CRESCENT BIOPHARMA, INC.
For the period ended Dec 2, 2025. Filed Dec 4, 2025.
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Dec 2, 2025 · Filed Dec 4, 2025
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Contents
Forward-Looking Statements
Certain statements in this Form 8-K, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the potential benefits of treatment with the Company’s product candidates, the expected benefits or opportunities with respect to the strategic partnership between the Company and Kelun-Biotech, the ability for each of CR-001 and CR-003 (SKB105) to perform as monotherapies and in combination, the potential for CR-001 to be developed in additional combinations, including with proprietary ADC pipeline assets, the timing of regulatory submission, design, enrollment, indication selection, dosing, timing of initiation, progress, timing of readouts, and results of clinical trials for CR-001, CR-002, and CR-003 both as monotherapy and in combinations, pipeline expansion opportunities, the potential benefits of treatment with and the market for CR-001, the potential for CR-001 to be a foundational immuno-oncology backbone, the potential for CR-001’s anti-VEGF activity to normalize the vasculature at the tumor site to improve the localization and effectiveness of combination therapies, closing of the private placement, the Company’s agreement to register the securities issued in the private placement, the expected amount and use of proceeds from the private placement and the Company’s anticipated cash runway. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "plan," "possible," "project," "should," "will," "would" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, that the expected benefits of, and opportunities related to, the strategic partnership between the Company and Kelun-Biotech may not be realized by either party or may take longer to realize than anticipated, that the potential of CR-001 and/or CR-003 may change, that either party may fail to discover and develop any commercially successful product candidates through the strategic partnership, that CR-001, CR-002, or CR-003 may not receive regulatory approval and, if approved, such product candidates may not be commercially successful, that the Company has no clinical data regarding cancer patients that have been treated with
CR-001, CR-002, or CR-003 and there can be no assurance that the Company’s clinical trials will be completed successfully and/or produce results necessary to support regulatory approval for commercialization, that the Company may not reach the anticipated milestones at the times outlined in this release or at all, the Company’s limited operating history, including with respect to clinical trials, the Company’s historical losses and any future ability to generate revenue, the Company’s ability to raise capital to support its business plans, risks associated with clinical development and regulatory approval, risks related to the Company’s intellectual property, the Company’s reliance on third parties, including to help develop its product candidates and run its clinical trials, as well as to manufacture its product candidates, the Company’s dependence on key personnel, the Company’s estimates of market opportunity may prove to be inaccurate, significant disruptions of information technology systems or breaches of data security, litigation and regulatory risks, as well as those factors more fully described in the Company’s most recent filings with the Securities and Exchange Commission (including its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025), and the Company’s other filings with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this Form 8-K should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this Form 8-K, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This Form 8-K does not purport to summarize all of the conditions, risks and other attributes of an investment in the Company.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description |
| 4.1 | Form of Pre-Funded Warrant. |
| 10.1† | Amendment No. 1 to the License Agreement, dated December 2, 2025, by and between Crescent Biopharma Operating Company, LLC and Paragon Therapeutics, Inc. |
| 10.2†† | Form of Securities Purchase Agreement, dated December 4, 2025, by and between Crescent Biopharma, Inc. and each purchaser thereto. |
| 10.3 | Form of Registration Rights Agreement, dated December 4, 2025, by and between Crescent Biopharma, Inc. and the other parties thereto. |
| 99.1 | Press Release, dated December 4, 2025. |
| 99.2 | Press Release, dated December 4, 2025. |
| 99.3 | Investor Presentation, dated December 4, 2025. |
| 104 | The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL. |
| † | Certain portions of this exhibit (indicated by “[***]”) have been omitted because they are both (i) not material and (ii) customarily and actually treated as private or confidential. |
|---|---|
| †† | Exhibits and/or schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request by the Securities and Exchange Commission; provided, however, that the registrant may request confidential treatment pursuant to Rule 24b-2 under the Exchange Act for any exhibits or schedules so furnished. |
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