Innovator’s Pitch Challenge Winner Spotlight: Bram De Moor of You2Yourself

April 14, 2026 ~ Next Phase Admin ~ Leave a comment

Following its recognition as a winner of the Innovator’s Pitch Challenge at RESI Europe, You2Yourself is advancing a new approach to early disease detection through longitudinal biomarker monitoring. In this interview, Bram De Moor discusses the science behind URIMON, the company’s commercialization strategy, and how RESI has supported its investor engagement.

Bram De Moor
Founder & General Manager, You2Yourself

Caitlin Dolegowski
Program Director, LSN

Caitlin Dolegowski (CD): For those new to You2Yourself, how would you describe URIMON and the value of longitudinal biomarker monitoring in a way that resonates with investors?

Bram De Moor (BD): URIMON is a personalized, non-invasive, urine-based liquid biopsy platform that uses urinary miRNA profiling to detect multiple serious diseases — including prostate cancer, lung cancer, and cardiovascular disease — before symptoms appear. One urine sample generates simultaneous risk scores across multiple conditions.

The longitudinal dimension is key: repeated monitoring detects biological drift months to years before clinical symptoms — the difference between catching cancer at stage I versus stage III. With no needles, no clinic visit, and at-home collection with mail-in capability, URIMON is designed for scalable, population-level adoption.

CD: What makes your approach to early disease detection fundamentally different from traditional diagnostic models?

BD: Traditional diagnostics are reactive and often focus on a single biomarker. URIMON differs in three key ways:

Multi-disease detection from a single sample, analyzing hundreds of miRNA species simultaneously
Focus on molecular signals rather than anatomical changes, enabling earlier detection
Use of urine as a scalable, patient-friendly biofluid that captures signals from across the body

This approach provides a unified molecular health view, reducing fragmentation across specialties.

CD: You have built a unique biobank of longitudinal samples — how does this dataset strengthen your technology and create a competitive advantage?

BD: The URIMON Biobank, developed since 2019 with over 6,500 participants under IRB-approved and GDPR-compliant protocols, is a significant strategic moat.

It enables algorithm training on longitudinal patient data, including individuals who later develop disease, supporting prospective validation. It also ensures robustness across cohorts, allowing classifiers to generalize beyond a single institution.

Replicating this dataset would require years and substantial capital, making it a durable barrier to entry.

CD: How do you think about commercialization, particularly your subscription-based model and the path toward broader reimbursement and population-level adoption?

BD: Our strategy is staged to de-risk scaling. We are entering the market under the EU IVDR Article 5(5) in-house LDT framework to accelerate time to revenue.

Our subscription model (€299–499/year) targets individuals, employer groups, and occupational health programs, aligning recurring revenue with longitudinal monitoring.

Reimbursement will follow through HTA submissions in Europe, with FDA De Novo clearance as a parallel pathway in the U.S.

CD: What key milestones or inflection points should investors be watching as you move toward your planned 2027 market entry?

BD: Key milestones include:

Clinical validation and publication of performance data
Regulatory progress under IVDR and FDA pathways
Launch of commercial infrastructure and first paying customers
Strategic partnerships and completion of financing rounds
These milestones will demonstrate both technical validation and commercial traction.

CD: How did participating in RESI Europe and the Innovator’s Pitch Challenge impact your investor visibility and strategic conversations?

BD: RESI provided direct access to European and transatlantic investors actively seeking early-stage diagnostic companies — a highly targeted audience that is difficult to reach through traditional outreach.

The Innovator’s Pitch Challenge offered structured validation in a competitive setting, signaling credibility to institutional investors. It also led to new investor conversations and follow-up meetings now underway.

CD: Following your recognition at RESI Europe, what are the next key priorities for You2Yourself as you move into your next phase of growth?

BD: Our focus over the next 12–18 months includes:

Expanding clinical evidence through continued biobank growth and prospective studies
Securing financing through grants and a seed-to-Series A bridge round
Scaling team and infrastructure across lab, regulatory, and business development functions

With favorable market conditions — including advances in NGS, growing demand for preventive health, and regulatory clarity — You2Yourself is well positioned to lead in this space.

