FDA-Approved Shotok Labs: How Far Will They Go After Major Funding?

On September 2025, the U.S. Food and Drug Administration made the investigational new drug (IND) application for SL-325—Shattuck Labs’ DR3-blocking antibody candidate for inflammatory bowel disease—effective, authorizing its first human trials. In June 2024, the FDA granted orphan drug designation to SL-172154, the company’s acute myeloid leukemia (AML) candidate, qualifying it for development incentives such as market exclusivity and fee waivers upon approval. With the recent release of Phase 1 results for SL-325 and plans for subsequent studies and pipeline expansion, both programs are now firmly on the FDA regulatory track.

Shattuck Labs, headquartered in Austin, Texas, and Durham, North Carolina, is a clinical-stage biotech developing novel immunomodulatory antibodies, including DR3-blocking monoclonal antibodies and bispecifics targeting DR3 and the IL-23 receptor. Its Nasdaq-listed lead asset is SL-325 for inflammatory bowel disease, followed by SL-846, a dual DR3/IL-23R antibody, and SL-172154 for AML and myelodysplastic syndromes.

Recent company initiatives have focused on strengthening clinical validation and bolstering the balance sheet. On June 8, Shattuck reported that in a Phase 1 trial involving healthy volunteers, SL-325 demonstrated low immunogenicity, sustained DR3 blockade for over three months, and a favorable safety profile. The company now anticipates initiating a Phase 2b trial (RECEPTIVE-CD1) in Crohn’s disease patients in the third quarter of this year.

From a financial perspective, Shattuck disclosed on June 9 that the exercise of approximately 50.6 million common-share warrants issued in a private placement in August 2025 generated $54.9 million in proceeds. Combined with $90.4 million in cash and cash equivalents as of March 31, the company expects to fund operations through 2029. Also on June 9, an underwritten public offering of common stock and pre-funded warrants totaling $70.5 million closed on June 11. Form 4 filings on June 15 show that an Ovimed-affiliated fund participated by acquiring roughly 1,041,667 pre-funded warrants and 208,333 common shares, underscoring institutional confidence in Shattuck’s FDA-regulated pipeline and its financial runway.