Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 242

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 242
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 gene coverage enables selection of a wider array of therapies—including some that are not yet approved or immediately
actionable. As the number of approved therapies continues to increase, necessitating the addition of new genetic targets and revalidation of our assays, we may incur higher costs and risk losing customers to competitors if updates to our tests are
delayed.

Many of our competitors, either alone or with their collaborators, may have greater financial and/or other resources than we do, including larger and more
established manufacturing capabilities and marketing, sales, and support functions. Other competitors are in the process of developing novel technologies which may lead to products that rival or replace our products. While we cannot assure you how
the market will evolve, we believe our four pillars of differentiation provide competitive advantages that are difficult for others to replicate.

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For further discussion of the risks we face relating to competition, see the section titled “Risk factors—Risks Related to Our Business and Strategy—If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue or to achieve and then sustain profitability.” Intellectual Property The long-term success of our business depends on securing protection of our intellectual property through patent, trade secret, trademark, and other intellectual property rights. We also utilize non-disclosureagreements and proprietary information and inventions assignment agreements with employees, consultants, contractors and other third parties and maintain physical security of our premises and physical and electronic security of our information technology systems in order to strengthen the protection of our intellectual property. As of June 30, 2025, we held nine U.S. issued patents, which expire between August 2038 and March 2043, and 45 foreign patents, which expire between August 2038 and September 2041. Additionally, we had 14 pending U.S. patent applications and 31 foreign patent applications. We also held 4 U.S. registered trademarks and 13 foreign registered trademarks as of June 30, 2025. Our patent strategy is focused on seeking robust coverage for our core molecular counting technology (covered by U.S. is Patent No. 11,629,381, with a pending U.S. divisional application, granted patents in Australia, Brazil, China, Europe Hong Kong, India, Japan and South Korea (validated in 17 countries), and pending applications in Canada, Israel, Singapore, Japan (divisional), Europe (divisional), and Hong Kong (divisional), our dilution tagging technology (cover by U.S. Patent No. 12