 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the quarter ended March 31, 2026 and provided a corporate update on the advancement of its innovative DNase oncology platform.

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Recent Highlights

Generated robust translational data supporting the DNase I platform across multiple oncology settings

Completed process improvement and analytical development activities supporting future clinical manufacturing readiness

Established translational and biomarker insights intended to help inform and de-risk future clinical trial design

Collaboration partner received approval from Israeli Ministry of Health to conduct investigator-initiated exploratory study of DNase I in combination with anti-CD19 CAR T cells in large B-cell lymphoma

"We entered 2026 with a clear focus on advancing the translational, manufacturing and clinical foundation of our DNase I platform while maintaining financial discipline," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "During the quarter, we achieved important progress across investigator-initiated studies, translational research and manufacturing readiness activities. We believe the growing body of translational evidence supporting NET-targeting approaches, combined with the expanding understanding of NETs as drivers of tumor progression, immune suppression and therapy resistance, continues to strengthen the potential opportunity for DNase I as a differentiated adjunctive immuno-oncology therapy across multiple cancer settings."

Xenetic’s proprietary DNase technology is being developed as a potential adjunctive therapeutic approach designed to improve the effectiveness of existing cancer treatments, including immunotherapies, through the targeting of NETs, which are increasingly recognized as key drivers of immune suppression and therapeutic resistance within the tumor microenvironment.

Summary of Financial Results for First Quarter 2026

Royalty revenue for the three months ended March 31, 2026 increased approximately 36% to approximately $0.8 million, compared to approximately $0.6 million for the comparable prior year period, primarily driven by increased royalty payments recognized under the Company’s sublicense agreement with Takeda Pharmaceuticals Co. Ltd.

Research and development expenses for the three months ended March 31, 2026 decreased approximately 25% to approximately $0.7 million from approximately $0.9 million for the comparable prior year period, primarily due to lower preclinical and exploratory study costs, partially offset by increased manufacturing development efforts supporting the Company’s DNase I program.

General and administrative expenses for the three months ended March 31, 2026 decreased by approximately 1.4%, to approximately $0.6 million from approximately $0.7 million in the comparable quarter in 2025. The decrease was primarily due to a decrease in personnel costs and share-based expenses related to our interim Chief Executive Officer substantially offset by an increase in legal expenses related to our strategic review process during the first quarter of 2026 compared to the same period in 2025.

Net loss for the quarter ended March 31, 2026 decreased approximately 49% to approximately $0.5 million, compared to approximately $0.9 million for the same period in 2025.

The Company ended the first quarter of 2026 with approximately $7.3 million in cash and cash equivalents, compared to approximately $7.9 million as of December 31, 2025.

(Press release, Xenetic Biosciences, MAY 13, 2026, View Source [SID1234665642])

ZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION Trial

On May 13, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% – 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.

"This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with ZUSDURI remain disease-free through three years," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients."

As a non-surgical, in-office treatment, ZUSDURI offers patients an opportunity to achieve meaningful disease- and treatment-free living without the burden of repeated TURBT procedures under general anesthesia. The current standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates following surgery, patients often undergo multiple TURBTs over their lifetime, leading to a cycle of repeat procedures that can impact quality of life and increase cumulative risk, particularly in older patients with comorbidities. An estimated 59,000 patients with LG-IR-NMIBC recur annually.

"The ENVISION 36-month DOR data reinforce ZUSDURI’s potential to shift the treatment paradigm for recurrent LG-IR-NMIBC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time."

The most common (≥ 10%) adverse reactions (ARs), including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

(Press release, UroGen Pharma, MAY 13, 2026, View Source [SID1234665641])

Tyra Biosciences Reports First Quarter 2026 Financial Results and Recent Highlights

On May 13, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress.

