Absci Reports Business Updates and First Quarter 2025 Financial and Operating Results

Initiated dosing of participants in the first-in-human study of ABS-101 (anti-TL1A antibody), with interim data expected in the second half of 2025

ABS-201 (anti-PRLR) non-human primate (NHP) data demonstrate extended half life and high subcutaneous bioavailability; anticipate Phase 1 initiation in early 2026

Cash, cash equivalents, and short-term investments sufficient to fund operations into the first half of 2027

VANCOUVER, Wash. and NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative design, today reported financial and operating results for the quarter ended March 31, 2025.

"The initiation of our first-in-human study of ABS-101 officially marks Absci's transition to a clinical-stage biotech company, with ABS-201 also accelerating toward entering the clinic early next year," said Sean McClain, Founder and CEO. "As we continue to execute across our portfolio of wholly owned, partnered, and co-development programs, and with line of sight to additional new partnerships, I am excited for the pivotal updates we expect to share over the rest of this year, and beyond."

Recent Highlights

   -- Initiated dosing of participants in the first-in-human study of ABS-101, 
      a potential best-in-class anti-TL1A antibody. Absci expects to report 
      interim data from the ongoing study in the second half of 2025. 
 
   -- Released NHP data for ABS-201 (anti-PRLR) androgenetic alopecia program, 
      demonstrating: 
 
          -- Extended half life with potential to translate into Q8W-Q12W 
             dosing intervals in humans 
 
          -- High subcutaneous bioavailability in NHPs at greater than 90% 
 
          -- Excellent manufacturability and developability profile to 
             potentially enable future high concentration formulation of 
             greater than 150mg/mL 

Internal Pipeline Updates, Anticipated Program Progress, and 2025 Outlook

   -- ABS-101 (potential best-in-class anti-TL1A antibody): Today, Absci 
      announced that it has initiated dosing of participants in the 
      first-in-human study of ABS-101. The Phase 1 (ACTRN12625000212459p) 
      randomized, double-blind, placebo-controlled, first-in-human study of 
      single ascending doses of ABS-101 will evaluate safety, tolerability, 
      pharmacokinetics $(PK)$, and pharmacodynamics $(PD)$ in healthy volunteers. 
      The study is expected to enroll approximately 40 healthy adult 
      participants. The primary endpoint is safety and tolerability, with PK, 
      PD, and immunogenicity serving as secondary endpoints. The Phase 1 
      interim data readout is expected in the second half of 2025. 
 
   -- ABS-201 (potential best-in-class anti-PRLR antibody): ABS-201 is a 
      potential best-in-class anti-PRLR antibody in development for 
      androgenetic alopecia, an indication with significant unmet clinical need 
      and a large potential patient population of approximately 80 million 
      individuals in the U.S. alone. Absci has nominated a development 
      candidate with a preclinical profile suggesting high affinity and potency, 
      favorable safety and immunogenicity, extended half life for convenient 
      infrequent dosing, and excellent developability and manufacturability. 
      ABS-201 has the potential to offer a more efficacious and safe option as 
      compared to current standard of care, evidenced by a preclinical model 
      conducted for ABS-201 demonstrating improved hair regrowth compared to 
      minoxidil. Absci also today released results from its NHP study for 
      ABS-201, further supporting the program's potential to offer patients a 
      convenient, durable, efficacious treatment option for androgenetic 
      alopecia. Data from this study demonstrate extended half life and exhibit 
      potential to translate into Q8W-Q12W dosing intervals in humans. The 
      study also demonstrates high subcutaneous bioavailability of greater than 
      90% in NHPs, and the observed pharmacokinetic profile is projected to 
      result in substantial exposure at target organs (specifically skin and 
      hair follicles) at clinically relevant doses, which is expected to 
      translate into meaningful clinical efficacy. Additionally, ABS-201's 
      manufacturability and developability profile potentially enable a future 
      high concentration formulation of greater than 150 mg/mL. Absci 
      anticipates initiation of a Phase 1 clinical trial for ABS-201 in early 
      2026, with potential for an interim efficacy readout in the second half 
      of 2026. 
 
   -- ABS-301 (potential first-in-class antibody for undisclosed 
      immuno-oncology target): ABS-301 is a fully human antibody designed to 
      bind to a novel target discovered through Absci's Reverse Immunology 
      platform. Absci recently presented data for this program showing that 
      expression of ABS-301's target suggests broad potential in squamous cell 
      carcinomas and beyond. For this program, Absci has optimized an antibody 
      lead with high affinity and potency, and has successfully completed the 
      first in vivo target validation study. The findings from the study 
      demonstrate that signaling through the pathway drives a potent anti-tumor 
      response, providing strong rationale for advancing into in vivo efficacy 
      studies with ABS-301. These results support continued preclinical 
      development and further exploration of ABS-301's therapeutic potential. 
 
   -- ABS-501 (potential best-in-class novel AI-designed anti-HER2 antibody): 
      For this program, Absci has identified antibody leads using its zero-shot 
      de novo AI technology with the following characteristics: novel epitope 
      interactions, increased or equivalent affinity to trastuzumab in 
      preclinical settings, efficacious against a trastuzumab-resistant 
      xenograft tumor expressing wild-type HER2, and good developability. 
 
   -- Drug Creation Partnerships: Absci continues to make further progress on 
      its existing drug creation partnerships and anticipates signing one or 
      more partnerships, including with a Large Pharma company, in 2025. 

Absci continues to focus its investments and operations on advancing its internal pipeline of programs, alongside current and future partnered programs, while achieving ongoing platform improvements and operational efficiencies. Based on the company's current plans, Absci believes its existing cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the first half of 2027.

First Quarter 2025 Financial Results

Revenue was $1.2 million for the three months ended March 31, 2025 compared to $0.9 million for the three months ended March 31, 2024.

Research and development expenses were $16.4 million for the three months ended March 31, 2025 compared to $12.2 million for the three months ended March 31, 2024. This increase was primarily driven by advancement of Absci's internal programs, including direct costs associated with external preclinical development, and an increase in personnel costs and stock compensation expense.

Selling, general, and administrative expenses were $9.5 million for the three months ended March 31, 2025 compared to $8.7 million for the three months ended March 31, 2024. This increase was due to an increase in stock compensation expense.

Net loss was $26.3 million for the three months ended March 31, 2025, as compared to $22.0 million for the three months ended March 31, 2024.

Cash, cash equivalents, and short-term investments as of March 31, 2025 were $134.0 million, compared to $112.4 million as of December 31, 2024.

Webcast Information

Absci will host a conference call to discuss its first quarter 2025 business updates and financial and operating results on Tuesday, May 13, 2025 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. A webcast of the conference call can be accessed at investors.absci.com. The webcast will be archived and available for replay for at least 90 days after the event.

About Absci

Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation$(TM)$ 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. These include ABS-101, a potentially best-in-class antibody to treat inflammatory bowel disease $(IBD)$, as well as other indications, and ABS-201, a groundbreaking innovation in hair regrowth with the potential to redefine treatment possibilities for androgenetic alopecia, commonly known as male and female pattern baldness. Absci is headquartered in Vancouver, WA, with an AI Research Lab in New York City, and Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube.

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