Absci Corp (ABSI) Business

Item 1. Business

Overview

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 where unmet medical need is high and competition is low.

We have advanced our first two programs from AI design to IND (or foreign equivalent) in around two 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 selection and capital-efficient execution is central to our strategy.

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 developed, ABS-201 could establish a new treatment category in indications where current options remain inadequate. ABS-201 is being developed for two indications, androgenetic alopecia (AGA) or pattern hair loss (PHL) and endometriosis, each with large affected populations and significant unmet need:

•Androgenetic Alopecia: 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, which is limited by variable efficacy, poor compliance, and a lack of durable approaches. No approved therapy provides durable hair regrowth. We have dosed the first three single ascending dose cohorts with a favorable safety profile to date. Interim proof-of-concept data, including exploratory efficacy endpoints, are expected in the second half of 2026.

•Endometriosis: We plan to initiate a Phase 2 clinical trial of ABS-201 in endometriosis, a chronic condition estimated to affect approximately 10% of women of reproductive age worldwide. There is currently no FDA-approved disease-modifying therapy for endometriosis. The condition is associated with significant chronic pain, reduced quality of life, and impaired fertility, and treatment options are limited by inadequate long-term effectiveness and tolerability. PRLR signaling may contribute to both endometrial lesion development and pain-related pathways, which if demonstrated clinically, could support the potential for a non-hormonal and non-surgical treatment. A recent clinical trial has demonstrated clinical proof of concept for targeting PRLR for endometriosis. Our Phase 2 clinical trial for endometriosis is planned for the fourth quarter of 2026, subject to data from the ongoing HEADLINE trial and regulatory considerations.

Beyond ABS-201, we are advancing additional preclinical programs using our platform. We may seek partnerships or out-licensing arrangements for select pipeline assets, which would provide non-dilutive capital We believe we are positioned to execute on near-term catalysts while building long-term pipeline value.

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The AI Drug Creation Opportunity

Traditional drug discovery and preclinical development can take 4–6 years to go from discovery to clinical development at an aggregate cost of over $100 million per product candidate. Moreover, success rates for traditional drug discovery, as defined by successfully reaching a marketed product, are estimated at less than 5%. In all, it can take as much as 12–15 years, with costs estimated to exceed $1 billion to bring a drug to market.

Advances in AI are increasingly being applied to drug discovery and development. In May 2023, the U.S. Food and Drug Administration (FDA) acknowledged that AI has the potential to play an important role in drug development, including supporting efforts to improve aspects of the drug development process. Some industry participants and analysts have identified generative AI as a potential approach for designing potential drug candidates with specific attributes.

Our Integrated Drug Creation platform is the engine of our AI-native approach, allowing us to design anti-body based therapeutics that target underexplored biological mechanisms. We continue to expand our platform’s capabilities to support aspects of antibody drug discovery. Our AI models are designed to generate antibodies, including multispecific antibodies, in silico to target specific epitopes. These models are also designed to evaluate multiple characteristics that may be relevant to drug development.

We are leveraging our Integrated Drug Creation platform to:

•Design potential first-in-class and best-in-class therapeutics: We believe our Integrated Drug Creation platform, together with our generative AI models including Origin-1 (our de novo AI model), and AI lead optimization models, enables us to access underexplored mechanisms, unlock novel biology, and design therapeutics against difficult-to-drug targets with significant unmet medical need.

•Increase the potential probability of success: Our AI models have been designed to enable multi-parametric predictions and simultaneous optimization of attributes in parallel, which we believe may enable the design of product candidates with defined characteristics that may be relevant to clinical development and thus increase the potential for clinical success.

•Reduce time and cost to clinic: We believe our platform may support more efficient preclinical development timelines. For example, we demonstrated capital-efficient development by advancing our first two internal pipeline programs through to IND (or foreign equivalent) in around two years with a total investment of approximately $15 million per program.

Our strategy is to leverage our Integrated Drug Creation platform to create differentiated antibody-based therapeutics for our own pipeline and for our partners’ pipelines. We are currently advancing two internally developed programs in clinical development, including ABS-201, that are intended to address underexplored mechanisms where there is significant unmet medical need.

Our Integrated Drug Creation Platform

Absci is a clinical-stage, AI-native biopharmaceutical company. Our approach leverages a continuous feedback loop between advanced AI algorithms and wet lab validation. Each cycle refines our data and strengthens our models, facilitating rapid innovation and enhancing the precision of our therapeutic designs.

With the data to learn, the AI to create, and the wet lab to validate, we believe our lab-in-a-loop powers our ability to go from AI designs to wet lab-validated product candidates in as little as six weeks. Our proprietary Integrated Drug Creation platform supports the development of both internally developed and partnered programs that address underexplored biological mechanisms and enables the design of product candidates with defined target product profiles (TPPs).

Lab-in-a-loop

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Data to Train: We leverage a combined 77,000+ square feet wet-lab and dry-lab facility to generate high-quality data at scale for AI model training and testing. We have continuously generated high-quality data at scale for AI model training using technologies such as high-throughput Surface Plasmon Resonance (SPR) for affinity measurements of antibodies, SoluPro and the ACE assay, a bacterial synthetic-biology platform that allows for affinity measurement of antibody fragment libraries, and enrichment/ sorting/ titration of yeast and phage displayed AI-designed libraries. We also regularly make use of public biological datasets. Our ability to generate accurate data through efficient operational infrastructure generates high-quality data in a high-throughput manner to train and test our AI models.

AI to Create: We design product candidates using our generative AI models trained on both proprietary and public biological datasets. Our generative AI models can create epitope-specific product candidates against a therapeutic target of interest, including “hard-to-drug” targets. In addition, our AI lead optimization models enable parallel multi-parametric optimization to improve certain product candidate attributes including, but not limited to, tunable binding affinity, immunogenicity, pharmacological profile, and developability.

Wet Lab to Validate: We assess our product candidates with our wet lab's high-throughput functional validation capabilities, which are designed to prove our AI models in the lab. The quality and scale of wet lab data give us extensive training data, propelling our iterative design-build-test-learn cycle.

Our Integrated Drug Creation platform enables our core competencies in three broad areas:

•Target selection and discovery: Target selection is a strategic pillar of our AI-native approach, allowing us to identify opportunities where we can establish first-in-class or best-in-class positions. We prioritize targets considering multiple factors, including: (1) biological potential in underexplored mechanisms; (2) relevance to diseases with significant unmet medical need; (3) prior challenges in addressing the target using traditional antibody discovery approaches; and (4) suitability for design using our AI models for capital efficient development. We may also use our proprietary reverse-immunology technology to identify potentially desirable targets. This technology allows us to reconstruct prevalent immune-response antibodies from disease tissue to identify their corresponding antigens. This method can provide us with possible therapeutic targets, as well as their cognate antibody binding partners, for further potential validation and AI-optimization. In our Drug Creation Partnerships, targets are typically selected by our partners based on their own assessments.

•AI-guided antibody drug creation: Starting with an envisioned TPP as well as an antibody framework, target antigen and epitopes, we use generative AI models, such as our proprietary Origin-1 de novo antibody design models to create a library of relevant antibody designs predicted to

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bind to the target epitope(s) and desired attributes. These designs are filtered and sorted using AI models and then the top ranking designs are tested in our wet-lab to determine and validate key attributes, such as target epitope specificity, affinity, functionality, and developability.

