PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Nautilus Biotechnology, Inc. reported net losses of $15.9 million for Q3 2023 and $46.7 million for the nine months, driven by increased operating expenses [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $318.3 million, liabilities increased to $41.1 million, and stockholders' equity decreased to $277.3 million as of September 30, 2023 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $74,104 | $114,523 | | Short-term investments | $109,185 | $69,948 | | Long-term investments | $92,439 | $129,169 | | **Total Assets** | **$318,336** | **$350,052** | | **Liabilities & Equity** | | | | Total Liabilities | $41,063 | $35,128 | | Accumulated deficit | $(185,215) | $(138,564) | | **Total Stockholders' Equity** | **$277,273** | **$314,924** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss increased to $15.9 million for Q3 2023 and $46.7 million for the nine months, primarily due to higher research and development expenses Operating Results (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,996 | $9,571 | $34,785 | $28,085 | | General and administrative | $7,079 | $6,249 | $21,366 | $19,229 | | **Total operating expenses** | **$19,075** | **$15,820** | **$56,151** | **$47,314** | | Interest income | $3,197 | $1,889 | $9,517 | $2,929 | | **Net loss** | **$(15,878)** | **$(14,063)** | **$(46,651)** | **$(44,515)** | | Net loss per share | $(0.13) | $(0.11) | $(0.37) | $(0.36) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $37.8 million, while investing activities shifted to a $2.7 million use, resulting in a $40.4 million decrease in cash for the nine months Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,811) | $(35,429) | | Net cash (used in) provided by investing activities | $(2,675) | $38,315 | | Net cash provided by financing activities | $115 | $427 | | **Net (decrease) increase in cash** | **$(40,371)** | **$3,313** | | Cash at beginning of period | $115,477 | $186,461 | | **Cash at end of period** | **$75,106** | **$189,774** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's development-stage proteomics platform, confirm sufficient cash for 12 months, and outline accounting policies, investments, and lease commitments totaling $48.2 million - The company is a development-stage biotechnology firm focused on its proteomics platform, with all resources devoted to R&D, business planning, IP, and raising capital[31](index=31&type=chunk) - Management believes that its cash, cash equivalents, and short-term investments of **$183.3 million** as of September 30, 2023, are sufficient to fund operations for the next twelve months[37](index=37&type=chunk) - As of September 30, 2023, the company had total future minimum lease payments of **$48.2 million**, with a weighted-average remaining lease term of **6.9 years**[86](index=86&type=chunk)[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's development-stage proteomics platform, plans for a 2024 commercial launch, increased operating expenses, and strong liquidity with $183.3 million in cash and investments - Nautilus is a development stage company creating a platform technology for quantifying the proteome and has not yet generated any revenue[96](index=96&type=chunk)[97](index=97&type=chunk) - The company plans a three-phase commercial launch, with the second phase of early access engagements and associated revenue anticipated in **2024**, leading to a broader commercial launch[100](index=100&type=chunk) - As of September 30, 2023, the company had **$183.3 million** in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund operations for at least the next **12 months**[105](index=105&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operating expenses increased significantly in Q3 2023 and for the nine months, driven by higher R&D and G&A costs due to increased headcount and facilities expenses Comparison of Operating Expenses (in thousands) | Expense Category | Q3 2023 | Q3 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,996 | $9,571 | $2,425 | 25% | | General and administrative | $7,079 | $6,249 | $830 | 13% | | **Total operating expenses** | **$19,075** | **$15,820** | **$3,255** | **21%** | Comparison of Operating Expenses (Nine Months, in thousands) | Expense Category | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $34,785 | $28,085 | $6,700 | 24% | | General and administrative | $21,366 | $19,229 | $2,137 | 11% | | **Total operating expenses** | **$56,151** | **$47,314** | **$8,837** | **19%** | - The increase in R&D expenses for Q3 2023 was primarily due to a **$1.4 million** increase in salaries and benefits, a **$1.1 million** increase in lab supplies, and a **$0.9 million** increase in facilities costs, partially offset by a **$1.0 million** decrease in external development services[120](index=120&type=chunk)[121](index=121&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is strong with $275.7 million in cash and investments, sufficient for 12 months, but substantial additional funding will be required for future R&D and commercialization - As of September 30, 2023, the company had cash, cash equivalents and investments of **$275.7 million**[129](index=129&type=chunk) - Net cash used in operating activities was **$37.8 million** for the nine months ended September 30, 2023, primarily resulting from the net loss of **$46.7 million**, offset by non-cash charges like stock-based compensation[135](index=135&type=chunk)[136](index=136&type=chunk) - The company expects to require substantial additional funding for future operations and may seek it through equity or debt financing, though access to capital could be impacted by worsening global economic conditions[133](index=133&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate fluctuations, potentially impacting marketable debt securities by $1.7 million, and inflation affecting operational costs - The company's primary market risks are interest rate fluctuations and inflation[150](index=150&type=chunk) - A hypothetical **1.00% (100 basis point)** change in interest rates would change the fair value of the company's marketable debt securities by **$1.7 million** as of September 30, 2023[151](index=151&type=chunk) - Inflation affects the company by increasing the cost of labor, goods, and services, and the company may not be able to fully offset these increased costs[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of September 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** at a reasonable assurance level[154](index=154&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2023, that materially affected, or are reasonably likely to materially affect, the company's internal controls[155](index=155&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not currently a party to any legal proceedings that would individually or in the aggregate have a **material adverse effect** on its business[158](index=158&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks as a development-stage firm, including commercialization challenges, intense competition, supply chain issues, intellectual property protection, regulatory hurdles, and stock price volatility [Risks Related to Our Business](index=39&type=section&id=Risks%20Related%20to%20Our%20Business) Key business risks include a history of losses, dependence on the Nautilus platform's commercialization, intense competition, manufacturing challenges, and the need for additional capital - The company is a development stage entity with a history of net losses, no commercialized products, and its success is entirely dependent on the Nautilus platform, which is still in development[175](index=175&type=chunk)[176](index=176&type=chunk) - The company may not be able to successfully manufacture its products at scale, as it has no experience and relies on **single-source suppliers** for critical components like reagents and antibodies[190](index=190&type=chunk)[196](index=196&type=chunk) - The life sciences technology market is highly competitive, with rivals having greater financial resources, brand recognition, and established sales channels[199](index=199&type=chunk)[200](index=200&type=chunk) [Risks Related to Our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Intellectual property risks include challenges in obtaining and maintaining patent protection, uncertainties in patent law, global IP enforcement difficulties, and protecting trade secret confidentiality - The company's ability to successfully commercialize its products may be impaired if it cannot obtain and maintain sufficient intellectual property protection, as competitors could develop similar products[225](index=225&type=chunk) - Changes in U.S. patent law and court decisions regarding the patentability of life sciences inventions create uncertainty and could adversely impact the company's existing or future patents[230](index=230&type=chunk)[231](index=231&type=chunk) - The company relies on trade secrets and confidentiality agreements, which can be difficult to protect and may not prevent unauthorized disclosure or independent development of similar technologies by competitors[246](index=246&type=chunk) [Risks Related to Litigation](index=59&type=section&id=Risks%20Related%20to%20Litigation) Litigation risks include costly IP enforcement or defense, potential loss of rights, and product liability claims from undetected defects in the Nautilus platform - The company may become involved in expensive and time-consuming litigation to enforce its IP rights or defend against infringement claims, which could result in loss of rights or significant damages[268](index=268&type=chunk)[269](index=269&type=chunk) - The Nautilus platform's complex technology may contain undetected defects or errors, which could lead to product liability claims, warranty costs, and damage to the company's brand reputation[270](index=270&type=chunk) [Risks Related to Regulatory and Legal Compliance Matters](index=60&type=section&id=Risks%20Related%20to%20Regulatory%20and%20Legal%20Compliance%20Matters) Regulatory risks include potential FDA oversight for RUO products, compliance with complex data privacy and anti-corruption laws, and environmental health and safety liabilities - While currently sold as Research Use Only (RUO), the company's products could become subject to FDA regulation as medical devices, which would require a lengthy and expensive premarket clearance or approval process[274](index=274&type=chunk)[275](index=275&type=chunk)[281](index=281&type=chunk) - The