Applications are now open for upcoming Innovator’s Pitch Challenges. Companies can apply to pitch at RESI San Diego 2026 and take the stage in front of a global network of investors and partners.

Apply to Pitch at RESI San Diego

The Needle Issue #25

April 14, 2026 ~ Next Phase Admin ~ Leave a comment

Juan Carlos Lopez

Andy Marshall

The approval of multiple anti-amyloid monoclonal antibodies (mAbs) — aducanumab (Aduhelm; now withdrawn), lecanemab (Leqembi) and donanemab (Kisunla) — over the past five years has opened the era of disease-modifying Alzheimer’s drugs, albeit with only modest benefits in addressing cognitive decline (30% slowing) and associated serious safety risks, such as CNS inflammation and cerebral hemorrhages, which has limited clinical uptake. While many drug development programs target biological processes other than amyloid formation (e.g., tau and tangles, neurotransmitter receptors, neuroinflammation, autophagy, and mitochondrial or metabolic dysfunction), companies continue to optimize anti-amyloid monoclonals, but also look for alternative ways to therapeutically target Aβ.

Different mechanisms being targeted in Alzheimer’s human testing. Although amyloid has long dominated drug-development efforts, there are now more neuroinflammatory targets in phase 2 trials than anti-amyloid treatments. Source: *Alzheimer’s & Dementia: Translational Research & Clinical Interventions*

One alternative therapeutic modality to antibodies is chimeric antigen receptor (CAR) immune cell therapy. In recent weeks, we have been thinking a lot about in vivo chimeric antigen receptor (CAR)-T therapies, which were one of the dealmaking trends in 2025, and we recommend readers check out an excellent summary of trends in the area from the consultancy firm Scitaris (you don’t even have to give them your details to download the report).

CAR-T treatments have established their clinical niche as last-ditch treatments for B-cell malignancies, with some remarkable outcomes for late-stage patients. In some cases, they have been shown to be at least twice as effective as T-cell engager bispecific antibodies in clinical studies. But they remain rather blunt instruments.

Despite advances in the clinical management of cytokine-release syndrome and immune effector cell neurotoxicity syndrome (ICANS), CAR-T treatments continue to be associated with serious risks. And while there have been advances in managing these adverse events, atypical non-ICANS neurotoxicities (NINTs) can also create serious clinical management issues, with risk factors predisposing patients to development still only poorly understood.

That said, over the past year, we have seen an increasing trend for the use of CAR-T treatments outside oncology. They have started to be applied with promising efficacy in various areas of autoimmunity (systemic lupus erythrematosus, lupus nephritis, systemic sclerosis, Sjögren’s syndrome, antisynthetase syndrome, myasthenia gravis and idiopathic inflammatory myopathies) and neuroinflammatory conditions (multiple sclerosis). In this respect, a recent paper in Science caught our attention. In it, Marco Colonna and his colleagues at Washington University in St. Louis harness astrocytes to clear amyloid plaques by promoting their ability to phagocytize Aβ.

To that end, they used in vivo gene therapy to generate astrocytes carrying chimeric antigen receptors (“CAR-As”), a strategy not unlike the one used in cancer immunotherapy. Although both macrophages (CAR-Ms) and conventional CAR-Ts have been tested in preclinical models of Alzheimer’s disease with limited success, this study reports the first attempt to directly engineer astrocytes in the body to generate CAR-As.

CAR-A treatment of amyloid pathology in an AD-related model. The left panel shows the study design. The beneficial effect of CAR-A treatment depends on its improvement of astrocytic phagocytosis of Aβ, which results in reduced microglial burden and neuronal dystrophy (top right). The team tested two different CAR-As, which acted by different mechanisms converging on the same therapeutic effect (bottom right). Source: *Science*

In broad terms, the construct used to generate CAR-As consisted of an Aβ-binding domain and the phagocytic signaling protein MEGF10 (multiple epidermal growth factor-like domains protein 10). The team examined a variety of constructs and chose two for in vivo testing. One of them combined a fragment from the Aβ-binding antibody crenezumab and MEGF10, which is primarily expressed in astrocytes. The second construct combined a fragment of aducanumab with the phagocytosis receptor Dectin-1, which is primarily expressed in microglia.

