Company Description
Shattuck Labs, Inc. (NASDAQ: STTK) is a clinical-stage biotechnology company focused on the development of potential treatments for autoimmune, inflammatory, and other immune‑mediated diseases. The company describes itself as pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors, with a particular emphasis on the Death Receptor 3 (DR3)/TL1A pathway that has been clinically validated in inflammatory bowel disease (IBD).
According to Shattuck, its work centers on protein engineering and the creation of TNF receptor agonist and antagonist therapeutics. This expertise is reflected in its lead program, SL‑325, which the company characterizes as a potentially first‑in‑class DR3 antagonist (blocking) antibody. SL‑325 is designed to achieve a complete and durable blockade of the DR3/TL1A pathway, which Shattuck views as a key mechanism in IBD and other inflammatory and immune‑mediated or autoimmune diseases.
Core Program: SL‑325 and the DR3/TL1A Pathway
Shattuck reports that SL‑325 is a fully Fc‑silenced humanized immunoglobulin G monoclonal antibody. In preclinical studies described by the company, SL‑325 demonstrated high‑affinity binding to human DR3 and potent inhibition of TL1A binding to DR3. Shattuck also notes a favorable safety profile in non‑human primate studies and indicates that SL‑325 has been evaluated in GLP toxicology studies.
The company states that SL‑325 is being developed as a potential treatment for inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis as referenced in its private placement announcement, as well as other inflammatory and immune‑mediated or autoimmune diseases. Shattuck highlights that SL‑325 is intended to provide a more complete blockade of the DR3/TL1A pathway than approaches that target TL1A alone.
In multiple press releases, Shattuck describes SL‑325 as the first DR3 blocking antibody to enter clinical development and notes that it is being studied in a Phase 1 clinical trial in healthy volunteers. The Phase 1 trial is described as assessing safety, tolerability, immunogenicity, and pharmacokinetics, and is intended to determine a recommended Phase 2 dose and dosing schedule.
Scientific Rationale and Preclinical Insights
Shattuck’s communications emphasize a data‑driven rationale for targeting DR3 rather than its ligand, TL1A. The company reports that preclinical studies of SL‑325 show high‑affinity binding and superior activity over TL1A antibodies. It further notes that targeting the TNF receptor DR3, instead of TL1A, may avoid immune complex formation and stabilization of TL1A, which Shattuck suggests could influence immunogenicity profiles.
In preclinical work presented by the company, SL‑325 is described as having no evidence of residual agonism, full receptor occupancy at certain dose levels in non‑human primates, and durable receptor occupancy over several weeks. Shattuck also notes that no infusion‑related reactions were observed in those non‑human primate studies and that clinical pathology, gross pathology, and histopathology assessments were favorable at the evaluated doses.
Pipeline Beyond the Lead Candidate
Beyond SL‑325, Shattuck states that it is advancing multiple preclinical DR3‑based bispecific antibodies. These candidates are described as being designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with IBD. The company has indicated in several press releases that it continues to make progress in preclinical development of these bispecific antibodies and has discussed plans to nominate a lead bispecific candidate from its preclinical pipeline.
Shattuck has also referenced SL‑425 in prior descriptions as a half‑life extended version of SL‑325 and has mentioned multiple other preclinical DR3‑based bispecific antibodies in the context of IBD and related inflammatory conditions. These programs are positioned by the company as extensions of its DR3‑focused platform and its broader work in TNF receptor therapeutics.
Clinical‑Stage Status and Regulatory Milestones
Shattuck characterizes itself as a clinical‑stage biotechnology company. The company has announced the submission and effect of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for SL‑325 for the treatment of IBD. It has also reported the dosing of the first participants in a Phase 1 clinical trial of SL‑325 in healthy volunteers and has described the trial as including single‑ascending dose (SAD) and multiple‑ascending dose (MAD) components.