•AI-guided lead optimization: With multi-parametric AI lead optimization, we work to simultaneously evaluate and improve key attributes such as target epitope binding affinity, manufacturability, and other pharmacologic characteristics. The attributes of these optimized designs are also tested in our wet-lab to confirm whether the desired targeted preclinical profile has been met, and thus allow for further advancement through preclinical and, potentially, clinical development.

Origin 1: In January 2026 we released Origin-1, Absci’s platform for de novo design of full-length monoclonal antibodies against “zero-prior” epitopes. While several de novo antibody design models have succeeded in delivering binders against solved epitopes (binding sites that have already been structurally characterized with a known protein binder, these approaches do not prioritize a critical problem in therapeutic discovery: designing antibodies for targets and epitopes lacking solved complex structures with protein binders. Origin-1 was developed and validated to address this challenge. “Zero-prior-epitopes” refer to target sites that, to our knowledge have no published reports describing a protein (including, for example, an antibody) that binds to the target at the selected epitope.

Origin-1 consists of: (1) AbsciGen, the generative engine creating antibody structures and sequences, y structures and sequences, and (2) AbsciBind, an engine that scores and filters antibody candidates prior to experimental characterization. In contrast to traditional drug discovery campaigns, Origin-1 generated product candidates by screening fewer than 100 designs per target. Origin-1 has been successfully validated against four targets to date by showing binding, developability, and ~100nM functional potency confirmed across 5+ orthogonal assays. Additionally, structures of top binders for 2 example targets (COL6A3 and AZGP1) were confirmed by cryogenic electron microscopy (Cryo-EM), with experimental structures matching the design models closely, confirming Origin-1’s ability to generate epitope specific, atomically accurate binders.

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We believe this platform is potentially the first demonstration of de novo design of full-length monoclonal antibodies against "zero-prior" epitopes with atomically accurate complex structures and functional activity.

Origin-1 was developed using multiple years of proprietary data generation. Our lab-in-a-loop platform continuously feeds wet-lab validation data back into the models, capturing the fundamental binding mechanics and rules often absent from public datasets.

Our Business Model

Our business model is designed to drive value through our AI-native approach to therapeutic discovery and development. We leverage our Integrated Drug Creation platform to (1) build and advance an internal pipeline of differentiated therapeutic programs that we advance through clinical development and commercialization, (2) generating internally developed programs that are subsequently partnered or out-licensed following certain value inflection points (anywhere from preclinical through early phases of clinical

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development), and (3) strategically partnering with third parties to leverage our Integrated Drug Creation platform to support early discovery efforts in a variety of deal structures.

Internally Developed Programs: Our pipeline includes internally developed programs designed to address areas of significant unmet medical need, including programs that we believe may have the potential to represent first-in-class or disease-modifying approaches. These programs have been generated using our platform capabilities, including de novo antibody design, multi-parameter candidate optimization and reverse immunology approaches. We intend to advance a limited number of internally developed programs, such as ABS-201, through clinical development and potential commercialization. For other internally generated programs, we may seek to enter into collaboration, partnership or out-licensing arrangements at various stages of development, which may include preclinical stages or early phases of clinical development, to support the advancement of selected programs and continued development of our platform.

Partnered Programs: We may enter into drug creation collaborations for drug creation programs and co-development partnerships with third parties. Our drug creation collaboration programs may include up-front fees and research fees, as well as potential clinical and/or commercial milestones and royalties. Through our co-development partnerships, we collaborate to develop drug creation programs to certain value inflection points before considering partnering or out-licensing opportunities and may include mutual cost-sharing and/or technology contributions. Absci has had a track record of partnerships with leading biopharmaceutical companies including Merck, AstraZeneca, Almirall and others.

Strategy

Our strategy is focused on generating internally developed programs that address underexplored biological mechanisms in areas of significant unmet medical need, including programs that we believe may have the potential to represent first-in-class or disease-modifying approaches. We intend to advance a limited number of programs that we believe are best aligned with our capabilities through clinical development and potential commercialization. For other internally generated programs, we may seek to enter into collaboration, partnership or out-licensing arrangements at various stages of development, which may include preclinical stages or early phases of clinical development, in order to support the advancement of selected programs and the continued development of our platform

Our strategy is driven by our AI-native approach and Integrated Drug Creation platform, which encompasses cutting edge generative AI models that are integrated with our lab-in-the-loop, which assesses and validates our AI model designs. By leveraging our lab-in-the-loop, we drive a continuous learning cycle—data to train, AI to create, and wet lab to validate—that accelerates AI model innovation and thus continually improves our Integrated Drug Creation platform. With each iteration, our Integrated Drug Creation platform refines its predictive capabilities, improving design capabilities and allowing us to create better antibody-based therapeutics against increasingly challenging targets that are beyond the reach of traditional drug discovery approaches.

Advancing a diverse portfolio of internally developed programs: We are advancing a portfolio of internally developed programs, each designed using our generative AI models, including our Origin-1 de novo AI models, and our AI-driven lead optimization models. These programs span multiple therapeutic areas and focus on areas with significant unmet medical need. We are increasingly leveraging our platform to create antibody-based therapeutics, including multi-specific antibodies, against complex and hard-to-drug targets. We intend to advance a limited number of programs that we believe are best aligned with our capabilities through clinical development and potential commercialization. For other internally developed programs, we may seek to enter into collaboration, partnership or out-licensing arrangements at various stages of development, which may include preclinical stages or early phases of clinical development. Our portfolio approach ensures our value is anchored in a repeatable engine capable of generating a sustainable pipeline of best-in-class or first-in-class therapeutics.

Continuous investment in our team and integrated drug creation platform: We intend to maintain our technological differentiation through continued investment in our team and platform. We expect to maintain an integrated team of subject matter experts in AI, drug discovery, disease biology, protein engineering, and clinical development. We expect to grow and enhance our intellectual property portfolio to protect and secure the value of our innovations, including the assets we generate using our platform. We may continue to evaluate strategic and synergistic technology acquisitions to expand and strengthen our capabilities and deepen our expertise in the aforementioned areas.

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Enabling the development of new antibody modalities: Our ability to design, construct and rapidly screen large numbers of molecules enables us to evaluate billions of unique protein variants in silico and hence to increase the probability of finding the most promising product candidate. We design and optimize new-to-nature modalities driven by our AI models.

Advancing AI drug creation by leveraging our proprietary data: We use data generated through our programs and design campaigns to support the continued development of our AI models. Through iterative design cycles, we seek to refine these models to support the design of antibody-based therapeutics with desired pharmacologic attributes. Advancement of our AI model capabilities is expected to further expand our landscape of addressable targets while also increasing the speed of creating drug candidates against those targets. The more data we generate, the more design campaigns we complete, the more our AI models advance, all of which we believe will enable us to create new and better antibody-based therapeutics against increasingly challenging targets.

Strengthening our position as a partner of choice through platform differentiation: We have entered into drug creation partnerships with pharmaceutical companies, biotechnology companies and other third parties to support the development of programs generated using our platform. These collaborations may include provisions for upfront payments, research funding, milestone payments and royalties on potential future product sales. We may also seek to enter into collaboration, partnership or out-licensing arrangements for certain internally developed programs at various stages of development, which may include preclinical stages or early phases of clinical development.

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Internally Developed Programs

Our pipeline is composed of internally developed 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’, or ‘disease modifying’ profiles. As of December 31, 2025, we are advancing five wholly-owned, internally developed programs as well as several undisclosed internal pipeline programs currently in early discovery phase.

