Day 2Tuesday, 18 March 2025

Location: Exhibit Hall Stage

Increasingly, smaller biotech companies are launching their new drugs themselves, rather than relying on large pharmaceutical companies to make this happen for them. How can they get it right the first time?

Managers of biotech companies with a drug in late-stage clinical development face a challenge: as their asset progresses well in clinical trials, they need to decide whether to license it out or market it themselves. In the European Union, the number of companies that market only a single pharmaceutical product has increased from four in 2014 to 33 in 2024. This panel will discuss the deciding factors for successfully marketing a product independently in Europe.

What are the pros and cons of launching a product oneself instead of licensing it out? Which products are better suited for out-licensing? How does the EMA support

biopharmaceutical companies that are applying for marketing authorization for a pharmaceutical product for the first time? What role does the harmonized HTA assessment procedure play in market access and reimbursement, and how can it be aligned with marketing authorization?

Location: Exhibit Hall Stage

The biotech industry is rapidly evolving, with new therapeutic areas and innovative funding models emerging to drive advancements in healthcare. This panel explores the interdependent ecosystem of biotechs, research collaborators, and funding models, and how they are revolutionizing the business of biotech. We examine the latest trends in therapeutic areas, including gene therapy, immunotherapy, and precision medicine, and how they are transforming drug development. We also explore the role of research collaborators, such as CROs, in driving innovation and accelerating drug development. Finally, we discuss the latest funding models, including venture capital, public-private partnerships, and crowdfunding, and how they are changing the way biotechs raise capital and bring new therapies to market. By examining the interplay between these key elements, we provide insights into the future of the biotech industry and the potential for continued innovation in healthcare.

Location: Coral 1

Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company's lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 1/2a trial in patients with advanced solid tumors including pancreatic cancer. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor of MEK currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company's development pipeline also includes several early-stage programs.

Location: Coral 1

AmMax Bio ("AmMax") is a venture-backed clinical-stage oncology company focused on the development of first-in-class therapeutics to address significant unmet needs and large market potential. It was founded in 2020 out of a partnership with Amgen wherein AmMax gained an exclusive worldwide right to AMB-066. Amgen has a minority stake in AmMax.

AmMax has an experienced management that has a proven track record and collectively covers the entire spectrum of drug development and commercialization across multiple modalities. It is led by Larry Hsu, Ph.D., who founded and led the successful IPO of Impax Laboratories on the NASDAQ with over $3 billion in market cap.

Leveraging its translational science expertise and clinical development experience, AmMax has built a robust portfolio. At the core of its portfolio are AMB-066, in Phase 2, for colorectal cancer minimal residual disease (CRC MRD) and AMB-104, an antibody-drug conjugate (ADC), for acute myeloid leukemia (AML) and solid tumors.

AMB-066 has the potential to be the first-to-market treatment for CRC MRD, an indication representing potentially a $6 billion market in the US and 5EU. CRC MRD is diagnosed by positive ctDNA and the lack of radiographic evidence of tumor in patients post surgery with/without peri-operative therapies. These patients are at a much higher risk to develop metastasis, typically within 12 months, and are currently without treatment options.

AMB-104 is the only ADC in active development that targets colony stimulating factor 1 receptor (CSF1R) to address the significant unmet needs in AML. AMB-104's unique mechanism of action also renders it the potential to target a wide range of solid tumors. Even with several approved therapies, AML is poorly served: ~20-40% of newly diagnosed don't achieve CR1 and > 50% of CR1 relapse within 3 years; Significant portions of patients have no actionable biomarkers; Existing therapies in the R/R setting have limited efficacy with OS <10% at 3 years.

Location: Coral 1

Precirix is a private biotechnology company dedicated to extending and improving the lives of cancer patients by designing and developing precision radiopharmaceuticals, using camelid single-domain antibodies (sdAb) labelled with radiometals. Our precision radiometal sdAb platform technology allows us to rapidly and reliably generate highly precise TRT for any cancer surface target, with unparalleled tumor retention, rapid blood clearance and minimized off-target effects

