Crescent Biopharma (NASDAQ: CBIO) posts Q1 2026 loss and oncology pipeline update
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Crescent Biopharma reported first quarter 2026 results alongside a detailed oncology pipeline update. The company is running its global Phase 1/2 ASCEND trial of CR-001, a PD-1 x VEGF bispecific antibody, across multiple solid tumors and preparing ADC combination trials beginning in the second half of 2026.
CR-002, a PD-L1–targeted ADC, is planned to enter the clinic in the second half of 2026, while CR-003, an ITGB6-targeted ADC, is already in a Phase 1/2 study in China. Multiple proof-of-concept data readouts are anticipated starting in early 2027.
Financially, Crescent ended March 31, 2026 with cash and cash equivalents of $189.2 million, which management expects will fund operations into 2028. Q1 2026 revenue was $1.0 million, research and development expense was $17.9 million, general and administrative expense was $7.9 million, and net loss was $23.3 million, or $0.70 per basic and diluted share.
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Negative
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Insights
Crescent advances oncology pipeline while sustaining typical early-stage losses.
Crescent Biopharma highlights steady progress across three oncology programs. CR-001 is in the global Phase 1/2 ASCEND trial, with initial proof-of-concept data expected in Q1 2027 and additional combination data from chemotherapy and ADC regimens through mid-2027.
CR-002 and CR-003 expand the company’s antibody-drug conjugate strategy, with CR-002 targeting PD-L1 and CR-003 targeting ITGB6. Both are aligned to Phase 1/2 timelines between the second half of 2026 and year-end 2027, subject to successful trial execution and regulatory interactions.
On the financial side, cash and cash equivalents of $189.2 million as of March 31, 2026 are described as sufficient to fund operations into 2028. Q1 revenue of $1.0 million from a Kelun-Biotech license contrasts with an R&D spend of $17.9 million and a net loss of $23.3 million, consistent with a clinical-stage biotech prioritizing pipeline development.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Cash and cash equivalents: $189.2 million
Q1 2026 revenue: $1.0 million
Research and development expense: $17.9 million
+4 more
7 metrics
Cash and cash equivalents
$189.2 million
As of March 31, 2026; anticipated to fund operations into 2028
Q1 2026 revenue
$1.0 million
Three months ended March 31, 2026; from CR-001 license agreement
Research and development expense
$17.9 million
Three months ended March 31, 2026; up from $10.6 million in 2025
General and administrative expense
$7.9 million
Three months ended March 31, 2026; up from $3.6 million in 2025
Net loss
$23.3 million
Three months ended March 31, 2026; compared with $15.1 million in 2025
Net loss per share
$0.70
Basic and diluted for ordinary shareholders, Q1 2026
Shares outstanding
33.4 million shares
Ordinary shares and equivalents issued and outstanding as of March 31, 2026
Key Terms
bispecific antibody, antibody-drug conjugates (ADCs), Phase 1/2 clinical trial, Investigational New Drug (IND) application, +2 more
6 terms
bispecific antibody medical
"CR-001, a PD-1 x VEGF bispecific antibody, in multiple solid tumor types"
A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.
antibody-drug conjugates (ADCs) medical
"novel antibody-drug conjugates (ADCs). By leveraging multiple modalities"
Antibody-drug conjugates (ADCs) are advanced medicines that combine a targeted antibody with a powerful drug, acting like a guided missile to deliver treatment directly to cancer cells while sparing healthy tissue. This precision approach can improve effectiveness and reduce side effects, making ADCs a promising area of biotech innovation. For investors, advancements in ADC technology can signal potential growth opportunities in the pharmaceutical and healthcare sectors.
Phase 1/2 clinical trial medical
"ASCEND, a global, open-label Phase 1/2 clinical trial evaluating CR-001"
A phase 1/2 clinical trial is an early human study that combines first-in-people safety and dosing checks (phase 1) with an initial look at whether the treatment appears to work (phase 2). Think of it as a short test drive where researchers both confirm the product won’t cause serious harm and gather early signs it could be effective; for investors, successful results reduce risk and can unlock value-creating milestones like larger trials or regulatory discussions.
