On August 7, 2025 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported operational highlights and financial results for the second quarter ended June 30, 2025 (Press release, Intellia, AUG 7, 2025, View Source [SID1234654984]).

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"We are exceeding many of our internal expectations," said Intellia President and Chief Executive Officer John Leonard, M.D. "The enthusiasm from both patients and physicians for Intellia’s late-stage programs has resulted in strong enrollment numbers that allow us to plan to enhance the Phase 3 MAGNITUDE trial in ATTR-CM and accelerate completion of the Phase 3 HAELO study in HAE ahead of our original plans. We are full steam ahead in achieving our mission of getting one-time therapies to more patients."

Second Quarter 2025 and Recent Operational Highlights

Hereditary Angioedema (HAE)

Lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002): Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapy designed to knock out the KLKB1 gene in the liver, with the goal of lifelong control of HAE attacks after a single dose.
Recruitment ended earlier than expected during the second quarter and the Company now expects to complete randomization in the global Phase 3 HAELO study during the third quarter 2025.
Intellia presented three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study after receiving a single dose of lonvo-z. Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 on June 15 in Glasgow, United Kingdom. In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12, 2025 data cutoff, all 10 patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Across all three dose levels, lonvo-z was generally well tolerated and showed a safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to three years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing.
Intellia expects to present additional data from the ongoing Phase 1/2 study in the second half of 2025.
The Company is on track to submit a Biologics License Application (BLA) in the second half of 2026.

Transthyretin (ATTR) Amyloidosis

Nexiguran ziclumeran (nex-z, also known as NTLA-2001): Nex-z is an investigational in vivo CRISPR-based therapy designed to inactivate the TTR gene in liver cells, thereby preventing the production of transthyretin (TTR) protein for the treatment of ATTR amyloidosis. Nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose. Intellia leads development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.
ATTR Amyloidosis with Cardiomyopathy (ATTR-CM):
Enrollment in the global Phase 3 MAGNITUDE trial is progressing ahead of the Company’s projections and the Company is tracking to enroll at least 650 patients cumulatively by year-end. Intellia is amending the MAGNITUDE study to expand enrollment to approximately 1,200 patients from 765 patients, subject to health authority review. Expanding the patient number in the study would provide a more robust dataset, particularly in the stabilizer stratum, which we believe will be very important to patients, clinicians, and payers. This change has no expected impact on previously projected enrollment timelines or the Company’s projected cash runway.
In May 2025, the Company presented Phase 1 wild-type vs. variant ATTR-CM data at the Heart Failure 2025 Meeting in Belgrade, Serbia. The data showed that nex-z reduced TTR production and showed promise for treating both wild-type (ATTRwt) and variant (ATTRv) ATTR-CM with a favorable safety profile. Absolute TTR levels dropped from 222.4 to 16.5 μg/mL (ATTRwt) and 132.0 to 16.6 μg/mL (ATTRv). Functional capacity and clinical biomarkers were favorably impacted in both patient groups. Evidence of stability or improvement in disease progression markers were observed across both populations at similar rates. The most commonly reported treatment-related adverse events were IRR, which were mild or moderate, and did not result in any discontinuations. Observed liver enzyme abnormalities were not considered serious, were asymptomatic and resolved spontaneously without medical intervention or sequelae.
Intellia expects to present longer-term data from ATTR-CM patients in the Phase 1 study in the second half of 2025. The data will include updated measures of clinical efficacy and safety.
Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN):
Enrollment is ahead of schedule in the global Phase 3 MAGNITUDE-2 study. Intellia now expects enrollment to be completed in the first half of 2026.
In May 2025, the Company presented positive two-year follow-up Phase 1 data in an oral presentation at the 2025 Peripheral Nerve Society (PNS) Annual Meeting in Edinburgh, United Kingdom. Across patients who received a one-time dose of 0.3 mg/kg or higher (n=33), the mean serum TTR reduction by Day 28 was 90% (corresponding mean absolute serum TTR level of 23.8 µg/mL), with levels remaining virtually unchanged through at least 24 months. Among the 18 patients with 24 month mNIS+7 endpoint assessments, 13 showed improvements of ≥ 4 points, which is considered to be a clinically meaningful threshold. Most of the patients in the cohort who had progressed on patisiran improved, and only a single patient among the 18 had a deterioration of ≥ 4. Nex-z was generally well tolerated across all patients and at all dose levels tested. Treatment-related adverse events were consistent with those described for the cardiomyopathy population.
In September 2025, the Company will present interim Phase 1 extended data in a symposium at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors in Baveno, Italy.

Platform and Company Updates

Intellia is pioneering novel CRISPR-based gene editing technologies, such as gene writing and extrahepatic lipid nanoparticle (LNP) delivery technologies, to create highly differentiated in vivo and ex vivo product candidates. The Company’s proprietary platform technologies are being researched and developed to expand therapeutics opportunities to support the mission of transforming lives of people with severe diseases, including the possibility of curative genome editing therapeutics.
Intellia has expanded its commercial and medical affairs teams to build a strong foundation for commercial readiness. Since the beginning of the year, the company welcomed two key leaders: Jim McNinch, Vice President, U.S. Head of Sales and Ben Newman, Vice President, Commercial Operations, as well as several additional senior leaders with responsibilities for commercial data and field operations, marketing, pricing, patient services, market access, forecasting and medical communications. The company has largely completed the buildout of the commercial and medical affairs leadership teams.

