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CRESCENT BIOPHARMA, INC.

For the period ended Dec 31, 2025. Filed Feb 26, 2026.

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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.

FY2025 · Filed Feb 26, 2026

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

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

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Contents

Table of Contents

Page No.
Part I
Item 1.Business6
Item 1A.Risk Factors58
Item 1B.Unresolved Staff Comments100
Item 1C.Cybersecurity101
Item 2.Properties102
Item 3.Legal Proceedings102
Item 4.Mine Safety Disclosures102
Part II
Item 5.Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities103
Item 6.Reserved104
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations105
Item 7A.Quantitative and Qualitative Disclosures about Market Risk119
Item 8.Financial Statements and Supplementary Data120
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure157
Item 9A.Controls and Procedures157
Item 9B.Other Information157
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections157
Part III
Item 10.Directors, Executive Officers and Corporate Governance158
Item 11.Executive Compensation164
Item 12.Security and Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters169
Item 13.Certain Relationships and Related Transactions, and Director Independence173
Item 14.Principal Accountant Fees and Services177
Part IV
Item 15.Exhibits and Financial Statement Schedules178
Signatures182

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including, without limitation, statements regarding our future results of operations and financial position, business strategy, the length of time that we believe our existing cash resources will fund our operations, our market size, our potential growth opportunities, our preclinical and future clinical development activities, the efficacy and safety profile of our product candidates, the potential therapeutic benefits and economic value of our product candidates, the timing and results of preclinical studies and clinical trials, the expected impact of macroeconomic conditions, the timing of the Option Agreement Termination (as defined herein), and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “predict,” “target,” “intend,” “could,” “would,” “should,” “project,” “plan,” “expect,” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause actual results to differ materially from current expectations include the initiation, execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, our development activities and those other factors we discuss in Part I, Item 1A. “Risk Factors” in this Annual Report on Form 10-K. You should read these risk factors and the other cautionary statements made in this report as being applicable to all related forward-looking statements wherever they appear in this report. The risk factors are not exhaustive and other sections of this report may include additional factors which could adversely impact our business and financial performance.

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Preliminary and interim results from any trial and results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

As used in this Annual Report on Form 10-K, unless otherwise specified or the context otherwise requires, the terms “we,” “our,” “us,” and the “Company” refer to Crescent Biopharma, Inc. and its subsidiaries. All brand names or trademarks appearing in this Annual Report on Form 10-K are the property of their respective owners.

SUMMARY OF THE MATERIAL RISK FACTORS ASSOCIATED WITH OUR BUSINESS

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

Risks Related to Our Financial Condition and Capital Requirements

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 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.

Risks Related to Clinical Development and Regulatory Approval

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 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 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.

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.

Risks Related to Our Reliance on Third Parties

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.

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.

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.