Tag Archives: science

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

3 Mar

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
 CaitiCaitlin 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.

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The Needle Issue #24

24 Feb
Juan-Carlos-Lopez
Juan Carlos Lopez		 Andy-Marshall
Andy Marshall

X-ray crystallography has long been the go-to workhorse for providing atomic structures of drugs interacting with their protein targets. Increasingly, those static snapshots are being complemented by readouts from experimental analytical tools based on nucleic magnetic resonance (NMR) spectroscopy and cryoelectron microscopy (cryo-EM), offering drug developers a broader window into proteins as dynamic, breathing molecules. This is spurring a raft of new service provider startups, including AIffinity (Brno-Medlánky, Czech Republic), NexMR (Zürich, Switzlerand), CryoCloud (Utrecht), and Intellicule (West Lafayette, IN), all of which aim to supply drug-discovery teams with state-of-the-art platforms providing structural data with rapid turnaround times and low cost.

As many of the most compelling ‘undruggable’ targets are renowned shape shifters — aggregation-prone proteins like Tau, amyloid precursor protein (APP) or huntingtin in neurodegenerative diseases, or transcription factors like P53, KRAS and c-MYC in oncology — a lot of therapeutic startup activity has recently focused around so-called ‘intrinsically disordered proteins’ (IDPs). The ability to attain markedly different conformations under different conditions allows IDPs not only to play moonlighting roles or serve as hubs in signaling networks, but also to localize into liquid- phase condensates (or membrane-less organelles — attributes that make them acutely sensitive to mutations that can compromise specificity and lead to nonspecific binding, resulting in toxicity and disease.

As IDPs frequently resist attack by conventional drug discovery approaches, a slew of startups has sprung up to try to go after this target class, many using new structural techniques. These include Peptone (London, UK), Dewpoint Therapeutics (Boston, MA), brainQR Therapeutics (Göttingen, Germany), and Kodiform Therapeutics (Oxford, UK). Just last month, Topos Bio secured a $10.5 million seed round to “tackle ‘undruggable’ proteins driving Alzheimer’s and cancer”. Dewpoint also just announced it has dosed its first patient in a phase 1/2a trial of its lead beta-catenin program in gastric cancer and elected its MYC development candidate to take forward.

An important postscript to the startup activity targeting undruggable IDPs is that more conventional ‘druggable’ target classes, like tyrosine kinases, may also represent a fruitful hunting ground for dynamic conformational states that may have been missed by traditional crystallographic approaches. Given that conventional drug targets have relatively well-trodden clinical and commercial development paths, they may also represent simpler starting points and testing grounds for commercial programs aiming to apply the new analytical approaches to support medicinal chemistry programs around validated targets.

In a paper recently published in Science, the team of Charalampos (Babis) Kalodimos at St. Jude Children’s Research Hospital use high-resolution NMR spectroscopy to gain structural insight into how SRC family tyrosine kinases (Src, Hck, and Lck) achieve processive phosphorylation of multisite substrates.

The SRC enzyme family is essential for rapid and coordinated signaling in processes such as cell migration and T-cell activation. In addition, SRC family kinases are frequently overexpressed in tumors, contributing to the activation not only of multiple scaffold or signaling proteins, such as receptor tyrosine kinases (e.g., EGFR, FGFR, PDGFR or IGF1R), but also of downstream effectors (e.g., MAPKs, FAK, paxillin, p130Cas, ELMO1 and RAC1). Although there are approved drugs like the multikinase inhibitor Sprycel (dasatinib) that bind the SRC active site, these drugs have such extensive off-target and adverse side effects that there is a pressing need for new paths to more-selective SRC inhibitors.

SRC enzymes share a conserved domain organization, with a disordered N-tail, a tandem SH3–SH2 module, a kinase domain, and a disordered C-tail. All can carry out processive phosphorylation — a phenomenon where the enzyme phosphorylates multiple residues in a substrate during a single encounter. Each of these catalytic cycles typically requires ATP binding, phosphate transfer and ADP release, and ADP release is often the rate-limiting step. So, a question that has long puzzled structural biologists is how ADP-release–constrained kinases achieve sufficiently rapid turnover to successfully perform their function.

