Shattuck Labs, Inc.

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and related notes appearing in this Quarterly Report on Form 10-Q, as well as the audited financial statements, notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this Quarterly Report on Form 10-Q. You should carefully read the “Cautionary Note About Forward-Looking Statements” of this Quarterly Report on Form 10-Q and the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025 to gain an understanding of the important factors that could cause actual results to differ materially from the results described below.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and related notes appearing in this Quarterly Report on Form 10-Q, as well as the audited financial statements, notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, including but not limited to, statements of our plans, objectives, expectations and intentions. Our actual results or outcomes, and the timing of our results or outcomes, could differ materially from those discussed in these forward-looking statements. Risks, uncertainties and other factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this Quarterly Report on Form 10-Q, in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025 and in our other filings with the SEC. You should carefully read the “Cautionary Note About Forward-Looking Statements” of this Quarterly Report on Form 10-Q and the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025 to gain an understanding of the important factors that could cause actual results or outcomes, and the timing of results or outcomes, to differ materially from the results or outcomes described below.

Previous wording

SL-325 is a high-affinity DR3 blocking monoclonal antibody. DR3 is the sole known receptor for tumor necrosis factor like ligand 1A ("TL1A"). In our head-to-head preclinical studies, SL-325 blocked TL1A binding to DR3 better than sequence equivalents of leading TL1A blocking antibodies. We believe that the underlying biological differences in the expression of DR3 and TL1A, and the design characteristics of SL-325, may allow SL-325 to achieve best-in-class clinical remission rates in patients with inflammatory bowel disease ("IBD") due to a more complete and durable blockade of the clinically validated DR3/TL1A pathway. Additionally, we expect that SL-325 has the potential to demonstrate a superior immunogenicity profile in comparison to TL1A blocking antibodies. By targeting DR3 instead of TL1A, we expect to avoid the formation of immune complexes, which we believe are the primary source of immunogenicity for all TL1A blocking antibodies, and lead to high rates of anti-drug antibody (“ADA”) formation toward TL1A targeting antibodies. ADA to TL1A targeting antibodies has been shown to reduce efficacy in IBD patients. We are currently conducting a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) Phase 1 clinical trial evaluating SL-325 in healthy volunteers. We expect this Phase 1 clinical trial to be completed in the second quarter of 2026. We expect to initiate a randomized, placebo-controlled Phase 2 clinical trial evaluating SL-325 in patients with Crohn’s Disease (“CD”) in the third quarter of 2026.

Current wording

SL-325 is a high-affinity DR3 blocking monoclonal antibody. DR3 is the sole known receptor for tumor necrosis factor like ligand 1A ("TL1A"). In our head-to-head preclinical studies, SL-325 blocked TL1A binding to DR3 better than sequence equivalents of leading TL1A blocking antibodies. We believe that the underlying biological differences in the expression of DR3 and TL1A, and the design characteristics of SL-325, may allow SL-325 to achieve best-in-mechanism clinical remission rates in patients with inflammatory bowel disease ("IBD") due to a more complete and durable blockade of the clinically validated DR3/TL1A pathway, and a potentially best-in-mechanism immunogenicity profile.

Previous wording

In addition to SL-325 and SL-425 (a half-life extended version of SL-325), we are developing bispecific antibodies which co-target DR3 and other clinically validated targets in immune mediated and inflammatory diseases. Inhibition of the TL1A/DR3 axis may be mechanistically distinct from the IL-23/IL-23R, IL-17/IL-17R, TSLP/TSLP-R or α4β7/MADCAM-1 axes (as examples). Thus, dual inhibition of the TL1A/DR3 axis with coformulated or bispecific antibodies may provide additive clinical benefit in a variety of immune mediated and inflammatory diseases. As seen with TL1A directed antibodies, two third-party TL1A-directed bispecific antibodies, AMG966 and RO7837195, have also demonstrated nearly 100% ADA formation following a single dose in Phase 1 clinical trials. The mechanism of ADA formation was reported to be secondary to large immune complex formation for AMG966, which we believe is also true for RO7837195. The emerging clinical data from TL1A-directed bispecific antibodies is similar to the prior failure of TNFα-directed bispecific antibodies, which we believe is because both TNFα and TL1A are soluble trimeric proteins found in the blood, and cause immunogenicity secondary to large immune complex formation. We expect that our DR3-directed bispecific antibodies to be less immunogenic than TL1A-directed bispecifics. DR3 may thus provide a differentiated target in a bispecific antibody format, providing advantages over TL1A-directed bispecific antibodies. Additionally, development of bispecific antibodies may enable more efficient clinical development than is expected for multi-antibody coformulations, and may avoid some of the challenges associated with potential immunogenicity in certain coformulations, as described above.

