ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026 Conference

On March 5, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported post-hoc subgroup analyses of the ITM-11 Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In patients with pancreatic neuroendocrine tumors (P-NETs), data showed that n.c.a. 177Lu-edotreotide (ITM-11) prolonged progression-free survival (PFS) and achieved higher objective response rates (ORR) when compared to everolimus. Data were presented by Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France, in a mini-oral presentation and in an accompanying poster at the 23rd Annual Meeting of the European Neuroendocrine Tumor Society (ENETS), held March 4-6, 2026 in Krakow, Poland.

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As previously announced at ENETS 2025, the COMPETE trial met its primary endpoint of PFS (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO (Free ESMO Whitepaper) 2025, ITM announced that COMPETE also met a key secondary endpoint of ORR (21.9% vs 4.2%, p<0.0001) in patients with GEP-NETs.

The COMPETE study enrolled a total of 309 GEP-NET patients, including 178 (57.6%) patients with P-NETs randomized 2:1 to either 177Lu-edotreotide (n=119) or everolimus (n=59). Of the 178 P-NET patients, 150 (84.3%) had non-functional tumors, meaning they did not produce hormones causing clinical symptoms, and 28 (15.7%) had functional tumors, in which excess hormone production can cause symptoms such as hypoglycemia (insulinoma), or diarrhea and peptic ulcer (Zollinger Elison syndrome).

Key findings in the P-NETs population showed:

Median PFS was longer in the 177Lu-edotreotide arm compared to everolimus (24.5 months vs. 14.7 months; p=0.114; HR 0.70, 95% CI [0.45, 1.09]) and ORR in the 177Lu-edotreotide arm was 33.3% vs. 3.6% in everolimus arm.
ORR in the 177Lu-edotreotide arm was ≥ 30% in P-NET patients with non-functional disease, across all patients regardless of line of therapy and Ki-67 index. This includes 38.1% ORR in P-NET patients with non-functional disease and 34.2% ORR in patients with a Ki-67 index ≥10%.
Median overall survival was numerically longer in the 177Lu-edotreotide arm compared to everolimus (65.7 months vs. 49.3 months) at the time of analyses; data continue to mature with ongoing five-year follow up.
The overall safety profile in P-NET patients receiving 177Lu-edotreotide compared to everolimus was similar or potentially improved, and included fewer serious adverse events (SAEs) (29.1% vs. 43.1%). Lower incidence of adverse events suspected to be related to the study drug was seen in the 177Lu-edotreotide arm vs. everolimus arm (83.8% vs. 96.6%).
"Given that the data on peptide receptor radionuclide therapy in pancreatic NETs has been limited to date, we are encouraged by the activity of 177Lu-edotreotide observed in this prespecified exploratory subgroup of patients with Grade 1 or 2 pancreatic NETs, who represented approximately 58% of trial participants," said Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France.

"These additional results from our Phase 3 COMPETE trial provide important insights into treatment options for patients with pancreatic NETs, and further enhance the robust clinical data of 177Lu-edotreotide," said Dr. Celine Wilke, chief medical officer of ITM.

177Lu-edotreotide (ITM-11) is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

ENETS Oral Presentation Details
Title: 177Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study
Date and Time: March 5, 2026, 11:00 am-12:30 pm CET Session; 11:50-11:57 am CET Oral Presentation
Session and Room Number: Clinical Science, Session 2B: Abstract session; Theatre Hall (S2)
Presenter: Thomas Walter, PhD, MD, Professor of Gastroenterology, Hospices Civil of Lyon, France

The e-poster will be accessible to registered participants during the event and available on www.enets.org after the conference.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular standard-of-care therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors.

(Press release, ITM Isotopen Technologien Munchen, MAR 5, 2026, View Source [SID1234663322])

Phio Pharmaceuticals Reports 2025 Year-End Financial Results and Business Update

On March 5, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported its financial results for the year ended December 31, 2025, and provided a business update.

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"Final cohort results mark the culmination of a productive 2025 fiscal year for Phio," said Robert Bitterman, Present and CEO. "Concluding the Phase 1b study with favorable safety, tolerability and pathology data, advancing the CMC and toxicology initiatives while extending our cash runway into 2027 are noteworthy milestones on our continuing pathway to potential approval."

Recent Corporate Updates

PH-762 Clinical Progress

PH-762 is currently being evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762. The study was fully enrolled in November 2025 with a total of 22 patients, 20 with cutaneous squamous cell carcinoma, one with melanoma and one with Merkel cell carcinoma. While final study data is pending formal analysis, an FDA submission intended to propose and seek guidance for next steps in clinical study design for PH-762 is targeted for the second quarter of 2026.

In July 2025, Phio entered into a comprehensive drug substance development services agreement with a US manufacturer. The manufacturer will provide analytical and process development and cGMP manufacture of Phio’s lead development compound PH-762. The cGMP material will support future pivotal clinical development of PH-762.