"Our dabogratinib ‘3×3’ strategy continues to advance with steady progress across all three programs," said Todd Harris, Ph.D., Chief Executive Officer of TYRA. "We are taking a differentiated, data-driven approach by aligning our development strategy with the patient journey in FGFR3-driven diseases and conditions. The dosing of the first patient in SURF303 marks an important milestone, as we initiate a potentially registrational study in LG-UTUC that could support TYRA’s first NDA submission. With multiple clinical data readouts expected this year, we remain focused on unlocking the full potential of selective FGFR3 inhibition with oral dabogratinib."

Doug Warner, M.D., Chief Medical Officer of TYRA, commented, "In urologic cancers, we see a significant opportunity to address what we believe is a very challenging treatment paradigm for patients that is currently dominated by procedure-based, intravesical therapies. We are developing dabogratinib as a once-daily (QD) oral therapy designed to maintain continuous pressure on the tumor and, if successful, may represent a meaningful shift in how these patients are treated."

Dr. Warner continued, "In achondroplasia, we believe our approach with oral dabogratinib may also be transformational. Recently presented data demonstrate that prenatal dosing further delayed premature fusion of synchondroses and increased the area of the foramen magnum. These data expand our perspective on the potential benefits of earlier FGFR3 inhibition as we advance BEACH301. We have now cleared the fourth dose level in our safety sentinel cohort and remain on track to report initial results in the fourth quarter of this year."

First Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

In the first quarter of 2026, TYRA advanced its "dabogratinib 3×3" strategy: developing the first orally available, FGFR3 selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

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Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with low grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. The Company has dosed the first patient in SURF303, with initial results expected in 2027.

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Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade intermediate risk non-muscle invasive bladder cancer (IR NMIBC). To date, there are more than 20 patients enrolled at US and international trial sites, and the Company expects to report initial three-month complete response data from both dose cohorts in August 2026.
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Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia (ACH). The study has enrolled the safety sentinel cohort and has successfully cleared four dose levels, with no notable safety events reported to date. The study remains on track, with initial results from the safety sentinel cohort, including 6-month average height velocity and safety data, expected in the fourth quarter of 2026.
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Presented Clinical Progress and New Preclinical Results at Key Scientific/Medical Meetings. During the first quarter of 2026 and in April, TYRA presented posters on dabogratinib for urologic cancers (SURF302 and SURF303 trials-in-progress) at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (ASCO GU), and the European Association of Urology Congress (EAU 26). TYRA will also present a trials-in-progress poster on SURF302 at the 2026 American Urologic Association (AUA) meeting. In May 2026, at the Fusion Conference on FGFR Biology, TYRA presented new preclinical results with oral dabogratinib for the treatment of ACH. When administered to pregnant mice from embryonic day 14.5 through birth then to Fgfr3Y367C/+ neonates postnatally, dabogratinib significantly increased the foramen magnum area and resulted in open synchondroses. Prenatal plus postnatal treatment further delayed premature fusion of the synchondroses compared with the postnatal alone treatment protocol (Starrett et al., 2025). Posters associated with these meetings can be accessed on the TYRA website.

Corporate

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Appointed Habib Dable to Board of Directors. In April 2026, TYRA announced the appointment of Habib Dable to its Board of Directors. Mr. Dable brings more than 30 years of leadership experience across the global biopharmaceutical industry, including deep expertise in building and scaling blockbuster franchises and guiding companies through transformative growth. Mr. Dable most recently served as President and Chief Executive Officer of Acceleron Pharma Inc., where he led the company through a period of significant growth culminating in its acquisition by Merck in 2021. Prior to Acceleron, Mr. Dable spent 22 years at Bayer AG in positions of increasing responsibility, including President of U.S. Pharmaceuticals and Executive Vice President, Global Head of Specialty Medicine. During his tenure, he provided leadership across multiple therapeutic areas, including ophthalmology, neurology, hematology, and cardiology, and oversaw the global launch of EYLEA. Mr. Dable currently serves as an advisor at RA Capital Management, L.P.
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Strengthened Balance Sheet with ATM Utilization. In the first quarter of 2026, TYRA received $147.9M in net proceeds, after deducting fees and other expenses, following utilization of the Company’s "at-the-market" offering program, issuing and selling 4,690,532 shares of common stock to a large investment management firm.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

