tradingkey.logo
tradingkey.logo
Pesquisar

Teleconferência de Resultados do 3º Trimestre de 2026 da Nautilus Biotechnology (NAUT): Cronograma de Lançamento do Voyager e Autonomia de Caixa

TradingKey27 de out de 2026 às 21:52
facebooktwitterlinkedin
Ver todos os comentários(0)

A Nautilus Biotechnology registrou receita de US$ 0,2 milhão no 3º trimestre de 2026 e ampliou o prejuízo líquido para US$ 15,6 milhões. A empresa encerrou o período com US$ 114,3 milhões em caixa, projetando folga até o 1º trimestre de 2028. A Nautilus elevou a projeção de receita total para 2026 acima de US$ 0,5 milhão e planeja iniciar a pré-venda da plataforma Voyager no início de 2027, com envios previstos para o meio do ano. A gestão avalia captação de capital até meados de 2027 para expandir portfólio e equipe comercial, focando em ensaios de proteoformas e validações tecnológicas.

Resumo gerado por IA

Principais Destaques

  • A Nautilus Biotechnology registrou receita de US$ 0,2 milhão no 3º trimestre de 2026, proveniente de serviços do programa Early Access e subvenções, refletindo seu estágio comercial inicial antes do lançamento da plataforma Voyager.
  • O prejuízo líquido ampliou para US$ 15,6 milhões, ou US$ 0,12 por ação, ante US$ 13,6 milhões, ou US$ 0,11 por ação, no mesmo período do ano anterior. As despesas operacionais subiram 10%, atingindo US$ 16,9 milhões.
  • O caixa, equivalentes de caixa e investimentos encerraram o trimestre em US$ 114,3 milhões. A administração espera que o plano financeiro atual garanta folga de caixa (cash runway) até o 1º trimestre de 2028.
  • A empresa agora espera que a receita total de 2026 supere a projeção anterior de aproximadamente US$ 0,5 milhão. A receita do 4º trimestre deve crescer sequencialmente, mesmo sem as contribuições do programa SEEDS, financiado pela ARPA-H.
  • A Nautilus planeja abrir a pré-venda da plataforma Voyager no início de 2027 e iniciar os envios dos instrumentos no meio de 2027. Espera-se que os ensaios de Tau, AKT1 e um segundo ensaio oncológico estejam amplamente disponíveis no lançamento comercial dos envios.
  • A empresa permanece focada em desenvolver 20 ensaios de proteoformas até meados de 2028. Ela pode captar capital adicional entre agora e meados de 2027 para expandir seu portfólio de ensaios, capacidades da plataforma e equipe comercial.

Dados Financeiros Principais

Métrica3T26Comparação / Comentários
ReceitaUS$ 0,2 milhãoReceita de serviços do Early Access e subvenção da Michael J. Fox Foundation
Despesas operacionaisUS$ 16,9 milhõesAlta de aproximadamente 10% ante US$ 15,5 milhões no 3T25
Despesas de P&DUS$ 10,2 milhõesAlta de aproximadamente 6% ante US$ 9,6 milhões, impulsionada principalmente por custos com pessoal, laboratório e serviços profissionais
Despesas com vendas, gerais e administrativas (SG&A)US$ 6,8 milhõesAlta de aproximadamente 15% ante US$ 5,9 milhões, impulsionada por custos jurídicos, de marketing e de pessoal
Prejuízo líquidoUS$ 15,6 milhõesEm comparação com US$ 13,6 milhões no 3T25
Prejuízo líquido por açãoUS$ 0,12Em comparação com US$ 0,11 no 3T25
Caixa, equivalentes de caixa e investimentosUS$ 114,3 milhõesQueda em relação aos US$ 129,2 milhões no final do 2T26
Consumo trimestral de caixaAproximadamente US$ 14,9 milhõesRefletiu investimentos no desenvolvimento de ensaios e preparação para o lançamento

Desempenho Operacional e dos Negócios

A Nautilus está concentrando seus recursos na análise de proteoformas por meio de sua plataforma Voyager e tecnologia de Mapeamento Iterativo (Iterative Mapping). A plataforma foi projetada para analisar moléculas de proteínas intactas com resolução de molécula única, em vez de inferir proteínas a partir de fragmentos ou medições médias entre moléculas.

No Congresso Mundial da HUPO, a empresa apresentou dados iniciais de ensaios oncológicos direcionados a AKT1, EGFR e P53. Os coeficientes de variação médios foram de 8,8% para AKT1, 3,6% para EGFR e 6,6% para P53, todos abaixo da meta de 10% da empresa. Seu ensaio de tau, em estágio mais avançado, apresentou um coeficiente de variação médio de 5,5%.

O ensaio AKT1 deve entrar no Early Access no final de 2026. A administração informou que o AKT1 estava em fase de verificação e validação, o EGFR em estágio avançado de desenvolvimento e o P53 avançando logo atrás do EGFR.

A Nautilus também reconheceu sua primeira receita proveniente do Programa Early Access e do desenvolvimento de um ensaio de proteoforma de alfa-sinucleína financiado pela Michael J. Fox Foundation. Sua pesquisa sobre tau foi publicada na Nature Methods durante o 3º trimestre, fornecendo validação revisada por pares para a tecnologia de Mapeamento Iterativo.

A empresa espera receber até US$ 6 milhões ao longo de quatro anos por sua participação no Consórcio SEEDS, financiado pela ARPA-H. O trabalho engloba a proteína tau na doença de Alzheimer, EWS::FLI1 no sarcoma de Ewing, estudos em biofluidos e tecidos, além de posterior otimização da plataforma. A receita será reconhecida à medida que os trabalhos forem concluídos.

