On March 25, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported its financial results for the fourth quarter and year ended December 31, 2025 and provides an update on recent corporate developments.

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"While we have consistently made meaningful and measurable progress across our (Z)-endoxifen development strategy in oncology over the last 12 months, we continue to explore the best opportunities to leverage the technology where it may help to address serious health conditions and unmet medical needs. As we continue to keep a careful eye on opportunities in the breast cancer space, we are also diligently working to advance (Z)-endoxifen in certain rare disease indications, such as Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS)," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics’ President and Chief Executive Officer. "To date, we have published work that identifies the opportunity for (Z)-endoxifen, while achieving both FDA Rare Pediatric Disease and Orphan Drug designations. We believe these FDA designations are important for future development as they both help to speed the FDA review process as well as provide potential financial benefits in the future."

"In the meantime, we are consciously aligning our resources with the demands of potential commercialization, even as we have added new professionals to our team to help drive both our rare disease and breast cancer programs forward. With a strong balance sheet and a strategically focused team, we believe we are well-positioned to execute and advance our clinical programs toward key value-creating milestones," concluded Dr. Quay.

Clinical & Regulatory Progress & Announcements

Atossa Highlighted Emerging Opportunity for (Z)-Endoxifen in Duchenne Muscular Dystrophy, Including Symptomatic Female Carriers, Following Peer-Reviewed Publication and Scientific Presentation – The published article, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD)," surveys the DMD treatment landscape and details how (Z)-endoxifen’s pharmacology could address multiple downstream drivers of disease, including inflammation, fibrosis, calcium dysregulation, mitochondrial dysfunction, and lipid abnormalities. The paper emphasizes (Z)-endoxifen’s direct estrogen-receptor (ER) modulation, allosteric inhibition of PKC (notably PKC-β1), and effects along AKT/mTOR and NF-κB axes, mechanisms that together may help slow disease progression when used as an adjunct to standard care. Notably, the authors underscore (Z)-endoxifen’s potential to deliver more consistent therapeutic exposures than tamoxifen by bypassing CYP2D6 metabolic variability, an important limitation of the pro-drug approach. As illustrated in the mechanistic diagram, page 7 of the publication, the paper maps (Z)-endoxifen’s ER-dependent and ER-independent signaling effects relevant to dystrophic muscle.
Atossa Therapeutics Received FDA Rare Pediatric Disease Designation for (Z)-Endoxifen for Duchenne Muscular Dystrophy – In December 2025, Atossa announced that the U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment of DMD. RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher ("PRV"), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$200 million.
Atossa Therapeutics Won the 2025 Clinical Trials Arena Research and Development Excellence Award in Precision Endocrine Therapy Category – In December 2025, Atossa announced that it had been selected as a winner of the 2025 Clinical Trials Arena Excellence Awards. The Company was honored with the Research and Development Award in the Precision Endocrine Therapy category. Atossa earned this recognition for its innovative work advancing (Z)-endoxifen, its lead precision-engineered endocrine therapy. (Z)-endoxifen is a potent selective estrogen receptor modulator/degrader (SERM/D) with additional PKCβ1 inhibition, designed to provide consistent systemic exposure independent of CYP2D6 metabolism. The therapy is being evaluated across metastatic, neoadjuvant, adjuvant, and breast cancer risk-reduction settings, with an emerging application in DMD.
Atossa Therapeutics Received FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of Duchenne Muscular Dystrophy – In January 2026, Atossa announced that the U.S. Food and Drug Administration ("FDA") Office of Orphan Products Development ("OOPD") granted Orphan Drug Designation to (Z)-endoxifen for the treatment of DMD. Orphan Drug Designation is granted by FDA to therapies intended to treat rare diseases or conditions. The designation is designed to encourage drug development by offering certain potential incentives, such as regulatory support and, if the product ultimately receives marketing approval for the designated indication, eligibility for a period of market exclusivity.
Atossa Announces Additions to Management Team