Upcoming Events

The Company will participate in the following events during the third quarter of 2025:

Citi 2025 Biopharma Back to School Conference, Sept. 3, Boston
Wells Fargo Health Care Conference, Sept. 4, Boston
Bernstein Healthcare Forum, Sept. 23, New York
5th International ATTR Amyloidosis Meeting for Patients and Doctors, Sept. 25-26, Baveno, Italy

Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $630.5 million as of June 30, 2025, compared to $861.7 million as of December 31, 2024. The decrease in cash, cash equivalents and marketable securities includes approximately $65.0 million of non-recurring cash payments in the first half of 2025 associated with the Company’s previously announced portfolio prioritization, workforce reduction, and real estate consolidation. The Company’s cash, cash equivalents and marketable securities as of June 30, 2025 are expected to fund operations into the first half of 2027 and into the anticipated first commercial launch.
Collaboration Revenue: Collaboration revenue was $14.2 million during the second quarter of 2025, compared to $6.9 million during the second quarter of 2024. The $7.3 million increase was mainly driven by cost reimbursements related to our collaboration with Regeneron Pharmaceuticals, Inc.
R&D Expenses: Research and development (R&D) expenses were $97.0 million during the second quarter of 2025, compared to $114.2 million during the second quarter of 2024. The $17.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services offset by an increase in the advancement of our lead programs. Stock-based compensation expense included in R&D expenses was $14.1 million for the second quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $27.2 million during the second quarter of 2025, compared to $31.8 million during the second quarter of 2024. The $4.6 million decrease was primarily related to lower stock-based compensation, offset in part by increased expenses related to the ongoing buildout of our commercial infrastructure. Stock-based compensation expense included in G&A expenses was $8.0 million for the second quarter of 2025.
Net Loss: Net loss was $101.3 million for the second quarter of 2025, compared to $147.0 million during the second quarter of 2024.

Conference Call to Discuss Second Quarter 2025 Results

The Company will discuss these results on a conference call today, Thursday, August 7 at 8 a.m. ET.
To join the call:

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.
Please visit this link for a simultaneous live webcast of the call.

A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on August 7 at 12 p.m. ET.

On August 7, 2025 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2025 and provides a business update (Press release, INmune Bio, AUG 7, 2025, View Source [SID1234654983]).

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Q2 2025 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● Released top-line data from the MINDFuL phase 2 trial in 208 patients with MCI and early Alzheimer’s.

● The trial missed its primary cognitive endpoints in the 200 modified mITT patients enrolled, however;

● XPro demonstrated a positive impact on the primary cognitive endpoint EMACC in a pre-defined subset of 100 patients (50%) with two or more biomarkers of inflammation, defined as the enriched population.

● Additional data from the MINDFuL trial was presented by a Key Opinion Leader, Dr. Sharon Cohen of the Toronto Memory Program, at the Alzheimer’s Association International Conference (AAIC) on July 29th. This data is summarized in the forest plot below.

Figure Legend: With the enriched population underpowered for detecting statistically significant changes, the Company and third-party statisticians relied on Cohen’s d effect sizes to evaluate the meaningfulness of observed changes. These effect sizes, though small, consistently favored XPro over placebo on the primary endpoint and multiple secondary and exploratory endpoints (see figure). Across most endpoints, XPro showed favorable trends, with effect sizes approaching the 0.2 threshold for clinical relevance.

The clinical endpoints shown in the forest plot include:

● EMACC (Early Mild Alzheimer’s Cognitive Composite)-Performance-based measure of Cognition: empirically derived composite of neuropsychological tests that are widely used in clinics.

● ISRL (International Shopping List Test, delayed recall) – Performance-based measure of Memory. Delayed recall component of widely used word-list learning test.

● CDR-SB (Clinical Dementia Rating Scale – Sum of Boxes) – Clinician-rated measure that combines Cognition and Function: interview with study partner and patient as well as some performance-based items completed by patient.

● NPI (Neuropsychiatric Interview) – Caregiver-reported measure of the patient’s psychiatric symptoms.

● ECog (Everyday Cognition) – Caregiver reported questionnaire: caregiver rates the patient’s change in cognition (skills now as compared to 10 years ago – prior to cognitive decline)

● GAS (Goal Attainment Scale) Personalized Patient and caregiver-rated scale where the specific goals and items are chosen by patient and caregiver and they rate change on the goals over the course of the study.

● Presented a poster at the Keystone Symposia that showed that XPro significantly reduces amyloid formation and improves clinical measures of brain function in patients with TBI (tTaumatic Brain Injury).

CORDStrom Platform:

● Received a favorable written opinion from The United States Patent and Trademark Office (USPTO), acting as the International Search Authority, on all claims in INmune Bio’s international patent application PCT/US25/17028, titled "THERAPEUTIC COMPOSITIONS COMPRISING POOLED, CULTURE-EXPANDED HUMAN UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS."

● Partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for CORDStrom and the Company’s other cell therapy platforms. This is an essential part of our ambitious timeline to transfer the manufacturing site, validate the large-scale manufacturing process and all of the analytical assays in time for MAA and BLA submissions next year. Much of this work continues to provide data to strengthen our existing IP position portfolio.

