On February 26, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported business updates and financial results for the fourth quarter and year ended December 31, 2025.

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"2025 was a time of accomplishment and resiliency for Intellia as we presented encouraging longer term Phase 1/2 clinical data for both lonvo-z and nex-z, rapidly enrolled patients in our three Phase 3 trials, commenced activities to prepare for a potential lonvo-z launch in HAE and responded to the clinical holds on our nex-z Phase 3 trials late in the year," said Intellia President and Chief Executive Officer John Leonard, M.D. "We expect the year ahead to be a pivotal one, highlighted by our topline Phase 3 data and planned BLA submission for lonvo-z, which has the potential to transform the HAE treatment paradigm by freeing most patients from both their attacks and chronic therapy. Additionally, we are focused on resuming our forward momentum with nex-z by completing patient enrollment in MAGNITUDE-2 and resolving the clinical hold on MAGNITUDE."

Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the KLKB1 gene in the liver, drive consistent, deep and potentially lifelong reduction in kallikrein levels, and dramatically reduce or eliminate HAE attacks via a one-time treatment.

In the fourth quarter at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, Intellia presented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg) dose of lonvo-z in the company’s ongoing Phase 1/2 clinical trial in patients with HAE. Observations from the analysis included durable reductions in plasma kallikrein in all patients at month 24, a high percentage of patients achieving prolonged attack-free status (for at least seven months and up to 32 months for patients with the longest follow-up) and a well-tolerated safety profile for lonvo-z.
Intellia sponsored a blinded market research study in late 2025 with 104 U.S. HAE patients and 151 U.S. HAE treating physicians. After reviewing a blinded target product profile aligned with lonvo-z’s Phase 1/2 clinical data, 99% of patients said they would be at least somewhat likely – and 64% said they would be extremely or very likely – to take lonvo-z if prescribed. Additionally, 92% of healthcare providers indicated they would prescribe a product with this profile, estimating they would prescribe it to 54% of the approximately 4,000 patients with HAE under their care.
This weekend, the company will present four posters at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place February 27 – March 2 in Philadelphia, Pennsylvania (poster numbers 003, 005, 061 and 716). The presentations include three-year follow-up data from patients receiving a one-time 50 mg dose of lonvo-z and new survey findings assessing the chronic treatment burden and unmet needs among patients living with HAE.
Dosing in the global HAELO Phase 3 clinical trial was initiated in January 2025 and was completed in September 2025, with 80 patients enrolled. Intellia expects to report HAELO topline data by mid-2026 and, if the data are supportive, submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
To prepare for a planned launch in the first half of 2027, the company has expanded its field medical team, strengthened engagement with treating physicians and patient advocacy groups, initiated its payer engagements and advanced its launch strategy. In 2026, the company intends to build its field sales and reimbursement teams, finalize its distribution models, identify U.S. treatment centers and advance its pricing and access planning strategy.
Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis

Nex-z is an investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.

In the fourth quarter at the American Heart Association (AHA) Scientific Sessions, Intellia presented positive follow-up data from the ongoing Phase 1 clinical trial of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). Observations from these longer-term data included consistent and durable reductions in serum TTR through up to three years of follow up, stability or improvement in multiple markers of cardiomyopathy for most patients and encouraging mortality data.
As previously reported, on October 29, 2025, the FDA placed a clinical hold on the Investigational New Drug (IND) applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with ATTR-CM and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.
On January 27, 2026, the company announced the FDA lifted the clinical hold on the IND for MAGNITUDE-2. The company is in the process of resuming MAGNITUDE-2 enrollment.
Intellia’s engagement with FDA is ongoing regarding the clinical hold on the IND for the MAGNITUDE Phase 3 clinical trial of nex-z for patients with ATTR-CM. The company plans to provide an update once alignment has been achieved on the path forward for this program.
Fourth Quarter and Full-Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $605.1 million as of December 31, 2025, compared to $861.7 million as of December 31, 2024. The company’s cash, cash equivalents and marketable securities as of December 31, 2025 are expected to fund operations into the second half of 2027 and through lonvo-z’s anticipated U.S. commercial launch for HAE.