First Quarter Financial Results

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Cash, Cash Equivalents and Short-Term Investments. As of March 31, 2026, TYRA had cash, cash equivalents and marketable securities of $383.5 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended March 31, 2026 were $33.5 million compared to $25.0 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, partially offset by a decrease in development activities for other programs. Personnel expenses also increased, driven by headcount growth to support expanding clinical and development activities.

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General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2026 were $8.5 million compared to $6.9 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth.
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Net Loss. First quarter net loss was $39.3 million compared to $28.1 million for the same period in 2025.

Upcoming Anticipated Clinical Milestones:

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SURF303: initial results – 2027
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SURF302: initial three-month complete response data – August 2026
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BEACH301: initial results from safety sentinel cohort – Q4 2026

About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3 selective inhibitor to enter clinical development, and it has been studied in more than 100 patients to date across multiple clinical studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, MAY 13, 2026, View Source [SID1234665640])

Protara Therapeutics Announces First Quarter 2026 Financial Results and Provides a Business Update

On May 13, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported a business update and announced financial results for the first quarter ended March 31, 2026.

"We’re pleased with the productive discussions we’ve had with the FDA around TARA-002 in LMs," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We intend to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027. Later this month, we look forward to presenting updated safety and durability data from the STARBORN-1 trial at the ISSVA World Congress and hosting an investor webinar with KOL perspectives."

Mr. Shefferman added, "In NMIBC, we continue to establish TARA-002’s potential as a differentiated treatment through a robust clinical data set demonstrating excellent safety, promising efficacy and encouraging durability, as well as a convenient and tolerable method of administration, in both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naive patients. Looking ahead, we remain focused on completing enrollment in the BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and initiating the ADVANCED-3 registrational trial in BCG-Naïve patients, both in the second half of the year. Additionally, our THRIVE-3 program for IV Choline Chloride remains on track, and we expect to announce interim results in the second half of 2026."

Recent Progress and Highlights

TARA-002 in LMs

Under Breakthrough Therapy designation, Protara is engaged in an ongoing dialogue with the FDA and has received confirmation that the review of TARA-002 has been moved from the Office of Vaccines Research and Review to the Office of Therapeutic Products, which has significant experience in pediatric rare disease and is the review division for TARA-002 in NMIBC.
Based on engagement with the FDA, the Company intends to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.
Protara plans to host a virtual investor webinar discussing TARA-002 in LMs at 4:30 pm ET on May 19, 2026. The event will provide an overview of TARA-002 in LMs, KOL perspectives on the unmet need and TARA-002’s potential role in the treatment paradigm. The live event and accompanying slides can be accessed visiting the Events and Presentations section of the Company’s website View Source A replay of the webcast will be archived for a limited time following the event.
The Company will present updated interim safety and durability data from the ongoing Phase 2 STARBORN-1 trial evaluating TARA-002 in macrocystic and mixed cystic LMs in a poster session at the ISSVA World Congress on May 20, 2026 in Philadelphia, Pennsylvania.
TARA-002 in NMIBC

The Company expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in the second half of 2026.
The Company will present updated 12-month landmark results for TARA-002 in BCG-Naïve NMIBC patients in Cohort A of the ADVANCED-2 trial during a poster presentation at the AUA Annual Meeting on May 15, 2026 in Washington, D.C.
The Company is planning a proposed registrational trial in BCG-Naïve and potentially BCG-Exposed patients. Protara continues to engage with the FDA on aspects of the analysis plan and intends to initiate the ADVANCED-3 trial in the second half of 2026.
IV Choline Chloride for Patients on Parenteral Support (PS)