In December 2025, Phio entered into a development services agreement with a US laboratory to conduct a non-clinical toxicology study, which is required by the FDA prior to commencing a pivotal human clinical trial for registration purposes.

Capital Sourcing

During 2025, Phio strengthened its balance sheet through a series of equity financings and warrant exercises that generated approximately $23.7 million in net proceeds. These transactions extended the Company’s cash runway into the first half of 2027 and will support ongoing clinical development, operational requirements and strategic initiatives.

Patent Portfolio Enhancement and Rationalization

Phio’s patent portfolio includes 54 issued patents, 49 of which cover our INTASYL platform, and of those 27 cover immuno-oncology compounds and therapeutic uses. There are 20 pending patent applications, encompassing what we believe to be important new RNAi compounds and their use as therapeutics, chemical modifications of RNAi compounds that improve the compounds suitability for therapeutic uses and compounds directed to specific targets. The patents that may issue from these pending applications will, if issued, be set to expire between 2029 and 2038.

Scientific News

During 2025, Phio presented new data on PH-762 at several conferences including American Academy of Cancer Research (AACR) (Free AACR Whitepaper), Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and at the Annual Oligonucleotide Therapeutics Society (OTS). The Company was also invited to present its Phase 1b clinical trial data for PH-762 at the American Academy of Dermatology (AAD) in the Late-Breaking Research Session.

Financial Results

Cash Position

At December 31, 2025, the Company had cash and cash equivalents of approximately $21.0 million as compared with approximately $5.4 million at December 31, 2024.

During the year ended December 31, 2025, we completed multiple financings generating total net proceeds of approximately $20.6 million after deducting placement agent fees and offering expenses.

Research and Development Expenses

Research and development expenses for the year ended December 31, 2025 increased 27% as compared with the year ended December 31, 2024. The increase was due to the advancement of our PH-762 clinical program, planning for an upcoming PH-762 toxicology study and higher employee compensation costs.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2025 increased 23% as compared to the year ended December 31, 2024. The increase was due to higher outsourced professional accounting and legal services and stock-based compensation costs.

Net Loss

Net loss was approximately $8.7 million, or ($1.45) per share, for the year ended December 31, 2025 as compared with a net loss of approximately $7.2 million, or ($9.08) per share, for the year ended December 31, 2024. The increase in net loss was primarily due to the changes in research and development and general and administrative expenses, as described above.

(Press release, Phio Pharmaceuticals, MAR 5, 2026, View Source [SID1234663307])

HUTCHMED Reports 2025 Full Year Results and Business Updates

On March 5, 2026 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13) reported its financial results for the year ended December 31, 2025 and provides updates on key clinical and commercial developments.

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HUTCHMED to host results webcasts at 8:00 a.m. EST / 1:00 p.m. GMT / 9:00 p.m. HKT in English on Thursday, March 5, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, March 6, 2026. 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 glossary of abbreviations is on page 29.

Global commercial progress, delivery of sustainable growth and robust balance sheet

FRUZAQLA (fruquintinib ex-China) in-market sales by Takeda were up 26% to $366.2 million (2024: $290.6m), propelled by successful launches, and additional reimbursement coverage, driven by need for novel non-chemotherapy treatments in CRC and ongoing positive experiences of oncologists in 3L+.
ELUNATE (fruquintinib in China) in-market sales were $100.1 million (2024: $115.0m), with strong growth in H2 (H2 up 33% vs. H1).
ORPATHYS (savolitinib) triggered an $11.0 million milestone payment from AstraZeneca for securing China approval for its third lung cancer indication.
Net income attributable to HUTCHMED of $456.9 million (2024: $37.7m), with a cash balance of $1.4 billion at year end, boosted by a $415.8 million divestment gain net of tax.

Antibody-Targeted Therapy Conjugate ("ATTC") platform advances into clinical trials, paving the way for a rich pipeline of new drug candidates entering the clinic

Initiated first clinical trial on first ATTC drug candidate HMPL-A251 in December 2025, quickly following its pre-clinical data presentation at AACR (Free AACR Whitepaper)-NCI-EORTC Conference in October 2025.
Next ATTC drug candidates entered clinical trials, with the HMPL-A580 trial initiated in March 2026, and the third candidate HMPL-A830 aiming to begin Phase I by year end.
Pursuing potential opportunities for partnering ATTC drug candidates with multinational pharmaceutical companies in 2026.

