10-Q: Shattuck Labs Reports Promising Phase 1 Data, Plans Phase 2b Trial

Shattuck Labs, Inc. (STTK) announced positive Phase 1 data for its lead candidate SL-325, demonstrating a favorable safety profile and complete receptor occupancy, while also reporting increased cash reserves from recent financings.

Summary

• Shattuck Labs, Inc. (STTK) filed its Form 10-Q for the quarterly period ended June 30, 2026.
• The company reported a net loss of $29.9 million for the six months ended June 30, 2026, compared to $26.2 million for the same period in 2025.
• As of June 30, 2026, Shattuck Labs had $208.3 million in cash and cash equivalents and short-term investments.
• The company shared positive Phase 1 clinical trial data for its lead product candidate, SL-325, indicating good tolerability and complete inhibition of the TL1A/DR3 axis.
• Shattuck Labs plans to initiate a Phase 2b clinical trial for SL-325 in Crohn's disease in Q3 2026, with data expected in the first half of 2028.
• The company also provided an update on its second candidate, SL-846, a dual DR3 and IL-23 receptor blocking bispecific antibody, with preclinical data expected in H2 2026 and Phase 1 data in 2027.
• Significant financing activities occurred, including a $75.0 million ATM offering and a $86.2 million public offering in June 2026, bolstering liquidity.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a cautiously optimistic filing, with significant progress in clinical trials and substantial funding, balanced by the inherent risks of drug development and ongoing operational losses.

Positives

• Positive Phase 1 clinical trial results for SL-325, showing good tolerability, dose-proportional PK, and complete inhibition of TL1A binding to DR3.
• SL-325 demonstrated a low treatment-emergent anti-drug antibody (ADA) rate of 3.7%, significantly lower than reported rates for anti-TL1A antibodies.
• Modeling suggests SL-325 may enable quarterly maintenance dosing in IBD patients.
• The company raised substantial capital through multiple financing rounds, including a $75.0 million ATM facility and an $86.2 million public offering in June 2026, significantly increasing cash reserves.
• Cash and cash equivalents and short-term investments totaled $208.3 million as of June 30, 2026, providing an estimated runway into 2029.
• Preclinical data for SL-846 suggests equipotency or greater potency compared to control antibodies.
• The company has a related party license revenue agreement with Kayak Therapeutics, Inc., generating $1.0 million in license revenue and $0.2 million in sublease income.

Negatives

• Continued net losses, with a loss of $29.9 million for the six months ended June 30, 2026.
• An accumulated deficit of $460.4 million as of June 30, 2026.
• The company is highly dependent on future financing and collaborations, with no assurance of their availability on acceptable terms.
• Research and development expenses increased by 34.8% for the three months ended June 30, 2026, indicating rising costs.
• The discontinuation of SL-172154 contributed to a decrease in R&D expenses for specific programs but indicates pipeline adjustments.
• The company has not generated any revenue from product sales and does not expect to do so for several years, if ever.

Risks

• The company has incurred losses since inception and anticipates continued losses, requiring substantial future funding.
• Failure to obtain adequate additional funding could negatively impact the company's financial condition and ability to pursue clinical operations and R&D.
• The timing, progress, and expected results of nonclinical studies and clinical trials are subject to significant risks and uncertainties.
• The company is highly dependent on a limited number of contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs).
• The commercialization of product candidates, if approved, is subject to regulatory approvals, market acceptance, and reimbursement.
• Intellectual property protection and potential need for third-party licenses present ongoing risks.
• Macroeconomic conditions such as inflation, interest rate fluctuations, and geopolitical events could adversely affect operations.
• The company is subject to the inherent risks of drug development, including potential for unexpected results in nonclinical studies and clinical trials.

Future Outlook

The company anticipates continued significant expenses and operating losses in the near term due to ongoing R&D activities, including advancing SL-325 through Phase 2 development and initiating Phase 1 for SL-846. Future funding requirements are expected to be met through equity and debt financings or collaborations. Management believes current cash and investments are sufficient to fund projected operations for at least the next twelve months.

