Crescent Biopharma expects CR-001 data in Q1 2027
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Crescent Biopharma (CBIO) reported third-quarter 2026 results and clinical-program updates. Cash and cash equivalents were $289.4 million as of September 30, including $133.4 million in net proceeds from its July public offering; Crescent expects its cash to fund operations into the second half of 2028. Net loss was $37.7 million, compared with $24.6 million a year earlier.
Crescent completed dose escalation in its global Phase 1/2 ASCEND trial of CR-001, with more than 125 patients dosed, and is enrolling chemotherapy-combination expansion cohorts. Initial monotherapy data are expected in the first quarter of 2027, including preliminary response results for a first-line NSCLC cohort of up to 12 patients. The first patient has been dosed in the global Phase 1/2 APOLLO trial of CR-002, with initial data expected in the second half of 2027. Kelun-Biotech expects initial mid-2027 data from a Phase 2 study combining CR-001 with sac-TMT in NSCLC.
1 point · 0 major0 major · 1 point
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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.$289.4 million in cash is expected to fund operations into the second half of 2028.
Negative
- Moderate pointNet loss was $37.7 million, compared with $24.6 million in the 2025 quarter.
Filing Explained
The release adds an ownership-count detail: as of
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, or exhibit attachments filed with this report.
Key Figures
Cash and cash equivalents: $289.4 million
Cash runway: Into the second half of 2028
Net loss: $37.7 million
+5 more
8 metrics
Cash and cash equivalents
$289.4 million
As of September 30, 2026
Cash runway
Into the second half of 2028
Crescent's stated expectation for existing cash and cash equivalents
Net loss
$37.7 million
Three months ended September 30, 2026; compared with $24.6 million in 2025
License agreement revenue
$3.117 million
Three months ended September 30, 2026
Research and development expenses
$34.3 million
Three months ended September 30, 2026; compared with $20.3 million in 2025
Net proceeds from July public offering
$133.4 million
Included in cash and cash equivalents as of September 30, 2026
Patients dosed in ASCEND
More than 125 patients
CR-001 global Phase 1/2 trial
First-line NSCLC cohort
Up to 12 patients
ASCEND cohort for preliminary antitumor response results
Key Terms
PD-1 x VEGF bispecific, antibody-drug conjugate (ADC), overall response rate (ORR), pharmacokinetics, +1 more
5 terms
PD-1 x VEGF bispecific medical
"CR-001, its investigational PD-1 x VEGF bispecific"
antibody-drug conjugate (ADC) medical
"CR-002, a PD-L1-targeted ADC"
An antibody-drug conjugate (ADC) is a targeted medical treatment that combines an antibody, which acts like a guided missile seeking out specific cells, with a powerful drug to destroy those cells. It is designed to deliver medication directly to diseased cells, minimizing damage to healthy tissue. For investors, ADCs represent innovative therapies with potential for high growth, especially if they prove effective in treating difficult-to-cure conditions.
overall response rate (ORR) medical
"antitumor response as measured by overall response rate (ORR)"
Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.
pharmacokinetics medical
"safety, tolerability, pharmacokinetic and pharmacodynamic data"
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
IND clearances regulatory
"partnership achieved 9 IND clearances this year"
Earnings Snapshot
License agreement revenue: $3.117 million · Guidance included
Third quarter 2026
License agreement revenue
$3.117 million
2025 quarter: —
Research and development expenses
$34.3 million
Compared with $20.3 million in the 2025 quarter
General and administrative expenses
$8.7 million
Compared with $5.5 million in the 2025 quarter
Net loss
$37.7 million
Compared with $24.6 million in the 2025 quarter
Net loss per ordinary share, basic and diluted
$0.90
Compared with $1.27 in the 2025 quarter
Guidance
Crescent expects existing cash and cash equivalents to fund operations into the second half of 2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Crescent expect initial CR-001 results?