Pipeline progress as planned across late-stage clinical portfolio

Positive FRUSICA-2 Phase III (leading to NMPA sNDA acceptance) and PDAC Phase II results presented at ESMO (Free ESMO Whitepaper) and ESMO (Free ESMO Whitepaper) Asia. ELUNATE with sintilimab in 2L kidney cancer achieved mPFS of 22.2 vs. 6.9 months with axitinib/​everolimus. SULANDA-based combination in 1L metastatic PDAC also showed significant mPFS improvement and an OS benefit trend (data immature), leading to Phase III initiation.
Positive ESLIM-02 Phase III wAIHA results for sovleplenib meeting primary endpoint of durable response rate within 24 weeks. ITP NDA was accepted by the NMPA in February 2026 and wAIHA filing is planned in H1 2026. ESLIM-01 updated results at ASH (Free ASH Whitepaper) showed maximum duration of response of 25.9 weeks with median duration of exposure of around 20 months under a tolerable safety profile. According to IQVIA, ITP has 41,000 new patients every year, on top of another 430,000 existing patients, while wAIHA adds another 26,000 per year in China.
SACHI China and SAVANNAH global lung cancer trials of ORPATHYS combined with TAGRISSO presented at ASCO (Free ASCO Whitepaper) and ELCC conferences, with the data supporting approvals in China and Switzerland, respectively. Enrollments completed for SAFFRON global and SANOVO China Phase III trials with readouts expected within next 12 months.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "Our team’s expertise in the science of creating novel medicines, enhanced by advanced AI tools, positions HUTCHMED as a leader in advancing new modalities. Leveraging this leadership, we actively continue to explore new technologies, assets and targets to complement our portfolio, ready to make good use of our strong balance sheet.

Our Business Development team has encountered interest from multinational pharmaceutical companies to cooperate on the development and launch of novel drug candidates with potential to become global market leaders. Any such potential partnerships would further validate the scientific and commercial value of our new platforms, whilst allowing HUTCHMED to leverage the multinational partners’ advantages regarding global development and marketing expertise to accelerate its novel medicines to address large unmet needs around the world. This strategy has been successfully demonstrated with FRUZAQLA and will be applied to our ATTC technology, which is expected to bear its first fruits this year.

Our company is at a pivotal point. We have repositioned our commercial team to better meet challenges in our environment and to spur sales growth in China, delivering significant improvements from the second quarter of 2025. With late-stage programs, we have demonstrated impressive clinical results in Phase III trials leading to NDA filings, and we have proven experience in gaining approval with major regulatory authorities. Moreover, our large molecule technology platforms have graduated from novel drug discovery into clinical development, with two such drug candidates so far. We see this as a golden opportunity for HUTCHMED to not just work alongside with world leaders in the field, but also to increase our R&D investment and expedite the broad therapeutic potential of our platforms."

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, "2025 has been challenging and we have implemented changes to adjust dynamically our commercial operations. Our sales team has been streamlined and is now well positioned to support growth of our key drugs, with improving sales during the second half of the year. This is all part of ensuring we have a sustainable operation that is ready for the future, where strong earnings from our commercial products drive the development of an exciting pipeline. Our next wave of products, such as sovleplenib and fanregratinib, are currently under regulatory review, strengthening sales and earnings visibility of next few years. Our strong balance sheet with $1.4 billion in cash helps support expeditious development of our ATTC technology platform and its novel drug candidates. 2025 was the third consecutive year of profits for HUTCHMED and we aim to remain financially self-sufficient in discovering and developing more innovative assets into clinical phase."

Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, "We are in a new era of innovative drug development where both speed and quality are more crucial than ever. The HUTCHMED team has consistently risen to this challenge and the past year has been no exception. The late-stage clinical pipeline continues to progress and excite us, whilst our prolific drug discovery engine also continues at pace. We are particularly enthusiastic about the potential of our ATTC platform, originated by our scientists to combine the potency of small-molecule targeted therapy with the selectivity of antibodies. This approach leverages our over 20 years of hard work developing novel, efficacious medicines with better safety profiles, allowing optimum dosing and duration of treatment. We presented preclinical data on our first ATTC candidate at a major conference in October, obtained IND approval in China and the US in November, and dosed our first patient in December. Our team is well equipped with deep knowledge in drug development and experience in gaining approval for quality products around the world."

2025 FULL YEAR RESULTS & BUSINESS UPDATES

I. COMMERCIAL OPERATIONS

Total in-market sales, including FRUZAQLA, ELUNATE, SULANDA and ORPATHYS, of $524.7 million achieved growth in 2025 of 5% despite regulatory and commercial headwinds in the first half of 2025. Our performance in the second half of 2025 represents a significant inflection point with 24% growth of in-market sales compared to first half of 2025 as we begin to see the benefits of repositioning our commercial team to support continued growth.

FRUZAQLA in-market sales by Takeda were up 26% in 2025 at $366.2 million, driven by strong growth following approvals in 38 countries to date, including over 15 in 2025. Recent growth was primarily due to continued launches across Europe, Asia and the Americas (late 2025 launches included Portugal, Belgium, South Korea and Mexico), as it addresses a need for new colorectal cancer treatments. Subsequent reimbursement is also progressing, with availability to date in almost 20 countries, which led to strong uptake, most recently seen following the UK NICE recommendation. The increase was partially offset by the sales impact of the US Medicare Part D Redesign that affected many prescription medicines in 2025. FRUZAQLA stands out with its overall safety profile and low pill burden, alongside attractive efficacy data.