Using NMR spectroscopy with cryogenic probes — which reduce electronic/thermal noise and increase sensitivity up to five-fold compared with room-temperature probes — the St. Jude team characterized the conformational ensemble of the Src kinase domain and identified three interconverting states: a predominant active state, a previously described inactive Src/CDK-like state, and a hitherto unknown low-populated intermediate state positioned linearly between the other two. Structural determination revealed that this intermediate state displays features that are distinct from the active and inactive states. Its activation loop is partially folded, the P-loop is displaced inward, and the αC helix is shifted upward. This conformation binds ADP poorly relative to the active and inactive states, suggesting that it facilitates nucleotide release.

Using mutational analyses, the researchers then confirmed the functional importance of this intermediate state. Variants that eliminated this intermediate state while stabilizing the active state showed slower ADP dissociation, reduced catalytic turnover and impaired processive phosphorylation of the multisite Src substrate p130Cas. Instead of generating a fully phosphorylated substrate in a single binding event, these mutants accumulated partially phosphorylated intermediates. Equivalent mutations in other kinases of the SRC family, Lck and Hck, similarly reduced catalytic efficiency and impaired multisite phosphorylation of their respective physiological substrates CD3ζ and ELMO1 in Jurkat cells. Furthermore, these mutations compromised cellular functions measured via in vitro assays, including T-cell activation using Lck-deficient Jurkat cells and migration of mouse embryo fibroblasts lacking Src, Yes and Fyn in the presence of fibronectin. These molecular and functional findings indicate that the intermediate state is evolutionarily conserved and essential for processive activity across the SRC family.

Mechanistically, the work establishes that rapid ADP release, enabled by transient sampling of a structurally constrained intermediate, is critical for sustaining catalytic turnover rates that exceed the speed of substrate dissociation. More broadly, it shows that kinase conformational landscapes are tuned not only for switching between active and inactive states, but also for optimizing specific kinetic steps within the catalytic cycle.

From a drug developer’s standpoint, because Sprycel and other inhibitors target the active or inactive conformations of the SRC active site, the identification of a low-populated, functionally indispensable intermediate suggests a completely new strategy to target tyrosine kinases: selectively stabilize or destabilize the intermediate state to fine-tune catalytic turnover and processivity rather than simply blocking activity. Targeting such transient conformations could enable more precise modulation of signaling output, potentially improving selectivity and reducing off-target effects in kinase-directed therapies.

We look forward to seeing how many more of these intermediate states are uncovered in other kinase targets and whether pharmacological inhibitors targeting this state have advantages over orthosteric or allosteric chemotypes that conventionally have been used to inhibit the kinase active site or lock it in an inactive conformation. What is clear is that ultrafast NMR measurements of binding and state behavior are a powerful differentiating tool for understanding kinase activity where static structures aren’t enough.

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RESI IPC Winner VerImmune Advances a New Immuno-Oncology Playbook  

18 Feb

VerImmune is an emerging biotechnology company advancing a novel virus-inspired platform designed to redirect the body’s existing immune memory toward hard-to-treat diseases. The company participated in RESI JPM as part of the Enterprise Singapore delegation, reflecting Singapore’s growing role as a global hub for biomedical innovation and cross-border collaboration. In this conversation, Founder & CEO Joshua Wang shares insights into VerImmune’s scientific approach, clinical ambitions, and momentum following recognition as an Innovator’s Pitch Challenge (IPC) winner. 

Joshua Wang
 CaitiCaitlin Dolegowski

Caitlin Dolegowski (CD): For readers who are just discovering VerImmune, how do you describe the company and its scientific focus? 

Joshua Wang (JW): VerImmune is an IND-enabling stage biotechnology company leveraging the natural architecture of viruses to create a self-assembling Virus-inspired Particle (ViP™) platform for targeted therapeutic delivery of diverse payloads for oncology, autoimmunity, and animal health indications

VerImmune’s lead ViP program, VERI-101, is pioneering a new First-in-Class immuno-oncology paradigm that repurposes existing CMV-specific T-cell memory cells (present in ~85% of adults globally) to recognize and eliminate solid and metastatic tumors in a tumor-type-agnostic manner, either as a monotherapy or in combination with existing standards of care.

