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Get filing alertsShattuck Labs reports Phase 1 data for SL-325, plans Phase 2b Crohn's trial in Q3 2026
Filed June 9, 2026 · Period ending June 8, 2026 · ~1 min read
Key Changes
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Phase 1 trial of SL-325 showed 3.7% anti-drug antibody rate (2 of 54 participants) with no serious adverse events, potentially enabling quarterly dosing; company expects to initiate 174-patient Phase 2b Crohn's disease trial in Q3 2026 with primary endpoint data in H1 2028.
Item 8.01 — Other Events verify on EDGAR → -
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Item 8.01 — Other Events verify on EDGAR →
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SL-846 bispecific antibody (DR3 x IL-23R) is in IND-enabling toxicology studies with safety/immunogenicity data expected H2 2026 and IND filing planned for H1 2027; preclinical data showed potency comparable to approved IL-23 inhibitors.
Item 8.01 — Other Events verify on EDGAR →
Summary
Shattuck Labs disclosed Phase 1 results for SL-325, its lead DR3 blocking antibody, showing a favorable safety and immunogenicity profile that supports advancement to Phase 2b testing. The trial in 72 healthy volunteers demonstrated complete receptor occupancy at all tested doses with durable target engagement lasting over 10 weeks, potentially enabling quarterly maintenance dosing.
Critically, only 3.7% of participants developed anti-drug antibodies—substantially lower than the 48-100% rates reported for competing TL1A-blocking antibodies—which the company attributes to its mechanism of blocking the DR3 receptor rather than binding soluble TL1A. The company plans to initiate RECEPTIVE-CD1, a 174-patient Phase 2b trial in moderate-to-severe Crohn's disease, in Q3 2026.
The trial will evaluate two dose levels against placebo with endoscopic response at 12 weeks as the primary endpoint, with results expected in the first half of 2028. This represents the key near-term value inflection point for the lead asset. Separately, Shattuck disclosed that warrant holders exercised approximately 96% of outstanding warrants from its August 2025 financing, generating $54.9 million in gross proceeds that extend the company's cash runway into 2029 based on current operational plans. The company also provided an update on SL-846, a bispecific antibody targeting both DR3 and IL-23R, with IND filing expected in the first half of 2027.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Shattuck Labs announced Phase 1 trial data for SL-325 and outlined 2026-2027 clinical milestones including a Phase 2b Crohn's trial and IND filing.
Added in current filing · verify on EDGAR →
On June 8, 2026, Shattuck Labs, Inc. (the “Company” or “Shattuck”) issued a press release announcing data from its Phase 1 clinical trial of SL-325, its lead DR3 blocking antibody.
The company disclosed Phase 1 clinical trial data for SL-325, its lead DR3 blocking antibody. This represents a key development milestone for the company's lead drug candidate, though the specific results are not detailed in the 8-K itself.
Added in current filing · verify on EDGAR →
initiation of RECEPTIVE-CD1 Phase 2b trial of SL-325 in Crohn’s disease, expected in the third quarter of 2026
Shattuck expects to initiate a Phase 2b trial called RECEPTIVE-CD1 for SL-325 in Crohn's disease during Q3 2026. This advancement from Phase 1 to Phase 2b represents progression of the lead asset into a larger, potentially pivotal study in a specific indication.
Added in current filing · verify on EDGAR →
IND filing for SL-846 (DR3xIL-23R bispecific), which is expected in the first half of 2027
The company plans to file an Investigational New Drug application for SL-846, a DR3xIL-23R bispecific antibody, in the first half of 2027. This would enable clinical trials for a second pipeline asset, expanding the company's development portfolio beyond SL-325.
Event · Item 8.01 — Other Events
Shattuck released Phase 1 trial data for SL-325 showing favorable safety and immunogenicity, announced Phase 2b trial design, and disclosed $49.3M in warrant exercises.
Added in current filing · verify on EDGAR →
Immunogenicity: Antidrug antibodies (“ADA”) to SL-325 were detected in 3.7% [2/54] of participants who received SL-325. ... In these two participants, ADA were low titer (≤16), and no impact to PK or receptor occupancy was observed.