THRIVE-3, the Company’s registrational Phase 3 clinical trial, is ongoing, and the Company expects to report interim results in the second half of 2026.
First Quarter 2026 Financial Results

As of March 31, 2026, unrestricted cash and cash equivalents and marketable debt securities totaled $177.4 million. The Company expects its cash and cash equivalents and marketable debt securities will be sufficient to fund its planned operations and milestones into 2028.
Research and development expenses for the first quarter of 2026 increased to $13.6 million from $9.1 million for the prior year period. This increase was primarily due to a $2.2 million increase in direct expenses for our product candidates and a $2.2 million increase in indirect expenses not directly attributable to one specific product candidate. The increase in direct expenses was primarily due to higher ongoing costs associated with the ADVANCED-2 trial for NMIBC as well as start-up costs related to the ADVANCED-3 trial for NMIBC.
General and administrative expenses for the first quarter of 2026 increased to $6.1 million from $5.0 million for the prior year period. The increase was primarily due to personnel-related expenses, including stock-based compensation.
For the first quarter of 2026, Protara incurred a net loss of $17.8 million, or $0.31 per share, compared with a net loss of $11.9 million, or $0.29 per share, for the same period in 2025. Net loss for the first quarter of 2026 included approximately $1.4 million in stock-based compensation expenses.
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Lymphatic Malformations

Lymphatic Malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Protara’s focus is on macrocystic and mixed cystic LMs, for which there are no currently approved therapies. They are most frequently present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics; recurrent infection; and cosmetic and other functional disabilities. TARA-002 has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA for the treatment of LMs.

About IV Choline Chloride for Patients on Parenteral Support

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function and play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 78% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver dysfunction, which can lead to hepatic failure. Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first FDA approved IV choline formulation for PS patients. It has been granted Orphan Drug designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition and has been granted Fast Track designation as a source of choline when oral or enteral nutrition is not possible, insufficient or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claiming a method of treating choline deficiency with a choline composition, each with a term expiring in 2041.

(Press release, Protara Therapeutics, MAY 13, 2026, View Source [SID1234665639])

Precigen Reports First Quarter 2026 Financial Results and Business Updates

On May 13, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported first quarter 2026 financial results and business updates.

"We are thrilled with the strength of the PAPZIMEOS launch and the pace of revenue growth as we drive broad commercial success across the US and work toward expanded market opportunities in additional geographies and the pediatric patient population," said Helen Sabzevari, PhD, President and CEO of Precigen. "Looking ahead, we are excited to advance the next chapter of our AdenoVerse platform through the continued development of PRGN-2009 in HPV-associated cancers, and look forward to sharing more details on our broader pipeline progress later this year. We are also proud to once again collaborate with the Recurrent Respiratory Papillomatosis Foundation in recognizing RRP Awareness Day for the third consecutive year on June 11, reflecting our deep and long-standing commitment to the RRP community. This year’s event carries particular significance as adult patients now have access to an approved treatment, PAPZIMEOS, for the first time in the more than 100-year history of this disease."

"We are encouraged by the strong progress we are seeing as PAPZIMEOS continues to gain traction, with approximately 400 patients currently enrolled in the PAPZIMEOS patient hub, of which a noteworthy 25% are from the community setting," said Phil Tennant, Chief Commercial Officer of Precigen. "We are focused on converting hub enrollment into treated patients, and we look forward to building on this progress in the second quarter and beyond as more sites become activated, the impact of the permanent J-code takes hold, and our targeted site support helps deliver a seamless journey to treatment."

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first treatment that addresses the root cause of RRP.

· National prescribing growth: PAPZIMEOS is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment. Building on strong community practice demand, the Company’s target footprint has been expanded beyond the initial list, with increased engagement across community practices reflecting the broad interest seen since the full deployment of the PAPZIMEOS field team in September 2025.