CD: What unmet medical need are you targeting, and how does your platform or approach differentiate you in the immunology landscape? 

JW: Despite recent blockbuster innovations like checkpoint inhibitors (PD-1/PD-L1) , antibody drug-conjugates and radioligand therapies, resistance to these treatments and other standards-of-care becomes inevitable and cancer recurs. This inevitably creates a large population of post-failure patients with limited to no options.
Hence, the biggest unmet need in oncology remains dealing with such cancer resistance and recurrence.

VerImmune has discovered that within these patient populations, regardless of previous treatment, most patients still retain a robust immunity to viruses.

VerImmune targets this preserved anti-viral immune memory and repurposes it against tumors, bypassing previous mechanisms of immune or genetic resistance.

Since all patients have pre-existing viral immunity (e.g to CMV which is what VERI-101 targets), VerImmune’ s approach represents a distinct and potentially category-defining modality in immuno-oncology, with clear strategic and partnering value in the post-failure setting and most importantly, giving patients one more shot at a treatment opportunity!

CD: What was your experience participating in the Innovator’s Pitch Challenge at RESI JPM? 

JW: As part of the Enterprise Singapore startup delegation from Singapore, participating at the Innovator’s Pitch Challenge at JPM RESI 2026 was a high-impact international opportunity as it occurred alongside 90+ other companies from around the world in a forum with concentrated investor and partner visibility. We were truly honored to win 2nd place which provides further external validation of our science, platform, and commercialization strategy before a global audience.

CD: With so many strong companies presenting, what feedback or reactions stood out to you from judges or attendees? 

JW: Despite a challenging biotech financing environment, which does not favor highly novel new mechanisms and approaches, we were encouraged that judges and attendees acknowledge the strategic logic that the post-PD1/ADC/RLT failure population still retains active anti-viral immunity. They highlighted the novelty of redirecting intact, non-exhausted viral immune memory rather than attempting to generate new anti-tumor immunity or introduce another small-molecule payload, viewing it as a differentiated and refreshing timely approach.

CD: How has RESI JPM helped advance investors, partners, or industry conversations for VerImmune? 

JW: Yes, being recognized as a winner has amplified the visibility of VerImmune’s approach and strengthened its perceived credibility. It has led to increased inbound interest from investors seeking to learn more, rather than relying primarily on outbound outreach.

CD: Where does the company currently stand in terms of funding, partnerships, or key development stages? 

JW: We are currently at the IND-enabling stage whereby we have already had a successful pre-IND meeting with the FDA which confirmed alignment on our planned GLP Toxicology studies and CMC manufacturing scale up to GMP clinical material. We are currently working to build up a syndicate to raise our Series A to close this financing which will advance our lead ViP program- VERI-101 into first-in-human clinical trials.

CD: What milestones or inflection points are most important for VerImmune in the coming months? 

JW: A key milestone is completing our Series A, which will enable full execution of our ongoing IND-enabling activities and transition VerImmune into a clinical-stage company with VERI-101 advancing into first-in-human studies.

The deadline to apply for the Innovator’s Pitch Challenge at RESI Europe has been extended to February 23. Applicants are encouraged to act quickly, as submissions are reviewed on a rolling basis.

Apply to Pitch at RESI Europe 2026

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Europe Doesn’t Have a Capital Problem. It Has a Translation Problem 

10 Feb

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

DF-News-09142022

Across Europe, early-stage life science innovation isn’t held back by a lack of capital. It’s held back by a lack of translation. Brilliant ideas emerge every day from universities, startups, and labs, but too few of them cross the chasm into fundable, scalable ventures. Not because investors are uninterested, but because the signal is still forming. 

That is the gap RESI Europe is built to fill.

RESI Europe is intentionally focused on companies in the earliest stages of formation: seed, Series A, and Series B. In practical terms, that means seed financings up to $2M, Series A rounds up to $10M, and Series B rounds up to $50M. RESI is also cross-domain by design, connecting drugs, devices, diagnostics, and digital health under one roof so that cross-silo innovation can actually be seen and underwritten. These companies are not yet de-risked. They are still shaping their data, refining their narrative, and clarifying what kind of asset they are becoming. 