Investigational New Drug (IND) application regulatory
"on track to submit an Investigational New Drug (IND) application to the FDA"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
proof-of-concept data medical
"proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027"
license agreement revenue financial
"The revenue recognized in 2026 is the result of the $20.0 million upfront payment received from Kelun-Biotech pursuant to the license agreement"
Earnings Snapshot
Revenue: $1.0 million
Q1 2026
Revenue
$1.0 million
Net loss
$23.3 million
R&D expenses
$17.9 million
G&A expenses
$7.9 million
Cash and cash equivalents
$189.2 million
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________________________________________________________________________________
FORM 8-K
________________________________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): April 29, 2026
________________________________________________________________________________________________
(Exact Name of Registrant as Specified in Charter)
________________________________________________________________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (617 ) 430-5595
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
________________________________________________________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||||||||
The | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition.
On April 29, 2026, Crescent Biopharma, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 and Exhibits 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by Crescent Biopharma, Inc. on April 29, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CRESCENT BIOPHARMA, INC. | ||||||||||||||
| Date: April 29, 2026 | By: | /s/ Joshua Brumm | ||||||||||||
| Name: | Joshua Brumm | |||||||||||||
| Title: | Chief Executive Officer | |||||||||||||
Crescent Biopharma Reports First Quarter 2026 Financial Results and Recent Business Highlights
ASCEND Phase 1/2 global clinical trial ongoing, evaluating CR-001, a PD-1 x VEGF bispecific antibody, in multiple solid tumor types in first-line and previously treated patients; first ADC combination trial with CR-001 on track to initiate in second half of 2026
Phase 1/2 trial of CR-003, an ITGB6-targeted ADC, ongoing in China
CR-002, a PD-L1-targeted ADC, on track to enter the clinic in second half of 2026
Multiple key clinical data readouts anticipated beginning in Q1 2027
Waltham, Mass., April 29, 2026 – Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced financial results for the first quarter ended March 31, 2026 and recent business highlights.
“Crescent’s execution on the advancement of our pipeline this quarter positions us for meaningful clinical data readouts in 2027 from CR-001, our potentially best-in-class PD-1 x VEGF bispecific antibody, as well as our differentiated ADC programs. The innovative design of our Phase 1/2 ASCEND study of CR-001 enables us to quickly generate comprehensive data for this next generation immuno-oncology backbone both as monotherapy and in combination with standard of care chemotherapy in multiple tumor types, and we’re also working with our partner, Kelun-Biotech, to deliver ADC combination data,” said Joshua Brumm, chief executive officer of Crescent. “We are pleased that both our global ASCEND trial and the Phase 1/2 trial of CR-003 in China are progressing well. We are on track to initiate two more trials during the second half of 2026, with the first ADC combination study for CR-001 and planned clinic entry for CR-002. This continued momentum underscores our commitment to delivering transformative therapies for people living with cancer.”
Recent Business Highlights & Anticipated Milestones
CR-001, PD-1 x VEGF bispecific antibody
•CR-001 is an investigational tetravalent bispecific antibody that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. Enrollment is ongoing in ASCEND, a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients.
•A trial in progress abstract of the ASCEND study design has been accepted for poster presentation during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29-June 2, 2026 in Chicago: “ASCEND: A phase 1/2, dose-escalation, optimization, and dose-expansion study to evaluate the safety and antitumor activity of CR-001 in adults with locally advanced or metastatic solid tumors.”
•Under its strategic collaboration, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., (“Kelun-Biotech”) exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-001 (SKB118) in China in the first half of 2026.
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•Crescent also plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003. Initiation of the first Phase 1/2 combination trial of CR-001 with a Kelun-Biotech ADC is expected in the second half of 2026 in China.
