CRESCENT BIOPHARMA, INC.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

CBIO$13.65+0.8%Stored close · as of Nov 9, 2026

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Contents

Summary Risk Factorsiii

Summary Risk Factors

We are subject to a number of risks that, if realized, could materially harm our business, prospects, operating results, and financial condition. Some of the more significant risks and uncertainties we face include those summarized below. The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in Part II, Item 1A “Risk Factors” of this Form 10-Q. Please carefully consider all the information in this Form 10-Q, including the full set of risks set forth in the “Risk Factors” section, and in our other filings with the SEC before making an investment decision regarding the Company.

●	We are a preclinical-stage biotechnology company with a limited operating history on which to assess our business; we have not initiated, conducted, or completed any clinical trials, and have no products approved for commercial sale.
●	We have historically incurred losses and we anticipate that we will continue to incur losses for the foreseeable future.
●	We have never generated revenue from product sales and may never be profitable.
●	We may not be able to raise the capital that we need to support our business plans.
●	Raising additional capital may cause dilution to our shareholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.

●	Drug development and obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.
●	We are substantially dependent on the success of our lead program, CR-001, and our anticipated clinical trials of such program may not be successful.
●	We may not be able to meet requirements for the chemistry, manufacturing, and control of our programs.
●	We face competition from entities that have developed or may develop programs for the diseases addressed by product candidates developed by us.
●	The United States Food and Drug Administration (“FDA”) and comparable foreign regulatory approval processes are lengthy and time consuming and we may not be able to obtain or may be delayed in obtaining regulatory approvals for our product candidates.
●	Disruptions at the FDA and other government agencies could negatively affect the review of our regulatory submissions, which could negatively impact our business.
●	Even if we obtain regulatory approval, we will be subject to ongoing regulatory obligations.
●	We may fail to achieve our projected development goals in the time frames we announce and expect.

Risks Related to Our Intellectual Property

●	We do not currently own any issued patents and a substantial part of our patent portfolio is in-licensed. Our ability to obtain and protect patent rights and protect other proprietary rights is uncertain.
●	We may fail in obtaining or maintaining necessary rights to our programs.
●	We may be subject to patent infringement claims or may need to file such claims.
●	Our ability to protect our products may be impaired by changes to patent laws.
●	Our patent protection could be reduced or eliminated for non-compliance with legal requirements.
●	We may fail to identify or interpret relevant third-party patents.
●	We may become subject to claims challenging the inventorship or ownership of our intellectual property.
●	Patent terms may be inadequate to protect our competitive position of our programs.
●	Our technology licensed from various third-parties in the future may be subject to retained rights.

iii

●	We expect to rely on agreements with third parties to develop our product candidates. If we are unable to maintain collaborations or licensing arrangements, or if our collaborations or licensing arrangements are not successful, our business could be negatively impacted.
●	Third parties we rely on for the execution of nonclinical studies and clinical trials may fail to carry out their contractual duties.
●	We may be unable to use third-party manufacturing sites, our third-party manufacturers may encounter difficulties in production, or we may need to switch or create third-party manufacturer redundancies.

Other Risk Factors - Risks Related to Employee Matters, Managing Growth, Other Risks Related to Our Business, and Owning Our Ordinary Shares

●	Our business is dependent on key personnel and we will be harmed if we cannot recruit and retain highly qualified personnel to successfully implement our business strategy.
●	In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
●	Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
●	Significant disruptions of information technology systems or breaches of data security could adversely affect our business.
●	Changes in and failures to comply with United States and foreign privacy and data protection laws, regulations, and standards may adversely affect our business, operations, and consolidated financial performance.
●	We may become exposed to costly and damaging liability claims and our insurance may not cover all damages from such claims.
●	Our business could be adversely affected by macroeconomic conditions, including tariffs.
●	We do not anticipate paying any dividends in the foreseeable future.
●	Future sales of shares by existing shareholders could cause our share price to decline.
●	Future sales and issuances of equity and debt could result in additional dilution to our shareholders and could cause our share price to decline.

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