Unlike broad partnering events that are optimized for finished stories, RESI Europe’s product is filtration, not exposure. The investors and partners who participate specialize in early risk and engage before all the questions are answered, because that is when the partnership has the greatest leverage. And RESI does this at a registration cost typically around half of what many large European partnering conferences charge, making serious early-stage partnering accessible rather than exclusive. 

Partnering at this stage is not about acceleration.

It is about preparation. 

Europe does not need more capital flowing into the same mature assets. It needs a mechanism to translate potential into signal and the clarity to underwrite early-stage opportunities. Without that translation, meetings happen but decisions do not. Not because the science is weak, but because the story is still illegible.​ 

RESI Europe exists to make early innovation readable and to bring investors, strategics, and entrepreneurs together around the translational work that must happen before Phase II-level legibility is possible. 

Capital follows clarity.

Clarity requires translation.

That is what RESI Europe is built to deliver. 

Register for RESI Europe

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The Needle Issue #23

10 Feb
Juan-Carlos-Lopez
Juan Carlos Lopez		 Andy-Marshall
Andy Marshall

In our past issue, we took a look at all the financing deals that The Needle has covered since our inaugural issue. This week we turn our attention to last year’s deal making in the preclinical biotech space.

In 2025, preclinical dealmaking didn’t just slow — it polarized. Capital clustered around AI-enabled discovery, China-sourced assets, and in vivo CAR-T cell therapies, while entire therapeutic categories effectively disappeared from licensing activity. Based on the 131 publicly disclosed preclinical transactions in our sample, we reveal where early-stage risk capital is still flowing — and where it has quietly retreated.

Similar to the data we reported in our past newsletter, our analysis captures only publicly disclosed deals (partnerships, research collaborations, licenses, joint ventures, reverse mergers, equity investments and options) on business wires, industry news sites, and venture-fund sources. In the preclinical space, many deals are carried out in stealth, and companies in some important regions (like China) don’t use business wires or news sources traditionally available in the West. For these reasons, our estimates underestimate the true level of early-stage preclinical dealmaking.

In total, we tracked 131 preclinical deals over the year, of which 42 were licensing deals, 64 were strategic partnerships/collaborations and 14 were mergers and acquisitions (M&As). In keeping with early stage’s exploratory nature, the importance of stealth, and the non-compensatory nature of much of the work done, over half of the publicly announced strategic partnerships (35 deals; 55%) had no terms disclosed. As one would expect, a smaller proportion of the licensing deals failed to provide terms, but even for this category, 8 of the 48 transactions (17%) didn’t give financial details. Four of the 14 M&As that we tracked also made no mention of deal terms.

US-headquartered companies continue to dominate the dealmaking landscape, whether it is research collaborations, licensing or trade sales. One reason for the dominance of companies in the US — and the UK, which is second in deal activity — is likely simple math; a greater number of companies are financed and built in these countries compared with the rest of the globe (see The Needle Issue #22).

Strategic partnerships in 2025 favored platforms over products — and Western biotechs over Asian peers.

The 64 strategic partnerships we tracked had upfront payments that ranged from $5 million to $110 million, but the median ($35.5 million) underscores how concentrated value remains in a handful of outlier platform deals.

US companies accounted for 37 of the 64 deals (58%). Three notable partnering big-ticket deals involved biotechs splashing out large sums on preclinical collaborations, with the payers showing interest in branching out into new therapeutic modalities: last May, CRISPR Therapeutics (San Diego, CA) pivoted from gene editing to siRNA, paying $95 million to Sirius Therapeutics (Shanghai, China) to co-develop a long-acting siRNA designed to selectively inhibit Factor XI for thrombosis; in December, Regeneron Pharmaceuticals (Tarrytown, NY) spent $150 million (and made an equity investment) to jointly develop Tessera Therapeutics’ (Somerville, MA) target-primed reverse transcription therapy (TSRA-196), which uses lipid nanoparticles (LNPs) to deliver RNAs encoding an engineered reverse transcriptase (‘gene writer’), writer-recognition motifs, and a SERPINA1 template to correct a mutation in alpha 1 antitrypsin deficiency; and later the same month, peptide developer Zealand Pharma (Søborg, Denmark) announced a transaction with OTR Therapeutics (Shanghai, China), paying $20 million upfront for small-molecule programs centered around validated targets of Zealand’s franchise in cardio-metabolic disease.