Clinical Stage Programs

ABS-201

In December 2025, we initiated the HEADLINE™ Phase 1/2a clinical trial for ABS-201 (NCT07317544). This trial is designed to demonstrate safety, tolerability and proof of concept as a potential therapeutic treatment for androgenic alopecia (AGA). We have successfully dosed the first three cohorts in the single ascending dose (SAD) portion of the ongoing Phase 1/2a HEADLINE trial, and ABS-201 has been well tolerated to date, with favorable emerging safety data. We anticipate reporting preliminary safety, tolerability, and pharmacokinetic (PK) data in the first half of 2026, with interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027. We believe that this study can also provide supporting first-in-human safety, tolerability, and PK data to support a Phase 2 clinical trial evaluating ABS-201 in patients with endometriosis, which we anticipate initiating in the fourth quarter of 2026, with potential proof-of-concept data in the second half of 2027. Targeting the underexplored PRLR signaling pathway, ABS-201 is designed to provide durable, disease-modifying effects for both androgenetic alopecia (AGA) and endometriosis—two indications characterized by massive patient populations and a lack of effective, durable therapies.

ABS-201 for the Treatment of AGA

Epidemiological Overview

AGA, commonly known as pattern hair loss, is a multifactorial progressive disorder that affects approximately 80 million people in the United States. For approximately 50 million men in the United States with AGA, hair loss is most prominent in the vertex and frontotemporal regions. For approximately 30 million women in the United States, AGA hair loss is most prominent at the crown and top of the head, which is visible as wider center parting of the hair.

AGA is usually diagnosed through clinical evaluation, involving a history of gradual onset after puberty and often, but not necessarily, a familial history of baldness. AGA can significantly affect quality of life. Individuals with AGA often experience negative impacts on self-image and self-confidence, which can alter social behavior and emotional well-being. The psychosocial consequences of AGA, including increased stress, anxiety, and social withdrawal, can result in meaningful health-related impairments, highlighting the importance of addressing the condition.

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AGA is characterized by the progressive miniaturization of hair follicles, resulting in a transition from thick, pigmented terminal hairs to thin, short, and unpigmented vellus-like hairs. We believe, based on prior third party non-human primate studies, our own animal studies, and our human ex-vivo hair follicle organ culture studies, that prolactin signaling is an underexplored and key upstream driver of hair follicle miniaturization. Moreover, current FDA-approved treatments for AGA, which target dihydrotestosterone (DHT) and/or seek to increase blood flow to hair follicles, provide limited and/or variable efficacy, are inconvenient and thus patient compliance is limited, and some have been reported to cause potential sexual and neurological side effects. Additionally, incremental limitations exist for women of reproductive age. We believe that an antibody-based therapeutic with a favorable safety profile, meaningful and durable hair growth combined with a convenient administration profile, if successfully developed and approved, could represent a potential new category of treatment— a biologic therapy for hair loss.

Role of prolactin and ABS-201 in AGA - Mechanism of action

Prolactin has been reported in published literature to induce the catagen (regression) phase and cessation of pigmentation in human scalp hair follicles, suggesting that inhibition of prolactin receptor (PRLR) signaling may influence hair follicle cycling and pigmentation. ABS-201 is designed to target PRLR and inhibit PRLR signaling. We believe this mechanism may represent a potential therapeutic approach for the treatment of AGA. By inhibiting PRLR signaling, ABS-201 is intended to influence the balance of hair follicle cycling between the catagen (regression) and anagen (growth) phases. Preclinical data suggest that PRLR signaling may act upstream of DHT in pathways associated with hair growth and related signaling factors. In addition, inhibition of PRLR signaling may influence hair follicle stem cell dynamics and hair follicle function, which as depicted in the figure below, could contribute to hair growth and pigmentation; however, these potential effects have not been demonstrated in any clinical studies of ABS-201 to date.

Preclinical human ex vivo hair follicle organ culture studies

We evaluated the proposed mechanism of action of ABS-201 in a preclinical study using human ex vivo hair follicle organ cultures derived from frontotemporal male scalp skin. This area of the scalp is known to be androgen-sensitive and most commonly affected by AGA. This model is a relevant preclinical translational tool for assessing the biological mechanisms underlying human hair growth. In this study we organ-cultured male scalp skin with ABS-201, or IgG control in presence or absence of PRL for 6 days and performed quantitative (immuno) histomorphometry analyses. ABS-201 blocked PRLR signaling, promoted the anagen phase of the human hair follicles, and promoted hair shaft production. The study also demonstrated that ABS-201 protected and expanded the hair follicle niche, which is the local microenvironment in the hair follicle that maintains and regulates hair follicle stem cells. Importantly, ABS-201 alone (without the addition of exogenous PRL) compared to immunoglobulin control also demonstrated growth-promoting effects,

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indicating neutralization of intrafollicular PRL. As shown in the graphic below, ABS-201 was shown to prolong anagen and inhibit catagen and stimulate hair matrix proliferation.

Key preclinical findings demonstrated hair growth activity of ABS-201 in human ex vivo hair follicle organ culture with the potential to reverse miniaturization by facilitating vellus to terminal hair follicle reconversion include:

•ABS-201 prolonged the anagen (growth) phase of the hair cycle and inhibited the transition to catagen (regression) phase.

•ABS-201 increased key hair growth factors like IGF1 and FGF7 which support follicle viability and follicle growth, respectively, and promoted proliferation of hair matrix keratinocytes.

•ABS-201 protected and expanded the hair follicle stem cell niche by preventing the death of K15+ stem cells involved in follicle regeneration and restoring CD34+ progenitors that activate hair follicle stem cells.

•ABS-201 increased hair quality by stimulating keratin production independent of the hair cycle.

Preclinical mouse study

We evaluated ABS-201 in a preclinical study for short term hair growth in female mice. Up to 11 mice per group were shaved until the skin was visible, then randomized into treatment groups based on skin color and initial body weight. Hair growth scores were recorded twice weekly using a predefined scale. ABS-201 isotype control (both biweekly i.p.) and 5% daily topical minoxidil were compared to untreated animals. ABS-201 significantly increased hair regrowth compared to minoxidil and corresponding controls in this short-term

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hair regrowth model (p0.0001), achieving full hair growth after 22 days, whereas minoxidil achieved only approximately one-third hair growth in the same period, as shown in the figure below.

Evidence from external non-human primate study

In a published preclinical study conducted in aged stump-tailed macaques, treatment with a prolactin receptor antibody was associated with stimulation of hair growth, nearly doubling the number of terminal hairs after six months even in previously fully bald areas and showing a sustainable impact even after four years post-treatment. Notably, the stump-tail macaque model is considered to be a predictive animal model for male and female pattern hair loss in humans.

Preclinical toxicology studies

ABS-201 was well tolerated in GLP-compliant repeat-dose toxicology studies in rats and cynomolgus monkeys. Across the 4-week rat study and the 4-week and 26-week nonhuman primate studies, no findings of human relevance were observed in both species up to 600 mg/kg, the highest dose tested.

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Clinical Trials

In December 2025, we initiated a Phase 1/2a clinical trial of ABS-201, referred to as HEADLINE™ (NCT07317544). This trial is designed to evaluate the safety, tolerability and preliminary efficacy of ABS-201 in healthy volunteers with and without AGA. The trial is a randomized, double-blind, placebo-controlled study expected to enroll up to 227 male and female healthy volunteers at multiple sites in Australia.

