Form 8-K

8-K — Shattuck Labs, Inc.

Accession: 0001628280-26-070613

Filed: 2026-11-05

Period: 2026-11-05

CIK: 0001680367

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — sttk-20261105.htm (Primary)

EX-99.1 (sttk_3q2026earningsrelease.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: sttk-20261105.htm · Sequence: 1

sttk-20261105

0001680367FALSE00016803672025-08-072025-08-07

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2026

Shattuck Labs, Inc.

(Exact name of registrant as specified in its charter)

Delaware 001-39593 81-2575858

(State or other jurisdiction of

incorporation or organization) (Commission File Number) (I.R.S. Employer

Identification Number)

500 W. 5th Street, Suite 1200

Austin, TX 78701

(Address of principal executive offices including zip code)

(512) 900-4690

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuance to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.0001 per share STTK The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act

☐

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Shattuck Labs, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

Exhibits

Exhibit

Number Description of Exhibit

99.1

Press release issued by Shattuck Labs, Inc. regarding its financial results for the quarter ended September 30, 2026, dated November 5, 2026.

104 The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Shattuck Labs, Inc.

Date: November 5, 2026

By:

/s/ Dr. Taylor Schreiber

Dr. Taylor Schreiber

Chief Executive Officer

(principal executive officer)

EX-99.1

Filename: sttk_3q2026earningsrelease.htm · Sequence: 2

Document

Exhibit 99.1

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

–Initiated the RECEPTIVE-CD1 Phase 2b clinical trial of SL-325 in Crohn’s disease; 12-week induction data expected in the first half of 2028 –

–Announced RECEPTIVE-HS1 Phase 2 clinical trial of SL-325 in hidradenitis suppurativa; trial initiation expected in the fourth quarter of 2026 –

–Presented preclinical data for SL-846 at UEG Week 2026, including data from a chronic toxicology study in non-human primates –

AUSTIN, TX and DURHAM, NC, Nov. 05, 2026 -- 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 third quarter ended September 30, 2026 and provided recent business highlights.

“We are very excited to begin Phase 2 clinical development with SL-325 in both Crohn’s disease and hidradenitis suppurativa. We believe these two studies will allow direct comparisons with the TL1A antibody class and evaluate the efficacy that may be left on the table due to the potential immunogenicity liabilities of TL1A antibodies,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In addition, SL-846 has demonstrated a compelling profile in preclinical studies, and we expect to share initial Phase 1 clinical data for what we expect to be a first-in-class DR3 by IL-23 receptor blocking antibody in 2027."

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, hidradenitis suppurativa (HS), and other inflammatory and immune-mediated diseases. Phase 1 clinical trial results demonstrated favorable safety and tolerability, potentially best-in-mechanism immunogenicity with an antidrug antibody rate of 3.7%, and highly durable inhibition of TL1A binding to DR3 that may enable quarterly maintenance dosing.

•Initiated the RECEPTIVE-CD1 Phase 2b clinical trial of SL-325 in patients with moderately-to-severely active Crohn's disease.

◦Randomized, double-blind, placebo-controlled trial designed to evaluate three dose levels of SL-325 compared with placebo in approximately 232 patients, randomized 1:1:1:1.

◦Primary endpoint is endoscopic response at 12 weeks. These data are expected in the first half of 2028.

•Announced plans to initiate the RECEPTIVE-HS1 Phase 2 clinical trial of SL-325 in patients with moderate to severe hidradenitis suppurativa, with trial initiation expected in the fourth quarter of 2026.

◦HS is the second Phase 2 indication for SL-325 and expands development beyond IBD.

◦Submitted an Investigational New Drug (IND) application to the FDA in October 2026.

◦Designed RECEPTIVE-HS1 as a randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating two dose levels of SL-325 compared with placebo in approximately 150 patients, randomized 1:1:1.

◦Primary endpoint is HiSCR50 response at Week 16, with data expected in the first half of 2028.

•Appointed Shoba Ravichandran, M.D., as Senior Vice President, Clinical Development, to lead the clinical development of SL-325 in HS. Dr. Ravichandran brings more than 20 years of drug development experience, including leading the global approval of Cosentyx in HS at Novartis.

SL-846

Shattuck’s lead bispecific product candidate, SL-846, is a potentially first-in-class, half-life extended DR3 x IL-23 receptor (IL-23R) blocking antibody for the treatment of inflammatory and immune-mediated diseases.

