Financial Data and Key Metrics Changes - Total operating expenses for Q1 2025 were $18.8 million, a 13% decrease from $21.6 million in Q1 2024, reflecting a focus on cost efficiency [28] - Research and development expenses decreased to $11.5 million from $12.9 million year-over-year [28] - General and administrative expenses were $7.3 million in Q1 2025 compared to $8.7 million in the prior year [29] - Overall net loss for Q1 2025 was $16.6 million, down from $18.7 million in the prior year [29] - Cash, cash equivalents, and investments at the end of the quarter totaled approximately $193 million, compared to $206 million at the end of 2024 [30] Business Line Data and Key Metrics Changes - The company is advancing its tau proteoform assay and broad scale proteome assay, with significant progress reported in transitioning these assays towards readiness for larger scale applications [11][12] - The tau proteoform assay exceeded expectations in reproducibility and accuracy, with a median percent error of approximately 10% and a median coefficient of variation of 1.5% [15][16] - The platform demonstrated a dynamic range exceeding four orders of magnitude, significantly better than current methods [19] Market Data and Key Metrics Changes - There is significant interest from customers and partners in the company's tau capabilities and targeted proteoform detection, with ongoing discussions with large pharma companies and academic institutions [9][10] - The company conducted in-depth interviews with over 30 proteomics researchers to understand customer segments and drivers of adoption, confirming strong interest in both targeted proteoform and broad scale discovery capabilities [8][9] Company Strategy and Development Direction - The company aims to unlock the full potential of the proteome, focusing on both targeted proteoform analysis and broad scale discovery as significant untapped opportunities in biology [27] - The anticipated launch of the platform is planned for late 2026, with a focus on ensuring cash runway extends well beyond that point [29][30] - The company is prioritizing partnerships that demonstrate the capabilities of measuring complete intact protein proteoforms at single molecule resolution [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made towards the launch of the platform and the positive feedback received from potential customers and partners [10][32] - The company is monitoring supply chain exposure closely, particularly regarding tariffs, but has not yet seen any significant impact on sourcing materials [40][41] - Management emphasized the importance of customer research and understanding market requirements to ensure a successful commercial launch [60][61] Other Important Information - The company reduced its headcount by approximately 16% to extend its cash runway and focus resources on key development milestones [29] - The verification and validation process for the tau assay was crucial for building confidence in the entire platform, as it shares core components with the broad scale proteome assay [58] Q&A Session Summary Question: Update on tau-related partnerships - Management confirmed ongoing discussions with partners in both pharma and academic sectors, expecting to sign an initial partnership in the first half of 2025 [36] Question: Supply chain exposure to tariffs - Management stated that they are monitoring the situation closely and have not yet seen any effects on sourcing materials or prices [40] Question: Economics of targeted protein proteoform partnerships - Management indicated that they are exploring a range of business models for partnerships, focusing on demonstrating the technology's capabilities rather than immediate revenue [44][46] Question: Milestones for converting partnership interests - Management explained that the initial phase involves educating potential partners about the technology, with excitement noted across all customer segments [52] Question: Potential blind spots impacting commercial launch - Management expressed confidence in their understanding of the work ahead and the importance of product reliability and market positioning for a successful launch [56][59]

Core Viewpoint - Nautilus Biotechnology, Inc. reported financial results for Q1 2025, highlighting progress in its Tau proteoform assay and a reduction in operating expenses, while also noting a net loss that improved compared to the previous year [1][2][4]. Financial Performance - Operating expenses for Q1 2025 were $18.8 million, a 13% decrease from $21.6 million in Q1 2024, attributed to cost optimization and reduced stock-based compensation [3]. - The net loss for Q1 2025 was $16.6 million, compared to a net loss of $18.7 million in the same period last year [4][12]. - Cash, cash equivalents, and investments totaled $192.8 million as of March 31, 2025 [4]. Business Development - The CEO emphasized the assay's reproducibility, accuracy, and compatibility with customer needs, indicating confidence in the platform's application in Alzheimer's and neurodegenerative disease research in 2025 [2]. - The company is focused on advancing its proteome analysis platform, aiming to democratize access to proteomics and enhance research capabilities in human health [6]. Cash Flow and Investments - Cash flows from operating activities showed a net cash used of $13.9 million for Q1 2025, an improvement from $16.3 million in Q1 2024 [13]. - The company generated $19.5 million from investing activities, primarily from securities maturities [14]. Balance Sheet Overview - Total assets as of March 31, 2025, were $227.7 million, down from $242.7 million at the end of 2024 [10][11]. - Total liabilities were $33.3 million, slightly decreased from $34.0 million at the end of the previous year [11]. - Stockholders' equity was $194.4 million, down from $208.7 million at the end of 2024, with an accumulated deficit of $289.6 million [11].