Collaboration Revenue: Collaboration revenue was $23.0 million for the fourth quarter of 2025, compared to $12.9 million for the fourth quarter of 2024. The increase was primarily driven by the recognition of $9.0 million in revenue related to the termination of the license and collaboration agreement with SparingVision SAS and an increase in cost reimbursements related to the company’s collaboration with Regeneron.
R&D Expenses: Research and development (R&D) expenses were $88.7 million for the fourth quarter of 2025, compared to $116.9 million for the fourth quarter of 2024. The $28.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services, partially offset by an increase in facility-related expenses as well as clinical trial expenses related to nex-z. Stock-based compensation expense included in R&D expenses was $10.5 million for the fourth quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $33.1 million for the fourth quarter of 2025, compared to $32.4 million for the fourth quarter of 2024. Stock-based compensation expense included in G&A expenses was $6.2 million for the fourth quarter of 2025.
Net Loss: Net loss was $95.8 million for the fourth quarter of 2025, compared to $128.9 million for the fourth quarter of 2024.

Conference Call Information
The company will host a conference call and webcast today at 8:00 a.m. ET to discuss recent updates and the company’s fourth quarter and full-year 2025 financial results. To join the webcast, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. To join by phone, U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726 approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call. A replay of the webcast will be available for approximately 90 days.

(Press release, Intellia, FEB 26, 2026, View Source [SID1234663078])

On February 26, 2026 ImmVira Group reported preliminary positive results from its clinical trial evaluating MVR-T3011, an oncolytic virus, in BCG-naïve high-risk papillary Ta/T1 NMIBC patients for its leading oncolytic virus product, MVR-T3011, via intravesical administration. The data were presented in a poster at the ASCO (Free ASCO Whitepaper) GU 2026 Conference in San Francisco, California.

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In the study involving 18 BCG-naïve high-risk papillary Ta/T1 NMIBC patients treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU (3 patients) and 1×1010 PFU (15 patients), preliminary data as of December 31, 2025, demonstrated encouraging efficacy and durability. Among the 14 evaluable patients, the 12-month recurrence-free-survival (RFS) rate was 100% (3/3) at the 2×109 PFU dose level. At the 1×1010 PFU dose level, the 3-month RFS rate was 100% (11/11). The 6-month and 9-month RFS rates were 75% (3/4) and 66.7% (2/3), respectively, but these data are preliminary, given the small patient numbers reaching those timepoints.

Consistent with BCG-unresponsive clinical data, MVR-T3011 maintained a favorable safety profile in this study with most treatment-emergent adverse events (TEAEs) being at Grades 1 or 2. No treatment-related adverse events (TRAEs) were observed.

Bladder cancer ranks as the ninth most prevalent cancer worldwide[1], with approximately 75% of cases classified as NMIBC. While Bacillus Calmette-Guerin (BCG) remains the current SOC for high-risk NMIBC, global shortages have limited its availability. As a result, oncolytic immunotherapy, which offers enhanced immune activation and potential durability, is emerging as a promising alternative.

"We are highly encouraged by the preliminary efficacy and safety data from the study," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "MVR-T3011 shows its potential to serve as a reliable and widely accessible alternative to BCG, ultimately benefiting patients worldwide."

(Press release, Immvira, FEB 26, 2026, View Source [SID1234663094])

On February 26, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the full year ended December 31, 2025, and provided a business update.

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"2025 was fundamentally transformative for BioCryst. We achieved full-year profitability for the first time in the company’s history, driven by strong commercial execution that delivered the highest level of new patient prescriptions in the U.S. since the initial launch of ORLADEYO, even as the treatment landscape continued to evolve. We also advanced key business development initiatives that streamlined our operations and further strengthened our leadership position in hereditary angioedema. We entered 2026 with strong momentum, completing the acquisition of Astria Therapeutics to grow our HAE portfolio to meet the needs of more patients, while adding to our long-term growth trajectory well into the next decade," said Charlie Gayer, President and Chief Executive Officer of BioCryst.

