Absci CEO Sean McClain

Absci says it is about a year away from its lead AI-designed therapeutic entering the clinic—one of several pipeline candidates whose development the company says it will be better able to fund after completing an oversubscribed $86.4 million public offering.

Absci will generate $80.8 million in net proceeds from the public offering, which began February 27 and ended Friday. The company offered 19.205 million shares at $4.50 a share—up 18% before Friday’s closing at $5.46. The offering included 2.505 million shares representing a full exercise of the 30-day option held by underwriters.

When combined with the $97.7 million in unrestricted cash, cash equivalents, and short-term investments reported as of December 31, 2023, Absci says it has enough capital to fund its operations into the first half of 2027.

Those operations will include further development of its Integrated Drug Creation™ platform and drug candidates generated through the platform—starting with ABS-101, which is designed to treat inflammatory bowel disease (IBD) by targeting tumor necrosis factor-like cytokine 1A (TL1A).

ABS-101 is in the candidate selection phase. Last month, Absci began IND-enabling studies for ABS-101, with the goal of evaluating some of the compound’s properties. Based on results from the IND-enabling studies, Absci plans to submit an IND to the FDA in the first quarter of next year, to be followed by the start of a Phase I clinical trial in the first half of 2025

“I’ve gotten some sage advice that you raise capital when it’s available, not when you need it. So, the capital was there. The momentum was there. We didn’t need to raise it. We’re opportunistic with raising the capital here, and it was 100% the right decision,” Absci CEO Sean McClain told GEN Edge.

Growing field targets TL1A

ABS-101 is one of several candidates in a growing field of drugs designed to target TL1A, a member of the tumor necrosis factor family that has been shown to be abnormally expressed in autoimmune diseases, including IBD, rheumatoid arthritis, psoriasis, primary biliary cirrhosis, systemic lupus erythematosus, and ankylosing spondylitis. Other such candidates include:

  • RVT-3101, Roche’s TL1A-directed antibody candidate being developed for IBD, including ulcerative colitis (UC) and Crohn’s disease (CD)
  • Tulisokibart (MK-7240), which is being developed by Merck & Co., for the treatment of immune-mediated diseases, including UC, CD, and other autoimmune conditions
  • Anti-TL1A (TEV-48574), a human IgG1 monoclonal antibody being developed for UC and CD

Roche assumed rights to develop, manufacture, and commercialize RVT-3101 in the United States and Japan last December when it completed an up-to-$7.25 billion acquisition of the drug’s original developer Telavant Holdings. Telavant was jointly formed by Roivant Sciences and Pfizer in 2022 to develop and commercialize RVT-3101 in the United States and Japan. Telavant was 25%-owned by Pfizer, which held commercialization rights to the drug outside of those countries and previously sought to develop RVT-3101 under the name PF-06480605.

RVT-3101 is under study in a Phase II trial in moderately to severely active CD (NCT05910528 ) that was active but not recruiting patients as of February 2, according to ClinicalTrials.gov.

Tulisokibart was originally developed as PRA-023 by Prometheus Biosciences, which Merck acquired last year for $10.8 billion. Merck first renamed the drug MK-7240, and last fall gave it its current name. Tulisokibart is in a Phase III trial in patients with moderately to severely active UC (MK-7240-001, NCT06052059), as well as a Phase II safety and efficacy study in patients With systemic sclerosis associated with interstitial lung disease (ATHENA-SSc-ILD or MK-7240-007, NCT05270668).

At the 42nd Annual J.P. Morgan Healthcare Conference in January, Absci presented preclinical data on ABS-101 showing it to have a potentially superior product profile compared to RVT-3101 and MK-7240 by demonstrating equal or superior potency data from multiple biophysical and cellular assays.

Three advanced lead versions of ABS-101 demonstrated high affinity, high potency, favorable developability, and extended half-life. In addition, using its de novo AI model, Absci designed ABS-101 toward a specific epitope with the aim of achieving superior potency and lower immunogenicity.

Potential quarterly dosing

The company expects those properties will enable ABS-101 to better stand out from the TL1A candidates of competitors—such as the potential for dosing every eight weeks, and potentially every three months.

