Shattuck Labs Inc

Current report

We have received orphan drug designation for SL-172154 for the treatment of AML, and we may seek orphan drug designation for certain future product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.

Current report

We have received orphan drug designation from the U.S. Federal Food and Drug Administration (“FDA”) for SL-172154 for the treatment of AML. Although we may seek orphan product designation for some or all of our other product candidates, we may never receive such designations. Under the Orphan Drug Act, the FDA may designate a drug or biological product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. Orphan drug designation must be requested before submitting a biologics license application. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA.

Current report

In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity for the orphan patient population. Exclusive marketing rights in the United States may also be unavailable if we or our collaborators seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective.

Current report

Even with an orphan drug designation for our current and potential future product candidates, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products. Further, even if we obtain orphan drug exclusivity for an existing or future product candidate, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties still can be approved for the same condition even with an orphan drug designation. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is safer, more effective, or makes a major contribution to patient care. Orphan drug designation neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory review or approval process.

Current report

None.

Previous report

(c) Director and Section 16 Officer Rule 10b5-1 Trading Arrangements

Previous report

On March 5, 2024, Helen Boudreau, amember of the Company’s Board of Directors, entered into a Rule 10b5-1 trading arrangement (as defined in Item 408 of Regulation S-K). Ms. Boudreau’s plan provides for the potential sale of up to 60,000 shares of the Company’s common stock issuable upon the exercise of options. The plan terminates on the earlier of (i) September 30, 2024, (ii) the first date on which all trades have been executed or all trading orders relating to such trades set forth in the plan have expired or (iii) such time as the plan is otherwise terminated according to its terms.

Previous report

On March 6, 2024, Casi DeYoung, the Company’s Chief Business Officer, entered into a Rule 10b5-1 trading arrangement. Ms. DeYoung’s plan provides for the potential sale of up to (i)32,082 shares of the Company’s common stock, (ii)3,500 shares of restricted common stock issuable upon the vesting of such shares and (iii)30,000 shares of the Company’s common stock issuable upon the exercise of options. The plan terminates on the earlier of (i) March 1, 2025, (ii) the first date on which all trades have been executed or all trading orders relating to such trades set forth in the plan have expired or (iii) such time as the plan is otherwise terminated according to its terms.

Previous report

On March 12, 2024, Lini Pandite, the Company’s Chief Medical Officer, modified an existing Rule 10b5-1 trading arrangement, originally adopted on April 3, 2023, to modify (i) the sale periods, (ii) the minimum prices at which sales may be made and (iii) the termination date under the plan. The original plan provided for the potential sale of up to 83,514 shares of the Company’s common stock. Prior to its modification, no shares of common stock were sold pursuant to the original plan. The modified plan provides for the potential sale of up to 83,514 shares of the Company’s common stock and terminates on the earlier of (A) May 30, 2025, (B) the completion of the sale of the maximum number of shares under the plan or (C) such time as the plan is otherwise terminated according to its terms.