Shattuck Labs, Inc.

Previous wording

We expect to initiate RECEPTIVE-CD1, an international, randomized, placebo-controlled, double-blinded Phase 2b clinical trial evaluating SL-325 in patients with Crohn’s Disease (“CD”) in the third quarter of 2026. In this study, approximately 232 patients with moderately-to-severely active Crohn’s disease (CDAI score between 220-450) will be randomized 1:1:1:1 to receive high-dose SL-325, middle-dose SL-325, low-dose SL-325 or placebo. The induction phase of treatment is expected to be 12 weeks, followed by a 38-week maintenance period, and patients will also be eligible for a long-term extension study thereafter using a treat-through design. Patients who are randomized to the placebo arm during induction will be eligible to switch to high-dose SL-325 after the 12-week induction period. The primary endpoint of the study is endoscopic response at 12 weeks, and the key secondary endpoint is clinical remission. Data from the induction portion of the trial are expected in the first half of 2028.

Current wording

In the third quarter of 2026, we initiated RECEPTIVE-CD1, an international, randomized, placebo-controlled, double-blinded Phase 2b clinical trial evaluating SL-325 in patients with Crohn’s disease (“CD”). In this study, approximately 232 patients with moderately-to-severely active Crohn’s disease (CDAI score between 220-450) are expected to be randomized 1:1:1:1 to receive high-dose SL-325, middle-dose SL-325, low-dose SL-325 or placebo. The induction phase of treatment is expected to be 12 weeks, followed by a 38-week maintenance period, and patients will also be eligible for a long-term extension study thereafter using a treat-through design. Patients who are randomized to the placebo arm during induction will be eligible to switch to high-dose SL-325 after the 12-week induction period. The primary endpoint of the study is endoscopic response at 12 weeks, and the key secondary endpoint is clinical remission. Data from the induction portion of the trial are expected in the first half of 2028.

Previous wording

We believe that SL-325 could demonstrate superior efficacy to TL1A blocking antibodies in the RECEPTIVE-CD1 study as a result of two key advantages. First, TL1A blocking antibodies reported anti-drug antibody formation in 48-82% of subjects in similarly designed Phase 1 clinical trials where SL-325 had an ADA rate of 3.7%. In subsequent Phase 2 clinical trials, the leading TL1A blocking antibodies (tulisokibart, duvakitug and afimkibart) all demonstrated potentially best-in-disease clinical remission rates at the time of induction, however the absolute number of patients in clinical remission did not increase between induction and maintenance. We believe that this limitation is due to the underlying immunogenicity of anti-TL1A antibodies, leading to accelerated drug clearance and secondary non-response over time. Because SL-325 has a superior immunogenicity profile, we believe that improved remission rates could be observed both at the induction and maintenance time points relative to the TL1A class.

Current wording

We believe that SL-325 could demonstrate superior efficacy to TL1A blocking antibodies in the RECEPTIVE-CD1 and RECEPTIVE-HS1 studies as a result of two key advantages. First, TL1A blocking antibodies reported anti-drug antibody formation in 48-82% of subjects in similarly designed Phase 1 clinical trials whereas SL-325 had an ADA rate of 3.7%. In subsequent Phase 2 clinical trials, the leading TL1A blocking antibodies (tulisokibart, duvakitug and afimkibart) all demonstrated potentially best-in-disease clinical remission rates at the time of induction, however the absolute number of patients in clinical remission did not increase between induction and maintenance. We believe that this limitation is due to the underlying immunogenicity of anti-TL1A antibodies, leading to accelerated drug clearance and secondary non-response over time. Because SL-325 has a superior immunogenicity profile, we believe that improved remission rates could be observed both at the induction and maintenance time points relative to the TL1A class.

Previous wording

Second, DR3 is a more stably expressed target than TL1A. The complete and durable inhibition of TL1A binding observed in our Phase 1 study, at low doses of SL-325 is distinct from what has been reported for TL1A blocking antibodies. Instead, TL1A blocking antibodies lead to multi-log increases in the serum concentration of total TL1A, which may contribute to persistent signaling and incomplete suppression of DR3 activation, particularly in tissues. The RECEPTIVE-CD1 study may provide evidence that, in addition to an immunogenicity advantage, SL-325 could provide enhanced efficacy relative to TL1A blocking antibodies as a result of more complete suppression of DR3 activation.