For obvious reasons, target discovery and drug screening comprise about a third of collaborations and partnership agreements, but do not figure much in licensing and M&A. Mentions of machine learning in partnering deals (18.2% of 2025’s deals, with several in the top 10 grossing set) suggest large-language and other models are an increasingly established facet of preclinical development. Neurodegenerative disorders garnered the second largest number of partnering transactions in our 2025 sample. And, with all the noise around GLP-1s and other incretins, metabolic disease and obesity were the focus of 11% of deals.

Perhaps the most counterintuitive finding in the partnership data is the near-total absence of China-headquartered companies — despite their dominance in preclinical licensing. This may reflect geopolitical friction, IP risk tolerance or a Western preference for control in collaborations. Alternatively, the absence may reflect the limitations of Haystack’s methodology for collecting data. Certainly, the partnership data contrasts starkly with our licensing data, which show Chinese assets performing so well that they are biting at the heels of US companies and running far ahead of UK companies. In contrast, for strategic partnerships, it was UK-, and South Korea-based firms that were most prominent behind the US (15%, and 7% of dealmaking, respectively).

For licensing, the shift to Asia seen in later parts of the biotech pipeline is also manifest in the preclinical space.

Chinese companies were involved in nearly a quarter of all the licensing deals made last year, clinching 11 out of the 48 deals we tracked. This interest in early-stage Chinese assets mirrors last year’s banner deals for later-stage assets, such as Pfizer’s ex-China rights acquisition of 3SBio’s (Shenyang, China) PD-1 x VEGF bispecific antibody for $1.25 billion, or GSK’s $1.10 billion acquisition of Jiangsu Hengrui’s (Lianyungang, China) phosphodiesterase 3/4 inhibitor and oncology portfolio. Overall, deals seeking access to assets from Asian biotechs (companies based in China, South Korea, Singapore and Taiwan) comprised 33% of all preclinical licensing transactions in our sample.

Looking at the preclinical licensing as a whole, upfront amounts ranged from $0.7 million to $700 million, with a median value of $35 million. Most deals centered around cancer, followed by autoimmune, neurodegenerative and metabolic diseases.

What was perhaps most surprising is that we didn’t see any licenses for preclinical assets in the cardiovascular space, suggesting that the interest of a few years ago has somewhat diminished (although assets for heart disease still made up 4% of partnering agreements). Notably absent from preclinical licensing in 2025: cardiovascular, pulmonary, skeletomuscular, hepatic, pain, psychiatry, women’s health, sleep, hearing, and stroke. This pattern perhaps reinforces the industry’s retrenchment toward genetically anchored, biologically de-risked indications. Together, these licensing gaps underscore a 10-year low in early-stage risk appetite outside traditional blockbuster categories.

The top 10 licensing deals from last year are listed in the Table below. Of this elite tier of top-grossing deals, cancer and autoimmune comprised the lion’s share (70%), with neurodegenerative, neurodevelopmental, metabolic, and ophthalmic disease all represented. Only two of the top 10 deals involved traditional small molecules (with one additional license for a molecular glue), whereas biologics accounted for seven. While small molecules still comprise the biggest chunk of licensing activity (18.9%), deals trended toward bispecific and multispecific antibodies for cancer immunology and autoimmune indications — and biopharma was prepared to pay: Of the 8 licensing transactions for multispecifics in our sample, IGI Therapeutics’ (New York, NY) deal with Abbvie, and CDR Life’s (Zurich, Switzerland) agreement with Boehringer Ingelheim, ended among the top 10 grossing deals of the year.