•Presented preliminary preclinical data for SL-846 at UEG Week 2026, including data from the GLP toxicology study in non-human primates, which showed the following:

◦Well tolerated through the top dose of 100 mg/kg.

◦No evidence of DR3 or IL-23R agonism.

◦Full and durable blockade of TL1A binding to DR3, and complete blockade of IL-23 signaling.

◦Data from the NHP study support potential quarterly subcutaneous dosing in humans.

◦NHP and in silico analyses suggest that SL-846 may have a superior immunogenicity profile to TL1A directed bispecific antibodies; projected human anti-drug antibody rate of between 8-12%.

•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 events. Details will be included on the Events & Presentations section of the Company’s website.

•Evercore ISI 9th Annual Healthcare Conference, November 30-December 1, 2026. Management will participate in a fireside chat, and in one-on-one meetings.

•Piper Sandler 38th Annual Healthcare Conference, December 2-3, 2026. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs will present at the conference, and management will participate in one-on-one meetings.

Third Quarter 2026 Financial Results

•Cash and Cash Equivalents and Investments: As of September 30, 2026, cash and cash equivalents and short-term investments were $196.3 million, as compared to $86.1 million as of September 30, 2025.

•Research and Development (R&D) Expenses: R&D expenses were $21.6 million for the quarter ended September 30, 2026, as compared to $7.6 million for the quarter ended September 30, 2025.

•General and Administrative (G&A) Expenses: G&A expenses were $5.5 million for the quarter ended September 30, 2026, as compared to $4.1 million for the quarter ended September 30, 2025.

•Net Loss: Net loss was $25.2 million for the quarter ended September 30, 2026, or $0.14 per basic and diluted share, as compared to a net loss of $10.1 million for the quarter ended September 30, 2025, or $0.14 per basic and diluted share.

Financial Guidance

As of September 30, 2026, cash and cash equivalents, and short-term investments, were $196.3 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 demonstrated high

affinity binding and superior activity over TL1A antibodies, and provided 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 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 is being evaluated in a Phase 2 clinical trial in patients with Crohn’s disease, with data from the induction portion of the trial expected in the first half of 2028. We also expect to evaluate SL-325 in a Phase 2 clinical trial in patients with hidradenitis suppurativa, with data from the primary treatment portion of the trial expected in the first half of 2028.

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 that has been 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 blocking 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 and SL-846; the anticipated timing of initiation of a Phase 2 clinical trial of SL-325 in patients with HS; the clinical benefit, safety and tolerability of SL-325; the anticipated release of data from SL-325; the 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. Neill

Chief Financial Officer

Shattuck Labs, Inc.

InvestorRelations@shattucklabs.com

SHATTUCK LABS, INC.

CONDENSED BALANCE SHEETS

(Unaudited)

(In thousands)

September 30,

2026

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

61,758

54,192

Investments

134,553

23,873

Prepaid expenses and other current assets

5,293

4,410

Total current assets

201,604

82,475

Property and equipment, net

3,628

6,114

Investment in related party

1,000

Other assets

1,743

1,437

Total assets

207,975

91,026

Liabilities and Stockholders’ Equity

Current Liabilities:

Accounts payable

3,922

2,101

Accrued expenses

8,836

4,951

Total current liabilities

12,758

7,052

Non-current operating lease liabilities

1,555

1,584

Total liabilities

14,313

8,636

Stockholders’ equity:

Common stock

Additional paid in capital

679,365

512,906

Accumulated other comprehensive (loss) income

(62)

Accumulated deficit

(485,651)

(430,529)

Total stockholders' equity

193,662

82,390

Total liabilities and stockholders' equity

207,975

91,026

SHATTUCK LABS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except share and per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

2026

2025

2026

2025

Related party license revenue

—

1,000

—

1,000

Operating expenses:

Research and development

21,566

7,618

44,213

26,218

General and administrative

5,480

4,098

14,533

12,919

Expense from operations

27,046

11,716

58,746

39,137

Loss from operations

(27,046)

(10,716)

(58,746)

(38,137)

Other income

1,843

660

3,623

1,921

Net loss

(25,203)

(10,056)

(55,123)

(36,216)

Unrealized gain (loss) on investments

(68)

Comprehensive loss

(25,202)

(10,054)

(55,191)

(36,215)

Net loss per share – basic and diluted

(0.14)

(0.39)

(0.62)

Weighted-average shares outstanding – basic and diluted

183,224,648

72,184,818

142,408,056

58,102,543

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