In December 2025, the first participant was dosed in the HEADLINE clinical trial. As of March 24, 2026, the first three single ascending dose (SAD) cohorts were fully enrolled and dosed, with eight healthy volunteers in each cohort. Enrollment of the fourth SAD cohort, which is expected to include eight healthy volunteers, is ongoing. We currently expect to initiate three multiple ascending dose (MAD) cohorts in the second quarter of 2026, each planned to enroll approximately 49 healthy volunteers with AGA.

This clinical trial is primarily designed to evaluate the safety and tolerability of ABS-201 in healthy volunteers with and without AGA and includes exploratory analyses that may inform preliminary assessments of efficacy. Primary endpoints include the incidence of treatment-emergent adverse events, changes in clinical laboratory parameters, vital signs, electrocardiogram assessments and injection-site reactions. Secondary endpoints include pharmacokinetic/pharmacodynamic parameters, immunogenicity assessments and exploratory efficacy measures related to hair growth. The planned MAD cohort sample size is large enough to detect a nominally significant difference in target area hair count between the ABS-201 and placebo groups. However, such an analysis would not be multiplicity-adjusted and report only nominal p-values, consistent with its exploratory nature. We currently expect to report interim safety and tolerability data in the first half of 2026. Additional interim analyses, including evaluation of exploratory efficacy endpoints, are currently expected in the second half of 2026. The complete proof-of-concept data is anticipated in early 2027, with one-year safety follow-up data expected later in 2027. We believe that an antibody-based therapeutic like ABS-201, with a favorable safety profile, meaningful and durable hair growth combined with a convenient administration profile, if successfully developed and approved, could represent a potentially new category of treatment: a biologic therapy for hair loss.

ABS-201 for the Treatment of Endometriosis

Epidemiological Overview

Endometriosis is a chronic, estrogen-dependent, inflammatory disease defined by endometrial-like lesions found outside the uterus and is prevalent in up to 10% of reproductive age women worldwide. Pain is the most common symptom of endometriosis and can be chronic or “cyclical,” meaning that the sensation of pain worsens before and during the period.

Endometriosis may be diagnosed based on patient history, physical examination, and/or imaging findings. Definitive diagnosis, however, typically requires surgical visualization and biopsy of suspected endometriosis lesions. Endometriosis is diagnosed in 12–32% of women having surgery for pelvic pain, and in up to 50% of women having surgery for infertility. Access to early diagnosis is limited in many settings and the average time to diagnosis is between 4 and 12 years. Endometriosis remains underdiagnosed, which is predicted to improve if better treatments are developed. Current therapeutic options are limited and there are currently no disease modifying therapeutics approved by the FDA for the treatment of endometriosis.

Mechanism of action

Published literature suggests that PRL and PRLR may play a role in the development of endometrial lesions and associated pain in patients with endometriosis. PRL and PRLR expression has been reported to be elevated in endometrial tissue from patients with endometriosis, and prolactin signaling has been associated with processes involved in lesion growth, inflammatory signaling and pain pathways. Based on these observations, inhibition of PRLR signaling may influence pathways associated with lesion development and pain perception. As a result, ABS-201 may have the potential to affect both lesion growth and pain-related pathways. Because prolactin signaling is independent of sex-hormone pathways, targeting PRLR may represent a non-hormonal therapeutic approach; however, the safety and efficacy of ABS-201 for the treatment of endometriosis have not been established.

Preclinical mouse study

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In an endometriosis mouse model, we were able to show that ABS-201 decreased overall pain experience. This effect was observed across both spontaneous and evoked pain measures in a homologous transplant mouse model of endometriosis, where animals treated with ABS-201 showed significantly increased locomotion (a surrogate for reduced non-evoked pain) compared to control treated animals, as shown in the graphic below, and improved mechanical withdrawal thresholds in Von Frey testing compared to control treated animals. These functional improvements were accompanied by reductions in inflammatory cytokines, including TNFα, IL-1β, and CCL2 in peritoneal fluid, supporting a link between prolactin receptor blockade, decreased inflammation, and reduced pain behavior.

Clinical Trials

We intend to evaluate, and if possible, rely on the data generated from the HEADLINE trial, together with other available information, as part of our assessment of potential next steps for the ABS-201 program. We believe that this study will provide supporting first-in-human safety, tolerability, and PK data to support a Phase 2 clinical trial evaluating ABS-201 in patients with endometriosis. Based on these and other considerations, we anticipate initiating a Phase 2 clinical trial evaluating ABS-201 in endometriosis in the fourth quarter of 2026, subject to review of available data, regulatory considerations and other factors, with potential proof-of-concept data in the second half of 2027.

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ABS-101

ABS-101 is in development as a potential treatment for Inflammatory Bowel Disease (IBD). In May 2025, we initiated a Phase 1 clinical trial in healthy volunteers. Despite a favorable early safety profile and not withstanding positive interim Phase 1 results as announced in November 2025, we made the strategic decision to prioritize ABS-201 in the development of AGA and endometriosis where there are significant unmet medical needs and greater potential return on investment. As such, we will seek a partner for ABS-101 rather than advance it through later-stage development ourselves, including a partnership focused on exploring a potential first-in-class indication outside of IBD.

Preclinical Stage Programs

We are advancing early-stage oncology and immunology and inflammation programs, which include ABS-301, a potential first-in-class oncology asset discovered through our reverse immunology platform and ABS-501, a potentially differentiated HER2 program. We continue to use our platform to develop additional early-stage programs addressing challenging targets in various indications with areas of significant unmet medical need. We plan to provide more information about these additional programs selectively and to seek partnerships or out-licenses for select programs as they advance.

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Competition

Internally developed programs

We may face competition from pharmaceutical and biotechnology companies that are developing therapeutics that address the same disease targets and/or indications addressed by our internally developed programs. Competitors may obtain FDA or other regulatory approval for their products more rapidly or earlier than us, which could result in our competitors establishing a strong market position before we are able to enter the market. Competition for our active internally developed programs may include:

•ABS-201 in AGA: Existing FDA-approved treatments for AGA include oral minoxidil, oral finasteride, oral dutasteride, and topical minoxidil, which are currently established as standard of care despite their limitations. We are aware of several drug candidates that are in clinical development for AGA including Hope Medicine’s HMI-115, Veradermics’ VDPHL01, Pelage Pharmaceuticals’ PP405, and Cosmo Pharmaceuticals’ Clascoterone.

•ABS-201 in Endometriosis: Newer development candidates for non-hormonal antibody-based therapies for endometriosis currently include Hope Medicine’s HMI-115, Chugai Pharmaceuticals’ AMY-109, and GenSci’s Genakumab as well as other non-antibody-based clinical trials focused on non-hormonal pain treatments.

•ABS-101: There are several companies with product candidates targeting TL1A in clinical development for the treatment of IBD, including Merck’s MK-7240, Roche/Roivant’s RVT-3101, Sanofi/Teva’s TEV-48574 TL1A, Spyre’s SPY002, AbbVie’s ABBV-701, and Xencor’s XmAb942. Beyond the competitors for IBD, there will be additional competitors for the indications outside of IBD that we or a potential partner may explore.

Integrated Drug Creation platform

Our Integrated Drug Creation platform comprises, in part, cutting edge generative AI models aimed at designing differentiated antibody-based therapeutics, including against hard-to-drug targets. There are multiple potential competitors developing technologies that seek to improve target identification and drug design or discovery.