Current wording

As seen with TL1A directed monoclonal antibodies, two third-party TL1A-directed bispecific antibodies, AMG966 and RO7837195, have also demonstrated nearly 100% ADA formation following a single dose in Phase 1 clinical trials. The mechanism of ADA formation was reported to be secondary to immune complex formation for AMG966, which we believe could also be true for RO7837195. Both of these antibodies utilized monovalent, ‘1x1’, bispecific antibody formats, similar to other TL1A directed bispecific antibodies which are continuing in clinical development, including XmAb412 and CLD-423. The emerging clinical data from TL1A-directed bispecific antibodies is similar to the prior failure of TNFα-directed bispecific antibodies, which we believe is because both TNFα and TL1A are soluble trimeric proteins found in the blood, and cause immunogenicity secondary to immune complex formation. We expect our DR3-directed bispecific antibodies to be less immunogenic than TL1A-directed bispecifics. DR3 may thus provide a differentiated target in a bispecific antibody format, potentially providing advantages over TL1A-directed bispecific antibodies. Additionally, development of bispecific antibodies may enable more efficient clinical development than is expected for multi-antibody coformulations, and may avoid some of the challenges associated with potential immunogenicity in certain coformulations.

Previous wording

For the three months ended March 31, 2026 and 2025, our net loss was $14.8 million and $13.7 million, respectively. We have not been profitable since inception, and as of March 31, 2026, we had an accumulated deficit of $445.3 million and $90.4 million in cash and cash equivalents. We expect to continue to incur significant expenses and operating losses in the near term in connection with our ongoing activities, as we:

Current wording

For the six months ended June 30, 2026 and 2025, our net loss was $29.9 million and $26.2 million, respectively. We have not been profitable since inception, and as of June 30, 2026, we had an accumulated deficit of $460.4 million and $208.3 million in cash and cash equivalents and short-term investments. We expect to continue to incur significant expenses and operating losses in the near term in connection with our ongoing activities, as we:

Previous wording

•continue Phase 1 clinical development of our lead product candidate, SL-325;

Current wording

•initiate and advance through Phase 2 clinical development for our lead product candidate, SL-325, in Crohn's disease;

Previous wording

•initiate nonclinical studies and clinical trials for additional product candidates that we may identify in the future, including potential DR3 based bispecific antibodies targeting DR3 together with another biologically relevant target;

Current wording

•initiate nonclinical studies and clinical trials for SL-846, including our planned Phase 1 clinical trial, and any additional product candidates that we may identify in the future, including other potential DR3 based bispecific antibodies targeting DR3 together with another biologically relevant target;

Previous wording

The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, inflation, slower growth or recession, changes in trade policies, including tariffs or other trade restrictions or the threat of such actions, instability or volatility in the global capital and credit markets, supply chain weaknesses, financial institution instability, changes to fiscal and monetary policy or government budget dynamics and instability in the geopolitical environment. Such challenges have caused, and may continue to cause, recession fears, high interest rates, foreign exchange volatility, and inflationary pressures. At this time, we are unable to quantify the potential effects of this economic instability on our future operations.

Current wording

The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, inflation, slower growth or recession, changes in trade policies, including tariffs or other trade restrictions or the threat of such actions, instability or volatility in the global capital and credit markets, supply chain weaknesses, financial institution instability, changes to fiscal and monetary policy or government budget dynamics, military conflicts, and instability in the geopolitical environment. Such challenges have caused, and may continue to cause, recession fears, high interest rates, foreign exchange volatility, and inflationary pressures. At this time, we are unable to quantify the potential effects of this economic instability on our future operations.

Previous wording

•expenses incurred to conduct our clinical trials, including expenses associated with clinical trials of SL-325 and any potential product candidates we may advance in the future;

Current wording

•expenses incurred to conduct our clinical trials, including expenses associated with clinical trials of SL-325, future planned clinical trials of SL-846, and any potential product candidates we may advance in the future;

Previous wording

1 Expenses for SL-325 that were incurred prior to it being nominated as a product candidate are included in "other pipeline compounds” in the table above.