Total consolidated revenue for oncology products decreased 21% to $214.4 million as compared to 2024, primarily due to a $20 million commercial milestone payment from Takeda recognized in 2024 and lower sales in China for ELUNATE, SULANDA, and ORPATHYS due to the aforementioned headwinds. As with in-market sales, oncology product revenue in China have reached a similar inflection point with sales growth of 23% in the second half of 2025 compared to the first half.

Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $71.1 million. Other Ventures revenue, mainly from prescription drug distribution, remained flat at $263.0 million, leading to total consolidated revenue of $548.5 million.

($ in millions) In-market Sales* Consolidated Revenue**
2025 2024 % Change (CER) 2025 2024 % Change (CER)
FRUZAQLA $366.2 $290.6 +26% (+26%) $89.4 $110.8 -19% (-19%)
ELUNATE $100.1 $115.0 -13% (-13%) $76.9 $86.3 -11% (-11%)
SULANDA $27.0 $49.0 -45% (-45%) $27.0 $49.0 -45% (-45%)
ORPATHYS $28.9 $45.5 -36% (-36%) $18.6 $24.5 -24% (-24%)
TAZVERIK $2.5 $0.9 +158% (+156%) $2.5 $0.9 +158% (+156%)
Oncology Products $524.7 $501.0 +5% (+5%) $214.4 $271.5 -21% (-21%)
Takeda upfront, regulatory milestones and R&D services $51.6 $67.0 -23% (-23%)
Other revenue (R&D services and licensing) $19.5 $24.9 -21% (-21%)
Total Oncology/​Immunology $285.5 $363.4 -21% (-21%)
Other Ventures $263.0 $266.8 -1% (-1%)
Total Revenue $548.5 $630.2 -13% (-13%)

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

** FRUZAQLA represents manufacturing revenue, royalties and commercial milestone paid by Takeda to HUTCHMED; 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 HUTCHMED’s sales of the products to third parties.

II. 2025 REGULATORY UPDATES

Savolitinib MAA approved (temporary authorization) by Swissmedic combined with TAGRISSO for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.
Savolitinib sNDA accepted by NMPA with priority review for 3L GC with MET amplification in December.
Savolitinib sNDA approved by NMPA combined with TAGRISSO for 2L EGFRm NSCLC with MET amplification in June, triggering $11.0 million milestone from AstraZeneca.
Savolitinib sNDA approved by NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January, and approved in Hong Kong for under the 1+ Mechanism in February.
Fanregratinib NDA accepted by NMPA with priority review in 2L IHCC in December.
Fruquintinib sNDA accepted by NMPA combined with sintilimab for 2L renal cell carcinoma in June.
Tazemetostat NDA conditionally approved by NMPA for 3L R/R follicular lymphoma with EZH2 mutation in March.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET

Published SACHI China Phase III results in The Lancet after presentation 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).
Completed enrollment of SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399); and completed enrollment of SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).
SAFFRON topline results expected in H2 2026, which could support global filings.
SANOVO topline results expected in late 2026 or early 2027.
Achieved positive data in Phase ІІ 3L gastric cancer registration cohort for MET-amplified patients, supporting the China NDA (NCT04923932).

Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a highly selective oral inhibitor of VEGFR

Presented FRUSICA-2 registration Phase III results at ESMO (Free ESMO Whitepaper) 2025 for 2L RCC, in combination with TYVYT achieving mPFS of 22.2 months versus 6.9 months with axitinib/everolimus (HR 0.373; p<0.0001), and ORR of 60.5% vs 24.3%, with mDoR of 23.7 vs 11.3 months (NCT05522231).

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk

Achieved positive results in Phase III part of ESLIM-02 trial for warm AIHA in China in January 2026, having met its primary endpoint of durable response rate within 24 weeks of treatment. A sNDA submission to the NMPA is planned in the first half of 2026 (NCT05535933).
Resubmitted NDA for ESLIM-01 ITP with additional stability studies in February 2026, to meet NMPA stipulation of a lower impurity limit. Rolling data planned to be submitted in the second half of 2026. The company is pursuing potential partnership to continue overseas development.

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR and CSF-1R

Presented Phase II part results of a China Phase II/III for 1L metastatic PDAC patients at ESMO (Free ESMO Whitepaper) Asia, combined with camrelizumab, nab-paclitaxel and gemcitabine, achieving mPFS of 7.2 months vs 5.5 months with nab-paclitaxel and gemcitabine alone (HR 0.499; p=0.0407), and ORR of 67.7% vs 41.9%. Initiated Phase III part in December 2025 (NCT06361888).