The Phase 1 trial of SL-325 in 72 healthy volunteers showed very low immunogenicity, with only 3.7% developing antidrug antibodies, which were low-titer and did not affect drug performance. The company states this immunogenicity profile is expected to lead to improved efficacy compared to competing anti-TL1A antibodies. Complete DR3 receptor occupancy was achieved at all tested doses, with effects lasting over 10 weeks, potentially enabling quarterly dosing via autoinjector.
Added in current filing · verify on EDGAR →
Safety: SL-325 was well tolerated at all dose levels and upon repeat dosing, with a favorable safety profile consistent with the TL1A inhibitor class. ... There were no serious treatment-emergent adverse events (“TEAEs”) or serious adverse events. ... All treatment-related adverse events (“TRAEs”) were Grade 1. TRAEs were observed in 12 participants.
SL-325 demonstrated a clean safety profile with no serious adverse events and only mild (Grade 1) treatment-related adverse events in 12 of 72 participants. The pharmacodynamic data showed no evidence of DR3 agonism or unwanted immune activation, supporting the drug's mechanism as a pure DR3 blocking antibody.
Added in current filing · verify on EDGAR → · paraphrased
The RECEPTIVE-CD1 clinical trial is designed as a randomized, double-blind, placebo-controlled Phase 2b clinical trial to evaluate the safety and efficacy of two dose levels of SL-325 as monotherapy versus placebo in moderate-to-severe Crohn's disease. RECEPTIVE-CD1 is expected to enroll approximately 174 patients, randomized 1:1:1, with patients receiving either low dose SL-325, high dose SL-325, or placebo. The primary endpoint is expected to be endoscopic response at Week 12, and the key secondary endpoint will be clinical remission at Week 12. The primary endpoint, endoscopic response at 12 weeks, is expected to be disclosed in the first half of 2028.
Shattuck announced the design of its Phase 2b trial in Crohn's disease, enrolling approximately 174 patients across the US, Canada, and Europe. The trial will test two dose levels against placebo with a 12-week induction period followed by 40-week maintenance. Primary efficacy data is expected in the first half of 2028, representing a key value inflection point approximately $5.6 million two years out.
Added in current filing · verify on EDGAR →
SL-846 is Shattuck’s lead bispecific product candidate and is designed to simultaneously bind to DR3 and to IL-23 receptor, blocking the interaction with TL1A and IL-23, respectively, while avoiding the risk of immune complex formation and resulting ADA challenges of the TL1A-based bispecifics. ... SL-846 is currently being evaluated in an ongoing IND-enabling GLP toxicology study in non-human primates. Safety and immunogenicity data are expected in the second half of 2026. ... Shattuck expects to submit an IND for SL-846 in the first half of 2027.
Shattuck disclosed progress on SL-846, a dual-targeting bispecific antibody blocking both DR3 and IL-23 receptor. Preclinical data showed potency equal to or better than comparator drugs risankizumab and icotrokinra. The company is conducting toxicology studies with results expected in the second half of 2026, targeting an IND submission in the first half of 2027.
Added in current filing · verify on EDGAR →
On June 9, 2026, the Company announced that it had received notices to exercise an aggregate of approximately 50.6 million outstanding common stock warrants, representing approximately 96% of the warrants issued in the Company’s August 4, 2025 private placement. As of March 31, 2026, the Company had received aggregate gross proceeds of approximately $5.6 million from the exercise of 5,147,773 warrants and expects to receive additional aggregate gross proceeds of approximately $49.3 million from the exercise of an additional 45,438,709 warrants.
Shattuck disclosed that holders of approximately 96% of warrants from its August 2025 private placement have exercised, generating approximately $49.3 million in additional gross proceeds beyond the $5.6 million already received. This strengthens the company's cash position to fund ongoing clinical development.
Event · Exhibit 99.1
Added in current filing · verify on EDGAR →
Antidrug antibodies (“ADA”) to SL-325 were detected in 3.7% [2/54] of participants who received SL-325.
