Absci Announces Positive Interim Phase 1 Data from the HEADLINE™ Trial of ABS-201, a Novel Antibody Targeting the Prolactin Receptor (PRLR)

Study medication appears well tolerated, with favorable safety data across all blinded single ascending dose (SAD) cohorts

Estimated half-life of at least 65 days supports potential for ABS-201 targeted dosing interval of two or three injections over six-month period

First multiple ascending dose (MAD) of ABS-201 in cohort of androgenetic alopecia (AGA) participants has been initiated

Interim proof-of-concept data anticipated in the second half of 2026, with full proof-of-concept data in early 2027

VANCOUVER, Wash. and NEW YORK, June 24, 2026 — Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today reported positive interim Phase 1 data from its first-in-human trial of ABS-201, an investigational anti-prolactin receptor (PRLR) antibody.

“We are particularly encouraged by the emerging safety, pharmacokinetic, and immunogenicity profile observed to date," said Ransi Somaratne, MD, Chief Medical Officer of Absci. "We look forward to further characterizing ABS-201’s clinical profile and potential in the ongoing MAD portion of the HEADLINE trial for AGA, and to initiating a Phase 2 trial for endometriosis later this year.”

Key Phase 1 Interim Findings

The ABS-201 Phase 1 trial (NCT07317544) is an ongoing, first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate the safety and pharmacokinetics (PK) of ABS-201 in healthy volunteers with and without androgenetic alopecia (AGA). These data comprise 32 healthy adult participants enrolled into four planned single ascending dose (SAD) cohorts. Dose levels evaluated were 150 mg, 450 mg, 900 mg and 1800 mg administered intravenously (IV). Interim blinded safety data from these cohorts as of the June 8, 2026 data cutoff are summarized below. Following review of blinded SAD safety and PK data by the trial’s Safety Review Committee, the study has advanced into the subcutaneous multiple ascending dose (MAD) portion in participants with AGA.

Safety: Blinded, aggregate interim data suggest study drug was well tolerated and exhibited a favorable safety and tolerability profile. No serious adverse events were reported as of the data cutoff date. All treatment-emergent adverse events (TEAEs) were mild in severity except for a single moderate TEAE (headache) in SAD cohort 3, which was assessed as unlikely related to study treatment. Treatment-related TEAEs were reported in 5 participants and were all mild. The most frequently reported TEAE across cohorts was headache (4 participants). The interim safety data as of the data cutoff date are summarized as follows.

Cohort

SAD 1

SAD 2

SAD 3

SAD 4

Dose (ABS-201 or matched placebo randomized 3:1)

150 mg IV or Placebo

450 mg IV or Placebo

900 mg IV or Placebo

1800 mg IV or Placebo

n=

8

8

8

8

At least one TEAE

4 (50%)

6 (75%)

4 (50%)

2 (25%)

At least one TESAE

0 (0%)

0 (0%)

0 (0%)

0 (0%)

At least one treatment-related TEAE****1

0 (0%)

2 (25%)

2 (25%)

1 (13%)

At least one moderate TEAE****2

0 (0%)

0 (0%)

1 (13%)

0 (0%)

1 Assessed as possibly/likely or definitely related to study treatment; all such events were mild in severity. 2 One case of headache (SAD 3 cohort), assessed as unlikely related to study treatment. TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event; IV = intravenous Q8W = once every 8 weeks. Percentages are based on the number of participants dosed (N) in each cohort.

PK: Based on available interim pharmacokinetic data across all four SAD cohorts, including Day 56 follow-up in the lower-dose cohorts, half-life for ABS-201 is estimated to be at least 65 days. These results support the potential for dosing two or three times over a six month period, pending confirmation through continued follow-up across all cohorts. The following graph depicts drug concentrations by dosing group over time.

Immunogenicity: No apparent impact of anti-drug antibodies (ADAs) on PK was observed based on interim data in the SAD cohorts.

About ABS-201 and Androgenetic Alopecia Androgenetic alopecia, commonly known as male-pattern or female-pattern hair loss, affects approximately 80 million Americans. The condition causes crown balding and receding hairlines in men, and progressive hair thinning in women. Currently, the only FDA-approved treatments – minoxidil and finasteride – show limited efficacy and notable side effects, leaving patients with limited therapeutic options.

ABS-201 represents a novel therapeutic approach targeting prolactin receptors to stimulate hair follicle regeneration and promote durable hair regrowth as demonstrated in in vivo studies. In preclinical studies, the antibody demonstrated statistically significant superior hair regrowth compared to minoxidil in a preclinical mouse model. Absci anticipates interim proof-of-concept data from its ongoing HEADLINE™ study in the second half of 2026, with full proof-of-concept data in early 2027.

About the ABS-201 HEADLINE Trial

The HEADLINE trial (NCT07317544) is a Phase 1/2a, randomized, double-blind, placebo-controlled, first-in-human trial evaluating the safety, tolerability, and preliminary proof-of-concept of an investigational treatment in participants with or without AGA. The trial is designed to enroll up to 227 healthy adult volunteers across SAD and MAD cohorts. In the SAD phase, participants received IV doses of 150 mg, 450 mg, 900 mg, or 1800 mg of ABS-201 or placebo. The MAD phase is evaluating doses of 300 mg, 600 mg, and 1200 mg SC (subcutaneous), or matching placebo. The primary endpoints are safety and tolerability. Secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, target area hair count (TAHC), target area hair width (TAHW), target area darkening/pigmentation (TAHD), and patient/investigator-reported outcomes. Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027.

About Absci Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci’s 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. Alongside collaborations with top pharmaceutical, biotech, tech, and academic leaders, Absci is advancing its own pipeline of AI designed therapeutics including ABS-201™, a novel approach in hair regrowth with the potential to redefine treatment possibilities for androgenetic alopecia, commonly known as male and female pattern hair-loss. ABS-201 is also being investigated as a potential “best-in-class” therapeutic for endometriosis, a condition with significant unmet medical need and market potential. Absci is headquartered in Vancouver, WA, with AI Research Labs in New York City and Serbia, and an Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube.

Absci® standard character mark, ABS-201™, and Integrated Drug Creation™ are trademarks and registered trademarks of Absci Corporation.

Investor Contact

Alexander D.H. Khan Corporate Vice President Head of Investor Relations investors@absci.com

Media Contact

press@absci.com

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