BELACT® DEVELOPMENT

Focused Entry. Broader Cardiovascular Potential.

BELACT® is the lead investigational pharmaceutical development program based on the D016 recombinant hyaluronidase technology.

Its U.S. development strategy considers complementary paths: a focused orphan-oriented approach with homozygous familial hypercholesterolemia (HoFH) being evaluated as the planned lead indication, and broader cardiovascular development opportunities supported by Pantarhin’s U.S. intellectual-property position.

Development sequence and indication prioritization will depend on scientific evidence, regulatory interaction, clinical feasibility and capital requirements.

D016 Technology HoFH Planned Lead Indication Cardiovascular Development Investigational

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BELACT® is investigational. No indication is approved, and no FDA expedited-development designation has been granted.

Development Rationale

Translating D016 Biology Into Pharmaceutical Development

BELACT® evaluates whether the biochemical and biological characteristics of D016 can support a differentiated pharmaceutical development approach within defined cardiovascular settings.

The scientific rationale is based on the investigation of extracellular-matrix structures and their potential relevance to selected cardiovascular disease processes.

BELACT® integrates findings from biochemical characterization, biological research and preclinical studies into a defined development framework.

The scientific rationale provides a basis for investigation. It does not establish clinical efficacy or therapeutic benefit.

D016 BiologyCardiovascular ContextPreclinical EvidencePharmaceutical Development

Development Strategy

One Program. Two Strategic Development Paths.

BELACT® remains one pharmaceutical development program. Pantarhin evaluates two complementary strategic paths so that indication prioritization can reflect scientific evidence, regulatory feasibility, intellectual-property context and capital efficiency.

01 · Focused Development Path

HoFH – Planned Lead Indication

Homozygous familial hypercholesterolemia (HoFH) is being evaluated as the planned lead indication for a focused orphan-oriented development strategy.

Its clearly defined patient population may provide a focused framework for clinical and regulatory development of BELACT®.

The final development pathway remains subject to further scientific evaluation, regulatory interaction and development planning.

HoFH has not received orphan designation for BELACT®, and no expedited FDA status has been granted.

02 · Broader Development Path

Cardiovascular Disease

Pantarhin’s U.S. intellectual-property portfolio includes issued therapeutic-use patents relevant to defined prevention and treatment applications within cardiovascular disease.

This broader field therefore remains an important strategic development opportunity for BELACT® and the underlying D016 technology.

Potential indications and development sequencing will be selected according to the available evidence, unmet medical need, regulatory feasibility, clinical-development requirements and capital efficiency.

No specific broader cardiovascular indication has been established for clinical development or regulatory approval.

HoFHOrphan-Oriented PathCardiovascular OpportunityIndication Prioritization

Development Framework

A Staged Pharmaceutical Development Framework

BELACT® is advanced through a staged development framework integrating scientific, preclinical, pharmaceutical and regulatory activities.

Scientific Development

Evaluation of D016 biology, mechanism-related hypotheses and indication-specific relevance

Preclinical Development

Assessment of pharmacological effects, dose and exposure relationships, safety-related parameters and model-specific findings

Pharmaceutical Development

Characterization, formulation, manufacturing development, analytical methods and quality attributes

Regulatory Strategy & Development

Scientific and regulatory interaction supporting indication prioritization and potential clinical development

Potential Clinical Development

Clinical investigation may follow where supported by the available evidence and applicable regulatory authorizations

Progression between these activities depends on the evolving evidence package and the requirements applicable to the respective stage of development.

SciencePreclinicalPharmaceutical DevelopmentRegulatory StrategyPotential Clinical Development

Development Decision Points

Progression Based on Evidence and Readiness

BELACT® development is guided by defined decision points at which the available scientific, preclinical, pharmaceutical, regulatory and strategic information is reviewed collectively.

Scientific Evidence

Consistency and relevance of the available experimental findings

Preclinical Evidence

Pharmacological findings, dose and exposure relationships and safety-related observations

Pharmaceutical Readiness

Analytical characterization, formulation, manufacturing understanding and quality attributes

Regulatory Requirements

Requirements identified through applicable regulatory guidance and interaction

Development Feasibility

Whether the evidence, infrastructure and capital requirements support the next stage

Progression is not predetermined. Each subsequent development step depends on the evidence and readiness available at the respective decision point.

U.S. Regulatory Strategy

Evaluating Applicable FDA Development Pathways

Regulatory planning for BELACT® is integrated into the pharmaceutical development program and evolves together with the scientific, preclinical and pharmaceutical-development evidence package.

As development advances, Pantarhin intends to evaluate applicable FDA expedited-development pathways for BELACT®, including Fast Track designation where the relevant statutory and scientific criteria may be met.

For the focused HoFH path, Pantarhin also intends to evaluate the applicability of an orphan-focused U.S. regulatory strategy.

Regulatory interactions are intended to clarify development requirements, indication strategy and potential clinical-development design.

No Fast Track, Orphan Drug or other expedited regulatory designation has been granted. Regulatory interaction or eligibility assessment does not constitute approval, endorsement or confirmation of future clinical or regulatory success.

FDA StrategyFast Track EvaluationOrphan-Focused StrategyNo Designation Granted

Clinical Development Context

Clinical Development Requires Evidence and Authorization

Potential clinical investigation of BELACT® would depend on the maturity of the scientific, preclinical, pharmaceutical and regulatory evidence package.

Clinical development may be considered where the available data support an appropriate benefit-risk assessment and where applicable regulatory and ethical requirements have been met.

The population, endpoints, dose selection and scope of any future clinical program would be determined by the selected indication, available evidence and applicable regulatory framework.

No clinical outcome is predetermined, and the planned lead indication remains subject to development and regulatory evaluation.

Evidence PackageBenefit-Risk AssessmentRegulatory AuthorizationClinical Investigation

Development Guided by Evidence and Strategy

BELACT® is being advanced as one investigational pharmaceutical development program with a focused HoFH-oriented entry path and broader cardiovascular development opportunities. Scientific evidence, intellectual-property context, regulatory strategy, pharmaceutical readiness and capital requirements will inform indication sequencing and subsequent development decisions.

D016 TechnologyHoFHCardiovascular DevelopmentU.S. Regulatory Strategy

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