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 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2026, and highlighted recent corporate updates.

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"Despite typical first-quarter seasonality and unusual weather-related disruption early in the quarter, we saw a clear recovery in February and March," said Craig Collard, Chief Executive Officer of Heron. "Our Acute Care franchise continues to perform with strong year-over-year growth, and we remain confident in our full-year framework as deferred elective procedures return and our commercial catalysts such as IGNITE 2.0, unique J-Codes, and planned sales force expansion for the Acute Care franchise continue to build through 2026."

"As environmental conditions normalized, we saw momentum rebuild through February and exited March with improved trends. We maintained disciplined cost management and expect temporary gross margin pressure to normalize as we work through higher-cost CINVANTI inventory over the next two quarters," said Ira Duarte, Executive Vice President and Chief Financial Officer of Heron.

Business Highlights

•
Heron generated total net revenue of $34.7 million in Q1 2026 and ended the first quarter with $44.8 million in cash, cash equivalents and short-term investments. The Company reaffirmed full-year 2026 guidance of net revenue of $173 million to $183 million and Adjusted EBITDA of $10 million to $20 million.

•
Acute Care franchise updates: Net revenue increased 32% year-over-year, including ZYNRELEF net revenue of $10.2 million and APONVIE net revenue of $3.4 million in Q1 2026.

•
Commercial expansion: Heron’s planned sales force expansion remains on track for Q3 2026, with recruitment underway to increase coverage and account depth across the portfolio.

ZYNRELEF:
•
Demand units increased by 22% year-over-year. IGNITE, the commercial alignment program for ZYNRELEF, demonstrated 111% growth in target accounts by year-end 2025. This success resulted in expansion of included target accounts in January 2026 by 40% and extension of the program throughout 2026 with IGNITE 2.0.

•
ZYNRELEF continues to benefit from NOPAIN Act reimbursement and an increasingly predictable payment experience among 110 million covered commercial lives as accounts increasingly apply the permanent product-specific J-code (J0668).

APONVIE:

•
APONVIE demand units increased 68% year-over-year. Accordingly, a key performance metric, Average Daily Units, in Q1 2026 increased 70% over Q1 2025.

•
APONVIE has gained P&T approval in 1,902 accounts totaling 5.8 million medium-to-high PONV risk procedures. Broad adoption of APONVIE continued, with ordering accounts increasing 67% year-over-year.

•
APONVIE’s permanent product-specific J-code (J8502) became active April 1, 2026, which further streamlines billing and supports broader access as utilization expands.

•
Fifth Consensus Guidelines for the Management of PONV included APONVIE as the only FDA-approved intravenous NK-1 antagonist for prevention of PONV in adults and elevated the role of NK-1 antagonists in multimodal prophylaxis strategies.

•
Oncology Supportive Care franchise updates: Net revenue was $21.1 million in Q1 2026, including CINVANTI net revenue of $20.5 million and SUSTOL net revenue of $0.6 million reflecting the previously communicated wind-down of SUSTOL by the end of 2026.

CINVANTI:

•
CINVANTI maintained 25% market share in the NK1 CINV category in Q1 2026, equivalent to the average of 25% for the past 12 months.

•
The REIGNITE program, with a goal of returning CINVANTI to steady growth, secured formulary wins and the near-term pipeline represents an increase of approximately $10 million net revenue on an annual basis in potential new opportunity.

•
Heron reached a settlement agreement with Baxter Healthcare Corporation in CINVANTI patent litigation, and the U.S. District Court for the District of Delaware dismissed the pending litigation between the parties on April 28, 2026.

•
Active promotion of CINVANTI as part of Heron’s planned expansion of its sale force for Q3 2026.

•
CINVANTI surpassed 5 million demand units sold since launch

•
Development update: The ZYNRELEF prefilled syringe (PFS) lifecycle program

•
This late-stage program to improve Operating Room efficiency with a Ready-to-Use product remains funded and on track. As previously announced, registration batches have been manufactured and placed on stability, and the Company will receive 12-month stability data in the first quarter of 2027. Heron is continuing CMC and device-related readiness activities to support the filing.

