BLLN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited financial statements and the related notes included in Item 1 of this Quarterly Report. The following discussion and analysis as well as other parts of this Quarterly…

• In May 2026, we announced the launch of Unity ConfirmTM, a circulating fetal cell-based, non-invasive confirmation assay designed to enable confirmation of high-risk screening results. The new assay isolates intact circulating fetal cells from a simple maternal blood draw using BillionToOne’s Fetal …

• In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complem…

• platform beyond genomic profiling to address chemotherapy safety (PGx) and clonal hematopoiesis (CH) — two critical decision points in selecting the right therapy for patients. Our current development efforts focus on MRD detection, leveraging our platform’s exceptional sensitivity to identify trace…

• Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of the over one million smNGS-based tests that we have processed since our initial launch, over 45% of them, or approximately 676,000 tests, were processed within the last 12 months end…

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited financial statements and the related notes included in Item 1 of this Quarterly Report. This discussion and analysis as well as other parts of this Quarterly Report c…

• In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complem…

• 1 Bower, X., Wignall, J., Varga, M. G., Zhu, J., O’Sullivan, M., Searle, N. E., Hong, L. K., Dogruluk, T., Li, Z., Farmer, T. E., Rosas-Linhard, E., Luong, J., Lin, E., Simon, M. E., Tsao, D. S., Bosch, J. R. T., Palmer, G., Gajra, A., Huynh, C., & Zhou, W. (2025). Validation of a liquid biopsy assa…

• 2 More than 50% more actionable/reportable mutations when compared to the comparator products in the aggregate. Actual percentages may vary depending on the individual comparator test.

• since inception, and had an accumulated deficit of $280.7 million as of September 30, 2025, we had net income of $1.5 million for the nine months ended September 30, 2025 compared to a net loss of $30.1 million for the nine months ended September 30, 2024. During the nine months ended September 30, …

Text added vs the prior filing · source: 10-Q · 2026-05-06

• We are exposed to market risk for changes in interest rates related primarily to our cash and cash equivalents and our indebtedness. As of March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $537.5 million and $496.0 million, respectively, held primarily in cash deposits and mo…

• Our operations are currently conducted almost entirely in the United States as international markets represented less than 1% of our revenue during the three months ended March 31, 2026. If we choose to expand internationally, our results of operations and cash flows may become subject to fluctuatio…

• We are also exposed to inflation risk and inflationary factors, such as increases in raw material and overhead costs, which could impair our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate …

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• We are exposed to market risk related to changes in interest rates. We had cash and cash equivalents of $97.3 million, $191.5 million and $195.2 million as of December 31, 2023 and 2024 and September 30, 2025, respectively. Our cash and cash equivalents consist of cash held in sweep accounts, checki…

• We do not believe that inflation has had a material effect on our business, financial condition, or results of operations. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through increases in revenue as increases in infl…

• Our operations are currently conducted almost entirely in the United States as international markets contribute less than 1% of our revenue. If we choose to expand internationally, our results of operations and cash flows may become subject to fluctuations due to changes in foreign currency exchange…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Management performed additional procedures, including supplementary analyses and enhanced review procedures, to provide reasonable assurance regarding the reliability of the financial statements. Notwithstanding the material weaknesses and based on the additional analyses and procedures performed, M…

• We previously reported material weaknesses in our internal control over financial reporting, and they remained unremediated as of March 31, 2026, relating to the following:

• •We did not design and maintain an effective control environment commensurate with our financial reporting requirements. Specifically, we lack a sufficient complement of resources with the appropriate knowledge, experience, and training to appropriately analyze, record and disclose accounting matter…

• •We did not design and maintain effective controls to appropriately analyze, account for, and present and disclose amounts related to certain financial instruments. Specifically, we did not design and maintain controls to appropriately analyze, account for, and present and disclose amounts related t…

• •We did not design and maintain effective user access controls to ensure appropriate segregation of duties and to adequately restrict user and privileged access to appropriate personnel in creating and posting journal entries.

