Shattuck Labs, Inc.

Previous wording

We are planning initial clinical development of SL-325 for patients with IBD, including UC and CD. The clinical success of several TL1A blocking antibodies to date suggests that SL-325 may have monotherapy disease modifying activity early in clinical development. As described above, we believe that targeting DR3 may be more efficacious than targeting TL1A in patients with IBD. We expect to file an Investigational New Drug ("IND") application for SL-325 in the third quarter of 2025, and we expect to complete enrollment in the full Phase 1 clinical trial in the second quarter of 2026.

Current wording

We are planning initial clinical development of SL-325 for patients with IBD, including UC and/or CD. The clinical success of several TL1A blocking antibodies to date suggests that SL-325 may have monotherapy disease modifying activity early in clinical development. As described above, we believe that targeting DR3 may be more efficacious than targeting TL1A in patients with IBD. We expect to initiate enrollment in our Phase 1 clinical trial of SL-325 in the third quarter of 2025, and we expect to complete enrollment in the full Phase 1 clinical trial in the second quarter of 2026.

Previous wording

For the three months ended March 31, 2025 and 2024, our net loss was $13.7 million and $18.5 million, respectively. We have not been profitable since inception, and as of March 31, 2025, we had an accumulated deficit of $395.4 million and $60.9 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, 2025 and 2024, our net loss was $26.2 million and $40.1 million, respectively. We have not been profitable since inception, and as of June 30, 2025, we had an accumulated deficit of $407.9 million and $50.5 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:

Previous wording

•retain key personnel and infrastructure to support our nonclinical development, research and manufacturing, and future clinical development efforts;

Current wording

•retain key personnel and infrastructure to support our nonclinical development, research, manufacturing, and future clinical development efforts;

Previous wording

Collaboration revenue decreased by $1.1 million, or 100.0%, to $0.0 million for the three months ended March 31, 2025 from $1.1 million for the three months ended March 31, 2024. The decrease in collaboration revenue was a result of completing all obligations and recognizing all revenues associated with the Ono and ImmunoGen collaboration agreements in 2024.

Current wording

Collaboration revenue decreased by $1.6 million, or 100.0%, to $0.0 million for the three months ended June 30, 2025 from $1.6 million for the three months ended June 30, 2024. The decrease in collaboration revenue was a result of completing all obligations and recognizing all revenues associated with the Ono and ImmunoGen collaboration agreements in 2024.

Previous wording

Research and development expenses decreased by $6.3 million, or 39.0%, to $9.9 million for the three months ended March 31, 2025 from $16.3 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily a result of a decrease of $5.0 million in clinical and research and development expenses as a result of the discontinuation of SL-172154 and related oncology projects, a decrease in compensation and related benefit expenses of $2.2 million as a result of workforce reductions in 2024, a decrease of $0.5 million in research and development work for other pipeline compounds and a $0.4 million decrease in work performed pursuant to the collaboration agreement with Ono offset by an increase of $2.1 million in research and development expenses for SL-325.

Current wording

Research and development expenses decreased by $10.6 million, or 54.9%, to $8.7 million for the three months ended June 30, 2025 from $19.2 million for the three months ended June 30, 2024. The decrease in research and development expenses was primarily a result of a decrease of $8.9 million due to the discontinuation of SL-172154, a decrease in compensation and related benefit expenses of $2.2 million as a result of workforce reductions in 2024, a decrease of $1.5 million in research and development work for other pipeline compounds, and a decrease of $0.4 million associated with the termination of the Ono Agreement offset by an increase of $2.4 million in research and development expenses for SL-325.

Previous wording

Other income decreased by $0.8 million or 55.4%, to $0.7 million for the three months ended March 31, 2025 from $1.5 million for the three months ended March 31, 2024 primarily as a result of a decrease in our average investment balance.

Current wording

Other income decreased by $0.8 million, or 59.3%, to $0.6 million for the three months ended June 30, 2025 from $1.4 million for the three months ended June 30, 2024. The decrease is a result of a decrease in investments and funds held in our money market accounts.

Previous wording

General and administrative expenses decreased by $0.4 million, or 8.7%, to $4.5 million for the three months ended March 31, 2025 from $4.9 million for the three months ended March 31, 2024 primarily as a result of decreased compensation and related benefit expenses as a result of the workforce reduction in 2024.

Current wording

General and administrative expenses decreased by $1.4 million, or 13.7%, to $8.8 million for the six months ended June 30, 2025 from $10.2 million for the six months ended June 30, 2024. The decrease is primarily a result of decreased compensation and related benefit expenses as a result of workforce reduction in 2024.

Previous wording

In July 2022, we entered into a sales agreement ("the Sales Agreement") with Leerink Partners LLC (formerly known as SVB Securities LLC) (the "Sales Agent") pursuant to which we may offer and sell up to $75 million of shares of our common stock from time to time in an at-the-market facility (the "ATM Facility"). The Sales Agent is generally entitled to compensation at a commission equal to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. As of March 31, 2025, there were no sales pursuant to the ATM Facility We are currently subject to General Instruction I.B.6 of Form S-3, which limits the amount that we may sell under the ATM Facility. After giving effect to these limitations and the current public float of our common stock, we determined that we currently may offer and sell from and after March 27, 2025 shares of our common stock having an aggregate offering price of up to $24.5 million under the Sales Agreement.

