Coya Therapeutics Inc

Item 1A. Risk Factors.

As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission, or SEC, on March 16, 2026, except as follows. Any of these factors could result in a significant or material adverse effect on our result of operations or financial conditions. Additional risk factors not presently known to us may also impair our business or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

If our license agreement with The Methodist Hospital is terminated, we could lose our rights to key components enabling our Treg Modalities.

Key components of the technology utilized in our Treg Modalities have been in-licensed pursuant to an Amended and Restated Patent and Know How License Agreement, (the Methodist License Agreement), between us and The Methodist Hospital located in Houston, Texas (the Methodist). Pursuant to the Methodist License Agreement, Methodist granted to us an exclusive, worldwide, royalty-bearing, sublicensable license under specified patents and patent applications related to Treg technology in the field of therapeutics. Pursuant to the Methodist License Agreement, we are also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, royalties (subject to customary reductions) ranging from 1% to 10% of annual worldwide net sales of such licensed product. The applicable royalty percentage increases as Licensed Products are used to treat from only one to more than three indications and if a given licensed product utilizes only Treg cell therapy or is a combination of both Treg cell therapy and exosomes. Therefore, the lowest tier is paid when there is only a single indication being addressed with a single product. There is only one low double-digit tier with such tier bearing only on combination products where there are three or more indications being served. We are also required to pay a low single digit percentage for certain licensed services. We are required to pay mid-teens royalties on sublicense revenue.

The term of the Methodist License Agreement extends until expiration of the last of the patent rights licensed to us by the Licensor, which is currently expected to occur in approximately 2046. The Licensor may terminate the Methodist License Agreement or convert it into a non-exclusive license upon the occurrence or non-occurrence of certain events subject to the terms and conditions therein, such as (i) not Actively Attempting to Develop or Commercialize (as defined in the Methodist License Agreement) for a continuous period of 6 months anytime beginning October or our Quarterly Report on Form 10-Q for the period ended March 31, 2026 filed with the SEC on May 12, 2025, (ii) breach of obligation to make timely payments or reports by us, (iii) an uncured material breach by us, (iv) the cessation of our business or our insolvency, liquidation or receivership. If the Licensor terminates or narrows the Methodist License Agreement, we could lose the use of intellectual property rights that may be material or necessary to the development or production of our product candidates, which could impede or prevent our successful commercialization of such product candidates and materially adversely affect our business, financial condition, results of operations and growth prospects.

Furthermore, our Methodist License Agreement with the Licensor is field-specific and has been granted to us 6. Any of these factors could result in the field of therapeutics. This Methodist License Agreement permits Licensor to practice the licensed rights, and to allow non-profit academic third parties to practice the licensed rights fa significant or certain academic purposes. As such, certain patents in a patent family that is licensed to us by the Licensor have been licensed to at least one other third party. Although these patents should not be omaterial adverlapping with our licensed patents, there is a risk that inadvertent overlap may occur, and thus resources may have to be expended to resolve any such overlap and to prevent other licensees from practicing under our licensed patents rights. If any of the foregoing were to occur, it could delay our development and commercialization of ose effect on our product candidates, which in turn could materially adversely affect our business, financial condition, results of oresult of operations and growth prospects.

Duration of patent terms may be or finadequate to protect our competitive position on our product candidates for an adequate amount of time, and the expiration of our patents may subject us to increased competition.

As of the date of this Quarterly Report on Form 10-Q, our patent estate derived from our relationship with The Houston Methodist Hospital included one pending U.S. provisional patent application, seven pending U.S. non-provisional patent applications, 43 pending foreign patent applications, and three pending Patent Cooperation Treaty (PCT) applications, each co-owned with or in-licensed from The Houston Methodist Hospital. To date, no patents have been issued. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2040, 2042 and 2044-2046 without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. These patent applications are directed to our Treg and exosome compositions and methods of use, methods of Treg and exosome manufacture, and methods of in vivo Treg expansion via combination therapies, among other things. We have filed intellectual property 

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claims on the contents of the exosomes, namely the micro RNncial conditions. As that are reproducibly represented from batch to batch. Many of these micro RNAs confer anti-inflammatory functionality as a mechanism of action and may explain the exosomes immunomodulatory function. The exosome field is an emerging and new area at present and understanding the functional aspects of the exosomes is an important but evolving regulatory aspect. We have filed intellectual property claims for compositions of matter that teach the reproducible micro RNA contents. All of our Houston Methodist Hospital patent applications have composition and method claims, with the exception of a biomarker patent application, which has only method claims.

In addition, our patent estate derived from our relationship with ARScience Biotherapeutics, Inc. (described below) includes three pending U.S. non-provisional patent applications one issued U.S. patent, nine pending foreign patent applications and two issued foreign patents. The issued U.S. patent is expected to expire in 2042, the issued foreign patents are expected to expire in 2039, and if any other patents issue from or claim priority to one or more of these patents or patent applications, the patents are expected to expire between 2039 and 2041, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The ARScience Biotherapeutics, Inc. patents and patent applications have composition, method, and/or utility claims. 

Our patent estate derived from odditional risk factors not presently known to us may also impair our relationship with Dr Reddys Laboratories includes two pending U.S. non-provisional patent applications, one issued U.S. patent, 15 pending foreign patent applications and five issued foreign patents. The issued U.S. patent is expected to expire in 2042, the issued foreign patents are expected to expire in 2039, and if any other patents issue from or claim priority to one or more of these patents or patent applications, the patents are expected to expire in 2039, 2041 and 2042, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental feebusiness or results of operations. The Dr. Reddys patents andpatent applications have composition and method claims. 

Our patent estate derived from our relationship with the University of Nebraska includes two non-provisional U.S. patent applications, and one foreign patent application. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2043 and 2044, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The University of Nebraska patent applications have composition and/or use claims. 

Finally, our patent estate derived from our relationship with Carnegie Mellon includes two U.S. non-provisional patent applications. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2040 and 2044, without giving effect to any potential patent term extensionsWe may disclose changes to such factors or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Carnegie Mellon patent applications have composition and method claims.

We can provide no assurance that we will be able to file or receive adisclose additional patent protection for our product candidates.

Patent expiration dates may be shortened or lengthened by a number of fafactors, including terminal disclaimers, patent term adjustments, supplemental protection certificates and patent term extensions. Patent term extensions and supplemental protection certificates, and the like, may b from time to time impacted by the regulatory process and may not significantly lengthen patent term. On our patent protection could also be reduced or eliminated for noncompliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies. In addition, if we fail to apply for applicable patent term extensions or adjustments, we will have a more limited time during which we can enforce our granted patent rights.

Given the amount of time required for the development, testing and regulatory review of product candidates, patents protecting such candidates might expire before or shortly after such product candidates are commercialized. We expect to seek extensions of patent terms in the United States and, if available, in other countries where we have or will obtain patent rights. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent; provided that the patent is not enforceable for more than 14 years from the date of drug approval, which is limited to the approved indication (or any additional indications approved during the period of extension). Furthermore, only one patent per approved product can be extended and only those claims directed to the approved product, a method for using it or a method for manufacturing it may be extended. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If we are responsible for patent prosecution and maintenance of patent rights in-licensed to us, we could be exposed to liability to the applicable patent owner. If we or our licensors fail to maintain the patents and patent applications covering our product candidates and technologies, we may not be able to prevent a competitor from marketing products that are the same as or similar to our product candidates. Further, others commercializing products similar or identical to ours, and our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case, which could increase competition for our product candidates and materially adversely affect our business, financial condition, results of operations and growth prospects.

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future filings with the SEC.