Atossa Therapeutics Strengthened Clinical Leadership Team with the Addition of Two Experienced Biopharma Executives – Atossa announced the engagement of Kathy Puyana Theall, M.D., as Medical Director – Breast Oncology, and Adebola Giwa, M.D., as Medical Director – Rare Diseases. We believe the addition of these two highly experienced physicians and clinical leaders meaningfully strengthens Atossa’s ability to execute on its (Z)-endoxifen development strategy across both breast cancer and rare disease programs, including DMD and MAS, as the Company advances toward key clinical and regulatory milestones.
Comparison of Years-Ended December 31, 2025 and 2024

Operating Expenses. Total operating expenses were $37.1 million for the year ended December 31, 2025, which was an increase of $9.5 million, from the year ended December 31, 2024 of $27.6 million. Factors contributing to the increased operating expenses in the year ended December 31, 2025 are explained below.

Research & Development Expenses. The following table provides a breakdown of major categories within R&D expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):

For the Year Ended December 31,

2025

2024

Increase

Increase (%)

Research and Development Expense

Clinical and non-clinical trials

$16,204

$10,107

$6,097

60 %

Compensation

3,206

2,928

278

9 %

Professional fees and other

1,775

1,082

693

64 %

Research and Development Expense Total

$21,185

$14,117

$7,068

50 %

As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:

Clinical and pre-clinical trial expense increased $6.1 million for the year ended December 31, 2025 compared to the prior year due to an increase in spending for the (Z)-endoxifen trials, including an increase in drug development costs.
The increase in R&D compensation expense of $0.3 million for the year ended December 31, 2025 compared to the prior year was due primarily to an increase in cash compensation expense of $0.4 million resulting from an increase in headcount. This increase was partially offset by a non-cash stock-based compensation expense decrease of $0.1 million compared to the prior year due to the weighted average fair value of stock options amortizing in 2025 being lower than 2024.
The increase in R&D professional fees and other of $0.7 million for the year ended December 31, 2025 compared to the prior year was primarily attributable to higher regulatory consulting fees in 2025 related to our (Z)-endoxifen program.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):

For the Year Ended December 31,

2025

2024

Increase
(Decrease)

Increase (%)
(Decrease)

General and Administrative Expense

Compensation

$6,062

$5,458

$604

11 %

Professional fees and other

9,191

7,164

2,027

28 %

Insurance

703

882

(179)

(20) %

General and Administrative Expense Total

$15,956

$13,504

$2,452

18 %

The increase in G&A compensation expense of $0.6 million for the year ended December 31, 2025 compared to the prior year was due to an increase in both cash compensation expense of $0.2 million and non-cash stock-based compensation expense of $0.4 million. The increase in cash compensation expense compared to the prior year was primarily driven by salary, bonus and severance costs for a former executive of $0.4 million, partially offset by a decrease in cash bonus related to terminations and reductions in expected bonus payouts in 2025. The non-cash stock-based compensation expense increase was driven by an increase in the fair value of grants to members of our Board of Directors (the Board) which amortize over one year.
G&A professional fees and other expenses increased by $2.0 million for the year ended December 31, 2025 compared to the prior year due primarily to an increase in legal fees of $1.8 million for the year ended December 31, 2025 driven by the costs for our ongoing litigation and patent defense which increased by $1.6 million compared to the prior year. Investor relations expense increased by $0.3 million for the year ended December 31, 2025 compared to the prior year due to changes in investor outreach and broader investor relations strategy. Partially offsetting the increases, our accounting fees decreased by $0.3 million for the year ended December 31, 2025 compared to the prior year due to the inclusion of higher auditor fees associated with our 2024 Registration Statement on Form S-3 and our at the market offering facility.
The decrease in G&A insurance expense of $0.2 million for the year ended December 31, 2025 compared to the prior year was due primarily to lower negotiated insurance premiums associated with our Director’s and Officer’s insurance and other key insurance policies in 2025.
Interest Income. Interest income of $2.4 million for the year ended December 31, 2025 represented a decrease of $1.7 million compared to the prior year, and was due primarily to a decrease in the average funds invested in our money market account.

Impairment Charge on Investment in Equity Securities. For the year ended December 31, 2024, we wrote down our Investment in equity securities by $1.7 million due to impairment of our investment in Dynamic Cell Therapies, Inc.