The Phase 1 trial of SL-325, a DR3 blocking antibody, showed only 3.7% of participants developed antidrug antibodies, which the company characterizes as potentially best-in-mechanism. The two participants who developed ADA had low titer levels (≤16) with no impact on pharmacokinetics or receptor occupancy. The company states this low immunogenicity profile is expected to lead to improved efficacy compared to anti-TL1A antibodies.
Added in current filing · verify on EDGAR →
Complete DR3 occupancy, as measured by blockade of TL1A binding, was observed at doses of 0.1 mg/kg and higher in all participants. ... Complete inhibition of TL1A binding was durable for more than 10 weeks, and extended PK modeling suggests that complete inhibition of TL1A binding may be sustained for greater than 3 months at doses of greater than1 mg/kg of SL-325.
SL-325 achieved complete DR3 receptor occupancy at all tested doses (0.1 mg/kg and higher), with durable TL1A binding inhibition lasting over 10 weeks. Modeling suggests inhibition may extend beyond 3 months at doses above 1 mg/kg. The drug was well tolerated with no serious adverse events and all treatment-related adverse events were Grade 1. The company also reported no evidence of DR3 agonism.
Added in current filing · verify on EDGAR →
The RECEPTIVE-CD1 clinical trial is designed as a randomized, double-blind, placebo-controlled Phase 2b clinical trial to evaluate the safety and efficacy of two dose levels of SL-325 as monotherapy versus placebo in moderate-to-severe Crohn’s disease. ... RECEPTIVE-CD1 is expected to enroll approximately 174 patients, randomized 1:1:1, with patients receiving either low dose SL-325, high dose SL-325, or placebo. ... The primary endpoint, endoscopic response at 12 weeks, is expected to be disclosed in the first half of 2028.
Shattuck plans to initiate the RECEPTIVE-CD1 Phase 2b trial in Q3 2026, enrolling approximately 174 patients with moderate-to-severe Crohn's disease across the US, Canada, and Europe. The trial will evaluate two dose levels of SL-325 versus placebo with a 12-week induction period followed by 40-week maintenance. Primary endpoint results (endoscopic response at 12 weeks) are expected in the first half of 2028.
Added in current filing · verify on EDGAR →
SL-846 is currently being evaluated in an ongoing IND-enabling GLP toxicology study in non-human primates. Safety and immunogenicity data are expected in the second half of 2026. ... Shattuck expects to submit an IND for SL-846 in the first half of 2027.
Shattuck's lead bispecific candidate SL-846, which blocks both DR3 and IL-23 receptor, is in IND-enabling toxicology studies with safety and immunogenicity data expected in H2 2026. The company plans to submit an IND in the first half of 2027, with Phase 1 initiation expected in H1 2027. Preclinical data showed SL-846 was equipotent or more potent than risankizumab and icotrokinra controls.
Event · Exhibit 99.2
Added in current filing · verify on EDGAR →
As of March 31, 2026, the Company had received aggregate gross proceeds of approximately $5.6 million pursuant to the exercise of 5,147,773 warrants. The Company expects to receive additional aggregate gross proceeds totaling approximately $49.3 million from the exercise of 45,438,709 common stock warrants since March 31, 2026.
The company provided a breakdown showing that $5.6 million in proceeds from 5.1 million warrant exercises were received by March 31, 2026, with an additional $49.3 million expected from 45.4 million warrants exercised after that date. This timing detail clarifies when the capital was or will be received.
Added in current filing · view on EDGAR →
Together with existing cash and cash equivalents and short term investments of approximately $90.4 million as of March 31, 2026, Shattuck expects to be able to fund operations into 2029. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received (other than from the exercise of these common stock warrants), proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.
Shattuck disclosed that combining the warrant proceeds with its existing $90.4 million in cash, cash equivalents, and short-term investments as of March 31, 2026, the company expects to fund operations into 2029. This guidance is based on current operational plans and excludes potential additional capital raises, business development proceeds, or expanded clinical activities.
Event · Exhibit 99.3
Shattuck Labs disclosed Phase 1 clinical data for SL-325, a DR3 blocking antibody, and announced a planned Phase 2b trial in Crohn's disease.