The authors packaged the constructs in an adeno-associated viral (AAV) vector under the control of an astrocyte-specific promoter and injected them intravenously into 5xFAD mice (which carry five familial Alzheimer’s disease (FAD) mutations, driving rapid Aβ plaque formation, synaptic loss, and cognitive decline starting around 2–4 months). Both CAR-As reduced amyloid burden and neuritic dystrophy, and the treatment worked both in the prophylactic and therapeutic settings.

Single-nucleus RNA sequencing and immunostaining showed that the CAR-As adopted the transcriptomic profile of activated astrocytes and readily clustered around amyloid plaques. Microglial cells, in turn, also responded to the treatment by showing a reduction of the disease-associated transcriptomic profile that is often seen after administration of monoclonal anti-Aβ antibodies. This is of interest because this disease profile of microglial cells has been suggested to contribute to the inflammatory reaction sometimes seen after Alzheimer’s immunotherapy.

A caveat of the study is that the authos saw no improvements in cognition following therapy, albeit behavioral results in mouse models have been notoriously poor at predicting outcomes in humans. However, the translational questions don’t stop there.

If in clinical practice the CAR-A approach would require an AAV vector, then immunogenicity of the treatment is going to be an issue. Pre-exposure to AAV is often a problem for gene-therapy programs, where patients are much younger. Given that Alzheimer’s is a disease associated with an elderly population, immunogenicity is likely to be exacerbated. Similarly, the delivery of 10¹³–10¹⁴ viral genomes to elderly patients living with Alzheimer’s—many of whom will already have a brain prone to neuroinflammation—makes the specter of unwanted side effects a major concern. In this respect, finding Alzheimer’s patients whose disease stage and age would be appropriate for a therapy with potentially highly toxic consequences for fragile recipients is also difficult to gauge.

That is not to say that CAR-immune cell therapy may not have a place in CNS disease. It just seems like neurological conditions, such as multiple sclerosis where patients are younger and potentially less fragile, are the place where much of the translational groundwork and clinical management for CAR-A or CAR-T therapies must be worked out before moving into neurodegenerative disease for elderly and cognitively compromised patients.

Technical Risk – From Belief to Evidence

April 7, 2026April 7, 2026 ~ Next Phase Admin ~ Leave a comment

By Dennis Ford, Founder & CEO, Life Science Nation (LSN)

In the first article, The Problem Is Not the Science, Life Science Nation established that investability begins with defining a real, urgent market need. But once that foundation is clear, the next question becomes unavoidable: does the product actually work, and can that be demonstrated in a way others trust?

The next focus is technical risk, where belief must become evidence. It outlines how companies move from early signals to reproducible, credible, and translatable results—covering mechanism of action, proof of concept, reproducibility, safety, and scalability.

Once market risk is clear, the next question becomes unavoidable: does the product work, and can that be demonstrated in a way that others trust?

This is where many companies overestimate their position. Early data, promising signals, or strong academic foundations often create internal confidence. But investors are not evaluating belief; they are evaluating evidence. The distance between those two states defines technical risk.

Technical risk is not simply about whether something works once. It is about whether it works consistently, whether the mechanism is credible, and whether the results can survive the transition from controlled environments into real-world use.

The first layer of clarity comes from the mechanism of action. There must be a coherent explanation of how the biology or technology produces the intended effect. This is not a description of experimental outcomes; it is a causal story. Without it, data is difficult to interpret and harder to trust.

Proof of concept establishes that the signal exists. This can take the form of in vitro data, animal models, early human data, or a working prototype, but it must be observable and measurable. Reproducibility then determines whether that signal can be relied upon. A single experiment is not enough. Results must hold across time, cohorts, and independent attempts.

Translatability introduces another layer of complexity. What works under ideal conditions does not always work in patients, clinics, or real-world settings. Understanding how findings extend beyond the initial model is critical, particularly in biologically complex indications.

Safety, performance, and durability define the product profile. Even if effective, a product must be safe enough for its intended use, deliver a meaningful effect, and sustain that effect over time. A transient or marginal benefit rarely justifies the cost and risk of development.

