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CRESCENT BIOPHARMA, INC.

For the period ended Jun 30, 2026. Filed Jul 30, 2026.

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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.

Jun 30, 2026 · Filed Jul 30, 2026

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

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Summary Risk Factorsiii

Summary Risk Factors

Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. The principal risks and uncertainties affecting our business include the following:

We are a clinical-stage biotechnology company with a limited operating history on which to assess our business; we have not 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 may not be able to raise the capital that we need to support our business plans.

Raising additional capital may cause additional 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 current and anticipated clinical trials of such program may not be successful.

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.

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 our patent portfolio is in-licensed from Paragon Therapeutics, Inc, (“Paragon”) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”).

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.

iv

Our technology licensed from Paragon and Kelun and any technology licensed from other third-parties in the future may be subject to retained rights.

We may be unable to protect the confidentiality of our trade secrets and other proprietary information.

We may become subject to litigation under the Biologics Price Competition and Innovation Act of 2010 (“BPCIA”) in connection with patent rights for our product candidates.

We currently and in the future expect to rely on agreements with third parties to develop our product candidates. If we are unable to maintain our current or future collaborations or licensing arrangements, or if our current or future collaborations or licensing arrangements are not successful, our business could be negatively impacted. Additionally, in some instances, our agreements with third parties may include certain indemnification provisions which, if triggered, may negatively impact our business.

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.

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, including any shares issuable upon exercise of any pre-funded warrants, 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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