Tazemetostat (TAZVERIK in China), a first-in-class, oral inhibitor of EZH2

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

Positive Phase II registration study data supporting NDA accepted by the NMPA with priority review for IHCC with FGFR2 fusion/rearrangement in December 2025 (NCT04353375).

IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT

HUTCHMED has developed its comprehensive Antibody-targeted therapy conjugates (ATTCs) platform, next-generation solutions for small-molecule inhibitor payloads conjugated to monoclonal antibodies to deliver dual mechanisms of action, designed to meet critical medical needs. Each unique payload has broad potential to lead to a family of antibody conjugate drug candidates from this platform.

HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker

First ATTC drug candidate, based on our PI3K/PIKK inhibitor payload to address the significant challenges faced in targeting this pathway, including on-target toxicities that restrict dosing and feedback loops that enable pathway reactivation. PI3K/PIKK inhibitor payload ATTCs are designed to enhance targeted delivery directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure.
Presented preclinical data at AACR (Free AACR Whitepaper)-NCI-EORTC in October 2025, showing robust antitumor activity with synergistic and bystander killing effects, including compared to co-administration of antibody and payload.
Initiated global Phase I/IIa trial in December 2025, evaluating HMPL-A251 in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors, with sites in the US and China.

HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a PI3K/PIKK inhibitor payload linked to a humanized anti-EGFR IgG1 antibody, via a cleavable linker

Second ATTC based on the PI3K/PIKK inhibitor payload. EGFR is a well-recognized driver in tumor formation and disease progression. Modulation of the PI3K/AKT/mTOR pathway is required for EGFR-mediated tumorigenesis or resistance to EGFR-targeted therapy.
Preclinical data have shown that PAM pathway inhibition synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be presented at an upcoming scientific conference.
Initiated global trial in March 2026, evaluating in EGFR solid tumors, with US and China sites.

Further preclinical progress with antibody drug conjugates

Progressed ATTC drug candidate HMPL-A830, with plans for global IND filings and clinical trial initiations in 2026.

V. COLLABORATION UPDATES

Further progress with ImageneBio on drug candidate IMG-007, discovered by HUTCHMED

HUTCHMED holds approximately 3.8% of ImageneBio, which has the rights to and is developing IMG-007.

Initiated ADAPTIVE Phase IIb trial for moderate-to-severe atopic dermatitis, a randomized, placebo-controlled dose-finding study in approximately 220 patients (NCT07037901). Presented at ISDS positive results from the US/Canada Phase IIa study, showing rapid onset and durable clinical activity after four weeks, well tolerated safety profile without pyrexia or chills, and an extended half-life (NCT05984784).
Presented positive results of a US/Canada Phase IIa trial for severe alopecia areata at ISDS, showing clinical signal of hair regrowth, progressive reduction in scalp hair loss without plateauing by week 36, partial restoration of hair keratins in the scalp, and a well-tolerated safety profile (NCT06060977).

VI. OTHER VENTURES

Other Ventures consolidated revenue, predominantly from the prescription drug distribution business in China, were steady at $263.0 million.
HUTCHMED divested a 45.0% equity interest in SHPL for $608.5 million in cash in April 2025, retaining a 5.0% equity interest. As a result, HUTCHMED’s share of equity in earnings of SHPL in 2025 decreased to $24.6 million.
Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $25.5 million (2024: $47.7m), primarily due to the equity interest disposal in SHPL.

VII. SUSTAINABILITY

The 2025 Sustainability Report will be published in April 2026 alongside the 2025 Annual Report, showcasing our achievements across 11 goals and targets. We have initiated a new target-setting cycle, engaging with the various business units. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026 we will develop this into a final list, including a detailed roadmap for achievement and monitoring.

In 2024 and 2025, the Company conducted a thorough climate risks financial impact assessment, focusing on both physical risks, particularly flood risks and heat stress; and transition risks, such as policy changes. In response to the risks and opportunities identified, we developed targeted mitigation measures to address potential damage and business interruptions. Our transition planning is integrated with the new targets planning, ensuring effective management of risks while capitalizing on the opportunities outlined in the assessments.

Throughout 2025, our sustainability initiatives garnered significant recognition, resulting in 10 prestigious awards from leading industry organizations and consistently strong performance in major ESG ratings. Notably, we were honored as an ESG Leading Enterprise for a third consecutive year and received accolades for Leading Environmental Initiatives and Leading Social Initiatives from Bloomberg Businessweek. Our commitment is reflected in our maintained A ratings from both MSCI and Wind, and A- rating from Hang Seng Corporate Sustainability; our upgrade to B- Prime (top decile rank) from ISS; and ESG Risk rating score further reduced to 21.9 (10th percentile, lower is better) by Sustainalytics. Additionally, we were included in the S&P Global Sustainability Yearbook 2025 as one of the top industry performers. Our efforts were further validated as we ranked third in ESG Excellence in Extel’s Asia Executive Team Survey, based on feedback from over 5,400 portfolio managers and analysts.

