Tonix Pharmaceuticals Holding Corp.

Current report

We have received a paragraph IV certification notice from a generic manufacturer seeking approval to market a generic version of TONMYA prior to the expiration of our Orange Book-listed patents. If generic manufacturers are successful in their use of litigation or regulatory means to obtain approval for generic versions of TONMYA, our revenue and results of operations would be adversely affected.

Current report

The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) permits the FDA to approve abbreviated new drug applications (“ANDAs”) for generic versions of branded drugs. The ANDA process permits competitor companies to obtain marketing approval for a drug with the same active ingredient as a branded drug, but does not generally require the conduct and submission of clinical efficacy studies for the generic product. In place of such clinical studies, an ANDA applicant usually submits data demonstrating that its product is bioequivalent to the branded product.

Current report

We own four patents that cover TONMYA and have listed those patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). For listed patents relevant to a proposed generic product, an ANDA applicant generally must certify that the patent has expired, that approval is sought only after the patent expires, or that the patent is invalid, unenforceable or will not be infringed by the proposed product. A certification in the last category is known as a paragraph IV certification and requires notice to the NDA holder and patent owner. For a listed method-of-use patent, an applicant may instead submit a section viii statement if it seeks approval only for uses not covered by that patent.

Current report

After receiving a paragraph IV notice, we may, if we have a proper basis, bring a patent infringement action against the ANDA applicant. If we commence such an action within 45 days after receiving the notice, the FDA generally may not grant final approval of the ANDA for 30 months from our receipt of the notice, subject to earlier termination upon expiration of the applicable patent, settlement of the litigation, a court decision in favor of the ANDA applicant, or such shorter or longer period as the court may order. Patent litigation of this kind, including discovery, trial and any appeals, is expensive and time-consuming. If the ANDA applicant prevails, generic versions of TONMYA could enter the market before our patents expire.

Current report

On October 1, 2026, we received a notice letter (the “Notice”) from DRL stating that DRL had submitted an ANDA to the FDA seeking approval to market a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg, prior to the expiration of the TONMYA Patents, each of which is listed in the Orange Book for TONMYA and is scheduled to expire on March 14, 2034. The Notice includes a paragraph IV certification alleging that the TONMYA Patents are invalid, unenforceable and/or will not be infringed by DRL’s proposed generic product. Under the Hatch-Waxman Act, we have 45 days from our receipt of the Notice to commence a patent infringement action against DRL in order to obtain the 30-month stay of FDA approval of DRL’s ANDA described above. We intend to vigorously enforce our intellectual property rights relating to TONMYA, including by commencing patent infringement litigation against DRL within the 45-day period. If we do not commence litigation within the 45-day period, the 30-month stay will not apply, and the FDA could approve DRL’s ANDA once DRL satisfies the other applicable requirements for approval, subject to the expiration of regulatory exclusivity for TONMYA in August 2028. Even if we commence litigation within the 45-day period, the 30-month stay may expire or be terminated before the litigation is resolved, and the FDA could approve DRL’s ANDA upon the earliest of the expiration of the 30-month stay, a decision in the litigation that is favorable to DRL, or the entry of a settlement order or consent decree stating that the TONMYA Patents are invalid or not infringed, subject in each case to any applicable regulatory exclusivity and other requirements for FDA approval. DRL or other generic manufacturers may also seek declaratory judgments of non-infringement or invalidity, or challenge the TONMYA Patents in proceedings before the U.S. Patent and Trademark Office, such as inter partes review. Also, we may receive additional paragraph IV notices from other generic manufacturers seeking approval of generic versions of TONMYA. We cannot predict the outcome of these matters, including whether any litigation we commence will be successful, or the timing thereof.

Current report

The approval of any ANDA for a generic version of TONMYA, or developments in related patent litigation, could negatively affect the market price of our common stock. Enforcing and defending our patents is likely to be costly and will divert significant management time and attention, and we may not be able to recover our litigation costs. If a court finds the TONMYA Patents invalid or unenforceable, or finds that the product of DRL or any other ANDA filer does not infringe them, generic competition for TONMYA could follow once any applicable regulatory exclusivity expires, which would have a material adverse effect on our revenue and results of operations. In addition, a generic manufacturer may elect to launch a generic version of TONMYA “at risk” after FDA approval but before final resolution of the litigation, and any damages we may recover may not fully compensate us for lost sales. Generic products are typically sold at significantly lower prices than branded products, and the introduction of a generic version of TONMYA could rapidly reduce our sales volume and pricing, including through substitution by pharmacies and pressure from third-party payors. If we resolve any patent litigation through settlement, the terms of the settlement could permit generic entry before our patents expire, and settlement agreements between brand and generic manufacturers may be subject to review by the Federal Trade Commission and the U.S. Department of Justice and to challenge by private plaintiffs, which could result in additional costs, investigations or litigation.

Current report

Our use of artificial intelligence could adversely affect our business, financial condition and results of operations

Current report

We use artificial intelligence (“AI”) and computational tools in research, drug development and corporate activities. Inaccurate or biased outputs may remain undetected despite human review, misdirect resources or delay development and regulatory submissions. AI predictions may not translate into clinical safety or efficacy. Use of AI, including third-party services, may expose confidential or personal information, create infringement claims or impair protection of our intellectual property. Service outages and changes in vendor terms may disrupt operations, increase expenses or compromise our proprietary information. Evolving laws and regulatory expectations may increase compliance costs or limit acceptance of AI-supported analyses. These risks could result in litigation, liability, reputational harm and increased costs.