RankAlpha logo
Back to Rankings

STTK

Shattuck LabsB
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
12
Stored
Transcripts
1
Recent loaded
Latest report
2026-08-11
Investor release

Document history

Earnings documents stored for STTK.

12 shown
Investor releaseQuarter not tagged2026-08-11

Shattuck Labs Reports Second Quarter 2026 Financial Results and Recent Business Highlights

GlobeNewswire
– Phase 1 clinical trial results for SL-325 demonstrated a favorable safety profile, a potentially best-in-mechanism immunogenicity profile, and durable DR3 blockade of TL1A binding, potentially enabling prolonged dosing intervals – – RECEPTIVE-CD1 Phase 2b clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – – Announced lead DR3 x IL-23 receptor blocking, half-life extended bispecific antibody product candidate, SL-846, with initial Phase 1 clinical data expected in 2027 – –Strengthened balance sheet with approximately $208.3 million in cash and cash equivalents and short-term investments as of June 30, 2026, expected to fund operations into 2029 – AUSTIN, Texas and DURHAM, N.C., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the second quarter ended June 30, 2026 and provided recent business highlights. "The Phase 1 clinical data for SL-325 has checked all of the boxes and positions SL-325 as a potentially winning antibody in the TL1A/DR3 axis heading into Phase 2 clinical development," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "The RECEPTIVE-CD1 Phase 2b clinical trial in Crohn’s disease is on track to initiate in the third quarter, and is designed to establish the efficacy profile of SL-325 across three dose levels, both at induction and at maintenance time points. As we expected, clinical proof of concept for the TL1A/DR3 axis is now emerging outside of IBD. We are pleased to see this continued momentum for the class, and we believe that blocking DR3 will prove more efficacious than blocking TL1A across any indication where TL1A is implicated." DR3 Program Development in 2026 Shattuck is advancing a pipeline of DR3-targeted monoclonal and bispecific antibody product candidates for the treatment of inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones include: SL-325 Shattuck’s lead clinical-stage product candidate, SL-325, is a potentially first-in-class DR3 blocking antibody for the treatment of Crohn's disease, ulcerative c…Read full document

– Phase 1 clinical trial results for SL-325 demonstrated a favorable safety profile, a potentially best-in-mechanism immunogenicity profile, and durable DR3 blockade of TL1A binding, potentially enabling prolonged dosing intervals – – RECEPTIVE-CD1 Phase 2b clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – – Announced lead DR3 x IL-23 receptor blocking, half-life extended bispecific antibody product candidate, SL-846, with initial Phase 1 clinical data expected in 2027 – –Strengthened balance sheet with approximately $208.3 million in cash and cash equivalents and short-term investments as of June 30, 2026, expected to fund operations into 2029 – AUSTIN, Texas and DURHAM, N.C., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the second quarter ended June 30, 2026 and provided recent business highlights. "The Phase 1 clinical data for SL-325 has checked all of the boxes and positions SL-325 as a potentially winning antibody in the TL1A/DR3 axis heading into Phase 2 clinical development," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "The RECEPTIVE-CD1 Phase 2b clinical trial in Crohn’s disease is on track to initiate in the third quarter, and is designed to establish the efficacy profile of SL-325 across three dose levels, both at induction and at maintenance time points. As we expected, clinical proof of concept for the TL1A/DR3 axis is now emerging outside of IBD. We are pleased to see this continued momentum for the class, and we believe that blocking DR3 will prove more efficacious than blocking TL1A across any indication where TL1A is implicated." DR3 Program Development in 2026 Shattuck is advancing a pipeline of DR3-targeted monoclonal and bispecific antibody product candidates for the treatment of inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones include: SL-325 Shattuck’s lead clinical-stage product candidate, SL-325, is a potentially first-in-class DR3 blocking antibody for the treatment of Crohn's disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Phase 1 clinical trial results for SL-325 demonstrated a potentially best-in-mechanism profile. Key findings from the Phase 1 clinical trial include: RECEPTIVE-CD1 Phase 2b clinical trial of SL-325 in patients with moderately-to-severely active Crohn's disease is expected to initiate in the third quarter of 2026. SL-846 Shattuck’s lead bispecific product candidate, SL-846, is a potentially first-in-class, half-life extended DR3 x IL-23 receptor blocking antibody for the treatment of inflammatory and immune-mediated diseases. SL-846 is currently being evaluated in an ongoing IND-enabling GLP toxicology study in non-human primates. Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study are expected to be presented in a poster at UEG Week, to be held October 17-20, 2026. Shattuck expects to initiate a Phase 1 healthy volunteer clinical trial of SL-846 and report initial data in 2027. Upcoming Events Shattuck plans to participate in the following upcoming event(s). Details will be included on the Events & Presentations section of the Company’s website. 21st Annual Wells Fargo Healthcare Conference, September 8-10, 2026. Management will participate in one-on-one meetings. Citi’s 2026 Biopharma Back to School Conference, September 9-10, 2026. Management will participate in one-on-one meetings. Cantor Global Healthcare Conference, September 9-11, 2026. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs will participate in a fireside chat, and management will participate in one-on-one meetings. United European Gastroenterology Week (UEGW), October 17-20, 2026. Shattuck will present posters containing preclinical and non-human primate toxicology data for SL-846. Capital Markets Update Shattuck completed an underwritten public offering with aggregate gross proceeds of approximately $86.2 million. As of July 1, 2026, all of the common stock warrants issued in the Company's August 2025 private placement have been exercised, resulting in aggregate gross proceeds of approximately $57.1 million. Second Quarter 2026 Financial Results Cash and Cash Equivalents and Investments: As of June 30, 2026, cash and cash equivalents and short-term investments were $208.3 million, as compared to $50.5 million as of June 30, 2025. Research and Development (R&D) Expenses: R&D expenses were $11.7 million for the quarter ended June 30, 2026, as compared to $8.7 million for the quarter ended June 30, 2025. General and Administrative (G&A) Expenses: G&A expenses were $4.5 million for the quarter ended June 30, 2026, as compared to $4.4 million for the quarter ended June 30, 2025. Net Loss: Net loss was $15.2 million for the quarter ended June 30, 2026, or $0.12 per basic and diluted share, as compared to a net loss of $12.5 million for the quarter ended June 30, 2025, or $0.24 per basic and diluted share. Financial Guidance As of June 30, 2026, cash and cash equivalents, and short-term investments, were approximately $208.3 million. Shattuck’s current cash and cash equivalents, and short-term investments are expected 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, 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 potentially 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 is a fully Fc-silenced, fully human immunoglobulin G monoclonal antibody. In a recently completed Phase 1 clinical trial, SL-325 demonstrated a favorable safety profile, a potentially best-in-mechanism immunogenicity profile, no evidence of residual DR3 agonism, and provided durable blockade of TL1A binding to DR3 at low doses. SL-325 will be evaluated in a Phase 2b clinical trial in Crohn’s disease patients, which is expected to initiate in the third quarter of 2026. About SL-846 SL-846 is a potentially first-in-class Death Receptor 3 (DR3) by IL-23 receptor (IL-23R) blocking bispecific antibody designed to achieve complete and durable blockade of the clinically validated DR3/TL1A and IL-23/IL-23R pathways. Shattuck’s preclinical studies demonstrate high affinity binding to both DR3 and IL-23R, with equivalent or superior in vitro potency in comparison to benchmark IL-23 controls (sequence equivalents of risankizumab and icotrokinra) in a variety of preclinical assays. SL-846 is an Fc-silenced, half-life extended, fully human immunoglobulin G bispecific antibody currently being evaluated for safety, tolerability, immunogenicity, and pharmacodynamics in an IND-enabling GLP toxicology study in non-human primates. About Shattuck Labs, Inc. Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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, Shattuck’s expectations regarding: plans for its preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of initiation of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates; the anticipated timing of initiation of a Phase 1 clinical trial of SL-846; the clinical benefit, safety and tolerability of SL-846; the anticipated release of data from SL-846; the potential clinical significance of clinical and preclinical data and expectations regarding the time period over which the Company’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan,” “anticipate” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes 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 it 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 Shattuck’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond its control and subject to change. Actual results or outcomes, or the timing of actual results or outcomes, could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the Company’s preclinical studies, clinical trials and research and development programs, including the timing and costs thereof; the Company’s ability to enroll patients in its clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the Company’s ability to advance product candidates into, and successfully complete, nonclinical studies and clinical trials; the timing or likelihood of regulatory filings and approvals; the implementation of the Company’s business model, strategic plans for its business and product candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its technology; liquidity and capital resources, including the time period over which current capital resources are expected to the fund the Company’s operations; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC. Shattuck claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims 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: Andrew R. NeillChief Financial OfficerShattuck Labs, [email protected]

Investor releaseQuarter not tagged2026-06-08

Shattuck Labs Reports Good Safety Results for Phase 1 Study of Drug Candidate for Immune-Related Disease

MT Newswires

Shattuck Labs (STTK) said Monday its phase 1 study of SL-325, a treatment for immune-related disease