Projeções da Administração

A administração espera que a receita do 4º trimestre de 2026 venha principalmente de subvenções e serviços do Early Access. Excluindo qualquer contribuição do SEEDS, a receita do 4º trimestre deve crescer sequencialmente devido à atividade de fim de ano do Early Access.

A receita total de 2026 agora deve superar a projeção anterior da empresa de aproximadamente US$ 0,5 milhão. O crescimento das despesas operacionais para o ano completo deve permanecer na faixa de um único dígito.

A empresa apresentou o seguinte cronograma (roadmap) de produtos:

  • Final de 2026: previsão de entrada do ensaio AKT1 no Early Access.
  • Início de 2027: previsão de lançamento comercial do Voyager e abertura de pré-vendas.
  • Meados de 2027: previsão do início dos envios dos instrumentos, com disponibilidade geral dos ensaios para tau, AKT1 e um segundo ensaio oncológico.
  • Final de 2027: planejamento de kits de ensaios adicionais, juntamente com a previsão de redução de cerca de 100 vezes nas exigências de volume de amostra.
  • Meados de 2028: meta de 20 ensaios de proteoformas.

A administração descreveu 2027 como um ano de consolidação de bases e 2028 como o período em que a Nautilus espera expandir seus negócios de forma mais substancial.

Riscos e Pontos de Atenção

A Nautilus permanece em fase comercial inicial, com receita limitada e prejuízos operacionais contínuos antes do lançamento do Voyager. A execução depende da conclusão da validação das unidades beta, da finalização de preços e especificações, e da entrega dentro do prazo do instrumento, consumíveis, softwares e ensaios.

A administração está avaliando uma potencial captação de recursos entre agora e meados de 2027. Os fundos apoiariam a expansão de ensaios, desenvolvimento da plataforma e contratações para a equipe comercial, mas qualquer financiamento poderá impactar a estrutura de capital da empresa.

Clientes acadêmicos permanecem preocupados com o financiamento do NIH e de outros órgãos governamentais. A administração apontou a incerteza em relação às subvenções S10 para compra de grandes equipamentos como um problema específico para as instalações em 2027, embora tenha afirmado que a Nautilus está atualmente menos vulnerável devido ao seu estágio inicial e à exposição a projetos farmacêuticos e financiados por filantropia.

A adoção pelos clientes também dependerá se os dados de proteoformas se mostrarem aplicáveis no desenvolvimento de medicamentos e diagnósticos. A administração destacou que os clientes buscam conteúdo de ensaios mais amplo, maior sensibilidade, menores exigências de amostra e suporte a tipos adicionais de amostra, incluindo biofluidos.

Destaques da Sessão de Perguntas e Respostas dos Analistas

Pipeline comercial: A administração afirmou que a equipe de vendas de três pessoas estruturou prioritariamente um pipeline focado na proteína tau desde abril de 2026. Esse pipeline sustenta a expectativa de crescimento sequencial da receita do Early Access no 4º trimestre. As atividades voltadas para oncologia estão começando com o AKT1, e a empresa planeja expandir sua equipe comercial em 2027.

Prontidão para o lançamento: Os principais marcos incluem a alocação e operação de uma unidade beta em 2026, a validação da confiabilidade do instrumento e a garantia de que consumíveis, software em nuvem e múltiplas aplicações estejam prontos para os envios em meados de 2027.

Demanda e utilização do instrumento: A Nautilus espera demanda inicial de clientes acadêmicos, instituições sem fins lucrativos e empresas farmacêuticas. A administração indicou que a aquisição própria do instrumento faz sentido financeiro quando o cliente atinge cerca de US$ 0,5 milhão em uso anual de consumíveis, embora os clientes possam levar algum tempo para alcançar esse nível.

Oportunidade em IA: A administração vê os dados de proteoformas altamente reproduzíveis como um potencial insumo de treinamento para futuros modelos biológicos de IA. Ela enfatizou que essa continua sendo uma oportunidade de longo prazo e que conjuntos de dados de treinamento em larga escala para essa aplicação ainda estão em estágio inicial.

Casos de uso para a proteína tau: O trabalho no Early Access inclui biologia mecanicista, estudos de mecanismo de ação terapêutica e descoberta de biomarcadores. A administração destacou pesquisas sobre diferenças em sistemas de modelos, variação regional da tau no cérebro, conexões entre o genótipo APOE e formas fosforiladas de tau, e a estratificação de patologias neurodegenerativas mistas.

Despesas de capital: A administração não prevê atualmente gastos relevantes com instalações de produção, instalações gerais ou equipamentos. O uso de caixa planejado é direcionado principalmente para ensaios, preparação do lançamento, desenvolvimento de mercado e contratações comerciais.

Transcrição Completa da Teleconferência de Resultados


Transcrição completa da teleconferência de resultados

Comentários da administração

Operator

Good day, and thank you for standing by. Welcome to Nautilus Biotechnology Q3 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to Investor Relations. Please go ahead.

Unknown Attendee

Thank you. Earlier today, Nautilus released financial results for the quarter ended September 30, 2026. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an e-mail to investorrelations@nautilus.bio.

Joining me today from Nautilus are Sujal Patel, Co-Founder and CEO; Parag Mallick, Co-Founder and Chief Scientist; and Anna Mowry, Chief Financial Officer.

Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the press release Nautilus issued today.

Except as required by law, Nautilus disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast on October 27, 2026.

With that, I'll turn the call over to Sujal.

