On March 27, 2025 Shattuck Labs, Inc. (Shattuck) (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, reported financial results for the fourth quarter and full year ended December 31, 2024 and provided recent business highlights (Press release, Shattuck Labs, MAR 27, 2025, View Source [SID1234651539]).

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"Shattuck made the difficult but appropriate decision to terminate our SL-172154 program in 2024, and rapidly transitioned to our potential first-in-class DR3 blocking antibody, SL-325," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In February, we presented preclinical results from our IND-enabling GLP toxicology study for SL-325 at ECCO, demonstrating differentiation from TL1A blocking monoclonal antibodies, along with a favorable safety profile, full receptor occupancy, and lack of DR3 agonism. Our encouraging preclinical data underscore SL-325’s potential for DR3 blockade to provide potentially best-in-class clinical remission rates for IBD patients. We are on track for an IND filing in the third quarter of this year and are excited to begin generating data with the first-ever DR3 blocking antibody to enter clinical trials. Shattuck remains well-positioned to fund operations and clinical development of SL-325 into 2027."

DR3 Program Development in 2025

•Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 antagonist antibody. SL-325 is a DR3 blocking antibody for the treatment of IBD and other inflammatory and immune-mediated diseases.
◦IND filing expected in the third quarter of 2025.
◦Phase 1 clinical trial will evaluate safety, tolerability, and pharmacokinetics, and determine the recommended Phase 2 dose and dosing schedule of SL-325, with complete enrollment expected in the second quarter of 2026.
•Shattuck continues to develop multiple preclinical DR3-based bispecific antibodies, which are designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with IBD. Shattuck plans to nominate a lead bispecific candidate from its preclinical pipeline in 2025.

Fourth Quarter 2024 Business Highlights and Other Recent Developments

DR3 Program Development
•Shattuck Labs participated in an oral presentation at ECCO in February 2025.
◦Preclinical studies of SL-325 in NHP demonstrated a favorable safety profile with no infusion-related reactions observed, no changes in clinical pathology parameters, gross pathology, or histopathology analysis, and a No Observed Adverse Effect Level determined to be 100mg/kg, the top administered dose;
◦Full receptor occupancy at 1 mg/kg or greater, durable for >28 days, no Treg expansion or activation of CD3 T cells observed; and •Differentiation from TL1A blocking monoclonal antibodies may yield a distinct profile for bispecific antibody development. Notably, by targeting DR3, immune complex formation and stabilization of TL1A is not expected with SL-325, which may improve the immunogenicity profile as compared to TL1A targeting agents and allow for the development of DR3-based bispecific antibodies. Durable blockade of constitutively expressed DR3 may translate to higher complete remission rates.
•Shattuck Labs presented a poster at the 2025 Crohn’s & Colitis Foundation Congress in February.
◦Data from in vitro preclinical development and characterization of SL-325 were presented.
◦SL-325 is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody that demonstrated high affinity binding to human DR3 and potent antagonistic properties with no evidence of residual agonism.
Upcoming Events
•Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website.
◦24th Annual Needham Virtual Healthcare Conference, April 7–10, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs, will participate in a presentation on April 9, 2025.

Fourth Quarter and Full-Year 2024 Financial Results

•Cash and Cash Equivalents and Investments: As of December 31, 2024, cash and cash equivalents and investments were approximately $73.0 million, as compared to $130.6 million as of December 31, 2023.

•Research and Development (R&D) Expenses: R&D expenses were $15.4 million for the quarter ended December 31, 2024, as compared to $15.2 million for the quarter ended December 31, 2023. R&D expenses for the year ended December 31, 2024 were $67.2 million, as compared to $74.3 million for the year ended December 31, 2023. This decrease for the full year was primarily driven by decreases in manufacturing costs associated with SL-172154 and research expenses associated with other research programs.
•General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the quarter ended December 31, 2024, as compared to $4.4 million for the quarter ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024 were $19.1 million, as compared to $19.3 million for the year ended December 31, 2023. This decrease for the full year was primarily the result of a decrease in insurance, software, and information technology costs.

•Net Loss: Net loss was $18.7 million for the quarter ended December 31, 2024, or $0.37 per basic and diluted share, as compared to a net loss of $17.7 million for the quarter ended December 31, 2023, or $0.41 per basic and diluted share. Net loss for the year ended December 31, 2024 was $75.4 million, or $1.49 per basic and diluted share, as compared to $87.3 million, or $2.05 per basic and diluted share, for the year ended December 31, 2023.

Financial Guidance

As of December 31, 2024, cash and cash equivalents and investments were approximately $73.0 million. Shattuck’s current cash and cash equivalents are expected to fund operations into 2027. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

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. SL-325 has completed a GLP toxicology study in non-human primates, with an IND filing expected in the third quarter of 2025.