Shattuck Labs Submits Investigational New Drug Application for SL-325

Shattuck Labs has confirmed that its Investigational New Drug Application (IND) for SL-325 is in effect. The biotechnology company is developing bi-functional fusion proteins for cancer and autoimmune disease treatment. Its lead product, SL-172154, is in a Phase IA/B clinical trial for acute myeloid leukemia and HR-MDS. The company has completed the Phase IA dose-escalation portion and is enrolling patients in the Phase IB expansion cohorts.

Shattuck Labs, Inc. (NASDAQ: STTK) has announced that its Investigational New Drug (IND) application for SL-325 has been successfully submitted and is expected to receive clearance from the U.S. Food & Drug Administration (FDA) in Q3 2025. The biotechnology company is making significant strides in its development of bi-functional fusion proteins for cancer and autoimmune disease treatment. SL-325 is a potentially first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway.

Shattuck Labs' lead product, SL-172154, is currently in a Phase IA/B clinical trial for acute myeloid leukemia and HR-MDS. The company has completed the Phase IA dose-escalation portion and is now enrolling patients in the Phase IB expansion cohorts. The company's recent financial results for the second quarter ended June 30, 2025, reflect a cash balance of approximately $50.5 million and aggregate proceeds from a recent oversubscribed private placement of up to $103 million, less offering expenses, expected to fund operations into 2029. This funding is crucial for Shattuck Labs to transition seamlessly into multiple Phase 2 clinical trials for its lead asset, SL-325, and other preclinical DR3-based bispecific antibodies.

Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs, stated, "The second quarter of 2025 was a productive period for Shattuck, as we prepared and successfully submitted an IND application to the U.S. Food & Drug Administration (FDA). We expect to begin enrollment in our Phase 1 clinical trial, subject to regulatory alignment, in healthy volunteers later this quarter, and to complete the trial during the second quarter of 2026."

The company's financial guidance indicates that as of June 30, 2025, cash and cash equivalents were approximately $50.5 million, which does not include the anticipated net proceeds from the private placement announced on August 5, 2025. The total anticipated proceeds from the oversubscribed private placement, combined with current cash and cash equivalents, are expected to fund operations into 2029. The closing of the private placement is contingent upon the IND clearance for SL-325 and the satisfaction of other customary closing conditions.

Shattuck Labs continues to develop multiple preclinical DR3-based bispecific antibodies, which are designed to inhibit both the DR3/TL1A axis and other biologically relevant targets for the treatment of patients with inflammatory bowel disease (IBD). The company plans to nominate a lead bispecific candidate from its preclinical pipeline in 2025.

References:
[1] https://www.biospace.com/press-releases/shattuck-labs-reports-second-quarter-2025-financial-results-and-recent-business-highlights