[Q1 2025 Earnings Release](index=1&type=section&id=Nautilus%20Biotechnology%20Reports%20First%20Quarter%202025%20Financial%20Results) [Business Highlights](index=1&type=section&id=Business%20Highlights) Nautilus made significant progress in Q1 2025 on its Tau proteoform assay, with internal testing confirming performance aligned with launch specifications for 2025 researcher utilization - Continued development progress was made on the Tau proteoform assay, with internal verification and validation results aligning with anticipated launch specifications[3](index=3&type=chunk) - The company is confident that researchers will begin using the Nautilus platform in **2025** to study the role of Tau proteoforms in Alzheimer's and other neurodegenerative diseases[3](index=3&type=chunk) [First Quarter 2025 Financial Performance](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) Nautilus improved operational efficiency in Q1 2025, reducing operating expenses by **13%** to **$18.8 million** and narrowing net loss to **$16.6 million**, while maintaining **$192.8 million** in liquidity Key Financial Metrics | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Operating Expenses | $18.8 million | $21.6 million | -13% | | Net Loss | $16.6 million | $18.7 million | Improved by $2.1M | - The decrease in operating expenses was attributed to cost optimization, timing of R&D activities, and reduced stock-based compensation and professional services costs[4](index=4&type=chunk) - As of March 31, 2025, the company held **$192.8 million** in cash, cash equivalents, and investments[6](index=6&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) The unaudited financial statements for Q1 2025 show total assets of **$227.7 million**, a net loss of **$16.6 million**, and **$13.9 million** net cash used in operating activities [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Nautilus reported total assets of **$227.7 million**, total liabilities of **$33.3 million**, and total stockholders' equity of **$194.4 million** Condensed Consolidated Balance Sheets (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$227,690** | **$242,743** | | Total Current Assets | $141,601 | $132,826 | | **Total Liabilities** | **$33,255** | **$34,013** | | Total Current Liabilities | $8,156 | $7,632 | | **Total Stockholders' Equity** | **$194,435** | **$208,730** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, Nautilus reported total operating expenses of **$18.8 million** and a net loss of **$16.6 million**, or **($0.13)** per share, showing improvement from the prior year Condensed Consolidated Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $11,536 | $12,930 | | General and administrative | $7,308 | $8,677 | | **Total operating expenses** | **$18,844** | **$21,607** | | Interest income | $2,231 | $2,877 | | **Net loss** | **$(16,613)** | **$(18,730)** | | **Net loss per share, basic and diluted** | **$(0.13)** | **$(0.15)** | [Consolidated Statements of Cash Flows](index=5&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operating activities was **$13.9 million**, with a net increase in cash, cash equivalents, and restricted cash of **$5.6 million** for the period Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,937) | $(16,266) | | Net cash provided by investing activities | $19,511 | $22,353 | | Net cash provided by financing activities | $18 | $245 | | **Net increase in cash, cash equivalents and restricted cash** | **$5,592** | **$6,332** | | **Cash, cash equivalents and restricted cash at end of period** | **$34,240** | **$26,731** | [Other Information](index=1&type=section&id=Other%20Information) Nautilus will host a conference call on April 29, 2025, to discuss Q1 results, with the report also containing standard forward-looking statements regarding inherent business risks - A conference call to discuss Q1 2025 results is scheduled for Tuesday, April 29, 2025, at 8:30 AM Eastern Time[7](index=7&type=chunk) - The report includes forward-looking statements concerning business operations, financial performance, and product launch timelines, which are subject to substantial risks and uncertainties[9](index=9&type=chunk)[10](index=10&type=chunk) - The company is a development stage life sciences company focused on creating a platform technology for proteome analysis[8](index=8&type=chunk)

