–   RECEPTIVE-HS1 Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS) expected to initiate in 2026; data from the 16-week treatment period expected in the first half of 2028   –

–   HS is the second Phase 2 indication for SL-325 and expands development beyond IBD   –

–   Announces appointment of Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development; Dr. Ravichandran to lead the HS clinical development program   –

–   Cash runway guidance remains unchanged, with existing cash expected to fund operations into 2029   – 

AUSTIN, TX and DURHAM, NC, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today announced its plans to evaluate SL-325 in a Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS).

“We are excited to see the recent clinical validation of the TL1A/DR3 axis in patients with moderate to severe HS. We expect, by targeting DR3 instead of TL1A, SL-325 may provide potentially best-in-mechanism efficacy in indications where the TL1A/DR3 axis is proven active. Only a few biologic therapies are available to patients with moderate to severe HS, and the emerging data support the potential for TL1A/DR3 blockade to provide best-in-disease efficacy,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We are also very pleased to welcome Dr. Shoba Ravichandran to the team as Senior Vice President, Clinical Development. Dr. Ravichandran’s deep clinical development experience, including leading Cosentyx to approval in HS, will be important in driving toward Phase 2b data for the RECEPTIVE-HS1 study in the first half of 2028.”

RECEPTIVE-HS1 Phase 2 Trial of SL-325 in Hidradenitis Suppurativa

The RECEPTIVE-HS1 study is designed as a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the efficacy and safety of two dose levels of SL-325 versus placebo in patients with moderate to severe HS. The trial will include a 16-week placebo-controlled treatment period followed by an extension period with SL-325 through Week 52.

• RECEPTIVE-HS1 is expected to enroll approximately 150 patients, randomized 1:1:1 to receive low dose SL-325, high dose SL-325, or placebo.
• The trial is expected to enroll patients with moderate to severe HS who have five or more abscesses and inflammatory nodules (AN count), no more than 20 draining tunnels, and Hurley stage II or III disease.
• The primary endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, defined as at least a 50% reduction in AN count, with no increase in abscess or draining tunnel counts relative to baseline.
• Key secondary endpoints include the proportion of patients achieving HiSCR75 at Week 16, as well as safety and tolerability.
• Patients randomized to the placebo arm for the initial 16-week treatment period may elect to receive SL-325 during the extension period.
• In addition to efficacy, the RECEPTIVE-HS1 study will further characterize the pharmacokinetics and immunogenicity of SL-325 in patients with HS.
• IND submission is expected in October 2026.
• Week 16 data for the primary and secondary endpoints are expected to be disclosed in the first half of 2028.
  
  

Appointment of Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development

Dr. Shoba Ravichandran joins Shattuck Labs as Senior Vice President, Clinical Development, and brings more than 20 years of drug development experience, including five successful major U.S. and global regulatory filings. She spent over a decade at Novartis, and in her most recent role as Senior Global Program Clinical Head, led the global approval of Cosentyx in HS and Phase 3 start-up activities for remibrutinib in HS.

Dr. Ravichandran commented, “I am delighted to join the Shattuck team and lead development of SL-325 in HS, a disease with very high unmet need and one where I believe SL-325 can be a differentiated and exciting future treatment option for patients.”

About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses and draining tunnels. The pathogenesis of HS is multifactorial and involves dysregulation of both innate and adaptive immune responses, including Th1- and Th17-associated inflammatory pathways. HS is estimated to affect approximately 1% of the global population, although prevalence estimates vary by geography and methodology. The disease can cause chronic pain, irreversible tissue damage and scarring, and can substantially impair quality of life. DR3 was shown to be highly expressed in HS lesions, and in greater abundance than TL1A. Importantly, the extent of DR3 expression was shown to correlate with the expression of other validated pathways in HS, including IL-17A, IL-17F, TNFα and IL-1R1, highlighting the therapeutic potential of targeting DR3.

About SL-325
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’s preclinical studies demonstrated high affinity binding and superior activity over TL1A antibodies, and provided a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is a fully Fc-silenced, fully human immunoglobulin G monoclonal antibody. In a Phase 1 clinical trial, SL-325 demonstrated a favorable safety profile, a potentially best-in-mechanism immunogenicity profile, no evidence of residual DR3 agonism, and provided durable blockade of TL1A binding to DR3 at low doses. SL-325 is being evaluated in a Phase 2 clinical trial in patients with Crohn’s disease, with data expected in the first half of 2028.

About Shattuck Labs, Inc.
Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially 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: plans for its preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of initiation and expected enrollment of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the anticipated timing of initiation and expected enrollment of a Phase 2 clinical trial of SL-325 in patients with hidradenitis suppurativa; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates; the anticipated timing of initiation of a Phase 1 clinical trial of SL-846; the clinical benefit, safety and tolerability of SL-846; the anticipated release of data from SL-846; the potential clinical significance of clinical and preclinical data and expectations regarding the time period over which the Company’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan,” “anticipate” 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 it 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 U.S. Securities and Exchange Commission (SEC)), many of which are beyond its control and subject to change. Actual results or outcomes, or the timing of actual results or outcomes, could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the Company’s preclinical studies, clinical trials and research and development programs, including the timing and costs thereof; the Company’s ability to enroll patients in its clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the Company’s ability to advance product candidates into, and successfully complete, nonclinical studies and clinical trials; the timing or likelihood of regulatory filings and approvals; the implementation of the Company’s business model, strategic plans for its business and product candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its technology; liquidity and capital resources, including the time period over which current capital resources are expected to the fund the Company’s operations; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC. Shattuck 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:
Andrew R. Neill
Chief Financial Officer
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com