On August 7, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for diseases with high unmet need, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Precision Biosciences, AUG 7, 2025, View Source [SID1234654994]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team continues to be very disciplined about executing our plans and is making strong progress advancing our clinical stage PBGENE-HBV program while rapidly advancing PBGENE-DMD toward the clinic," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "The early Phase 1 safety and efficacy data for PBGENE-HBV from the first cohort of the Phase 1 ELIMINATE-B trial establishes proof of activity for our novel gene editing approach for chronic Hepatitis B. Our data shows that we have a novel, safe and active drug in all patients treated with a durable effect in one third of patients reinforcing the mechanism of PBGENE-HBV to eliminate cccDNA. We are very pleased with the safety profile demonstrated in Cohorts 1 and 2 which has enabled the Data Monitoring Committee to endorse enrolling Cohort 3 this month to test the next higher dose. Concurrently, we are accelerating the development of our second program, PBGENE-DMD, and were proud to receive both Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), underscoring the significant unmet need for new therapeutic options for patients living with DMD."

"Given the unmet need, opportunity and enthusiasm for PBGENE-HBV and PBGENE-DMD, we are taking proactive steps to invest fully in these two programs while extending our expected cash runway to the second half of 2027 through a significant reduction in our non-program related annual operating expenses. These actions are expected to enable commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. Our team remains committed to delivering transformative therapies in areas with significant unmet need and, with a longer cash runway, we believe we are now even better positioned to deliver the meaningful clinical data that is expected by patients and shareholders for both of our wholly-owned programs," added Mr. Amoroso.

Wholly Owned Portfolio

PBGENE-HBV (Viral Elimination Program): PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B.

On August 6, 2025, Precision announced Phase 1 safety and efficacy data for Cohort 1, the lowest dose level in the ELIMINATE-B trial. Cohort 1 consisted of three patients each of whom received three planned administrations of 0.2 mg/kg of PBGENE-HBV dosed approximately eight weeks apart. The primary objective is to characterize the safety of PBGENE-HBV. PBGENE-HBV was well-tolerated in all three patients in Cohort 1. Across Cohort 1, no patient experienced above a Grade 2 treatment-related adverse event, a serious adverse event, or dose-limiting toxicity. No clinically significant lab abnormalities were observed, including liver enzymes and platelets.

PBGENE-HBV demonstrated a substantial HBsAg reduction in all three patients in Cohort 1 with best response reductions of 56%, 69% and 47% compared to baseline HBsAg levels (ranging between 562-11,813 IU/mL) in patients one, two and three, respectively. One of three patients (33%) in Cohort 1 achieved a durable HBsAg reduction of approximately 50% from baseline that was maintained as of the data cutoff-date (July 28, 2025), which was seven months after initial dosing. This data provides evidence of the ability of PBGENE-HBV to drive a durable antiviral response by editing the viral DNA at the source of chronic Hepatitis B infection. There was no association between baseline HBsAg and efficacy in Cohort 1.

Precision also announced initial safety data from Cohort 2 (0.4 mg/kg) in the ELIMINATE-B study. As of the data cutoff, one patient received three dose administrations with two weeks of follow-up, and two patients received one dose administration with four weeks of follow-up. In these patients, no adverse events above Grade 2 were observed. No serious adverse events or dose limiting toxicities were observed, and no cumulative adverse effects were observed. There were no clinically significant elevations of liver transaminases. One additional patient did not complete their dose due to a transient infusion-related serious adverse event that resolved within minutes. The Data Monitoring Committee determined that this transient reaction was not dose-related or dose-limiting. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recently recommended initiation of Cohort 3.

The Company is on track to complete dosing of all three patients across all dose administrations in Cohort 2 and commence dosing Cohort 3. The Company expects to provide a data update later in 2025.

PBGENE-DMD (Muscle Targeted Excision Program): PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit.

The FDA granted PBGENE-DMD Rare Pediatric Disease designation in June 2025 for the treatment of DMD, highlighting the significant unmet need for new therapeutic options. This was followed in July 2025 by the FDA granting PBGENE-DMD Orphan Drug Designation, re-enforcing the need for new and better treatments. With the Rare Pediatric Disease designation, Precision may be eligible to receive a Priority Review Voucher upon FDA approval of PBGENE-DMD.