Core Viewpoint - Nautilus Biotechnology, Inc. is set to report its financial results for the first quarter of 2025 on April 29, 2025, before market opening [1]. Company Overview - Nautilus Biotechnology, Inc. is a development stage life sciences company headquartered in Seattle, Washington, with research and development operations in San Carlos, California [3]. - The company is focused on creating a platform technology aimed at quantifying and understanding the complexity of the proteome, with a mission to democratize access to proteomics and advance human health and medicine [3]. Upcoming Events - The management will host a conference call on April 29, 2025, at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss the financial results, business developments, and future outlook [2]. - The live audio of the conference call will be accessible on the "Investors" section of the company's website [2].

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $20.0 million, roughly equal to Q4 2023 and $0.9 million above the previous quarter [35] - Net loss for Q4 2024 was $17.6 million compared to $17.0 million in the prior-year period [36] - For fiscal year 2024, net loss was $70.8 million, an increase of 11% year-over-year from $63.7 million in fiscal year 2023 [37] Business Line Data and Key Metrics Changes - Research and development expenses in Q4 2024 were $12.8 million compared to $12.5 million in the prior-year period, while general and administrative expenses were $7.2 million in Q4 2024 compared to $7.5 million in the prior-year period [36] - Operating expenses for fiscal year 2024 were $81.5 million, an increase of 7% from $76.2 million in fiscal year 2023 [37] Market Data and Key Metrics Changes - The company ended the year with approximately $206 million in cash, cash equivalents, and investments compared to $264 million at the end of the previous year [39] Company Strategy and Development Direction - The company now expects the launch of its proteome analysis platform to occur in late 2026, focusing on reducing technical risk and maximizing performance [29][33] - The company plans to engage in significant partnerships to explore tau proteoform landscapes and aims to provide leading researchers access to its platform for tau proteoform-related studies in 2025 [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver a game-changing product to the market, emphasizing the importance of rigorous financial discipline and operational adjustments to extend the cash runway through 2027 [33][41] - The company anticipates that 2025 will be a pivotal year for applying the platform's capabilities to important questions about tau proteoforms in Alzheimer's disease [30] Other Important Information - The company reduced its headcount by approximately 16% to align resources with development goals and extend its cash runway [33][38] - The company is focused on optimizing assay configurations and surface chemistry to enhance the performance of its platform [29][55] Q&A Session Summary Question: Could you elaborate on your plan to modify the assay configuration and surface chemistry? - Management explained that the modifications aim to enhance specific binding of affinity reagents to proteins and differentiate non-specific binding, addressing issues related to probe labeling and surface chemistry [48][49][52] Question: Does the planned change impact the cost structure of the platform? - Management indicated that the changes may have a positive impact on the consumable side and that the previously mentioned pricing of approximately $1 million for the instrument remains valid [54][55] Question: What are the key milestones and timing over 2025 and into 2026? - Management outlined milestones including providing access to the platform for tau proteoform studies, signing partnerships, and decoding a significant number of proteins from complex samples [82][84] Question: How does your platform's performance compare to other tau protein platforms? - Management highlighted that their platform uniquely measures proteoforms in high throughput and sensitivity, allowing for detailed insights into Alzheimer's disease [89][92] Question: Is the late 2026 launch for both broadscale discovery and targeted platforms? - Management clarified that both modalities are heading to market with different strategies, with broadscale discovery launching commercially in late 2026 while proteoform capabilities will be introduced through partnerships [95][100]

Delivering on the Promise of the Proteome FEBRUARY 27, 2025 Safe harbor This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the size and growth of the protein analysis market; Nautilus Biotechnology's anticipated total addressable market; the performance, value and enabling nature of Nautilus Biotechnology's proteomics and proteoform analysis techn ...