About (Z)-Endoxifen

(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company’s proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa’s (Z)-endoxifen is not approved for any indication.

Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, MAR 25, 2026, View Source [SID1234663911])

(Press release, Atossa Therapeutics, MAR 25, 2026, View Source [SID1234663911])

On March 25, 2026 Hengrui Pharma (600276.SH; 01276.HK) reported robust financial results for the full year 2025, fueled by its dual strategy of innovation and globalization. Revenue increased 13% year-on-year to RMB 31.63 billion, and net profit attributable to shareholders increased by 21.8% to RMB 7.72 billion.

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Innovation remained the engine of Hengrui’s growth: Innovative drug sales increased by 26.1% year-on-year to RMB 16.34 billion, contributing 58.3% to total drug sales. This was driven by a robust pipeline across therapeutic areas, with oncology products contributing RMB 13.24 billion in revenue (+18.5% YoY), and non-oncology products contributing RMB 3.10 billion in revenue (+73.4% YoY).

Hengrui kept innovation at its core, with R&D expenditure reaching RMB 8.72 billion in 2025, accounting for 27.6% of total revenue, of which RMB 6.96 billion was expensed. During the year, the company secured seven approvals for Class 1 innovative drug, one for a Class 2 innovative drug, and six for new indications of marketed innovative drugs. The pace of regulatory progress accelerated with 15 NDA/BLAs accepted by the NMPA. Meanwhile, 28 drug candidates entered Phase III clinical trials, 61 progressed to Phase II, and 28 NMEs entered Phase I for the first time.

The company currently has over 100 proprietary innovative products in clinical development and is conducting more than 400 clinical trials. This robust portfolio will be further supported by approximately 53 innovative product and indication approvals anticipated during 2026-2028.

2025 marked another year of accelerated progress in Hengrui’s global expansion. Licensing revenue rose 25.6% to RMB 3.39 billion, cementing the growing global recognition and value of the company’s innovative portfolio. During the year, the company completed five overseas business development transactions for innovative drugs with leading MNCs and biotechs, highlighted by a strategic collaboration with GSK. In parallel, the company continued to advance its self-developed assets and global regulatory efforts, with multiple innovative assets entering global clinical trials.

Additionally, Hengrui successfully listed on the Hong Kong Stock Exchange, raising total proceeds of HK$11.4 billion (US$1.5 billion), including the over-allotment option — marking the largest pharmaceutical IPO in Hong Kong in the past five years and further strengthening its access to global capital.

Looking ahead, Hengrui will continue to focus on addressing unmet clinical needs with its differentiated innovative portfolio, placing equal emphasis on independent R&D and open collaboration to expand access to innovative drugs for patients worldwide.

(Press release, Hengrui Pharmaceuticals, MAR 25, 2026, View Source [SID1234663910])

On March 25, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the fourth quarter and full year ended December 31, 2025, and other recent business developments.

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"We expect this year to be a transformative one for Celcuity. We plan to release topline results from the PIK3CA mutant cohort of our Phase 3 VIKTORIA-1 study in the second quarter of 2026, which, if positive, could potentially advance the standard-of-care second line therapy for a significant number of patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "Additionally, our efforts remain on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026."

Fourth Quarter 2025 Business Highlights and Other Recent Developments

● In December 2025, updated efficacy and safety results from the Phase 3 VIKTORIA-1 PIK3CA WT cohort were presented at the 2025 San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being measures.

○ For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median progression free survival ("PFS") was 16.6 months with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) versus 1.9 months for fulvestrant (HR=0.14; 95% CI: 0.08-0.28; p<0.0001).

○ The gedatolisib triplet delayed time to definitive deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7 months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet versus 4.0 months for fulvestrant. Additionally, for the first 8 cycles of treatment, the patients’ assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib.
○ As reported earlier, the gedatolisib triplet was generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3+ TRAEs for the gedatolisib triplet and fulvestrant included neutropenia (62.3% and 0.8% of patients, respectively); stomatitis (19.2% and 0%); rash (4.6% and 0%); and hyperglycemia (2.3% and 0%). No patients experienced Grade 4 hyperglycemia. TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group and 0% in the fulvestrant group.