Sujal Patel

Thanks, Marissa, and thank you all for joining us today. Last quarter, I walked you through a deliberate decision to concentrate our resources on proteoforms. This quarter, I want to talk to you about what proteoforms are and why we believe they're one of the most important opportunities in life sciences and how we're building the foundation for meaningful long-term growth.

Let me start with the idea that guides everything we do. We are making functional biology measurable. For decades, proteomics has primarily been about telling us how much protein is present. While the quantity of a protein is meaningful information, it's not the whole story. Most of today's tools don't have the resolution and scale required to measure the myriad of function driving modifications that vary across every protein molecule. Shotgun mass spectrometry breaks proteins into peptides and infers the proteins from those pieces.

Most affinity assays estimate average abundances by measuring a singular epitope on a protein. Either way, functionally distinct protein molecules are undifferentiated as the information about splice variants, truncations and which modifications co-occur on the same molecule is lost. That matters because the complexity of human biology does not come from the number of genes we carry.

Consider the banana. The banana has almost 40,000 protein-coding genes. As humans, we are clearly more complex than a banana. And in the early days of the Human Genome Project, scientists expected humans to have well over 100,000 genes. In fact, we only have about 20,000, half as many as a banana. The reality is that, our complexity comes from the functional biology layer above the genome and particularly from the many forms each protein can take. Those genes are merely the instruction manual for building the machinery of life.

A single gene can give rise to many distinct proteoforms shaped by splicing, sequence variation and by many modifications that occur after a protein is made. Each molecule is a discrete functional unit, and its form determines what it does, how it signals, who it interacts with and where it sits spatially in the cell. The specific form a protein takes often determines what it actually does, where it goes, what it binds to and what pathway it turns on and which phenotypes it ultimately drives.

AKT1 is a good example. It is a central switch in cancer signaling and whether that switch is on depends on which sites are phosphorylated together on the same molecule. Two cells can carry the same amount of AKT1 and be in completely different signaling states.

Tau is another example. In Alzheimer's disease, what matters is not just how much tau is present, but which modified forms accumulate. Since proteoforms were never previously measurable at scale, it was never possible to use this critical information to understand health and disease. Proteoform resolution provides valuable novel information for drug development and precision medicine, and it has not been accessible at scale until today.

We built Iterative Mapping, the method that powers our Voyager platform to change that. It reads millions to billions of single intact protein molecules across a massively parallel array, so it can resolve each molecule's functional state rather than breaking it apart or averaging them away. When you can see that layer of molecular resolution, you're looking at an entirely new kind of biological insight.

We believe no one else can deliver the resolution and scale our platform can. That is what we mean by making functional biology measurable, and I believe the value of this approach will become increasingly clear as our data reaches more scientists. We believe that proteoform resolution at scale will be a critical foundation for AI and biomedicine. The industry is starting to build large data sets to train the next generation of AI models, and those models are only as good as the data they learn from. We believe highly reproducible proteoform data is exactly the differentiated data they will need to learn functional biology.

To accelerate our proteoform road map, we effectively tripled the number of people and resources focused on proteoform development, and we set a goal of developing 20 proteoform assays by the middle of 2028. That plan is now in motion and 2 things give me confidence in where we're heading. The first is the pull we're seeing from the scientific community. Second is the evidence that we can execute against our road map.

Let me take each in turn. On the pull from the community, at this year's HUPO World Congress, the leading global proteomics meeting hosted by the Human Proteome Organization, proteoforms were such a pervasive theme that one article covering the conference in Chemical & Engineering News ran under the headline, "Proteins Don't Exist: Scenes from HUPO 2026."

We also hosted a panel with 3 leading researchers whose labs develop and apply some of the field's most advanced protein analysis technologies. Birgit Schilling of the Buck Institute for Research on Aging, Jochen Schwenk of KTH Royal Institute of Technology, and Bernd Wollscheid of ETH Zurich to ask, "Will proteoforms change our understanding of biology?"

I want to share some of their perspectives. Dr. Schilling put it simply, "My thought is proteoforms are critical everywhere. These proteoforms influence function. They influence really everything that makes a cell work." Dr. Wollscheid also noted, "We operate under the assumption, like everybody else, there are no proteins, only proteoforms. And I think we have an opportunity to not only decode individual proteoforms, but also individual proteoform-specific complexes which have functional relevance."

When we ask what customers need, they consistently want more proteoforms, more sample types and more applications. A great example came when we announced our partnership in the SEEDS Consortium. SEEDS is funded up to $51.7 million by the Advanced Research Projects Agency for Health, or ARPA-H. We expect to receive up to $6 million over the 4-year program to apply our Voyager platform to tau in Alzheimer's disease and EWS::FLI1 in Ewing sarcoma, our first work in pediatric cancer.

The data is expected to help train AI models on disordered proteins, which today's models handle poorly. Our work with both SEEDS and the Michael J. Fox Foundation are early examples of a broader opportunity, large-scale studies coupled with custom development. As we work more deeply with pharma, we expect partners to want to build assays for their own targets beyond what's on our price list. We're ready to build those assays and to help apply them across large cohorts.

Turning to the second reason for my confidence in our plan, our track record of early execution. At HUPO, we shared first data from 3 of our oncology proteoform assays targeting AKT1, EGFR and P53. To put the results in context, first, let's go back to tau. We believe it delivers some of the most reproducible detailed proteomics data in the world, both internally and with our partners at the Buck Institute, the Voyager platform delivered a median coefficient of variation, or CV, of 5.5%. That reproducibility is what makes our data trustworthy and scalable and makes it possible to build AI on top of it.

