On May 11, 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 first quarter ended March 31, 2026.

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"It has been a remarkable start to 2026 for Intellia," said John Leonard, M.D., Intellia President and Chief Executive Officer. "With lonvo-z, we achieved a historic milestone by presenting the world’s first Phase 3 data for an in vivo gene editing candidate and initiated a rolling BLA submission as we seek to provide a highly differentiated one-time treatment option to people living with HAE. We also recently resumed patient screening for both of our Phase 3 clinical trials in ATTR and strengthened our balance sheet with an underwritten public offering. We look forward to achieving additional important milestones during the remainder of the year."

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

Designed as a one-time treatment that is administered in an outpatient setting, lonvo-z is an in vivo CRISPR gene editing candidate that is intended to inactivate the kallikrein B1 (KLKB1) gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks.

In April, Intellia announced positive topline results from the global Phase 3 HAELO clinical trial of lonvo-z in HAE.
The trial met its primary endpoint. For the six-month efficacy evaluation period (weeks 5 to 28), a one-time infusion of lonvo-z reduced attacks by 87% versus placebo, with a mean monthly attack rate of 0.26 in the lonvo-z arm compared with 2.10 in the placebo arm (p<0.0001).
The trial met all of its key secondary endpoints with statistical significance (p<0.0001). These included a 62% rate of patients who were entirely attack free and therapy free in the lonvo-z arm for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm.
Favorable safety and tolerability data were observed for lonvo-z. The most common treatment emergent adverse events (TEAEs) during the primary observation period (infusion through week 28) were infusion-related reactions, headache and fatigue. All TEAEs reported as of the data cutoff (February 10, 2026) were mild or moderate (Grade 1 or Grade 2) and there were no serious adverse events observed in the lonvo-z arm.
As of the data cutoff, all patients who received lonvo-z at baseline or in crossover after week 28 remained free from long-term prophylaxis therapy.
Intellia announced in April that it has initiated a rolling biologics license application (BLA) submission to the U.S. Food and Drug Administration (FDA) to seek regulatory approval for lonvo-z. Pursuant to the regenerative medicine advanced therapy (RMAT) designation granted to lonvo-z by the FDA, a rolling BLA allows the company to submit portions of the BLA on an ongoing basis and provides the FDA with an opportunity to accelerate its review. Intellia plans to complete its BLA submission in the second half of 2026 to support a potential U.S. launch of lonvo-z in the first half of 2027.
In the first quarter, Intellia presented several posters at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The presentations included three-year follow-up data from patients receiving a one-time 50 milligram dose of lonvo-z and new survey findings assessing the chronic treatment burden and unmet needs among patients living with HAE.
Additional clinical data from HAELO will be presented at the 2026 European Academy of Allergy and Clinical Immunology Congress (EAACI), taking place June 12-15 in Istanbul, Türkiye (abstract #100217).

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. (Regeneron).

In the first quarter, the FDA lifted the clinical holds from the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z in ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively. Patient screening activities are advancing in both trials.
Intellia plans to complete patient enrollment in MAGNITUDE-2 in the second half of 2026.

Upcoming Events
The company will participate in the following events during the second quarter of 2026:

Bank of America Securities Health Care Conference, May 12, Las Vegas
RBC Capital Markets Global Healthcare Conference, May 20, New York
Jefferies Global Healthcare Conference, June 3, New York
EAACI Congress, June 12-15, Istanbul, Türkiye

