Nautilus Biotechnology(NAUT)
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Nautilus Biotechnology(NAUT) - 2024 Q2 - Quarterly Report
2024-07-30 20:10
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, 2024 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 98-1541723 ...
Nautilus Biotechnology(NAUT) - 2024 Q2 - Quarterly Results
2024-07-29 22:07
Exhibit 99.1 Nautilus Biotechnology Reports Second Quarter 2024 Financial Results SEATTLE, WA, July 30, 2024 – Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or "Nautilus"), a company pioneering a single- molecule proteome analysis platform, today reported financial results for the second quarter ended June 30, 2024. "In Q2, we saw continued progress against core development goals for each of the components of our platform," said Sujal Patel, CEO of Nautilus. "We believe we are pioneering a fundamentally new a ...
Nautilus Biotechnology(NAUT) - 2024 Q1 - Quarterly Report
2024-04-30 20:09
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, 2024 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. (Address of principal executive offices) (Zip Code) (206) 333-2001 (Regis ...
Nautilus Biotechnology(NAUT) - 2024 Q1 - Quarterly Results
2024-04-29 22:12
Exhibit 99.1 Nautilus Biotechnology Reports First Quarter 2024 Financial Results SEATTLE, WA, April 30, 2024 – Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or "Nautilus"), a company pioneering a single molecule proteome analysis platform, today reported financial results for the first quarter ended March 31, 2024. "We continued to make solid progress against our core development goals in Q1," said Sujal Patel, CEO of Nautilus. "We remain incredibly focused on increasing the scale, stability, and reproducibil ...
Nautilus Biotechnology(NAUT) - 2023 Q4 - Annual Report
2024-02-28 12:04
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, 2023 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 ...
Nautilus Biotechnology(NAUT) - 2023 Q4 - Annual Results
2024-02-28 12:03
Exhibit 99.1 Nautilus Biotechnology Reports Fourth Quarter and Fiscal Year 2023 Financial Results SEATTLE, WA, February 28, 2024 – Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or "Nautilus"), a company pioneering a single molecule proteome analysis platform, today reported financial results for the fourth quarter and fiscal year ended December 31, 2023. "2023 was a year of significant accomplishment and foundational progress for Nautilus; progress that will continue to build our momentum as we move through 2 ...
Nautilus Biotechnology(NAUT) - 2023 Q3 - Quarterly Report
2023-10-31 20:02
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)
Nautilus Biotechnology(NAUT) - 2023 Q2 - Quarterly Report
2023-08-02 20:03
[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)
Nautilus Biotechnology(NAUT) - 2023 Q1 - Quarterly Report
2023-05-02 20:08
Financial Performance - As of March 31, 2023, Nautilus Biotechnology reported total assets of $345.9 million, a decrease from $350.1 million as of December 31, 2022[20]. - The company incurred a net loss of $14.97 million for the three months ended March 31, 2023, compared to a net loss of $15.76 million for the same period in 2022, representing a 5% improvement[22]. - Total operating expenses for Q1 2023 were $18.06 million, up from $16.02 million in Q1 2022, reflecting a 12.7% increase[22]. - Cash and cash equivalents decreased to $88.5 million as of March 31, 2023, down from $114.5 million at the end of 2022, indicating a cash decrease of 22.8%[20]. - The company reported interest income of $3.1 million for Q1 2023, significantly higher than $0.26 million in Q1 2022, marking an increase of over 1,100%[22]. - Nautilus Biotechnology's accumulated deficit increased to $153.5 million as of March 31, 2023, compared to $138.6 million at the end of 2022[20]. - The company had total stockholders' equity of $303.7 million as of March 31, 2023, down from $314.9 million at the end of 2022, a decrease of 3.5%[20]. - Cash used in operating activities for Q1 2023 was $12.52 million, compared to $12.34 million in Q1 2022, indicating a slight increase in cash outflow[29]. - The company expects to continue incurring net operating losses and negative cash flows from operations for the foreseeable future[34]. - The company raised approximately $345.5 million from PIPE investors and the business combination, with transaction costs of about $18.2 million[35]. - As of March 31, 2023, the company had cash, cash equivalents, and short-term investments totaling $167.3 million, which is expected to fund operations for the next twelve months[35]. - The company may need to seek additional equity or debt financing if capital resources are exhausted sooner than expected[35]. - The company has not experienced any losses related to credit risk on cash or investments, indicating a stable financial position[39]. - The company recorded depreciation expense of $400,000 for the three months ended March 31, 2023, compared to $300,000 for the same period in 2022, indicating a year-over-year increase of 33.3%[59]. - The company had 