After about a year of development, AKT1, EGFR and P53 are already performing in line with tau, our most mature assay, which took roughly 5 years to build. Median CVs were 8.8% for AKT1, 3.6% for EGFR and 6.6% for P53, all well below our 10% target and far better than industry norms, closer to 25%. That is a remarkable result. It tells us our core capability carries over from one target to the next, and it gives us confidence in the development of all 3 assays and the ones behind them.

Stepping back, we have accomplished a great deal this year. We launched our Early Access Program and brought in our first Early Access customers, including Baylor College of Medicine. The Michael J. Fox Foundation is funding the development of an alpha-synuclein proteoform assay for Parkinson's disease, and that work is well underway. We recognized our first revenue from both the early access program and the MJFF grant.

In Q3, our tau proteoform work was published in Nature Methods, a peer-reviewed validation of the Iterative Mapping method and accompanied by a News & Views article in the same issue. In the News & Views commentary, Albert Heck of Utrecht University wrote that Iterative Mapping might be a valuable platform that could even be used clinically to assay tau proteoform landscapes, supporting diagnosis and stratification of disease subtypes, and potentially even assessing the effect of therapy, and can be adapted to measure the proteoform landscapes of other proteins.

In a small cohort analyzed in the paper, tau proteoform analysis distinguished people with Alzheimer's disease from cognitively normal individuals and the clearest signal came from proteoforms with as many as 4 phosphorylations on the same molecule, information a single site measurement cannot capture.

Rounding out our accomplishments year-to-date, we moved 3 oncology assays into development and shared their first data. We were selected to participate in SEEDS, and we remain on track to place our first beta unit this year.

Looking ahead, here's what you should expect from us in the next several quarters. We expect to bring our AKT1 proteoform assay into early access in late 2026. We're working with our early access partners to generate additional tau data, and we look forward to sharing those results as they're published.

In early 2027, we expect to announce the commercial launch of the Voyager platform and open for preorders. In mid-2027, we expect to begin instrument shipments and introduce general availability of our tau and AKT1 assay kits as well as general availability for a second oncology assay.

We expect additional assays to be available through early access at the same time so customers can begin generating data on them right away, and we plan to follow by introducing more kits in late 2027. Between now and general availability of our consumable kits in late 2027, we also expect to reduce our sample input requirements by roughly 100-fold. We anticipate this improvement will enable us to measure extremely low abundance proteins in biofluids such as blood.

Putting all that together, we believe our commercial path is not dependent on any single future application and that proteoforms on their own represent an incredibly compelling business opportunity. The scientific need is real, the data shows we can deliver and the instrument assays that bring it to customers are maturing into commercial-grade products.

With that, I'll turn the call over to Anna.

Anna Mowry

Thanks, Sujal. Our results this quarter reflect where we are as a company, in an early commercial phase, with revenue coming from early access services and grant funding and the commercial launch of the Voyager platform still ahead of us. We are encouraged by the engagement we are seeing across academic and pharma customers and collaborators.

Total revenue for the third quarter was $0.2 million, consisting of grant revenue for our Michael J. Fox Foundation funded alpha-synuclein proteoform assay development and service revenue from our early access program. As a reminder, early access is our initial phase of commercial engagement, focused on serving our first customers and delivering the highest quality data possible. Working through the operational details of each engagement is exactly what this phase is for and what we are learning reinforces our confidence that our pricing and margin expectations for the commercial platform are achievable over the long term.

In Q4, we expect revenue to again come primarily from grant funding and early access services. With our participation in the SEEDS program, we expect to recognize grant revenue as the work is performed over the 4-year program. Excluding any potential contribution from our ARPA-H funded SEEDS work, we expect fourth quarter revenue to grow sequentially from the third quarter, driven by year-end early access activity. As a result, we now expect total 2026 revenue to exceed our prior outlook of approximately $0.5 million.

Total operating expenses were $16.9 million for the third quarter of 2026, an increase of approximately 10% from $15.5 million in the prior year period.

Research and development expenses were $10.2 million, up approximately 6% from $9.6 million in the prior year period, driven primarily by higher personnel costs and higher laboratory and professional services costs as we advance our proteoform assay development.

Selling, general and administrative expenses were $6.8 million, up approximately 15% from $5.9 million in the prior year period, driven primarily by higher legal, marketing and personnel costs. Net loss for the third quarter of 2026 was $15.6 million or $0.12 per share, compared to a net loss of $13.6 million or $0.11 per share in the prior year period. We remain disciplined in how we manage expenses and cash, and we expect full year operating expense growth in the single digits.

We ended the third quarter with $114.3 million in cash, cash equivalents and investments compared to $129.2 million at the end of the second quarter, reflecting cash use of approximately $14.9 million in the quarter. Based on our current trajectory, we believe our financial plan funds a cash runway that extends into the first quarter of 2028.

Finally, on capital. As Sujal described, we believe proteoforms represent a significant market opportunity, and we see tremendous potential to begin capturing it by continuing to invest in our technology, capabilities and team.

Our current runway gives us a strong foundation, and we are exploring the option to raise funds between now and mid-2027 to invest in 3 areas. Expanding our proteoform assay portfolio, extending the platform's capabilities and building the commercial team to serve and scale our customer base. We are actively evaluating the right path to do so, one that positions Nautilus to capture this market and serves our shareholders well.

Back to you, Sujal.

Sujal Patel

Thanks, Anna. Let me leave you with 4 points. First, we're making functional biology measurable. Proteoforms give scientists an entirely new layer of biological insight, and we believe our platform is uniquely positioned to deliver it.