More specifically, in the field of AI-based drug design and discovery we may face competition from companies attempting to use AI to design therapeutics. Representative examples include Generate Biomedicines, Inc. and Xaira Therapeutics, Inc., among others. In the future we may face competition from companies currently offering adjacent technology (e.g. AI-enabled small molecule design) that may seek to develop antibody design capabilities. Representative examples include Recursion Pharmaceuticals, Inc., and Isomorphic Labs Limited, among others. Moreover, other pharmaceutical and biotechnology companies seeking to develop AI capabilities for biologic drug design may also pose competition.

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We also face competition from entities that have made substantial investments in developing treatments for the therapeutic indications which our internal programs and partnered programs target. These competitors may include large and specialty pharmaceutical and biotechnology companies.

For a discussion of the risks we face relating to competition, see “Risk Factors—Risks Related to Biologic Drug Development”.

Intellectual Property

We strive to protect and enhance the proprietary technology, inventions, know-how and improvements that we believe are commercially important to our business by seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties, that cover our Integrated Drug Creation platform, as well as our internally developed programs. We also rely on trade secret protection and confidentiality agreements to protect our proprietary technologies and know-how to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We also endeavor to continue to innovate and seek in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of AI-guided drug creation. Our success will depend significantly on our ability to obtain and maintain patent and other proprietary protection for our technology, our ability to defend and enforce our intellectual property rights and our ability to operate without infringing any valid and enforceable patents and proprietary rights of third parties. We also protect the integrity and confidentiality of our data, know-how and trade secrets by maintaining physical security of our premises and physical and electronic security of our information systems.

We have a broad intellectual property estate that includes numerous patent families covering key aspects of our Integrated Drug Creation platform and internally developed programs which is intended to provide multiple layers of protection. These patent families encompass filings covering AI-guided drug design and discovery, internally developed programs (such as composition of matter, method of use etc.), and technology relevant to our proprietary assays, cell lines and expression technology. Overall, our intellectual property estate includes 69 issued or granted patents and 53 pending patent applications worldwide, which includes 12 issued U.S. patents and 20 pending regular U.S. patent applications. We also have granted patents in the EU, Australia, Japan, Canada, China, Hong Kong, Israel, Mexico and South Korea, as well as other countries. Our patents and patent applications, if issued, are expected to expire between August 2033 and December 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.

As of December 31, 2025, we owned registered trademarks and service marks to Absci’s stylized A logo, Absci®, SoluPro®, Bionic SoluPro®, and Unlimit with us® (design). We also use various other trademarks, service marks and trade names in our business, including but not limited to, the Absci AI logo mark, IgDesign, Translating Ideas into Drugs, Integrated Drug Creation, Creating drugs at the speed of Ai, and Denovium.

In addition to patent and trademark protection, we also utilize other forms of intellectual property protection, including copyright, internal know-how and trade secrets, when such other forms are better suited to protect a particular aspect of our intellectual property position. For example, our trade secrets encompass certain algorithms associated with our AI-guided drug creation deep learning AI models, our computational antibody and target discovery technology, manufacturing protocols for our E. coli SoluPro strains, libraries of protein folding solutions and design of molecular libraries for drug discovery. We believe our proprietary rights are strengthened by our comprehensive approach to intellectual property protection. It is our policy to require our employees, consultants, advisors and other independent contractors to execute confidentiality and invention assignment agreements upon accepting employment, consulting or similar relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. We also take precautions through the use of security measures to prevent the release of our proprietary information to third parties.

Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees, consultants, advisors and other independent contractors, these agreements may be breached and we may not have adequate remedies for any breach. In addition, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. As a result, we may not be able to

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meaningfully protect our trade secrets and other proprietary technology. For a discussion of the risks we face relating to intellectual property, see “Risk Factors—Risks Related to our Intellectual Property.”

Environmental, Social and Governance (ESG)

We are integrating ESG considerations into our business strategy as we continue to grow. The Nominating and Corporate Governance Committee of the Board (the “Committee”) oversees and coordinates with the Board and its other committees the periodic review of corporate responsibility and ESG matters pertaining to the Company, which may include the evaluation of industry practices, investor views, reputational impact, legal standards, and overall risks and benefits of ESG initiatives, as well as public reporting on these matters.

Government Regulation

Regulations Related to the Discovery, Development, Approval and Commercialization of Biotherapeutics

Our focus is on the use of our Integrated Drug Creation platform to enable us and our partners to improve the speed and success of biologic product discovery and development efforts. As such, we are subject to a number of regulations, such as those governing our laboratory facilities as well as regulations that ordinarily apply to companies in the life sciences, biotechnology and pharmaceutical sectors and industries. We believe that the long-term success of our business depends, in part, on our, and our current or future partners’ ability to successfully develop and sell products identified and created through our platform technology.

Government authorities in the United States, at the federal, state and local level, and in the European Union and other countries and jurisdictions, extensively regulate, among other things, the research, clinical development, testing, manufacturing, quality control approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical products, including biological products such as those that we or our partners develop. The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. If we or our partners fail to comply with applicable laws or regulations at any time, we or our partners may become subject to administrative or judicial sanctions or other legal consequences, including among other things, restrictions on marketing or manufacturing, withdrawal of products, product recalls, fines, warning letters, untitled letters, clinical holds on clinical studies, refusal of the FDA to approve pending applications or supplements to approved applications, suspension or revocation of product approvals, product seizure or detention, refusal to permit the import or export of products, consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs, mandated modification of promotional materials, issuance of safety alerts, Dear Healthcare Provider letters, injunctions or the imposition of civil or criminal penalties.

We or our partners must obtain the requisite approvals from the applicable regulatory authority prior to the commencement of clinical studies or marketing of a biological product in those countries. The requirements and process governing the conduct of clinical trials, product licensing, coverage, pricing and reimbursement vary from country to country. In the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other federal, state, local and foreign statutes and regulations. The process required by the FDA before biologics may be marketed in the United States generally involves the following:

•completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s applicable good laboratory practices regulations (GLP);

•submission to the FDA of an application for an IND, which must become effective before clinical trials may begin;

•approval of the protocol and related documentation by an independent institutional review board (IRB), or ethics committee at each clinical site before each trial may be initiated;

•performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (GCPs), and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

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•preparation of and submission to the FDA of a biologics license application (BLA), for marketing approval that includes sufficient evidence of establishing the safety, purity, and potency of the proposed biological product for its intended indication, including from results of nonclinical testing and clinical trials;

•satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with current good manufacturing practices (cGMPs), to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

•potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

•review of the product candidate by an FDA advisory committee, where appropriate and if applicable;

•payment of user fees for FDA review of the BLA (unless a fee waiver applies); and

•FDA review and approval of the BLA, resulting in the licensure of the biological product for commercial marketing.

We intend to selectively create our own product candidates and to advance such product candidates to certain value inflection points, anywhere from preclinical validation through clinical development to clinical proof of concept in humans trials with requisite cGMP manufacturing scale-up.

Preclinical and Clinical Development

Before testing in humans, a product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to applicable federal/national, supranational, state and local level regulations and requirements, including GLP, requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND or to a foreign regulatory authority through a comparable application, such as a clinical trial application (CTA). An IND is a request for authorization from the FDA to administer an investigational new drug to humans. In the United States, an IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under written trial protocols detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

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For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

•Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

•Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

•Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and product labeling.