company is subject to various U.S. federal and state laws regarding data privacy and security, such as the CCPA and HIPAA, and failure to comply could result in **significant fines** and harm to the business[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk) - Expansion of commercial activities outside the U.S. would subject the company to anti-corruption laws like the FCPA, where violations could lead to **civil or criminal penalties**[295](index=295&type=chunk) [Risks Related to our Operations](index=67&type=section&id=Risks%20Related%20to%20our%20Operations) Operational risks include IT system disruptions, data breaches, dependence on key personnel, talent competition, managing growth, and global supply chain interruptions - The company relies on IT systems that are vulnerable to cybersecurity attacks and data breaches, which could lead to the loss of trade secrets, litigation, and **significant liability**[304](index=304&type=chunk)[305](index=305&type=chunk) - The company is highly dependent on its senior management and key scientific personnel, particularly founders Sujal Patel (CEO) and Parag Mallick (Chief Scientist), and the loss of their services could harm the business[312](index=312&type=chunk)[313](index=313&type=chunk) - Global supply chain interruptions, exacerbated by political tensions, could negatively impact the development and commercialization of the company's products[322](index=322&type=chunk) [Risks Related to Our Common Stock](index=71&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Common stock risks include high price volatility, significant influence by principal stockholders, potential dilution from future share sales, and no anticipated dividends - The market price of the company's Common Stock has been and may continue to be **highly volatile** due to factors such as operating results, product development timelines, and broader market conditions[329](index=329&type=chunk) - As of September 30, 2023, directors, executive officers, and holders of more than 5% of common stock collectively owned approximately **69.0%** of outstanding shares, giving them significant influence over stockholder matters[335](index=335&type=chunk) - The company does not anticipate paying any dividends in the foreseeable future and plans to retain earnings to fund operations and growth[338](index=338&type=chunk) [General Risk Factors](index=75&type=section&id=General%20Risk%20Factors) General risks include public company compliance costs, limitations on NOL utilization, internal control failures, and reduced disclosure requirements as an emerging growth company - Operating as a public company results in **significant legal, accounting, and compliance expenses**, which will increase further once the company is no longer an "emerging growth company"[346](index=346&type=chunk) - The company's ability to use its federal and state net operating loss carryforwards (NOLs) may be limited by Section 382 of the Internal Revenue Code due to ownership changes[350](index=350&type=chunk) - The company is an "emerging growth company" and a "smaller reporting company," which allows for reduced disclosure requirements that may make its common stock less attractive to investors[358](index=358&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=79&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - None[363](index=363&type=chunk) [Item 3. Defaults Upon Senior Securities](index=79&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period - None[364](index=364&type=chunk) [Item 4. Mine Safety Disclosures](index=79&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[365](index=365&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) No other information was reported during the period - None[366](index=366&type=chunk) [Item 6. Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, employment agreements, and officer certifications - Lists exhibits filed with the report, including corporate governance documents, employment agreements, and SEC-required certifications[368](index=368&type=chunk)[369](index=369&type=chunk)

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis, market risk disclosures, and internal controls [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents Nautilus Biotechnology, Inc.'s unaudited condensed consolidated financial statements, detailing balance sheets, operations, and cash flows Condensed Consolidated Balance Sheet Highlights (Unaudited) | (in thousands) | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $72,139 | $114,523 | | Short-term investments | $91,156 | $69,948 | | Total current assets | $166,703 | $187,209 | | Total assets | $330,767 | $350,052 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $7,890 | $6,791 | | Total liabilities | $41,094 | $35,128 | | Accumulated deficit | $(169,337) | $(138,564) | | Total stockholders' equity | $289,673 | $314,924 | Condensed Consolidated Statements of Operations (Unaudited) | (in thousands, except per share data) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,912 | $8,856 | $22,789 | $18,514 | | General and administrative | $7,104 | $6,616 | $14,287 | $12,980 | | **Total operating expenses** | **$19,016** | **$15,472** | **$37,076** | **$31,494** | | Interest