Location: Coral 1

Tempus aims to transform precision medicine by delivering Intelligent Diagnostics, harnessing AI to elevate laboratory testing in healthcare. These diagnostics enhance accuracy by connecting lab results directly to each patient's clinical data, creating personalized insights that guide treatment options, drug recommendations, trial selections, and clinical care pathways tailored to individual patient profiles.
At the core is the Tempus Platform, which integrates an advanced technology framework with an operating system that liberates healthcare data from traditional silos, making it actionable for physicians and researchers. With one of the largest global libraries of clinical and molecular oncology data, Tempus seeks to embed AI, including generative AI, across diagnostics to support data-driven decision-making. This platform empowers healthcare professionals to provide highly personalized care, leveraging a robust dataset that informs clinical insights and optimizes patient outcomes.
Recent advancements in cloud computing, imaging technologies, large language models, and cost-efficient molecular profiling-paired with an increasingly digital healthcare ecosystem-have created a ripe environment for scaled AI implementation. Despite the availability of healthcare data, many practitioners remain limited in their ability to apply it meaningfully. Most traditional diagnostic approaches focus on isolated data points, like specific biomarkers, rather than a comprehensive, integrated clinical profile necessary for precision care.
Tempus addresses this gap by establishing seamless data channels between providers, allowing a continuous flow of information across healthcare settings. This infrastructure enables real-time data exchange, empowering diagnostic labs, life sciences, and clinical institutions to access actionable insights. The Tempus Platform is actively deployed across the U.S., primarily in oncology, and is expanding into neuropsychology, radiology, and cardiology.

Location: Coral 1

FoRx Therapeutics develops innovative small molecule inhibitors that target DNA Damage Response (DDR) pathways for anti-cancer therapy. Since DNA damage is a hallmark of cancer and requires continuous repair, the company's approach is to inhibit distinct DDR proteins and deprive cancer cells of their repair capability, resulting in the cells' death.

The company's pipeline encompasses novel, first-in-class as well as differentiated, best-in-class programs for oncology indications. The lead program is a highly potent and selective PARG inhibitor, FORX-428, which is being evaluated in IND enabling studies. The company is currently in the process of transitioning to a clinical organization and has recruited a CMO to advance FORX-428 through clinical studies.
FoRx Therapeutics has 15 employees and is backed by EQT Life Sciences (formerly LSP), M Ventures, Omega Funds, Novartis Venture Fund and Pfizer Ventures, having raised a total of 30 million CHF in Seed Financing and 10 million CHF in Bridge Financing.

Location: Coral 1

Graph Therapeutics (Graph) is an AI-driven precision immunology startup developing a unique target validation platform that integrates multi-modal ex vivo perturbation screening with matched molecular profiling in primary patient samples. Our platform addresses a critical bottleneck in immune disease drug development - the lack of robust, clinically realistic target validation prior to expensive asset development. By bringing forward key elements of translational validation to the discovery phase, we can significantly reduce the current ~90% failure rate of clinical trials.

Our approach uniquely combines functional validation through siRNA knockdowns in disease-relevant primary cell models with matched multi-modal profiling at single-cell resolution, capturing morphology, transcriptomics, and protein expression in the same cells. This is integrated with clinical benchmarking through systematic comparison to standard of care drug responses in a lab-in-the-loop framework that continuously incorporates validation data to improve target predictions.

Graph builds on a decade of experience pioneering similar approaches in oncology, including development of the only ex vivo precision medicine platform validated through prospective interventional trials. We are currently funded by leading deep tech investors including Merantix Ventures, having raised €3.1M in pre-seed. Graph is actively developing core target validation capabilities alongside our sterile inflammation discovery program, positioning us to rapidly validate novel therapeutic targets as they emerge from our platform. Our goal is to build the industry's most comprehensive validation stack for immune disease targets, enabling better and faster therapeutic development for millions of patients with immune-mediated diseases.

Location: Coral 1

ImmunOs Therapeutics AG has developed a proprietary human leukocyte antigen (HLA)-based platform to generate a novel class of biologic therapeutics for the treatment of cancer and autoimmune disease.
Its lead asset IOS-1002 is in Phase I clinical trial in solid cancer.
ImmunOs is backed by an international consortium of top-tier investors, including Gimv, Pfizer Ventures, Mission BioCapital, BioMed Partners and Doublepoint Ventures.