Which leads us to mergers. Overall, we tracked 14 M&A deals last year in the preclinical space. According to Dealforma data presented at JP Morgan, private biopharma accounted for just over 55% of merger activity in 2025 on par with previous years. In the Haystack data, 12 of the 14 acquisitions for preclinical programs were for US-based private companies, reinforcing the historical trend of American biotechs outperforming those in the rest of the world in terms of negotiating successful exits for their investors.

The biggest story in early-stage mergers from last year, though, was biopharma’s ravenous appetite for in vivo CAR-T cell therapy, with Capstan, Orbital and Interius comprising 3 of the 14 acquisitions recorded by Haystack, all of which ranked among the top 5 highest upfront payments. As our sampling commenced in April 2025, we missed another deal: AstraZeneca’s acquisition of lentiviral in vivo CAR-T therapy developer Esobiotec, originally announced in March 2025 with an upfront of $425 million. All in all, in vivo CAR-T therapies claimed 4 of the top 5 acquisitions last year.

The use of lipid nanoparticles (LNPs) in many of these in vivo CAR-T platforms (Orbital, Aera Therapeutics, Stylus Medicine, MagicRNA, Orna Therapeutics, Byterna Therapeutics and Strand Therapeutics) and elsewhere (Tessera, Starna Therapeutics, Nanovation Therapeutics, United Immunity, Genevant Sciences, Pantherna Therapeutics, eTheRNA Immunotherapies, and Beam Therapeutics) also underlies a continuing theme of investment and dealmaking around drug delivery platforms.

Apart from LNPs, several drug delivery deals also centered around antibody shuttles that can take biologics and siRNAs across the blood–brain barrier into the CNS. These included Manifold Bio/Roche, Vect-Horus/Secarna, Ophidion/Neuronasal, JCR/Acumen and Denali/Royalty Pharma. This year will see more of these shuttles enter clinical testing, with Alector’s transferrin shuttle AL137, a subcutaneous anti-amyloid beta antibody, slated for an IND submission.

In sum, the preclinical dealscape in 2025 reveals an industry willing to fund innovation — but only when paired with platform leverage, delivery, or late-stage optionality. As Haystack tracks dealmaking through 2026, the key question will not be whether capital returns to early-stage biotech, but whether it broadens beyond today’s narrow set of ‘acceptable’ risks. We look forward to tracking deals throughout 2026 and identifying new emerging trends in biotech deals.

 

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Advancing Women’s Health Diagnostics Through Glycoproteomics: Proseek Bio at the Innovator’s Pitch Challenge 

3 Feb

Interview with Paula Cerqueira, VP of Scientific Strategy

Proseek Bio is advancing a new approach to women’s health diagnostics by translating cutting-edge glycoproteomics into clinically deployable tools. In this interview, Michelle Hill, CEO of Proseek Bio, discusses the company’s focus on ovarian cancer pre-surgical triage, the unmet clinical needs driving its platform, and how participating in the Innovator’s Pitch Challenge at RESI JPM shaped investor conversations as the company prepares for global expansion.

Michelle Hill
 CaitiCaitlin Dolegowski

Caitlin Dolegowski (CD): For those unfamiliar with Proseek Bio, how do you describe the company and its core technology or therapeutic focus? 

Michelle Hill (MH): Proseek Bio is an Australian diagnostics company focused on women’s health, developing blood-based tests designed to improve how complex conditions are assessed and managed in clinical practice. Ovarian cancer is our first indication, with an initial focus on pre-surgical triage.

Our platform is built on advanced glycoproteomics, integrating multiple protein biomarkers into a single algorithmic score to support clinical decision-making. Rather than relying on any one marker, this multi-analyte approach reflects the biological complexity of disease and enables more informative risk assessment at critical clinical decision points.

What differentiates Proseek Bio is our strong translational focus. The underlying science has been validated through years of academic and clinical research, and we are now converting that work into regulated, scalable diagnostic products for real-world healthcare systems. By targeting earlier decision points such as triage, we aim to support more appropriate referral and intervention, with a longer-term goal of expanding our platform across additional women’s health indications.

CD: What unmet need are you addressing, and why is now the right time for your approach? 