•Crescent anticipates reporting:
•Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients in multiple solid tumor types. A backfill cohort of first-line NSCLC patients is planned as part of this readout.
•Initial data of CR-001 in combination with standard of care chemotherapy in first-line and previously treated patients by mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial.
•Initial data from the Phase 1/2 trial in China of CR-001 in combination with a Kelun-Biotech ADC in mid-2027 (Q2/Q3).
CR-002, topoisomerase inhibitor ADC targeting PD-L1
•CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
•Crescent is on track to submit an Investigational New Drug (IND) application to the FDA for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003, topoisomerase inhibitor ADC targeting integrin beta-6 (ITGB6)
•CR-003 is an investigational topoisomerase inhibitor ADC directed to ITGB6, which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker.
•A Phase 1/2 trial of CR-003 (also known as SKB105) in participants with advanced solid tumors led by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027. Under its strategic collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China.
First Quarter 2026 Financial Results
Cash position: Cash and cash equivalents were $189.2 million as of March 31, 2026, which is anticipated to fund operations into 2028.
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Revenue: Revenue for the three months ended March 31, 2026 was $1.0 million compared to no revenue in 2025. The revenue recognized in 2026 is the result of the $20.0 million upfront payment received from Kelun-Biotech pursuant to the license agreement for CR-001.
Research and development (R&D) expenses: R&D expenses were $17.9 million and $10.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase in R&D expenses is the result of continued development of CR-001 and CR-002.
General and administrative (G&A) expenses: G&A expenses were $7.9 million and $3.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase in G&A expenses is the result of personnel costs, including share-based compensation, and professional services associated with operating as a public company.
Net loss: Net loss was $23.3 million and $15.1 million, or $0.70 and $19.63 per basic and diluted share, for the three months ended March 31, 2026 and 2025, respectively.
Shares outstanding: As of March 31, 2026, Crescent had approximately 33.4 million shares of the Company’s ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.
About Crescent Biopharma
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Forward-Looking Statements
Certain statements in this press release, 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 Crescent’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation the timing and success of the Phase 1/2 ASCEND trial for CR-001, the timing of clinical data readouts, the expected benefits or opportunities with respect to the strategic partnership between Crescent and Kelun-Biotech, the timing of initiation and success of clinical trials for the Company’s other product candidates, including CR-002 and CR-003, and Crescent’s expected cash runway. 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
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differ materially from current expectations include, but are not limited to, that the expected benefits of, and opportunities related to, the potential of CR-001 may change, that CR-001 may not receive regulatory approval and, if approved, may not be commercially successful, that there can be no assurance that Crescent’s clinical trials will be completed successfully and/or produce results necessary to support regulatory approval for commercialization, that Crescent may not reach the anticipated milestones at the times outlined in this release or at all, that the expected benefits of, and opportunities related to, that Crescent's current or future collaborations, including the current collaboration with Kelun-Biotech, may not be successful, Crescent’s limited operating history, including with respect to clinical trials, Crescent’s historical losses and any future ability to generate revenue, Crescent’s ability to raise capital to support its business plans, risks associated with clinical development and regulatory approval, risks related to Crescent’s intellectual property, Crescent’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, as well as those factors more fully described in Crescent’s most recent filings with the Securities and Exchange Commission (including its Quarterly Report on Form 10-Q), and Crescent’s other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligation to update or revise these forward-looking statements.
