Curacle Pipeline and Business Update — September 2026

Progress and development plans as of September 22, 2026.

Curacle is translating its research into global partnerships and further development, while preparing its next clinical studies and reviewing priorities across its pipeline. The following update highlights progress in its lead programs, government-supported research and business operations.

Lead Pipeline Progress

MT-103 / MMT-205: Development Following Global Licensing

Following the global licensing agreement signed in May 2026, Memento Medicines is advancing the retinal disease program under the development code MMT-205. The agreement has a total potential value of up to US$1.078 billion. Curacle and MabTics also hold equity in Memento, alongside their contractual milestone and royalty interests.

Memento raised US$93 million in Series A financing in June, co-led by Forbion, RA Capital Management and Avego BioScience Capital, with participation from Sanofi Ventures and Samsara BioCapital. Representatives of these specialist investors also participate in Memento’s board, bringing experience in drug development, business development and investment.

IND-enabling studies are underway, with Memento targeting clinical trial initiation in 2027. Clinical entry would trigger the first development milestone under the agreement. MT-103 is designed to combine Tie2 activation, VEGF inhibition and blockade of Ang-2 binding to Tie2 in a single bispecific antibody. Its development strategy draws on preclinical data on vascular leakage, abnormal angiogenesis and retinal vascular stability.

CU01: Phase 3 Planning, Intellectual Property and Licensing

In a Korean Phase 2b study involving 240 patients with diabetic kidney disease, CU01 significantly reduced urinary albumin-to-creatinine ratio (UACR) versus placebo. Estimated glomerular filtration rate (eGFR) remained broadly stable relative to baseline over 24 weeks. The study also showed a more pronounced UACR reduction when CU01 was added to background standard therapy, including RAAS and SGLT2 inhibitors, compared with standard therapy alone.

These findings are informing the next stage of development. New use-patent applications have been filed in Korea, the United States, China and Japan, with a PCT international application supporting broader protection. Freedom-to-operate and patent landscape studies were completed with specialist advisers by August 2026.

Curacle has held preliminary discussions with Korea’s Ministry of Food and Drug Safety on the direction of Phase 3 design and the regulatory pathway. Discussions with Korean pharmaceutical companies regarding domestic rights are ongoing, while preparations for global licensing draw on the clinical data and expanded patent portfolio.

CU06 / Rivasterat: Preparing a U.S. Phase 2b IND Submission

Curacle is targeting the fourth quarter of 2026 for submission of an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2b study in diabetic macular edema. A prior FDA Type C meeting informed the development strategy, and a global contract research organization is supporting trial design and operations.

A U.S. contract manufacturing organization has been engaged for clinical supply. Manufacturing and final IND documentation are in progress. The planned study will assess visual acuity and safety against a control group in a larger population and over a longer treatment period than Phase 2a, with first patient dosing targeted for 2027.

Four Programs Selected for Government Support

MT-201, MT-501, CU72 and CP02 were selected for government-supported research programs in 2026, providing funding for further development.

MT-201: Antithrombotic Antibody

MT-201 was selected for the Korea Drug Development Fund (KDDF) program. The antibody targets protein disulfide isomerase (PDI), which is involved in platelet activation and pathological thrombus formation. Preclinical work is evaluating antithrombotic activity and effects on normal hemostasis, with the aim of reducing the bleeding risk associated with antithrombotic treatment.

MT-501: AI-Enabled International Collaboration in Vasculitis

MT-501 was selected for an R&D program supported by Korea’s Ministry of SMEs and Startups. The international collaboration with Boston University will combine MabTics’ EAGLES antibody discovery platform with bioinformatics, AI and in silico antibody design. The bispecific antibody is designed to activate Tie2 and inhibit the C5 axis, addressing vascular stability and inflammation together.

CU72: AI-Assisted Lead Discovery for Idiopathic Pulmonary Fibrosis

CU72 was selected for a government program supporting collaboration between pharmaceutical and biotech ventures. Curacle and Standigm are combining AI-based molecular design and optimization with Curacle’s synthesis, pharmacokinetics, safety and animal-model capabilities to identify a preclinical small-molecule candidate.

CP02: Expansion in Companion Animal Medicines

Building on CP01, which is in a Phase 3 study in dogs, Curacle is expanding its veterinary research. The company was selected for Jeonbuk’s regulatory free zone program for next-generation veterinary medicines. CP02 is intended to support candidate discovery and further research in areas of unmet need, including kidney disease in cats.

Additional Pipeline Programs

MT-101, a Tie2-activating antibody for kidney disease, remains a focus of global partnering based on its preclinical data. MT-202 combines PDI inhibition with Tie2 activation to address thrombus formation and vascular stability. Curacle and MabTics are refining indications and development strategies for MT-201 and MT-202 while pursuing preclinical data generation and early partnering opportunities.

CU71 is undergoing candidate optimization following efficacy studies in Alzheimer’s disease models. CU73, an oral small-molecule antithrombotic program, remains in exploratory research. MT-105 for inflammatory bowel disease is in candidate design, with efficacy evaluation planned next.

CU104 for ulcerative colitis and CU106 for use with immuno-oncology therapies are indication-expansion projects based on rivasterat (CU06). Their development plans are being considered alongside CU06’s global partnering strategy and would be refined with a future partner.

Portfolio Priorities and Business Operations

Cross-functional teams, joint workshops with MabTics and external disease-area experts are reviewing the portfolio. The review considers scientific differentiation, development timelines and costs, the competitive landscape, market potential and global licensing prospects. Curacle aims to complete this prioritization work by the end of 2026 and focus resources on its most competitive programs.

The active pharmaceutical ingredient (API) business, brought in-house through a merger in February 2026, generated approximately KRW 2 billion in revenue in the first half of the year. Curacle is also exploring opportunities in adjacent areas, including chemical raw materials.

Near-term priorities are the CU06 U.S. IND submission, continued development and licensing work for CU01, and domestic and international partnering for programs including CU06, MT-101, MT-201 and MT-202.

Adapted from Curacle’s Korean-language update published on September 22, 2026. Development timelines reflect the company’s plans as of that date.