MH: A key unmet need in women’s health diagnostics is the lack of objective tools that reflect real-time disease biology at early clinical decision points. In ovarian cancer pre-surgical triage, clinicians must assess risk using tests with limited biological resolution, which can lead to unnecessary intervention or delayed specialist referral.

Proseek Bio addresses this gap through glycoproteomics, focusing on the glycans attached to proteins that regulate how those proteins function. While genes indicate what could happen and proteins act as messengers, glycan patterns reveal what disease is actively doing in the body. These modifications change early in cancer and cannot be resolved by genomics or standard immunoassays. By integrating glycan and protein signals into a multi-biomarker signature, our tests aim to deliver more informative risk stratification.

The timing is right because advances in clinical mass spectrometry and data analytics have made this biology clinically scalable, enabling integration into existing laboratory workflows and routine care.

CD: What was your experience participating in the Innovator’s Pitch Challenge at RESI JPM? 

MH: Our first time participating in the Innovator’s Pitch Challenge at RESI JPM was an energising experience. Pitching to a room filled with sophisticated investors and peers reinforced the importance of clear, disciplined storytelling when presenting complex diagnostic technologies.

As part of the Brisbane Economic Development Agency cohort, we were proud to represent Brisbane’s growing life sciences ecosystem. Beyond the pitch, the table showcase led to thoughtful conversations with investors and fellow founders who were genuinely engaged with both the clinical problem and our translational approach.

Overall, the experience was validating and motivating. It confirmed that our focus on clinically deployable diagnostics in women’s health resonates with a global audience, and it was rewarding to see that reflected in the recognition we received.

CD: Out of 94 Innovator’s Pitch Challenge companies, what do you think helped Proseek Bio stand out to judges and attendees? 

MH: Women’s health remains significantly underrepresented in diagnostic innovation, and that focus clearly resonated with judges and attendees. Ovarian cancer, in particular, represents a high-impact unmet need, especially at early clinical decision points such as pre-surgical triage.

Proseek Bio was the only diagnostics company on the podium, reflecting the distinctiveness of our approach. By applying glycoproteomics to analyse glycan and protein signatures together, we deliver a more biologically informative assessment of disease activity while remaining compatible with existing clinical laboratory workflows.

Importantly, we were able to clearly articulate not just the science, but the pathway to a regulated, scalable diagnostic product. That combination of unmet clinical need, novel biology, and disciplined execution helped differentiate Proseek Bio in a very strong field.

CD: How did RESI JPM impact discussions with investors, partners, or potential collaborators? 

MH: Being recognised on the Innovator’s Pitch Challenge podium gave investors immediate confidence in both the opportunity and the discipline behind the company, and it strengthened engagement with potential partners. Overall, RESI JPM acted as a signal amplifier, reinforcing Proseek Bio’s readiness for global investment and collaboration while accelerating meaningful follow-on conversations.

CD: Where does Proseek Bio currently stand in terms of fundraising, partnerships, or development milestones? 

MH: Proseek Bio is currently completing its Seed round to support development of our first product, OC-Triage. This funding is enabling a clinical study, implementation of a quality management system, and ISO accreditation to support pilot manufacturing, alongside evaluation of OC-Triage with Australian clinical laboratory partners.

In parallel, we are preparing for a Series A focused on U.S. market entry. RESI JPM provided an important opportunity to initiate discussions with U.S.-based clinical and laboratory partners, laying the groundwork for future validation and commercial pathways.

Together, these milestones reflect a transition from technology validation to execution as Proseek Bio advances toward regulated, clinically deployable diagnostics in women’s health.

CD: What upcoming achievements or milestones are you most excited to share with the life sciences community? 

MH: Over the coming year, we are focused on completing the OC-Triage product and establishing pilot manufacturing under an ISO-accredited quality system. These milestones represent an important transition from development to regulated production readiness.

In parallel, we are advancing clinical evaluation with laboratory partners, which will be critical in demonstrating real-world performance and scalability. Together, these steps mark a shift from innovation to execution.

What excites us most is seeing years of science translate into something tangible: a product that can be manufactured, validated, and ultimately used to support better clinical decisions for women.