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• Notwithstanding the material weakness in our internal controls over financial reporting as of September 30, 2025, management has concluded that the financial statements included in this Form 10-Q present fairly, in all material respects, our financial position, results of operations and cash flows f…

• Previously Reported Material Weaknesses in Internal Control over Financial Reporting

• Our management previously determined that we did not design and maintain an effective control environment commensurate with our financial reporting requirements. Specifically, we lack a sufficient complement of resources with the appropriate knowledge, experience, and training to appropriately analy…

• •We did not design and maintain effective controls to appropriately analyze, account for, and present and disclose amounts related to certain financial instruments. Specifically, we did not design and maintain controls to appropriately analyze, account for, and present and disclose amounts related t…

• •We did not design and maintain user access controls to ensure appropriate segregation of duties and to adequately restrict user and privileged access to appropriate personnel in creating and posting journal entries. This material weakness did not result in a misstatement to the financial statements…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Litigation or any other legal, regulatory or administrative proceedings, regardless of the outcome, can result in substantial cost and diversion of our resources, including our management’s time and attention, and there can be no assurances that favorable final outcomes will be obtained.

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• Litigation or any other legal, regulatory or administrative proceedings, regardless of the outcome, can result in substantial cost and diversion of our resources, including our management’s time and attention, and there can be no assurances that favorable final outcomes will be obtained. For additio…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Investing in our Class A common stock involves a high degree of risk. In addition to the information set forth in this Quarterly Report on Form 10-Q, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial st…

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• A description of risks and uncertainties facing our business is set forth below. You should carefully consider the risks described below, as well as the other information in this Quarterly Report on Form 10-Q (“Quarterly Report”), including our financial statements and the related notes and the sect…

• The following is a summary of the most significant risks, challenges and uncertainties facing our business. This summary should be read in conjunction with the risk factors described below in this section and should not be considered an exhaustive list or summary of all of the significant or materia…

• •Our limited operating history and rapid growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter.

• •We primarily generate revenue from sales of our molecular diagnostic tests and we are highly dependent on them for our success.

• •If the government and other third-party payors fail to provide coverage and adequate payment for our existing and future tests, our revenue and prospects for profitability will be harmed.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• On March 6, 2026, John ten Bosch, our Senior Vice President of Laboratory Operations, entered into a pre-arranged stock trading plan. Such trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Mr. ten Bosch’s plan provides for, subject to certain marke…

• On March 6, 2026, Nancy Johnson, our Senior Vice President of Sales and Commercial Operations, entered into a pre-arranged stock trading plan. Such trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Ms. Johnson’s plan provides for, subject to certai…

• On March 6, 2026, Shan Riku Sakakibara, our Chief Product Officer, entered into a pre-arranged stock trading plan. Such trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Ms. Sakakibara’s plan provides for, subject to certain market price limits and…

• On March 6, 2026, David Tsao, our President, Chief Technology Officer and Director, entered into a pre-arranged stock trading plan. Such trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Mr. Tsao’s plan provides for, subject to certain market price…

• On March 6, 2026, Oguzhan Atay, our Chief Executive Officer and the Chair of our Board of Directors, entered into a pre-arranged stock trading plan. Such trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Mr. Atay’s plan provides for, subject to cer…

Text removed vs the prior filing · source: 10-Q · 2025-12-10

• Amendment No. 1 to the Note Purchase Agreement, dated as September 4, 2025, by and among by and among the Registrant, the purchasers party thereto, and BWCB SA LLC (an entity affiliated with Oberland Capital Management, LLC), as purchaser’s agent.

• Development and Commercialization Agreement with Janssen Biotech, Inc., dated July 11, 2025

• Amendment No. 1 to Development and Commercialization Agreement with Janssen Biotech, Inc., dated October 15, 2025

• Form of Indemnification Agreement by and between the Registrant and each of its directors and executive officers

• † The Registrant has omitted portions of the exhibit (indicated by “[*]”) as permitted under Item 601(b)(10) of Regulation S-K because such information is both (i) not material and (ii) information that the Registrant treats as private or confidential. The Registrant hereby undertakes to furnish sup…