Investor releaseQuarter not tagged2026-06-08

Shattuck Labs Announces Phase 1 Results for SL-325

GlobeNewswire
Potentially best-in-mechanism immunogenicity profile, with only 3.7% of participants developing antidrug antibodies Complete blockade of TL1A binding to DR3 for over 3 months expected at doses of 1 mg/kg and higher Well tolerated with a favorable safety profile consistent with the TL1A inhibitor class No evidence of DR3 agonism RECEPTIVE-CD1 Phase 2b clinical trial in patients with Crohn’s disease expected to initiate in the third quarter of 2026 Lead bispecific product candidate, SL-846 (DR3xIL-23R), currently being evaluated in IND-enabling toxicology studies; Phase 1 initiation expected in the first half of 2027 AUSTIN, TX and DURHAM, NC, June 08, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today announced data from its Phase 1 clinical trial of SL-325, Shattuck’s lead DR3 blocking antibody candidate. “SL-325 is now the first antibody that blocks the receptor for TL1A, known as DR3, to generate human clinical data. The profile of SL-325 is highly encouraging, including a potentially best-in-mechanism immunogenicity profile, saturation of DR3 at low doses of SL-325, and durable inhibition of TL1A binding for months after a single dose.” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “These data indicate that blocking DR3 with SL-325, or with our DR3 by IL-23 receptor blocking bispecific antibody candidate, SL-846, may substantially improve upon the efficacy shown to date with the TL1A inhibitor class, providing an opportunity to maximize potential efficacy for TL1A blockade in IBD and beyond.” Key Phase 1 Findings The Phase 1 trial is a first-in-human, randomized, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics (“PK”), receptor occupancy (“RO”), pharmacodynamics (“PD”), and immunogenicity of SL-325 in healthy volunteers. The study enrolled 72 participants, across six single-ascending dose cohorts, with doses ranging from 0.1 mg/kg to 30.0 mg/kg, and three multiple-ascending dose cohorts, with doses ranging from 1 mg/kg to 10 mg/kg. Immunogenicity: Antidrug antibodies (“ADA”) to SL-325 were detected in 3.7% [2/54] of participants who receive…Read full document

Potentially best-in-mechanism immunogenicity profile, with only 3.7% of participants developing antidrug antibodies Complete blockade of TL1A binding to DR3 for over 3 months expected at doses of 1 mg/kg and higher Well tolerated with a favorable safety profile consistent with the TL1A inhibitor class No evidence of DR3 agonism RECEPTIVE-CD1 Phase 2b clinical trial in patients with Crohn’s disease expected to initiate in the third quarter of 2026 Lead bispecific product candidate, SL-846 (DR3xIL-23R), currently being evaluated in IND-enabling toxicology studies; Phase 1 initiation expected in the first half of 2027 AUSTIN, TX and DURHAM, NC, June 08, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today announced data from its Phase 1 clinical trial of SL-325, Shattuck’s lead DR3 blocking antibody candidate. “SL-325 is now the first antibody that blocks the receptor for TL1A, known as DR3, to generate human clinical data. The profile of SL-325 is highly encouraging, including a potentially best-in-mechanism immunogenicity profile, saturation of DR3 at low doses of SL-325, and durable inhibition of TL1A binding for months after a single dose.” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “These data indicate that blocking DR3 with SL-325, or with our DR3 by IL-23 receptor blocking bispecific antibody candidate, SL-846, may substantially improve upon the efficacy shown to date with the TL1A inhibitor class, providing an opportunity to maximize potential efficacy for TL1A blockade in IBD and beyond.” Key Phase 1 Findings The Phase 1 trial is a first-in-human, randomized, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics (“PK”), receptor occupancy (“RO”), pharmacodynamics (“PD”), and immunogenicity of SL-325 in healthy volunteers. The study enrolled 72 participants, across six single-ascending dose cohorts, with doses ranging from 0.1 mg/kg to 30.0 mg/kg, and three multiple-ascending dose cohorts, with doses ranging from 1 mg/kg to 10 mg/kg. Immunogenicity: Antidrug antibodies (“ADA”) to SL-325 were detected in 3.7% [2/54] of participants who received SL-325. Pharmacokinetics and Receptor Occupancy: Pharmacodynamics: Clinical data now corroborate our previous preclinical findings that SL-325 is a pure DR3 blocking antibody. 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. RECEPTIVE-CD1 Phase 2b Trial of SL-325 in Crohn’s Disease 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. SL-325 will be administered intravenously, and the trial will include a 12-week induction period, followed by a 40-week maintenance period, for a total of 52 weeks of treatment for each patient enrolled. 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. RECEPTIVE-CD1 will enroll patients at clinical sites in the United States, Canada, and Europe. RECEPTIVE-CD1 is expected to enroll patients with moderate-to-severe Crohn’s disease, as defined with a Crohn’s Disease Activity Index (“CDAI”) score of between 220 and 450. The primary endpoint is expected to be endoscopic response at Week 12, and the key secondary endpoint will be clinical remission at Week 12. Patients randomized to the placebo arm will be eligible to receive SL-325 after the 12-week induction period. The primary endpoint, endoscopic response at 12 weeks, is expected to be disclosed in the first half of 2028. SL-846: A Dual DR3 and IL-23 Receptor Blocking Antibody 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 an Fc-silenced, half-life extended, IgG1 bispecific antibody. Preclinical data demonstrated that SL-846 was equipotent, or more potent, than sequence equivalents of risankizumab and icotrokinra controls in multiple in vitro and cell-based potency assays. 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. About SL-325 SL-325 is a potentially 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 is a fully Fc-silenced, fully human immunoglobulin G monoclonal antibody with a favorable safety profile, potentially best-in-mechanism immunogenicity profile, no evidence of residual DR3 agonism capable of providing durable blockade of TL1A binding to DR3 at low doses in a recently completed Phase 1 clinical trial. SL-325 is expected to be evaluated in a Phase 2b clinical trial in Crohn’s Disease patients initiating in the third quarter of 2026. About SL-846 SL-846 is a potentially first-in-class Death Receptor 3 (DR3) by IL-23 receptor (IL-23R) blocking bispecific antibody designed to achieve complete and durable blockade of the clinically validated DR3/TL1A and IL-23/IL-23R pathways. Shattuck’s preclinical studies demonstrate high affinity binding to both DR3 and IL-23R, with equivalent or superior in vitro potency in comparison to benchmark IL-23 controls (sequence equivalents of risankizumab and icotrokinra) in a variety of preclinical assays. SL-846 is an Fc-silenced, half-life extended, fully human immunoglobulin G bispecific antibody currently being evaluated for safety, tolerability, immunogenicity, and pharmacodynamics in an IND-enabling GLP toxicology study in non-human primates. About Shattuck Labs, Inc. Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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, Shattuck’s expectations regarding: plans for its preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of release of data from the Company’s ongoing Phase 1 clinical trial of SL-325; the anticipated timing of initiation of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates; the timing of nomination, release of preclinical data and development timelines of a lead bispecific antibody candidate; and expectations regarding the time period over which the Company’s capital resources will be sufficient to fund its 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 the Company believes 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 it 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 Shattuck’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond its 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 the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the Company’s preclinical studies and clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources, including the time period over which current capital resources are expected to the fund the Company’s operations; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent disclosure documents filed with the SEC. Shattuck claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims 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: Andrew R. NeillChief Financial OfficerShattuck Labs, [email protected]

Investor releaseQuarter not tagged2026-05-07

Shattuck Labs Reports First Quarter 2026 Financial Results and Recent Business Highlights

GlobeNewswire
Phase 1 clinical trial of SL-325 enrollment complete; data expected in the second quarter of 2026 – Phase 2 clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – AUSTIN, Texas and DURHAM, N.C., May 07, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the first quarter ended March 31, 2026 and provided recent business highlights. “We are pleased to have completed enrollment in our Phase 1 clinical trial of SL-325, and are looking forward to sharing a comprehensive data set on all single ascending dose and multiple ascending dose cohorts from this study in the second quarter of 2026, including safety and tolerability, pharmacokinetics, receptor occupancy, duration of receptor occupancy, pharmacodynamics, and immunogenicity data,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. DR3 Program Development in 2026 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include: The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and will determine the recommended Phase 2 dose and dosing schedule. Enrollment of all six single-ascending dose cohorts and all three multiple-ascending dose cohorts of the trial is now complete, with participant follow-up, data collection, and data analysis ongoing. Shattuck plans to present safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, pharmacodynamics, and immunogenicity data from this trial in the second quarter of 2026. Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026. Shattuck continues to develop multiple DR3-based bispecific antib…Read full document