Location: Coral 1

IO Biotech is transforming the treatment of cancer patients through the discovery and development of novel immune-modulating therapeutic vaccines, including the most clinically advanced therapeutic cancer vaccine program in development for 1st line patients with advanced melanoma

Corporate Positioning Statement:

Founded in 2014, IO Biotech (Nasdaq: IOBT) is a clinical-stage biopharmaceutical company dedicated to transforming the lives of cancer patients through novel therapeutic vaccines. IO Biotech is developing immune-modulating vaccines that turn the tumor microenvironment hostile to cancer and immune-suppressive cells. Early data suggests that these vaccines have the potential to improve patient outcomes without adding systemic toxicity.
IO Biotech's lead candidate, IO102-IO103, is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the TME by stimulating activation and expansion of T cells against IDO+ and PD-L1+ cells. IO102-IO103 is currently in a pivotal Phase 3 trial for advanced melanoma, with the primary endpoint expected to read out in the first half of 2025, and in Phase 2 trials for other advanced solid tumors and for resectable solid tumors. The U.S. Food and Drug Administration granted IO102-IO103 a breakthrough therapy designation for the treatment of advanced melanoma in combination with pembrolizumab in 2020.
The company is headquartered in Copenhagen, Denmark with U.S. headquarters in New York.

Location: Coral 1

Oncolys aims to contribute to the advancement of medical science, by bringing innovation to the existing treatments for "cancer" and "serious infectious diseases", leveraging our virology-based new drug discovery technologies.
Especially in the oncology area, Oncolys develops OBP-301(Telomelysin). OBP-301 is a gene-modified oncolytic adenovirus in which selectively replicate in cancer cells by introducing human telomerase reverse transcriptase (hTERT) promotor. Oncolytic adenovirus has much potential for cancer immunotherapy because its viral replication is highly immunogenic, and oncolysis induced by such virus releases tumor antigen and provides costimulatory danger signals. From the result of phase 1 clinical study in the US, Telomelysin showed abscopal effect, which non-injected tumor as well as injected tumor was regressed in melanoma patients after single injection into one single tumor and found that not only increasing infiltration of CD8 and antigen presenting cells but diminishing Treg cells in injected tumor site.
Oncolys BioPharma has completed a pivotal study of OBP-301 in Japan in Esophageal cancer combination with RT, and planning NDA in 4Q2024-1Q2025 (JP). OBP-301 clinical trials are also ongoing for Head and neck cancer, TNBC, and HCC.

Oncolys USA our fully owned subsidiary, was established in 2016 and plays a crucial role in expanding our reach within the US market, facilitating clinical trials and fostering collaborations within leading research institution. Oncolys USA is conducting several early phase I/II studies in Esophageal cancer Gastric cancer and is planning to initiate pivotal phase 2/3 study in esophageal cancer as first indication for approval in the US. In addition, Oncolys USA is planning on expanding the label of OBP-301 in the US to Head and Neck cancer and TNBC. Oncolys USA will have exclusive rights for OBP-301 and our second-generation oncolytic virus, OBP-702 within 2025

Location: Coral 1

Altevax is a French clinical-stage biotechnology company pioneering first-in-class immunotherapies using synthetic melanin to create biological nanoparticles that carry specific antigens. This innovative approach induces a robust and targeted immune response against tumors. Altevax's lead program focuses on glioblastoma (GBM), with a First-in-Human trial launched in November 2024.

Our proprietary technology serves as a versatile vaccine platform with potential applications across a wide range of cancers. Preclinical proof-of-concept studies have demonstrated the platform's efficacy in multiple animal models. By leveraging synthetic melanin as a carrier, Altevax enhances antigen presentation to the immune system, effectively activating T lymphocytes for a specific anti-tumor response.

Altevax targets TERT, an antigen highly expressed in glioblastoma cancer cells. The melanin-TERT nanoparticle vaccine stimulates a strong immune response, addressing the challenges posed by weakly immunogenic self-antigens by incorporating them into the melanin nanoparticle.

Altevax's proprietary platform represents a groundbreaking advancement in cancer immunotherapy. With its potential to address high unmet medical needs, this novel approach offers new hope for transforming treatment paradigms and improving outcomes for cancer patients.

Location: Exhibit Hall Stage

Break, breathe, and thrive!

Take a break from your busy schedule to recharge and rejuvenate by immersing yourself in moments of tranquility and self-care.

These sessions are designed to refresh your body and mind so you can get through a full conference day with more ease.

