Day 2Tuesday, 4 November 2025

Location: Exhibit Hall Stage

Europe has the talent, science, and ambition to lead in biotech innovation—but its potential remains fragmented across geographies and governance levels. In this session, we bring together voices from both the policy and industry sides to explore how Europe can intentionally design a more connected, competitive, and founder-friendly biotech landscape. What will it take to move from scattered regional hubs to a united front of innovation? What role should policymakers, incubators, and industry leaders play? And how do we translate the vision of a European biotech powerhouse into concrete action? Join us for a conversation at the intersection of strategy and implementation, where bold ideas meet operational reality.

Location: Exhibit Hall Stage

Biopharmaceutical companies with products in late-stage clinical development often encounter significant challenges when entering the European market. While the European Union offers a unified market authorization procedure, market access and reimbursement remain under the jurisdiction of individual member states—a situation unlikely to change in the near future. The harmonization of health technology assessments (HTA), which began rolling out in early 2025, focuses solely on clinical evaluations, leaving pricing decisions to be made independently by each country. Additionally, navigating the complex system of price referencing between European nations presents another layer of difficulty.

Despite these obstacles, Europe has seen the successful launch of innovative therapies, particularly in rare diseases.

This session will leverage case studies to explore key considerations for companies not yet established in Europe. It will provide insights into how to achieve successful market entry, address the challenges of the price referencing system, and evaluate the value of a therapy in the European context—whether for licensing or direct commercialization. Attendees will gain practical strategies for overcoming hurdles and tapping into the opportunities within the European biopharma market.

Location: Exhibit Hall Stage

The U.S. market for medicines has expanded in size and complexity in recent years and represents about 60% of the world market for branded drugs. European biotechs looking to reach patients in the U.S. and benefit from the commercial opportunities in that market have to contend with a range of regulatory, reimbursement and policy complexities. With a new Administration and new leadership in key government agencies in place, understanding the current dynamics is important for investors and biotechs alike. This panel discussion will focus on the implications for biotechs in terms of clinical development program design, accessing the U.S. market, strategic partnership opportunities, and balancing European focus with American opportunity.

Discussion areas will include:

• What are the most significant areas of change underway in the U.S.?

• What are the implications for the biotech sector?

• How are clinical development programs adapting to the Inflation Reduction Act and other FDA-led initiatives?

• How do European biotechs view U.S. market attractiveness and how has this changed?

Location: Exhibit Hall Stage

In the post-pandemic world, companies worldwide face fragile supply chains, and biotech is no exception. Resilient supply chains are essential to deliver life-saving biotech innovations to patients. They enable all regions to contribute to, and benefit from, global advances in biotechnology. Panelists from national trade associations and companies will explore both national and international viewpoints on supply chain challenges, opportunities, and shared priorities.

Location: Room 2

In biotech partnering, everyone talks about being the preferred partner - but how often do we act that way? In a world where "we'll circle back" can mean silence, and ghosting has become a silent industry norm, just getting a response from a pharma partner can feel like a win. This session brings together investors, pharma dealmakers, and biotech executives to explore the real value of candor in a sector where vague feedback and polite deflections waste time and stall innovation. From pitch meetings to scientific evaluations, we'll unpack how direct dialogue with real feedback can build better partnerships, faster decisions, and less churn for all parties. Clear communication is a win-win for investors, pharma and biotech companies, so why is it an exception and not the norm? Expect real talk, practical tactics and ideas, and no sugarcoating— just straight-up insights into creating a culture of clarity in biotech investment and dealmaking. Isn’t it overdue?

Location: Room 2

The Startup Spotlight is a pitch competition featuring the most innovative startup biotech companies. This live competition will give a group of hand selected startups the opportunity to pitch in front of the BIO-Europe audience. A panel of esteemed judges will evaluate the pitches and select the winners.

F2G is a clinical-stage biopharmaceutical company focused on the discovery development and commercialisation of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. Olorofim is F2G’s leading candidate from this class and has fungicidal activity against a broad range of mould infections including a variety of rare and resistant moulds that cause life-threatening infections for which current therapies have limitations or are ineffective including coccidioidomycosis. Olorofim is currently in a Phase 3 RCT study for invasive aspergillosis. Olorofim has received orphan drug status from the European Medicines Agency and orphan drug status, Qualified Infectious Disease Product (QIDP) designation and Breakthrough Therapy designation from FDA. F2G is headquartered in the UK with subsidiaries in the US and Austria.

Lmito Therapeutics is an innovation-driven biotech company pioneering therapies for neurological, autoimmune, and fibrotic diseases through metabolic reprogramming. Lmito aims to address root causes of chronic and rare diseases, delivering transformative benefits for patients with limited options.

[Scientific Platform]
Metabolic Reprogramming: Lmito's proprietary platform targets disease-driving cells like immune cells and fibroblasts in pathogenic microenvironments. By modulating cellular metabolism, Lmito's oral small molecules restore balance without broadly suppressing normal immune function.