Phase 1 clinical trial of SL-325 enrollment complete; data expected in the second quarter of 2026 – Phase 2 clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – AUSTIN, Texas and DURHAM, N.C., May 07, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the first quarter ended March 31, 2026 and provided recent business highlights. “We are pleased to have completed enrollment in our Phase 1 clinical trial of SL-325, and are looking forward to sharing a comprehensive data set on all single ascending dose and multiple ascending dose cohorts from this study in the second quarter of 2026, including safety and tolerability, pharmacokinetics, receptor occupancy, duration of receptor occupancy, pharmacodynamics, and immunogenicity data,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. DR3 Program Development in 2026 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include: The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and will determine the recommended Phase 2 dose and dosing schedule. Enrollment of all six single-ascending dose cohorts and all three multiple-ascending dose cohorts of the trial is now complete, with participant follow-up, data collection, and data analysis ongoing. Shattuck plans to present safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, pharmacodynamics, and immunogenicity data from this trial in the second quarter of 2026. Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026. Shattuck continues to develop multiple DR3-based bispecific antibodies. Shattuck’s lead bispecific antibody has entered IND-enabling activities. This bispecific antibody was designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck plans to disclose the targets of its lead bispecific product candidate, supporting preclinical data, and expected development timelines in the second quarter of 2026. Upcoming Events Shattuck plans to participate in the following upcoming event(s). Details will be included on the Events & Presentations section of the Company’s website. Leerink Partners Therapeutics Forum 2026 (Boston, MA), July 14-15, 2026. Management will participate in one-on-one meetings. First Quarter 2026 Financial Results Cash and Cash Equivalents and Investments: As of March 31, 2026, cash and cash equivalents and short-term investments were $90.4 million, as compared to $60.9 million as of March 31, 2025. Research and Development (R&D) Expenses: R&D expenses were $10.9 million for the quarter ended March 31, 2026, as compared to $9.9 million for the quarter ended March 31, 2025. General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2026, as compared to $4.5 million for the quarter ended March 31, 2025. Net Loss: Net loss was $14.8 million for the quarter ended March 31, 2026, or $0.13 per basic and diluted share, as compared to a net loss of $13.7 million for the quarter ended March 31, 2025, or $0.27 per basic and diluted share. Financial Guidance As of March 31, 2026, cash and cash equivalents were approximately $90.4 million. Shattuck’s current cash and cash equivalents, assuming the full exercise of the outstanding common stock warrants, are expected 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 the common stock warrants), 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 is a fully Fc-silenced, humanized immunoglobulin G monoclonal antibody with a favorable safety profile in non-human primates, currently being evaluated in a Phase 1 clinical trial. About Shattuck Labs, Inc. Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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, Shattuck’s expectations regarding: plans for its preclinical studies, clinical trials and research and development programs, particularly with respect to SL-325; the anticipated timing of release of data from the Company’s ongoing Phase 1 clinical trial of SL-325; the anticipated timing of initiation of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates; the timing of nomination, release of preclinical data and development timelines of a lead bispecific antibody candidate; and expectations regarding the time period over which the Company’s capital resources will be sufficient to fund its 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 the Company believes 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 it 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 Shattuck’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond its 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 the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the Company’s preclinical studies and clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources, including the time period over which current capital resources are expected to the fund the Company’s operations; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent disclosure documents filed with the SEC. Shattuck claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims 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: Andrew Neill Chief Financial Officer Shattuck Labs, Inc. [email protected] FINANCIAL INFORMATION SHATTUCK LABS, INC. CONDENSED BALANCE SHEETS (unaudited) (In thousands) SHATTUCK LABS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per share amounts)

Investor releaseQuarter not tagged2026-03-05

Shattuck Labs Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Business Highlights

GlobeNewswire
Phase 1 clinical trial of SL-325 ongoing, with data expected in the second quarter of 2026 – Phase 2 clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – AUSTIN, Texas and DURHAM, N.C., March 05, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided recent business highlights. “SL-325 is now the first DR3 blocking antibody to generate human clinical data, and we are very pleased with the progress we have made in our Phase 1 clinical trial, which is nearly complete. We look forward to sharing the data from this trial in the second quarter, and anticipate initiating our Phase 2 clinical trial in Crohn’s disease in the third quarter,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include: The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and progressing as planned, and will determine the recommended Phase 2 dose and dosing schedule. Enrollment of all six single-ascending dose (SAD) cohorts is now complete, and full enrollment in the final multiple-ascending dose (MAD) cohort of the trial is expected to be completed in the second quarter of 2026. Shattuck expects to disclose safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, and immunogenicity data from this trial in the second quarter of 2026. Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026. Shattuck continues to develop multiple DR3-based bispecific antibod…Read full document

Phase 1 clinical trial of SL-325 ongoing, with data expected in the second quarter of 2026 – Phase 2 clinical trial of SL-325 in patients with Crohn’s disease expected to initiate in the third quarter of 2026 – AUSTIN, Texas and DURHAM, N.C., March 05, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided recent business highlights. “SL-325 is now the first DR3 blocking antibody to generate human clinical data, and we are very pleased with the progress we have made in our Phase 1 clinical trial, which is nearly complete. We look forward to sharing the data from this trial in the second quarter, and anticipate initiating our Phase 2 clinical trial in Crohn’s disease in the third quarter,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include: The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and progressing as planned, and will determine the recommended Phase 2 dose and dosing schedule. Enrollment of all six single-ascending dose (SAD) cohorts is now complete, and full enrollment in the final multiple-ascending dose (MAD) cohort of the trial is expected to be completed in the second quarter of 2026. Shattuck expects to disclose safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, and immunogenicity data from this trial in the second quarter of 2026. Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026. Shattuck continues to develop multiple DR3-based bispecific antibodies. Shattuck’s lead bispecific antibody has entered IND-enabling activities. This bispecific antibody was designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck plans to disclose the targets of its lead bispecific product candidate, supporting preclinical data, and expected development timelines in the first half of 2026. Appointment to Management Team Michael Choi, M.D., joined Shattuck Labs as Vice President of Clinical Development in November 2025. Dr. Choi brings extensive experience advancing inflammatory bowel disease programs, including as clinical lead at Morphic Therapeutic, where he led the development of MORF-057, its oral α4β7 antagonist. Earlier in his career, Dr. Choi served as Assistant Professor of Medicine at Harvard Medical School and Affiliated Faculty at the Harvard Stem Cell Institute. Dr. Choi received his medical degree from Cornell University, trained in Internal Medicine at UCSF, and completed his Gastroenterology Fellowship at Massachusetts General Hospital. Recent Events Shattuck participated in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025. Dr. Schreiber presented at the conference and management participated in one-on-one meetings. Shattuck participated in the Evercore ISI 8th Annual HealthCONx Conference on December 3-4, 2025. Dr. Schreiber participated in a fireside chat and management participated in one-on-one meetings. Shattuck participated in the Piper Sandler Virtual Novel Targets in Immunology Symposium on February 12-13, 2026. Dr. Schreiber, Andrew R. Neill, Chief Financial Officer, and Michael Choi, M.D., Vice President of Clinical Development participated in a fireside chat. Shattuck participated in the TD Cowen 46th Annual Health Care Conference on March 2-4, 2026. Dr. Schreiber presented at the conference and management participated in one-on-one meetings. Upcoming Events Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website. Leerink Global Healthcare Conference 2026 (Miami, FL), March 8-11, 2026. Dr. Schreiber will present at the conference and participate in one-on-one meetings. Capital Markets Update In the first quarter of 2026, Shattuck sold shares of its common stock under its at-the-market offering facility for aggregate gross proceeds of $21.4 million. As a result of these sales, accounts advised by T. Rowe Price Investment Management, Inc. reported beneficial ownership of more than 10% of the Company’s outstanding common stock. As of February 28, 2026, cash and cash equivalents and short-term investments were approximately $94.5 million (unaudited), which includes the gross proceeds of $21.4 million from sales of Shattuck’s common stock under its at-the-market offering facility, as described above. This amount is preliminary, has not been audited or reviewed by the Company’s independent registered public accounting firm, and is subject to change upon completion of the Company’s financial closing procedures. Fourth Quarter and Full-Year 2025 Financial Results Cash and Cash Equivalents and Investments: As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million, as compared to $73.0 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses were $9.1 million for the quarter ended December 31, 2025, as compared to $15.4 million for the quarter ended December 31, 2024. R&D expenses for the year ended December 31, 2025 were $35.3 million, as compared to $67.2 million for the year ended December 31, 2024. This full year decrease was a result of the discontinuation of the SL-172154 program and related workforce reductions and other pipeline compound costs, partially offset by an increase in SL-325 expenses primarily as a result of moving SL-325 into clinical development in 2025. General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended December 31, 2025, as compared to $4.2 million for the quarter ended December 31, 2024. General and administrative expenses for the year ended December 31, 2025 were $17.2 million, as compared to $19.1 million for the year ended December 31, 2024. This full year decrease was primarily the result of a decrease in compensation and related benefit expenses as a result of workforce reductions in 2024 as well as a decrease in legal fees. Net Loss: Net loss was $12.6 million for the quarter ended December 31, 2025, or $0.12 per basic and diluted share, as compared to a net loss of $18.7 million for the quarter ended December 31, 2024, or $0.37 per basic and diluted share. Net loss for the year ended December 31, 2025 was $48.8 million, or $0.70 per basic and diluted share, as compared to $75.4 million, or $1.49 per basic and diluted share, for the year ended December 31, 2024. Financial Guidance As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million. Shattuck’s current cash and cash equivalents and short-term investments, including the gross proceeds from its sale of common stock under its at-the-market offering facility of $21.4 million in the first quarter of 2026, and assuming the full exercise of the outstanding common stock warrants, are expected 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, 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 is a fully Fc-silenced, humanized immunoglobulin G monoclonal antibody with a favorable safety profile in non-human primates, currently being evaluated in a Phase 1 clinical trial. About Shattuck Labs, Inc. Shattuck Labs, Inc. is a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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 release of data from our ongoing Phase 1 clinical trial of SL-325; the expected timing of enrollment in the MAD cohort of our Phase 1 clinical trial of SL-325; the anticipated timing of initiation of a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates the timing of nomination, release of preclinical data and development timelines of a lead bispecific antibody candidate; 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 preclinical studies and 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, 2024, 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: Andrew Neill Chief Financial Officer Shattuck Labs, Inc. [email protected]