FINANCIAL HIGHLIGHTS

Revenue for the year ended December 31, 2025 was $548.5 million compared to $630.2 million for the year ended December 31, 2024.

Oncology/​Immunology consolidated revenue amounted to $285.5 million (2024: $363.4m):
FRUZAQLA revenue was $89.4 million (2024: $110.8m), impacted primarily due to $20 million commercial payment recognized from Takeda in 2024. In-market sales by Takeda were $366.2 million (up 26%) driven by strong growth following approvals in 38 countries to date, including over 15 in 2025.
ELUNATE revenue was $76.9 million (2024: $86.3m), which reflects our initiatives to enhance controls over commercial operations to align with the evolving regulatory landscape and uphold the highest compliance standards. We also streamlined our sales force to build a more efficient commercial organization and to enhance productivity. These initiatives only temporarily weighed on performance, with revenue growth of 29% in the second half of 2025 compared to the first half. This recovery was supported by refocusing on top-tier hospitals and high-potential provinces to maintain our leading market share position in 3L mCRC, and the contribution from the EMC indication that successfully broadened the addressable patient population for ELUNATE.
SULANDA revenue was $27.0 million (2024: $49.0m), which reflects competition from new NRDL entries. In response, we have transformed our marketing strategies which allowed us to maintain the leading position of SULANDA in the NET TKI market and stabilize sales in the second half of 2025 (H2 up 13% vs H1 2025).
ORPATHYS revenue was $18.6 million (2024: $24.5m), impacted by strong competition in the METex14 skipping NSCLC setting. However, sales stabilized in the second half of 2025 as AstraZeneca continues its efforts to increase MET testing as the standard-of-care for late-stage NSCLC.
TAZVERIK revenue was $2.5 million (2024: $0.9m) with increased sales in mainland China since July 2025 following its approval in March 2025.
Takeda upfront, regulatory milestones and R&D services revenue were $51.6 million (2024: $67.0m), due to less R&D and regulatory support services since FRUZAQLA is now fully launched.
Other revenue of $19.5 million (2024: $24.9m), includes $8.5 million (2024: $13.9m) cost reimbursement from partners, which decreased as trials advanced into later stage of development, and a regulatory milestone of $11.0 million from AstraZeneca following China NDA approval for SACHI.
Other Ventures consolidated revenue of $263.0 million (2024: $266.8m) remained flat.

Net Expenses for the year ended December 31, 2025 were $507.4 million compared to $592.5 million for the year ended December 31, 2024, reflecting prioritization of R&D and disciplined cost management.

Cost of Revenue was $336.3 million (2024: $348.9m), generally aligned with lower Oncology/​Immunology revenue. Cost of revenue as a percentage of oncology product revenue remained stable at 39% (2024: 34%).
R&D Expenses were $148.3 million (2024: $212.1m) as we complete higher costs late-stage trials for our assets which have led to NDA applications and approvals. As a result, China and US R&D spending reduced by $36.2 million and $27.6 million, respectively. Nevertheless, we maintain and are committed to ongoing investment in discovery to deliver sustained innovation and have plans to accelerate investment in the global clinical trials of our earlier-stage ATTC programs.
S&A Expenses were $103.0 million (2024: $112.9m). The decrease was mainly due to a reduction in S&A expenses for oncology products which was $33.8 million or 15.8% of oncology product revenue (2024: $45.1m or 16.6%). This efficiency improvement highlights the successful streamlining of the sales force structure and the implementation of spending controls.
Other Items generated net income of $80.2 million (2024: $81.4m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes.

Gain on divestment of SHPL, net of tax was $415.8 million for the year ended December 31, 2025.

Net Income attributable to HUTCHMED for the year ended December 31, 2025 was $456.9 million compared to $37.7 million for the year ended December 31, 2024.

$0.53 basic earnings per ordinary share / $2.66 basic earnings per ADS in 2025 (2024: $0.04 basic earnings per ordinary share / $0.22 basic earnings per ADS).

Cash, Cash Equivalents and Short-Term Investments were $1,367.3 million as of December 31, 2025 compared to $836.1 million as of December 31, 2024.

Adjusted Group (non-GAAP) net cash inflows excluding financing activities in 2025 were $523.3 million mainly due to the receipt of $608.5 million gross proceeds from the partial divestment of SHPL offset by a related $59.5 million capital gain tax payment; $10.0 million regulatory approval milestone payment; and $14.1 million in capital expenditures (2024: net cash outflow of $19.5m mainly due to $17.9m of capital expenditures).
Net cash generated from financing activities in 2025 totaled $7.8 million mainly due to $6.3 million net amount drawn from bank borrowings (2024: net cash outflow of $30.7m mainly due to purchases for equity awards of $36.1m).

Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 0.4% during 2025, which has impacted consolidated financial results as highlighted.

