8-K: Absci Reports Positive ABS-101 Primate Study Results and New Cancer Center Collaboration

Absci Corporation announced positive results from non-human primate studies for its lead drug candidate, ABS-101, and a new collaboration with Memorial Sloan Kettering Cancer Center.

Summary

• Absci Corporation has released its second quarter 2024 financial results and provided business updates.
• The company reported revenue of $1.3 million for the quarter, a decrease from $3.4 million in the same period last year.
• Research and development expenses increased to $15.3 million, up from $12.1 million year-over-year, due to increased lab operations and IND-enabling studies for ABS-101.
• Net loss for the quarter was $24.8 million, an improvement from a $41.7 million loss in the same quarter of 2023, which included a non-cash goodwill impairment charge.
• Cash, cash equivalents, and short-term investments totaled $145.2 million as of June 30, 2024, down from $161.5 million at the end of the previous quarter.
• Absci announced positive results from non-human primate studies for ABS-101, showing a 2-3x extended half-life compared to other antibodies in clinical development.
• The company also entered into a collaboration with Memorial Sloan Kettering Cancer Center to co-develop up to six novel oncology therapeutics.
• Absci anticipates initiating Phase 1 clinical studies for ABS-101 in early 2025, with an interim data readout expected in the second half of 2025.
• The company expects to select a development candidate for ABS-201 in the second half of 2024 and complete mode-of-action validation studies for ABS-301 in the same period.
• Absci expects a gross use of cash of approximately $80 million for the fiscal year ending December 31, 2024, and believes its current cash will fund operations into the first half of 2027.

Sentiment

Score: 7

Explanation: The document presents a mix of positive and negative information. The positive highlights include the promising ABS-101 results and the new collaboration, while the negative aspects include decreased revenue and increased R&D expenses. Overall, the sentiment is moderately positive due to the potential of the technology and the progress in the pipeline.

Positives

• The non-human primate study results for ABS-101 are very promising, showing a significant extension in half-life.
• The collaboration with Memorial Sloan Kettering Cancer Center is a significant partnership for Absci.
• The company is making progress on its internal pipeline programs, with key milestones expected in the near term.
• Absci has a strong cash position that is expected to fund operations into the first half of 2027.
• The ability to formulate ABS-101 at a high concentration supports the development of a subcutaneous formulation.

Negatives

• Revenue decreased to $1.3 million for the quarter, down from $3.4 million in the same period last year.
• Research and development expenses increased to $15.3 million, up from $12.1 million year-over-year.
• The company experienced a net loss of $24.8 million for the quarter, although this is an improvement from the previous year due to a one-off goodwill impairment charge in 2023.
• Cash reserves decreased from $161.5 million to $145.2 million in the quarter.

Risks

• The company's success is dependent on the successful development and commercialization of its drug candidates.
• Clinical trials may not replicate the positive results observed in preclinical studies.
• Absci relies on third parties for manufacturing and supply of its product candidates.
• The company's partnerships may not be successful, and partners may not pursue development and commercialization of programs.
• Market conditions and regulatory developments could impact the company's activities.

Future Outlook

Absci anticipates initiating Phase 1 clinical studies for ABS-101 in early 2025 and expects to select a development candidate for ABS-201 and complete mode-of-action validation studies for ABS-301 in the second half of 2024. The company believes its current cash will fund operations into the first half of 2027.

Management Comments

• Sean McClain, Founder and CEO, stated that recent achievements demonstrate solid execution across all aspects of the business.
• Sean McClain highlighted the importance of the new results for ABS-101 and the addition of Memorial Sloan Kettering as a collaborator.

Industry Context

Absci's focus on generative AI for drug creation aligns with the growing trend of using AI to accelerate drug discovery and development. The collaboration with a major cancer center like Memorial Sloan Kettering highlights the increasing interest in AI-driven approaches for oncology therapeutics.

Comparison to Industry Standards

• The 2-3x extended half-life of ABS-101 in non-human primates is a significant improvement compared to other anti-TL1A antibodies in clinical development, such as those from Merck (MK-7240), Roche (RVT-3101), and Sanofi (TEV-48574).
• The ability to formulate ABS-101 at a high concentration of 200 mg/mL is a positive development, as it supports the development of a subcutaneous formulation, which is generally preferred over intravenous administration.
• Absci's timeline of approximately 2 years and $14-16M from target to IND is a significant reduction compared to industry estimates, which typically range from 5-7 years and $50-100M.
• The company's use of AI for de novo antibody design and multi-parametric optimization is a novel approach that could lead to differentiated therapeutics with improved properties.

Stakeholder Impact

• Shareholders may react positively to the promising ABS-101 results and the new collaboration.
• Employees may be motivated by the progress in the pipeline and the company's growth.
• Customers and partners may be interested in the potential of Absci's technology and its ability to create differentiated therapeutics.
• Suppliers and creditors may view the company's strong cash position as a positive sign.

Next Steps

• Absci will continue to advance ABS-101 through IND-enabling studies.
• The company will select a development candidate for ABS-201 in the second half of 2024.
• Absci will complete mode-of-action validation studies for ABS-301 in the second half of 2024.
• The company will initiate Phase 1 clinical studies for ABS-101 in early 2025.
• Absci will continue to pursue drug creation partnerships.

Key Dates

Keywords

Generative AI, Drug Creation, Antibody Therapeutics, ABS-101, Oncology, Clinical Trials, Biologics, Partnerships, Half-life, Subcutaneous Formulation