Protagonist Therapeutics, Inc

“Our future success is substantially dependent on our ability and the ability of our collaborators to timely complete clinical trials and obtain marketing approval for, and then successfully commercialize, our clinical-stage product candidates, such as Icotyde and rusfertide. We currently have no product candidates that are approved for commercial sale, and we may never develop a marketable product. We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to our current product candidates and the development of other product candidates, includ…”

“We do not have complete control over many of the factors upon which the successful development and commercialization of our product candidates will be dependent, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of our collaborators. For product candidates that are licensed to third parties, including Icotyde and rusfertide, we generally will not have discretion over marketing decisions. If we or our collaborators do not receive marketing…”

“Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. Our operations to date have been limited to developing our technology, undertaking pre-clinical studies and clinical trials of our pipeline candidates, conducting research to identify additional product candidates and entering into partnerships with collaborators for certain of our product candidates. We have not yet successfully developed an approved product or generated revenue from product sales or successfully completed a pivotal registration trial for one of our prod…”

“company, many of which are outside of our control, and past results, including operating or financial results, should not be relied on as an indication of future results.”

“JNJ filed an NDA with the FDA in July 2025 and sought regulatory approval with additional global regulatory authorities thereafter for Icotyde in moderate-to-severe plaque psoriasis, and Takeda submitted an NDA for rusfertide for the treatment of PV in December 2025. There can be no guarantee that the FDA or other regulatory authorities will ultimately approve these products. For instance, the FDA could, where applicable, refuse to file our or our collaborators applications, require additional clinical or non-clinical data, request further analyses, conduct an advisory committee review, identi…”