Finally, manufacturability, scalability, and data integrity complete the picture. A product that cannot be produced consistently and at scale cannot become a company. Data that is poorly designed, uncontrolled, or selectively presented undermines confidence, even when the underlying science is strong.

Technical risk is resolved when the product moves from an interesting idea to something that consistently works, can be trusted, and can be translated into real-world use.

Core Elements of Technical Risk

Mechanism of action
Proof of concept
Reproducibility
Translatability
Safety
Performance and durability
Manufacturability and scalability
Data quality and integrity

Next in the series: Regulatory Risk — Navigating the Path to Approval

Fundraising Bootcamp Ahead of RESI Europe 2026: Preparing Founders for Investor Engagement

March 10, 2026 ~ Next Phase Admin ~ Leave a comment

By Greg Mannix, VP, EMEA Business Development, LSN

Life Science Nation (LSN), in collaboration with Cuatrecasas, will host an exclusive Fundraising Bootcamp in Lisbon ahead of RESI Europe 2026, offering early-stage life science and healthcare executives a focused opportunity to refine their fundraising strategy and strengthen investor engagement skills.

Taking place the day before the conference, the bootcamp will bring together founders, investors, and industry experts for an interactive session designed to help companies better position themselves for capital and partnerships within the global life science ecosystem.

Event Details

Date and Time: Sunday, March 22, 2026 | 2:00 PM – 5:30 PM
Location: Cuatrecasas Law Firm
Av. Fontes Pereira de Melo 6
1050-121 Lisboa, Portugal
Cost: Free to attend (registration required)

This workshop will focus on practical, real-world fundraising insights that early-stage companies can immediately apply when engaging with investors at RESI Europe and beyond. Participants will hear directly from experienced professionals who work with startups and investors across the life science sector.

Agenda Highlights

Signal, Legibility, and Risk Mitigation in Global Fundraising
Learn how investors interpret signals when evaluating early-stage companies and how founders can structure their development plans to become more “legible to capital.” The discussion will also explore strategies for mitigating risk in global fundraising environments.

Shark Tank Session (Company Pitch)
Selected companies will have the opportunity to present their pitch and receive direct feedback from experienced investors and industry professionals in an interactive format designed to sharpen messaging and highlight areas for improvement.

Networking
The bootcamp will conclude with time for founders and participants to connect with fellow entrepreneurs, investors, and industry experts before the start of RESI Europe.

This pre-conference session provides a valuable opportunity for innovators preparing for RESI Europe to strengthen their fundraising approach, refine their investor messaging, and begin building connections within the RESI community.

Space is limited, and applications will be accepted in the order they are received.

Life Science Nation looks forward to welcoming founders and investors to Lisbon for this interactive fundraising session ahead of RESI Europe 2026.

Hot Investor Mandate: Investment Arm of Large Healthcare Enterprise Invests and Partners With Innovations With China and Global Market Potential

March 10, 2026March 10, 2026 ~ Next Phase Admin ~ Leave a comment

The firm is the investment arm of a diversified healthcare enterprise headquartered in Asia with international operations. The broader organization operates across medical innovation incubation, manufacturing, and large-scale commercialization, with a strong focus on technology-driven healthcare solutions and intellectual property development. Through its investment activities, the firm supports innovative healthcare companies by providing capital as well as access to industrial capabilities and commercialization infrastructure. The broader organization maintains a large healthcare distribution platform serving hospitals and pharmacies nationwide, enabling portfolio companies to access substantial market channels. The firm evaluates global investment opportunities with strong potential for commercialization in the China market.

The firm focuses on life sciences and healthcare opportunities spanning therapeutics, diagnostics, medical devices, R&D tools, and AI-enabled healthcare platforms. Areas of particular interest include oncology and immuno-oncology, advanced therapeutic modalities such as cell and gene therapy, and innovative medical technologies with clear clinical application. Through its technology innovation initiatives, the organization collaborates with research institutions to identify and develop original scientific breakthroughs, including first-in-class medicines and novel medical devices. While the firm frequently evaluates later-stage assets and partnership opportunities, it also considers early-stage technologies with strong scientific differentiation and long-term commercial potential.