Open to all, without prerequisites.

Sustainability Focus Area: Social Responsibility

Location: Coral 3

Join leading pharma and venture investors and unravel strategies for navigating the current dealmaking landscape. Uncover trends, actionable insights, and key considerations for building successful partnerships, along with the tools to thrive in today’s competitive environment to drive impactful collaborations.

Location: Exhibit Hall Stage

This session focuses on how to communicate with pharmaceutical regulators about the use of digital health technologies in pivotal trials of drugs and biologics.

Location: Coral 3

Explore the advancing oncology landscape, with its multiple innovation areas and partnerships. Delve into the emerging therapies, latest breakthroughs in precision medicine and recent deals, along with addressing the shortcomings, enabling to redefine the future of cancer treatment.

Location: Coral 3

Discover the future of obesity care, with a focus on advancements in weight-loss drugs and the essential characteristics for next-generation therapies. Hear experts discuss the challenges and opportunities ahead, along with the implications and partnering strategies to reshape the landscape of obesity management.

Location: Coral 3

As Pharma reshapes its pipelines to keep pace with market needs and scientific breakthroughs, venture capitalists play a pivotal role in identifying the next wave of transformative therapies. Drawing inspiration from Milan's legacy of trendsetting in fashion and art, this panel explores how VCs forecast what Pharma will need in five years' time. What defines game-changing science, and how can investors distinguish the breakthroughs that will set the future stage? Panelists will share their strategies for search and evaluation, reveal what truly stands out to Pharma, and discuss how aligning innovation with Pharma's evolving priorities can create a lasting impact. Join us for a forward-looking conversation on how to set the stage for a future that defines the industry.

Location: Exhibit Hall Stage

The European biotech sector stands at a pivotal moment, balancing groundbreaking innovation with persistent financing challenges. Despite thriving advancements in therapeutics, diagnostics, and platform technologies, securing capital—especially during the critical "valley of death" between early-stage R&D and commercialization—remains a significant hurdle. Recent discussions on global biotech financing trends have highlighted the cautious IPO market in Europe and the evolving priorities of venture capitalists and pharmaceutical companies. However, equity financing is not the only available option. Venture debt has emerged as a crucial non-dilutive funding mechanism, enabling biotech companies to extend cash runways, achieve key clinical milestones, and navigate funding gaps between equity rounds. As the sector seeks sustainable growth, strategic deployment of venture debt may prove essential in bridging financial shortfalls and accelerating innovation.

Location: Exhibit Hall Stage

Discover how your organisation can benefit from partnering with Australia’s world-leading clinical trial ecosystem.

Sector leaders will discuss why Australia is the international home of high-quality, efficient, cost-effective clinical trials.

The panel will outline Australia’s efficient approvals process, IND-free regulatory framework, world-class clinical workforce and facilities, high-quality FDA and EMA recognised data outputs, genetically diverse participant recruitment pool, robust IP protections, and generous R&D tax incentives.

Location: Exhibit Hall Stage

An update on the progress of the working group for the internationalization of the biotech industry. The seminar will cover Italian programs and strategies to enhance the national Life Sciences and Biotech ecosystem globally, with a strong focus on attracting investments.

Location: Coral 2

The journey from concept to company is both exhilarating and challenging in the biotech industry, where innovation and investment intersect. This session will spotlight proven expertise in fostering groundbreaking biotech startups and Biovelocita, the first Pan-European investment strategy dedicated to accelerating biotech company creation. Industry leaders will discuss the critical ingredients for success, from identifying transformative science to scaling ventures across Europe. With insights into navigating early-stage challenges, securing funding, and driving innovation, this panel will provide a roadmap for translating bold ideas into thriving companies that redefine the future of healthcare.

Location: Coral 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 Spring audience. A panel of esteemed judges will evaluate the pitches and select the winners.

Startup Finalists: *Presenting in order

CereCura Nanotherapeutics: CNS/Neurology

Inverna Therapeutics: Rare & Orphan Diseases

MediSieve: Cell & Gene Therapies

BlackfinBio Ltd: CNS/Neurology

Dimer Pharmaceuticals: Oncology

Cycuria Therapeutics GmbH: Oncology

HHC Medical: Cell & Gene Therapies

STAb Therapeutics: Cell & Gene Therapies