Business Combination and Financial Overview - Nautilus Biotechnology completed a business combination on June 9, 2021, resulting in the issuance of 20,000,000 shares for gross proceeds of $200 million[24]. - The company incurred net losses of $70.8 million and $63.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $273.0 million as of December 31, 2024[207]. - The company expects to incur substantial losses and negative cash flows for the foreseeable future, despite anticipated cost-savings from workforce reductions[207]. - The company may need to raise additional capital to fund its development and commercialization plans[196]. Market Potential and Growth - The global proteomics market is estimated at approximately $27 billion annually as of 2022, with a projected growth to $55 billion by 2027, representing a CAGR of 15%[31]. - The proteomics market represents one of the largest untapped opportunities in biological sciences today, with substantial potential applications in various fields[53]. - Approximately 95% of FDA-approved drug targets are proteins, highlighting the critical importance of understanding the proteome in pharmacology[45]. - The company anticipates significant demand for proteomic data in preclinical and clinical drug development, enhancing understanding of drug interactions and resistance mechanisms[126]. Technology and Platform Development - Nautilus aims to develop a proteome analysis platform capable of identifying approximately 95% of proteins in a sample, significantly enhancing the characterization of the proteome[28]. - The Nautilus platform is expected to generate up to approximately 35 terabytes of digital protein data per run, utilizing advanced machine learning for data analysis[35]. - The platform is designed to measure billions of individual protein molecules simultaneously, achieving extreme sensitivity and a wide dynamic range[74]. - The Nautilus platform aims to democratize proteomics, with initial applications in precision medicine and a growth path into clinical diagnostics and machine-learning powered drug discovery[42]. Research Collaborations and Partnerships - The company has established research collaborations with major biopharma companies and academic institutions, including Genentech and Amgen, to validate its technology[32]. - The company has signed research collaboration agreements with Genentech, Amgen, and The University of Texas MD Anderson Cancer Center to explore the utility of its platform technology[148]. - The company plans to engage future customers through research collaborations to generate data and publications that highlight the value of single-molecule proteomics[144]. Commercialization Strategy - Nautilus plans a phased commercialization strategy, starting with partnerships and moving towards a broad commercial launch of its proteome analysis system[32]. - The company plans to commercialize the Nautilus platform through the sale of instrumentation, reagent consumables, and a SaaS analytics software[129]. - The go-to-market strategy includes three phases, focusing on building value propositions and leveraging partnerships to drive commercial momentum[143]. - The company anticipates that the Nautilus platform will facilitate large sample size studies, making previously impractical research feasible[116]. Competitive Landscape - The life sciences market is highly competitive, with major competitors including Thermo Fisher Scientific and Bruker Corporation, among others[153]. - The company believes it has significant competitive advantages due to its novel approach to proteomic technology and the unique capabilities of its platform[154]. Regulatory Environment - The FDA issued a final rule in May 2024 that phases out enforcement discretion for most laboratory-developed tests (LDTs), classifying in vitro diagnostics as medical devices under the Federal Food, Drug, and Cosmetic Act[164]. - International sales of medical devices will be subject to the IVD Medical Device Regulation (IVDR) in the EU, which aims to improve quality and safety standards for in vitro diagnostic medical devices[168]. - The company is subject to various federal and state laws regarding the collection and protection of health-related personal information, including the Health Insurance Portability and Accountability Act (HIPAA) and the California Consumer Privacy Act (CCPA)[171]. Challenges and Risks - The company may face significant delays in product development and commercialization due to the scientific and technical complexity of the Nautilus platform[211]. - The company has experienced difficulties with co-development partners in delivering component technologies on time, which could impact development timelines[209]. - The company has no experience in manufacturing its products at commercial scale, which could delay commercialization and result in lost revenue[220]. - The company may face increased compliance costs and potential liability due to evolving data privacy regulations, including the General Data Protection Regulation (GDPR) in the European Economic Area[172]. Intellectual Property and Innovation - The company has secured a strong intellectual property portfolio with numerous key patents since its inception in 2016[33]. - As of December 31, 2024, the company owned or held exclusive licenses to 31 issued U.S. patents and approximately 136 pending foreign patent applications, with patents expected to expire between 2026 and 2044[177]. - The technology aims to create a broad portfolio of affinity reagent probes through in-house development and strategic partnerships, enhancing its application range[110]. Employee and Organizational Structure - The company had 155 employees as of December 31, 2024, with over one-third holding doctorate degrees, and 110 engaged in research and development activities[187]. - The company is in the early stages of establishing a commercial organization focused on the Nautilus platform, requiring substantial financial resources for hiring and development[222].

