SEATTLE, April 16, 2025 (GLOBE NEWSWIRE) -- Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or “Nautilus”), a company pioneering a single-molecule proteome analysis platform, today announced it will report financial results for the first quarter 2025 before market open on Tuesday, April 29, 2025. The company’s management will webcast a corresponding conference call beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss its results, business developments, and outlook. Live audio of the webcast w ...

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 ...

Nautilus Biotechnology (NAUT) Q4 2024 Earnings Call February 27, 2025 06:40 PM ET Company Participants Ji-Yon Yi - Investor Relations HeadSujal Patel - Co-Founder, CEO, President, Secretary & DirectorParag Mallick - Co-Founder, Chief Scientist & DirectorAnna Mowry - Chief Financial OfficerSubbu Nambi - Managing DirectorDaniel Brennan - Managing Director Conference Call Participants Yuko Oku - AnalystNone - Analyst Operator Good day and thank you for standing by. Welcome to the Nautilus Fourth Quarter and Fu ...

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]

Core Insights - Nautilus Biotechnology, Inc. is set to report its financial results for Q4 and the full year of 2024 on February 27, 2025, before market open [1] - A conference call will be held to discuss the results, business developments, and outlook, starting at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time [2] - Nautilus is a development stage life sciences company focused on creating a platform technology for protein analysis, aiming to advance the field of proteomics and improve access to proteomic data [3]

Financial Performance - The net loss for the nine months ended September 30, 2024 was $53,186 thousand, compared to a net loss of $46,651 thousand for the same period in 2023, representing an increase of approximately 14%[14]. - For the three months ended September 30, 2024, Nautilus Biotechnology reported a net loss of $16.446 million, compared to a net loss of $15.878 million for the same period in 2023, reflecting an increase in losses of approximately 3.6%[18]. - The company reported total operating expenses of $61,496 thousand for the nine months ended September 30, 2024, compared to $56,151 thousand for the same period in 2023, an increase of approximately 9.5%[14]. - Cash used in operating activities for the nine months ended September 30, 2024, was $44.836 million, compared to $37.811 million for the same period in 2023, indicating an 18.4% increase in cash outflow[22]. Assets and Liabilities - Total current assets decreased from $176,837 thousand as of December 31, 2023 to $144,205 thousand as of September 30, 2024, a decline of approximately 18.4%[11]. - Cash and cash equivalents decreased from $19,397 thousand as of December 31, 2023 to $4,409 thousand as of September 30, 2024, a decrease of approximately 77.3%[11]. - Total liabilities decreased from $40,212 thousand as of December 31, 2023 to $36,270 thousand as of September 30, 2024, a reduction of approximately 9.7%[12]. - The company’s total stockholders' equity decreased from $265,353 thousand as of December 31, 2023 to $223,434 thousand as of September 30, 2024, a decline of approximately 15.8%[13]. Accumulated Deficit - The company’s accumulated deficit increased from $202,239 thousand as of December 31, 2023 to $255,425 thousand as of September 30, 2024, an increase of approximately 26.3%[13]. - The company had an accumulated deficit of $255.425 million as of September 30, 2024, compared to $185.215 million as of September 30, 2023, representing an increase in the deficit of approximately 37.8%[19]. Research and Development - Research and development expenses for the three months ended September 30, 2024 were $12,288 thousand, compared to $11,996 thousand for the same period in 2023, reflecting an increase of 2.4%[14]. - The company has been focused on research and development activities related to its proteomics platform since its incorporation in 2016[24]. Stock and Equity - The weighted-average shares used in computing net loss per share attributable to common stockholders for the nine months ended September 30, 2024 was 125,302,440, compared to 124,896,975 for the same period in 2023[14]. - The company issued 367,813 shares of common stock upon the exercise of vested stock options during the nine months ended September 30, 2024, raising $415,000[22]. - The total additional paid-in capital increased to $478.115 million as of September 30, 2024, from $464.509 million as of September 30, 2023, marking an increase of approximately 2.6%[19]. - The total potentially dilutive common share equivalents increased to 17,484,880 from 14,710,602 year-over-year[84]. Cash and Investments - Nautilus Biotechnology's cash, cash equivalents, and restricted cash at the end of the period on September 30, 2024, was $5.411 million, down from $75.106 million at the end of September 30, 2023, a decrease of approximately 92.8%[22]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling $221.2 million[139]. - The carrying amount of cash equivalents approximates fair value due to short maturities of these instruments[139]. Risks and Future Financing - The company may require additional equity or debt financing in the future, depending on growth rate and research and development spending[30]. - The company is subject to risks similar to pre-clinical stage companies in the biopharmaceutical industry, including dependence on key individuals and the need for adequate financing[34]. - The company is exposed to inflation risk, which has impacted labor and goods costs, potentially affecting future operational expenses[140]. Accounting and Reporting - The company is evaluating the impact of new accounting standards on its consolidated financial statements, including ASU 2023-07 and ASU 2023-09[50][51]. - The company’s estimates and assumptions in financial reporting may differ from actual results, impacting future financial statements[31]. - The company had no income tax expense or benefit recognized for the three and nine months ended September 30, 2024, due to a full valuation allowance against deferred tax assets[61].