In preclinical data presented at the ASGCT (Free ASGCT Whitepaper) annual meeting in May 2025, PBGENE-DMD demonstrated significant and durable functional improvement in a humanized DMD mouse model. Following AAV delivery, PBGENE-DMD restored the body’s ability to produce a functional dystrophin protein broadly across multiple muscle types, including cardiac and skeletal muscles. Over the course of nine months, mice treated with PBGENE-DMD showed increased dystrophin protein expression resulting in substantial and sustained functional muscle improvement. In addition, PBGENE-DMD-edited dystrophin mRNA transcript in muscle satellite stem cells, which are progenitor cells for new muscle cells, supports the potential for long-term durability.

In July 2025, Precision announced new preclinical data building upon previous data shared at the ASGCT (Free ASGCT Whitepaper) annual meeting. These data demonstrated that PBGENE-DMD produced a three-fold increase in dystrophin-positive muscle cells between three and nine months in the quadricep, gastrocnemius (calf), heart, and diaphragm. In the gastrocnemius specifically, up to 85% of cells were dystrophin-positive, indicating a high degree of productive gene editing. This broad increase in dystrophin-positive cells combined with the increased dystrophin protein detected in tissues further validates the improved muscle function that was observed over time and may be attributable to edited satellite cells.

Precision is advancing the final U.S. investigational new drug (IND)-enabling toxicology studies with an anticipated IND and/or clinical trial application (CTA) filing targeted by the end of 2025 with initial clinical data expected in 2026.

PBGENE-3243 (Mutant Mitochondrial DNA Elimination Program): PBGENE-3243 is a first-of-its-kind potential treatment for m.3243-associated mitochondrial disease that is designed to specifically target and eliminate mutant m.3243G mitochondrial DNA, thereby eliminating the root cause of the disease. Precision has paused development of PBGENE-3243 to prioritize its two lead programs, PBGENE-HBV and PBGENE-DMD.

Partnered In Vivo Gene Editing Programs

iECURE-OTC (Gene Insertion Program): Led by iECURE, ECUR-506 is an ARCUS-mediated in vivo gene editing program currently in a first-in-human Phase 1/2 trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. Preliminary data from the study presented at ASGCT (Free ASGCT Whitepaper) in May demonstrated a complete clinical response from three months post-exposure to the end of study at six months, as defined by the study protocol. The patient is now more than one year of age and is eating appropriate levels of protein for a child of his age. iECURE has reported that a second infant with severe OTC deficiency was dosed in the first half of 2025.

The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain, and iECURE expects to complete enrollment in 2025 and anticipates complete data from the trial in the first half of 2026.

PBGENE-NVS (Gene Insertion Program): Precision continues to advance its gene editing program with Novartis to develop a custom ARCUS nuclease for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. The collaborative intent is to insert, in vivo, a therapeutic transgene as a potential one-time transformative treatment administered directly to the patient to overcome disparities in patient access to treatment with other therapeutic technologies, including those that are targeting an ex vivo gene editing approach.

Non-Core Ex Vivo Programs

Azer-Cel (azercabtagene zapreleucel allogeneic CAR T treatment for cancer): Imugene Limited, Precision’s clinical stage partner developing azer-cel for oncology indications, announced updated clinical data in July 2025. In the updated data in patients diagnosed with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), two additional patients achieved a Complete Response and three additional patients achieved a Partial Response. Imugene reported that, as a result of the new data, the best overall response rate for azer-cel in DLBCL reached 75% and the Complete Response rate reached 55%. Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL, Imugene expects to request an end of Phase 1 meeting with the FDA in the fourth quarter of 2025 to present the data and discuss designs for a pivotal/registrational trial for azer-cel.

Other Announcements

Mark Sulkowski, M.D., Professor of Medicine at the Johns Hopkins University School of Medicine and renowned expert in hepatic and infectious diseases has expanded his advisory role with Precision BioSciences. In the newly created role, Head Clinical Development Advisor, Dr. Sulkowski will work closely with Precision’s leadership and cross-functional teams to support clinical strategy across the development lifecycle for the Company’s on-going PBGENE-HBV Phase 1 clinical trial as well as initiation of later stage trials. His advisory role will focus on optimizing clinical trials, including translational integration, and aligning scientific rationale with regulatory objectives.