Crescent expects initial CR-001 monotherapy data in the first quarter of 2027, including preliminary antitumor response measured by overall response rate in a first-line NSCLC cohort of up to 12 patients. Safety, tolerability, pharmacokinetic and pharmacodynamic data are expected from more than 125 treatment-naïve and previously treated patients across multiple solid tumor types.
How many participants are expected in the CR-002 APOLLO study, and when is data expected?
APOLLO's dose-escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants, with an opportunity for additional participants in expansion cohorts. Crescent anticipates initial data in the second half of 2027, including safety, tolerability, pharmacokinetics and preliminary antitumor activity.
How much cash did Crescent report and how long does it expect it to fund operations?
Crescent reported $289.4 million in cash and cash equivalents as of September 30, 2026, and expects its existing cash and cash equivalents to fund operations into the second half of 2028.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): November 12, 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 November 12, 2026, Crescent Biopharma, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 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 November 12, 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: November 12, 2026 | By: | /s/ Joshua Brumm | ||||||||||||
| Name: | Joshua Brumm | |||||||||||||
| Title: | Chief Executive Officer | |||||||||||||
Crescent Biopharma Reports Third Quarter 2026 Financial Results and Recent Business Highlights
Completed dose escalation in Phase 1/2 ASCEND trial of CR-001 with more than 125 patients dosed across United States, Europe and South Korea; enrolling standard of care chemotherapy combination expansion cohorts; on track for initial monotherapy data, including antitumor response for first-line non-small cell lung cancer (NSCLC) cohort in Q1 2027
Multiple Phase 2 studies of sacituzumab tirumotecan (sac-TMT) in combination with CR-001 ongoing in China led by partner, Kelun-Biotech, with initial data in NSCLC expected in mid-2027; additional antibody-drug conjugate (ADC) combinations planned; partnership achieved 9 IND clearances this year
First patient dosed in global Phase 1/2 APOLLO trial of CR-002, a PD-L1-targeted ADC
On track for multiple clinical data readouts in 2027 and more than 2,000 patients dosed across the portfolio by mid-year
Waltham, Mass., November 12, 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 third quarter ended September 30, 2026 and recent business highlights.
“This has been a defining year for Crescent. We advanced three programs into the clinic and established a leading position in developing next generation IO and ADC combinations which we believe have the potential to redefine cancer care. Together with our partner Kelun-Biotech, we have achieved a remarkable nine IND clearances, and anticipate that more than 2,000 patients will be dosed across our portfolio by mid-2027. We plan to aggressively pursue additional combination opportunities that can further our efforts to develop CR-001 as a best-in-class IO backbone therapy. Building on the pipeline progress we outlined last month, we are pleased to have now commenced patient dosing in the global APOLLO trial of CR-002, our PD-L1-targeted ADC,” said Joshua Brumm, chief executive officer of Crescent. “The team’s strong execution has positioned us for several meaningful clinical data readouts in 2027, beginning in the first quarter with monotherapy results from our global ASCEND trial of CR-001, including first-line NSCLC patients, followed by initial standard of care chemotherapy combination data from multiple tumor types. We are poised for an exciting year ahead as we work to deliver the next wave of therapies for people living with cancer.”
Recent Business Highlights & Anticipated Milestones
CR-001, PD-1 x VEGF Bispecific Antibody
Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001
•In October 2026, Crescent announced completion of dose escalation in ASCEND, a global Phase 1/2 trial of CR-001, its investigational PD-1 x VEGF bispecific, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea.
•Crescent is on track to report initial monotherapy data from ASCEND in the first quarter of 2027, including:
◦Preliminary antitumor response as measured by overall response rate (ORR) from a first-line NSCLC cohort of up to 12 patients.
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◦Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously treated patients across multiple solid tumor types.
•Patient dosing has commenced in ASCEND expansion cohorts which are evaluating CR-001 with various standard of care chemotherapy combinations across several solid tumor types in treatment-naive and previously treated patients, including first-line NSCLC, colorectal, biliary tract, gastric and endometrial cancers. Crescent is on track to report initial data from hundreds of patients in mid-2027 (Q2/Q3).