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Financial Statements – HUTCHMED will today file with the US Securities and Exchange Commission its Annual Report on Form 20-F.

FINANCIAL GUIDANCE

HUTCHMED provides full year 2026 guidance for Oncology/​Immunology consolidated revenue in the range of $330 million to $450 million. This guidance reflects continued growth momentum of HUTCHMED’s China commercial operations, ongoing global commercial expansion of FRUZAQLA, and new partnership opportunities for novel drug candidates. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that:

The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and
The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement.

FINANCIAL SUMMARY

Condensed Consolidated Balance Sheets Data

(in $’000) As of December 31,
2025 2024
Assets
Cash and cash equivalents and short-term investments 1,367,275 836,110
Accounts receivable 126,750 155,537
Other current assets 73,317 74,908
Property, plant and equipment 94,623 92,498
Investment in equity investees 10,865 77,765
Other non-current assets 80,267 37,378
Total assets 1,753,097 1,274,196
Liabilities and shareholders’ equity
Accounts payable 45,533 42,521
Other payables and accruals 208,892 256,124
Bank borrowings 93,160 82,806
Deferred revenue 51,547 98,503
Other liabilities 102,703 22,389
Total liabilities 501,835 502,343
Company’s shareholders’ equity 1,237,926 759,929
Non-controlling interests 13,336 11,924
Total liabilities and shareholders’ equity 1,753,097 1,274,196

Condensed Consolidated Statements of Operations Data

(in $’000, except share and per share data) Year Ended December 31,
2025
2024
Revenue:
Oncology/​Immunology – Marketed Products 214,356 271,534
Oncology/​Immunology – R&D 71,183 91,831
Oncology/​Immunology Consolidated Revenue 285,539 363,365
Other Ventures 262,973 266,836
Total revenue 548,512 630,201

Operating expenses:
Cost of revenue (336,349 ) (348,884 )
Research and development expenses (148,295 ) (212,109 )
Selling and administrative expenses (103,028 ) (112,913 )
Total operating expenses (587,672 ) (673,906 )

Gain on divestment of an equity investee 476,896 —
Other income, net 60,955 42,598
Income/(loss) before income taxes and equity in earnings of equity investees 498,691 (1,107 )
Income tax expense (2,477 ) (7,192 )
Income tax expense – Divestment of an equity investee (61,133 ) —
Equity in earnings of equity investees, net of tax 22,651 46,469
Net income 457,732 38,170
Less: Net income attributable to non-controlling interests (823 ) (441 )
Net income attributable to HUTCHMED 456,909 37,729

Earnings per share attributable to HUTCHMED (US$ per share)
– basic 0.53 0.04
– diluted 0.52 0.04
Number of shares used in per share calculation
– basic 858,276,608 855,351,683
– diluted 872,891,120 872,829,129

Earnings per ADS attributable to HUTCHMED (US$ per ADS)
– basic 2.66 0.22
– diluted 2.62 0.22
Number of ADSs used in per ADS calculation
– basic 171,655,322 171,070,337
– diluted 174,578,224 174,565,826

(Press release, Hutchison China MediTech, MAR 5, 2026, View Source [SID1234663323])

Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates

On March 5, 2026 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"In pemvidutide, we have a unique and differentiated compound with the potential to address critical unmet needs of patients with serious liver diseases such as MASH. We are committed to taking the necessary steps to realize its value for all of our stakeholders and have significantly progressed our efforts to strengthen our financial and operational foundation," said Jerry Durso, President and Chief Executive Officer of Altimmune. "We remain focused on ensuring that we have the means and the capabilities to successfully execute Phase 3 development in MASH and capture the significant opportunities ahead of us. We have a number of important inflection points in 2026, most notably the upcoming initiation of our Phase 3 trial of pemvidutide in MASH, for which we are actively finalizing the study plan. Finally, we look forward to the topline data from our RECLAIM Phase 2 trial of pemvidutide in AUD, which we expect to release in the third quarter."

Recent Highlights and Anticipated Milestones

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Positive 48-week data from IMPACT Phase 2b trial reported in December 2025
Statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), with continued reductions from 24-week timepoint
These markers are strongly associated with MASH histologic changes
These results build upon the statistically significant MASH resolution and positive trends in fibrosis improvement observed at 24 weeks
Additional weight loss from 24 to 48 weeks at the 1.8 mg dose with no evidence of plateauing
Greater adherence to treatment in pemvidutide arms, as shown by lower discontinuation rate than placebo group
Adherence likely attributable to favorable safety and tolerability profile of pemvidutide
Breakthrough Therapy Designation granted by FDA
Breakthrough Therapy Designation was granted based on 24-week data from IMPACT trial
This designation is awarded to therapies designed to treat serious or life- threatening conditions that have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on a clinically significant endpoint
Successful End-of-Phase 2 Meeting with FDA
Alignment on Phase 3 registrational trial design confirmed following receipt of meeting minutes
Global Phase 3 trial expected to evaluate multiple pemvidutide doses over a 52-week treatment period with biopsy-based endpoints to support potential accelerated approval
Company has submitted request for scientific advice to European regulators