Financial Guidance for 2026

Item

2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA

(in millions)

Net Revenue

$173 to $183 million

Adjusted EBITDA

$10 to $20 million

Cash, cash equivalents, and short-term investments were $44.8 million as of March 31, 2026.

Net Revenue Performance – Three Months Ended March 31

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 13,629

$ 10,302

$ 3,327

32.3%

APONVIE

$ 3,394

$ 2,260

$ 1,134

50.2%

ZYNRELEF

$ 10,235

$ 8,042

$ 2,193

27.3%

Oncology

$ 21,082

$ 28,601

($ 7,519)

(26.3%)

CINVANTI

$ 20,535

$ 25,742

($ 5,207)

(20.2%)

SUSTOL

$ 547

$ 2,859

($ 2,312)

(80.9%)

Total Net Revenue

$ 34,711

$ 38,903

($ 4,192)

(10.8%)

Conference Call and Webcast

Heron will host a conference call and live webcast on Monday, May 11, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

(Press release, Heron Therapeutics, MAY 11, 2026, View Source [SID1234665438])

On May 11, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the first quarter ended March 31, 2026, and provided an update on its recent corporate activities.

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"I am pleased to announce our new $1 billion share repurchase program and that we project to repurchase at least $400 million in 2026, which is a reflection of our strong cash generation and confidence in the long-term value and durability of our business. We started 2026 with exceptional momentum, highlighted by three new recent collaboration and licensing agreements with Vertex, Oruka and GSK, demonstrating the strong interest in Hypercon and ENHANZE and showcasing the real potential to exceed our goal of three new SC delivery platform deals this year. The two Hypercon multi-target agreements confirm the strong interest of biopharma companies to reduce injection volume through hyperconcentration and allow more flexible administration in the home. Our new multi-target agreement with GSK represents a significant opportunity for ENHANZE with multiple promising oncology targets, including its first potential application with antibody drug conjugates. This momentum creates durable new royalty opportunity beginning in the 2030s and extending to at least the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme.

"The growing number of indications for our approved products and new Phase 3 data milestones represent increased opportunity for ENHANZE. Most recently, VYVGART Hytrulo was FDA-approved for all serotypes of generalized myasthenia gravis (gMG), representing a significant expansion of addressable patients. The VYVGART Hytrulo opportunity is further extended with positive Phase 3 data in ocular myasthenia gravis, increasing the MG addressable market by an additional 7,000 patients in the U.S. alone. Additionally, DARZALEX Faspro gained its 12th and 13th approved indications and expanded further in newly diagnosed and early second line multiple myeloma patients, the two largest, longer-duration of treatment patient populations. Takeda also announced positive Phase 2/3 data for its 20% immunoglobulin TAK-881 in patients with primary immune deficiency, creating the potential for the 11th ENHANZE product launch."

"Our opportunity with ENHANZE was further enhanced in the quarter by two new Phase 1 study starts, increasing the number of ENHANZE products in development to nine, well on our way to the expected 13 ENHANZE products in development by year-end 2026. We project these ENHANZE products have the potential for approvals beginning in 2029+, creating a new wave of royalty revenue. The five signed Hypercon agreements, which include the opportunity for 17 targets to be developed, with first approvals projected in the 2030/2031 time period represents a third exciting wave of new royalty revenue opportunity. This continued performance and progress resulted in strong first quarter financial results and we are pleased to reaffirm our 2026 outlook, including expectations for ENHANZE royalty revenue to exceed $1 billion for the full year," Dr. Torley concluded.

Recent Corporate Highlights:
•In May 2026, the Company announced a new share repurchase program to repurchase up to $1 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026.

Recent Partner Highlights:
•In May 2026, argenx announced U.S. Food and Drug Administration ("FDA") approval of a supplemental Biologics License Application ("sBLA") for VYVGART Hytrulo with ENHANZE for the treatment of adult patients with generalized myasthenia gravis ("gMG") including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
•In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE with multiple oncology targets, including the first potential application in antibody-drug conjugates ("ADCs"). Under the terms of the agreement, GSK will make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme’s Hypercon technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka will make an upfront payment and potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon technology.
•In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE in Primary Immunodeficiency Disease.
•In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Hypercon technology for use in up to three targets. Under the terms of the agreement, Vertex will make a $15 million upfront payment and potential future milestone payments and royalties on net sales of products developed using the Hypercon technology.