Investor releaseQuarter not tagged2025-11-07

Shattuck Labs Reports Third Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
–First participants dosed in Phase 1 clinical trial of SL-325 in healthy volunteers – – Closed a private placement of up to $103 million in August 2025 to support advancement of SL-325 – – Appointments of Dan Baker, M.D., and Mona Ashiya, Ph.D. to the Board of Directors – AUSTIN, TX and DURHAM, NC, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (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, today reported financial results for the quarter ended September 30, 2025 and provided recent business highlights. “In the third quarter of 2025, SL-325 became the first DR3 blocking antibody to enter clinical development, and our Phase 1 trial is proceeding as we anticipated” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “With the successful closing of our private placement, and assuming the full exercise of the common stock warrants issued in the private placement, we are well-capitalized to advance SL-325 into Phase 2 trials. We are executing with discipline and remain focused on generating data that supports SL-325 as a potentially first-in-class DR3 blocking antibody.” Business Highlights Shattuck closed a private placement of up to approximately $103 million in August 2025, with proceeds from the financing, assuming full exercise of the common stock warrants issued therein, expected to fund operations into 2029 and advance SL-325 through multiple clinical milestones, including a Phase 2 clinical trial in IBD, and potentially another autoimmune disease. DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 antagonist antibody for the treatment of IBD and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325 include: IND clearance for SL-325 occurred in August 2025. First participants dosed in the single-ascending dose (SAD) portion of the Phase 1 clinical trial in the third quarter of 2025. The Phase 1 trial is evaluating safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers, and will determine the recommended Phase 2 dose and dosing schedule of SL-325. Enrollment of SAD and mul…Read full document

–First participants dosed in Phase 1 clinical trial of SL-325 in healthy volunteers – – Closed a private placement of up to $103 million in August 2025 to support advancement of SL-325 – – Appointments of Dan Baker, M.D., and Mona Ashiya, Ph.D. to the Board of Directors – AUSTIN, TX and DURHAM, NC, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (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, today reported financial results for the quarter ended September 30, 2025 and provided recent business highlights. “In the third quarter of 2025, SL-325 became the first DR3 blocking antibody to enter clinical development, and our Phase 1 trial is proceeding as we anticipated” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “With the successful closing of our private placement, and assuming the full exercise of the common stock warrants issued in the private placement, we are well-capitalized to advance SL-325 into Phase 2 trials. We are executing with discipline and remain focused on generating data that supports SL-325 as a potentially first-in-class DR3 blocking antibody.” Business Highlights Shattuck closed a private placement of up to approximately $103 million in August 2025, with proceeds from the financing, assuming full exercise of the common stock warrants issued therein, expected to fund operations into 2029 and advance SL-325 through multiple clinical milestones, including a Phase 2 clinical trial in IBD, and potentially another autoimmune disease. DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 antagonist antibody for the treatment of IBD and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325 include: IND clearance for SL-325 occurred in August 2025. First participants dosed in the single-ascending dose (SAD) portion of the Phase 1 clinical trial in the third quarter of 2025. The Phase 1 trial is evaluating safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers, and will determine the recommended Phase 2 dose and dosing schedule of SL-325. Enrollment of SAD and multiple-ascending dose (MAD) portions is expected to be completed in the second quarter of 2026. Safety, tolerability, DR3 occupancy, immunogenicity, and PK data will be evaluated in this open-label study, and Shattuck expects to disclose initial results by 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 continues to make progress in the preclinical development of its bispecific antibodies in-line with expectations. Shattuck plans to announce a lead bispecific candidate from its preclinical pipeline in the first half of 2026. Appointments to Board of Directors Dan Baker, M.D., industry expert, and Mona Ashiya, Ph.D., Member at OrbiMed, appointed to Shattuck’s Board of Directors in August 2025. Recent Events Shattuck participated in the H.C. Wainwright 27th Annual Global Investment Conference, September 8-10, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck, presented at the conference and participated in one-on-one meetings. Upcoming Events Shattuck plans to attend the following investor conference(s). Details will be included on the Events & Presentations section of the Company’s website. Piper Sandler 37th Annual Healthcare Conference (New York City, NY), December 2nd, 2025. Management will participate in one-on-one meetings. Evercore ISI 8th Annual Healthcare Conference (Miami, FL), December 3rd-4th. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs, will participate in a fireside chat hosted by covering analyst Jon Miller, and management will participate in one-on-one meetings. Third Quarter 2025 Financial Results Cash and Cash Equivalents and Short-Term Investments: As of September 30, 2025, cash and cash equivalents and short-term investments were $86.1 million, as compared to $90.1 million as of September 30, 2024. Research and Development (R&D) Expenses: R&D expenses were $7.6 million for the quarter ended September 30, 2025, as compared to $16.3 million for the quarter ended September 30, 2024. General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the quarter ended September 30, 2025, as compared to $4.6 million for the quarter ended September 30, 2024. Net Loss: Net loss was $10.1 million for the quarter ended September 30, 2025, or $0.14 per basic and diluted share, as compared to a net loss of $16.6 million for the quarter ended September 30, 2024, or $0.33 per basic and diluted share. Financial Guidance As of September 30, 2025, cash and cash equivalents and short-term investments were approximately $86.1 million. Shattuck’s current cash and cash equivalents and short-term investments, assuming the full exercise of the outstanding common stock warrants, are expected 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, 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 is a fully Fc-silenced humanized immunoglobin G monoclonal antibody with a favorable safety profile in non-human primates. 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 potential first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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: expectations regarding the timing for completion of enrollment of patients in the Phase 1 trial for SL-325; the anticipated timing for completion of the Phase 1 trial for SL-325; expectations regarding the timing for release of the results of the Phase 1 trial for SL-325; anticipated Phase 2 clinical trials for SL-325; anticipated timing for nomination of an additional development candidate from the Company’s preclinical pipeline; and the time period over which the Company’s capital resources will be sufficient to fund its anticipated operations, including whether the common stock warrants will be exercised and provide the Company with additional capital. 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 the Company believes 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 the Company 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 Shattuck’s filings with the SEC), many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expected results of the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the Company’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; Shattuck’s expectations regarding the overall benefit of the strategic prioritization of its pipeline; liquidity and capital resources, including whether the common stock warrants will be exercised and provide the Company with additional capital; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent disclosure documents filed with the SEC. The Company claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims 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: Andrew R. Neill Chief Financial Officer Shattuck Labs, Inc. [email protected]

Investor releaseQuarter not tagged2025-08-14

Shattuck Labs Reports Second Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
– Submitted Investigational New Drug (IND) application to evaluate SL-325 in a Phase 1 clinical trial in healthy volunteers; clearance expected in Q3 2025 – – On track to dose first participant in Phase 1 clinical trial for SL-325 in Q3 2025 – – Cash balance of approximately $50.5 million at end of Q2 2025 – – Aggregate proceeds from recent oversubscribed private placement of up to $103 million, less offering expenses, expected to fund operations into 2029 – AUSTIN, TX and DURHAM, NC, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (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, today reported financial results for the second quarter ended June 30, 2025 and provided recent business highlights. “The second quarter of 2025 was a productive period for Shattuck, as we prepared and successfully submitted an IND application to the U.S. Food & Drug Administration (FDA),” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We expect to begin enrollment in our Phase 1 clinical trial, subject to regulatory alignment, in healthy volunteers later this quarter, and to complete the trial during the second quarter of 2026. Following our recent private placement, led by OrbiMed, we are in a strong position and expect to transition seamlessly into multiple Phase 2 clinical trials for our lead asset, SL-325, and fund our operations into 2029.” DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 blocking antibody for the treatment of IBD and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325 include: An IND was submitted to the FDA for SL-325 in July 2025; clearance expected in the third quarter of 2025. Phase 1 clinical trial will evaluate safety, tolerability, immunogenicity and pharmacokinetics in healthy volunteers, and determine the recommended Phase 2 dose and dosing schedule of SL-325. Subject to regulatory alignment, dosing of the first participant in the single-ascending dose (SAD) portion of the trial is expected in the third quarter of 2025, and the multiple-ascending dose (MAD) portion of the trial is expected to commen…Read full document