● The complete database of clinical data from the randomized, double-blind trial of CORDStrom in Recessive Dystrophic Epidermolysis Bullosa (RDEB) has now been delivered from the trial sponsor to an independent statistical analysis company which is applying a statistical analysis plan devised by INmuneBio. We believe this will enrich the data presented by the Sponsor previously and we anticipate the data being available in Q4.

INKmune Platform:

● Following success in meeting the primary endpoint at completion of the phase I aspect of the CARE-PC trial we opened the phase II in Q1 this year and quickly enrolled the first three patients. Early analysis of blood samples for the biomarkers of interest demonstrated that both secondary endpoints of NK activation and NK cell proliferation in vivo had been met.

● Determined that patients with low NK cell function responded better to treatment, with substantial increases in NK cell potency. This allows us to screen patients in future trials to direct treatment only to those with the ability to respond, in the same way that patients have been screened for suitability for treatment with checkpoint inhibitor drugs.

● We await receipt of results of PSMA-PET scans for most of the trial subjects, although initial results from the phase I patients showed reduction or control of individual lesions in a background of worsening disease.

● Having reviewed the current data, we concluded that the CARE-PC trial has provided all the data needed to design a future randomized trial and we have closed the trial to further recruitment to ensure completion of follow-up by end of Q4 of 2025 as planned.

Corporate:

● Dr. RJ Tesi retires as CEO.

● David Moss appointed President & CEO and to the Board of Directors.

● Cory Ellspermann appointed as Interim CFO.

● Kelly Ganjei appointed as Chairman of the Board.

● Closed a $19 million registered direct offering.

Upcoming Events and Milestones:

● End of phase 2 meeting regarding the MINDFuL trial with the FDA expected to take place in the fourth quarter.

● The Company will file a publication on the MINDFuL trial results expected to be available this month.

● The Company remains on track to file a Marketing Authorization Application (MAA) in the UK and Biologic License Application (BLA) for CORDStrom in RDEB by mid-2026.

● We have ambitious plans to develop a pipeline of additional indications for CORDStrom which we will pursue with non-dilutive funding or partnerships.

● Additional data from Greater Orman Street Hospital on RDEB patients treated with CORDStrom expected in the fourth quarter.

● More patient data from the INKmune ongoing phase 2 trial in metastatic castration-resistant prostate cancer will be released as it becomes available.

Financial Results for the Second Quarter Ended June 30, 2025:

● Net loss attributable to common stockholders for the quarter ended June 30, 2025 was approximately $24.5 million, compared to approximately $9.7 million during the quarter ended June 30, 2024.

● Research and development expenses totaled approximately $5.9 million for the quarter ended June 30, 2025, compared to approximately $7.1 million during the quarter ended June 30, 2024.

● General and administrative expenses were approximately $2.3 million for the quarter ended June 30, 2025, compared to approximately $2.8 million during the quarter ended June 30, 2024.

● Impairment of acquired in-process research and development intangible assets was $16.5 million during the quarter ended June 30, 2025 compared to none recorded during the quarter ended June 30, 2024.

● Other income, net was approximately $0.1 million for the quarter ended June 30, 2025, compared to approximately $0.1 million during the quarter ended June 30, 2024.

● As of June 30, 2025, the Company had cash and cash equivalents of approximately $33.4 million.

● As of August 7, 2025, the Company had approximately 26.6 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching the operator.

Date: August 7th, 2025

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-225-9448 Participant Dial-in (international): +1-203-518-9783

Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link:

View Source;tp_key=2300519883

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 21, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11159128.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics. The CORDStrom product platform shares many similarities, including reagents, equipment, and procedures, with the Company’s INKmune oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign with resource and environmental efficiencies.

Initially developed at the INKmune manufacturing facilities utilizing UK academic grant funding, CORDStrom is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.

On August 7, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported financial results and business highlights for the second quarter ended June 30, 2025 (Press release, In8bio, AUG 7, 2025, View Source [SID1234654982]).

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Key Highlights:

Durable Four-Year PFS Milestone in Glioblastoma:

A patient in IN8bio’s INB-200 clinical trial has now surpassed four years without progression, a significant clinical milestone in front-line, grade IV glioblastoma (GBM), demonstrating the potential for extended overall survival and the durability of IN8bio’s therapy.
Positive Clinical Data Presented at ASCO (Free ASCO Whitepaper) 2025:

IN8bio presented positive new data showing that GBM patients receiving multiple doses of INB-200 achieved mPFS of 16.1 months as of May 31, 2025, more than double the 6.9 months typically observed with the standard-of-care Stupp protocol.
40% of patients receiving multiple doses remain progression-free for over 18 months with no significant toxicities observed as of May 31, 2025.
Award for Innovative Cell Therapy Manufacturing:

The Company was recognized with the Host Region USA East Abstract Award at the ISCT 2025 Annual Meeting for its DeltEx platform. IN8bio showcased its robust manufacturing processes and scalable technology platform, essential for advancing cell therapy treatments with consistency and operational efficiency.
New Preclinical Data in Autoimmune Diseases:

IN8bio presented exciting new preclinical results at ASGCT (Free ASGCT Whitepaper) 2025 for its innovative gamma-delta T cell engager (INB-619). INB-619 demonstrated complete, targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, representing a potentially safer immunotherapy alternative with the ability to drive deeper B cell depletion.
William Ho, CEO and co-founder, IN8bio, commented, "We believe this quarter clearly demonstrates our ability to deliver transformative outcomes in cancer and autoimmune disease. We had an oral presentation at ASCO (Free ASCO Whitepaper), reached a remarkable four-year PFS milestone in a grade IV glioblastoma patient, demonstrated the potential of our T cell engager platform to treat autoimmune diseases, and highlighted our robust cell therapy manufacturing capabilities. We’re proud of these continued accomplishments, which demonstrate our ability to be a leader in gamma-delta T cell therapies and highlight our potential to help transform the treatment of cancer and autoimmune disease. We’ve also extended our runway into June 2026."

Upcoming Anticipated Pipeline Milestones and Events

Update on enrollment in INB-100 expansion cohort in leukemia patients
Glioblastoma clinical update from INB-200 and INB-400 clinical trials
Additional preclinical data from INB-619 T cell engager program for cancer and autoimmune diseases in 4Q25
Second Quarter 2025 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2025, compared with $5.2 million in the prior year. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program and reduced personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024.
General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended June 30, 2025, compared with $3.5 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $0.7 million. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services.
Net loss: The company reported a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the three months ended June 30, 2025, compared with a net loss of $8.6 million, or $5.51 per basic and diluted common share, for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $1.2 million, along with one-time charges related to the Company’s pipeline prioritization announcement in September 2024.
Cash position: As of June 30, 2025, the Company had cash of $13.2 million, compared with $10.2 million for the comparable prior year.

On August 7, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Immunocore, AUG 7, 2025, View Source [SID1234654980]).

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"We are delighted to announce robust revenue for the first half of 2025, a 32% year-over-year increase. This is testament to our steadfast dedication to expanding access to KIMMTRAK in the US and across the globe," said Bahija Jallal, Chief Executive Officer of Immunocore. "Our Phase 3 TEBE-AM trial remains on schedule to complete enrollment in the first half of 2026, and we are making good progress with our other two Phase 3 trials: PRISM-MEL-301 and ATOM. We are also advancing our Phase 1/2 trials in oncology and infectious diseases and preparing for the clinical trial applications for our autoimmune candidates, further underscoring the depth and diversity of our platform."

Second Quarter 2025 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 28 countries globally to date for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

KIMMTRAK net product sales were $98.0 million and $191.8 million for the three and six months ended June 30, 2025, respectively, representing increases of 30% and 32% respectively, as compared to the same periods in 2024.
15% year-over-year quarterly growth in the United States, with demand continuing to grow, duration of treatment extending, and the majority of patients treated in the community setting (70%).
71% year-over-year quarterly growth in Europe and in international regions combined, driven by increased demand, new country launches, and completion of price negotiations in France and Germany.
The Company signed a distribution and commercialization agreement with Er-Kim Pharmaceuticals for KIMMTRAK, for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, in Turkey, the Middle East, North Africa, Caucasus and the Commonwealth of Independent States regions.
2L+ advanced cutaneous melanoma

The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.

PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company has now activated over 150 clinical trial sites around the world, enrolling patients in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.
The trial is currently randomizing to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm.
In a pre-planned analysis, the Independent Data Monitoring Committee (IDMC) reviewed the safety of the first 30 patients randomized and recommended to continue the study with no changes. The trial is on track for selection of the go-forward brenetafusp dose in the second half of 2025; this analysis will be conducted by an IDMC.
Despite approved therapies, there remains a need for improved progression-free survival and overall survival, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and Europe.
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
The Company estimates that, across all solid tumors, the annual number of eligible patients worldwide who test positive for HLA-A*02:01 is up to 150,000.
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.

ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company will report data from the single ascending dose portion of the trial at the 2025 American Association for the Study of Liver Diseases’ Meeting in November 2025.

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a clinical trial application (CTA) or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.

Corporate update
On August 5, 2025, Rob Perez resigned as director of the Company, effective September 16, 2025. The Company expresses its appreciation to Mr. Perez for his dedication and service to Immunocore for the last 6 years.

Financial Results
For the second quarter ended June 30, 2025, the Company generated net product sales of $98.0 million compared to $75.3 million for the same period in 2024. Sales of KIMMTRAK were $64.1 million in the United States, $33.0 million in Europe, and $0.8 million in the international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.

For the quarter ended June 30, 2025, research and development (R&D) expenses were $69.0 million compared to $51.1 million for the same period in 2024. The increase was due to preclinical expenses related to the advancement of the Company’s autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations, and clinical expenses related to the progression of the Company’s Phase 3 trials, primarily TEBE-AM and PRISM-MEL-301.

For the quarter ended June 30, 2025, SG&A expenses were $42.8 million compared to $38.6 million for the same period in 2024. The increase was primarily due to costs related to business support functions to support the Company’s growing pipeline and global commercial expansion.

Net loss for the quarter ended June 30, 2025, was $10.3 million, as compared to a net loss of $11.6 million for the same period in 2024. Basic and diluted loss per share was $0.20 for the quarter ended June 30, 2025, as compared to a basic and diluted loss per share of $0.23 for the same period in 2024.

