Shattuck Labs Announces IND for SL-325 Is in Effect for the Treatment of Inflammatory Bowel Disease

Rhea-AI Summary

Shattuck Labs (NASDAQ: STTK) announced that its Investigational New Drug (IND) application for SL-325, a potentially first-in-class DR3 antagonist antibody for treating Inflammatory Bowel Disease (IBD), is now in effect with the FDA.

The company plans to initiate its Phase 1 clinical trial in Q3 2025, with expected completion in Q2 2026. The trial will be a randomized, double-blind, placebo-controlled study evaluating single and multiple ascending doses in healthy volunteers. The company's financial position is strengthened by cash reserves and anticipated proceeds of up to $103 million from a recent private placement, expected to fund operations into 2029.

Positive

• First-in-class DR3 blocking antibody advancing to human trials
• Strong financial position with funding secured until 2029
• Favorable safety profile demonstrated in non-human primate studies
• Potential $103 million additional funding from warrant exercise

Negative

• Phase 1 trial completion not expected until Q2 2026
• Early-stage clinical development with no proven efficacy in humans yet

– SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases –

– The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025 –

– Current cash and cash equivalents, plus the anticipated aggregate proceeds of up to $103 million from recent private placement, assuming full exercise of common stock warrants, expected to fund operations into 2029 –

AUSTIN, TX and DURHAM, NC, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, today announced that the Company’s Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) for SL-325 for the treatment of inflammatory bowel disease is in effect. SL-325, a potentially first-in-class DR3 blocking antibody, is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody, demonstrated high-affinity binding to human DR3 and potent inhibition of TL1A binding to DR3 in preclinical studies, and a favorable safety profile in non-human primate studies.

Dosing of the first participant is expected this quarter, and enrollment of the Phase 1 clinical trial is expected to be completed in the second quarter of 2026. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) trial in healthy volunteers evaluating safety, tolerability, and pharmacokinetics. Data from the trial will guide the doses and schedule for potential evaluation in Phase 2 clinical trials.

“An open IND marks a significant milestone as we continue to advance our lead asset, SL-325, and we are excited to begin collecting clinical data for the first DR3 blocking antibody tested in humans this quarter,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck.

About SL-325

SL-325 is a potential 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’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. Shattuck expects to commence a Phase 1 clinical trial in healthy volunteers in the third quarter of 2025.

About Shattuck Labs, Inc.

Shattuck Labs, Inc. (Nasdaq: STTK) is a biotechnology company specializing in the development of potential treatments for autoimmune/inflammatory diseases. The Company is developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (IBD) and other inflammatory autoimmune diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor agonist and antagonist therapeutics come together in its lead program, SL-325, a potential first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A pathway. The Company has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com. 

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Shattuck’s expectations regarding: the aggregate amount of proceeds to be received from the private placement, including whether the common stock warrants will be exercised and provide the Company with additional capital; the use of proceeds from the private placement; expectations regarding the timing for enrollment of and dosing of patients in the Phase 1 trial for SL-325; the anticipated timing for completion of the Phase 1 trial for SL-325; expectations regarding the results of the Phase 1 trial for SL-325; anticipated Phase 2 clinical trials for SL-325; and the time period over which our capital resources will be sufficient to fund the Company’s anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Shattuck’s filings with the Securities and Exchange Commission (SEC)), many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expected results of the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the Company’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; Shattuck’s expectations regarding the overall benefit of the strategic prioritization of its pipeline; liquidity and capital resources; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent disclosure documents filed with the SEC. The Company claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

Investor & Media Contact:
Conor Richardson
Vice President of Investor Relations
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com

FAQ

What is Shattuck Labs' (STTK) SL-325 drug candidate?

SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for treating Inflammatory Bowel Disease (IBD). It is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody that showed high-affinity binding to human DR3 in preclinical studies.

When will Shattuck Labs begin its Phase 1 trial for SL-325?

Shattuck Labs plans to dose the first participant in Q3 2025, with the Phase 1 trial expected to be completed in Q2 2026.

How long can Shattuck Labs fund its operations?

With current cash reserves and potential proceeds of up to $103 million from a recent private placement (assuming full warrant exercise), Shattuck Labs expects to fund operations into 2029.

What type of clinical trial is planned for SL-325?

The Phase 1 trial will be a randomized, double-blind, placebo-controlled study with single-ascending dose (SAD) and multiple-ascending dose (MAD) components in healthy volunteers, evaluating safety, tolerability, and pharmacokinetics.

What makes Shattuck Labs' SL-325 unique in IBD treatment?

SL-325 is potentially the first DR3 blocking antibody to be tested in humans, representing a novel approach to treating Inflammatory Bowel Disease and other inflammatory conditions.