Current wording

In July 2022, we entered into a sales agreement ("the Sales Agreement") with Leerink Partners LLC (formerly known as SVB Securities LLC) (the "Sales Agent") pursuant to which we may offer and sell up to $75 million of shares of our common stock from time to time in an at-the-market facility (the "ATM Facility"). The Sales Agent is generally entitled to compensation at a commission equal to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. As of June 30, 2025, there were no sales pursuant to the ATM Facility. Our Registration Statement on Form S-3 expired on July 29, 2025, and therefore no sales can be made under the Sales Agreement until such time as we file a new Registration Statement on Form S-3. Based on the public float of our common stock as of the date of the filing of our Annual Report on Form 10-K for the year ended December 31, 2024, we are currently subject to General Instruction I.B.6 of Form S-3 and therefore may not sell more than one-third of the market value of our common stock held by non-affiliates until our public float exceeds $75.0 million.

Previous wording

Until we obtain regulatory approval to market our product candidates, if ever, we cannot generate revenues from sales of our products. Even if we are able to sell our products, we may not generate a sufficient amount of product revenues to finance our cash requirements. Accordingly, it will be necessary for us to seek to raise additional capital through equity offerings and/or debt financings or from other potential sources of liquidity, which may include new collaborations, licensing or other commercial agreements for one or more of our development programs or patent portfolios. Additionally, we are currently evaluating our options related to the advancement of our platform of mRNA/LNP administered multifunctional GLP-1 constructs and our TRIM7 program, which may include the independent financing of a subsidiary or spun-out entity. There can be no assurance that such funding may be available to us on acceptable terms, or at all. The issuance of equity securities may result in dilution to stockholders and the issuance of debt securities may have rights, preferences and privileges senior to those of our common stock and the terms of any such debt securities could impose significant restrictions on our operations. The failure to raise funds as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies. Additionally, if additional funding is not secured when required, we may need to delay or curtail our operations until such funding is received, which would have a material and adverse impact on our business prospects and results of operations.

Current wording

Until we obtain regulatory approval to market our product candidates, if ever, we cannot generate revenues from sales of our products. Even if we are able to sell our products, we may not generate a sufficient amount of product revenues to finance our cash requirements. Accordingly, it will be necessary for us to seek to raise additional capital through equity offerings and/or debt financings or from other potential sources of liquidity, which may include new collaborations, licensing or other commercial agreements for one or more of our development programs or patent portfolios. Additionally, we are currently evaluating our options related to the advancement of our TRIM7 program, which may include the independent financing of a subsidiary or spun-out entity, or an out-license to a third-party. There can be no assurance that such funding may be available to us on acceptable terms, or at all. The issuance of equity securities may result in dilution to stockholders and the issuance of debt securities may have rights, preferences and privileges senior to those of our common stock and the terms of any such debt securities could impose significant restrictions on our operations. The failure to raise funds as and when needed will have a negative impact on our financial condition and ability to pursue our business strategies. Additionally, if additional funding is not secured when required, we will need to delay or curtail our operations until such funding is received, which would have a material and adverse impact on our business prospects and results of operations.

Previous wording

We believe that our cash and cash equivalents as of March 31, 2025 are sufficient to fund projected operations into 2027.

Current wording

We believe that our cash and cash equivalents as of June 30, 2025 are sufficient to fund projected operations into 2027. This does not include the anticipated proceeds from the Private Placement. The total anticipated gross proceeds from the Private Placement of up to approximately $103 million, which includes the potential proceeds to be received upon the full exercise of the common stock warrants, combined with current cash and cash equivalents, are expected to fund operations into 2029.

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 offset by net noncash operating charges of $2.8 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, 2025, net cash used in operating activities was $22.5 million and primarily reflected our net loss of $26.2 million, offset by net noncash operating charges of $5.7 million for stock-based compensation, depreciation expense, accretion of investments, and non-cash operating lease expense and $2.0 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 process development activities to optimize our manufacturing processes.

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $16.2 million and a $0.8 million decrease in our operating assets and liabilities offset by noncash operating charges of $3.2 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, 2024, net cash used in operating activities was $27.1 million and primarily reflected our net loss of $40.1 million and an $6.7 million net change in our operating assets and liabilities, offset by noncash charges of $6.3 million in stock-based compensation, depreciation expense, amortization 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 the maturities of investments.

Current wording

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

Previous wording

During the three months ended March 31, 2024, net cash used in investing activities was $33.3 million, which was the total net effect of purchases and maturities of investments.

Current wording

During the six months ended June 30, 2024, net cash used in investing activities was $38.7 million, which was the result of purchases of investments net of maturities.

Previous wording

Net Cash Provided by Financing Activities

Current wording

Net Cash (Used In) Provided by Financing Activities

Previous wording

We have evaluated the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation exemptions to the requirements for (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of (a) the last day of the fiscal year (i) following the fifth anniversary of the completion of our initial public offering, (ii) in which we have total annual gross revenues of at least $1.235 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (b) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Current wording

We have evaluated the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation exemptions to the requirements for, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and, (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of, (a) the last day of the fiscal year, (i) following the fifth anniversary of the completion of our initial public offering, (ii) in which we have total annual gross revenues of at least $1.235 billion or, (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or, (b) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.