Interested in pitching your company to a highly engaged investor audience focused on early-stage life science innovation? Applications are now open for the Innovator’s Pitch Challenge at RESI Europe. Selected companies receive direct feedback from a dedicated group of investors, access to 1:1 partnering, and visibility with global industry leaders.

Apply to pitch and position your company for meaningful investor conversations.

Apply to Pitch at RESI Europe 2026

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The Reality of European Global Partnering

27 Jan

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

DF-News-09142022

Every March, early-stage life science teams spend thousands of euros to attend one of Europe’s biggest partnering weeks. They show up expecting investors, deal momentum, and progress. Most leave with something else: lots of vendor and service provider meeting requests, and a shorter cash runway.

For seed, Series A, and early Series B companies, Lisbon is not a winter party celebration. It is a stress test. And the platforms you choose will either compound your progress or quietly drain your capital.

The Cost Reality No One Likes to Say Out Loud

Standard passes and bundled “week in Lisbon” packages routinely run from 3,000 to 5,000 euros per person, before flights and hotels. For late-stage companies, that may be acceptable. For early-stage teams living on grants, founder savings, or a small seed round, it is a major bet.

By contrast, RESI Europe is typically priced in the 1,500-2,500 euro range because it is built specifically for founders, innovators, and regional cohorts raising seed, Series A, and early Series B funding. The goal is not to sell access at any cost. It is to make high-quality global partnering economically accessible at a stage when every euro still must justify itself.

Here is the problem. Many founders pay the higher prices and then discover that a large share of their so-called “investor” meetings are with service providers selling you something. The badge may say partner or advisor, but the economics are reversed. The startup becomes the customer, not the one being backed.

That outcome is not accidental. It is how large conference ecosystems monetize scale.

Lisbon Does Not Create Strategy. It Exposes It.

Big conference weeks amplify whatever strategy you bring. If you arrive without preparation and focus, you get more noise, more meetings you did not need, and a bigger bill. If you arrive with discipline, targeted investors, and a follow-up system, Lisbon can work.

The problem is that most mega-events are optimized for volume, not readiness. More people. More meetings. More urgency. That model works for late-stage transactions. It fails early-stage teams.

Early-stage companies need fewer things done well:

  • Investors and licensing partners who write first checks
  • Fewer vendor-driven meetings
  • A way to turn first conversations into real follow-up and progress

Proof That a Different Model Works

At JPM Week in January, RESI was designed explicitly around early-stage investing. Roughly 800 companies actively seeking capital and licensing deals participated alongside more than 800 qualified investors and licensing partners from around the world.

Participation was not open-ended. Investor categories were defined. Registrations per firm were capped to protect the signal in the room. The result was not fewer meetings. It was better, more compelling meetings.

That same discipline is what matters in Lisbon.

Why the LSN Partnering Backbone Beats Scale

LSN, owner of the RESI conference series, also owns a premier database of capital investors and licensing partners in the life sciences and offers programs for de-risking early-stage assets and for preparing and executing global roadshows, as well as services like BD Assist, which actually sets up the meetings for you. RESI has five global partnering events annually.

A partnering backbone asks different questions. Are you spending time with partners who fit your stage and product? Have you reduced scientific, regulatory, and execution risk before asking for capital? Do you have a system to re-engage after the week ends? When the answer is yes, Lisbon stops being a gamble.

The Real Fight

The real battle for Lisbon is not about who has the biggest crowd or the loudest brand. It is about who is actually built for early-stage innovation and who is pricing and designing their platform around scale.

For founders, investors, and regions focused on seed, Series A, and early Series B, the smart move is to start the week with early-stage as the priority, not the afterthought, and with “investor” meaning capital and licensing partner, not a sales pitch. Plug Lisbon into a backbone that keeps working after the noise fades. That is how early-stage teams win Lisbon. And that is where the fight really is.

If You’re Coming to Lisbon

RESI Europe will take place in Lisbon with an in-person conference followed by virtual partnering, giving early-stage teams both face-to-face and online access to global investors and licensing partners at founder-level pricing. If you want your Lisbon week to start in a room built for early-stage innovation, not a room selling to you, RESI is where that week should begin.

Register for RESI Europe

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