First Quarter Partner Highlights:
•In March 2026, Pfizer nominated a new undisclosed non-exclusive target to be studied with ENHANZE.
•In March 2026, Janssen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted approval for self or caregiver administration of DARZALEX (daratumumab) SC formulation for patients living with multiple myeloma from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training, making it the first oncology injectable approved for self-administration in Europe.
•In March 2026, Janssen announced the FDA approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
•In February 2026, argenx announced positive topline results from the Phase 3 ADAPT oculus trial of VYVGART with ENHANZE in ocular myasthenia gravis.
•In January 2026, argenx initiated a Phase 1 study to evaluate ARGX-124 with ENHANZE.
•In January 2026, Janssen announced the FDA approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

First Quarter 2026 Financial Highlights:
•Total revenue was $376.7 million, compared to $264.9 million in the first quarter of 2025. The 42% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $240.7 million in royalties, an increase of 43% compared to $168.2 million in the first quarter of 2025, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly DARZALEX SC by Janssen, VYVGART Hytrulo by argenx and Phesgo by Roche in all geographies and contributions from other recently launched products.
•Cost of sales was $79.2 million, compared to $48.4 million in the first quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the first quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $25.6 million, compared to $14.8 million in the first quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025.
•Selling, general and administrative expense was $57.9 million, compared to $42.4 million in the first quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense.
•Operating income was $184.5 million, compared to $141.5 million in the first quarter of 2025.
•Net income was $150.0 million, compared to $118.1 million in the first quarter of 2025.
•EBITDA was $218.3 million, compared to $162.0 million in the first quarter of 2025. Adjusted EBITDA was $229.5 million, compared to $162.0 million in the first quarter of 2025.1
•GAAP diluted earnings per share was $1.22, compared to $0.93 in the first quarter of 2025. Non-GAAP diluted earnings per share was $1.60, compared to $1.11 in the first quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $320.9 million on March 31, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations.

Financial Outlook for 2026
The Company is reiterating its 2026 financial guidance ranges, which were last provided on February 17, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.

•Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025.
•Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon and Surf Bio investment of approximately $60 million.
•Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company’s earnings per share guidance includes new Hypercon and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases.

Table 1. 2026 Financial Guidance
Guidance Range
Total Revenue $1.710 to $1.810 billion
Royalty Revenue $1.130 to $1.170 billion
Adjusted EBITDA1
$1.125 to $1.205 billion
Non-GAAP Diluted EPS1
$7.75 to $8.25

1 EBITDA, Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. Reconciliations between GAAP reported and Non-GAAP financial information for actual results are provided at the end of this earnings release.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2026 today, Monday, May 11, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

(Press release, Halozyme, MAY 11, 2026, View Source [SID1234665437])

On May 11, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered into an exclusive strategic collaboration with Sino Biopharmaceutical, (SBP Group), through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), to accelerate bepirovirsen in mainland China at launch. Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B (CHB) under priority regulatory review in China. CTTQ is a market leader in hepatitis B in China with one of the country’s most comprehensive liver disease portfolios and a broad commercial footprint covering more than 5,000 medical centres across care settings. CTTQ has played a significant role in advancing the diagnosis and treatment of hepatitis B in China.

The collaboration combines GSK innovation with CTTQ’s local scale and in-market execution to reach more patients, more quickly. Under the agreement, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy. The agreement also grants GSK the ability to review certain early-stage pipeline assets of the SBP Group to evaluate the potential for collaboration opportunities outside China.

Mike Crichton, President International, GSK, said: "Chronic hepatitis B affects 75 million people in China1 and is a leading cause of liver cancer in the country.2 By combining GSK’s innovation with CTTQ’s extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China’s most pressing healthcare priorities."