Management Comments

• SL-325 was well-tolerated by all participants in the Phase 1 trial, with only mild (Grade 1) treatment-related adverse events observed.
• No evidence of DR3 agonism was observed, confirming that SL-325 is a pure DR3 blocking antibody.
• The PK profile for SL-325 demonstrated dose-proportional increases in Cmax and AUC across all dose levels, with an estimated half-life of approximately 16 days.
• Complete inhibition of TL1A binding to DR3 was observed at all dose levels, with durability of receptor occupancy exceeding 1 month at all dose levels and exceeding 76 days at doses of 1 mg/kg or greater.
• Treatment emergent anti-drug antibodies (ADA) were detected in 3.7% (2/54) of study participants, with low titers.
• We expect to initiate RECEPTIVE-CD1, an international, randomized, placebo-controlled, double-blinded Phase 2b clinical trial evaluating SL-325 in patients with Crohn's Disease (CD) in the third quarter of 2026.
• We expect to share additional pre-clinical data, including data from our ongoing non-human primate toxicology study for SL-846, in the second half of 2026, and to share initial Phase 1 clinical data for SL-846 in 2027.

Industry Context

StockSavvy.ai notes that Shattuck Labs operates in the highly competitive and capital-intensive biotechnology sector, focusing on inflammatory and immune-mediated diseases. The company's strategy of developing first-in-class DR3 blocking antibodies positions it within a growing area of therapeutic interest, aiming to differentiate from existing TL1A blocking antibodies through potentially superior efficacy and immunogenicity profiles.

Comparison to Industry Standards

• Anti-TL1A antibodies (afimkibart, tulisokibart, SPY-002, and XmAb942) have reported treatment emergent ADA rates between 48-82% in Phase 1 healthy volunteer studies, significantly higher than SL-325's 3.7% rate.
• Leading TL1A blocking antibodies (tulisokibart, duvakitug, and afimkibart) showed potentially best-in-disease clinical remission rates at induction in Phase 2 trials, but did not show increased remission rates between induction and maintenance, which Shattuck Labs attributes to immunogenicity.
• Third-party TL1A-directed bispecific antibodies (AMG966 and RO7837195) have demonstrated nearly 100% ADA formation, suggesting a potential advantage for Shattuck's DR3-directed bispecific approach (SL-846).
• The development of bispecific antibodies like SL-846 may offer more efficient clinical development compared to multi-antibody co-formulations, potentially avoiding immunogenicity challenges.

Legal Proceedings

• The company is not presently a party to any material legal proceedings, and is not aware of any pending or threatened legal proceeding that would have a material adverse effect.

Related Party Transactions

• In August 2025, Shattuck granted Kayak Therapeutics, Inc. an exclusive license to its oncology-focused TRIM7 program, receiving $1.0 million in preferred stock as upfront consideration, recognized as license revenue.
• Shattuck subleases lab space, office space, and lab equipment to Kayak for one year for $0.3 million, with $0.2 million recognized for the six months ended June 30, 2026, recorded as a reduction to R&D expenses.
• An officer of Shattuck was elected to Kayak's board in November 2025, making Kayak a related party.

Stakeholder Impact

• Shareholders may experience dilution from ongoing equity financings, but also benefit from potential future value creation from pipeline advancements.
• Employees are subject to stock-based compensation, aligning their interests with the company's success.
• Creditors are not significantly impacted as the company relies on equity financing rather than substantial debt.
• Suppliers and CDMOs/CROs are key partners, with potential for increased business as clinical trials progress.

Next Steps

• Initiate RECEPTIVE-CD1, an international Phase 2b clinical trial for SL-325 in Crohn's Disease in Q3 2026.
• Data from the induction portion of the RECEPTIVE-CD1 trial are expected in the first half of 2028.
• Share additional pre-clinical data for SL-846 in H2 2026.
• Share initial Phase 1 clinical data for SL-846 in 2027.
• Continue to advance SL-325 through Phase 2 clinical development.
• Initiate Phase 1 clinical development for SL-846 in 2027.

Key Dates

Recommendation

The company has demonstrated promising clinical data for its lead candidate and secured significant funding, providing a runway for development. However, the inherent risks of drug development, continued operational losses, and the long path to potential commercialization warrant a cautious 'hold' stance. Investors should monitor clinical trial progress and future financing needs.

Keywords

biotechnology, clinical-stage, drug development, DR3, TL1A, monoclonal antibody, Crohn's disease, inflammatory diseases