Core Technology: DelSiTechâ„¢ Silica Matrix

The operational foundation of DelSiTech is its patented Silica Matrix technology platform. This platform relies on a low-temperature sol-gel process to encapsulate active pharmaceutical ingredients (APIs) inside a non-porous, biocompatible, and completely biodegradable silica (SiO2) matrix.

Unlike traditional polymer-based matrices (such as PLGA) which degrade via bulk erosion and can cause acidic microenvironments or unstable "burst release" profiles, the Silica Matrix operates through a predictable surface erosion mechanism.

Key features of this material technology include: * Zero-Order Release Profile: Provides stable, linear drug release kinetics with minimal to no initial burst release or therapeutic tailing. * Broad Biomolecule Compatibility: Physically and chemically stabilizes fragile active agents, including single-stranded antisense oligonucleotides (ASOs), messenger RNA (mRNA), monoclonal antibodies (mAbs), complex biologics, and viral vectors. * Tunable Degradation: The degradation rate of the matrix can be precisely programmed from days up to a full year by adjusting the density of hydroxyl (-OH) groups within the silica network. * Environmental Sustainability: The natural silica degrades into non-toxic silicic acid, which is safely excreted by the body and helps reduce active pharmaceutical residues or non-biodegradable plastics from accumulating in the environment.

Product Platforms and Routes of Administration

DelSiTech has engineered its core silica matrix into two primary commercial delivery platforms designed to optimize patient adherence and therapeutic outcomes:

1. Injectable Silica Composite (Parenteral Delivery)

This platform blends drug-loaded silica microparticles with a specialized silica hydrogel, creating an easily syringeable composite depot. It is optimized for high drug loading and can be designed for delivery via multiple parenteral routes: * Subcutaneous (SC) and Intramuscular (IM) injections. * Localized delivery including Intra-articular (joints), Intra-tumoral, Intrathecal, and Intra-operative administration. * Delivers therapeutics continuously over a timeframe ranging from 1 to 12 months from a single injection, matching the performance profiles needed for chronic conditions.

2. Ophthalmic Silica Platforms (Ocular Delivery)

DelSiTech addresses compliance and bioavailability bottlenecks in ophthalmology via two specialized configurations: * Topical Silica Eye Drops: An ophthalmic silica composite designed for conjunctival delivery. Unlike traditional drops that wash away within minutes, these eye drops slowly dissolve over 24 to 48 hours, providing stable, day-and-night therapeutic levels in tear fluid with a single daily application. * Injectable Ocular Delivery: Formulated for intravitreal administration using a fine 30-gauge needle. It provides steady, near zero-order drug release in the back of the eye for several weeks to six months, lowering the required frequency of invasive intraocular injections.

Proprietary In-House Pipeline

DelSiTech leverages its drug delivery platforms to develop "added-value" products and supergenerics aimed at chronic therapeutic segments where patient compliance heavily impacts treatment efficacy.

| Product Candidate | Therapeutic Area | Description / Mechanism | Current Phase | | :--- | :--- | :--- | :--- | | DST-101 | Metabolic Disease | Undisclosed ultra-long-acting injectable targeting metabolic disorders (e.g., obesity or diabetes care). | Pharmaceutical Development | | DST-102 | Metabolic Disease | Secondary ultra-long-acting candidate designed to reduce annual dosing frequency. | Research Stage | | DST-201 | Pain Management | Non-opioid, long-acting small molecule injectable intended to manage postoperative or chronic pain without dependency risks. | Research Stage | | DST-2105 | Ophthalmology | First-in-class long-acting artificial tear silica eye drop formulation for the treatment of severe Dry Eye syndrome. | Clinical (Phase 1 completed for safety/tolerability) |

Note: The company previously advanced DST1308, an entecavir-based three-month long-acting subcutaneous injection for chronic hepatitis B virus (HBV) treatment, alongside partner-supported programs in HIV prevention utilizing broadly neutralizing antibodies (bNAb PGT-121) backed by the Bill and Melinda Gates Foundation.

Commercial Services and Business Model

DelSiTech operates as a full-service contract research and development partner for the biopharmaceutical sector, providing specialized services across the drug optimization lifecycle:

• Feasibility Studies: Partners supply their proprietary target molecules, which DelSiTech's laboratories formulate into preliminary silica-based matrices. These formulations undergo strict in-vitro dissolution testing to verify compatibility, loading capacity, and target release profiles.
• Formulation Optimization and Scale-Up: For successful candidates, engineering teams refine the sol-gel and spray-drying manufacturing parameters to achieve optimal particle morphology and high-yield manufacturing scalability.
• Preclinical Supply and Analytical Development: DelSiTech manufactures active and placebo test items under precise laboratory conditions to support partner-led preclinical pharmacokinetics (PK), pharmacodynamics (PD), and toxicological evaluations.
• Technology Licensing: Upon validation of a stable drug-silica compound, DelSiTech enters into long-term commercial licensing agreements, granting partners regional or global exclusivity to market the resulting combination product.