In its public updates, Shattuck links these clinical milestones to its strategy of generating data to support SL‑325 as a potentially first‑in‑class DR3 blocking antibody. The company’s disclosures also connect its clinical plans with its financing activities, noting that proceeds from private placements are expected to support advancement of SL‑325 through Phase 1 and into planned Phase 2 trials in IBD and potentially other autoimmune or inflammatory diseases.
Corporate and Capital Markets Profile
Shattuck Labs, Inc. is incorporated in Delaware and lists its common stock on The Nasdaq Global Select Market under the ticker symbol STTK, as confirmed in multiple Form 8‑K filings. Those filings also identify the company’s principal executive offices as being located in Austin, Texas, and the company states in its press releases that it has offices in both Austin, Texas and Durham, North Carolina.
The company has used private placements and other equity financings to support its research and development programs. For example, Shattuck has announced a private placement of up to approximately $103 million in gross proceeds, led by institutional investors, with associated common stock and warrant structures. The company has also disclosed inducement equity awards granted under Nasdaq Listing Rule 5635(c)(4) in connection with new hires, reflecting its use of equity‑based compensation as part of its employment and governance practices.
Focus on Autoimmune and Inflammatory Diseases
Across its press releases, Shattuck consistently describes its therapeutic focus as autoimmune/inflammatory diseases and inflammatory and immune‑mediated diseases. Within this broad category, IBD is highlighted as a primary indication for SL‑325, with the company also referencing other inflammatory autoimmune diseases and autoimmune or inflammatory conditions as potential areas of interest.
The company’s participation in scientific and medical conferences, such as meetings focused on gastroenterology, inflammatory bowel disease, and immunology, aligns with this stated focus. Shattuck has reported presentations of preclinical data for SL‑325 at conferences including those organized by IBD‑focused foundations and professional societies, as well as investor‑oriented healthcare conferences where it discusses its development plans and scientific rationale.
Engagement with the Scientific and Investment Communities
Shattuck’s news releases describe active engagement with both scientific and financial audiences. The company has participated in key opinion leader (KOL) panels on DR3/TL1A biology and IBD, investor conferences hosted by healthcare‑focused banks and research firms, and scientific meetings where it presents preclinical data on SL‑325 and its DR3‑based platform.
Through these activities, Shattuck communicates its development strategy, the mechanistic basis for targeting DR3, and the status of its clinical and preclinical programs. The company also uses periodic financial results announcements, furnished to the U.S. Securities and Exchange Commission (SEC) via Form 8‑K, to summarize its cash position, research and development spending, and expectations about how long its capital resources may support its operations, while noting that such expectations are subject to risks and uncertainties as described in its SEC filings.
Regulatory Filings and Governance
Shattuck Labs files periodic and current reports with the SEC, including Form 8‑K reports that disclose material events such as private placements, changes to the Board of Directors, and financial results. For example, the company has reported the appointment of new directors associated with a significant private placement, as well as the resignations of certain other directors and the resulting changes in board composition.
These filings also confirm the company’s listing status on The Nasdaq Global Select Market and provide details on securities such as common stock, pre‑funded warrants, and common warrants issued in connection with financings. Shattuck’s 8‑K and 8‑K/A filings further indicate that certain financial press releases are furnished, rather than filed, under SEC rules, which has implications for how those disclosures are incorporated into other regulatory documents.
Summary
In summary, Shattuck Labs, Inc. is a Nasdaq‑listed, clinical‑stage biotechnology company that focuses on autoimmune, inflammatory, and immune‑mediated diseases through the lens of TNF superfamily receptor biology. Its lead program, SL‑325, is described as a potentially first‑in‑class DR3 blocking antibody aimed at IBD and related conditions, supported by preclinical data and an ongoing Phase 1 clinical trial in healthy volunteers. The company complements this lead asset with preclinical DR3‑based bispecific antibody programs and uses equity financings and SEC‑registered securities to fund its research and development activities.