[Therapeutic Pipeline]
Lmito's pipeline includes LMT801, a neurometabolic reprogramming asset for neuropathy and neuroinflammation in IND-enabling stage with FDA Orphan Drug Designation; LMT503, an immunometabolic reprogramming asset for inflammatory bowel disease in Phase 1 trial approved by EMA; LMT837, a fibrometabolic reprogramming asset for idiopathic pulmonary fibrosis and ALS in IND-enabling stage; and LMT3012, a PKM2 activation asset for autoimmune and fibrotic diseases in preclinical development.

[Strategic Partnerships & Validation]
•JLABS Korea Portfolio Company: As an inaugural member of Johnson & Johnson Innovation - JLABS Korea, Lmito benefits from global mentorship, resources, and a collaborative ecosystem accelerating R&D and growth.
•Lmito holds a strong patent portfolio for its lead compounds and platform technologies, ensuring long-term competitive advantage.
•Series B Funding Stage: Lmito is actively raising Series B capital to advance clinical programs and expand its pipeline.
•Business Development: The company is open to strategic partnerships, licensing, and investment opportunities.

Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers.

The company uses its proprietary Peptide Drug Conjugate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Its flagship drug is currently being commercialized in Europe with partnership agreements for South Korea, the Middle East and Africa and elsewhere.

Oncopeptides is also developing several new compounds based on its two proprietary technology platforms PDC and SPiKE.

The company was founded in 2000, has about 80 employees with operations in Sweden, Germany, Austria, Spain and Italy. Oncopeptides is listed on Nasdaq Stockholm with the ticker ONCO.

For more information see: www.oncopeptides.com

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization.

For more information about Precigen, visit www.precigen.com.

Founded in 2024 as a spin-off from the University of Limoges, Curlim brings together three PhD scientists and a C-level Business person to tackle one of the biggest unmet needs in neurology: effective treatment for hereditary peripheral neuropathies. Our first mission: to develop a breakthrough therapy for Charcot-Marie-Tooth disease type 1A (CMT1A) — the most common hereditary neuropathy, caused by progressive demyelination and axonal damage. Our operational team is composed of an over 20 year experience CDO, bringing his expertise to all our workflows, CMC, preclinical and clinical studies, a PhD in neuroscience in charge of regulatory affairs and preclinical aspects, a development engineer involved in the development of CLM001 nanodrug, a FP&A junior manager dealing with administrative and finance topics and a CEO who has held C-level positions across various healthcare environments.

Evox Therapeutics is an Oxford-based biotechnology company devoted to developing transformative therapeutics for neurological and neurodegenerative diseases by uniting engineered exosomes with next-generation genome editors. Evox is advancing a focused pipeline of first-in-class therapeutics for genetically defined CNS disorders. Our lead ATXN2 programme for spinocerebellar ataxia type 2 and amyotrophic lateral sclerosis is on track for CTA-enabling studies set to begin in 2026. A second programme targeting MSH3 for Huntington’s disease is progressing in parallel, and the modular nature of ExoEdit™ positions us to scale rapidly across additional repeat-expansion and monogenic indications. Evox’s growth is funded by blue-chip investors, including Redmile, OrbiMed, GV, Invus, and Lilly, and reinforced by validating strategic partnerships.

Herantis Pharma is a clinical-stage biotechnology company developing HER-096, a disease modifying therapy for Parkinson’s disease. The company completed Part 1 of the Phase 1b trial in November 2024 and received encouraging data about the behavior of HER-096 in the human body, in particular information about the appropriate dose level and regimen supporting the preparation for the Phase 2 study. In January 2025, the Phase 1b trial progressed to the second part, where the HER-096 investigational drug was administered to Parkinson's patients for the first time. From the placebo-controlled second part of the trial, we will receive noteworthy new information about the safety of repeated doses of HER-096 and possible biomarker data related to the potential treatment response. In addition, we will monitor the symptoms of Parkinson's patients during the four-week dosing period and the following four-week observation period, both using clinical assessment and a wearable device that continuously monitors motor symptoms. Topline data from the Phase 1b clinical trial is expected in September-2025. In July 2024, Herantis obtained a financing of 3.6 million Euros from the two leading Parkinson’s charities, the Michael J. Fox Foundation and Parkinson’s UK, after a comprehensive review of our science, underlining the groundbreaking potential of HER-096. These organizations are closely following our progress in the HER-096 development program with great interest. The same applies to the pharmaceutical industry. Herantis is now among a limited group of companies worldwide that are preparing for Phase 2 clinical trials with a drug candidate that aims to stop or slow the progression of Parkinson's disease.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland.

Vesper Bio is a private, VC-backed, clinical stage company with world-leading domain expertise in Vps10p domain receptors. Developing oral therapy for Frontotemporal Dementia and a rich pipeline of first-in-class small molecule sortilin modulators for a number of critical unmet medical needs.

AltRegen is a clinical-stage biopharmaceutical company dedicated to developing first-in-class therapies for age-related macular degeneration (AMD), a leading cause of vision loss in the elderly. Our mission is to restore and preserve sight by targeting the earliest pathogenic changes in retinal aging.