“We introduced a half-life extension technology, and we showed in mouse PK (pharmacokinetic) studies that we have a superior half-life. And what this is going to enable us to do is be able to go from once monthly to likely once quarterly dosing,” McClain said.  “We do see this as being differentiated, and definitely a beneficial attribute to engineer in.”

Not compared in the JPM data was Sanofi/Teva’s Anti-TL1A, which is in a Phase IIb clinical trial (NCT05668013) designed to assess the efficacy and dose response of two different maintenance dose regimens of the drug subcutaneous, administered every four weeks (Q4W) in adults with moderate to severe UC and CD. The trial’s primary completion date is in February 2026.

At the 19th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO), held February 21–24 in Stockholm, Sweden, Teva presented positive safety, tolerability, and pharmacokinetic data for anti-TL1A showing rapid and sustained suppression of free TL1A, confirming the target engagement of the drug, as well as a well-tolerated safety profile in patients with asthma—results gathered from a Phase I study in healthy volunteers and patients with mild asthma, and a Phase II study in patients with severe asthma.

Teva says the data it presented at ECCO supported continued clinical investigation for moderate-to-severe IBD, including UC and CD.

Also in Absci’s pipeline are two preclinical candidates. One is ABS-201, a lead optimization phase drug to be developed for an undisclosed indication that according to the company has significant unmet need. Absci envisions ABS-021 as standing out as a potentially best-in-class drug showing high efficacy following once monthly or less frequent, low-volume, subcutaneous injection.

Also in Absci’s pipeline is ABS-301, which according to the company, is a potentially first-in-class immuno-oncology candidate in lead optimization phase, discovered through the company’s reverse immunology​ platform. ABS-301’s target is an immune evasion strategy to limit immune infiltration and turn tumors immunologically “cold.” Absci reasons that ABS-301 treatment in cancer may release immune suppression and permit immune cells to infiltrate the tumor, allowing for a robust anti-tumor response.

A fourth candidate disclosed by Absci at its inaugural R&D Day last fall, ABS-401, is no longer in development, with McClain saying that data proved disappointing. ABS-401 was a target evaluation phase candidate that was previously believed to hold potential in immune-mediated conditions such as psoriasis, where it could differentiate itself from other drugs by offering a treatment option in poorly served patient populations.

Asked whether Absci will work to develop another psoriasis candidate, McClain said: “We have new candidates that we have elected, and we eventually will talk about. We have not disclosed what indications or therapeutic areas we’re going to be focused on.”

16 programs

According to its prospectus, Absci has 16 active drug development programs in progress with various partners. Five of them are in development with PrecisionLife, a computational biology company focused on precision drugs for chronic diseases.

In December, Absci and PrecisionLife agreed to partner on discovering and developing biotherapeutics for up to five mutually agreed-upon targets and indications addressing unmet medical needs, then jointly evaluate options to most effectively advance those programs against their chosen targets. The companies did not disclose the value of their partnership.

Two additional active drug programs of Absci are partnered with Almirall. In November, the companies agreed to develop and commercialize AI-designed therapeutics for chronic and debilitating skin diseases, through a collaboration that could generate more than $650 million for Absci.

Also among Absci’s active drug program partners:

  • AstraZeneca—The biopharma giant has committed to join Absci in delivering an AI-designed antibody against an oncology target. AstraZeneca has agreed to pay Absci up to $247 million in upfront commitment, R&D funding, and milestone payments.
  • Merck—Four active programs in undisclosed therapeutic areas—one initiated in December 2019, the other three through an up to $610 million collaboration launched in January 2022.
  • Alpha Cancer Technologies—One active oncology program launched in August 2019.
  • SFJ Pharmaceuticals—One active hematology program launched in April 2019.
  • Undisclosed partners—Two active programs in undisclosed therapeutic areas, one launched in March 2023 and the other, in July 2023.

In the prospectus of its public offering, Absci acknowledged that it will finish 2024 in the red.

The company projected approximately $0.3 million in revenue for the first quarter and $5.7 million for all of 2024—while operating expenses are expected to range from $24 million to $26 million during Q1, and from $120 million to $122 million for all of this year. The expenses figures include a $21.3 million goodwill impairment that was recorded within operating expenses in the three months ending June 30, 2023.

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