Business Updates

In October 2025, the company completed the sale of its European ORLADEYO business to Neopharmed Gentili S.p.A. The transaction enabled BioCryst to simplify its operating structure and sharpen its strategic focus on its core U.S. business.

In December 2025, the company received FDA approval for the ORLADEYO pellet formulation for patients ages 2 to <12 with HAE, making it the first and only targeted oral prophylactic therapy for children living with HAE.

In January 2026, the company completed its acquisition of Astria Therapeutics, Inc., initially announced in October 2025. Through the transaction, BioCryst added navenibart to its HAE portfolio. Navenibart is an injectable, long-acting, monoclonal antibody inhibitor of plasma kallikrein currently in Phase 3 clinical development for HAE prophylaxis.

The navenibart Phase 3 program is currently enrolling and is on track to support regulatory filing by the end of 2027. The program consists of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial. ALPHA-ORBIT is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of navenibart over a six-month treatment period, with dosing arms every three months (Q3M) and every six months (Q6M). After completing ALPHA-ORBIT, eligible participants may continue into the ORBIT-EXPANSE trial, in which all participants will receive navenibart in either Q3M or Q6M regimens.

New positive, interim results from the long‑term, open‑label ALPHA‑SOLAR trial show sustained, robust HAE attack suppression with navenibart administered every three and six months. The mean and median HAE attack rate reductions from baseline were 92% and 97% in the Q3M dosing arm and 90% and 97% in the Q6M dosing arm. Long-term data up to 24 months show durable efficacy and a favorable safety profile for both dosing regimens. BioCryst will present these results in a late-breaking presentation, and other abstracts, at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, February 27–March 2, 2026.

A Phase 1 trial of BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, is currently enrolling and has begun dosing patients. The company expects to report data from this program in up to 12 patients by the end of 2026.
Full Year 2025 Financial Results

Non-GAAP figures are provided with adjustments, as applicable, for the sale of the European ORLADEYO business, stock-based compensation, workforce reduction costs, and transaction-related costs. Management believes that the presentation of these non-GAAP figures can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods by excluding both the impact of divestitures and other items that can vary significantly across time periods.

Total revenues were $874.8 million and operating profit was $341.0 million for the full year 2025, compared to total revenues of $450.7 million and an operating loss of $2.5 million for the full year 2024. On October 1, 2025, BioCryst sold its European ORLADEYO business, resulting in the recognition of $243.3 million of revenue related to the license of intellectual property to Neopharmed Gentili S.p.A. On a non-GAAP basis, total revenues were $592.9 million (+45% y-o-y) and operating profit was $214.2 million (+198% y-o-y).

Research and development expenses, excluding stock-based compensation expense, in 2025 were $136.6 million (-5% y-o-y) on a GAAP basis and $133.0 million (-5% y-o-y) on a non-GAAP basis. Research and development expenses included increases in program costs for BCX17725 and avoralstat driven by manufacturing and clinical activities as we advance our Phase 1 studies, as well as increased IND-enabling activities across our early-stage pipeline programs. These increases were offset by lower personnel related costs and the close out of the Factor D program.

Sales and marketing expenses, excluding stock-based compensation expense, in 2025 were $177.1 (+16% y-o-y) million on a GAAP basis and $144.1 million (+23% y-o-y) on a non-GAAP basis. The increase was driven by distribution costs primarily attributed to increased sales, process development costs, the transition of certain safety and regulatory support roles from research and development due to commercial progression, pediatric launch support and other compensation expenses related to strong ORLADEYO sales performance.

General and administrative expenses, excluding stock-based compensation expense, in 2025 were $116.0 million (+45% y-o-y) on a GAAP basis and $85.0 million (+21% y-o-y) on a non-GAAP basis. The increase was driven by compensation, headcount growth in certain functions, and the transition of certain quality support roles from research and development to general and administrative in connection with ORLADEYO’s continued commercial progression.