Second, Iterative Mapping is core to the Voyager platform, and we'll continue to build on it with more assays, more sample types and new applications like the one ARPA-H is supporting.

Third, we have confidence in our road map. The performance we've established on tau is carrying over to the next round of targets and the funnel behind our goal of 20 assays by mid-2028 is in place.

And fourth, proteoforms are the foundation of our growth strategy. With the Voyager platform approaching launch and a growing library of assays behind it, we believe we are well positioned for the next phase of our commercial journey.

This year, we put proteoforms at the center of our strategy, proved our assays can scale from one target to the next and earned validation from Nature Methods, the Michael J. Fox Foundation and ARPA-H. The year ahead is about putting that capability in customers' hands, starting with preorders in early 2027 and instrument shipments in mid-2027. I have never been more confident in our team's ability to deliver.

Thank you again for joining us today. With that, we're happy to take your questions. Operator?

Operator

[Operator Instructions] Our first question comes from the line of Subbu Nambi of Guggenheim.

Perguntas e respostas

Subhalaxmi Nambi

On the SEEDS funding, could you provide some additional detail? Is that evenly spread over the course of the program? And is it based on milestones you need to hit? And what's the best use of those funds right now?

Sujal Patel

Yes. This is Sujal. So the SEEDS program is separated into different program goals with different institutions, the Buck Institute and Georgetown leading the efforts for our part of SEEDS. And revenue will be recognized over the course of the 4-year period as we complete work. And I don't know if anything else you want to add on that, but I think those are the basics of it right now. We just signed that agreement to get going on it this week here. And so we'll look forward to getting started shortly.

Subhalaxmi Nambi

I have an AI question. What is the tangible opportunity like today with AI data set building for commercial partners given you sit in a unique spot with tau? And what have you seen on the oncology front in terms of inbounds?

Sujal Patel

Yes. Let me try to address your AI question a little bit more broadly. I think that if you look at the industry, there is definitely a huge AI wave and a lot of it is very real, a little bit of it is hype today. If you look at the areas where AI has been really successful in 2026, there are some areas in biology, it's been successful, for example, this lab in the loop concept, which enables you to design experiments, learn from them with AI, design the next experiment with AI and iterate faster.

There's been good success in antibody design and small molecule design. And at the end of this year, if you kind of look at the state of things, we're just now seeing companies that are formed and are trying to take large cohorts and analyze them for genomic information or for proteomic information to try to discover trends and learnings that we haven't been able to discover with humans.

Our view is that, that last piece represents a huge opportunity, but the training set required for frontier models doesn't yet exist. Because if you look at the training set that you could get with mass spectrometry-based proteomics or traditional assays that are affinity-based proteomic products, the data between the various techniques doesn't agree. The CVs are 20%, 30%, even 40% in many cases. And if you can't even agree on what proteins are in a sample, how are you going to understand what's upregulated, what's downregulated, what are the magnet changes that are occurring. That is where we see Nautilus' opportunity.

The proteoform assays that we are building are doing 2 things. They are providing an extremely high reliability, low CV, very precise measurement of what's going on with critical biomarkers in disease-relevant molecular pathways. And the second thing we're doing is we're providing this layer of intelligence because we don't just see the biomarker in its gene encoded form. We see the modifications, the splice forms, the sequence variants, and we see those co-occurring on a single molecule.

That is incredibly critical because each molecule has a different function, different degradation, signaling, different molecular pathways that it participates in based on the combination of those modifications. We're already seeing that with the early evidence that we're seeing with the Buck Institute in tau with other early access customers. And now we're beginning that work in AKT1 and in the future with other oncology markers.

So I think applying this proteoform technology to AI and frontier models on large cohorts is going to be a massive long-term opportunity that will be a driver for us. We're just at the beginning of that wave today.

Subhalaxmi Nambi

Sujal, I really appreciate you giving that level of detail. It was really helpful. Last one for me on the commercial side, as oncology comes online alongside tau, can you just talk through how you're approaching these 2 different call points from a pipeline and sales perspective?

Sujal Patel

Yes, that's a good question, Subbu. Let me give you a little bit of perspective. Just to kind of tell you where the pipeline and commercial build is today. So in March, we hired Amber Faust, who is our Head of Worldwide Sales. In April, we hired the 2 sales reps that we have in the company today. So it's a sales team of 3. If you kind of look at April to the end of Q3, which we just reported, it's about 6 months. And so that team came on board. They closed some of the early, early activities that we had before we had a sales team related to tau and early access. And then they really began pipeline building for tau. Everything that we see in the pipeline today, for the most part, is really tau related.

And as Anna talked about in her prepared remarks, the pipeline is strong enough that we can predict today that we do expect revenue to grow sequentially in Q4, even without any contribution from SEEDS, the ARPA-H grant. And so we're seeing good trends in terms of pipeline growth on tau. And keep in mind, it's still early, right? We -- it hasn't even been 60 days since our seminal Nature Methods publication. The team is just building pipeline.

As we start to look at our Q4 activities, a lot of those activities are still related to tau, but we're beginning the activities related to AKT1. And as I said on our previous earnings call, we have a small sales team today, but they're a mighty team. They all know the proteomic space really well. And we're confident that they're able to handle both the neurodegeneration and oncology activities over the course of the next couple of quarters, but you should expect that we are going to continue to grow that commercial team in 2027.

Operator

Our next question comes from the line of Dan Brennan of TD Cowen.