● In January 2026, the FDA accepted for filing Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA WT ABC. The FDA granted Priority Review and assigned a PDUFA goal date of July 17, 2026.

● In March 2026, efficacy and safety results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib were published in the Journal of Clinical Oncology. The cohort consisted of patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed while on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

● As reported previously, the results from the VIKTORIA-1 Phase 3 PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- ABC:

○ The hazard ratio for the gedatolisib triplet is more favorable than has ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.
○ The 7.3-months incremental improvements in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of endocrine therapy-based regimen.
○ Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR ("PAM") pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
○ Median duration of response ("DOR") of 17.5 months and incremental objective response rate ("ORR") improvement of 31% relative to control for the gedatolisib triplet is the highest reported for an endocrine therapy-based regimen in second line HR+/HER2- ABC.

Fourth Quarter and Full Year 2025 Financial Results

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2025, compared to the fourth quarter and full year ended December 31, 2024.

Total operating expenses were $49.2 million for the fourth quarter of 2025, compared to $36.4 million for the fourth quarter of 2024. Operating expenses for the full year 2025 were $172.2 million, compared to $113.3 million for the full year 2024.

Research and development ("R&D") expenses were $37.6 million for the fourth quarter of 2025, compared to $33.5 million for the prior-year period. Of the $4.1 million increase in R&D expenses, $8.6 million was related to increased employee and consulting expenses, of which $5.3 million related to commercial headcount additions and other launch-related activities. These amounts were partially offset by a $4.5 million decrease primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial.

R&D expenses for the full year 2025 were $145.0 million, compared to $104.2 million for the prior year. Of the $40.8 million increase in R&D expenses, $26.7 million was related to increased employee and consulting expenses, of which $13.1 million related to commercial headcount additions and other launch-related activities. The remaining $14.1 million increase was primarily related to activities supporting our ongoing clinical trials, a development milestone payment under the license agreement with Pfizer, and other commercial launch-related activities.

General and administrative ("G&A") expenses were $11.6 million for the fourth quarter of 2025, compared to $3.0 million for the prior year period. Of the $8.6 million increase, $6.9 million was related to increased employee-related and consulting expenses, of which $5.4 million related to non-cash stock-based compensation. The remaining $1.7 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses.

G&A expenses for the full year 2025 were $27.2 million, compared to $9.1 million for the prior year. Of the $18.1 million increase in G&A expenses, $14.9 million was related to increased employee-related and consulting expenses, of which $10.4 million related to non-cash stock-based compensation. The remaining $3.2 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses.

Net loss for the fourth quarter of 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, for the fourth quarter of 2024. Net loss for the full year 2025 was $177.0 million, or $3.79 per share, compared to a net loss of $111.8 million, or $2.83 per share, in 2024. Non-GAAP adjusted net loss for the fourth quarter of 2025 was $38.4 million, or $0.73 per share, compared to non-GAAP adjusted net loss of $32.3 million, or $0.75 per share, for the fourth quarter of 2024. Non-GAAP adjusted net loss for the full year 2025 was $150.8 million, or $3.22 per share, compared to non-GAAP adjusted net loss of $101.9 million, or $2.58 per share, for 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the fourth quarter of 2025 was $36.4 million, compared to $27.8 million for the fourth quarter of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million, compared to $83.5 million for the full year 2024. Cash, cash equivalents and short-term investments were $441.5 million at the end of fiscal year 2025 and are expected to finance our operations through 2027.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using the weblink below. A replay of the webcast will be available on the Celcuity website following the live event. View Source;tp_key=9ff20687c4.

(Press release, Celcuity, MAR 25, 2026, View Source [SID1234663909])

On March 25, 2026 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, reported a collaboration with Converge Bio, a company known for its leading AI platform for drug discovery and development, to accelerate and enhance Purple Biotech’s next-generation tri-specific antibody platform leveraging advanced generative AI capabilities.