Financial Data and Key Metrics Changes - Total operating expenses for Q3 2024 were $19.1 million, roughly equal to Q3 2023, and $1.7 million below the previous quarter [46] - Research and development expenses were $12.3 million in Q3 2024, compared to $12.0 million in the prior year [46] - Overall net loss for Q3 2024 was $16.4 million, compared to $15.9 million in the prior year [47] - Cash balance at the end of Q3 2024 was approximately $221.2 million, down from $232.9 million at the end of the previous quarter [50] - The company anticipates total operating expense growth for the full year 2024 to be roughly 10%, better than the previous guidance of 15% to 20% [51] Business Line Data and Key Metrics Changes - The company is focused on two use cases: broad scale discovery and targeted proteoform quantification, with significant progress reported in both areas [24][40] - The development of proteoform capabilities is prioritized, particularly with tau as a biomarker for neurodegenerative diseases [62] Market Data and Key Metrics Changes - The company has seen increased interest from both pharma and academic sectors regarding proteoform analysis, particularly in the context of tau [82][102] - The market for broad scale proteomics is recognized as a large multibillion-dollar opportunity, with existing assays and workflows [82] Company Strategy and Development Direction - The company aims to launch its broad scale product in late 2025, with a focus on proving out the proteoform business opportunity in the first half of 2025 [42][44] - Engagements with large pharma partners and key academic collaborators are expected to accelerate, using tau as the first biomarker [42][43] - The company is committed to tight financial management while maximizing cash runway into 2027 [51][52] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that getting a product to market is taking longer than initially anticipated but remains confident in the development focus [53] - The company is encouraged by the positive feedback from researchers and the potential impact of its platform on biomedical research [8][40] Other Important Information - The company has welcomed Ken Suzuki as the first Chief Marketing Officer to help educate the market and drive revenue [10] - Significant participation in the World HUPO Congress was noted, where the company shared new proteoform data and engaged with the proteomics community [21][26] Q&A Session Summary Question: Reasons for higher than expected fallout rate for affinity probe candidates - Management explained that extensive characterization of probes revealed variability in their performance, which is being addressed through ongoing development efforts [55][56] Question: Update on developmental proteoform capabilities towards launch - Management indicated that while broad scale capabilities were initially expected to launch first, proteoform capabilities are being prioritized due to customer interest [60][62] Question: Metrics to assess corporate goals moving into 2025 - Key metrics include development milestones related to proteoform capabilities and the ability to decode a significant number of proteins from cell lysate [72][73] Question: Areas of increased investment moving into 2025 - Investment will focus on product development and targeted investments in the commercial team, while maintaining tight spend management [74][75] Question: Interest in discovery versus targeted opportunities - Management noted strong interest in both areas, with a significant push from customers for proteoform studies [81][82] Question: Pricing strategy and market dynamics - The company plans to finalize pricing strategies closer to launch, with indications that initial pricing may be higher due to market validation [97][98] Question: Academic and government funding landscape for proteomics - Management observed a flat funding environment but noted strong interest in their disruptive platform from both academic and pharma customers [101][102] Question: Key technical hurdles to achieve the milestone of 500 to 2000 proteins - Management emphasized the need for sufficient platform ready probes and improvements in labeling strategies to meet this milestone [110][112]