Cash, cash equivalents and marketable securities were $882.8 million as of June 30, 2025, as compared to $820.4 million as of December 31, 2024. The Company expects to pay, in the second half of 2025, approximately $65 million in sales-related rebate accruals.

On August 7, 2025 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13) reported its financial results for the six months ended June 30, 2025 and provides updates on key clinical and commercial developments (Press release, Hutchison China MediTech, AUG 7, 2025, View Source [SID1234654979]).

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HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, August 7, 2025, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, August 8, 2025. After registration, investors may access the live webcast at www.hutch-med.com/event.

All amounts are expressed in US dollars unless otherwise stated. A list of abbreviations is in the Glossary at the end of the page.

Global commercial progress and delivery of sustainable growth
ORPATHYS (savolitinib) secured China approval of its third lung cancer indication for EGFRm NSCLC patients with MET amplification after progression on EGFR inhibitor treatment in combination with TAGRISSO (osimertinib) on June 30, 2025, in time to be eligible for potential national reimbursement negotiation towards the end of this year. This combination offers the only oral, chemotherapy-free approach to a sizable percentage (~30%) of these patients. The approval triggered a $11.0 million milestone payment from AstraZeneca which markets both ORPATHYS and TAGRISSO.
FRUZAQLA (fruquintinib ex-China) in-market sales by Takeda were up 25% to $162.8 million (H1-24: $130.5m) as its geographical coverage expanded to more than 30 countries. ELUNATE (fruquintinib China) achieved $43.0 million (H1-24: $61.0m) reflecting intensifying competitive pressures and streamlining of our salesforce structure, but growth has returned recently. Total Oncology/​Immunology consolidated revenue, including milestone and service income, was $143.5 million (H1-24: $168.7m).
Net income attributable to HUTCHMED of $455.0 million was achieved in the first half of 2025 (H1-24: $25.8m), with a cash balance of $1.36 billion as of June 30, 2025, significantly boosted by a $416.3 million divestment gain, net of tax from the disposal of a partial equity stake in a non-core joint venture and divestment proceeds.

Pipeline progress and new technology platform
Positive results from the SACHI China and SAVANNAH global lung cancer trials of ORPATHYS in combination with TAGRISSO were presented at ASCO (Free ASCO Whitepaper) and ELCC conferences. SACHI showed mPFS of 8.2 months with this oral combination compared to 3.0 months with chemotherapy, and SAVANNAH showed 7.4 months with this oral combination. This is the only treatment option that demonstrated statistically significant results in a biomarker-directed pivotal clinical trial in MET amplified, EGFR TKI refractory NSCLC patients. Enrollment in the SAFFRON global Phase III trial is expected to complete in the second half of this year and readout in the first half of 2026.
Phase II/III trial on SULANDA (surufatinib) in combination with AiRuiKa (camrelizumab) and chemotherapy for previously-untreated metastatic pancreatic cancer patients is progressing well, targeting data readout in the second half of 2025. An earlier study presented promising updated data at ASCO (Free ASCO Whitepaper) with ORR of 51.1% (vs 24.4% with chemotherapy) and mPFS of 7.9 months (vs 5.4 months).
Positive FRUSICA-2 Phase III results supported the China approval submission for ELUNATE with TYVYT (sintilimab) in previously-treated kidney cancer. Details to be presented at ESMO (Free ESMO Whitepaper) Congress. Prior Phase Ib/II study showed ORR of 60.0% and mPFS of 15.9 months.
New Antibody-Targeted Therapy Conjugates (ATTC) platform drug candidates have been selected, planning to enter clinical development in late 2025. We also plan to present pre-clinical data at a scientific conference before the end of this year. Successful development of multiple ATTC molecules is expected to lead to collaboration and licensing opportunities in the future. Initial responses from potential partners are very positive.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "With a strong balance sheet, robust operations and an exciting new ATTC platform, HUTCHMED is ready to enter a new phase of growth. Partnering is still a strategic focus, with multinational pharmaceutical companies remaining favorable towards such licensing opportunities with China biotech companies. In recent months we have seen markets’ sentiment and performance have significantly improved. China domestic drug policy and pricing environment also manifest strengthened support for innovative drug development, with the potential introduction of a commercial insurance drug list later this year, targeting a diversified, multi-layered healthcare social security payment system down the road.

We intend to prudently and actively deploy resources to expedite the development of a series of drug candidates from our novel ATTC platform, including synchronous clinical development in China and overseas. Our 20 years of knowledge of in-house discovery, experience in running large-scale pivotal trials, collaboration with international partners and success in obtaining global regulatory approvals empower us to bring forth more innovative medicines to address large unmet needs around the world."

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "We concluded the first half of 2025 with several important milestones achieved, some earlier than expected. The presentation of SACHI data at ASCO (Free ASCO Whitepaper) in a late-breaking oral presentation at the beginning of June was impressive, validating both the clinical strength and commercial advantages of ORPATHYS in the market. This is the first biomarker-selected pivotal study globally for EGFR TKI refractory lung cancer patients, demonstrating clear clinical benefits for these patients. The China approval of ORPATHYS at the end of June for this indication, six months after filing acceptance, was ahead of schedule and in time to qualify for national reimbursement negotiation. Also in June, the third indication of ELUNATE for kidney cancer was accepted for review by the NMPA, supported by positive data in the FRUSICA-2 Phase III trial, to be presented at ESMO (Free ESMO Whitepaper) Congress. We also launched TAZVERIK (tazemetostat), our first hematological oncology drug, in July following approval in March.

