Shattuck Labs Inc

Item 1A. Risk Factors

Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Other than the risk factors below, there have been no material changes from the risk factors disclosed in Item 1A of our Annual Report on Form 10-K.

We will require additional funding in order to complete development of our product candidate(s), including SL-325, and commercialize our products, if approved. Additional funding may not be available on acceptable terms, or at all. If we are unable to raise capital when needed, we will be forced to delay, reduce, or eliminate our product development programs and other operations.

Based on our current business plans, we estimate that our existing cash and cash equivalents and, short-term investments wand potential future proceeds from the exercise of all outstanding common stock warrants will enable us to fund our operating expenses into 20279. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect, requiring us to seek additional funds sooner than planned through public or private equity or debt financings or other sources, such as strategic collaborations. 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.

Additionally, the Private Placement Holders of our outstanding common stock warrants are not obligated to exercise their warrants, and they may not close as expected. Tchoose to exercise on a cashless basis to the extent permitted by the Private Placement is subjeterms of the warrants, prevailing market conditions, or applicable regulations. If warrant holders elect to certain closing conditions and there can be no assurannot to exercise their common stock warrants, we will not receive any associated cash proceeds, which could adversely affect our liquidity, capital resources, and our ability to fund operations, strategic investments, or debt service that it will be completed on the anticipatewe may have anticipated financing with such proceeds. In addition, even if holders elect to exercise, a cashless exercise would result in the surrender of warrants for a net number of shares based on the spread between the exercise price and terms or at all. If he market price, without the payment of the exercise price in cash, further reducing the cash we would othe Private Placement does not close, our ability to furwise expect to receive. Market volatility, the trading price of our common stock relative to the common stock warrant exercise price, the remaining term of the common stock warrants, regulatory or contractual limitations, and our opinvestor portfolio considerations and continue may increase the likelihood that common stock warrants will eithe development of our product candidatesr remain unexercised or be exercised on a cashless basis. Any shortfall in expected cash proceeds from common stock warrant exercises could be marequire us to seek alterially annative financing on less favorable terms, curtail or delay planned adversectivities, or otherwise negatively affected.impact our business, financial condition, and results of operations

We may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may materially and adversely affect the

31

development of our product candidates. Our ability to raise additional funds will depend on financial, economic, and market conditions and other factors, over which we may have no or limited control. Additional funds may not be available when we need them, on terms that are acceptable to us or at all.

Disruptions at the FDA and other government agencies could negatively affect the review of our regulatory submissions, which could negatively impact our business.

The ability of the FDA to review and approve regulatory submissions can be affected by a variety of factors, including disruptions caused by government shutdowns, changes in leadership at FDA and/or the department of health and human services, reduced staffing in the federal government, and public health crises. There have been mass layoffs of federal employees since the start of the current presidential administration in January 2025, the impact of which is unclear at this time. Such disruptions could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. In addition, the current presidential administration has led and is expected to continue to lead to changes in the leadership of various U.S. federal regulatory agencies and changes to U.S. federal government policy that have led to, in some cases, legal challenges and uncertainty around the funding, functioning and policy priorities of U.S. federal regulatory agencies.

34

We are unable to predict the extent to which the current presidential administration may impose or seek to impose leadership or policy changes at the U.S. federal regulatory agencies responsible for regulating our business or changes to rules and policies impacting our operations. Government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related government agencies. These budgetary pressures may reduce the FDAs ability to perform its responsibilities. If a significant reduction in the FDAs workforce occurs, the FDAs budget is significantly reduced or a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions or take other actions critical to the development of our most advanced product candidate, SL-325, or other product candidates, which could have a material adverse effect on our business.

For example, the U.S. government has been shut down since October 1, 2025, and the Senate has repeatedly failed to advance funding bills to reopen it, and the timing for restoring funding is uncertain. The FDA has not been able to accept applications for new drugs, generics, biologics, biosimilars or medical devices that require payment of a user fee while the shutdown is in effect. Any resulting delay in the acceptance, review or approval of our investigational new drug applications, clinical trial applications, marketing applications, facility inspections or lot-release/testing activities could delay or increase the cost of our clinical trials, manufacturing scale-up, product launches or post-approval changes. A prolonged U.S. federal government shutdown could materially delay our regulatory timelines, clinical development, reimbursement decisions and access to capital. If the shutdown continues or recurs, we could experience material adverse impacts on our operations, business and financial condition.

Current and future laws and regulations may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.

Heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare therapies, which could result in reduced demand for our product candidate(s) or additional pricing pressures. Under the Inflation Reduction Act (the IRA), orphan drugs were previously exempted from the Medicare drug price negotiation program, but only if they had one orphan designation and the only approved indication(s) related to disease or condition. If a product were to have received multiple orphan designations or have multiple approved indications, it would not qualify for the orphan drug exemption. The One Big Beautiful Bill Act of 2025 eliminated this restriction and now all orphan drugs, regardless of the number of orphan designations or indications, are eligible for exemption from the Medicare drug price negotiation program. We cannot be sure whether additional legislation or rulemaking related to the IRA will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

We may fail to qualify for Our business could be adversely affected by econtinued listomic downturns, inflation, fluctuating on The Nasdaq Global Select Market, which could make it more difficult for our stockholdinterest rates, changes in trade policies, including tariffs or other trade restrictions or the threat of such actions, natural disasters to sell their shares.

We are required to satisfy , public health crises, such as pandemics, political crises, geopolitical events, or othe continued listing requiremenr macroeconomic conditions, which could have a material and adverse effect on our results of The Nasdaq Goperations and financial condition.

The global Select Maeconomy, including credit and financial market (Nasdaq) to maintain such listings, has experienced extreme volatility and disruptions, including, among other things, the maintenance of a minimum closing bid price of $1.00 per share. On August 8, 2025, we received written notice from Nasdaq that we were notdiminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, fluctuating interest and in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on Nasdaq. Nasdaq Listing Rule 5450(a)(1) requires lisflation rates, changes in trade policies, including tariffs or other trade restrictions or the threat of such action, and uncertainty about economic stability. For example, in September 2025, the United securitiStates maintain a minimum clannounced the imposing bid price of $1.00 per share, tion of up to 100% tariffs on imported brand Nasdaq Listing Rule 5810(c)(3)(A) provides that a failureed or patented pharmaceuticals, subject to meet the minimum closing bid price requirement exists if the deficiency continues for a periodcertain exceptions. There remains substantial uncertainty as to when such tariffs may go into effect and whether such tariffs would apply to the importation of 30 consecuactive business days (the Minimum Bid Price Rule).

The notifpharmaceutical ingredients or bulk drug products that are intended for use in clinication of noncompliance does not impacl trials and, more generally, about the listing or tradduration of existing of our commtariffs, tariff levels, implementation stock on Nasdaq at this time,of announced tariffs, litigation challenging tariffs and we have 180 calendar days,hether additional tariffs or until February 4, 2026, to regain compliance with the Minimum Bid Price Rule. To regain compliance, retaliatory actions may be imposed, modified or suspended

35

Furthe closing bid price of our common stock murmore, fluctuating interest be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 4, 2026. If we do not regain compliarates, coupled with reduced government spending and volatility in financial markets, may increase economic unce prior to February 4, 2026, we expertainty and affect to be eligible for an additional 180 calendar daconsumer spending, and ongoing military compliance period.

We intend to actively monitornflicts throughout the world have created extreme volatility in the closing bid price of our common stockglobal capital markets and are committed to regainingmay have further global economic compliance with the Minimum Bid Price Rule prior tonsequences, including disruptions of the expiration of all aglobal supplicable compliance periods. Howey chain. Any such volatility and disruptions may adver, there can be no assurance that we will be able to regain compliance with the Minimum Bid Price Rulesely affect our business or the third parties on whom we rely. Inf the event that we do not regain compliance with the Minimum Bid Price Rule prior to the expiration of the compliance period(s), we expect to receive written notification that ourquity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more common stock is subjecstly, more dilutive, or more difficult to delisting. If our common stock is delisted by Nasdaq, we could face significant mobtain in a timely manner or on favorable terms, if at all. Increased inflation raterials can adverse consequencesly affect us by increasing our costs, including:

limited availability of market quotations for our labor and employee benefit common stock;

redusts.

We have experienced liquidity with respect to our common stock;

a determinaand may in the future experience disruption thas as a result our shares are penny stock, which will require brokers traf such macroeconomic conditions, including delays or difficulties in initiating or expanding in our shares to adhere to more stclinical trials and manufacturing sufficient rules, and which may limit demand for our quantities of materials. Any one or a common stock among certain investors;

a limited amount of news and analyst coverage for our company; and

a decreased ability to issue additional securitiebination of these events could have a material and adverse effect on our results or obtain addif operationals and financing in the future.

32

al condition.