Shattuck Labs, Inc.

Previous wording

We are a biotechnology company specializing in the development of potential treatments for inflammatory and immune-mediated diseases. We are developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (“IBD”) and other inflammatory and immune-mediated diseases. Our expertise in protein engineering and the development of novel tumor necrosis factor (“TNF”) receptor therapeutics come together in our lead program, SL-325, which we believe could be a first-in-class death receptor 3 (“DR3”) antagonist antibody.

Current wording

We are a clinical-stage biotechnology company specializing in the development of potential treatments for inflammatory and immune-mediated diseases. We are developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (“IBD”) and other inflammatory and immune-mediated diseases. Our expertise in protein engineering and the development of novel tumor necrosis factor (“TNF”) receptor therapeutics come together in our lead program, SL-325, which we believe could be a first-in-class death receptor 3 (“DR3”) antagonist antibody.

Previous 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.

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 have initiated enrollment in our Phase 1 clinical trial of SL-325, and we expect to complete enrollment in the full Phase 1 clinical trial in the second quarter of 2026.

Previous wording

Several attempts have been made to develop bispecific antibodies targeting TL1A, including a TL1A and TNFα blocking antibody known as AMG966. As discussed above, TL1A blocking antibodies stabilize serum TL1A as a result of immune complex formation between soluble TL1A and anti-TL1A antibodies. These immune complexes are believed to contribute to the high rates of ADA formation with TL1A blocking monoclonal antibodies. In the case of AMG966, the bispecific antibody was shown to stabilize both soluble TL1A and TNFα, which led to large immune complex formation and the rapid development of high-titer neutralizing ADA responses in patients treated in a phase 1 clinical trial. AMG966 was discontinued as a result of this immunogenicity. Because DR3 is a membrane-restricted target, immune complex formation is not expected either for SL-325, SL-425, or DR3 directed bispecific antibodies. Nomination of a lead bispecific candidate from our preclinical pipeline is expected in 2025.

Current wording

Several attempts have been made to develop bispecific antibodies targeting TL1A, including a TL1A and TNFα blocking antibody known as AMG966. As discussed above, TL1A blocking antibodies stabilize serum TL1A as a result of immune complex formation between soluble TL1A and anti-TL1A antibodies. These immune complexes are believed to contribute to the high rates of ADA formation with TL1A blocking monoclonal antibodies. In the case of AMG966, the bispecific antibody was shown to stabilize both soluble TL1A and TNFα, which led to large immune complex formation and the rapid development of high-titer neutralizing ADA responses in patients treated in a Phase 1 clinical trial. AMG966 was discontinued as a result of this immunogenicity. Because DR3 is a membrane-restricted target, immune complex formation is not expected either for SL-325, SL-425, or DR3 directed bispecific antibodies.

Previous 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:

Current wording

For the nine months ended September 30, 2025 and 2024, our net loss was $36.2 million and $56.7 million, respectively. We have not been profitable since inception, and as of September 30, 2025, we had an accumulated deficit of $417.9 million and $86.1 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

We have no products approved for commercial sale, and we have not generated any revenue from commercial product sales. Our total revenue to date has been generated from our collaboration and research agreements with various third parties. Revenue recognized in 2024 was a result of collaboration agreements with Ono Pharmaceutical Co., Ltd (“Ono”) and ImmunoGen, Inc. (“ImmunoGen”). We have completed all of our obligations and recognized all revenues associated with the collaboration agreements with ImmunoGen and Ono in 2024.

Current wording

We have no products approved for commercial sale, and we have not generated any revenue from commercial product sales. To date, we have recognized revenue generated from collaboration and research agreements with various third parties. Revenue recognized in 2024 was a result of collaboration agreements with Ono Pharmaceutical Co., Ltd (“Ono”) and ImmunoGen, Inc. (“ImmunoGen”). We have completed all of our obligations and recognized all revenues associated with the collaboration agreements with ImmunoGen and Ono in 2024.

Previous wording

We expect that our general and administrative expense may decrease in the future due to workforce reductions that occurred as a result of the discontinuation of SL-172154. If any of our current or future product candidates advances to 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

We have experienced reduced general and administrative expense due to the workforce reductions that occurred as a result of the discontinuation of SL-172154. 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.

Previous 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.

Current wording

License and collaboration revenue decreased by $2.0 million, or 66.6%, to $1.0 million for the three months ended September 30, 2025 from $3.0 million for the three months ended September 30, 2024. The decrease in revenue was a result of completing all obligations and recognizing all revenues associated with the Ono and ImmunoGen collaboration agreements in 2024, offset by license revenue recognized pursuant to the Kayak Agreement for $1.0 million.

Previous 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.

Current wording

Research and development expenses decreased by $8.7 million, or 53.3%, to $7.6 million for the three months ended September 30, 2025 from $16.3 million for the three months ended September 30, 2024. The decrease in research and development expenses was primarily a result of a decrease of $7.1 million due to the discontinuation of SL-172154, a decrease in compensation and related benefit expenses of $1.6 million as a result of workforce reductions in 2024, a decrease of $1.1 million in research and development work for other pipeline compounds, and a decrease of $0.2 million associated with the termination of the Ono Agreement, offset by an increase of $1.2 million in research and development expenses for SL-325.

Previous 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.

Current wording

Other income decreased by $0.6 million, or 47.0%, to $0.7 million for the three months ended September 30, 2025 from $1.2 million for the three months ended September 30, 2024. The decrease is a result of a decrease in investments and funds held in our money market accounts.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2025 and 2024.

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024;

Previous wording

Collaboration revenue decreased by $2.7 million, or 100.0%, to $0.0 million for the six months ended June 30, 2025 from $2.7 million for the six 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.

