ABSI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are a clinical-stage biopharmaceutical company using an AI-native approach to develop differentiated antibody therapeutics. Our integrated drug creation platform combines Origin-1, our generative design model, with rapid validation using our lab-in-the-loop. We focus on underexplored mechanisms w…

• We have advanced our first two programs from AI design to IND (or foreign equivalent) in around 2 years with a total investment of approximately $15 million per program, compared to an industry average of 4–6 years at a cost of greater than $50 million. This combination of underexplored target selec…

• Our lead product candidate, ABS-201, is an anti-prolactin receptor (PRLR) antibody engineered with an extended half-life to support a patient-friendly dosing interval. We believe PRLR is an underexplored target with the potential to provide durable, disease-modifying effects. If successfully develop…

• Our pipeline is composed of programs which leverage our differentiated capabilities in de novo design, multi-parametric lead optimization, and reverse immunology. These programs have been designed to address areas with significant unmet medical needs with potential ‘first-in-class’, ‘best-in-class’,…

• ABS-201 is being evaluated in the HEADLINE™ Phase 1/2a clinical trial (NCT07317544) for AGA, a condition affecting approximately 80 million people in the United States. Our own patient and clinician surveys, as well as those of other parties, show broad dissatisfaction with current standard of care,…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We are a clinical-stage biopharmaceutical company advancing potential breakthrough antibody therapeutics with generative AI. Our Integrated Drug Creation platform comprises, in part, cutting edge generative AI models aimed at designing better antibody therapeutics, including against hard-to-drug tar…

• Antibody therapeutics represent a growing market and significant medical opportunity, yet the biopharmaceutical industry faces challenges in bringing these potentially life-changing medicines to patients. Leveraging our synthetic biology roots, we expect our Integrated Drug Creation platform to impr…

• Our business model is focused on monetizing our Integrated Drug Creation platform by generating internally developed programs that are later partnered or out-licensed following certain value inflection points (anywhere from preclinical through clinical development) or by partnering with third partie…

• Internally developed programs: We believe that by developing our own pipeline, we will create optionality for enhanced monetization and validation of our Integrated Drug Creation platform. Moreover, our pipeline reflects internally developed programs which highlight our differentiated capabilities, …

• As of November 12, 2025, we have identified five wholly owned, internally developed programs focusing on cytokine biology, as well as several undisclosed internal pipeline programs currently in early discovery phases.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• evaluation, management concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective at the reasonable assurance level.

• There was no change in our internal control over financial reporting that occurred during the three months ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• There was no change in our internal control over financial reporting that occurred during the three months ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

• We are a clinical-stage company. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential product candidates and undertaking preclinical and early clinical studies related to ou…

• We do not anticipate generating any revenue from commercial product sales, if ever, until we successfully complete the clinical development of, and achieve regulatory approval for, any of our internally developed programs, all of which are still in clinical and preclinical development.

• In addition to the development of our internally developed programs, we began entering into drug creation collaborations for drug creation programs and co-development partnerships with third parties in 2018. We are still early in the adoption phase of our drug creation collaboration business model, …

• Our revenue to date has been generated primarily from drug creation activities conducted through these partnered programs. In addition, we expect our expenses to increase as we advance our internally developed

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Quarterly Report and in our other public filings in evaluating our business. The occurrence of any of the events or developments described b…

• Our current business has a limited operating history, which may make it difficult to evaluate our business and predict our future performance.

• Our current business has a limited operating history. We began commercial operations in 2018. Before engaging in commercial operations, we focused primarily on technology development. Our revenue to date has been generated primarily from drug creation activities through partnerships, and we do not a…

• •develop and advance our product candidates from our internally developed programs through preclinical and clinical development and potential marketing approval and commercialization;

• •drive adoption of our Integrated Drug Creation platform by validating them through the advancement of our internally developed programs and by attracting and retaining partners;