Chronic hepatitis B is a national health priority in China. The latest National Action Plan for the Prevention and Treatment of Viral Hepatitis (2025-2030) has set out functional cure as a treatment goal for Hepatitis B. Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen (HBsAg) – are undetectable in the blood for at least 6 months after stopping all treatment. Functional cure is associated with a meaningful reduction in the risk of long-term complications, including liver cancer.3

Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 phase III trials, which demonstrated statistically significant and clinically meaningful functional cure rates.

Collaboration terms
Under the terms of the agreement, CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years. The term may be extended thereafter by mutual agreement. GSK will book sales of bepirovirsen supplied to CTTQ through the collaboration.

GSK also has the ability to review certain early-stage pipeline assets of the SBP Group to evaluate potential collaboration opportunities outside China.

About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic Hepatitis B (CHB) occurs when the immune system is unable to clear the virus, resulting in long-lasting infection. CHB affects more than 250 million people worldwide. Each year, the disease causes approximately 1.1 million deaths.1 Many patients often require lifelong antiviral therapy for viral suppression; making functional cure a critical goal in disease management.

CHB remains a significant public health challenge in China, affecting an estimated 75 million people and causing approximately 450,000 deaths annually.1 84.4% of patients with liver cancer in China are associated with CHB infection.2 Functional cures are associated with a significant reduction in the risk of long-term liver complications, including liver cancer.3

About bepirovirsen
Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), designed to inhibit the replication of viral DNA in the body, suppress the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulate the immune system to increase the chances of a durable and sustained response.

GSK licensed bepirovirsen from Ionis and collaborated with them on its development. Bepirovirsen has been recognised by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Priority Review, Fast Track and Breakthrough Designations from the US FDA, Priority Review and Breakthrough Therapy designation in China and SENKU designation in Japan.

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(Press release, GlaxoSmithKline, MAY 11, 2026, View Source [SID1234665436])

On May 11, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, reported data this week featuring its off-the-shelf CAR T-cell programs FT819, FT839, and FT836 at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting to be held in Boston, MA, May 11–15, 2026.

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"We are excited to highlight our leadership in delivering off-the-shelf CAR T cells with less-intensive or no conditioning chemotherapy to ensure broad patient accessibility," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "With FT819, we are demonstrating that it is feasible to drive CAR T-cell efficacy with less-intensive or no conditioning chemotherapy in SLE and believe that eliminating the need for intensive conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cellular therapies. With our next generation CAR T-cell programs, FT836 and FT839, we are illustrating that through precise multiplexed-engineering of iPSCs to generate clonal master banks that serve as the starting point for large scale manufacture of uniform and consistent drug product, it is feasible to tackle complex multicellular diseases, support functional persistence without the need for intensive conditioning chemotherapy, and create synergy with standard-of-care therapies to deliver effective treatments for patients with unmet need."

Presentation Summaries Include:

Title: FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy; Poster Presentation Date / Time: Tuesday, May 12, 5:00 PM – 6:30 PM ET

FT819 is the Company’s off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell program, which is currently being investigated in a Phase 1 study for patients with moderate-to-severe systemic lupus erythematosus (SLE) including lupus nephritis and extrarenal lupus (NCT06308978). Data presented this week shows that in Regimen B of the Phase 1 study with a data cutoff of April 9, 2026, a single dose of FT819 without conditioning chemotherapy and in the presence of background therapy demonstrated meaningful clinical responses at dose level 1 in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS). The positive clinical outcomes were supported mechanistically by the observation that B cells in the periphery as well as in secondary lymphoid tissue (nasopharyngeal swabs) were significantly depleted. Notably, depletion (79% on average) of major B cell clones (as defined by B cell receptor sequencing) were observed, with the depletion lasting up to 12 months following treatment. Collectively, preliminary data demonstrate that treatment with FT819 without conditioning chemotherapy and in the presence of background therapy can drive comprehensive changes in B cell repertoire that are associated with clinical benefit, alongside a favorable safety profile. Patient treatment at the higher dose of 900 million cells (dose level 2) has been initiated.