Core Insights - Nautilus Biotechnology, Inc. reported significant advancements in 2024, including the first quantitative measurement of biological variation in tau proteoforms related to Alzheimer's Disease, and improvements in their proteome analysis platform [2] - The company anticipates a commercial launch of its proteome analysis platform in late 2026, following necessary modifications to reduce technical risks and enhance performance [2][7] Financial Performance - For Q4 2024, operating expenses remained flat at $20.0 million compared to Q4 2023, while total operating expenses for the fiscal year 2024 increased by $5.3 million, or 7%, to $81.5 million due to headcount growth [3] - The net loss for Q4 2024 was $17.6 million, slightly higher than the $17.0 million loss in Q4 2023, and the total net loss for the fiscal year 2024 was $70.8 million, compared to $63.7 million in 2023 [4][13] - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $206.3 million, which is expected to provide a runway through 2027 [4][8] Operational Outlook - The company plans to maintain operating expenses at or below 2024 levels in 2025, while also announcing a reduction in headcount by approximately 16% to align resources with development goals [7][8] - Nautilus will host a conference call to discuss the financial results and business developments on February 27, 2025 [5]

Financial Performance - Net loss for Q4 2024 was $17.6 million, compared to a net loss of $17.0 million in Q4 2023; the total net loss for the fiscal year 2024 was $70.8 million, up from $63.7 million in 2023[4] - Operating expenses for Q4 2024 were $20.0 million, unchanged from Q4 2023, while total operating expenses for the fiscal year 2024 increased by $5.3 million or 7% to $81.5 million compared to $76.2 million in 2023[3] - Research and development expenses for the fiscal year 2024 were $50.5 million, an increase from $47.3 million in 2023[15] - General and administrative expenses for the fiscal year 2024 rose to $31.0 million from $28.9 million in 2023[15] - Interest income for the fiscal year 2024 was $10.8 million, down from $12.6 million in 2023[15] - The accumulated deficit increased to $273.0 million as of December 31, 2024, compared to $202.2 million in 2023[13] - The total assets decreased to $242.7 million as of December 31, 2024, from $305.6 million in 2023[13] Cash and Investments - Cash, cash equivalents, and investments totaled $206.3 million as of December 31, 2024, expected to provide a runway through 2027[5][9] Strategic Initiatives - A headcount reduction of approximately 16% was announced to align resources with key development goals and extend the cash runway[8] - The company announced a projected launch of its proteome analysis platform in late 2026, reflecting ongoing development efforts[8]

Core Insights - Nautilus Biotechnology, Inc. is participating in the TD Cowen 45th Annual Healthcare Conference, highlighting its engagement in the healthcare sector [1] - The management of Nautilus is scheduled for a fireside chat on March 3, 2025, at 1:50 p.m. Eastern Time, which will be accessible via a live and archived webcast [2] - Nautilus is a development stage life sciences company focused on creating a platform technology for quantifying the proteome, aiming to democratize access to proteomics and advance human health and medicine [3] Company Overview - Nautilus Biotechnology is headquartered in Seattle, with its research and development center located in the San Francisco Bay Area [3] - The company's mission is to transform the field of proteomics by enabling significant advancements in human health and medicine [3]