Stock-based compensation increased due to a modification to extend the post-termination exercise period of certain vested stock option awards at the time of retirement for certain individuals to the original expiration date and an increase in restricted stock unit awards granted.

Interest expense was $78.9 million for the full year 2025 (-20% y-o-y). The decrease was primarily driven by the payoff of the Pharmakon Term Loan in 2025 and a decrease in the effective interest rate during the period in which the debt was outstanding in 2025. The payoff of the Pharmakon Term Loan, totaling $323.7 million, resulted in a one-time loss on extinguishment of debt of $17.3 million for the full year 2025.

Other income was $12.1 million for the full year 2025, which was primarily comprised of the impacts from the sale of our European ORLADEYO business. There was no other income for the full year 2024.

Cash, cash equivalents, restricted cash and investments totaled $337.5 million at December 31, 2025. Net cash utilization for the full year 2025 was $5.4 million. Excluding the impacts of the payoff of the Pharmakon loan and related expenses totaling $333.6 million and the net proceeds from the sale of our European ORLADEYO business to Neopharmed Gentili S.p.A. totaling $243.0 million, there was $85.2 million of cash generated during 2025.

Financial Outlook for 2026
The company maintained its expectation for full year 2026 global net ORLADEYO revenue to be between $625 million and $645 million and for full year 2026 total revenue, including RAPIVAB (peramivir injection), to be between $635 million and $660 million.

The company also maintained its expectation for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to be between $450 million and $470 million.

Item As of February 26, 2026 As of January 12, 2026
ORLADEYO revenue Unchanged $625 million to $645 million
Total revenue Unchanged $635 million to $660 million
Non-GAAP operating expense Unchanged $450 million to $470 million

Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, FEB 26, 2026, View Source [SID1234663060])

On February 26, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following upcoming conferences:

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TD Cowen 46th Annual Healthcare Conference
Presentation: March 2, 2026 at 9:50 a.m. ET
Boston, MA
Barclays 28th Annual Global Healthcare Conference
Fireside Chat: March 11, 2026 at 9:30 a.m. ET
Miami, FL
The live and archived webcasts will be available at View Source

(Press release, Iovance Biotherapeutics, FEB 26, 2026, View Source [SID1234663079])

On February 26, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported its financial results for the fourth quarter and full year ended December 31, 2025.

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Recent Financial Highlights

Generated total revenues of $665.5 million in the fourth quarter of 2025, compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. Product revenues grew 39.8% over the same period.
Generated a gross margin1 of 66.9% in the fourth quarter of 2025, compared to a gross margin1 of 62.9% in the fourth quarter of 2024.
Generated total revenues of $2,306.1 million in the full year 2025, compared to $1,696.9 million in the full year 2024, an increase of 35.9%. Product revenues grew 36.2% over the same period.
Generated a gross margin1 of 64.7% in the full year of 2025, compared to a gross margin1 of 60.3% in the full year of 2024.
Processed approximately 923,600 tests in the fourth quarter of 2025, compared to approximately 792,800 tests in the fourth quarter of 2024, an increase of 16.5%.
Processed approximately 3,525,500 tests in the full year 2025, compared to approximately 3,064,600 tests in the full year 2024, an increase of 15.0%.
Processed approximately 233,300 oncology tests in the fourth quarter of 2025, compared to approximately 150,800 in the fourth quarter of 2024, an increase of 54.7%.
Processed approximately 800,800 oncology tests in the full year 2025, compared to approximately 528,200 in the full year 2024, an increase of 51.6%.
Achieved positive cash inflow of approximately $107.6 million2 in the full year 2025.
"We delivered an outstanding finish to 2025 with record test volumes, strong revenue that exceeded our January pre-announcement, and gross margins well ahead of our expectations even as we continued to invest significantly throughout the year," said Steve Chapman, chief executive officer of Natera. "With solid momentum already in 2026, we remain focused on our mission to transform the management of disease worldwide by expanding access to our testing and advancing the data that supports better patient care."