We believe sales growth should improve in second half of 2025, with the help of indication expansion in China and better market penetration overseas. In the near term, we shall start clinical development of multiple drug candidates from our ATTC program, a crucial technology platform, which will enrich our pipeline and provide ample partnership opportunities."

2025 Interim Results & Business Updates
I. COMMERCIAL OPERATIONS
FRUZAQLA in-market sales by Takeda were up 25% in the first half of 2025 at $162.8 million, driven by strong growth following approvals in more than 30 countries to date, including over 10 new markets in 2025. Reimbursement was received in the US, Spain and Japan last year, and, in July 2025, positive recommendation was received for NHS reimbursement in England and Wales.

The China pharmaceutical sector has gone through multifaceted changes. To position HUTCHMED for sustainable long-term growth, HUTCHMED has streamlined its sales force to establish a more efficient commercial organization and enhance productivity. In the face of intensifying competition as its products mature, HUTCHMED has strengthened its strategy to continue to focus on science-driven commercial activities to further differentiate its products. In the first half of 2025, in-market sales in China for ELUNATE, SULANDA and ORPATHYS decreased as compared to the first half of 2024, reflecting competition and the transitional effects of the changes in our sales team and marketing strategy.

Total in-market sales were down 4%. Consolidated revenue dropped 22% due to lower China in-market sales, offset by flat FRUZAQLA revenue.

Other Oncology/​Immunology revenue, consisting of upfront or milestones, R&D services and licensing to our partners increased 9% to $44.4 million. Revenue from Other Ventures, comprising prescription drug distribution, remained flat, leading to total consolidated revenue of $277.7 million, down 9%.

* FRUZAQLA, ELUNATE and ORPATHYS mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively.

** FRUZAQLA represents manufacturing revenue and royalties paid by Takeda; ELUNATE represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA and TAZVERIK represent the HUTCHMED’s sales of the products to third parties.

II. REGULATORY UPDATES
Savolitinib sNDA approved by the NMPA for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO, triggering $11.0 million milestone from AstraZeneca, in June 2025.
Savolitinib sNDA approved by the NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January 2025. Savolitinib approved in Hong Kong for METex14 NSCLC under the 1+ Mechanism in February 2025.
Tazemetostat NDA conditionally approved by the NMPA for 3L R/R follicular lymphoma with EZH2 mutation in March 2025.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET
Presented SACHI China Phase III results at ASCO (Free ASCO Whitepaper) 2025 for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO, showing mPFS of 8.2 months compared to 4.5 months with chemotherapy in ITT population (HR 0.34), and 6.9 months compared to 3.0 months in post third-generation EGFR TKI-treated subgroup (HR 0.32, both p<0.0001) (NCT05015608).
Presented SAVANNAH global Phase II results at ELCC 2025 for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO, showing ORR of 56%, mPFS of 7.4 months and mDoR of 7.1 months (NCT03778229).
Continued enrolling SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399) and the study will potentially support global filings; and SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).
Completed enrollment of China Phase II registrational study for 3L gastric cancer patients with MET amplification (NCT04923932).
Potential upcoming clinical milestones for savolitinib:

Complete SAFFRON Phase III enrollment in the second half of 2025, data readout in the first half of 2026.
Complete SANOVO China Phase III enrollment in the second half of 2025.

Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a selective oral inhibitor of VEGFR
Positive results of FRUSICA-2 China Phase III in 2L RCC in March 2025 (NCT05522231).
Presented China Phase II IIT results at AACR (Free AACR Whitepaper), in combination with TUOYI (toripalimab) or TYVYT, in 2L and above MSS/pMMR CRC, showing mPFS of 13.2 months and mOS of 29.0 months (NCT04483219).

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk
Ongoing ESLIM-01 ITP NMPA NDA review stipulates a lower impurity limit, requiring further manufacturing validation and stability test. Target re-submission in first half of 2026, with additional data rolling in during second half of 2026. In the future, the company will look to continue overseas development.
Published China Phase II results in warm AIHA in China at EHA (Free EHA Whitepaper) and in The Lancet Haematology in 2025, demonstrating overall response rate of 66.7% and a favorable safety profile (NCT05535933).
Completed ESLIM-02 China Phase III enrollment for warm AIHA in June 2025 (NCT05535933).
Potential upcoming regulatory milestones for sovleplenib:

ESLIM-01 NMPA NDA re-submission in first half of 2026 (NCT05029635).
ESLIM-02 NMPA sNDA submission in first half of 2026 (NCT05535933).

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR and CSF-1R
Potential upcoming clinical milestone for surufatinib:

Data readout of Phase II part of a China Phase II/III HUTCHMED-sponsored trial for 1L metastatic PDAC patients, in combination with AiRuiKa, nab-paclitaxel and gemcitabine in late 2025 (NCT06361888).