income | $3,222 | $776 | $6,320 | $1,040 | | **Net loss** | **$(15,808)** | **$(14,689)** | **$(30,773)** | **$(30,452)** | | Net loss per share, basic and diluted | $(0.13) | $(0.12) | $(0.25) | $(0.24) | Condensed Consolidated Statements of Cash Flows (Unaudited) | (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,073) | $(25,864) | | Net cash (used in) provided by investing activities | $(15,750) | $50,258 | | Net cash provided by financing activities | $99 | $341 | | **Net (decrease) increase in cash** | **$(41,724)** | **$24,735** | - The company has incurred net operating losses and negative cash flows since inception and expects this to continue. As of June 30, 2023, the accumulated deficit was **$169.3 million**. However, management believes that its cash, cash equivalents, and short-term investments of **$163.3 million** will be sufficient to fund operations for the next twelve months[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results, highlighting its development-stage status, lack of revenue, and significant R&D investments [Overview](index=25&type=section&id=Overview) Provides an overview of Nautilus as a development-stage life sciences company, its commercial launch plans, and current liquidity - Nautilus is a development-stage life sciences company creating a platform technology to quantify the proteome. The company has devoted substantially all resources to R&D, has no products available for commercial sale, and has not generated any revenue since its inception in 2016[96](index=96&type=chunk)[97](index=97&type=chunk) - The company plans a three-phase commercial launch for its proteomics platform: 1. **Collaboration Phase**: Currently ongoing with biopharmaceutical companies and key opinion leaders to validate performance 2. **Early Access Phase**: Anticipated to begin with associated revenue in 2024 3. **Broad Commercial Launch**: Expected to follow the early access phase in 2024[100](index=100&type=chunk) - As of June 30, 2023, the company had cash, cash equivalents, and short-term investments of **$163.3 million**, which is believed to be sufficient to fund planned operating expenses and capital expenditures for at least the next 12 months[105](index=105&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Analyzes the company's operating results, detailing changes in R&D, G&A expenses, and net loss for the periods Comparison of Operating Results for the Three Months Ended June 30, 2023 and 2022 | (in thousands) | Q2 2023 | Q2 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,912 | $8,856 | $3,056 | 35% | | General and administrative | $7,104 | $6,616 | $488 | 7% | | **Total operating expenses** | **$19,016** | **$15,472** | **$3,544** | **23%** | | **Net loss** | **$(15,808)** | **$(14,689)** | **$(1,119)** | **8%** | - Research and development expenses increased by **$3.1 million (35%)** in Q2 2023 compared to Q2 2022, primarily due to a **$1.4 million** increase in salaries and related compensation, a **$1.3 million** increase in laboratory supplies, and a **$1.1 million** increase in facilities costs[120](index=120&type=chunk) Comparison of Operating Results for the Six Months Ended June 30, 2023 and 2022 | (in thousands) | H1 2023 | H1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,789 | $18,514 | $4,275 | 23% | | General and administrative | $14,287 | $12,980 | $1,307 | 10% | | **Total operating expenses** | **$37,076** | **$31,494** | **$5,582** | **18%** | | **Net loss** | **$(30,773)** | **$(30,452)** | **$(321)** | **1%** | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Details the company's funding sources, cash position, and cash flow activities - The company has funded operations primarily through private placements and proceeds from the 2021 Business Combination. As of June 30, 2023, cash, cash equivalents, and investments totaled **$286.7 million**, with an accumulated deficit of **$169.3 million**[127](index=127&type=chunk) - Net cash used in operating activities was **$26.1 million** for the six months ended June 30, 2023, primarily resulting from a net loss of **$30.8 million**, offset by non-cash charges like stock-based compensation (**$6.0 million**)[133](index=133&type=chunk) - Net cash used in investing activities was **$15.8 million** for the first six months of 2023, driven by **$46.8 million** in security purchases, partially offset by **$32.2 million** in proceeds from maturities[135](index=135&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Outlines the company's primary market risk exposures, including interest rate and inflation risks - The company is exposed to interest rate risk on its investments. As of June 30, 2023, a hypothetical **1.00% (100 basis point)** change in interest rates would alter the fair value of its marketable debt securities by approximately **$2.2 million**[146](index=146&type=chunk) - Inflation affects the company by increasing the cost of labor, goods, and services, and it is acknowledged to have had some effect on financial results during the periods presented[147](index=147&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2023 - Based on an evaluation as of June 