In some cases, the FDA may require, or firms may voluntarily pursue, post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators.

Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the biological product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP. To help reduce the risk of the introduction of adventitious agents with use of biological products, the Public Health Service Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the biologic, findings from animal or in vitro testing that suggest a significant risk for human subjects, and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The FDA, the sponsor or the IRB may suspend a clinical study at any time on various grounds, including a finding that the research patients or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the biological product candidate has been associated with unexpected serious harm to patients. Additionally, if the trial is being overseen by a data safety monitoring board or committee, this group may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or on other grounds, such as interim data suggesting a lack of efficacy.

Biologics License Application (BLA) Submission and Review

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product candidate for one or more indications. The BLA must include all relevant data available from preclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product

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candidate’s chemistry, manufacturing, controls, and proposed labeling, among other things. Under the Prescription Drug User Fee Act (PDUFA), as amended, each BLA must be accompanied by a significant application user fee to the FDA, unless a waiver or exemption applies, which is adjusted on an annual basis. The FDA has sixty days from the applicant’s submission of a BLA to either issue a refusal to file letter or accept the BLA for filing, indicating that it is sufficiently complete to permit substantive review. The FDA has substantial discretion in the approval process and may refuse to accept any application or decide that the data is insufficient for approval, and may require additional preclinical, clinical or other studies before it accepts the filing.

Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten months after it accepts the application for filing, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process may be significantly extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product candidate is safe, pure and potent for its intended use, and whether the facility in which it is manufactured, processed, packed or held meets standards designed to assure and preserve the product’s identity, safety, strength, quality, and purity. The FDA may convene an advisory committee, typically a panel that includes clinicians and other experts, to provide clinical insight on applications which present difficult questions of safety or efficacy and to review, evaluate and recommend whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA, the FDA will conduct a pre-approval inspection of the facility or facilities where the product is manufactured to determine whether the facilities comply with cGMPs. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically audit data from clinical trials to ensure compliance with GCPs. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A Complete Response Letter usually describes all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response Letter without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete Response Letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification, which may include the potential requirement for additional clinical studies and/or other significant and time-consuming requirements related to preclinical studies and manufacturing. If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, withdraw the application or request a hearing. Even if such data and information is submitted, the FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a product is granted, such approval will be granted for a particular indication(s) and may entail limitations on the indicated uses for which such product may be marketed. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval of the BLA on other changes to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-market testing or clinical trials and surveillance to monitor the effects of approved products. The FDA may also place other conditions on approvals including the requirement of a Risk Evaluation and Mitigation Strategy (REMS), to assure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as

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restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Expedited Development and Review Programs

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing new product candidates that meet certain criteria. Specifically, product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and nonclinical or clinical data demonstrate the potential to address areas of significant unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. A sponsor may request fast track designation of a product candidate concurrently with, or at any time after, submission of an IND, and the FDA must determine if the product candidate qualifies for such designation within 60 day of receipt of the sponsor’s request. The sponsor of a fast track product has opportunities for frequent interactions with the FDA review team during product development and, once a BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. A sponsor may request that a product candidate be designated as a breakthrough therapy concurrently with, or at any time after, the submission of an IND, and the FDA must determine if the product candidate qualifies for breakthrough therapy designation within 60 days of receipt of the sponsor’s request. The benefits of breakthrough therapy designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product, including involvement of senior managers and experienced review staff in a cross-disciplinary review.

Any marketing application for a product candidate submitted to the FDA for approval, including a product candidate with a fast track designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval. A product candidate is eligible for priority review if it has the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease or condition compared to available therapies. For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date. The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biological product designated for priority review in an effort to facilitate the review.

Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product candidate generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled

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post-marketing clinical trials to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), the FDA is permitted to require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Sponsors are also required to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a drug or indication approved under accelerated approval if, for example, the sponsor fails to conduct such studies in a timely manner and send the necessary updates to the FDA, or if a confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products being considered for accelerated approval, the FDA generally requires, unless the sponsor is otherwise informed by the agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval review period, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may grant orphan designation to a biological product candidate intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a product for this type of disease or condition will be recovered from sales in the United States for that product. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same approved use or indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or if the holder of the orphan exclusivity cannot assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan exclusivity does not prevent the FDA from approving a different product for the same disease or condition, or the same product for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

A designated orphan drug may not receive orphan exclusivity if it is approved for a use or indication that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Pediatric Trials and Exclusivity

Under the Pediatric Research Equity Act (PREA), a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA requires that a sponsor who is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan (PSP), within sixty days of an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data

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from pediatric studies along with supporting information. The FDA and the sponsor must reach agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers. Sponsors who conduct studies of their product candidate in children can be eligible for pediatric exclusivity. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which attaches to the twelve-year exclusivity period for reference biologics, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

Post-Approval Requirements

Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims or changes of the site of manufacture, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA.

The FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. Biological product manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain organizational, procedural and documentation requirements with respect to manufacturing and quality assurance activities. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. BLA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms, and, in certain circumstances, qualified suppliers to these firms. These firms and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them. Manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

a.restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

b.fines, warning or untitled letters or holds on post-approval clinical studies;

c.refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

d.product seizure or detention, or refusal of the FDA to permit the import or export of products;

e.consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

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f.mandated modification of promotional materials and labeling and the issuance of corrective information;

g.the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

h.injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biological products. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict a manufacturer’s communications on the subject of off-label use of their products.

U.S. Patent Term Restoration

Depending upon the timing, duration and specifics of the FDA approval of the use of our biological product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved biological product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. In addition, a patent can only be extended once and only for a single product. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we may intend to apply for restoration of patent term for one of our patents, if and as applicable, to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.

Biosimilars and Reference Product Exclusivity

The Affordable Care Act of 2010 (ACA) includes a subtitle called the Biologics Price Competition and Innovation Act (BPCIA), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. This amendment to the Public Health Service Act attempts to minimize duplicative testing. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. This does not include a supplement for the biological product or a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, unless that change is a modification to the structure of the biological product and such modification changes its safety, purity, or potency. During

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this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products.

Government Regulation Outside the United States

In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical studies or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical study application much like the IND prior to the commencement of human clinical studies.

The requirements and process governing the conduct of clinical studies, product licensing, pricing and reimbursement vary from country to country. If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

The requirements for conducting clinical trials in Australia, where we are conducting a Phase 1/2a clinical trial for ABS-201, are as follows:

Conducting clinical trials for therapeutic drug candidates in Australia is subject to regulation by Australian governmental entities. Approval for inclusion in the Australian Register of Therapeutic Goods (“ARTG”) is required before a pharmaceutical drug product may be marketed in Australia.

Typically, the process of obtaining approval of a new therapeutic drug product for inclusion in the ARTG requires compilation of clinical trial data. Clinical trials conducted using “unapproved therapeutic goods” in Australia, being those which have not yet been evaluated by the Therapeutic Goods Administration (“TGA”) for quality, safety and efficacy must occur pursuant to either the CTN or Clinical Trial Exemption (“CTX”), process.

The CTN process broadly involves: (i) completion of pre-clinical laboratory and animal testing; (ii) submission to a Human Research Ethics Committee (HREC) of all material relating to the clinical trial; (iii) final approval for the conduct of the clinical trial by the institution or organization at which the clinical trial will be conducted (Approving Authority), having due regard to the advice from the HREC; and (iv) notification of the clinical trial to the TGA.