Added in current filing · view on EDGAR →
Phase 1 first-in-human trial evaluated the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamic (PD) effects of SL-325 in healthy participants (NCT07158437) Key Findings Well tolerated across all dose levels, with a safety profile similar to those reported for anti-TL1A mAbs Prolonged blockade of TL1A binding at low doses may support quarterly maintenance dosing intervals No evidence of DR3 agonism, confirming SL-325 is a pure DR3 blocking antibody Potentially best-in-mechanism immunogenicity profile with ADA rate of 3.7%
The company completed a Phase 1 trial of SL-325 in 72 healthy participants across single and multiple ascending dose cohorts. The drug was well tolerated with no serious adverse events, demonstrated prolonged target engagement potentially enabling quarterly dosing, and showed a low anti-drug antibody rate of 3.7% (2 of 54 participants). These results support advancement to Phase 2 testing.
Added in current filing · view on EDGAR →
Study Design Elements Double-blind, placebo-controlled IV induction and maintenance Dose selection informed by Phase 1 PK/RO based QSP modeling with >95% TL1A signal inhibition throughout the dosing interval Population Moderate to severe CD (CDAI 220-450) All patients have opportunity to receive SL-325 N = 174, randomized 1:1:1 Key Endpoints Primary: Endoscopic response at 12 weeks Secondary: Clinical remission at 12 weeks
Shattuck announced a planned Phase 2b trial (RECEPTIVE-CD1) in moderate-to-severe Crohn's disease enrolling 174 patients randomized 1:1:1 across two SL-325 dose levels and placebo. The trial will evaluate endoscopic response at 12 weeks as the primary endpoint. Initiation is expected in Q3 2026 with 12-week induction data anticipated in the first half of 2028.
Added in current filing · view on EDGAR →
SL-846 – A Potentially First-In-Class DR3 x IL-23R Half-Life Extended Bispecific Antibody DR3 Binding Arm IL-23R Binding Arm Same binding epitope as SL-325 Avoids risk of immune complex formation Enables binding in cis to IL-23R expressing cells Validated mechanism of action (icotrokinra) Similar in vitro potency when compared to icotrokinra and risankizumab
The company disclosed SL-846, a potentially first-in-class bispecific antibody targeting both DR3 and IL-23R with half-life extension. Preclinical data showed potency comparable to approved IL-23 inhibitors. The company expects non-human primate toxicology and immunogenicity data in the second half of 2026 and Phase 1 initiation in the first half of 2027.
Added in current filing · view on EDGAR →
SL-325 ADA assay has a sensitivity of 5 ng/mL and assay tolerance up to SL-325 concentrations of 160 µg/mL in serum Data includes all participants from all SAD and MAD cohorts in all dose levels in the study** ADA were observed in 2/54 participants who received SL-325. In the two participants who developed ADA, titers remained low (8 and 16), without any impact on PK or RO
The Phase 1 trial demonstrated a 3.7% anti-drug antibody rate (2 of 54 participants), substantially lower than the 48-100% rates reported for competing TL1A-blocking antibodies in Phase 1 trials. The low immunogenicity is attributed to SL-325's mechanism of blocking the DR3 receptor rather than binding soluble TL1A, which avoids immune complex formation. The company positions this as a potentially best-in-mechanism profile.
Added in current filing · view on EDGAR →
A Single Dose of SL-325 Blocked TL1A Binding in a Dose-Dependent Manner for Months DR3 occupancy was measured by inhibition of TL1A binding Full DR3 occupancy was achieved even at the lowest dose of 0.1 mg/kg Dose-dependent extension in the duration of TL1A blockade was observed, lasting months at ≥1 mg/kg Durable inhibition of TL1A binding could enable quarterly dosing intervals in the maintenance phase of therapy for SL-325
Pharmacokinetic analysis showed dose-proportional exposure with an estimated half-life of 16 days. Receptor occupancy data demonstrated that even a single low dose achieved full DR3 occupancy, with blockade lasting months at doses of 1 mg/kg or higher. This durability may enable quarterly maintenance dosing and potentially subcutaneous administration via autoinjector.
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