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[149](index=149&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[150](index=150&type=chunk) [PART II - OTHER INFORMATION](index=37&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers other essential information, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would materially affect its business or financial condition - As of the reporting date, the company is not a party to any legal proceedings expected to have a material adverse effect on its business or financial condition[154](index=154&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Outlines comprehensive risks related to business, intellectual property, litigation, regulatory compliance, operations, and common stock [Risks Related to Our Business](index=39&type=section&id=Risks%20Related%20to%20Our%20Business) Details business-specific risks, including the company's development stage, platform reliance, and dependence on single-source suppliers - The company is a development-stage entity with a history of net losses in every period, an accumulated deficit of **$169.3 million** as of June 30, 2023, and has not yet commercialized any products or generated revenue[170](index=170&type=chunk) - The business is entirely dependent on the success of the Nautilus platform, which remains in development and is subject to scientific, technical, and market acceptance challenges. The company anticipates early access revenue in **2024** and a broader commercial launch in **2024**[171](index=171&type=chunk)[173](index=173&type=chunk) - The company relies on single-source suppliers for critical components like click-reagent modified oligos and nano-fabricated biochips, and the loss of any such supplier could significantly harm the business[191](index=191&type=chunk) [Risks Related to Our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Outlines risks associated with intellectual property, including protection, changes in patent laws, and reliance on trade secrets - The company's success depends on its ability to obtain and maintain sufficient intellectual property protection. Failure to do so could allow competitors to develop similar products and impair commercialization efforts[220](index=220&type=chunk) - Changes in U.S. patent laws and interpretations, particularly regarding the patentability of inventions in the life sciences, create uncertainty and could diminish the value of the company's intellectual property[225](index=225&type=chunk) - The company relies on trade secrets and confidentiality agreements to protect unpatented know-how, but these can be difficult to protect and may not prevent independent development or unauthorized disclosure by third parties[241](index=241&type=chunk) [Risks Related to Litigation](index=59&type=section&id=Risks%20Related%20to%20Litigation) Addresses potential litigation risks, including intellectual property enforcement, infringement defense, and product liability claims - The company may become involved in costly and time-consuming litigation to enforce its intellectual property rights or defend against infringement claims from others, with potentially adverse outcomes[263](index=263&type=chunk)[264](index=264&type=chunk) - The Nautilus platform's novel and complex technology may contain undetected defects or errors, which could lead to product liability claims, warranty costs, and damage to the company's reputation[265](index=265&type=chunk) [Risks Related to Regulatory and Legal Compliance Matters](index=60&type=section&id=Risks%20Related%20to%20Regulatory%20and%20Legal%20Compliance%20Matters) Covers regulatory and legal compliance risks, including FDA regulation for clinical use, product reclassification, and data privacy laws - Currently, products are for **Research Use Only (RUO)**. If the company markets them for clinical diagnostic use, it would become subject to FDA regulation, requiring a lengthy and expensive premarket clearance or approval process[269](index=269&type=chunk)[270](index=270&type=chunk) - The FDA could disagree with the **RUO** classification and assert that the products are medical devices, which would subject the company to regulatory enforcement and potentially halt sales[277](index=277&type=chunk) - The company is subject to various federal and state data privacy laws (e.g., **CCPA**, **HIPAA**). Failure to comply could result in significant fines, legal proceedings, and reputational harm[283](index=283&type=chunk)[284](index=284&type=chunk)[286](index=286&type=chunk) [Risks Related to our Operations](index=67&type=section&id=Risks%20Related%20to%20our%20Operations) Addresses operational risks, including dependence on key personnel, IT system disruptions, and impacts from global economic conditions - The company is highly dependent on its key personnel, particularly CEO **Sujal Patel** and Chief Scientist **Parag Mallick**, and the loss of their services could significantly delay or prevent the achievement of business objectives[307](index=307&type=chunk) - A significant disruption in information technology systems or a data security breach could damage the company's reputation, lead to litigation, and result in significant liability[300](index=300&type=chunk)[301](index=301&type=chunk) - Unfavorable global economic conditions, supply chain interruptions, and