Tazemetostat (TAZVERIK in China), a first-in-class, oral inhibitor of EZH2
TAZVERIK NDA approved by the NMPA for 3L R/R follicular lymphoma with EZH2 mutation.
Continued enrolling SYMPHONY-1 China portion of the Phase III portion of the global study, in combination with lenalidomide and rituximab, in 2L follicular lymphoma patients (NCT04224493).

Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
Completed enrollment of China Phase II registrational trial for IHCC with FGFR fusion / rearrangement in February 2025 (NCT04353375).

Ranosidenib (HMPL-306), an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes
Continued enrolling RAPHAEL China Phase III trial for 2L R/R IDH1/2-mutant AML (NCT06387069).

IV. ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM
New in-house created platform with multiple potential IND candidates
HUTCHMED plans to initiate China and global clinical trials for our first ATTC drug candidate around the end of 2025, followed by multiple global IND filings for more ATTC candidates in 2026.

Our ATTC next-generation technology platform leverages over 20 years of expertise in targeted therapies with small molecules inhibitors. By linking a monoclonal antibody with a proprietary targeted small-molecule inhibitor (SMI) payload, our ATTC platform has the capability to derive multiple drug candidates targeting various oncology indications, including precision medicine against selective sub-types. These ATTC drug candidates enrich the next wave of clinical development with potential key advantages over traditional antibody-drug conjugates and/or small molecule medicines.

Better efficacy through synergistic antibody-small molecule targeted therapy combinations that will target specific mutations; overcome drug resistance to existing treatment.
Improved safety and prolonged treatment given lower off-tumor or off-target toxicity than small molecules, lower risk of myelosuppression and better safety than cytotoxin-based conjugates.
Attractive pharmacokinetics tackles difficult drug targets, enabled by antibody-guided delivery to target sites which will improve bioavailability and reduce drug-drug interactions.
Advantages over existing ADCs due to lower off-tumor toxicities from the SMI payload, released through lysosomal cleavage inside target cells, targets cell signaling pathway driven by mutation specific to tumor cells. It can be used in combination with established standard therapies such as chemotherapy and immunotherapy to further enhance efficacy.
Potential first-line applications, as chemo-free ATTC can potentially support combinations with other targeted therapies, chemotherapy and immunotherapy, in early-line settings with broad market potential.

V. COLLABORATION UPDATES
Further progress of candidate IMG-007, discovered by HUTCHMED
ImageneBio, Inc. (Nasdaq: IMA) – Inmagene and Ikena Oncology, Inc. completed a merger on July 25, 2025 and ImageneBio, Inc., the merged entity, holds the license rights to IMG-007 granted by HUTCHMED. HUTCHMED has an approximate 3.67% shareholding in ImageneBio, Inc.
Announced positive results of a US/Canada Phase IIa study of IMG-007 for atopic dermatitis in April 2025, showing week 16 mean change in EASI of 77% and EASI-75 response of 54% (NCT05984784).
Dosed the first patient in a US Phase IIb randomized, double-blind, placebo-controlled dose-finding study of IMG-007 for moderate-to-severe atopic dermatitis in July 2025, targeting to enroll 220 patients who have had inadequate response to and/or intolerance of topical therapies (NCT07037901).
Announced positive results of a US/Canada Phase IIa study of IMG-007 for severe alopecia areata in January 2025, showing mean reduction from baseline in Severity of Alopecia Tool (SALT) score of 30.1% by week 36 (NCT06060977).

VI. OTHER VENTURES
Other Ventures consolidated revenue, predominantly from the prescription drug distribution business in China, were steady at $134.2 million for the six months ended June 30, 2025.
HUTCHMED divested a 45.0% equity interest in SHPL for $608.5 million in cash in April 2025, retaining a 5.0% equity interest. A divestment gain, net of tax of $416.3 million was recognized during the first half of 2025. As a result, HUTCHMED’s share of equity in earnings of SHPL decreased to $23.1 million for the six months ended June 30, 2025.
Consolidated net income attributable to HUTCHMED from Other Ventures increased to $440.3 million (H1-24: $34.1m), primarily due to the SHPL interest disposal.

VII. SUSTAINABILITY
In April 2025, the 2024 Sustainability Report was published, highlighting the progress made in 11 goals and targets and enhanced climate actions, including improved Scope 3 data, tightened control over air travel and engagement with suppliers. This year, a comprehensive climate risks assessment is being conducted to further understand and quantify the potential financial impacts of climate change, including physical risks brought by flooding and heat stress, and transition risks for HUTCHMED under optimistic and pessimistic scenarios.

HUTCHMED has made notable progress in its ESG ratings, including ratings from CDP Worldwide, the Hang Seng Corporate Sustainability Index Series, ISS ESG, MSCI ESG, Sustainalytics, and S&P Global ESG. In May 2025, HUTCHMED ranked third in ESG Excellence in the Healthcare, Pharmaceutical, and Biotechnology sector in the Extel’s Asia Executive Team survey, reflecting feedback from over 5,400 portfolio managers and analysts. Extel ranked HUTCHMED as one of the Most Honored Companies; ranked it first in Best Board of Directors, Best CEO, Best IR Program and Best IR Professionals; as well as second in Best CFO and Best IR Team in the Healthcare, Pharmaceutical, and Biotechnology sector.