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $517.2 million as of March 31, 2026, compared to $605.1 million as of December 31, 2025. Additionally, in April 2026, the company executed an underwritten public offering of its common stock for approximately $207 million in gross proceeds. The company’s existing cash resources are expected to fund its operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. commercial launch for HAE in the first half of 2027. This guidance excludes all potential commercial revenues from lonvo-z.
Collaboration Revenue: Collaboration revenue was $15.0 million for the first quarter of 2026, compared to $16.6 million for the first quarter of 2025.
R&D Expenses: Research and development (R&D) expenses were $80.7 million for the first quarter of 2026, compared to $108.4 million for the first quarter of 2025. The decrease was primarily driven by lower costs for research materials and contracted services, employee-related expenses, and stock-based compensation. Stock-based compensation expense included in R&D expenses was $7.6 million for the first quarter of 2026.
G&A Expenses: General and administrative (G&A) expenses were $34.8 million for the first quarter of 2026, compared to $29.0 million for the first quarter of 2025. The increase was primarily driven by the ongoing buildout of the company’s commercial infrastructure and higher legal expenses, partially offset by lower stock-based compensation. Stock-based compensation expense included in G&A expenses was $5.9 million for the first quarter of 2026.
Net Loss: Net loss was $96.2 million for the first quarter of 2026, compared to $114.3 million for the first quarter of 2025.

(Press release, Intellia, MAY 11, 2026, View Source [SID1234665439])

On May 11, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported the expanded strategic research collaboration with Hokkaido University. This multi-year initiative is designed to produce actionable, high-quality, clinically relevant data that support the development of precision therapies and ultimately improve outcomes for cancer patients in Japan.

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In collaboration with Hokkaido University, BostonGene will conduct next-generation sequencing and perform integrated analysis of DNA, RNA and immune system profiling using its proprietary AI-powered platform to analyze genomic and immune profiles from tumor samples across more than 20 cancer types. These analyses will help identify patient-specific disease drivers, profile underlying immune signatures, and guide optimal therapeutic decision-making.

"BostonGene’s AI-powered platform gives us the advanced analytics needed to turn clinical data into actionable insights," said Dr. Ichiro Kinoshita, Principal Investigator and Professor at the Division of Clinical Cancer Genomics/Department of Medical Oncology at Hokkaido University, and Dr. Yutaka Hatanaka, Associate Professor at the Center for Development of Advanced Diagnostics (C-DAD), Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital. "By contributing our scientific expertise and patient samples, we’re driving a more personalized, effective approach to oncology for Japanese patients.

"This partnership exemplifies how BostonGene’s AI-driven insights translate complex patient data into meaningful advances in drug development and clinical care, while reinforcing our commitment to advancing translational oncology in Japan, where there is significant and urgent clinical need," said Yukimasa Shiotsu, President and Representative Director of BostonGene Japan.

(Press release, BostonGene, MAY 11, 2026, View Source [SID1234665462])

On May 11, 2026 Anaveon, a late-stage preclinical biotechnology company focused on reprogramming the immune system for the treatment of autoimmune and inflammatory diseases, reported that new clinical data from its legacy oncology asset ANV600 (sunekafusp alpha) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Following its strategic pivot to immunology, Anaveon is actively seeking global development and commercialization partners for its oncology portfolio to maximize the potential of these highly differentiated assets.

ANV600 is a first-in-class, non-blocking PD-1-targeted IL-2R-βγ agonist designed to selectively expand tumor-reactive PD-1+ CD8+ effector T cells while reducing the toxicities historically associated with IL-2 therapy. It is compatible with existing checkpoint inhibitors and is positioned for use in CPI-resistant and CPI-relapsed settings.

Key results from the EXPAND-1 Phase 1 study will be highlighted in the poster:

Manageable safety profile as monotherapy and in combination with pembrolizumab
Clear proof-of-mechanism: preferential proliferation of PD-1+ CD8+ T cells over regulatory T cells
Encouraging early clinical activity, including tumor shrinkage in a meaningful proportion of patients (including post-CPI and CPI-naïve), disease control, and durable benefit
Recommended Phase 2 dose established
ASCO Annual Meeting abstracts may be accessed online via View Source

Details of the poster presentations are as follows:

Presentation Details:

Title: EXPAND-1: A phase 1 dose escalation study of the novel PD-1 targeted IL-2R-βγ agonist Sunekafusp alpha (ANV600) as a single agent and in combination with Pembrolizumab in patients with advanced solid tumors