From a company and partnership perspective, the firm prioritizes opportunities with meaningful relevance to the China healthcare market and the ability to leverage the organization’s regulatory, manufacturing, and commercial infrastructure. The firm looks for strong scientific foundations, clear unmet clinical needs, differentiated product positioning, and credible strategies for market entry and expansion. Portfolio companies may benefit from support across R&D collaboration, industrial incubation, regulatory strategy, manufacturing scale-up, and nationwide commercialization. The firm maintains a flexible investment approach and may participate as either a lead investor or a co-investor depending on the opportunity and partnership structure.

If you are interested in more information about this investor and other investors tracked by LSN, please email salescore@lifesciencenation.com.

EU Webinar Series: From Discovery to Decision Making Early-Stage Life Science Legible to Capital

March 3, 2026March 3, 2026 ~ Next Phase Admin ~ Leave a comment

By Greg Mannix, VP, EMEA Business Development, LSN

Life Science Nation’s EU-focused webinar series, From Discovery to Decision: Making Early-Stage Life Science Legible to Capital, continues this week with Session III. Recordings of the first two sessions are available for those who would like to revisit the insights shared by active investors shaping early-stage healthcare financing.

This series examines a central question for early-stage companies: why strong science alone is not enough to secure capital, and how founders can structure development to become legible to investors.

Session I

Why Solid Science Fails to Translate Before Capital Even Considers It

Hosted by Richard Berenson, Managing Partner, Venzyme Catalyst

Watch the recording:
https://youtu.be/ODbukG6cjNM?si=9lj-BGKRhv2wJISW

In Session I, Richard Berenson offered a candid investor perspective on why many early-stage assets stall before diligence begins. He emphasized that the issue is often not a shortage of capital, but a failure of translation.

Scientific merit alone does not make an opportunity investable. Investors must see clarity around risk reduction, defined milestones, regulatory trajectory, and capital deployment strategy. Companies that struggle to articulate this framework may be filtered out long before meaningful evaluation takes place.

The discussion reframed from fundraising challenges as structural alignment issues rather than capital scarcity.

Session II

Legibility, Signal, and the Real Work Between Seed and Series B

Hosted by Karim Galzhar, Partner, OKG Capital

Watch the recording:
https://youtu.be/Dak112sslq4?si=9MpLvecop5Jxw4_E

Session II built on this foundation with a deeper examination of how investors form conviction between Seed and Series B.

Karim Galzhar outlined what global investors require to underwrite early-stage risk. Signals are formed across scientific validation, regulatory planning, commercial strategy, and disciplined capital use. Data alone does not create signals. Structured progress and stage-appropriate positioning.

The session highlighted how companies can unintentionally dilute signals by engaging the wrong forums too early or by misaligning fundraising expectations with development readiness.

Session III — This Wednesday

Partnering Is Not Exposure. It Is Filtration

Wednesday, March 4 | 10:00 AM ET / 4:00 PM CET

Session III will feature Dennis Ford, Founder & CEO of Life Science Nation and creator of the RESI Conference Series, alongside Gregory Mannix, VP, International Business Development, Life Science Nation.

This session confronts a simple truth: great science does not raise capital, signal does. We will examine how investors actually price risk, why fundraising must be run as a disciplined global campaign, and how legibility turns complex science into an investable story.

We will also address a costly mistake: engaging the wrong partnering events and the wrong investors too early. Not every conference, forum, or investor fits every stage of development. Success requires selecting the right venues, building a stage-appropriate global target list, and engaging partners who are structurally aligned with your product. The goal is to replace activity with real transaction momentum.

Registration for Session III is open: https://us02web.zoom.us/webinar/register/WN_oe499TEOQGmrSnoAzNr1yw#/registration

Novotech at RESI JPM: Strategic Early Clinical Development for Biotech Sponsors

March 3, 2026March 3, 2026 ~ Next Phase Admin ~ Leave a comment

As a sponsor of RESI JPM, Novotech joined the RESI community during JPM Week to engage with emerging biotech companies at pivotal stages of development. Marina Mullins, VP of Early Clinical Development at Novotech, shared insight into the company’s biotech-focused model, global execution strategy, and evolving approach to early-phase clinical development.

Marina Mullins

Caitlin Dolegowski

Caitlin Dolegowski (CD): Can you briefly describe Novotech’s mission and core capabilities as a global CRO and scientific advisory partner?