Current wording

1 Expenses for SL-325 and SL-846 that were incurred prior to nomination as a product candidate are included in “other pipeline compounds”.

Previous wording

Research and development activities are central to our business model. We are focused on the preclinical and clinical development of SL-325 and other DR3 targeted assets, and conducting additional research on other potential product candidates. Product candidates in earlier stages of development generally have lower development costs than those in later stages of development. In 2026, we anticipate initiating Phase 2 clinical trial(s) for SL-325. Accordingly, we expect an increase in research and development and expense year-over-year, as we incur incremental clinical trial expenses and additional costs associated with commensurate increases in our workforce to support these efforts.

Current wording

Research and development activities are central to our business model. We are focused on the preclinical and clinical development of SL-325 and SL-846 and other DR3 targeted assets, including SL-425, and conducting additional research on other potential product candidates. Product candidates in earlier stages of development generally have lower development costs than those in later stages of development. In the third quarter of 2026, we anticipate initiating a Phase 2 clinical trial for SL-325, and continuing to advance SL-846 into Phase 1 clinical development in 2027. Additionally, we may initiate Phase 2 clinical trial(s) for SL-325 in indications outside of IBD. Accordingly, we expect an increase in research and development expenses year-over-year, as we incur incremental clinical trial expenses and additional costs associated with commensurate increases in our workforce to support these efforts.

Previous wording

Other income consists of interest earned on our cash, cash equivalents and short-term investments, which consists of amounts held in a money market fund and government obligations as well as investment fees and realized gain or losses on short-term investments (if any).

Current wording

Other income consists of interest earned on our cash, cash equivalents and short-term investments, which consists of amounts held in a money market fund and government obligations as well as investment fees and realized gains or losses on short-term investments (if any).

Previous wording

General and administrative expenses remained relatively unchanged for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025.

Current wording

General and administrative expenses were relatively flat for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

Previous wording

Research and development expenses increased by $1.0 million, or 10.4%, to $10.9 million for the three months ended March 31, 2026 from $9.9 million for the three months ended March 31, 2025. The increase in research and development expenses was primarily due to an increase of $0.6 million in SL-325 expenses primarily as a result of moving SL-325 into clinical development in 2025, an increase in personnel related costs of $0.7 million partially offset by a decrease of $0.3 million in other pipeline compounds cost.

Current wording

Research and development expenses increased by $4.0 million, or 21.8%, to $22.6 million for the six months ended June 30, 2026 from $18.6 million for the six months ended June 30, 2025. The increase in research and development expenses was primarily due to an increase of $6.0 million in expenses related to clinical and pre-clinical activities for SL-325 and SL-846 and an increase of $1.1 million in compensation and related benefits due to added headcount in support of SL-325 and SL-846, partially offset by a decrease of $3.4 million as a result of the discontinuation of SL-172154.

Previous wording

Since our inception, our primary sources of liquidity have been generated by sales of our common stock, pre-funded warrants, common stock warrants, convertible preferred stock, and convertible notes, and through collaboration agreements. As of March 31, 2026, we had an accumulated deficit of $445.3 million and $90.4 million of cash and cash equivalents.

Current wording

Since our inception, our primary sources of liquidity have been generated by sales of our common stock, pre-funded warrants, common stock warrants, convertible preferred stock, and convertible notes, and through collaboration agreements. As of June 30, 2026, we had an accumulated deficit of $460.4 million and $208.3 million of cash and cash equivalents and short-term investments.

Previous wording

In August 2025, we issued and sold 15,225,158 shares of common stock, pre-funded warrants to purchase up to 37,410,188 shares of common stock, and accompanying common stock warrants to purchase up to 52,635,346 shares of common stock for gross proceeds of $45.7 million. In 2026, 5,019,719 common stock warrants have been exercised for gross proceeds of $5.4 million and we may receive an additional $51.5 million in gross proceeds if the remaining common stock warrants are exercised.

Current wording

In August 2025, we issued and sold 15,225,158 shares of common stock, pre-funded warrants to purchase up to 37,410,188 shares of common stock, and accompanying common stock warrants to purchase up to 52,635,346 shares of common stock for gross proceeds of $45.7 million. During the six months ended June 30, 2026, 48,665,670 common stock warrants were exercised for gross proceeds of $52.8 million. Subsequently, in July 2026, we received an additional $4.2 million in gross proceeds when the remaining 3,841,622 common stock warrants were exercised in July 2026.