The CTX process broadly involves: (i) submission of an application to conduct a clinical trial to the TGA for evaluation and comment; (ii) a sponsor cannot commence a CTX trial until written advice has been received from the TGA regarding the application and approval for the conduct of the trial has been obtained from an ethics committee and the institution at which the trial will be conducted; (iii) receipt of written advice from the TGA regarding the application; and (iv) receipt of approval for the conduct of the trial from an ethics committee and the institution.

In each case, it is required that: (i) adequate and well-controlled clinical trials demonstrate the quality, safety and efficacy of the therapeutic product; (ii) evidence is compiled which demonstrates that the manufacture of the therapeutic drug product complies with the principles of cGMP; (iii) manufacturing and clinical data is derived to submit to the Australian Committee on Prescription Medicines, which makes recommendations to the TGA as to whether or not to grant approval to include the therapeutic drug product in the ARTG; and (iv) an ultimate decision is made by the TGA whether to include the therapeutic drug product in the ARTG.

Pre-clinical studies include laboratory evaluation of the therapeutic drug product as well as animal studies to assess the potential safety and efficacy of the drug. The results of the pre-clinical studies form part of the materials submitted to the HREC in the case of a CTN trial and part of the application to the TGA in the case of a CTX trial.

Clinical trials involve administering the investigational product to healthy volunteers or patients under the supervision of a qualified principal investigator. The TGA has developed guidelines for a CTN. Under the CTN process, all material relating to the proposed trial is submitted directly to the HREC of each institution at

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which the trial is to be conducted. An HREC is an independent review committee set up under guidelines of the Australian National Health and Medical Research Council. The role of an HREC is to ensure the protection of rights, safety and wellbeing of human subjects involved in a clinical trial by, among other things, reviewing, approving and providing continuing review of trial protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The TGA is formally notified by submission of a CTN application but does not review the safety of the drug or any aspect of the proposed clinical trial. The approving authority of each institution gives the final approval for the conduct of the clinical trial, having due regard to advice from the HREC. Following approval, responsibility for all aspects of the trial conducted under a CTN application remains with the HREC of each investigator’s institution.

The standards for clinical research in Australia are set by the TGA and the National Health and Medical Research Council, and compliance with GCP is mandatory. Guidelines, such as those promulgated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), are required across all fields, including those related to pharmaceutical quality, nonclinical and clinical data requirements and study designs. The basic requirements for preclinical data to support a first-in-human study under ICH guidelines are applicable in Australia. Requirements related to adverse event reporting in Australia are similar to those required in other major jurisdictions.

Biopharmaceutical Coverage and Reimbursement

Patients in the United States and in other countries generally rely on third-party payors to cover and reimburse all or part of the costs associated with their treatment, including the cost of prescription drugs. Adequate coverage and reimbursement from governmental healthcare programs (such as Medicare and Medicaid) and commercial payors is important to the acceptance of any product we may commercialize.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for determining the reimbursement rate that the payor will pay once coverage is approved. Third-party payors increasingly challenge the prices charged for pharmaceuticals, examine medical necessity, and review cost-effectiveness, and may impose utilization management controls (such as formularies, prior authorization, step therapy, quantity limits, and site-of-care restrictions). Payors may limit coverage to narrower patient subpopulations than those included in a product’s approved labeling, or may not cover a product at all. Even if coverage is provided, reimbursement levels may not be sufficient to support pricing levels necessary to achieve a reasonable return on investment, and net prices may be reduced by mandatory discounts, rebates, or other pricing concessions required by government healthcare programs or demanded by private payors.

In the United States, reimbursement decisions for new drugs are often influenced by the Centers for Medicare & Medicaid Services (“CMS”), and private payors may follow CMS coverage and payment policies to a substantial degree. Outside the United States, pricing and reimbursement of prescription pharmaceuticals are subject to government control in many countries, and there can be no assurance that favorable coverage and reimbursement levels will be available for any product we may develop.

Healthcare Laws and Regulations

Biopharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. These laws and regulations may constrain the business and financial arrangements and relationships through which we conduct our operations, including our relationships with our partners, customers, healthcare providers, and third-party payors. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, and transparency laws and regulations (including laws and regulations related to drug pricing and reimbursement; payments and other transfers of value to physicians and other healthcare providers; and, to the extent applicable, patient privacy and data protection and anti-bribery requirements). If our operations or those of our partners, vendors, service providers, collaborators, or other third parties with whom we do business are found to be in violation of any of such laws or any other governmental regulations that apply, by extension, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and responsible individuals may be subject to imprisonment, any of which could adversely affect our business, financial condition, results of operations, and prospects.

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Additional Regulations

In addition to the foregoing, state and federal U.S. laws regarding environmental protection and hazardous substances affect our business. These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business. We cannot predict, however, how changes in these laws may affect our future operations.

Healthcare Reform

Payors, whether domestic or foreign, governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to obtain coverage and adequate reimbursement for our products, if approved, and to sell them profitably. In particular, in 2010, the ACA was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (later increased to 70%, effective as of January 1, 2019, and subsequently replaced altogether by the Manufacturer Discount Program implemented by the Inflation Reduction Act of 2022 (IRA)) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s comparative effectiveness research.

The IRA also enacted significant changes intended to reduce prescription drug spending and beneficiary out-of-pocket costs, including redesigning the Medicare Part D benefit beginning in 2025 (including a lower annual out-of-pocket threshold), replacing the prior coverage gap discount framework with a new Part D Manufacturer Discount Program, requiring inflation-based rebates in certain contexts, and establishing a Medicare Drug Price Negotiation Program that permits CMS to set a “maximum fair price” for certain qualifying single-source drugs and biologics reimbursed under Medicare Part B and/or Part D. Subsequent legislation has further modified the Medicare negotiation framework. For example, the One Big Beautiful Bill Act of 2025 (“OBBBA”) expanded the scope of the orphan drug exclusion from Medicare price negotiation beginning with the initial price applicability year 2028, which may affect which products are eligible for negotiation and when, and it also included significant Medicaid-related changes (including provisions addressing eligibility processes and work requirements) that could place increased pressure on state Medicaid budgets and, in turn, utilization and reimbursement dynamics for prescription drugs.

Furthermore the IRA also allows for the Centers for Medicare & Medicaid Services to negotiate maximum prices for certain single-source drugs and biotherapeutics reimbursed under Medicare Part B and Part D, and makes other changes that affect manufacturer discount and rebate obligations and the Medicare Part D benefit design over time.

In addition, executive actions and proposed regulatory initiatives in 2025 and beyond have focused on further reducing prescription drug prices, including through “most-favored-nation” (“MFN”) pricing concepts and changes to distribution and purchasing models. CMS and its Innovation Center have also proposed and/or described MFN-based or international benchmark-based demonstration approaches for Medicare Part B and Part D (including the “GLOBE” model and related proposals), which, if implemented, could affect manufacturer rebate obligations and pricing and reimbursement dynamics for covered drugs.

Even where reforms are targeted to government programs, payors often look to Medicare coverage and payment policy as a reference point, and changes in government reimbursement or pricing dynamics can influence commercial reimbursement levels and contracting expectations. In addition, federal and state policymakers continue to consider and implement measures intended to increase pricing transparency, limit

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patient out-of-pocket costs, encourage substitution or the use of lower-cost alternatives, regulate or restrict certain manufacturer support programs, and otherwise reduce drug spending, including through proposals to establish most-favored-nation-based pricing in the United States.