Title: FT839: A Multi-Antigen Targeting Off-the-Shelf dual-CAR T cell for the Treatment of Pathogenic B and T Cells in Autoimmune Diseases; Oral Presentation Date / Time: Thursday, May 14, 8:30 AM – 8:45 AM ET

FT839 is a next generation, off-the-shelf dual CAR T-cell therapy targeting CD19 and CD38 to deplete multiple pathogenic immune cell populations that drive hematological and complex autoimmune diseases, including rheumatoid arthritis (RA), type I diabetes, and multiple sclerosis. Preclinical data to be presented show broad, selective depletion of pathogenic immune cell subtypes in RA and SLE disease samples, including over 99% of B cells, plasmablasts, and plasma cells and more than 90% of activated CD4+ and CD8+ T cells, while sparing non-activated T cells, which comprise most of the endogenous T-cell population. The presentation will also demonstrate that targeting capabilities of FT839 are further enhanced through synergistic pairing with standard-of-care (SOC) therapeutic monoclonal antibodies (mAb; e.g. rituximab) or clinically approved T-cell engagers (e.g. epcoritamab), to activate either the engineered Fc receptor, hnCD16, or the novel CD3 Fusion receptor, respectively, improving cytolytic activity by ~3.5-6x on CAR antigen negative targets. With Sword and ShieldTM technology, FT839 persistence is enhanced ~60x compared to CAR T cells lacking Sword and ShieldTM engineering in HLA-mismatched allogeneic settings, while the generation and expansion of product-specific immune cell responses are severely blunted (~1/900), thereby reducing the need for intensive conditioning chemotherapy. Importantly, non-product specific T cells were spared. FT839 is produced through a scalable and reproducible process that enables on-demand availability of a homogenous CAR T-cell therapy, overcoming key accessibility and safety limitations of autologous CAR T-cell therapies, selectively depleting disease-driving B lineage and activated T cells for the treatment of patients with complex autoimmune and hematological diseases.

Title: CAR T cells Targeting pan-Tumor Antigens MICA/B can be Uniquely Combined with SOC Treatments without Conditioning Chemotherapy for Broad and Effective Therapeutic Application in Cancer; Poster Presentation Date / Time: Wednesday, May 13, 5:00 PM – 6:30 PM ET

FT836 is a next generation, off-the-shelf CAR T-cell therapy that targets the novel and inducible pan-tumor antigens MICA/B. FT836 is engineered to enable rational combination with SOC therapeutics such as mAbs, chemotherapy, radiotherapy, and immune modulators across both hematological malignancies and solid tumor settings. Integrated engineered elements, including Sword and Shield technology, support broader and more universal application without the requirements for conditioning chemotherapy. Preclinical data to be presented demonstrate potent and durable control of multiple solid and liquid xenograft tumor models of varying origin and antigen expression by FT836 activity as a monotherapy or in combination with mAbs, such as trastuzumab, cetuximab, or daratumumab (up to 100% tumor control), underscoring its broad and universal therapeutic potential in cancer. FT836 also features Sword and Shield technology, enabling improved persistence (~20-30x) and selective containment of product-specific immune cell responses (~5x product specific and ~1x nonspecific), thereby enabling clinical strategies that are not reliant on conditioning chemotherapy. FT836 is shown to be rationally combined with established SOC therapeutics, including chemotherapy or radiotherapy, that complement its unique mechanisms of action and engineering profile to specifically upregulate both MICA/B (~2-3x) and the CXCR2 ligand CXCL8 (3-4X) expression, enhancing both the cytolytic activity (~5x) and specific trafficking (~2-3x) of FT836. In addition, FT836 is compatible with multiple myeloma standard of care therapeutics such as Bortezomib and Lenalidomide which further enhances the cytolytic activity of FT836 (1.25x + lenalidomide). Collectively, these data demonstrate the broad utility of FT836 and its ability to rationally combine with SOC therapeutic agents without the need for conditioning chemotherapy, supporting expanded patient access across both hematological and solid tumor indications. FT836 is currently being evaluated clinically in advanced solid tumor patients in combination with the trastuzumab and cetuximab (NCT07216105) and in relapsed and/or refractory multiple myeloma in combination with daratumumab (NCT07221032).

(Press release, Fate Therapeutics, MAY 11, 2026, View Source [SID1234665434])