124,866,392 shares issued and outstanding as of March 31, 2023[63]. - The company incurred a net loss of $15.0 million for the three months ended March 31, 2023, driven by operating losses and changes in assets and liabilities[128]. - The company reported a net increase in cash, cash equivalents, and restricted cash of $(26.0) million for the three months ended March 31, 2023[127]. Operational Challenges - The company relies on single-source suppliers for certain components, which poses a risk if these suppliers are lost[40]. - The company is subject to risks typical of pre-clinical stage biopharmaceutical companies, including dependence on key individuals and the need for additional financing[41]. - The COVID-19 pandemic has caused volatility in financial markets, which may affect the company's future access to capital[36]. - The company has not generated any revenue since its inception and relies on successful development and commercialization of its Nautilus platform for future revenue[96]. - The company is dependent on third parties for certain aspects of the development and commercialization of its proteomics platform, which remains in the development stage[154]. - The company may need to raise additional capital to fund its development and commercialization plans, which could impose additional operational restrictions[155]. - The company has experienced difficulties with co-development partners in delivering component technologies on time, which could impact development timelines[168]. - The company faces challenges in manufacturing its products at commercial scale, which could delay the commercialization of the Nautilus platform and result in lost revenue[181]. - The commercialization of the Nautilus platform is subject to numerous risks, including potential delays in product development and regulatory approvals[176]. - The company faces risks related to third-party collaborations for technology development, which could affect timelines and costs[195]. Future Prospects - The company plans to commercialize its proteomics platform in three phases, with meaningful early access engagements and associated revenue expected to begin at the start of 2024[99]. - Nautilus Biotechnology is currently in the collaboration phase with biopharmaceutical companies to validate the performance of its products, with a broader commercial launch anticipated in mid-2024[99]. - The company expects to invest significantly in sales, marketing, and distribution capabilities to achieve substantial revenue growth and profitability[183]. - The Nautilus platform's market acceptance will depend on its ability to demonstrate reliable performance and justify its anticipated costs compared to alternative products[180]. - Future funding requirements will depend on various factors, including the pace of development and potential changes in business strategy[106][124]. - The company anticipates meaningful early access engagements and associated revenue to begin at the start of 2024, leading into a broader commercial launch in mid-2024[170]. - Revenue is expected to primarily come from biotechnology companies and life science laboratories, with potential fluctuations due to customer spending policies[196]. Financial Risks - The company may face dilution of stockholder equity if additional funds are raised through equity securities[126]. - The company believes its current cash resources will be sufficient for at least 12 months, but may need to raise additional capital if liquidity requirements are not met[207]. - Potential risks associated with raising funds include dilution of stockholder equity and unfavorable terms if debt securities are issued[209]. - The company may face challenges in obtaining financing due to adverse global economic conditions and disruptions in financial markets[210]. - Investor concerns regarding the financial system could lead to less favorable financing terms, impacting the company's ability to acquire necessary funding[214]. - The financial stability of the company could be adversely affected by liquidity constraints or failures in the financial services industry[211]. Market Competition - Competition in the life sciences technology market is significant, with established companies holding competitive advantages[190]. - The company must continuously innovate to maintain market relevance and attract new customers[192]. - The Nautilus platform's market size may be smaller than estimated, impacting sales potential[185]. - The successful introduction of the Nautilus platform will require substantial engagement with the scientific community to encourage acceptance and validate its utility[179]. - The company relies on intellectual property protection to maintain a competitive edge, but faces risks related to the adequacy and enforcement of such protections[215]. - The patent application process is complex and costly, with uncertainties regarding the issuance and enforceability of patents[217].
Nautilus Biotechnology(NAUT) - 2023 Q1 - Earnings Call Transcript
2023-05-02 18:57
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]