Previous wording

In January 2026, we entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Sales Agent”), pursuant to which we may offer and sell up to $75.0 million of shares of our common stock from time to time through our ATM Facility. The Sales Agent is generally entitled to compensation at a commission equal to up to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. For the three months ended March 31, 2026, we sold 5,000,000 shares of common stock at $4.28 per share for gross proceeds of $21.4 million.

Current wording

In January 2026, we entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Sales Agent”), pursuant to which we may offer and sell up to $75.0 million of shares of our common stock from time to time through our ATM Facility. The Sales Agent is generally entitled to compensation at a commission equal to up to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. For the six months ended June 30, 2026, we sold 5,000,000 shares of common stock at $4.28 per share for gross proceeds of $21.4 million.

Previous wording

We believe that our cash and cash equivalents as of March 31, 2026, and assuming the full exercise of the outstanding common stock warrants, are sufficient to fund projected operations into 2029.

Current wording

We believe that our cash, cash equivalents and short-term investments as of June 30, 2026 are sufficient to fund projected operations into 2029.

Previous wording

During the three months ended March 31, 2026, net cash used in operating activities was $13.4 million and primarily reflected our net loss of $14.8 million and a $2.0 million decrease in our operating assets and liabilities partially offset by net non-cash operating charges of $3.4 million for stock-based compensation, depreciation expense, accretion of investments and non-cash operating lease expense. We expect to continue to use cash in our operating activities as we conduct our clinical trials and nonclinical studies, incur costs of manufacturing clinical trial and nonclinical study materials and continue process development activities to optimize our manufacturing processes.

Current wording

During the six months ended June 30, 2026, net cash used in operating activities was $23.6 million and primarily reflected our net loss of $29.9 million, partially offset by net noncash operating charges of $6.2 million for stock-based compensation, depreciation expense, accretion of investments, and non-cash operating lease expense and $0.3 million in net changes to our operating assets and liabilities. We expect to continue to use cash in our operating activities as we conduct our clinical trials and nonclinical studies, incur costs of manufacturing clinical trial and nonclinical study materials, and continue development activities to optimize our manufacturing processes.

Previous wording

During the three months ended March 31, 2025, net cash used in operating activities was $12.0 million and primarily reflected our net loss of $13.7 million and a $1.1 million decrease in our operating assets and liabilities partially offset by non-cash operating charges of $2.8 million for stock-based compensation, depreciation expense, accretion of investments and non-cash operating lease expense.

Current wording

During the six months ended June 30, 2025, net cash used in operating activities was $22.5 million and primarily reflected our net loss of $26.2 million and a $2.0 million net change in our operating assets and liabilities, partially offset by noncash charges of $5.7 million in stock-based compensation, depreciation expense, accretion of investments, and operating lease expense.

Previous wording

During the three months ended March 31, 2025, net cash provided by investing activities was $15.6 million, as a result of investment maturities.

Current wording

During the six months ended June 30, 2025, net cash provided by investing activities was $15.6 million, and primarily consisted of investments that matured during the period.

Previous wording

During the three months ended March 31, 2026, net cash provided by financing activities was $25.8 million and was primarily a result of proceeds from the sale of common stock and exercise of common stock warrants for $26.0 million.

Current wording

During the six months ended June 30, 2026, net cash provided by financing activities was $153.8 million and primarily consisted of proceeds from the sale of common stock, pre-funded warrants and common stock warrants for $100.8 million, the exercise of common stock warrants for $52.8 million and the exercise of stock options for $0.3 million.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, the accrual for research and development expenses, and the valuation of stock-based awards. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. We regularly evaluate our estimates and judgments, including those related to revenue recognition, the accrual for research and development expenses, and the valuation of stock-based awards. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

As of December 31, 2025, we ceased to qualify as an emerging growth company. We continue to qualify as a “smaller reporting company” as defined in Rule 12b-2 under the 1934 Securities and Exchange Act (the "Exchange Act") and thus will continue to be permitted to make certain reduced disclosures in the Annual Report on Form 10-K and other periodic reports.

Current wording

We qualify as a “smaller reporting company” as defined in Rule 12b-2 under the Securities and Exchange Act of 1934, as amended (the "Exchange Act") and are permitted to make use of certain reduced disclosure requirements in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and certain other filings.

Previous wording

We will continue to be a smaller reporting company so long as (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. As long as we remain a smaller reporting company we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

We will continue to be a smaller reporting company so long as (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. As long as we remain a smaller reporting company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.