· Patient hub enrollment: Enrollment in Precigen’s patient hub reached approximately 400 registered patients, reflecting robust and growing demand from both patients and physicians. Notably, 25% of hub-enrolled patients are from 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. Beyond hub enrollment, the Company’s field teams continue to identify additional patients outside the hub, further underscoring the breadth of unmet need and commercial opportunity in the RRP community.

· Positive payer coverage: PAPZIMEOS has private health plan coverage spanning approximately 215 million US lives, including the significant majority of leading insurers. With additional coverage under Medicare and Medicaid, PAPZIMEOS is accessible to an estimated 297 million US lives, or over 90% of insured lives in the US, reflecting broad and growing payer support for the therapy.

· Permanent J-code accelerating site activations and patient access: Effective April 1, 2026, the Centers for Medicare and Medicaid Services assigned a permanent J-code (J3404) to PAPZIMEOS, and early indicators suggest this is already streamlining site activations. J-codes are standardized reimbursement codes that enable healthcare providers to bill government and commercial insurers for physician-administered therapies, and the permanent J-code designation is expected to further simplify claims processing and facilitate broader patient access across both medical centers and community practices.

· PAPZIMEOS recommended as standard of care first-line treatment: In January 2026, an expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US.

· Upcoming ASCO (Free ASCO Whitepaper) clinical presentation: The Company will present updated durability of response data at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from May 29 to June 2, 2026, with a presentation titled "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."

· Strong presence at key medical and scientific meetings: At AAO-HNSF 2025, SITC (Free SITC Whitepaper) 2025, EUROGIN 2026, and COSM 2026, the Company presented long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease’s significant clinical, economic, and human impact.

· Redosing study enrolling patients: The Company’s open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).

· MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan drug designation by the European Commission.

· RRP Awareness Day 2026: For the third consecutive year, Precigen will collaborate with the Recurrent Respiratory Papillomatosis Foundation to co-host RRP Awareness Day on June 11. The annual initiative is dedicated to educating the public and medical community about RRP by amplifying the voices of patients, caregivers, advocates, and the healthcare community supporting them.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
· The Company plans to highlight progress across its AdenoVerse portfolio, including an update on PRGN-2009, by end of year.

FINANCIAL HIGHLIGHTS

"We are pleased with the launch performance of PAPZIMEOS, recognizing $21.6 million of net revenue in the first full quarter of its launch. In the second quarter of 2026, we are seeing continued strength in revenue growth from PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "As of March 31, 2026, the Company’s cash, cash equivalents, and investments totaled $56.7 million, which based on payment terms, did not include any collection of PAPZIMEOS related accounts receivable since launch of approximately $25.7 million. Based on our current revenue outlook and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026. Our forecasted expenditures include additional investments to progress both clinical and pre-clinical assets."

First Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues increased by $21.9 million compared to the three months ended March 31, 2025. The significant increase in total revenues for the three months ended March 31, 2026 was due to the ramp up of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Revenues related to the sale of PAPZIMEOS for the three months ended March 31, 2026 were $21.6 million. No PAPZIMEOS sales were recorded for the three months ended March 31, 2025, as the product had not yet been approved.

R&D expenses decreased by $4.8 million compared to the three months ended March 31, 2025, primarily due to the change in the accounting treatment of manufacturing costs as a result of the FDA approval of PAPZIMEOS.

Selling, general, and administrative (SG&A) expenses increased by $8.7 million compared to the three months ended March 31, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025.

Total other expense, net, decreased by $29.6 million compared to the three months ended March 31, 2025. This change was primarily attributable to the absence of a $32.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $2.9 million in interest expenses related to long term debt that originated in the third quarter of 2025.

Net loss was $7.9 million, or $0.02 per basic and diluted share, for three months ended March 31, 2026, compared to a net loss of $54.2 million, or $0.18 per basic and diluted share, for the three months ended March 31, 2025.

(Press release, Precigen, MAY 13, 2026, View Source [SID1234665638])