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Crescent Biopharma, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
Three Months Ended March 31, 2026 | Three Months Ended March 31, 2025 | ||||||||||
License agreement revenue | $ | 1,039 | $ | — | |||||||
Operating expenses | |||||||||||
Research and development | 17,903 | 10,627 | |||||||||
General and administrative | 7,865 | 3,597 | |||||||||
Total operating expenses | 25,768 | 14,224 | |||||||||
Loss from operations | (24,729) | (14,224) | |||||||||
Other income (expense): | |||||||||||
Interest income | 1,446 | 188 | |||||||||
Interest expense | — | (1,112) | |||||||||
Total other income (expense) | 1,446 | (924) | |||||||||
Net loss and comprehensive loss | $ | (23,283) | $ | (15,148) | |||||||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.70) | $ | (19.63) | |||||||
Net loss per share attributable to Series A non-voting convertible preferred shareholders, basic and diluted | (699.31) | — | |||||||||
Weighted-average ordinary shares outstanding used in computing net loss per share to ordinary shareholders, basic and diluted | 30,397,886 | 771,851 | |||||||||
Weighted-average Series A non-voting convertible preferred shares outstanding used in computing net loss per share to Series A non-voting convertible preferred shareholders, basic and diluted | 2,890 | — | |||||||||
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Summary Balance Sheet Data
(in thousands)
(Unaudited)
(in thousands)
(Unaudited)
March 31, 2026 | December 31, 2025 | ||||||||||
Assets | |||||||||||
Cash | $ | 189,163 | $ | 213,192 | |||||||
Other assets | 9,967 | 27,101 | |||||||||
Total Assets | $ | 199,130 | $ | 240,293 | |||||||
Liabilities and Shareholders' Equity | |||||||||||
Liabilities | $ | 15,283 | $ | 37,281 | |||||||
Shareholders' equity and convertible preferred shares | 183,847 | 203,012 | |||||||||
Total liabilities and shareholders' equity | $ | 199,130 | $ | 240,293 | |||||||
Contacts
Investors
Amy Reilly
Chief Communications Officer
amy.reilly@crescentbiopharma.com
617-465-0586
Media
Jenna Poist
Director, Corporate Communications
jenna.poist@crescentbiopharma.com
781-671-5019
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FAQ
How did Crescent Biopharma (CBIO) perform financially in Q1 2026?
Crescent reported a Q1 2026 net loss of $23.3 million, or $0.70 per share. Revenue reached $1.0 million from a CR-001 license payment, while R&D expenses were $17.9 million and G&A expenses were $7.9 million, reflecting ongoing clinical development and public-company costs.
What is Crescent Biopharma’s cash runway after Q1 2026?
Crescent ended March 31, 2026 with $189.2 million in cash and cash equivalents. Management states this balance is anticipated to fund operations into 2028, supporting multiple ongoing and planned Phase 1/2 trials across its CR-001, CR-002, and CR-003 oncology programs.
What are the key clinical milestones for Crescent Biopharma’s CR-001 program?
CR-001 is in the ASCEND Phase 1/2 trial in multiple solid tumors, with a trial-in-progress abstract accepted at ASCO 2026. Crescent expects proof-of-concept data in Q1 2027, followed by initial chemotherapy combination data and ADC combination data around mid-2027, subject to trial progress.
When will Crescent Biopharma’s ADC candidates CR-002 and CR-003 have clinical data?
Crescent plans to start a Phase 1/2 trial of CR-002 in solid tumors in the second half of 2026, targeting proof-of-concept data in the second half of 2027. For CR-003, proof-of-concept data from Kelun-Biotech’s Chinese Phase 1/2 trial are expected in Q1 2027, with combination data later in 2027.
How is Crescent Biopharma collaborating with Kelun-Biotech on its pipeline?
Under their collaboration, Kelun-Biotech has rights to develop and commercialize CR-001 in Greater China and is running regional trials, while Crescent holds rights to CR-003 outside Greater China. The partnership also supports ADC combination studies, including a planned CR-001 plus ADC trial in China in 2026.
What were the main drivers of Crescent Biopharma’s higher expenses in Q1 2026?
Research and development expenses rose to $17.9 million, primarily due to continued development of CR-001 and CR-002. General and administrative expenses increased to $7.9 million, mainly from higher personnel costs, share-based compensation, and professional services associated with operating as a public company.