– Submitted Investigational New Drug (IND) application to evaluate SL-325 in a Phase 1 clinical trial in healthy volunteers; clearance expected in Q3 2025 – – On track to dose first participant in Phase 1 clinical trial for SL-325 in Q3 2025 – – Cash balance of approximately $50.5 million at end of Q2 2025 – – Aggregate proceeds from recent oversubscribed private placement of up to $103 million, less offering expenses, expected to fund operations into 2029 – AUSTIN, TX and DURHAM, NC, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (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, today reported financial results for the second quarter ended June 30, 2025 and provided recent business highlights. “The second quarter of 2025 was a productive period for Shattuck, as we prepared and successfully submitted an IND application to the U.S. Food & Drug Administration (FDA),” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We expect to begin enrollment in our Phase 1 clinical trial, subject to regulatory alignment, in healthy volunteers later this quarter, and to complete the trial during the second quarter of 2026. Following our recent private placement, led by OrbiMed, we are in a strong position and expect to transition seamlessly into multiple Phase 2 clinical trials for our lead asset, SL-325, and fund our operations into 2029.” DR3 Program Development in 2025 Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 blocking antibody for the treatment of IBD and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325 include: An IND was submitted to the FDA for SL-325 in July 2025; clearance expected in the third quarter of 2025. Phase 1 clinical trial will evaluate safety, tolerability, immunogenicity and pharmacokinetics in healthy volunteers, and determine the recommended Phase 2 dose and dosing schedule of SL-325. Subject to regulatory alignment, dosing of the first participant in the single-ascending dose (SAD) portion of the trial is expected in the third quarter of 2025, and the multiple-ascending dose (MAD) portion of the trial is expected to commence in the fourth quarter of 2025. Phase 1 enrollment of the SAD and MAD portions of the clinical trial is expected to be completed 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 other biologically relevant targets for the treatment of patients with IBD. Shattuck plans to nominate a lead bispecific candidate from its preclinical pipeline in 2025. Recent Events Shattuck participated in the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs presented at the conference. Details are on the Events & Presentations section of the Company’s website. Shattuck participated in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs presented at the conference. Details are on the Events & Presentations section of the Company’s website. Upcoming Events Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website. H.C. Wainwright 27th Annual Global Investment Conference, September 8-10, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs will provide a corporate presentation, and management will participate in one-on-one meetings. Second Quarter 2025 Financial Results Cash and Cash Equivalents and Investments: As of June 30, 2025, cash and cash equivalents and investments were $50.5 million, as compared to $105.3 million as of June 30, 2024. Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended June 30, 2025, as compared to $19.2 million for the quarter ended June 30, 2024. General and Administrative (G&A) Expenses: G&A expenses were $4.4 million for the quarter ended June 30, 2025, as compared to $5.3 million for the quarter ended June 30, 2024. Net Loss: Net loss was $12.5 million for the quarter ended June 30, 2025, or $0.24 per basic and diluted share, as compared to a net loss of $21.6 million for the quarter ended June 30, 2024, or $0.42 per basic and diluted share. Financial Guidance As of June 30, 2025, cash and cash equivalents were approximately $50.5 million, which does not include the anticipated net proceeds from the private placement announced on August 5, 2025. The total anticipated proceeds from the oversubscribed private placement of up to approximately $103 million, less offering expenses, combined with current cash and cash equivalents, are expected to fund operations into 2029. The closing of the private placement is contingent upon the IND clearance for SL-325 and the satisfaction of other customary closing conditions. Shattuck intends to use the anticipated net proceeds from the private placement (including the potential proceeds to be received upon the full exercise of the accompanying common stock warrants) for the clinical development of SL-325, including multiple Phase 2 clinical trials in Inflammatory Bowel Disease (IBD) and potentially another autoimmune disease, and for general corporate purposes. 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. Shattuck expects to commence a Phase 1 clinical trial in healthy volunteers 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 inflammatory and immune-mediated diseases. The Company is developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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: the aggregate amount of proceeds to be received from the private placement, including whether the common stock warrants will be exercised and provide the Company with additional capital; the closing of the private placement and associated satisfaction of closing conditions, including with respect to clearance of the Company’s IND; the use of proceeds from the private placement; expectations regarding the timing for enrollment of and dosing of patients in the Phase 1 trial for SL-325; the anticipated timing for completion of the Phase 1 trial for SL-325; expectations regarding the results of the Phase 1 trial for SL-325; anticipated Phase 2 clinical trials for SL-325; anticipated timing for nomination of an additional development candidate from the Company’s preclinical pipeline; and 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 the Company believes 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 the Company 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 Shattuck’s filings with the SEC), many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expected results of the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the Company’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals, including FDA clearance of our IND filing, which is a closing condition for the Company’s private placement; Shattuck’s expectations regarding the overall benefit of the strategic prioritization of its pipeline; liquidity and capital resources; and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent disclosure documents filed with the SEC. The Company claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims 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. [email protected]

Investor releaseQuarter not tagged2025-05-03

Shattuck Labs First Quarter 2025 Earnings: US$0.27 loss per share (vs US$0.37 loss in 1Q 2024)

Simply Wall St.

Net loss: US$13.7m (loss narrowed by 26% from 1Q 2024). US$0.27 loss per share (improved from US$0.37 loss in 1Q 2024). Our free stock report includes 6 warning signs investors should be aware of before investing in Shattuck Labs. Read for free now. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is expected to decline by 104% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 17%. Performance of the American Biotechs industry. The company's shares are up 25% from a week ago. It's necessary to consider the ever-present spectre of investment risk. We've identified 6 warning signs with Shattuck Labs (at least 3 which are significant), and understanding them should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-05-02

Shattuck Labs Reports First Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
– Company advances SL-325 program with an IND filing expected in the third quarter of 2025 – – Cash balance of approximately $60.9 million as of March 31, 2025, expected to fund operations into 2027 – AUSTIN, TX and DURHAM, NC, May 01, 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-mediated diseases, today reported financial results for the first quarter ended March 31, 2025 and provided recent business highlights. “All IND-enabling activities and regulatory interactions remain on-track to initiate the Phase 1 clinical trial for SL-325 in the third quarter of this year. We believe SL-325 is fundamentally differentiated in its approach to targeting the clinically validated DR3/TL1A pathway and could potentially provide best-in-class clinical remission rates for IBD patients,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “Spending last quarter continued to come in line with expectations, and wind-down activities associated with the discontinued oncology programs have now been substantially completed. We continue to be well-positioned to fund operations into 2027, beyond the results from our Phase 1 clinical trial for SL-325.” 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. First patient in for the SAD portion of the trial expected in the third quarter of 2025. Phase 1 enrollment completion 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. First Quarter 2025 Business Highlights and Other Recent Developments Recent Events Shattuck p…Read full document

– Company advances SL-325 program with an IND filing expected in the third quarter of 2025 – – Cash balance of approximately $60.9 million as of March 31, 2025, expected to fund operations into 2027 – AUSTIN, TX and DURHAM, NC, May 01, 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-mediated diseases, today reported financial results for the first quarter ended March 31, 2025 and provided recent business highlights. “All IND-enabling activities and regulatory interactions remain on-track to initiate the Phase 1 clinical trial for SL-325 in the third quarter of this year. We believe SL-325 is fundamentally differentiated in its approach to targeting the clinically validated DR3/TL1A pathway and could potentially provide best-in-class clinical remission rates for IBD patients,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “Spending last quarter continued to come in line with expectations, and wind-down activities associated with the discontinued oncology programs have now been substantially completed. We continue to be well-positioned to fund operations into 2027, beyond the results from our Phase 1 clinical trial for SL-325.” 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. First patient in for the SAD portion of the trial expected in the third quarter of 2025. Phase 1 enrollment completion 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. First Quarter 2025 Business Highlights and Other Recent Developments Recent Events Shattuck participated in the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs presented at the Conference. Details are on the Events & Presentations section of the Company’s website. Shattuck Labs participated in an oral presentation at ECCO in February 2025. Full press release can be found here. Presentation can be found here. 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. Poster can be found here. 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 Labs to present at the PEGS Boston Summit on May 12, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs, will present on SL-325 in the Advances in Immunotherapy section of the conference. Details of the presentation will be on the Events & Presentations section of the Company’s website after the conclusion of the live event. Shattuck Labs to participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8-9, 2025. Company management will participate in scheduled one-on-one investor meetings. First Quarter 2025 Financial Results Cash and Cash Equivalents and Investments: As of March 31, 2025, cash and cash equivalents and investments were $60.9 million, as compared to $114.6 million as of March 31, 2024. Research and Development (R&D) Expenses: R&D expenses were $9.9 million for the quarter ended March 31, 2025, as compared to $16.3 million for the quarter ended March 31, 2024. General and Administrative (G&A) Expenses: G&A expenses were $4.5 million for the quarter ended March 31, 2025, as compared to $4.9 million for the quarter ended March 31, 2024. Net Loss: Net loss was $13.7 million for the quarter ended March 31, 2025, or $0.27 per basic and diluted share, as compared to a net loss of $18.5 million for the quarter ended March 31, 2024, or $0.37 per basic and diluted share. Financial Guidance As of March 31, 2025, cash and cash equivalents were approximately $60.9 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. About Shattuck Labs, Inc. Shattuck Labs, Inc. (Nasdaq: STTK) is a biotechnology company specializing in the development of potential treatments for inflammatory and immune-mediated diseases. The Company is developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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 expected initiation and trial design of, and timing of enrollment in, our expected Phase 1 and Phase 2 clinical trial of SL-325; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates the timing of nomination of a lead bispecific antibody candidate; 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 preclinical studies and 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, 2024, 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. [email protected]

Investor releaseQuarter not tagged2025-03-28

Shattuck Labs Full Year 2024 Earnings: Misses Expectations

Simply Wall St.

