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New words:
advocacy, advocated, agent, AIML, allegedly, artificial, biased, blocking, branch, cancelled, Chinese, citizenship, controversial, Cowen, cyber, declaratory, decoding, deficient, deployment, dismissing, DNA, ESG, expenditure, Florida, forfeited, incident, Indiana, intelligence, Iowa, IRS, landscape, machine, Montana, moot, motion, necessitate, Northern, Oregon, origami, Palamedrix, Pillar, pool, redevelopment, retaliation, shelf, solicitation, stewardship, succeed, suspend, TD, Tennessee, vigorously
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August, bearing, cleaning, commencing, cyclical, decontamination, deposit, discount, disinfecting, distancing, enrollment, estimate, expiring, high, HITECH, hygiene, impairment, intermittently, landlord, letter, masking, nationwide, nonrecurring, October, reinstitute, remotely, resumed, resurgence, retained, September, spread, substantive, susceptible, tenant, travel, turnover, usage, utilized, vaccination, ventilation, whichever
Financial report summary
?Competition
Thermo Fisher Scientific • Danaher • Agilent • Bruker • Standard BioTools • Quanterix • Seer Inc - Ordinary Shares • Quantum-Si Incorporated - Ordinary Shares • Olink Holding AB • SomaLogicRisks
- We are a development stage company that has incurred net losses in every period to date, has not yet commercialized any products, and expects to continue to incur significant losses as we develop our business. We may never achieve profitability.
- Our business is entirely dependent on the success of our Nautilus platform, which remains in the development stage and subject to scientific and technical validation. If we are unable to develop and commercialize our Nautilus platform successfully and in a manner that provides currently anticipated functionality and levels of performance, we may never be able to recognize any revenue, and our business, operating results, and financial condition will suffer.
- We have not yet commercially launched our Nautilus platform. We may not be able to launch our Nautilus platform successfully and even if it is successful, we may experience material delays in our commercialization program relative to current expectations.
- The commercialization of our products will require us to establish relationships and successfully collaborate with leading life science companies and research institutions, initially to test and validate our products and subsequently as we seek to expand the markets for our products. We may be unable to establish sufficient collaborations of this nature, and such collaborations could result in agreements that limit or otherwise impair our flexibility to pursue other strategic opportunities.
- Even if we are able to complete development of our Nautilus platform, we may not achieve or maintain significant commercial market acceptance.
- We have no experience in manufacturing our products at commercial scale. If we are unable to establish manufacturing capacity by ourselves or with partners in a timely manner after completing development, commercialization of our Nautilus platform would be delayed, which would result in lost revenue and harm our business.
- If we are unable to establish an effective commercial organization, including effective distribution channels and sales and marketing functions, we may not be successful in commercializing our Nautilus platform.
- The size of the markets for our Nautilus platform may be smaller than estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products.
- The life sciences technology market is highly competitive. If we fail to compete effectively, our business and results of operation will suffer.
- Even if our Nautilus platform is commercialized and achieves broad scientific and market acceptance, if we fail to improve it or introduce compelling new products, our revenue and our prospects could be harmed.
- We rely on third parties for development of certain aspects of the Nautilus platform, and any failure of these third parties to perform their respective obligations in a timely manner or to our specifications could negatively impact our timelines, costs or product performance.
- Our business will depend significantly on research and development spending by pharmaceutical companies as well as by academic and other research institutions. Any reduction in spending could limit demand for our products and adversely affect our business, results of operations, financial condition and prospects.
- Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- We have a limited operating history, which may make it difficult to evaluate our current business and the prospects for our future viability, and to predict our future performance.
- We may need to raise additional capital to fund our development and commercialization plans.
- If we are unable to obtain and maintain sufficient intellectual property protection for our products and technology, or if the scope of our intellectual property protection obtained is not sufficiently broad, competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
- The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
- We may not be able to protect our intellectual property rights throughout the world.
- We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
- Issued patents covering our products could be found invalid or unenforceable if challenged.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, and our business could be harmed.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position.
- Patent terms may be inadequate to protect our competitive position on our Nautilus platform for an adequate amount of time.
- Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed trade secrets of our former employers.
- If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
- Our use of open source software and failure to comply with the terms of the underlying open source software licenses could impose limitations on our ability to commercialize our products and provide third parties to our proprietary software.
- Intellectual property rights do not necessarily address all potential threats.
- We may become involved in litigation to enforce or defend our intellectual property rights, or defend ourselves from claims that we infringe the intellectual property rights of others, which litigation could consume significant resources and management time, and in which an adverse result could result in loss of our intellectual property rights, a requirement that we pay significant damages, and could prevent us from selling our products.
- Our products could have unknown defects or errors, which may give rise to claims against us and adversely affect market adoption of our Nautilus platform.
- If we are sued for product liability, we could face substantial liabilities that exceed our resources.
- Although our products currently are not labeled or intended for any use which would subject us to regulation by the FDA or other regulatory authorities, if we elect to label and promote any of our products as clinical or medical device products, we would be subject to regulation in the future and would be required to obtain prior approval or clearance by the FDA or other regulatory authorities, which could take significant time and expense and could fail to result in FDA clearance or approval for the intended uses we believe are commercially attractive.
- Our products could become subject to government regulation as medical devices by the FDA and other regulatory agencies even if we do not elect to seek regulatory clearance or approval to market our products for diagnostic purposes, which would adversely impact our ability to market and sell our products and harm our business. If our products become subject to FDA regulation, the regulatory clearance or approval and the maintenance of continued and post-market regulatory compliance for such products will be expensive, time-consuming, and uncertain both in timing and in outcome.
- We are currently subject to, and may in the future become subject to additional, U.S. federal and state laws and regulations imposing obligations on how we collect, store and process personal information. Our actual or perceived failure to comply with such obligations could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our future customer base, and thereby decrease our revenue.
- Our use of artificial intelligence and machine learning technologies may result in reputational harm or liability.
- If we commercialize our Nautilus platform outside of the United States, our international business could expose us to business, tax, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.
- Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations. Failure to comply with environmental laws and regulations could subject us to significant liability.
- Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Demand for our technology could be reduced by legal, social and ethical concerns surrounding the use of genetic information and biological materials.
- If we experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.
- We may be unable to manage our anticipated growth effectively.
- If we are unable to recruit and retain key executives and scientists, we may be unable to achieve our goals.
- We may acquire other companies or technologies, which could divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results.
- Unfavorable U.S. or global economic conditions as a result of multiple global events, including the COVID-19 pandemic, the conflicts in Eastern Europe and the Middle East, increasing interest rates, instability in the global financial markets, and general economic downturns, could adversely affect our ability to raise capital and our business, results of operations and financial condition.
- If our facilities become unavailable or inoperable, our research and development program and commercialization launch plan could be adversely impacted and manufacturing of our instruments and consumables could be interrupted.
- We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
- An active trading market for our Common Stock may never develop or be sustained.
- The market price of our Common Stock has been and may continue to be volatile, which could result in substantial losses for investors.
- There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
- Our principal stockholders and management own a significant percentage of our Common Stock and will be able to exercise significant influence over matters subject to stockholder approval.
- The sale or the perception of future sales of a substantial number of shares of our Common Stock could cause the market price of our Common Stock to drop significantly, even if our business is doing well.
- We will have broad discretion over the use of the proceeds to us from our “at the market” equity offering program and may apply the proceeds to uses that do not improve our operating results or the value of your securities.
- We do not expect to pay any dividends for the foreseeable future. Investors may never obtain a return on their investment.
- Our bylaws designate a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, and also provide that the federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, each of which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, stockholders, or employees.
- Delaware law and provisions in our certificate of incorporation and bylaws might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.
- We will continue to incur significant increased costs and management resources as a result of operating as a public company.
- We have broad discretion in the use of the net proceeds from the Business Combination and the PIPE Financing and may not use them effectively.
- Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to certain limitations.
- Changes in tax laws could have a material adverse effect on our future business, cash flows, results of operations or financial condition.
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which would harm our business.
- If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Common Stock.
- We are an “emerging growth company” and a “smaller reporting company” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our Common Stock less attractive to investors.
- Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common shares.
- Increased scrutiny of our environmental, social or governance responsibilities may result in additional costs and risks, and may adversely impact our reputation, employee retention, and willingness of customers and suppliers to do business with us.
Management Discussion
- Research and development expenses were $12.9 million for the three months ended March 31, 2024, compared to $10.9 million for the three months ended March 31, 2023, an increase of $2.1 million, or 19%. The increase was due to a $1.3 million increase in salaries, related benefits, and stock-based compensation, a $0.7 million increase in laboratory supplies and equipment expense, and a $0.4 million increase in facilities costs. These increases were caused by increased headcount during the period and a new lease that commenced in March 2023. These increases were partially offset by a decrease of $0.5 million in professional services and external development services as more development efforts were performed by the Company.