Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2025

Rhea-AI Summary

Shattuck Labs (NASDAQ: STTK) provided a corporate update highlighting key milestones for 2025, focusing on their DR3 blocking antibody program, SL-325. The company plans to present preclinical data at upcoming scientific conferences and expects several significant developments, including:

- GLP toxicology study data readout in Q1 2025
- IND filing in Q3 2025
- Phase 1 clinical trial initiation in Q3 2025
- DR3 bispecific development candidate nomination in H2 2025

The company reports a strong financial position with $90.1 million in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations into 2027. Management expressed optimism about SL-325's potential to achieve complete blockade of the DR3/TL1A signaling pathway based on non-human primate studies.

Positive

• Strong cash position of $90.1 million as of September 30, 2024
• Runway extended into 2027, beyond Phase 1 trial results
• Clear development timeline for SL-325 with multiple catalysts in 2025

Negative

• None.

Insights

Financial Analyst

The corporate update reveals a solid financial foundation with $90.1 million in cash and investments, providing runway into 2027. This extended cash runway is particularly important as it covers the critical Phase 1 clinical trial period for SL-325, reducing the immediate risk of dilutive financing. The company's strategic resource allocation appears well-planned, though the current market cap of $57.8 million suggests the market is significantly discounting the company's assets and potential.

The DR3 program's progression towards clinical trials represents a significant value inflection point. The planned IND filing and Phase 1 initiation in Q3 2025 could catalyze stock movement, especially if preclinical data from GLP toxicology studies in Q1 2025 demonstrate favorable safety profiles.

Biotechnology Research Analyst

The development of SL-325 as a DR3 blocking antibody targeting the TNF superfamily represents a novel approach in inflammatory disease treatment. The upcoming data presentation at ECCO Congress is particularly significant as it will showcase the drug's potential superiority in achieving complete DR3/TL1A pathway blockade. For general understanding, think of this mechanism like a more effective 'off switch' for inflammatory signals that contribute to conditions like Crohn's disease.

The planned transition from preclinical to clinical phase in 2025 marks a important evolution in the company's pipeline. The sequential milestones - GLP toxicology data, IND filing and Phase 1 initiation - provide multiple catalysts for potential value creation. The addition of DR3 bispecific candidates in H2 2025 further strengthens the pipeline depth.

Market Research Analyst

This update positions Shattuck strategically in the competitive inflammatory disease therapeutics landscape. The company's presence at high-profile conferences, particularly the J.P. Morgan Healthcare Conference, provides important visibility to institutional investors. The oral presentation slot at ECCO Congress indicates strong scientific interest in their approach.

The extended cash runway into 2027 demonstrates prudent financial management and reduces near-term financing pressure. However, the current market cap suggests an opportunity for value appreciation if clinical milestones are met. The multiple data readouts and development milestones throughout 2025 create a steady news flow that could drive investor interest and potential stock price catalysts.

AUSTIN, TX and DURHAM, NC, Jan. 02, 2025 (GLOBE NEWSWIRE) -- 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-related diseases, today announced a corporate update and highlighted upcoming key milestones anticipated in 2025.

“We have made considerable progress in the development of our potential first-in-class DR3 blocking antibody, SL-325,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “Based on observations from our preclinical, non-human primate (NHP) studies, we remain highly optimistic that SL-325 will achieve a more complete blockade of the clinically validated DR3/TL1A signaling pathway and are excited to be selected to present these data as an oral presentation at the upcoming European Crohn’s and Colitis Organization Congress. Our phase 1 clinical trial for SL-325 is expected to begin later this year, and we believe we are well-positioned to use resources efficiently to fund operations into 2027.”

DR3 Program Milestones Expected in 2025

• Preclinical SL-325 data readout from GLP toxicology study in NHPs expected in the first quarter of 2025.
• IND filing for SL-325 expected in the third quarter of 2025.
• SL-325 Phase 1 clinical trial initiation expected in the third quarter of 2025.
• Nomination of lead DR3 bispecific development candidate(s) anticipated in the second half of 2025.

Upcoming Scientific Presentations

• Abstract accepted for poster presentation at the upcoming Crohn’s and Colitis Congress, to be held February 6–8, 2025 in San Francisco, CA.
• Abstract accepted for oral presentation at the upcoming 20th European Crohn’s and Colitis Organization Congress, to be held February 19–22, 2025 in Berlin, Germany.

Upcoming Investor Conference Presentation

• 43^rd Annual J.P. Morgan Healthcare Conference (San Francisco, CA), January 13–16, 2025.
  • Format: Dr. Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer, will present the Company’s Corporate Presentation and participate in scheduled one-on-one investor meetings.
  • Date/Time: January 16, 2025, at 7:00 a.m. PT.
  • Location: The Westin St. Francis, San Francisco, California
  • A live webcast of the presentations will be available on the Events and Presentations section of the Company’s website. A replay of the webcast will be archived for up to 30 days following the presentation date.
    

Cash Position and Financial Guidance

As of September 30, 2024, cash and cash equivalents and investments were approximately $90.1 million. Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its planned operations into 2027, beyond results from its Phase 1 clinical trial of SL-325.

About SL-325

SL-325 is a first-in-class Death Receptor 3 (DR3) antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 pathway. Shattuck’s preclinical studies demonstrate high affinity binding, superior efficacy over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is currently being evaluated in a GLP toxicology study in non-human primates, with an IND filing expected 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 first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 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, our expectations regarding: plans for our preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of any regulatory filings for SL-325; the anticipated timing of our preclinical studies and clinical trials for SL-325; the clinical benefit, safety and tolerability of SL-325; and expectations regarding the time period over which our capital resources will be sufficient to fund our 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 we believe 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 us 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 our filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; our expectations regarding the overall benefit of the strategic prioritization of our pipeline; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim 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 are the key milestones for Shattuck Labs' (STTK) SL-325 program in 2025?

STTK's key milestones for SL-325 in 2025 include GLP toxicology study data in Q1, IND filing in Q3, Phase 1 trial initiation in Q3, and DR3 bispecific candidate nomination in H2 2025.

How long will Shattuck Labs' (STTK) current cash position last?

STTK's current cash position of $90.1 million is expected to fund operations into 2027, beyond the completion of SL-325's Phase 1 clinical trial.

When will Shattuck Labs (STTK) begin Phase 1 trials for SL-325?

Shattuck Labs plans to initiate Phase 1 clinical trials for SL-325 in the third quarter of 2025.

What upcoming scientific presentations does Shattuck Labs (STTK) have scheduled?

STTK will present at the Crohn's and Colitis Congress (February 6-8, 2025) and the European Crohn's and Colitis Organization Congress (February 19-22, 2025).