Net loss: US$75.4m (loss narrowed by 14% from FY 2023). US$1.49 loss per share (improved from US$2.05 loss in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 2.9%. Looking ahead, revenue is expected to decline by 121% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Performance of the American Biotechs industry. The company's shares are down 5.0% from a week ago. We should say that we've discovered 5 warning signs for Shattuck Labs (2 shouldn't be ignored!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-03-27

Shattuck Labs Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Highlights

GlobeNewswire
– Presented preclinical non-human primate (NHP) data at the 20th Congress of European Crohn’s and Colitis Organization in Inflammatory Bowel Diseases 2025 (ECCO) for SL-325, a potentially first-in-class blocking antibody to DR3, the receptor for TL1A; data demonstrated favorable safety profile, full receptor occupancy, lack of DR3 agonism – – SL-325 advances toward Phase 1; on track for IND filing in the third quarter of 2025 – – Cash balance of approximately $73.0 million as of December 31, 2024, expected to fund operations into 2027 – AUSTIN, TX and DURHAM, NC, March 27, 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-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided recent business highlights. “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 schedu…Read full document

– Presented preclinical non-human primate (NHP) data at the 20th Congress of European Crohn’s and Colitis Organization in Inflammatory Bowel Diseases 2025 (ECCO) for SL-325, a potentially first-in-class blocking antibody to DR3, the receptor for TL1A; data demonstrated favorable safety profile, full receptor occupancy, lack of DR3 agonism – – SL-325 advances toward Phase 1; on track for IND filing in the third quarter of 2025 – – Cash balance of approximately $73.0 million as of December 31, 2024, expected to fund operations into 2027 – AUSTIN, TX and DURHAM, NC, March 27, 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-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided recent business highlights. “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. About Shattuck Labs, Inc. Shattuck Labs, Inc. (Nasdaq: STTK) is a biotechnology company specializing in the development of potential treatments for inflammatory and immune-mediated diseases. The Company is developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A 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 expected initiation and trial design of, and timing of enrollment in, our expected Phase 1 clinical trial of SL-325; the anticipated timing of our preclinical studies for SL-425; the clinical benefit, safety and tolerability of SL-325; anticipated development of additional preclinical pipeline candidates the timing of nomination of a lead bispecific antibody candidate; 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 preclinical studies and 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, 2024, 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. [email protected]

TranscriptFY2023 Q32023-11-10

FY2023 Q3 earnings call transcript

Earnings source - 49 paragraphs
Operator

Good morning and welcome to the Shattuck Labs Third Quarter 2023 Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to your host, Conor Richardson, Vice President of Investor Relations at Shattuck Labs. Conor, please go ahead.

Conor Richardson

Thank you, operator. Good morning, everyone, and welcome to the Shattuck Labs conference call regarding our third quarter 2023 financial results and recent business updates. The press release reporting our financial results was issued pre-market this morning and can be found on the Investor Relations section of our website, shattucklabs.com. During this morning’s call, the Shattuck leadership team will provide a business overview of the third quarter 2023, including clinical development updates. Speaking on today’s call will be our Chief Executive Officer and Scientific Co-Founder, Dr. Taylor Schreiber; our Chief Medical Officer, Dr. Lini Pandite; and our Chief Financial Officer, Mr. Andrew Neill. We will then open the call for questions following our prepared remarks. Before we begin, I would like to remind you that today’s webcast contains forward-looking statements within the meaning of Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements represent management’s judgment as of today and may involve certain risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on these risks and uncertainties, please refer to our most recent quarterly report on Form 10-Q for the quarter ended September 30, 2023, and our other filings with the SEC, which are available from the SEC’s website or on our corporate website, shattucklabs.com. Any forward-looking statements represent our views as of today, November 9, 2023. With that, I will now turn the call over to Dr. Schreiber, our Chief Executive Officer. Taylor?

Taylor Schreiber

Thank you, Conor. Good morning, everyone, and thank you for joining us today. We are very pleased that our lead clinical stage product candidate, SL-172154, has advanced to a stage where we are able to begin sharing clinical data from both our hematologic and solid tumor programs. Importantly, we are also pleased to have observed our first responses and efficacy data across our clinical trials, including our Phase 1B clinical trial in platinum-resistant ovarian cancer and our Phase 1A/B clinical trial in acute myeloid leukemia or high-risk myelodysplastic syndromes. We look forward to providing more details throughout the call. For the rest of the call, we will refer to SL-172154 as 154. This morning. We will discuss interim data from our Phase 1B clinical trial of SL-172154 in combination with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. In addition, we will discuss the encouraging data from our ongoing Phase 1A/B clinical trial in acute myeloid leukemia or high-risk myelodysplastic syndromes that was described in an abstract released last week and will be presented at the American Society of Hematology Annual Meeting in early December. These data include dose escalation data for SL-172154 as monotherapy and in combination with azacitidine in primarily relapsed refractory AML and higher-risk MDS patients. As a reminder, SL-172154 is a dual-sided fusion protein. It inhibits the CD47 checkpoint receptor and also directly activates immune cells by CD40 engagement. The CD47 landscape has evolved significantly over the past 18 months. Several advanced programs have encountered significant challenges with toxicity, including destructive anemia. These safety issues and the related clinical challenges have led to significant skepticism regarding the potential clinical utility of the CD47 pathway. We believe, however, that these safety issues are the result of the design of some CD47 targeted agents and are not inherent to the CD47 target itself. We believe that conclusions currently being drawn regarding CD47 as a pathway should be confined only to specific individual agents. We designed SL-172154 to not engage Fc gamma receptors in order to avoid the anemias and other cytopenias that have plagued other agents in the class. Earlier this year at ASCO, we shared clinical data from our Phase 1A dose escalation clinical trial in platinum-resistant ovarian cancer or PROC patients. That data demonstrated that SL-172154 does not cause destructive anemia, and this observation remains true today. We remain encouraged by the safety and tolerability profile of SL-172154 to date. SL-172154 also differentiates from all other CD47 inhibitors through its CD40 agonist domain. This attribute of SL-172154 has already led to a differentiated pharmacodynamic profile and dose escalation studies and may contribute to improved response rates, accelerated kinetics of response and durability of responses in our [Technical Difficulty] Dr. Lini Pandite, our Chief Medical Officer, will expand [Technical Difficulty]. At a high level, our confidence is bolstered by the interim results of SL-172154 in combination with pegylated liposomal doxorubicin, which we will call PLD in patients with PROC. As of October 31, 2023, we have observed an overall response rate of 27%, which if it holds, would exceed the PLD monotherapy benchmark response rate of 4% in the Pfizer sponsored JAVELIN Ovarian 200 trial. We will also highlight recent data from our Phase 1A/B clinical trial evaluating SL-172154 both as monotherapy and in combination with azacitidine in patients with relapsed refractory higher-risk MDS and AML. We completed the dose escalation portion of this study in the second quarter of 2023. And these data will be presented at the upcoming ASH Annual Meeting in December. We have initiated two different frontline dose expansion cohorts, where SL-172154 is being combined with azacitidine in patients with previously untreated higher-risk MDS or TP53 mutant AML. We are very pleased with the momentum in this trial. And enrollment has proceeded very quickly, which we attribute to the high unmet need for these patients and our investigators’ enthusiasm regarding the differentiated profile of SL-172154. We look forward to sharing an interim update from the frontline dose expansion cohorts in conjunction with ASH next month. With that, I will now turn the call over to Lini, who will dive into our clinical programs and provide an update on recent clinical data and activities.

Lini Pandite

Thanks, Taylor, and good morning, everyone. 2023 continues to be a year of focused operational execution. I’m grateful for the relentless efforts of our team, our participating investigators and most importantly, the patients themselves that have enabled this progress. As Taylor outlined, I will first provide an update from our Phase 1B trial investigating SL-172154 in combination with PLD in patients with platinum-resistant ovarian cancer and then provide some color on the data in last week’s ASH abstract from our Phase 1A/B trial investigating SL-172154 in combination with azacitidine in patients with AML and higher-risk MDS. Let’s start with our ongoing Phase 1B combination clinical trial of SL-172154 in patients with platinum-resistant ovarian cancer. As of the data cutoff date of October 31, 2023, 16 patients with platinum-resistant ovarian cancer have been enrolled into this study. These patients have a median of 1.5 prior lines of systemic therapy. SL-172154 plus PLD had an acceptable safety profile, which was consistent with the safety profile of the individual agents. So SL-172154, the most common drug-related adverse event was infusion-related reaction, mostly Grade 1 or Grade 2. As of the data cutoff date of October 31, 2023, 11 patients were evaluable for efficacy. We offset three partial responses. One confirmed partial response and two, unconfirmed partial responses. As of November 9, 2023, both patients with unconfirmed partial responses are still on study and have not reached the date of confirmatory response assessment. Four patients had a best response of stable disease, and four patients had progressive disease. As of the data cutoff date of October 31, 2023, the disease characteristics of the patients enrolled in this trial are similar to the characteristics of the patients enrolled in the Pfizer sponsored JAVELIN Ovarian 200 trial, which is a recently published randomized trial that included a PLD controlled arm. In the JAVELIN trial, the overall response rate for patients treated with PLD monotherapy was 4%. Additionally, to date, a higher proportion of patients enrolled in our trial have bulky disease measuring over 5 cm in diameter and pre-treatment with bevacizumab, both of which are poor prognostic factors. We expect to complete enrollment of the expansion cohorts this quarter and to provide additional response and response durability data from the full cohort by mid-year 2024. Overall, we are encouraged by the emerging data from this combination cohort and look forward to update with more patients and longer follow-up. We are also continuing enrollment in our Phase 1B trial of SL-172154 in combination with mirvetuximab soravtansine in platinum-resistant ovarian cancer. Enrollment and dosing are progressing quickly. We expect to report initial combination data from this trial mid-year 2024. Let us now turn to the progress we have made in our Phase 1A/B clinical trial in AML and higher-risk MDS. In this trial, we are evaluating the safety, tolerability pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-172154 as both monotherapy and in combination with azacitidine, the current standard of care. As described in our ASH abstract, 37 adult patients with primarily relapsed refractory AML or higher-risk MDS have received SL-172154 as monotherapy or in combination with azacitidine. These patients had a median of two prior lines of therapy. There are 19 patients in the monotherapy cohort and 18 patients in the combination cohort as of the data cutoff date of May 25, 2023. In this trial, SL-172154 had an acceptable safety profile as a monotherapy and in combination. For SL-172154, the most common drug-related adverse events was infusion-related reactions, mostly Grade 1 or 2. Monotherapy responses have not been reported with CD47 targeted agents in heavily pre-treated relapsed refractory AML patients. Consequently, we were particularly encouraged by a monotherapy response in a heavily pre-treated relapsed refractory TP53 mutant AML patient. This patient had a rapid response to SL-172154 monotherapy, achieved a morphologic leukemia-free state and was subsequently taken to allogeneic transplant and remains leukemia free. Additionally, in other patients, we also observed anti-leukemic activity in the form of blast count reductions. We also enrolled several previously untreated TP53 mutant higher-risk MDS patients in the dose escalation portion of our trial. These data included in the ASH abstract. As of the data cutoff date of July 10, 2023, anti-tumor activity was observed in combination with azacitidine in two of four response-evaluable patients with previously untreated TP53 mutant higher-risk MDS. We observed one complete response in a treatment-related TP53 mutant higher-risk MDS patient who remains on study and one marrow complete response in a patient who has taken to bone marrow transplant. Two patients had best response of stable disease. One of whom was taken to transplant. Overall, we are encouraged by the growing body of data that validates the unique mechanism of action of SL-172154 and its therapeutic potential to address the unmet needs of patients with AML and higher-risk MDS. Our data continue to show evidence of CD40-driven pharmacodynamic activity, both in peripheral blood and bone marrow. We believe that CD40 activation and the resulting involvement of the adaptive immune system is important in the heme indications and may provide significant improvement to CD47 blockade in terms of both improved response rates and durability of response. We look forward to presenting the complete data of the dose escalation portion of the trial in relapse refractory patients at the ASH meeting. And sharing initial data from the frontline expansion cohorts during a company-sponsored event around the time of ASH next month. With that, I will now turn the call over to Mr. Neill to discuss our financial update. Andrew?