Our lead asset, ATR211, is a novel oral therapeutic derived from a proprietary triterpenoid saponin compound. Unlike current treatments that focus on late-stage complications such as neovascularization, ATR211 addresses the root cause of AMD by restoring the physiological function of Bruch’s membrane - a critical barrier that regulates nutrient and waste exchange between the retina and the choroid. Age-related biochemical and structural changes in this membrane impair retinal health and contribute to photoreceptor degeneration. ATR211 works by enhancing extracellular matrix remodeling and promoting waste clearance, thereby restoring metabolic support to the retinal pigment epithelium and photoreceptors. ATR211 is currently being evaluated in a Phase 2b clinical trial (SAMADI) in the United Kingdom, targeting patients with intermediate AMD. The trial is designed to assess functional outcomes, including improvements in dark adaptation and retinal sensitivity.

Founded by scientists with deep expertise in retinal biology, extracellular matrix research, and translational medicine, AltRegen is built on decades of academic and clinical insight. Our team brings together global collaborators across academia, CROs, and regulatory partners to accelerate the path to first approval. We are actively seeking strategic partnerships to support global development, commercialization, and new indications beyond AMD. With a strong scientific foundation and clear therapeutic differentiation, AltRegen aims to become a leader in the next generation of vision-restoring therapies.

Epion Therapeutics (Epion) is developing EpiSmart™, a minimally-invasive treatment for keratoconus and ectatic corneal disease that could bring early intervention to millions of patients globally. EpiSmart’s true epithelium-on approach – without chemical or physical disruption of the epithelium – is designed to reduce patient discomfort and significantly reduce recovery time versus current standards of care. Unlike current treatments for keratoconus, EpiSmart is designed to be implemented as early as initial diagnosis and on both eyes simultaneously. Results of Epion’s recent Phase 2 trial, the largest study to-date of corneal cross-linking as a treatment for keratoconus, indicate improvements in visual acuity after EpiSmart treatment at levels similar to currently available treatments. Of the 784 patients with keratoconus who were followed for 12 months, over 80% had stable or improved vision following EpiSmart treatment. Epion initiated Phase 3 clinical trials for the treatment of keratoconus with EpiSmart in Q4 2023. Funded by the AXA IM Global Health Fund and over 50 cornea specialists, Epion expects to read out its Phase 3 trial for FDA submission in early 2026.

NEORETESBIO Inc is a preclinical-stage biotech company developing a next-generation vascular-regenerative antibody platform that addresses the root causes of ischemic and degenerative diseases. Our lead asset, Tri-VasTrap™ (TVT), is a first-in-class Ang2 inhibitor and Tie2 activator that restores capillary perfusion, regenerates avascular areas, and normalizes microvascular architecture.
TVT has shown robust efficacy in preclinical models of retinal ischemia, demonstrating superiority over anti-VEGF agents by repairing ischemic microvasculature rather than merely blocking neovascularization. It is effective via both intravitreal and subcutaneous (SC) administration, with SC delivery offering a breakthrough opportunity to expand beyond ophthalmology to systemic vascular diseases such as diabetic nephropathy, stroke, and dementia.
With this unique mechanism and delivery flexibility, TVT has the potential to transform treatment paradigms for patients with chronic ischemia and perfusion deficits-conditions currently underserved by existing biologics. Our goal is to redefine anti-VEGF therapy with a regenerative, systemically accessible alternative.
NEORETESBIO is headquartered in Pangyo, South Korea, and is preparing IND-enabling studies through access to qualified CDMO and GLP partners.. We have secured multiple government-backed R&D programs (TIPS, KDDF, K-BioLabHub) and are on track for IND filing in retinal indications by 2027. Founded by Dr. Yong-In Kim, a veteran biologics leader from Abbott, Novartis, and Samsung, NEORETESBIO brings a proven track record and global development vision.
We are applying to present at BIO-Europe 2025 to showcase this novel approach and seek global partnerships to bring this innovation to patients worldwide.

Neuracle Genetics is a clinical-stage biotechnology company focused on developing innovative adeno-associated virus (AAV) gene therapies to address critical unmet needs in retinal and neurological diseases. Leveraging proprietary technologies, our product candidates are designed for optimal safety and efficacy, aiming to broaden access to transformative treatments for patients worldwide.

Our lead candidate, NG101, is a best-in-class AAV gene therapy for wet age-related macular degeneration (wAMD). In November 2024, NG101 received Fast Track designation from the FDA, underscoring its potential to meet a significant medical need. NG101 is currently in a Phase 1/2a clinical trial in the US and Canada and has demonstrated promising efficacy at the lowest dose with a clean safety profile.

Neuracle Genetics is also advancing two preclinical-stage assets: NG201 for neuropathic pain and NG103 for dry age-related macular degeneration (dAMD).

We are committed to pioneering AAV gene therapies that deliver lasting therapeutic impact, harnessing advanced AAV technology to improve patient outcomes and quality of life.

OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. A Phase 2 trial of urcosimod to treat neuropathic corneal pain patients was just completed by OKYO.