First Author: Markus Joerger

Abstract number: 2587

Session Title: Development Therapeutics-Immunotherapy

Poster board: 377

Location, Date and Time: Hall A, May 30, 2026, 1:30 to 3:00 pm, local time

"ANV600 has delivered compelling clinical proof-of-mechanism and a promising safety-efficacy profile in patients with advanced solid tumors," said Thaminda Ramanayake, Chief Executive Officer of Anaveon. "With strong interest from physicians at clinical sites for Phase 2 development, we believe this asset is ideally suited for a partner with the resources and expertise to bring it forward in CPI-resistant NSCLC and other immuno-oncology indications."

Anaveon’s oncology portfolio also includes ANV700, a preclinical proximity-activated PD-1-targeted IL-21 fusion protein with potential for synergistic effects when combined with IL-2-based approaches.

The company is now prioritizing its core immunology pipeline and is open to various partnering structures (license, co-development, or acquisition) for the oncology assets.

(Press release, Anaveon, MAY 11, 2026, View Source [SID1234665478])

On May 11, 2026 Kyntra Bio (Nasdaq: KYNB) reported financial results for the first quarter 2026 and provided an update on the company’s recent developments.

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"In the first quarter, we continued to make steady progress across our pipeline. We are encouraged by the pace of enrollment in our Phase 2 trial of FG-3246 in patients with mCRPC and are on track for the interim analysis in the fourth quarter of 2026. We remain confident in the potential of FG-3246 to deliver competitive progression free survival results in the Phase 2 monotherapy trial," commented Thane Wettig, Chief Executive Officer of Kyntra Bio. "In addition, following FDA feedback, we are finalizing the protocol for the pivotal Phase 3 trial of roxadustat for the treatment of lower-risk MDS, and anticipate trial initiation in the second half of 2026."

Key Highlights of First Quarter, Recent Developments, and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

•
Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the fourth quarter of 2026
•
Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO (Free ASCO Whitepaper) GU 2026
o
In biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, the combination of FG-3246 and enzalutamide led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, and a median rPFS of 10.1 months in patients who progressed on only one prior ARPI.
o
Higher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection.
o
Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial.
o
Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients.
Roxadustat

•
Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA
•
Company continues to explore the opportunity to develop roxadustat internally or with a strategic partner, with the goal of initiating the Phase 3 trial in the second half of 2026

Financial

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Total revenue from continuing operations for the first quarter of 2026 was $3.7 million, as compared to $2.7 million for the first quarter of 2025.
•
Net loss from continuing operations for the first quarter of 2026 was $15.1 million, or $3.74 net loss per basic and diluted share, compared to a net loss of $16.8 million, or $4.15 net loss per basic and diluted share, one year ago.
•
As of March 31, 2026, Kyntra Bio reported $100.3 million in cash, cash equivalents, investments, and accounts receivable.
•
The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

Conference Call and Webcast Presentation

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website.

About FG-3246 and FG-3180

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracer. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, MAY 11, 2026, View Source [SID1234665440])

On May 11, 2026 AbCellera (Nasdaq: ABCL) reported financial results for the first quarter of 2026 and positive interim results from the Phase 1 portion of its ongoing Phase 1/2 clinical trial of ABCL635. ABCL635 is a potential first-in-class antibody targeting the neurokinin 3 receptor (NK3R) for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We are excited to share interim Phase 1 data that show ABCL635 achieved robust NK3R target engagement at doses that were well-tolerated in healthy volunteers and a pharmacokinetic profile that may support a once monthly dosing regimen. We look forward to the efficacy readout from the Phase 2 data in Q3, which we believe will be highly de-risking for the program," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Through 2026 we are focused on delivering data readouts for our clinical programs, advancing ABCL688 and ABCL386 into IND-enabling studies, and selecting at least one additional development candidate. We continue to maintain our strong cash position, ending the quarter with approximately $655 million dollars in available liquidity to execute on our strategy."