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Key Highlights:

● Next-generation platform: New collaboration focused on further developing the Company’s tri-specific antibody platform by incorporating AI-driven molecule design and optimization

● Accelerated development: AI-powered approach designed to significantly reduce discovery timelines while improving candidate quality and developability profiles

● Strategic expansion: Broadens Purple Biotech’s platform capabilities to address additional high-value oncology targets and resistance mechanisms

● Validated AI partner: Converge Bio has completed over 40 programs with pharmaceutical and biotech companies

"We are excited to expand our relationship with Converge Bio, whose AI platform has already contributed valuable insights to our CAPTN-3 platform," said Gil Efron, Chief Executive Officer of Purple Biotech. "This collaboration is a natural extension of Purple Biotech’s strategy to lead innovation in multi-specific antibody therapies. By integrating Converge Bio’s generative AI with our deep expertise in tumor immunology and conditional activation, we aim to develop next-generation therapeutics that can address some of oncology’s most challenging targets with improved speed and precision. This collaboration positions Purple Biotech at the intersection of cutting-edge AI-driven drug discovery and innovative immuno-oncology, potentially accelerating our path to generate differentiated, high-quality therapeutic candidates with an improved probability of clinical success."

The collaboration will utilize Converge Bio’s proprietary AI platform, which integrates large-scale biological data with predictive modeling and iterative learning, to design and optimize antibody candidates. The CAPTN-3 platform has demonstrated the ability to generate novel, high-affinity antibodies and optimize protein sequences for improved manufacturability and developability. Purple Biotech will apply these AI-driven insights to develop novel T cell engagers, with the goal of creating drug candidates that combine optimal functional properties with favorable physicochemical characteristics.

This next-generation platform is designed to complement and build upon insights gained from Purple Biotech’s existing CAPTN-3 technology, which generates masked tri-specific antibodies that engage both T cells and NK cells. By leveraging AI to accelerate antibody design and optimization, Purple Biotech aims to expand its pipeline with additional high-quality candidates while reducing development timelines.

"Purple Biotech’s CAPTN-3 platform represents an innovative approach to immuno-oncology, and we’re thrilled to deepen our collaboration with Purple Biotech as they advance their next-generation tri-specific antibody capabilities," said Dov Gertz, CEO and co-founder of Converge Bio. "Our AI platform is purpose-built to tackle the complex challenges of antibody engineering – from achieving optimal binding kinetics to ensuring manufacturability at scale. This collaboration exemplifies how AI can accelerate the development of sophisticated biologics that have the potential to make a meaningful difference for cancer patients."

On March 25, 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 full year 2025 financial results and business updates.

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"With the FDA approval and launch of PAPZIMEOS, 2025 marked a transformational year for Precigen as we transitioned from a clinical-stage to a commercial-stage company and recognized our first commercial product revenues toward the end of the year," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are seeing strong alignment within the physician community around PAPZIMEOS as the first-line standard of care for adults with RRP, supported by its profile as the only approved therapy for RRP, the compelling safety and efficacy data, and the encouraging durability of response observed to date. This is an exciting time for Precigen, and we look forward to sharing further updates during our call regarding the significant momentum we’re seeing in the first quarter."

"Commercialization of PAPZIMEOS continues to move rapidly, with growing physician adoption and patient uptake since approval in August. Since deploying our full field organization, we have engaged all target medical institutions and are seeing prescriptions and active treatment across the United States in both major medical centers and community practices. Patient hub enrollment has surpassed 300 patients, reflecting strong demand, while payer coverage now extends to approximately 215 million lives across private insurers, as well as Medicare and Medicaid. The recently published Recurrent Respiratory Papillomatosis Foundation-sponsored expert consensus paper recommending PAPZIMEOS as the first-line standard of care for adults with RRP further reinforces the momentum we are seeing as we continue to see expanded patient access." said Phil Tennant, Chief Commercial Officer of Precigen.