Daniel Brennan

Maybe just as a follow-up, just any way to characterize, I know Sujal, you just mentioned about the sequential growth in 4Q. But just as -- any way to qualitatively discuss number of customers, number of projects, just things like that, like on early access. I know it's really early, but just to get a sense of what the pace of the progression or the funnel looks like?

Anna Mowry

Yes, Dan, I can speak to that. We aren't giving guidance on number or disclosing the number of customers, but I think what we can say is reiterating what Sujal just said is that, the sales team when they first came on, they had to prosecute the pipeline that we had and largely build their own pipeline. And so from what we are seeing in the pipeline today, we have the confidence to be able to say that we expect early access services revenue to grow in Q4. And then keep in mind, next year, we'll have the oncology assays in addition to tau that will drive customer acquisition from an early access standpoint.

Daniel Brennan

Got it. In terms of launching the commercial platform early '27, just what are the key milestones that need to happen between now and then to ensure that you're on time with that?

Sujal Patel

Yes. So Dan, if you look at -- so what we -- let me answer the question in 2 ways, right? Because you asked about launch, and there's 2 milestones that are key for next year. So one is the launch of our instrument, and that is really about getting pricing finalized, final specifications out in the world and getting ready to take preorders. And then the second is the big milestone, which is the actual ship in the middle of the year. And obviously, the launch just depends on the ship being on track.

In order for the ship to be on track, we are planning to ship a beta unit here this year. We are planning to get it operationalized and prove that the final instrument is fully capable. It's reliable. It does what it needs to do. The intention is in the middle of next year, we're shipping instrument consumables, we're shipping our software platform, cloud portal, and we're shipping a set of applications. And so expected to line up with that launch generally available is our tau assay, our ATP1 assay and the second oncology assay.

And in addition to that, we expect another -- a third oncology assay and somewhere around another 4 to 5 proteoforms that are in early access or just about to get into early access at that time. And so for us, there's a significant amount of content that's available for customers to consume to drive those instrument purchases. And so all those things being on time is our launch criteria. And I think that our execution in Q3 shows that we really are capable of advancing these assays through our pipeline quickly and still meeting the performance criteria, which is industry-leading that we first demonstrated with our tau assay.

So if you look at our assays today, we keep saying second and third oncology proteoform because we're not committing to what those are yet. But if you look at our current state, AKT1 is in verification and validation, EGFR is in late development and P53 is in development right behind that.

Daniel Brennan

Great. Maybe just final one would just be, assuming your time lines hold, how would a product like this launch in terms of it's novel, but the market, as you discussed it, is ready for something like this. Is this would be -- just we think ahead '27, '28, I know you're not going to give guidance right now, but I'm just trying to get a sense of the customer interest and how novel and different this is, just when it launches, how will you try to manage the launch in terms of ensuring that the product works in the field. But at the same time, if it does what it says it's going to do, I could anticipate a pretty strong demand for it. So just any color about kind of the interest, the pace of launch once it's out?

Sujal Patel

Yes. Dan, this is -- it's a good question. And the launch will look -- in our minds, it will look a lot like other disruptive technologies that are life science platforms that get introduced. So you could look as inspiration to products like 10x when they first came to market with their single cell genomics platform. You could look at products like Berkeley Lights and others as they got going. Berkeley Lights, I mentioned because their price point was around $2 million per instrument. So it's got a price point much higher than where we were.

And so generally, what happens is that from what we observe is that there is a new data modality, something that's bringing novel insight to the customer. Customers who are early customers in the academic and nonprofit research side often will apply for grants. They'll go get those instruments and they'll bring them in. And the difference between successful companies and those companies which don't achieve a high degree of success is how useful is the information that you get out of the platform? How actionable is it? Does it help you to build better diagnostics? Does it help you to accelerate drug development programs or to improve the efficacy of drug development programs.

And so for us, we expect that because this data is first-of-kind data that no one on the planet has seen, there's going to be great interest for the platform. And we expect, given that these proteoforms are critical to understanding disease pathway, critical to understanding how proteins are functioning within the cell and signaling within the cell. They're critical to understanding where in the cell the protein is. Is it on the cell surface? Is it in the nucleus? Is it in one area or the other?

Like we expect the data is going to be really important to drug discovery and to diagnostics. And it's not because we just think that we're hearing that from the scientific community. We've heard that at World HUPO from the KOLs who are on our panel and from others who visit us at the booth or had meetings with us. And so that's sort of at a high level how I think things will roll out.

For '27, I think that we have a sort of measured approach. We're going to get launched. We're going to have a few assays that are in early access -- sorry, there's a few assays that are in general availability, some others in early access. We're going to have to build funnel for the instrument purchases.

Today, if you look at our funnel, it's for both early access services and the very beginning of a few conversations around instrument. The funnel does represent all 3 sectors, academic, nonprofit research and pharma. And that's a good thing, right? Because for the most part, the grant funding cycle for instruments, the S10 grants, is largely behind us for '27 grant funding. So that means that we're going to have to go after pharma and philanthropically funded types of projects. There are plenty out there, but those are the things that we're dealing with for '27.

As we get to '28, I think things will be much more open for us as a company. One, we will be working hard with customers for the S10 grant cycle in '27, so that the grants come out in '28. And in addition to that, we'll have much, much more content available as we start to move through '28. We'll have something closer to 10 assays starting '28 and exiting with 20 or more proteoform assays. And so that's sort of how I think it will roll out. I think that '27 is a year where we set the foundation and '28 is a year where we really go and scale the business.

Operator

Our next question comes from the line of Puneet Souda of Leerink.

