Company Category: Diagnostics

Gate2Brain: Unlocking the Brain’s Therapeutic Potential Gate2Brain is a biotechnology company transforming how medicines reach the brain. We are pioneering a proprietary platform based on peptide shuttles capable of delivering a wide range of therapeutic agents—including small molecules, peptides, proteins, and nucleic acids—across the blood-brain barrier (BBB). Our approach opens new possibilities for treating brain diseases that remain underserved due to delivery limitations, setting a new standard for central nervous system (CNS) therapeutics. The Challenge: Crossing the Blood-Brain Barrier The blood-brain barrier is a highly selective shield that protects the brain from harmful substances, but it also blocks roughly 98% of therapeutic molecules. This makes the treatment of CNS diseases extraordinarily difficult. Despite decades of research, most strategies to bypass or overcome the BBB have fallen short, either lacking efficacy or raising safety concerns. At Gate2Brain, we address this challenge with a safe, effective, and scalable solution. Our Solution: Peptide Shuttle Technology Gate2Brain has developed a proprietary platform of BBB-crossing peptide shuttles with two differentiated mechanism of action, offering a groundbreaking advancement in brain delivery. Our shuttles exploit both transferrin-mediated and caveolin-mediated transcytosis, the latter being a novel, non-saturable and non-receptor-mediated pathway, making our approach highly differentiated. Key attributes of the platform include: • Two different Mechanisms of Action: Both preclinically validated adapting to your molecule needs. • Versatile Cargo Compatibility: Suitable for transporting small molecules, peptides, proteins, and nucleic acids across the BBB for different indications. • Scalable and Sustainable: Short peptides produced via green, cost-effective chemical synthesis. • Non-Invasive Delivery: Administered systemically, avoiding direct CNS injection or invasive procedures. Our shuttle peptides are protected by strong IP and have demonstrated compelling preclinical proof-of-concept in multiple models. The platform’s robustness is now being validated through our lead asset, G2B-002, which represents a critical milestone in demonstrating its full potential. G2B-002: Proof of Concept for Platform Validation Our first therapeutic candidate, G2B-002, is designed to treat brain tumors by enabling precise delivery of a clinically validated anticancer agent using our proprietary shuttle MiniAp4. Its first indication is Diffuse Intrinsic Pontine Glioma (DIPG)—a lethal, inoperable pediatric brain tumor with a median survival of less than one year and no curative treatment. Located in the brainstem, DIPG cannot be surgically removed, and the BBB severely limits the efficacy of conventional chemotherapies. G2B-002 is engineered to overcome this barrier and deliver its therapeutic payload directly to the tumor site, potentially improving outcomes while minimizing systemic toxicity. G2B-002 has received Orphan Drug Designation from both the EMA and FDA. The program is currently in IND-enabling studies, with the goal of initiating a first-in-human clinical trial at Hospital Sant Joan de Déu in Barcelona. Following the validation of the platform’s safety and efficacy in DIPG, we plan to expand G2B-002 to treat other pediatric and adult CNS malignancies, such as glioblastoma and high-grade gliomas. Business Model Gate2Brain is focused on delivering value through strategic collaborations and licensing, while simultaneously building an internal pipeline to demonstrate the platform’s transformative potential. 1. Strategic Collaborations and Platform Licensing We actively seek partnerships with pharmaceutical and biotech companies developing CNS-targeted therapeutics. Our brain delivery platform significantly enhances the brain uptake of partner molecules, enabling or improving treatments for a broad range of CNS conditions. • Flexible Collaboration Models • Cross-Modality Compatibility • Extending IP rights through NCE protection These collaborations serve as the cornerstone of our business model—scaling the impact of our technology, validating it across indications, and accelerating drug development for our partners. 2. Internal Therapeutic Pipeline (Platform Validation) Our internal pipeline demonstrates the power and versatility of our delivery technology, starting with G2B-002. This pipeline serves a dual purpose: to validate our platform in clinical settings and to generate high-value assets that can be developed independently or in collaboration with partners. Fundraising Strategy Gate2Brain is backed by a mix of public and private funding and has a clear financing roadmap to advance our platform and programs. Current and Upcoming Rounds: • €1.5M Bridge Round (Ongoing) Funding the completion of IND-enabling studies for G2B-002 and advancing key strategic collaborations • €10M Series A (Q1 2026) To fund a unicentric clinical trial for DIPG at Hospital Sant Joan de Déu and drive forward platform validation. Proceeds will also support business development, licensing efforts, and early pipeline expansion. Our fundraising strategy supports both immediate clinical goals and long-term growth, offering investors a high-impact opportunity to participate in a differentiated CNS platform with multi-asset and multi-partner potential. Vision for the Future At Gate2Brain, we envision a future where the blood-brain barrier is no longer a barrier to innovation. Our platform opens the door to safe, effective, and systemic delivery of therapeutics to the brain—offering hope to patients with brain tumors, rare pediatric diseases, and chronic neurological conditions. By combining scientific excellence with a strong collaborative spirit, we aim to redefine brain delivery and bring new treatments to those who need them most. Join Us Gate2Brain is more than a technology company, we are a purpose-driven team committed to solving one of medicine’s greatest challenges. Whether you are an investor, pharmaceutical partner, or mission-aligned collaborator, we welcome you to join us on this transformative journey.