Current wording

Second, DR3 is a more stably expressed target than TL1A. The complete and durable inhibition of TL1A binding observed in our Phase 1 study, at low doses of SL-325 is distinct from what has been reported for TL1A blocking antibodies. Instead, TL1A blocking antibodies lead to multi-log increases in the serum concentration of total TL1A, which may contribute to persistent signaling and incomplete suppression of DR3 activation, particularly in tissues. The RECEPTIVE-CD1 and RECEPTIVE-HS1 studies may provide evidence that, in addition to an immunogenicity advantage, SL-325 could provide enhanced efficacy relative to TL1A blocking antibodies as a result of more complete suppression of DR3 activation.

Previous wording

We also plan to evaluate SL-325 in other inflammatory and immune-mediated diseases where the DR3/TL1A axis is implicated.

Current wording

We may also evaluate SL-325 in other inflammatory and immune-mediated diseases where the DR3/TL1A axis is implicated.

Previous wording

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 multiplein vitro and cell-based potency assays. A GLP acute and chronic toxicology study in cynomolgus macaques investigating the safety, PK, RO and immunogenicity profile of SL-846 is currently underway.

Current wording

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. We have completed the in-life portion of a GLP acute and chronic toxicology study in cynomolgus macaques investigating the safety, PK, RO and immunogenicity profile of SL-846.

Previous wording

We expect to share additional pre-clinical data, including data from our ongoing non-human primate toxicology study for SL-846, in the second half of 2026, and to share initial Phase 1 clinical data for SL-846 in 2027.

Current wording

In October 2026 we shared additional preliminary preclinical data, including data from our chronic toxicology study in non-human primates for SL-846, at the United European Gastroenterology Week conference. We expect to initiate a Phase 1 clinical trial and share initial Phase 1 clinical data for SL-846 in 2027.

Previous 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:

Current wording

For the nine months ended September 30, 2026 and 2025, our net loss was $55.1 million and $36.2 million, respectively. We have not been profitable since inception, and as of September 30, 2026, we had an accumulated deficit of $485.7 million and cash and cash equivalents and short-term investments of$196.3 million. 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

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

Current wording

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

Previous 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;

Current wording

•initiate nonclinical studies and clinical trials for 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

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

Current wording

1 Expenses for 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 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.

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. We have initiated a Phase 2 clinical trial of SL-325 in patients with Crohn's disease. In addition, we expect to initiate a Phase 2 clinical trial of SL-325 in patients with HS in the fourth quarter of 2026, and we expect to advance SL-846 into Phase 1 clinical development in 2027. Accordingly, we expect an increase in research and development expenses year-over-year, as we incur incremental clinical trial expenses, including the manufacturing of clinical trial material to support these Phase 2 clinical trials, manufacturing process development for Phase 3 readiness, and additional costs associated with commensurate increases in our workforce to support these efforts.

Previous wording

If any of our current or future product candidates, including SL-325, continues to advance through clinical development, or obtains regulatory approval, we expect that we would incur increased expenses associated with building the appropriate general and administrative support for our increased research and development activities, or building a sales and marketing team.

Current wording

If any of our current product candidates, including SL-325 or SL-846, or future product candidates, continues to advance through clinical development, or obtains regulatory approval, we expect that we would incur increased expenses associated with building the appropriate general and administrative support for our increased research and development activities, and building a sales and marketing team.

Previous wording

Research and development expenses increased by $3.0 million, or 34.8%, to $11.7 million for the three months ended June 30, 2026 from $8.7 million for the three months ended June 30, 2025. The increase in research and development expenses was primarily a result of an increase of $3.2 million in clinical and non-clinical expenses for SL-325 and SL-846 and an increase of $0.4 million in compensation and related benefit expenses due to additional headcount to support a Phase 2 study in SL-325, partially offset by a decrease of $0.9 million as a result of the discontinuation of SL-172154.

Current wording

Research and development expenses increased by $13.9 million, or 183.1%, to $21.6 million for the three months ended September 30, 2026 from $7.6 million for the three months ended September 30, 2025. The increase in research and development expenses was primarily a result of an increase of $12.7 million in clinical, nonclinical, and development expenses for SL-325 and SL-846, and an increase of $1.1 million in compensation and related benefit expenses due to additional headcount primarily to support Phase 2 clinical trials of SL-325.