Michael Almisry

You have Michael Sonntag on for Puneet Souda. I think, first, I was wondering if you could offer any details on some of the use cases you're seeing from the early access tau work you're doing?

Sujal Patel

Yes. And why don't I let Parag walk through some of that?

Parag Mallick

Michael, it's a really great question. And I think we've been excited by the diversity of use cases that we're seeing. In general, I would categorize them into sort of 3 buckets. One is fundamental mechanistic biology. Two is disease biology, particularly associated with therapeutic development, mechanism of action type studies. And then three are really the foundational building blocks of biomarker discovery.

And so we saw that, for example, in the work that Taylor from NSCI presented on our webinar recently, where she was looking at the diverse model systems that are used in the field for -- particularly for drug screening studies. And today, if you look at those diverse model systems, you have iNeurons, you have stem cell models, et cetera. By just about any preexisting measure, they are indistinguishable despite the fact that they have very different responses to different therapeutics.

And so when she was looking and studying them using our platform, it was clear immediately that they actually have very different forms of tau, the proteoforms of tau are different. They change over time as the systems mature and age. And that's a level of detail that is critical to understand how drugs will function in those models. But today, pharma companies can't really tell them apart. So they're sort of picking all of them or picking it random. And so that was a really exciting study to be able to say, okay, well, here's why they're responding differently. They actually have fundamentally different flavors of tau.

Another sort of very interesting question that we've seen from our early adopters has been trying to understand how there's a challenge in Alzheimer's disease known as selective vulnerability. This is that Alzheimer's disease starts in one part of the brain and moves to other parts of the brain in a very specific manner. Again, big open question and understanding how the forms of tau differ across the different brain regions, and we're seeing very strong evidence that there are different flavors of tau in different parts of the brain.

The last point I'll just call out is really one that gets to biomarkers and maybe even prevention therapeutics. A study done by our collaborators at the Buck was looking at this APOE genotype, which is in a lipid biosynthesis pathway. It has basically nothing to do with tau, but it's one of the strongest markers for Alzheimer's disease. So people who have one mutation are likely to have Alzheimer's disease by the time they're 45, a different mutation is incredibly preventative and people are at extremely low risk. But the connection to the mechanism of Alzheimer's disease is -- was previously unknown.

And in some of their very first studies, it became clear that there were double and triple phosphorylated forms of tau that were associated with these mutations in a protein in a completely different pathway in a completely different part of the cell. And so really the first link between this key genetic driver of Alzheimer's disease and the actual pathology of the disease.

Maybe one last anecdote for you is really thinking about stratification. One of the major challenges that we have in neurodegenerative diseases is that people may have one neurodegenerative disease, Alzheimer's disease or they might have mixed pathologies. And most patients have mixed pathologies where they have a mix of supranuclear palsy or they will have Parkinson's disease and Alzheimer's disease. And so that makes drug development extremely challenging because you are developing a drug offensively for Alzheimer's disease, but your cohort in your trial contains mixed pathologies.

And then maybe the drug fails not because it doesn't work on Alzheimer's disease, but because the patient cohort that is being explored on has either one of multiple different neurodegenerative diseases that typically can't be disentangled until postmortem. And so there are active studies going on to try to understand these mixed pathologies and differentiate them.

Michael Almisry

Okay. Great. And then another question on academic funding. Another player in the high-res mass spec space has talked about budget flush on the academic side, potentially supporting a more favorable outlook on academic. I appreciate that your funnel is in a much earlier state. But I'm curious if you're seeing any changes in the tone or whatnot from prospective customers based on the situation in the grants.

Sujal Patel

I mean I think you hedged the question appropriately, which is that it's early for us. The primary changes in our pipeline are due to the fact that our team is just getting outreaches done, getting out there. We've had less than 60 days with the Nature Methods seminal publication to go out to customers and show the power of it. And so I think those are the types of activities that are largely driving the funnel increase as we head into Q4.

With respect to customer sentiment, what I think customers are still nervous about NIH funding in general and other sources of government funding. But I would say that funding still seems to happen, and it's still moving forward. I think that S10 grants in particular, for large instrument purchases is something that is a little bit more unknown than funding of other sources. And so it's something that we're paying particular attention to helping customers next year get those grant proposals in so that we've got continued momentum in placements of instrumentation in '28. And so that's what I would say about it. I think for us, we're less sensitive to it because we're so early.

Michael Almisry

Okay. Got it. And then my last question is more on the financial side. We talked a little bit about the steps you're taking for launch readiness. I saw that CapEx stepped up a little bit. I'm curious to what extent capital spending is part of the launch readiness plan, if we should be expecting anything meaningfully different than what we're seeing this year.

Anna Mowry

Thanks, Michael. Happy to speak to that. For the most part, our projections on cash runway into Q1 2028 are primarily around our investments in expanding our proteoform portfolio, getting ready for instrument launch and investing in our commercial team market development. We've got -- of course, we anticipate that capital spending grows along with our spending, but we're not seeing any material CapEx investments either in production facilities or facilities in general or equipment. Those are things that we would do in a very targeted way. And ultimately, it's not material from a cash burn standpoint.

Operator

[Operator Instructions] Our next question comes from the line of Max Masucci of ROTH Capital Partners.

Max Masucci

Congrats on a great update. So the SEEDS Consortium work includes some work on disease tissues and biofluids. Is it safe to assume that, that means CSF for the Alzheimer's work, or will you be evaluating blood samples? Just looking to understand at a high level how this work advances your efforts on the biofluid side.