geopolitical conflicts could adversely affect the company's ability to raise capital, develop its products, and execute its business plan[313](index=313&type=chunk)[316](index=316&type=chunk) [Risks Related to Our Common Stock](index=71&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Examines risks related to the company's common stock, including market price volatility, shareholder influence, and dividend policy - The market price of the company's common stock has been and may continue to be highly volatile due to factors such as operating results, development timelines, and broader market conditions[323](index=323&type=chunk) - As of June 30, 2023, directors, executive officers, and major shareholders collectively owned approximately **68.9%** of the outstanding common stock, enabling them to exercise significant influence over corporate matters[328](index=328&type=chunk) - The company does not expect to pay any dividends in the foreseeable future, meaning investors must rely on stock price appreciation for any return on investment[331](index=331&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=79&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the reporting period - None[355](index=355&type=chunk) [Item 3. Defaults Upon Senior Securities](index=79&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[356](index=356&type=chunk) [Item 4. Mine Safety Disclosures](index=79&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[357](index=357&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) The company entered into amended employment and severance agreements with executive officers, reflecting corporate structure changes - The Company entered into amended employment and severance agreements with its executive officers, with no material changes to compensation or terms of employment[358](index=358&type=chunk) [Item 6. Exhibits](index=80&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and officer certifications - A list of exhibits filed with the report is provided, including corporate governance documents, amended employment agreements for executive officers, and required SEC certifications[360](index=360&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number 001-39434 NAUTILUS BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 98-154172 ...

Financial Data and Key Metrics Changes - Total operating expenses for Q1 2023 were $18.1 million, an increase of $2.1 million compared to Q1 2022, and $1.8 million above the previous quarter [49] - The net loss for Q1 2023 was $15.0 million, compared to $15.8 million in Q1 2022 [49] - Cash, cash equivalents, and investments at the end of the quarter were approximately $302 million, down from $314 million at the end of the previous year [13] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2023 were $10.9 million, compared to $9.7 million in Q1 2022 [49] - General and administrative expenses were $7.2 million in Q1 2023, compared to $6.4 million in Q1 2022 [49] Market Data and Key Metrics Changes - The current annual proteomics market is estimated to be approximately $27 billion, growing at a 15% CAGR [5] Company Strategy and Development Direction - The company aims to provide ubiquitous access to the proteome for labs, researchers, and clinicians globally, with a focus on democratizing access to high-value proteomic data [19][24] - The planned launch of the Nautilus Proteome Analysis Platform, instruments, reagents, and software is set for mid-2024, with ongoing investments in scientific progress [11][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term impact of their innovation and the potential to expand the proteomics market [5] - The company anticipates an increase in cash burn but expects its cash runway to extend well into 2025, allowing for continued focus on scientific progress [13][27] Other Important Information - The company added 5 new patent applications and was granted 4 new U.S. patents in Q1, raising the total to 12 granted U.S. patents [22] - The First Access Challenge received a positive response from researchers, indicating strong interest in the platform [8][25] Q&A Session Summary Question: How do you anticipate each of these projects will specifically highlight and demonstrate the differentiated capabilities in the Nautilus platform? - Management highlighted the diversity of questions being asked across different medical domains and the unique materials being studied, showcasing the platform's sensitivity and dynamic range [51][52] Question: What is the status of the Early Access program and its key deliverables? - The Early Access program is designed to allow customers to test the technology ahead of the commercial launch, with a focus on generating valuable data and driving preorders [58][60] Question: How does the company view the clinical market's receptiveness to multi-analyte proteomics? - The company plans to focus on the research-only market in the medium term, with potential future involvement in clinical applications as the technology matures [55] Question: What is the expected pace of the commercial launch in 2024? - Management did not provide specific revenue guidance but indicated that the launch would be strategically paced, leveraging existing customer interest and market demand [62] Question: How is the supplier base for reagents and instruments being managed? - The company has established relationships with multiple suppliers to mitigate risks and ensure quality in both instrument assembly and consumable production [69]