Andrew Neill

Thank you, Lini, and good morning, everyone. As Conor mentioned at the onset of the call, the full financial results for the third quarter 2023 are available in our 10-Q and earnings press release filed premarket this morning. I would like to focus on a few key points from our disclosures. We continue to be well positioned financially. As of September 30, 2023, our cash and cash equivalents and investments were $101.1 million. In the third quarter of 2023, our research and development expenses were $24.2 million as compared to $18.9 million for the third quarter of 2022. In the third quarter of 2023, our general and administrative expenses were $5.1 million as compared to $6.6 million for the third quarter of 2022. Our net loss for the third quarter of 2023 was $27.5 million or $0.65 per basic and diluted share, as compared to a net loss of $24.6 million or $0.58 per basic and diluted share for the third quarter of 2022. Based on our current operating and development plans, we reiterate our financial guidance. Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations through year-end 2024, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on our company's current operational plans and excludes any capital that may be received, proceeds from any business development transactions and/or additional costs associated with clinical development activities that may be undertaken. With that, I'll hand the call back to Dr. Schreiber for final comments. Taylor?

Taylor Schreiber

Thank you, Andrew. In the third quarter of 2023, we made excellent progress across the four different ongoing expansion cohorts in our PROC, AML and higher-risk MDS trials. We expect several additional milestones and clinical updates through the end of this year. For data updates, we expect to first present complete data from the dose escalation portion of our Phase 1A/B clinical trial of SL-172154 in relapsed refractory AML and higher-risk MDS patients at the 65 ASH annual meeting. We also plan to present initial data from the frontline TP53 mutant AML dose expansion cohort and the frontline higher-risk MDS dose expansion cohort combining SL-172154 with azacitidine in the fourth quarter of this year during a company-sponsored event following ASH. For clinical program milestones, we expect to complete enrollment in the frontline higher-risk MDS cohort in the fourth quarter of 2023. We also plan to complete enrollment of our Phase 1B dose expansion cohort of SL-172154 in combination with PLD and PROC in the fourth quarter of this year. Should the initial results gathered in our heme and solid tumor studies hold as the size and maturity of these cohorts increase, SL-172154 would have first-to-market potential among CD47 agents and PROC, as well as both AML and higher-risk MDS. These are all areas of significant unmet medical need with multiple opportunities for accelerated development and subsequent registration directed studies. Taken together, I believe the combination of our experienced team, transformational science and protein engineering, as well as financial resources, puts us in a strong position to move beyond our next set of milestones and into 2024. Before we conclude today's call, I would once again like to thank our patients and their families, the entire Shattuck team, our investors and the many people who have been supportive along the way. With that, we are happy to take questions. Operator?

Operator

Thank you. [Operator Instructions] Your first question comes from the line of Jonathan Miller of Evercore ISI. Your line is open.

Jonathan Miller

Thank you so much for taking the question, guys, and congrats on getting to some real clinical data here. I'd love to start on the PROC study and ask a little bit more detail about the baseline characteristics of these patients. Obviously, these are platinum resistant, but can you give a little bit more granularity on what other variety of agents these patients have seen in their prior lines of therapy? And then maybe a little bit more open ended, as we think about comping this program to other CD47 programs, which obviously have – well, had not been gathering the excitement that they once did, what is your expectation for being able to demonstrate in these patients that are responding the impact of CD40 ligand side of the molecule on the efficacy that you're seeing?

Taylor Schreiber

Great. Well, good morning, Jon. Thank you and thanks for the questions. Lini, why don't you go ahead and answer Jon's first question around the baseline characteristics of these patients and how they compare to JAVELIN and then I'll follow you with the second part.

Lini Pandite

Thank you, Jon, for the question. Yes, these patients compare very well to the patients who were enrolled in the JAVELIN study. The majority of these patients and that's 88% of these patients, had failed the frontline platinum-containing regimen and were resistant to frontline platinum. So 100% of these patients had received platinum, 56% of these patients had also received bevacizumab. These patients have also received PARP inhibitors. That number isn't in the slide deck, but patients have received PARP as well.

Taylor Schreiber

Great. Thanks Lini. And, pardon me, with regard to how SL-172154 needs to show in these patients and how that compares to what's evolved in the AML and higher-risk MDS space with other CD47 inhibitors, as most of the audience probably knows, this has been an evolving space over the last three years and certain agents might have been discontinued in the AML and higher-risk MDS space early on purely for competitive reasons under the assumption that magrolimab would be first-to-market and therefore, the commercial opportunity might have dwindled. Clearly, that's changed, and we certainly look forward to Gilead sharing more data around exactly what happened with ENHANCE and ENHANCE-2 to as part of their new commitment to increase transparency. It seems, however, as though many of these patients enrolled to the magrolimab arms, may have discontinued earlier or may have had dose interruptions in a way that could have impacted the top line readouts of that study. And hopefully, we'll learn more about that. Regardless, SL-172154 has to stand on its own two feet in syndication, and clearly we're encouraged by the differentiated safety profile, the lack of destructive anemia. And in pre-clinical models, the activity of CD40 agonism translated to both improved response rates and improved response durability. And clearly in patients like this, improved CR rates, not just over the expectations of azacitidine alone, but over prior benchmarks with AZA plus, drugs like magrolimab are important to exceed. And if and only if you exceed those CR rates, you then have an opportunity of seeing an improved duration of response and improved overall survival. And so that's what we'll be looking to see and certainly share the first glimpse of that in proximity to ASH in December. And in the higher-risk MDS population, we're looking to exceed the azacitidine benchmark in terms of complete response, which comes from the Apria [ph] Study of about 22% by at least double. And in terms of the TP53 mutant AML cohort, where azacitidine alone delivers complete response rates in the low-single-digits. And the combination of AZA-Magro, we'll get more data I hope soon, but seems to deliver CR rates in the low-30%s. And again, we'll look to exceed that by a substantial margin. So these are things that we have to show on our own as the field, hopefully learns more about the other agents that have been discontinued.

Operator

Thank you. Your next question comes from the line of Joe Pantginis of H.C. Wainwright. Your line is open and everybody.

Joe Pantginis

Hey, everybody. Good morning. Thanks for taking the question and nice to see the early data. Congrats as well. So maybe Taylor, wanted to see if we could get or do some scenario analysis here, maybe start with the AML/MDS study? What do you – obviously the expansion cohorts need to read out, but could you envision a, say more targeted path for initial approval, say targeting TP53 or other focused mutation? And then also, can you provide any color with regard to the kinetics of the responses that you're starting to see in the AML/MDS study?

Taylor Schreiber

Sure, thanks for the question, Joe, and good morning. So as you know, one of the expansion cohorts is already specific to TP53 mutant AML patients where even in the frontline setting, there is a very high unmet medical need. And there certainly would be an opportunity for an accelerated path there if we were to first hit the CR rate in excess of 40% or so. I think that would be interesting and be a good indicator of what that could translate into in terms of duration of response, where we'll be looking to exceed something in the six-, seven-month range as a benchmark. And those are readouts that we expect to come in the first half of next year, having fully enrolled that TP53 mutant AML cohort during the third quarter and would be the basis for discussion with regulators about first, an incremental expansion of that study to confirm that data and subsequently, what the registration directed path could be there. But I do agree that there is a potential accelerated opportunity. In terms of the kinetics of response, I can comment on a couple of data points that we have and will certainly add to this soon. The – first of all, the relapsed refractory AML patient that is disclosed in the ASH abstract as a monotherapy responder, as Lini outlined, this was a tough patient. They've failed 7+3, they've failed FLAG, they've failed VEN-AZA. And then they came on to study and had a response within the first cycle of SL-172154 monotherapy. That's unusual for a patient like this, but it's consistent with the kinetics of response that we had observed with the pre-clinical equivalent of SL-172154 in various models. I can also say that the confirmed responder in PROC, that response started at the very first eight-week scan. And that's also the case with the two unconfirmed responders in PROC where that first eight-week scan, they met that PR criteria. So it appears that the kinetics of response to SL-172154 are rapid. And that's helpful, especially when looking at initial data sets and trying to forecast how that might translate.