Alcohol Use Disorder (AUD)

Topline data from RECLAIM Phase 2 trial of pemvidutide in AUD expected in third quarter 2026
The RECLAIM trial is evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with AUD over a 24-week treatment period
Enrollment was completed in November 2025, several months ahead of schedule, signaling significant interest from patients and providers in potential new AUD therapies

Alcohol-associated Liver Disease (ALD)

RESTORE Phase 2 trial of pemvidutide in ALD continuing to enroll
The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with ALD

Corporate Updates

Appointed Jerry Durso as Chief Executive Officer
Mr. Durso, who joined the Company’s Board of Directors in February 2025 and was appointed Chairman in August 2025, is an accomplished life sciences executive with more than 30 years of leadership experience in corporate and commercial strategy, business development and operations. His accomplishments include the development of a successful rare liver disease franchise at Intercept Pharmaceuticals, where he served as Chief Executive Officer until its acquisition by Alfasigma. Previously, he oversaw multiple blockbuster franchises during more than 20 years in senior leadership positions at Sanofi
Strengthened balance sheet
In January 2026, the Company completed a registered direct offering of common stock and pre-funded warrants with Alyeska Investment Group, resulting in gross proceeds of $75.0 million, and raised an additional $8.0 million via the At-the-Market (ATM) facility

Financial Results for the Three Months Ended December 31, 2025

Altimmune reported cash, cash equivalents and short-term investments totaling $274 million as of December 31, 2025, an increase of approximately 107% as compared to $132 million at December 31, 2024
As of February 28, 2026, the Company had approximately $340 million of cash and cash equivalents, reflecting the proceeds from the $75 million registered direct offering and $8 million from the sale of stock under the Company’s ATM facility
Research and development (R&D) expenses were $18.4 million for the three months ended December 31, 2025, compared to $19.8 million in the same period in 2024, with the decrease related to fluctuations in timing of Clinical Research Organization (CRO) related costs. R&D expenses for the quarter ended December 31, 2025, included $12.8 million in direct costs related to pemvidutide development activities
General and administrative (G&A) expenses were $10.5 million and $5.1 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily attributable to additional professional fees and compensation expenses, including a one-time stock compensation and payroll-related expense of approximately $2.6 million in the fourth quarter of 2025
Interest income was $2.4 million for the three months ended December 31, 2025
Net loss for the three months ended December 31, 2025, was $27.4 million, or $0.27 net loss per share, compared to a net loss of $23.2 million, or $0.33 net loss per share, in the same period in 2024

Financial Results for the Year Ended December 31, 2025

R&D expenses were $66.4 million for the year ended December 31, 2025, compared to $82.2 million in the same period in 2024, with the decrease primarily related to the timing of CRO development costs. The R&D expenses for the year ended December 31, 2025, included $42.4 million in direct costs related to pemvidutide development activities
G&A expenses were $28.1 million and $21.0 million for the 12 months ended December 31, 2025, and 2024, respectively. The G&A increase was primarily attributable to a one-time executive transition cost, as well as increases in professional fees and stock compensation and other labor-related expenses
Interest income was $7.5 million for the year ended December 31, 2025, compared to $8.1 million in the same period in 2024
Net loss for the three months ended December 31, 2025 was $88.1 million, or $1.00 net loss per share, compared to a net loss of $95.1 million, or $1.34 net loss per share, in the same period in 2024

Conference Call Information:
Date: March 5, 2026
Time: 8:30 a.m. Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.

The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing.

(Press release, Altimmune, MAR 5, 2026, View Source [SID1234663308])

Starton Therapeutics Files Patent Applications for the Use of CAR-T Cell Therapies in Combination with its Proprietary, Continuous Low-Dose Immunomodulatory Therapy, STAR-LLD, a formulation of Lenalidomide, for the Treatment of Blood Cancer

On March 5, 2026 Starton Therapeutics Inc. ("Starton"), a clinical-stage biotechnology company employing standard-of-care therapies with proprietary continuous delivery technologies, reported that it has filed patent applications covering the delivery of Starton’s proprietary continuous low-dose immunomodulatory imides (IMiDs) in combination with CAR-T cell therapies, which has the potential to enhance CAR-T activity and durability.

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"We are delighted to announce the filing of these provisional patent applications that incorporate both in vivo and ex vivo CAR-T cell therapies in combination with our proprietary subcutaneous formulation," said Pedro Lichtinger, Chairman and Chief Executive Officer of Starton. "We believe this combination has the potential to improve CAR-T cell expansion and persistence while minimizing the concomitant toxicity of the IMiD."

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

(Press release, Starton Therapeutics, MAR 5, 2026, View Source [SID1234663324])