Q1 2026 Business Summary and Program Updates

ABCL635 and ABCL575 continued to progress through clinical trials.
ABCL386 and ABCL688 are progressing through IND-enabling activities.
Generated a net loss of $43.2 million, compared to a net loss of $45.6 million in Q1 2025.
Ended the quarter with approximately $655 million in total available liquidity to execute on our strategy.
Clinical Update: ABCL635 Interim Phase 1 Data

Study Design

The Phase 1 trial of ABCL635 (NCT07118891) is a randomized, double-blind, placebo-controlled study designed to evaluate single and multiple doses of ABCL635 in healthy volunteers. A total of 40 healthy men and postmenopausal women were enrolled in the single ascending dose (SAD) part and treated with single doses ranging from 30 mg to 900 mg. The multiple ascending dose (MAD) part enrolled a total of 16 postmenopausal women who received multiple once monthly doses ranging from 300 mg to 600 mg.

Study Results

The interim Phase 1 data supported advancing ABCL635 into Phase 2. Data from the MAD part remain blinded, with safety follow-up visits ongoing. The unblinded interim data from the SAD part demonstrated the following:

A favorable tolerability profile: ABCL635 was well-tolerated across all doses, with no serious adverse events or elevations in liver enzymes. Treatment-emergent adverse events were generally mild and transient.
A pharmacokinetic profile that supports monthly dosing: ABCL635 exhibited an estimated half-life of ~24 days, supporting the potential for a once monthly subcutaneous dose.
Strong suppression of biomarkers of target engagement: To confirm target engagement of NK3R on kisspeptin, neurokinin B, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus, testosterone, a clinically validated surrogate biomarker of NK3R antagonism, was measured in male volunteers. ABCL635 demonstrated sustained and dose-dependent suppression of testosterone over a four-week period.
Based on these data, AbCellera advanced ABCL635 into a Phase 2 study, as announced earlier this year. The Phase 2 is a multicenter, randomized, double-blind, placebo-controlled trial with approximately 80 postmenopausal women designed to evaluate the efficacy of ABCL635 in reducing the frequency and severity of moderate-to-severe VMS.

Business Metrics

December 31, 2025

March 31, 2026

Partner-led programs with downstreams

44

40

In the clinic

5

5

In discovery or preclinical development

39

35

Molecules in the clinic with downstreams

14

14

Beginning in Q1 2026, AbCellera is reporting new business metrics to focus on programs and molecules with downstream participation which are believed to be progressing. At the end of Q1 2026, partners led 40 programs which AbCellera believes to be progressing and where AbCellera holds a downstream stake (down from 44 on December 31, 2025). In total, AbCellera held downstream stakes in 14 molecules in the clinic understood to be progressing on March 31, 2026.

Discussion of Q1 2026 Financial Results

Revenue – Total revenue was $8.3 million, compared to $4.2 million in Q1 2025.
Research & Development (R&D) Expenses – R&D expenses were $46.7 million, compared to $42.5 million in Q1 2025.
Sales, General, & Administrative (SG&A) Expenses – SG&A expenses were $12.3 million, compared to $19.1 million in Q1 2025.
Net Loss – Net loss of $43.2 million, or $(0.14) per share on a basic and diluted basis, compared to net loss of $45.6 million, or $(0.15) per share on a basic and diluted basis, in Q1 2025.
Liquidity – $531 million of total cash, cash equivalents, and marketable securities and approximately $124 million in available non-dilutive government funding, bringing total available liquidity to approximately $655 million to execute on AbCellera’s strategy.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

About ABCL635

ABCL635 is a potential first-in-class antibody drug for the non-hormonal treatment of moderate-to-severe VMS, commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G protein-coupled receptor (GPCR) expressed on KNDy neurons in the infundibular nucleus of the hypothalamus. ABCL635 is the first program from AbCellera’s GPCR and ion channel platform to advance into the pipeline, entering the clinic in July 2025. Additional details are available at www.abcellera.com/pipeline.

(Press release, AbCellera, MAY 11, 2026, View Source [SID1234665463])