Fourth Quarter and Year Ended December 31, 2025 Financial Results

Total revenues were $665.5 million in the fourth quarter of 2025 compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. The increase in total revenues was driven primarily by a 39.8% increase in product revenues, which were $661.2 million in the fourth quarter of 2025 compared to $472.9 million in the fourth quarter of 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.

Natera processed approximately 923,600 tests in the fourth quarter of 2025, including approximately 909,000 tests accessioned in its laboratory, compared to approximately 792,800 tests processed, including approximately 778,400 tests accessioned in its laboratory, in the fourth quarter of 2024.

In the fourth quarter of 2025, Natera recognized revenue on approximately 892,400 tests for which results were reported to customers in the period (tests reported), including approximately 878,000 tests reported from its laboratory, compared to approximately 771,700 tests reported, including approximately 758,200 tests reported from its laboratory, in the fourth quarter of 2024, an increase of 15.6% from the prior period.

Total revenues were $2,306.1 million in the full year 2025 compared to $1,696.9 million in the full year 2024, an increase of 35.9%. The increase in total revenues was driven primarily by a 36.2% increase in product revenues, which were $2,295.8 million in the full year 2025 compared to $1,685.1 million in the full year 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.

Natera processed approximately 3,525,500 tests in the full year 2025, including approximately 3,468,700 tests accessioned in its laboratory, compared to approximately 3,064,600 tests processed, including approximately 3,001,900 tests accessioned in its laboratory, in the full year 2024.

In the full year 2025, Natera recognized revenue on approximately 3,342,500 tests for which results were reported to customers in the period (tests reported), including approximately 3,288,600 tests reported from its laboratory, compared to approximately 2,926,400 tests reported, including approximately 2,867,400 tests reported from its laboratory, in the full year 2024, an increase of 14.2% from the prior period.

Gross profit2 for the three months ended December 31, 2025 and 2024 was $445.2 million and $299.6 million, respectively, representing a gross margin1 of 66.9% and 62.9%, respectively. Gross profit1 for the year ended December 31, 2025 and 2024 was $1,493.2 million and $1,023.2 million, respectively, representing a gross margin1 of 64.7% and 60.3%, respectively. Natera had higher gross margin1 in the fourth quarter of 2025 and for the full year 2025 primarily as a result of higher revenues and continued progress in reducing cost of revenues associated with tests processed. Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the fourth quarter of 2025 was $466.5 million, compared to $364.4 million in the same period of the prior year, an increase of 28.0%. Total operating expense for the full year 2025 were $1,801.4 million, compared to $1,245.5 million in the same period of the prior year, an increase of 44.6%. The increases in both periods were primarily driven by headcount growth to support new product offerings as well as increases in consulting and legal expenses. Amortization of acquired intangible assets for the fourth quarter and full year of 2025 was $1.7 million. No such amortization occurred in the fourth quarter or full year of 2024.

Loss from operations for the fourth quarter of 2025 was $22.8 million compared to $64.7 million for the same period of the prior year. Loss from operations for full year 2025 was $309.9 million compared to $222.3 million for the same period of the prior year.

Natera’s net loss for the full year 2025 was $208.2 million, or ($1.52) per diluted share, compared to a net loss of $190.4 million, or ($1.53) per diluted share, in 2024. Weighted average shares outstanding were 136.7 million in the full year 2025 compared to 124.7 million for the same period in the prior year.

At December 31, 2025, Natera held approximately $1,076.1 million in cash, cash equivalents, short-term investments and restricted cash, compared to $968.3 million as of December 31, 2024. As of December 31, 2025, Natera had a total outstanding debt balance of $80.3 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day SOFR plus 50 bps.

Financial Outlook

Natera anticipates 2026 total revenue of $2.62 billion to $2.70 billion; 2026 gross margin1 to be approximately 63% to 65%; selling, general and administrative costs to be approximately $1.125 billion to $1.225 billion; research and development costs to be $750 million to $850 million; and net cash inflow to be positive.

(Press release, Natera, FEB 26, 2026, View Source [SID1234663095])