Current wording

License and collaboration revenue decreased by $4.7 million, or 82.5%, to $1.0 million for the nine months ended September 30, 2025 from $5.7 million for the nine months ended September 30, 2024. The decrease in revenue was a result of completing all obligations and recognizing all revenues associated with the Ono and ImmunoGen collaboration agreements in 2024, offset by license revenue recognized pursuant to the Kayak Agreement for $1.0 million.

Previous wording

Research and development expenses decreased by $16.9 million, or 47.6%, to $18.6 million for the six months ended June 30, 2025 from $35.5 million for the six months ended June 30, 2024. The decrease in research and development expenses was primarily a result of a decrease of $13.6 million as a result of the discontinuation of SL-172154, a decrease in compensation and related benefit expenses of $4.4 million as a result of workforce reductions in 2024, a decrease of $2.5 million in research and development work for other pipeline compounds, and a decrease of $0.9 million associated with the termination of the Ono Agreement offset by an increase of $4.5 million in research and development expenses for SL-325.

Current wording

Research and development expenses decreased by $25.6 million, or 49.4%, to $26.2 million for the nine months ended September 30, 2025 from $51.8 million for the nine months ended September 30, 2024. The decrease in research and development expenses was primarily a result of a decrease of $20.7 million as a result of the discontinuation of SL-172154, a decrease in compensation and related benefit expenses of $6.0 million as a result of workforce reductions in 2024, a decrease of $4.2 million in research and development work for other pipeline compounds, offset by an increase of $4.9 million in research and development expenses for SL-325.

Previous 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.

Current wording

General and administrative expenses decreased by $1.9 million, or 12.9%, to $12.9 million for the nine months ended September 30, 2025 from $14.8 million for the nine months ended September 30, 2024. The decrease was primarily a result of $1.0 million in compensation and related benefit expenses as a result of workforce reduction in 2024, $0.5 decrease in legal intellectual property expenses and a $0.2 million decrease in insurance cost.

Previous wording

Other income decreased by $1.7 million, or 57.3%, to $1.3 million for the six months ended June 30, 2025 from $3.0 million for the six months ended June 30, 2024. The decrease is a result of a decrease in investments and funds held in our money market accounts.

Current wording

Other income decreased by $2.3 million, or 54.2%, to $1.9 million for the nine months ended September 30, 2025 from $4.2 million for the nine months ended September 30, 2024. The decrease is a result of a decrease in investments and funds held in our money market accounts.

Previous wording

On August 4, 2025, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to issue and sell, in a private placement, 15,225,158 shares of our common stock and pre-funded warrants to purchase up to 37,410,188 shares of our common stock, and accompanying common stock warrants to purchase up to 52,635,346 shares of common stock, or in lieu thereof, pre-funded warrants (the "Private Placement"). The purchase price per share of common stock and accompanying common stock warrant is $0.8677, and the purchase price per pre-funded warrant and accompanying common stock warrant is $0.8676, which is the purchase price per share of our common stock and accompanying common stock warrant minus the $0.0001 per share exercise price of such pre-funded warrant. In connection with the Private Placement, certain investors received the right to designate directors to our board of directors at closing.

Current wording

In August 2025, we issued and sold 15,225,158 shares of common stock, common stock warrants, 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. We may receive an additional $57.1 million in gross proceeds if all of the common stock warrants are exercised.

Previous wording

Our primary uses of cash and cash equivalents, and investments are to fund our operations, which consist primarily of research and development expenditures related to our programs, product development costs, research expenses, administrative support, and capital expenditures related to bringing in-house certain process development and manufacturing capabilities and working capital requirements. We anticipate incurring additional net losses and negative cash flows from operations in the near future until such time, if ever, that we can generate significant sales of our product candidates currently in development. Our future funding requirements will depend on many factors, including:

Current wording

Our primary uses of cash and cash equivalents, and short-term investments are to fund our operations, which consist primarily of research and development expenditures related to our programs, product development costs, research expenses, administrative support, and capital expenditures related to bringing in-house certain process development and manufacturing capabilities and working capital requirements. We anticipate incurring additional net losses and negative cash flows from operations in the near future until such time, if ever, that we can generate significant sales of our product candidates currently in development. Our future funding requirements will depend on many factors, including:

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 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.

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. 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

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.

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, offset by net noncash operating charges of $7.3 million and $2.5 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 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.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities was $43.1 million and primarily reflected our net loss of $56.7 million and an $4.3 million net change in our operating assets and liabilities, offset by noncash charges of $9.3 million in stock-based compensation, depreciation expense, amortization of investments, and operating lease expense.

Previous 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.

Current wording

During the nine months ended September 30, 2024, net cash used in investing activities was $39.5 million, which was the result of purchases of investments net of maturities.

Previous wording

Net Cash Provided by (Used in) Investing Activities

Current wording

Net Cash Provided by Financing Activities

Previous wording

During the six months ended June 30, 2025, net cash used in financing activities was $0.1 million and was primarily the result of taxes paid related to net share settlement of equity awards.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities was $44.4 million and was primarily the result of proceeds related to the sale of common stock, common stock warrants and prefunded warrants.

Previous wording

During the six months ended June 30, 2024, net cash provided by financing activities was $0.8 million and was primarily the result of $1.3 million in cash received for the exercise of stock options and purchases pursuant to our employee stock purchase plan offset by taxes paid related to net share settlement of equity awards of $0.4 million.

Current wording

During the nine months ended September 30, 2024, net cash provided by financing activities was $0.9 million and was primarily the result of $1.3 million in cash received for the exercise of stock options and purchases pursuant to our employee stock purchase plan offset by taxes paid related to net share settlement of equity awards of $0.4 million.