Outside the United States, many jurisdictions impose price controls, reference pricing, health technology assessments, and other market-access requirements, and may delay or limit reimbursement or constrain permissible pricing. We cannot predict the likelihood, nature, timing, or extent of future healthcare reform initiatives; however, ongoing reforms and cost-containment measures could materially adversely affect the pricing, coverage, reimbursement, and commercial viability of any products we may develop.

Anti-Corruption Laws

We are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended (FCPA), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities, such as the UK Bribery Act 2010 and the UK Proceeds of Crime Act 2002 (Anti-Corruption Laws). Among other matters, such Anti-Corruption Laws prohibit corporations and individuals from directly or indirectly paying, offering to pay or authorizing the payment of money or anything of value to any foreign government official, government staff member, political party or political candidate, or certain other persons, in order to obtain, retain or direct business, regulatory approvals or some other advantage in an improper manner. We can also be held liable for the acts of our third party agents under the FCPA, the UK Bribery Act 2010 and possibly other Anti-Corruption Laws. In the healthcare sector, anti-corruption risk can also arise in the context of improper interactions with doctors, key opinion leaders and other healthcare professionals who work for state-affiliated hospitals, research institutions or other organizations.

Human Capital

Our employees, who we refer to as “Unlimiters”, are essential to our ability to achieve our mission to design differentiated antibody-based therapeutics.

Our corporate values guide both our daily decision-making and our long-term cultural development, setting the tone for how we work together with a focus on respect for patients, diversity, and community:

•We believe in the impossible

•We are one team with one finish line

•We deliver results

•We innovate because lives depend on it

•We embrace our differences

•We do the right thing

We have integrated our values into our people processes, including the candidate selection and employee promotion processes, performance management, and recognition. Incorporating these values into our culture enables our people to translate ideas into impact as we strive to create a better, faster path to new medicines. Collectively and individually we are defying conventions and disrupting the biopharmaceutical industry with bold ideas and passionate pursuit of new possibilities.

As of December 31, 2025, we had 140 employees, many of whom have advanced post-graduate degrees, primarily engaged in research and development and general and administrative functions.

To facilitate talent attraction and retention, we strive to make Absci an inclusive, safe, and attractive workplace with opportunities to grow, develop, and connect, supported by competitive compensation and benefits, as well as social, community, health and well-being programs.

Compensation and benefits: Our compensation philosophy is designed to establish and maintain a fair and flexible compensation program that attracts and rewards talented individuals who possess the skills necessary to support our mission, drive achievement of company and individual goals and create long-term value for our stockholders. We provide employees with competitive cash compensation, an all employee equity program, and a wide range of benefits. Our short-term incentive or cash bonus program is designed to recognize and reward achievement of company goals and individual performance. Individual performance is

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measured by delivery of results and impact and demonstration of our corporate values. The principal purposes of our equity plans are to attract, retain, and motivate employees, consultants and directors through the granting of stock-based compensation awards that align the interests of our employees with our stockholders. All full-time employees receive an equity grant upon hire and are eligible for annual equity grants thereafter. Our employee benefits may vary by country and generally include an employee stock purchase plan, healthcare benefits for employees and their families, life and disability insurance, unlimited vacation, parental leave, retirement contributions, referral bonuses, access to mental health resources, wellness programs, and onsite services;

Training and development: We offer a number of educational resources and development opportunities with emphasis on internal mobility and fair and equitable talent practices. Employees take advantage of live courses, leadership programs, online training, team building events, seminars, conferences, lectures, university programs, peer-to-peer and leadership-guided training, and other learning opportunities across the company. All Unlimiters are eligible for an annual monetary stipend for continuing education and career development. Additionally, we have a paid internship program that offers university or graduate students real-world experience and the chance to work with our extraordinary people, while helping Absci identify and develop the next generation of Unlimiters.

Ethics and compliance: We have adopted and regularly review the Code of Business Conduct and Ethics (the Code) to aid our directors, officers and employees in making ethical and legal decisions when conducting business and performing day-to-day duties. All directors, officers and employees are required to review and sign an acknowledgment regarding the Code and to agree on an annual basis to comply with the Code. We have established a reporting hotline and web form that enables employees to anonymously report any suspected violations of the Code, and we have a strict non-retaliation policy for all claims brought forward in good faith.

Communication and employee engagement: We employ a variety of tools to facilitate open and direct communication including open forums with executives, employee surveys and engagement through company- and employee-led groups and committees. Our campuses are intentionally designed to create a space for collaboration and connection. We hold company wide meetings monthly and regularly schedule time for our colleagues to connect. We appraise and refine our employee programs through our company pulse surveys. Our annual employee engagement survey process utilizes a third-party survey tool, and we supplement this process with periodic pulse surveys to help us gauge ongoing progress and employee sentiment. The senior leadership team continues to identify key initiatives that tie directly back to employee feedback to further increase employee engagement.

Diversity, equity, inclusion and belonging (DEIB): Our vision is to deliver breakthrough therapeutics that address areas of significant unmet medical needs for broad and diverse patient populations. Achieving that vision isn’t possible unless we have a diverse and talented team and unless we live in a diverse and equitable world, where everyone can benefit from the potentially life-changing therapeutics we’re creating. We are committed to building a team with a variety of backgrounds, skills and perspectives. We believe that inclusiveness helps drive innovation and increases our understanding of the diverse group of patients we seek to benefit.

Health, safety, well-being: We are committed to promoting the health, safety, and well-being of our employees. Our Employee Safety Committee is comprised of cross-departmental members and meets regularly to review workplace safety and adherence to safety policies. We require annual workplace safety training to reinforce workplace safety procedures that may be useful in the event of emergency situations and to assist our employees in helping to prevent workplace accidents. We have numerous employees with current first aid, CPR, and AED certifications for emergency preparedness.

Corporate Information

We were originally formed in August 2011 as an Oregon limited liability company and later converted into a Delaware limited liability company in April 2016 under the name AbSci LLC. In October 2020, we completed a reorganization whereby we were converted from a Delaware limited liability company named AbSci LLC to a Delaware corporation under the name Absci Corporation.

Our principal executive offices are located at 18105 SE Mill Plain Boulevard, Vancouver, Washington 98683. Our telephone number is (360) 949-1041. Our website address is https://www.absci.com/. Information contained on, or that can be accessed through, our website should not be considered to be part of this Annual Report.

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You are advised to read this Annual Report in conjunction with other reports and documents that we file from time to time with the SEC. In particular, please read our Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K that we may file from time to time. You may obtain copies of these reports directly from us or from the SEC. In addition, the SEC maintains information for electronic filers (including Absci Corporation) at its website at www.sec.gov. We make our periodic and current reports available on our internet website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

Available information

Our Annual Reports on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K, proxy and information statements and amendments to reports filed pursuant to Sections 13(a), and 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act), are filed with the SEC. We are subject to the informational requirements of the Exchange Act and file or furnish reports, proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. Such documents and other information filed by us with the SEC are available free of charge on our investor relations website (https://investors.absci.com/) when such reports are available on the SEC’s website.

Investors and others should note that we may announce material information to the public through filings with the SEC, on our investor relations website (https://investors.absci.com/), press releases, public conference calls, and public webcasts. We encourage our investors and others to review the information disclosed through such channels as such information could be deemed to be material information. Please note that this list may be updated from time to time.