Quarter Ended June 30, 2025 Financial Results

"As Precision advances the ELIMINATE-B clinical trial and prepares to file an IND and/or CTA for the PBGENE-DMD program we have been closely managing our operating costs. Cost management is evident in our decision to pause development on PBGENE-3243 in the second quarter and is reflected in a $3.9 million reduction in our second quarter total operating expenses as compared to the same period last year," said Alex Kelly, Chief Financial Officer of Precision BioSciences. "We have also extended our expected cash runway to the second half of 2027 to enable meaningful clinical data readouts for PBGENE-HBV and PBGENE-DMD. In July 2025, we initiated an operating efficiency program, including reductions in early research, manufacturing and general & administrative operating expenses which are aimed at reducing our annual cash operating expenses in each of 2026 and 2027 by approximately $25 million compared to the 2025 annual cash expense level."

"In addition to significantly reducing our operating expenses, Precision will continue to pursue less dilutive sources of cash to even further extend the cash runway, including business development collaborations for future or deprioritized ARCUS programs as well as opportunities to monetize non-core program royalties and milestones," added Mr. Kelly.

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, Precision had approximately $84.8 million in cash, cash equivalents, and restricted cash. Based on its expected cash runway, Precision believes it is sufficiently capitalized to reach important milestones for both programs, including commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. The Company expects existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operating efficiencies, operational receipts, and availability of Precision’s at-the-market (ATM) facility to extend Precision’s cash runway into the second half of 2027.

Revenues: Total revenues for the quarter ended June 30, 2025, were less than $0.1 million, as compared to $49.9 million for the quarter ended June 30, 2024. The decrease was expected and primarily the result of $48.2 million of non-cash revenue recognized in the prior period which represented all remaining deferred revenue related to the Prevail Therapeutics Agreement at its conclusion in April 2024 under generally accepted accounting principles. The upfront cash from this collaboration was received and recorded on the balance sheet in January 2021.

Research and Development Expenses: Research and development expenses were $12.8 million for the quarter ended June 30, 2025, as compared to $17.2 million for the quarter ended June 30, 2024. The decrease of $4.4 million was primarily due to decreases in PBGENE-HBV direct expenses due to lower manufacturing and toxicology expenses as the program transitioned to the clinic in the fall of 2024. PBGENE-3243, which has been paused, and other research related expenses also decreased in the comparative period, offset by an increase in PBGENE-DMD expenses as the program was accelerated in the second quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $9.1 million for the quarter ended June 30, 2025, as compared to $8.5 million for the quarter ended June 30, 2024 as an increase in employee-related costs, including non-cash employee-related costs, offset a decrease in other general and administrative expenses.

Net Loss: Net loss was $23.5 million, or ($2.13) per share (basic and diluted), for the quarter ended June 30, 2025. Net income was $32.7 million, or $4.70 per share (basic) and $4.67 per share (diluted), for the quarter ended June 30, 2024.

On August 7, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported $153M Series B funding led by Kinnevik, with new investors Regeneron Ventures, ICONIQ, Amgen Ventures, Alderline Group (the family office of Alex Gorsky), JIC-VGI, LG Technology Ventures, and Gradiant Corporation, with continued participation from existing investors including FPV Ventures, Playground Global, Eli Lilly and Company, ANRI, and Potentum (Press release, Strand Therapeutics, AUG 7, 2025, View Source [SID1234655013]). To date, Strand has raised over $250M. As part of the financing, Ala Alenazi, Ph.D., of Kinnevik, will join the company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funding will advance Strand’s pipeline, led by STX-001, a programmable mRNA therapy that expresses the cytokine interleukin-12 (IL-12) directly from the tumor microenvironment. The company recently announced promising initial Phase 1 clinical data for patients with advanced solid tumors at the 2025 ASCO (Free ASCO Whitepaper) annual meeting, noting multiple RECIST responses (including cases of complete response and complete metabolic response), multiple cases of prolonged disease stabilization, and a favorable safety profile in treatment-resistant patients.

Earlier this year, Strand also presented preclinical data for STX-003, a world-first systemically administrable mRNA therapy with tumor targeting that is programmed to avoid off-target payload delivery (including liver avoidance), showing the first glimpse into the massive potential of their programmable mRNA genetic circuits. Data presented at the 2025 AACR (Free AACR Whitepaper) and ASGCT (Free ASGCT Whitepaper) annual meetings demonstrated the candidate’s potential to target expression of IL-12 to tumors following systemic administration of the LNP-mRNA drug, creating an effective anti-tumor therapy that was well tolerated.

IL-12 is a potent pro-inflammatory cytokine primarily produced by antigen-presenting cells such as macrophages and dendritic cells. IL-12 holds significant promise in cancer immunotherapy due to its robust immunostimulatory effects. STX-001 encodes IL-12 which Strand has designed so that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand’s approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity.

"We believe programmable RNA is the next frontier in therapeutics, and Strand has built the leading platform to unlock it," said Christian Scherrer, Senior Investment Director and Head of Health and Bio at Kinnevik. "Their early clinical data is outstanding, and the systemic delivery capability has the potential to reshape how we treat disease, starting with cancer, with more disease targets on the horizon. We look forward to partnering with founders Jake and Tasuku and the entire team as they move into this next phase of growth."

"With support from our investors, we’re advancing our vision of developing safe, effective, and accessible therapies through programmable genetic medicines, especially for those patients with few treatment options," said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. "Our initial STX-001 Phase 1 data provides early and strong clinical validation of our platform’s capabilities. We have observed systemic immune activation and anti-tumor responses, including responses in non-injected lesions, across multiple tumor types. Now is an exciting period of expansion for our existing clinical work, as well as the exciting breakthrough assets in our pipeline, all with the potential to transform the treatment of cancer and other serious diseases."

Strand’s proprietary platform for programmable and potent mRNA therapeutics is the first of its kind. Its therapies combine best-in-class engineered next-generation mRNA modalities, such as self-replicating mRNA and circular RNA, with genetically programmed logic circuits, allowing for precise, controlled therapeutic payload delivery directly into the cells/tissues themselves. The novel approach brings the potential to effectively treat cancer and other deadly chronic diseases through its targeted therapies that are scalable, accessible, and expand the treatment landscape for patients desperately in need.

About STX-001

STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly administered to tumors in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, announced its first patient dosed just before the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and presented the first data of the trial at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Additional details can be found at clinicaltrials.gov, using identifier: NCT06249048.

On August 7, 2025 Genmab reported Financial Results for the First Half of 2025 (Press release, Genmab, AUG 7, 2025, View Source [SID1234655264]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 7, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 7, 2025, View Source [SID1234654963]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With enrollment completed in our silevertinib Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC, we look forward to sharing a clinical update in the fourth quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Given the evolving competitive and regulatory landscape, we are also exploring partnership opportunities to advance silevertinib into pivotal development and bring this potential best-in-class treatment to patients as quickly as possible."

Recent Developments & Upcoming Milestones:

Silevertinib (BDTX-1535):

In July 2025, Black Diamond completed enrollment (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations.
In the fourth quarter of 2025, Black Diamond expects to disclose objective response rate (ORR) and preliminary duration of response (DOR) data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline NSCLC with non-classical EGFR mutations.
Black Diamond is exploring partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
The Company plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in 1H 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.

Financial Highlights

Cash Position: Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash used in operations was $9.2 million for the second quarter of 2025 compared to net cash used in operations of $14.7 million for the second quarter of 2024.
Research and Development Expenses: Research and development (R&D) expenses were $9.3 million for the second quarter of 2025, compared to $12.6 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
General and Administrative Expenses: General and administrative (G&A) expenses were $4.1 million for the second quarter of 2025, compared to $9.6 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
Net Income/Loss: Net loss for the second quarter of 2025 was $10.6 million, as compared to a net loss of $19.9 million for the same period in 2024.

Financial Guidance

Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.