Financial Data and Key Metrics Changes - For fiscal year 2022, operating expenses increased to $63.6 million from $50.5 million in 2021, representing a 26% increase driven by personnel costs and expenses related to operating as a public company [1] - The net loss for the full year was $57.9 million, up from $50.3 million in fiscal year 2021, marking a 15% year-over-year increase [2] - Total operating expenses for Q4 2022 were $16.3 million, which was $500,000 less than the same quarter last year, indicating a focus on controlling spending while investing in growth [33] Business Line Data and Key Metrics Changes - Research and development expenses in Q4 2022 were $9.6 million compared to $9.9 million in the prior year, while general and administrative expenses were $6.7 million, down from $6.9 million [34] - The company anticipates overall operating expenses to grow by approximately 40% from 2022 levels in 2023, while managing spending tightly to preserve investment capabilities [3] Market Data and Key Metrics Changes - The company ended the year with approximately $314 million in cash, cash equivalents, and investments, representing a trailing 12-month cash burn of approximately $48.5 million, with expectations for the cash runway to extend well into 2025 [5] Company Strategy and Development Direction - The company aims to revolutionize proteomics and positively impact health and lives globally, with a focus on commercial expansion leading up to a platform launch in mid-2024 [8][4] - The Nautilus First Access Challenge was announced to inspire researchers and unlock creativity in exploring biological insights, indicating a commitment to engaging the scientific community [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to manage resources effectively amid challenging financial conditions, with a focus on maximizing runway and balancing investments for scientific progress [32] - The management team believes that the product being developed has a strong value proposition and a wide competitive moat, with no significant competitive advancements observed in the proteomics space [96][97] Other Important Information - The company nearly doubled its patent portfolio to over 40 pending patent families filed in the U.S. and abroad, with a total of 11 granted U.S. patents [30] - The company is focused on building a commercial team closer to the launch date, reflecting a cautious approach to scaling operations in the current economic environment [76] Q&A Session Summary Question: Has the company's appetite for M&A changed recently? - Management indicated that while the M&A environment has picked up, there are no near-term plans for M&A, focusing instead on leveraging the balance sheet for platform development [42][55] Question: What advancements should be expected in the near term? - Management highlighted the importance of scientific conferences and continued data sharing with the scientific community as key indicators of progress towards the commercial launch [43][44] Question: What feedback has been received from the scientific community? - Positive feedback was noted regarding the platform's sensitivity, scale, and potential to complement existing mass spectrometry methods, with researchers expressing excitement about the capabilities [45][46] Question: What are the key features the clinical market will look for? - The management believes that the transition from single biomarker assays to broader protein panels will occur naturally, driven by the need for comprehensive analysis in clinical settings [98][99]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________________________ FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number 001-39434 NAUTILUS BIOTECHNOLOGY, INC. (Exact nam ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number 001-39434 NAUTILUS BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 98-15 ...

Nautilus Biotechnology, Inc. (NASDAQ:NAUT) Q3 2022 Earnings Conference Call November 1, 2022 8:30 AM ET Company Participants Sujal Patel - Co-Founder and CEO Parag Mallick - Co-Founder and Chief Scientist Anna Mowry - CFO Conference Call Participants Max Masucci - Cowen David Delahunt - Goldman Sachs Brandon Couillard - Jefferies Operator Ladies and gentlemen, thank you for standing by, and welcome to the Nautilus Q3 2022 Earnings Call. [Operator Instructions] I would now like to turn the call over to your ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant ...

Nautilus Biotechnology, Inc. (NASDAQ:NAUT) Q2 2022 Earnings Conference Call August 2, 2022 8:30 AM ET Company Participants Sujal Patel - Founder and Chief Executive Officer Anna Mowry - Chief Financial Officer Parag Mallick - Founder and Chief Scientist Conference Call Participants Stephanie Yan - Cowen and Company, LLC Tejas Savant - Morgan Stanley David Delahunt - Goldman Sachs Operator Thank you for standing by, and welcome to the Nautilus Biotechnology Second Quarter 2022 Earnings Conference Call. At th ...