KEY PROGRAM HIGHLIGHTS

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 for the treatment of adults with RRP.
· PAPZIMEOS prescribing, treatment, and distribution: Since full deployment of the PAPZIMEOS field team in September 2025, 100% of target medical institutions have been engaged. PAPZIMEOS is now being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.
· Strong patient and physician demand: To date, PAPZIMEOS patient hub enrollment has surpassed 300 registered patients, reflecting substantial patient and physician demand. In addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the Company’s field engagement efforts.
· Positive payer coverage: Patient access continues to expand, with private health plan coverage now estimated at approximately 215 million US lives, including the significant majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid. Collectively, coverage now extends to approximately 90% of insured lives in the US.
· J-code assigned: The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. J-codes are standardized reimbursement codes that allow healthcare providers to bill government and commercial insurers for physician-administered therapies. Assignment of a permanent J-code streamlines claims processing and will likely facilitate broader patient access.

· PAPZIMEOS recommended as new standard of care first-line treatment: In January 2026, an expert consensus 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.
· Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025, SITC (Free SITC Whitepaper) 2025, and EUROGIN 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 initiated: The Company initiated an open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec in adults with RRP (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.

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.
· PRGN-2009 Phase 2 clinical trial in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.

FINANCIAL RESULTS

"2025 was a game-changing year for Precigen with the FDA approval of PAPZIMEOS. We began preparing for the commercial launch of PAPZIMEOS well before the FDA’s approval and significantly increased our investment in commercialization efforts as 2025 progressed to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Our first sale of PAPZIMEOS was recorded in the fourth quarter of 2025 and we are encouraged by continued revenue momentum we’re seeing as we begin the new year. Based upon our present forecast, we expect 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, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives."

Full Year 2025 Financial Results Compared to Prior Year Period

Total revenues increased by $5.8 million compared to the year ended December 31, 2024. This increase was primarily driven by the commencement of PAPZIMEOS product revenue, which totaled $3.4 million in 2025, reflecting the first partial quarter of US commercial sales following the Company’s commercial launch, as well as higher collaboration and licensing revenue of $1.8 million as a result of the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement.

Research and development expenses decreased by $11.7 million, or 22.1%, compared to the year ended December 31, 2024. The decrease was primarily driven by a $5.4 million reduction in costs associated with ActoBio after the Company closed its operations in 2024. External services also declined by approximately $4.0 million, due to reduced activity for contract research organizations as a result of the strategic prioritization of the Company’s pipeline announced in the third quarter of 2024. In addition, the Company, upon FDA approval of PAPZIMEOS, began classifying manufacturing-related costs to inventory, which ultimately will be recorded as cost of products and services when the related inventory is sold. Manufacturing costs related to PAPZIMEOS were recorded as research and development expenses prior to the FDA approval of PAPZIMEOS.

Selling, General and Administrative (SG&A) expenses increased by $28.8 million, or 69.8%, compared to the year ended December 31, 2024. This increase was primarily due to a $27.3 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales force expansion, marketing and advertising, as well as professional and other fees associated with the commercial launch of PAPZIMEOS.

In connection with the suspension of ActoBio’s operations in 2024, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024. Additionally, in the second quarter of 2025, the Company recorded $3.9 million of impairment charges related to the Exemplar reporting unit, compared to $5.8 million of impairment charges related to the Exemplar reporting unit in the prior year period.

Total other income (expense), net, decreased from income, net of $7.0 million in 2024 to expense, net of $140.1 million in 2025. This decrease was primarily driven by a $139.5 million increase in the fair value of warrant liabilities prior to their reclassification into permanent equity in the third quarter of 2025. Substantially all of the increase in the fair value of warrant liabilities was as a result of an increase in the Company’s common stock price at the valuation date compared to December 31, 2024.

The Company recorded a $179.0 million non-cash deemed dividend on preferred stock in the third quarter of 2025 as a reduction to additional paid-in capital (and an increase in net loss attributable to common shareholders when computing net loss per share) in accordance with US Generally Accepted Accounting Principles (GAAP). On September 15, 2025, all of the outstanding Preferred Shares were converted into common shares.

Net loss attributable to common shareholders was $429.6 million, or $1.37 per basic and diluted share for the year ended December 31, 2025, compared to a net loss of $126.2 million, or $0.47 per basic and diluted share, for the year ended December 31, 2024. The inrease in net loss was primarily driven by non-cash items, including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares noted above (combined impact of $318.5 million or $1.02 per share)

(Press release, Precigen, MAR 25, 2026, View Source [SID1234663907])