Financial Highlights
Revenue for the six months ended June 30, 2025 was $277.7 million compared to $305.7 million for the six months ended June 30, 2024.
Oncology/​Immunology consolidated revenue amounted to $143.5 million (H1-24: $168.7m):
FRUZAQLA revenue was $43.1 million (H1-24: $42.8m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to its launch year. In-market sales by Takeda were $162.8 million (up 25%) driven by strong growth following approvals in more than 30 countries to date, including over 10 new markets in 2025.
ELUNATE revenue decreased to $33.6 million (H1-24: $46.0m) in its seventh year since launch, comprising manufacturing revenue, promotion and marketing services revenue and royalties. In-market sales decreased to $43.0 million, reflecting the intensifying competitive pressures from combination therapies of key competing products and their additional generics and biosimilars entry in 3L CRC. The launch of the entry of the new indication 2L EMC in 2025 and continuous inclusion of ELUNATE in key guidelines are expected to drive future growth.
SULANDA revenue decreased to $12.7 million (H1-24: $25.4m) in the face of strong competition for NET patients from new somatostatin analogues drugs with their inclusion in the NRDL and broader coverage. To counteract this challenge, we continue to drive awareness and product differentiation to uphold SULANDA position in TKI.
ORPATHYS revenue decreased to $9.0 million (H1-24: $13.1m) on in-market sales of $15.2 million, impacted by the launch and NRDL inclusion of several competing drugs for METex14 skipping Such results have not reflected expected growth from the recent approval for the much larger EGFR TKI-refractory, MET-amplified NSCLC patient population at the end of June 2025.
TAZVERIK revenue was $0.7 million (H1-24: $0.5m) mainly from sales in Hainan and Hong Kong. Launched in mainland China in July 2025 following its approval in March 2025.
Takeda upfront, regulatory milestones and R&D services revenue were $29.5 million (H1-24: $33.8m), of which $26.6 million was recognized from Takeda deferred revenue.
Other revenue of $14.9 million (H1-24: $7.1m), includes regulatory milestone of $11.0 million from AstraZeneca following China NDA approval for ORPATHYS combined with TAGRISSO.
Other Ventures consolidated revenue of $134.2 million (H1-24: $137.0m) remained flat.

Net Expenses for the six months ended June 30, 2025 were $239.0 million compared to $279.9 million for the six months ended June 30, 2024, reflecting strong cost control efforts.
Cost of Revenue decreased 7% to $167.6 million (H1-24: $180.1m), which was mainly due to lower Oncology/​Immunology revenue. Cost of revenue as a percentage of oncology product revenue remained stable at 39% (H1-24: 38%).
R&D Expenses reduced by 24% to $72.0 million (H1-24: $95.3m). While R&D investment outside of China reduced to $7.6 million (H1-24: $14.9m) as we continued to integrate our global R&D operations with China, the decrease was mainly driven by China with R&D investment of $64.4 million (H1-24: $80.4m) reflecting lower costs from completed studies which are under NDA review (e.g. ELUNATE in 2L RCC) or already led to NMPA approval in H1-25 (e.g. ORPATHYS in 2L NSCLC). Joint China and global clinical development effort ongoing to gear up for multiple drug candidates from our ATTC
S&A Expenses were $41.6 million (H1-24: $57.8m). The decrease was mainly due to a reduction in S&A expenses for oncology products which was $13.4 million or 13.5% of oncology product revenue (H1-24: $25.1 million or 19.6%) as sales force structure was streamlined and tighter spending controls imposed.
Other Items generated net income of $42.2 million (H1-24: $53.3m), mainly comprised of equity in earnings of SHPL, interest income and expense, foreign exchange and taxes. The decrease was primarily due to lower share of equity in earnings of SHPL at $23.1 million (H1-24: $33.8m) as our share decreased to 5% (H1-24: 50%) after the divestment of a partial stake in SHPL completed in April 2025.

Gain on divestment of SHPL, net of tax was $416.3 million for the six months ended June 30, 2025.

Net Income attributable to HUTCHMED for the six months ended June 30, 2025 was $455.0 million compared to $25.8 million for the six months ended June 30, 2024.
The net income attributable to HUTCHMED for the six months ended June 30, 2025 was $0.53 per ordinary share / $2.65 per ADS (H1-24: $0.03 per ordinary share / $0.15 per ADS).

Cash, Cash Equivalents and Short-Term Investments were $1,364.5 million as of June 30, 2025 compared to $836.1 million as of December 31, 2024.
Adjusted Group (non-GAAP) net cash inflows excluding financing activities in the first half of 2025 were $519.1 million mainly due to the receipt of $608.5 million gross proceeds from the partial divestment of SHPL, offset with the $59.5 million capital gain tax payment for the partial divestment of SHPL, $10.0 million regulatory approval milestone payment and $9.2 million in capital expenditures (H1-24: -$51.3m mainly due to $39.8 million net cash used in operating activities and $10.1 million of capital expenditures).
Net cash generated from financing activities in the first half of 2025 totaled $9.3 million mainly due to drawdowns of bank borrowings of $8.2 million (H1-24: net cash used in financing activities of $32.6m mainly due to purchases for equity awards of $36.1 million).

Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 0.8% during the first half of 2025, which has impacted consolidated financial results as highlighted.