Previous wording

Other income increased by $0.4 million, or 74.7%, to $1.0 million for the three months ended June 30, 2026 from $0.6 million for the three months ended June 30, 2025. The increase was a result of increased overall balances in investments and funds held in our money market accounts as a result of our recent financings.

Current wording

Other income increased by $1.2 million, or 179.2%, to $1.8 million for the three months ended September 30, 2026 from $0.7 million for the three months ended September 30, 2025. The increase was a result of increased investments and funds held in our money market accounts as a result of our recent financings.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2026 and 2025.

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2026 and 2025.

Previous 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.

Current wording

Research and development expenses increased by $18.0 million, or 68.6%, to $44.2 million for the nine months ended September 30, 2026 from $26.2 million for the nine months ended September 30, 2025. The increase in research and development expenses was primarily due to an increase of $16.3 million in expenses related to clinical, nonclinical and development activities for SL-325 and SL-846, and an increase of $1.6 million in compensation and related benefits due to additional headcount to support Phase 2 clinical trials in SL-325 and development of SL-846.

Previous wording

Other income increased by $0.5 million, or 41.2%, to $1.8 million for the six months ended June 30, 2026 from $1.3 million for the six months ended June 30, 2025. The increase was primarily a result of increased balances in investments and funds held in our money market accounts.

Current wording

Other income increased by $1.7 million, or 88.6%, to $3.6 million for the nine months ended September 30, 2026 from $1.9 million for the nine months ended September 30, 2025. The increase was primarily a result of increased balances in investments and funds held in our money market accounts as a result of our recent financings.

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 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.

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, convertible notes, and through collaboration agreements. As of September 30, 2026, we had an accumulated deficit of $485.7 million and cash and cash equivalents and short-term investments of $196.3 million.

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. 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.

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. As of September 30, 2026, all common stock warrants were exercised for cumulative gross proceeds of $57.1 million.

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 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.

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 nine months ended September 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

In June 2026, we issued and sold 13,691,876 shares of common stock, including the full exercise of the underwriters' option to purchase an additional 2,812,500 shares, and pre-funded warrants to purchase up to 7,870,624 shares of common stock, in a public offering for gross proceeds of $86.2 million. The purchase price of shares of common stock was $4.00 and the purchase price of each pre-funded warrant was $3.999 which was the purchase price per share of common stock less the $0.0001 per share exercise price of the pre-funded warrants.

Current wording

In June 2026, we issued and sold 13,691,876 shares of common stock, including the full exercise of the underwriters' option to purchase an additional 2,812,500 shares, and pre-funded warrants to purchase up to 7,870,624 shares of common stock, in a public offering for gross proceeds of $86.2 million. The purchase price of shares of common stock was $4.00 and the purchase price of each pre-funded warrant was $3.9999, which was the purchase price per share of common stock less the $0.0001 per share exercise price of the pre-funded warrants.

Previous 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.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities was $41.1 million and primarily reflected our net loss of $55.1 million, partially offset by net noncash operating charges of $9.3 million for stock-based compensation, depreciation expense, accretion of investments, and non-cash operating lease expense and $4.8 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 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.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $31.4 million and primarily reflected our net loss of $36.2 million and a $2.5 million net change in our operating assets and liabilities, partially offset by noncash charges of $7.3 million in stock-based compensation, depreciation expense, accretion of investments, and operating lease expense.

Previous wording

During the six months ended June 30, 2026, net cash used in investing activities was $121.1 million, and primarily consisted of purchases of investments net of maturities of investments during the period.

Current wording

During the nine months ended September 30, 2026, net cash used in investing activities was $109.4 million, and primarily consisted of purchases of investments net of maturities of investments during the period.

Previous 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.

Current wording

Net Cash Provided by Financing Activities

Previous 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.

Current wording

During the nine months ended September 30, 2026, net cash provided by financing activities was $158.0 million and primarily consisted of proceeds from the sale of common stock, pre-funded warrants and common stock warrants for $100.7 million, the exercise of common stock warrants for $56.9 million and the exercise of stock options and common stock purchased pursuant to the employee stock purchase plan for $0.7 million.

Previous 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.

Current wording

We qualify as a “smaller reporting company” as defined in Rule 12b-2 under the Securities 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.