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Protagonist Therapeutics Inc

For the period ended Dec 31, 2023. Filed Feb 27, 2024.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Feb 27, 2024

PTGX$135.90+2.9%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits
Contents

Table of Contents

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Item 1.​Business​3
Item 1A.​Risk Factors​30
Item 1B.​Unresolved Staff Comments​52
Item 1C.​Cybersecurity​52
Item 2.​Properties​53
Item 3.​Legal Proceedings​53
Item 4.​Mine Safety Disclosures​53
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PART II​​​​
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Item 5.​Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities​54
Item 6.​Reserved​55
Item 7.​Management’s Discussion and Analysis of Financial Condition and Results of Operations​56
Item 7A.​Quantitative and Qualitative Disclosures about Market Risk​72
Item 8.​Financial Statements and Supplementary Data​73
Item 9.​Changes in and Disagreements with Accountants on Accounting and Financial Disclosure​107
Item 9A.​Controls and Procedures​107
Item 9B.​Other Information​109
Item 9C.​Disclosure Regarding Foreign Jurisdictions that Prevent Inspections​109
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PART III​​​​
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Item 10.​Directors, Executive Officers, and Corporate Governance​109
Item 11.​Executive Compensation​109
Item 12.​Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters​109
Item 13.​Certain Relationships and Related Transactions, and Director Independence​109
Item 14.​Principal Accountant Fees and Services​110
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PART IV​​​​
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Item 15.​Exhibits, Financial Statement Schedules​110
SIGNATURES​115

PART I

Statements made in this Annual Report on Form 10-K contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are identified by words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “forecast,” “target,” “could,” “would,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss current expectations about future events, contain projections of future results of operations or financial condition, or state other “forward-looking” information. In addition, any statements other than statements of historical facts are forward-looking statements. These statements relate to our plans, objectives, goals, targets, expectations, intentions, priorities and projections of financial performance and the assumptions that underlie these statements. These forward-looking statements are subject to certain known and unknown risks, uncertainties and other factors that could cause actual results or outcomes, or the timing of such results or outcomes, to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in Item 1A, “Risk Factors” and elsewhere in this Annual Report on Form 10-K. In addition, statements that “we believe” and similar statements reflect our current beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Forward-looking statements are based on our management’s belief, estimates and assumptions and on information currently available to our management. These statements, like all statements in this Annual Report on Form 10-K, speak only as of the date of this Annual Report on Form 10-K, and except as required by law, we undertake no obligation to update or revise these statements in light of new information, future events, developments, changed expectations or otherwise. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading Item 1A,” Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

●We have no approved products and no historical commercial revenue, which makes it difficult to assess our future prospects and financial results.
●We are heavily dependent on the success of our product candidates in clinical development.
●Clinical development is a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development.
●Our product candidates may cause undesirable side effects or have other properties adversely impacting safety that delay or prevent their regulatory approval, restrict their approved labeling, or otherwise limit their commercial opportunity, including being required by an independent data monitoring committee or regulatory authorities to delay or halt or clinical trials, or if such side effects or adverse events are sufficiently severe or prevalent, to suspend or cease altogether further development of our product candidates.
●We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
●We have never generated any revenue from product sales and may never be profitable.
●We may require additional funding.
●Raising additional capital may cause dilution to our existing stockholders.
●We rely on JNJ Innovative Medicines (“JNJ”) (formerly Janssen Biotech, Inc., (“Janssen”)) to continue the development of product candidates subject to our license and collaboration with JNJ, and to successfully commercialize any resulting products, and we expect to rely on Takeda Pharmaceuticals USA, Inc., (“Takeda”) to successfully commercialize any products resulting from our collaboration agreement with Takeda.
●Our existing or future collaborations with third parties may not be successful.
●We rely on third parties to conduct our pre-clinical studies and clinical trials and are subject to risks associated with their businesses and performance of their obligations to us.
●We rely on third-party contract manufacturers to manufacture our drug substance and clinical drug product.
●If we are ultimately unable to obtain regulatory approval for our product candidates in the United States or other jurisdictions, our business will be substantially harmed.
●We have no marketing and sales organization and may not be able to effectively market and sell any products or generate product revenue if any of our product candidates are approved for marketing.
●If we commercialize our product candidates abroad, we will be subject to the risks of doing business outside of the United States.
●We face significant competition from other biotechnology and pharmaceutical companies.
●We may face risks to our business arising from outbreaks of disease, epidemics and pandemics, including risks to our ongoing and planned clinical trials and pre-clinical and discovery research.
●Unstable market and economic conditions, including elevated and sustained inflation, may have serious adverse consequences on our business, financial condition and stock price.
●Our success depends on our ability to attract, retain and motivate qualified executives and other personnel.
●We may experience difficulties in managing the growth of our organization.
●We are subject to risks associated with information technology systems or breaches of data security.
●Any misconduct by our employees, independent contractors, principal investigators, consultants and vendors could have a material adverse effect on our business.
●Our headquarters is located near known earthquake fault zones.
●If we are unable to obtain or protect intellectual property rights related to our product candidates and technologies, we may not be able to compete effectively in our markets.
●We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful.
●Patents covering our product candidates could be found invalid or unenforceable.
●Third party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.
●Our stock price has been and will likely continue to be volatile and may decline, regardless of our operating performance.
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.