Marina Mullins(MM) : Novotech is a global full-service clinical research organization and scientific advisory partner focused on accelerating the development of innovative therapeutics for biotech and small- to mid-sized pharmaceutical companies. The company provides integrated clinical trial services across Phase I–IV, with particular strength in early clinical development, regulatory strategy, medical oversight, biometrics, and operational execution.

With offices across Asia-Pacific, North America, and Europe, and long-standing site partnerships globally, Novotech combines regional expertise with global coordination to support sponsors from preclinical planning through proof-of-concept and beyond. Its model integrates scientific advisory and operational delivery, enabling sponsors to move efficiently from strategy to execution.

CD: What differentiates Novotech from other CROs in terms of clinical execution, expertise, or client support?

MM: Novotech differentiates itself through a biotech-centric approach and deep regional execution expertise. Rather than operating as a transactional service provider, the company works as a strategic partner, aligning development strategy with operational planning from the outset.

Key differentiators include strong early-phase capabilities, particularly in first-in-human and proof-of-concept studies; deep regulatory and operational experience across high-performance regions such as Australia, Asia, and North America; therapeutic expertise spanning oncology, infectious diseases, obesity, CNS, endocrine, rare diseases, and emerging modalities; and a partnership model designed to provide agility, senior oversight, and milestone-aligned execution.

This integrated structure allows sponsors to make data-driven decisions while maintaining timeline discipline and regulatory alignment.

CD: How does Novotech’s global footprint support biotech and pharma companies as they advance clinical development?

MM: Novotech’s global presence enables sponsors to strategically select development regions based on speed, regulatory pathway, patient access, and capital efficiency.

For example, Australia offers an established regulatory framework that allows certain first-in-human studies to proceed under the Clinical Trial Notification scheme without requiring an Investigational New Drug submission to the U.S. Food and Drug Administration. This can provide an efficient pathway to first patient while maintaining internationally recognized ethical and regulatory standards.

At the same time, Novotech’s footprint across Asia, North America, and Europe supports seamless program expansion into multi-regional trials. Sponsors benefit from consistent governance, harmonized data standards, and coordinated regulatory strategy as programs advance.

CD: As a sponsor of RESI during JPM Week, what were your key objectives for participating this year?

MM: Novotech’s objectives were centered on early engagement and strategic dialogue. The company aimed to connect with emerging biotech companies preparing for first-in-human or proof-of-concept studies, provide guidance on early development strategy and regulatory pathways, explore long-term partnerships beyond single studies, and support investor-backed companies in aligning clinical milestones with financing objectives.

RESI provided a focused environment to engage with innovative sponsors at critical inflection points in development.

CD: Who is Novotech most interested in connecting with?

MM: Novotech is particularly interested in engaging with early- to mid-stage biotech companies transitioning from preclinical to first-in-human studies, and companies seeking an integrated CRO partner that combines regulatory advisory, scientific strategy, and operational execution. The emphasis is on building strategic relationships with sponsors who value early alignment between scientific design, regulatory positioning, and clinical operations.

CD: Are there particular trends in early clinical development shaping Novotech’s ECD strategy?

MM: Regulators are placing greater emphasis on optimized dose selection and robust early-phase data packages, increasing the use of adaptive designs, expansion cohorts, and integrated pharmacokinetic and pharmacodynamic modeling in first-in-human studies.

There is also growing strategic use of healthy volunteer studies, where scientifically appropriate, to better characterize safety, pharmacokinetics, and target engagement before patient expansion. This can reduce downstream risk and improve capital efficiency.

Biotech sponsors are under pressure to generate milestone-defining data efficiently. As a result, early programs increasingly incorporate translational biomarkers, seamless SAD and MAD structures, and optional proof-of-concept expansion pathways within unified protocol frameworks.

Together, these trends reinforce a shift toward positioning early clinical development as a strategic foundation for the entire program lifecycle.

Interested in sponsoring an upcoming RESI conference?

To explore sponsorship opportunities, please contact resi@lifesciencenation.com. Life Science Nation would welcome the opportunity to meet and discuss organizational goals for connecting with the global RESI investor and innovator community.