Joe Pantginis

Great. Thanks, Taylor.

Taylor Schreiber

Thanks Joe.

Operator

Your next question comes from the line of Marc Frahm of TD Cowen. Your line is open.

Marc Frahm

Hey, thanks for taking my questions and congrats on the early response data today. Maybe you start it off with when – can you just explain the gap from the 16 who have seen drug and the 11, how many of those five are still on trial awaiting the first scan versus you having maybe discontinued for other reasons? And then are you seeing any – to the point of about half the patients who have had PARP expansion [ph] and half have not. I know its small numbers, but any sense that maybe efficacy is in one of those populations more than the other?

Taylor Schreiber

Great. Good morning, Marc. Thanks for the question. Lini, why don't you go ahead and take those. Lini, you might be on mute.

Lini Pandite

Sorry. Marc, can you repeat the first question? I lost the connection.

Marc Frahm

Oh sorry. Yes, the safety database has 16 patients in it today and 11 are efficacy evaluable. Can you just explain the kind of five patient cap there? How many of them are waiting for their first scan versus maybe discontinued for others?

Lini Pandite

Yes. All five are still on study. They are waiting for their first scan.

Marc Frahm

Okay. And then of the responses you're seeing, any sense that maybe this efficacy is more or less in the PARP experienced versus non-PARP eligible type of patient?

Lini Pandite

At the moment, Marc, it's too early to kind of draw those conclusions. The first patient had received PARP. The first patient with the PR had received PARP inhibitors. The second patient – the second – the next two patients have received Bev, so it's hard to draw any conclusions at this.

Marc Frahm

Okay, makes sense. And then thinking forward to next year, when we'll see the initial MIRV combo data. There's a couple of different populations based on MIRV expression level, sorry, fully expression levels. Just can you kind of frame how big of a data set you're expecting to be able to provide and the robustness you'll be able to look across those different expression levels?

Lini Pandite

Yes. We are expecting it to enroll up to 70 patients. That 70 patients will include high, medium and low. And we are working with ImmunoGen to benchmark what would be an interesting response rate and durability of response in each of those subgroups.

Operator

Your next question comes from the line of Kaveri Pohlman of BTIG. Your line is open.

Unidentified Analyst

Hi. Thank you for taking my question. I'm Christian. I'm on for Kaveri. So you actually answered part of my question and it was just about ELAHERE combo trial wanted to know what would you guys consider a meaningful ORR? Like are you guys has being close to determining that, considering that this is enrolling folate receptor alpha, medium and low expressers. But beyond that, I noticed that ELAHERE’s registrational trial required 100% of the patients to receive prior bevacizumab. So going forward, are there plans to also make this a requirement in that trial?

Taylor Schreiber

Great. Good morning, Christian thanks for the question. Lini, why don't you go ahead and take that question as well.

Lini Pandite

Thank you for the question. So the trial was designed with the exact eligibility criteria as SORAYA. So all patients were required to have received bevacizumab, and that's how the trial was written.

Unidentified Analyst

Got it. Thank you. And my next question is just about the PLD combo trial, are you guys planning to use biomarker analysis to determine differences in responders and nonresponders? If so, are you planning to use this to take eligible patients in the future?

Taylor Schreiber

Yes. Thanks, Christian. We are continuing to collect a variety of different biomarker data from these patients, some of which is similar to the data that was shared in our ASCO abstract earlier this year with regard to peripheral cytokine responses, margination of CD40 expressing cells, changes in the immunophenotype of both peripheral cells as well as through evaluation of pre- and on-treatment biopsies from these patients. And we hope certainly that, that data may inform a patient selection strategy or a responder, nonresponder analysis at a subsequent date. But we'll report on that as the size of the data set increases toward the end of the study.

Unidentified Analyst

Got it. Thank you. That’s helpful. Thanks for taking my questions.

Taylor Schreiber

No problem.

Operator

Thank you. [Operator Instructions] Your next question comes from the line of Yigal Nochomovitz of Citi. Your line is open.

Yigal Nochomovitz

Yes. Hi thanks for taking the question. On PROC, I was just wondering if you plan to look at or if you already have looked at any correlation between the platinum-free interval for these patients and the degree of response? And then on heme, with respect to the frontline studies in TP53 and higher-risk MDS, do you have any reason to believe or biologic hypothesis that the SL-172154 either combo would be potentially more effective in one of these cohorts versus the other? Thank you.

Taylor Schreiber

Sure. Yes, good morning Yigal. Thanks for the questions. As Lini mentioned, 88% of the patients enrolled to date in the PROC study progressed within the first six months of platinum. And so this is a fairly homogeneous poor prognosis group with rapid kinetics of disease. And we really – as Lini alluded to before, the size of the data set is not large enough where we can try to distinguish between did it make a difference if the patient progressed on platinum within one to three versus three to six months. All that we can say is that all of these patients were rapidly resistant to primary platinum. And then with regard to whether there's a difference in the subpopulations or TP53 mutant AML versus higher-risk MDS in conjunction with azacitidine, we're looking forward to sharing more data there soon with the frontline cohorts. And what I can say is that it's always been a little bit of a mystery why the TP53 mutant AML patients with some prior studies seem to do a bit better than the TP53 wild-type patients because otherwise, those are quite similar diseases. And one of the hypotheses that's been out there in the literature is that the TP53 mutant patients seem to have a higher mutational burden. Perhaps there were more tumor-infiltrating CD8+ T cells, i.e., perhaps it was a more immunogenic tumor to start than some of the TP53 wild-type patients. And part of the value proposition of adding a CD40 agonist to a CD47 inhibitor was framed around the expectation that some of those characteristics might be normalized because of the immune-activating potential of CD40. And so it's certainly something that we're looking at. And a priori, we can't necessarily say that, that would indeed be the case, but we'll be sharing data soon and following that over the next six to nine months.

Yigal Nochomovitz

Okay. Thank you.

Taylor Schreiber

You’re welcome.

Operator

And your next question comes from the line of Gil Blum of Needham & Company. Your line is open.

Gil Blum

Hey, good morning and thanks for taking our question. So maybe just to focus here on the ovarian cancer. What would you gauge as a go/no-go decision on PLD plus SL-172154? And – how relevant is PLD these days and PROC? I mean you faced some enrollment challenges here. So I'd love your $0.02 here. And I have a follow-up.

Taylor Schreiber

Yes, good morning Gil and thanks for the question. I mean, I can tell you that when we first started this study, there were many investigators who only joined the study because of the ELAHERE arm because as is highlighted by the JAVELIN study, PLD doesn't help very much in these patients. And – it's now – it took us about as long to enroll the first five patients in the study as it has to now complete this – complete enrollment in the study. And perceptions can be changed by data, right? And I think we're starting to see that SL-172154 is adding something in both heme and solids. And certainly, and – people always seem to shy away from the word synergy, and we can't say that quite yet. But if these data hold, then that's what this will mean in the PLD setting. This is an all-comer population and a response rate in excess of 25% in an all-comer PROC setting, non-biomarker selected in and of itself could be meaningful and could be very meaningful if it is accompanied by a duration of response that exceeds five months. And so those are benchmarks that we will be looking toward as we – as the data mature over the first half of next year. And similar to my comments on the TP53 mutant AML cohort in terms of what the next step would be, we'd be looking at an incremental expansion of the current study somewhere between adding 20 and 40 patients or so to confirm the results and to enroll those patients with our current momentum. And that would be the basis then of a regulatory discussion for the first registration-direct study.

Gil Blum

Excellent. Very helpful. And my follow-on is, can you get a sense of the behavior of the non-responding patients in stable diseases kind of – in immuno-oncology, a lot of times you see at least prolonged stable diseases. Thank you.

Taylor Schreiber

Sure. It's too early to say too much. As Lini alluded to, they were out of the balance of eight patients four had a best response of progressive disease and four had a best response of stable disease of varying lengths of time. And I think we need to wait and see the full data set from the initial 20-patient cohort before we can make any assertions about whether those patients with stable disease had stable disease for longer than you would expect in a patient population like this.

Gil Blum

All right, excellent. Thanks for taking our questions.

Taylor Schreiber

Thanks, Gil.

Operator

Thank you. This concludes the Q&A session of the call. At this time, I would like to turn the call back over to Taylor Schreiber, Chief Executive Officer of Shattuck Labs for closing remarks.

Taylor Schreiber

Thank you, operator, and thank you all for joining the Shattuck Labs' Third Quarter 2023 Financial Results and Business Update Conference Call. We appreciate your continued interest in Shattuck and we look forward to updating you on our milestones later this year. Thank you.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect. Have a wonderful day.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook