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Market ClerkRecap
Thu Sep 24 · markets closed3 signals on Sep 23178 insider buys this week · $231.5MCIRO short report next: Sep 29The week ahead

QSI

Quantum-Si Inc
NASDAQ · TECHNOLOGY · MEASURING & CONTROLLING DEVICES, NEC
0.76
−0.03 −3.31%
USD · close Sep 23

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How QSI rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
87%
of sentences unchanged
Added
57
new sentences
Dropped
54
sentences removed
Length
+180
words, now 28,453

New in FY2025

  • We incurred net losses of $101.3 million , $101.0 million and $96.0 million for the years ended December 31, 2025 , 2024 and 2023 , respectively.
  • As of December 31, 2025 , we had an accumulated deficit of $698.0 million .
  • Over the next several years, we expect to continue to devote substantially all of our resources towards development and commercialization of our products and research and development efforts for enhancements to current products, products in development, and additional products.
  • In December 2022, we initiated a controlled launch of Platinum for RUO, subsequently began a controlled commercial launch of Platinum in January 2023, and then moved to a full commercial launch of Platinum beginning the second quarter of 2024.
  • In January 2025, we announced the launch of our Platinum Pro benchtop sequencer.
  • First shipments of Platinum Pro occurred in March 2025.
  • In addition, in November 2024 we announced the development of a new hardware platform, Proteus TM , with an anticipated commercial launch date at the end of 2026.
  • To date we have generated limited product revenue from our existing products and may never generate revenue from our existing products or future products sufficient to offset our expenses or produce enough cash to sustain operations from our existing products or future products.
  • As of December 31, 2025 , we had cash and cash equivalents and investments in marketable securities totaling $215.8 million .
  • We are following a three-phase launch plan for commercialization, which included an early access limited release phase, a controlled commercial launch phase, and the current broad commercial availability phase, which is intended to drive awareness.
  • The development and launch of new products may slow or stop existing product revenue in anticipation of superior technology that is pending launch.
  • In November 2024, we announced the development of our Proteus platform, which is our next-generation protein sequencing hardware platform that utilizes a brand-new consumable architecture, both of which are anticipated to provide a far superior sequencing data output and analysis compared to our current Platinum Pro platform.
  • Further, throughout 2025, we have provided general development updates, including a comprehensive investor and analyst day update in November 2025 that highlights these significant feature improvements of Proteus, as well as an anticipated on-track commercial launch by the end of 2026.
  • As a result of the development of Proteus and its anticipated capabilities, we may experience customers or potential customers delaying any capital purchases or ongoing consumable purchases in anticipation of the launch of Proteus, potentially negatively affecting our revenue in the near term.
  • Our Proteus platform is anticipated to be commercially available by the end of 2026, with an expectation of customer-focused applications and capabilities.
  • If Proteus is not launched within our communicated time frame, or is delivered without the customer-focused applications and capabilities, it could materially impact any potential of long-term financial success and our market credibility.
  • Since November 2024, we have provided the overall market periodic updates on our Proteus platform development, including overall development status, initial views on capabilities and output, and indications or potential customer applications, as well as an anticipated commercial launch date by the end of 2026.
  • Development of a new product platform is inherently difficult, and can often experience delays resulting from hardware integration, inability to develop desired customer applications for the commercial launch, unforeseen regulatory issues, hardware supplier challenges or a variety of other challenges impacting a commercial launch.
  • If our Proteus platform experiences a commercial launch delay due to these reasons or other impacts on our development program, it could materially impact any long-term financial success of the Company, and further, materially impact and damage our market credibility, negatively impacting commercial success and company valuation.
  • Our use of artificial intelligence and machine learning is subject to evolving laws and regulations and risks associated with unauthorized use, and may not result in the competitive advantages desired, all of which could expose us to competitive risk and legal liability.
  • We use artificial intelligence, machine learning and automated decision-making technologies (“AI”) to assist in the performance, efficiency, and speed of various functions at the Company, including, but not limited to, general and administrative activities and research and development.
  • The regulatory framework for AI is rapidly evolving as many federal, state and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations for areas including but not limited to consumer protection and transparency, bias and discrimination, intellectual property, employment and use in regulated healthcare devices.
  • Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of AI at the Company.
  • As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations.
  • Further, the unauthorized use of AI tools can result in the exposure of sensitive data, including our intellectual property or trade secrets or the personal information of our employees, customers, or other business partners to unauthorized persons or to the public.
  • There can be no assurance that we will realize the desired or anticipated benefits from AI, or any at all.
  • Our use of AI could result in additional compliance costs, regulatory investigations and actions, and lawsuits; and If as a result, we are unable to use AI, it could make our business less efficient, result in competitive disadvantages, and our business, financial condition, results of operations and cash flows could be adversely affected.
  • Throughout 2025 the President of the United States issued executive orders directing the United States to impose new and changing tariffs on imports from many countries throughout the world, including many in which we buy materials and supplies from.
  • These tariffs have increased the cost of the certain products we source from these international jurisdictions and may affect future shipments from any of our foreign suppliers.
  • Supreme Court issued a ruling striking down certain tariffs previously imposed under the International Emergency Economic Powers Act (“IEEPA”).
  • Following the Supreme Court’s decision, the U.S. presidential administration announced its intention to invoke other laws to collect tariffs and announced new tariffs on imports from all countries, in addition to any existing non-IEEPA tariffs.
  • There remains substantial uncertainty regarding the duration of existing and newly announced tariffs, potential changes or pauses to such tariffs, tariff levels, and whether further additional tariffs or other retaliatory actions may be imposed, modified, or suspended, and the impacts of such actions on our business.
  • Further, the Supreme Court did not determine whether duties paid under the invalidated tariff structure must be refunded, contributing to the uncertainty of the tariff landscape.
  • We also cannot predict the extent to which other countries will impose duties, tariffs, taxes or other similar restrictions upon the import or export of goods and materials in the future, nor can we predict future U.S. trade policy.
  • These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions, and may significantly reduce global trade.
  • These changes could prevent or make it difficult or more expensive for us to obtain the materials or components needed for new products.
  • Geopolitical conflicts could adversely impact our operations or those of our suppliers, manufacturers or customers.
  • As of December 31, 2025, we had 138 full-time employees in the United States and 7 full-time employees internationally .
  • If these manufacturers should fail or not perform satisfactorily, or for economic or other reasons choose to end business with us, our ability to commercialize and supply our instruments and consumable offerings would be adversely affected.
  • In addition, if our products are authorized for use by the FDA as medical devices, we will need to contract with FDA-registered device establishments that are able to comply with current Good Manufacturing Practice requirements that are set forth in the QSR, unless explicitly exempted by regulation.

and 17 more.

Gone since FY2024

  • We incurred net losses of $101.0 million , $96.0 million and $132.4 million in the years ended December 31, 2024 , 2023 and 2022 , respectively.
  • As of December 31, 2024 , we had an accumulated deficit of $596.6 million .
  • Over the next several years, we expect to continue to devote substantially all of our resources towards development and commercialization of our products and research and development efforts for additional products.
  • In December 2022, we initiated a controlled launch of Platinum for RUO, and to date we have generated limited product revenue and may never generate revenue sufficient to offset our expenses or produce enough cash to sustain operations.
  • As of December 31, 2024 , we had cash and cash equivalents and investments in marketable securities totaling $209.6 million .
  • We commercially launched our first product, Platinum for RUO in December 2022.
  • We are following a three-phase launch plan for commercialization, which includes an early access limited release phase, the current controlled commercial launch phase, and a broad commercial availability phase.
  • On February 1, 2025, the President of the United States issued executive orders directing the United States to impose new tariffs on imports from Canada, Mexico and China.
  • Although a portion of these new tariffs have been temporarily suspended, other parts of these new tariffs are now in effect, and it is unclear for how long and to what extent such suspensions will remain in effect.
  • The U.S. has also announced new tariffs on foreign steel and aluminum, with such tariffs taking effect in early March.
  • The U.S. has further raised the possibility of new tariffs on imports from additional countries, including those in Europe.
  • The new tariffs likely will increase the cost of the products we source from these international jurisdictions and affect future shipments from any of our foreign suppliers.
  • Geopolitical conflicts, including the ongoing conflicts in Ukraine and Israel and Gaza, could adversely impact our operations or those of our suppliers, manufacturers or customers.
  • As of December 31, 2024 , we had 143 full-time employees in the United States and six full-time employees internationally .
  • In December 2022, we initiated a controlled launch of Platinum for RUO, and subsequently initiated a full commercial launch at the beginning of the second quarter 2024.
  • If these manufacturers should fail or not perform satisfactorily, our ability to commercialize and supply our instruments and consumable offerings would be adversely affected.
  • In addition, if our products are authorized for use by the FDA as medical devices, we will need to contract with FDA-registered device establishments that are able to comply with current Good Manufacturing Practice requirements that are set forth in the Quality System Regulations (“QSR”), unless explicitly exempted by regulation.
  • These companies include but are not limited to: Agilent Technologies, Bio-Rad Laboratories, Danaher, Luminex, Merck (and its subsidiary MilliporeSigma) and Thermo Fisher Scientific.
  • We also compete with a number of emerging growth companies that have developed, or are developing, proteomic products and solutions, such as: Nautilus Biotechnology, Olink Proteomics, Quanterix, Seer and Standard BioTools (including its recent acquisition of SomaLogic).
  • We are party to Technology and Services Exchange Agreements by and among us and certain affiliated companies, pursuant to which the parties agreed to share personnel and certain non-core technologies.
  • The sharing arrangements under the agreements may prevent us from fully utilizing our personnel and/or the technologies shared under the agreements.
  • Furthermore, if these agreements were to terminate, or if we were to lose access to these technologies and services, our business could be adversely affected.
  • We have entered into Technology and Services Exchange Agreements (the “TSEAs”) by and among us and other participant companies controlled by the Rothberg family, consisting of Butterfly Network, Inc., OrphAI Therapeutics, Inc., Hyperfine, Inc., 4Bionics LLC, identifeye HEALTH Inc.
  • (f/k/a Tesseract Health, Inc.), Liminal Sciences, Inc. and Detect, Inc.
  • The TSEA with Butterfly Network, Inc. was signed in November 2020, and the TSEA with the remaining participant companies was signed in February 2021 and became effective upon the closing of the Business Combination.
  • Under the TSEAs, we and the other participant companies may, in our or their discretion, permit the use of certain non-core technologies, which include any technologies, information or equipment owned or otherwise controlled by the participant company that are not specifically related to the core business area of the participant, such as software, hardware, electronics, fabrication and supplier information, vendor lists and contractor lists, with the other participant companies.
  • The TSEAs provide that ownership of each non-core technology shared by us or another participant company will remain with the company that originally shared the non-core technology.
  • In addition, any participant company (including us) may, in its discretion, permit its personnel to be engaged by another participant company to perform professional, technical or consulting services for such participant.
  • Unless otherwise agreed to by us and the other participant company, all rights, title and interest in and to any inventions, works-of-authorship, idea, data or know-how invented, made, created or developed by the personnel (employees, contractors or consultants) in the course of conducting services for a participant company (“Created IP”) will be owned by the participant company for which the work was performed, and the recipient participant company grants to the party that had its personnel provide the services that resulted in the creation of the Created IP a royalty-free, perpetual, limited, worldwide, non-exclusive, sub-licensable (and with respect to software, sub-licensable in object code only) license to utilize the Created IP only in the core business field of the originating participant company, including a license to create and use derivative works based on the Created IP in the originating participant’s core business field, subject to any agreed upon restrictions.
  • The technology and personnel-sharing arrangements under the TSEAs may prevent us from fully utilizing our personnel if such personnel are also being used by the other participant companies and may also cause our personnel to enter into agreements with or provide services to other companies that interfere with their obligations to us.
  • Created IP under the TSEAs may be relevant to our business and created by our personnel but owned by the other participant companies.
  • Furthermore, if the TSEAs were to terminate, or if we were to lose access to the technologies and services available pursuant to the TSEAs, our business could be adversely affected.
  • Other than the acquisition of Majelac, to date, the growth of our operations has been organic, and we have limited experience in acquiring other businesses or technologies.
  • As of December 31, 2024 , we had federal net operating loss carryforwards (“NOLs”) to offset future taxable income of approximately $388.3 million, of which $65.5 million will begin to expire in 2033 if not utilized.
  • We have completed an analysis through December 31, 2024 and no such ownership change has occurred.
  • Future changes in our stock ownership, including future offerings, as well as other changes that may be outside of our control, could result in additional ownership changes under Section 382 of the Code.
  • Under the TCJA, in general, NOLs generated in taxable years beginning after December 31, 2017 may offset no more than 80 percent of such year’s taxable income and there is no ability for such NOLs to be carried back to a prior taxable year.
  • In addition, the CARES Act eliminates the limitation on the deduction of NOLs to 80 percent of current year taxable income for taxable years beginning before January 1, 2021.
  • Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.
  • Medical product manufacturers’ use of social media platforms presents new risks.

and 14 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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