Parag Mallick

Max, yes, that's right. So the SEEDS Consortium work includes a couple of different elements. It includes running our existing assays for tau in both tissue samples as well as model systems. And then to your point, as well as in biofluids. It also includes building a new assay for running in tissues and biofluids for developing a biomarker assay for EWS::FLI1 cancer-specific biomarkers. And it includes a third piece as well, which is further platform optimization and development.

Max Masucci

Okay. Great. So maybe just a bigger picture question. You've attended HUPO for the past several years, right? This year you had more to share about the platform, a panel, poster presentations. What feedback coming out of HUPO or feedback coming from your early access customers has most influenced what you're prioritizing ahead of your launch, whether that's in terms of assay prioritization or use cases or something else?

Parag Mallick

I think number one that I see is that we are making a measurement that literally no one else in the world can make. There simply does not exist another technology in the world that is capable of single molecule resolution proteoform analysis at scale. And we're hearing that message resonate very loudly. We're hearing people saying, well, obviously, this is how biology works. And we've always wanted to be able to measure it, and they're excited about the opportunity to be able to look at this critical aspect of biology.

I think the -- in terms of how this is affecting our launch strategy, I think the -- it really is validating our thesis that when we talk to people, they -- what they care about are 2 things. They care about increasing the content, what proteins we're measuring, what additional proteoforms we're measuring and then they care about capabilities, things like increasing sensitivity, decreasing sample input requirements, moving to different types of matrices, sample types. You mentioned biofluids earlier. And so that's really driving our next stages of development is those 2 dimensions, increasing the content and increasing the capabilities.

And I'd just like to emphasize that in both of those dimensions, those really are just changes in the consumables on the platform. They have -- the instrument was designed to have a tremendous amount of functionality and capability. And so we're able to address those desires from the market through changes in reagent kits.

Sujal Patel

Max, this is Sujal. Just to add a little bit to Parag's response. One piece to your question was how does it inform our launch strategy. And I wanted to highlight that long-term success for Nautilus is about taking each application, tau, AKT1, EGFR and so forth, and showing and demonstrating for customers that there is real biological insight here that is critical information that's necessary for improving the efficacy and speed of drug development for the next generation of diagnostics for disease diagnosis, therapeutic response monitoring, therapy selection, MRD. That's the goal for us.

And so if you look at all of our activities today, early access, the collaborators, Michael J. Fox, ARPA-H, all of that is in the -- all of that has the end goal of giving us the biological information package that we can use to demonstrate to customers that there is a significant amount of utility in these applications that we're selling. That will sell more consumables, it will sell instruments. And so when I talk to investors, one of the things that I highlight is that look at the activities we're doing today, look at the types of partners that we have, how important are these partners in the community, and what are they doing with our platform because that's going to inform the future growth rate of our platform.

And one of the things I was most encouraged about at HUPO this year was not just the number of conversations, but the quality of conversations around proteoforms and their importance to biology and what that means for each of the scientists that we talk to in their labs and in their development programs.

Max Masucci

That's great color. Let me just lob one more in. It's safe to say there's an established demand environment for tau. As we look to 2027, 2028 and the utilization ramp for externally placed Voyager platforms, how much early instrument usage do you expect tau to drive on its own? And how important will the next 4 assays be in keeping those instruments busy?

Sujal Patel

Yes. So Max, I think that the way I would answer your question is I don't think about tau in a vacuum. We absolutely expect that at the middle of next year, when we ship instruments, concurrent with that ship, we will have the tau assay, AKT1 assay and another oncology assay in early access -- sorry, in general availability concurrent with the instrument, and we'll have another -- a third oncology assay and another set of 4 or 5 in early access or just about to reach early access.

We think that's a significant enough amount of content to begin driving instrument demand. And we think that consumables will likely -- not on this call, but in the previous call, we had said that we think that the instrument makes sense from a financial perspective for customers versus using services through a core laboratory, Nautilus, when they're going to scale to about $0.5 million of consumable pull-through annually on the instrument. And we think that, that's going to take some time for customers to get up to, but we certainly think that having a few assays in general availability and a big pipeline of deliveries of additional kits in 6 months is going to be enough content to keep these instruments busy.

Max Masucci

Nice update.

Operator

I'm showing no further questions at this time. I'd like to thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Este artigo pode conter conteúdo gerado ou traduzido por IA, revisado por humanos, destinado apenas para referência e informações gerais, não constituindo recomendação de investimento.

Aviso legal: as informações fornecidas neste site são apenas para fins educacionais e informativos e não devem ser consideradas consultoria financeira ou de investimento.

Comentários (0)

Clique no botão $, digite o código do ativo e selecione para vincular uma ação, ETF ou outro ticker.

0/500
Diretrizes de comentários
Carregando...

Artigos recomendados

tradingkey.logo
Aviso de risco: Nosso site e aplicativo móvel fornecem apenas informações gerais sobre determinados produtos de investimento. A Finsights não oferece, e o fornecimento de tais informações não deve ser interpretado como se a Finsights estivesse oferecendo, aconselhamento financeiro ou recomendação para qualquer produto de investimento.
Os produtos de investimento estão sujeitos a riscos significativos, incluindo a possível perda do valor investido e podem não ser adequados para todos. O desempenho passado dos produtos de investimento não é indicativo de seu desempenho futuro.
A Finsights pode permitir que anunciantes ou afiliados realizem, ou forneçam anúncios em nosso site, ou aplicativo móvel, ou em qualquer parte deles e pode ser compensada por eles com base em sua interação com os anúncios.
 © Copyright: FINSIGHTS MEDIA PTE. LTD. Todos os direitos reservados.