•Data from the expansion cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Pending results and further interactions with regulators, Crescent plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.
•Trial in progress posters of the ASCEND study design were featured during the European Society for Medical Oncology (ESMO) 2026 Congress held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting held November 4-8, 2026 in Phoenix, Arizona.
Multiple Studies Evaluating CR-001 in Combination with Novel ADCs
•Under a collaboration agreement, 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. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective antibody-drug conjugate (ADC) pipelines.
•Kelun-Biotech is conducting multiple Phase 2 trials in China evaluating CR-001 (SKB118) in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC. Initial data from a study in patients with locally advanced or metastatic NSCLC are expected in mid-2027 (Q2/Q3). Additional studies are underway in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, as well as in patients with advanced solid tumors.
•A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027.
CR-002, Topoisomerase Inhibitor ADC Targeting PD-L1
•Earlier this month, the first patient was dosed in the global Phase 1/2 APOLLO trial of CR-002, a topoisomerase inhibitor ADC targeting programmed cell death ligand 1 (PD-L1). APOLLO is designed to enroll patients in the United States, Europe and Asia Pacific with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. The study’s dose escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants with the opportunity for additional participants in expansion cohorts.
•Crescent anticipates reporting initial data from APOLLO in the second half of 2027, including safety, tolerability, pharmacokinetics and preliminary antitumor activity.
•Preclinical data for CR-002 will be featured in a poster presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held November 18-20, 2026 in Barcelona, Spain.
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CR-003, Topoisomerase Inhibitor ADC Targeting ITGB6
•Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105), an ITGB6-targeted ADC, in the United States, Europe and all markets outside of Greater China.
•A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).
Third Quarter 2026 Financial Results
Cash position: Cash and cash equivalents were $289.4 million as of September 30, 2026 which includes the $133.4 million in net proceeds from the July 2026 public offering. Crescent expects that its existing cash and cash equivalents will fund operations into the second half of 2028.
Research and development (R&D) expenses: R&D expenses were $34.3 million and $20.3 million for the three months ended September 30, 2026 and 2025, respectively. R&D expenses increased to support the increased clinical development on the global Phase 1/2 ASCEND trial and the costs incurred in preparation for the initiation on the global Phase 1/2 APOLLO trial.
General and administrative (G&A) expenses: G&A expenses were $8.7 million and $5.5 million for the three months ended September 30, 2026 and 2025, respectively. The increase in G&A expenses was primarily driven by increased personnel costs, including increased share-based compensation and professional service costs in continued support of the Company's pipeline.
Net loss: Net loss was $37.7 million and $24.6 million, or $0.90 and $1.27 per basic and diluted share, for the three months ended September 30, 2026 and 2025, respectively.
Shares outstanding: As of September 30, 2026, Crescent had approximately 44.1 million 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 as single agents and 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.
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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, beliefs, or strategies regarding the future of its pipeline and business including, without limitation: the timing and success of clinical data from the ASCEND monotherapy and combination trials of CR-001; the potential initiation and success of Phase 3 studies of CR-001; the timing and success of the Phase 2 combination trials for CR-001 and sac-TMT, including the potential initiation of additional ADC combination studies by Kelun-Biotech; the trial design, indication selection, and timing and success of clinical data for the global Phase 1/2 APOLLO trial of CR-002; the timing and success of clinical data from the Phase 1/2 trial of CR-003 as generated by Kelun-Biotech in China; the expected benefits or opportunities with respect to CR-001, CR-002, and CR-003, including each product’s potential to act as a single agent or combination agent; the anticipated number of patients dosed across the portfolio; and Crescent’s anticipated cash runway. Forward-looking statements generally relate to future events or 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 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 and involve a number of risks, uncertainties or other assumptions that may cause actual performance to be materially different from those expressed or implied by these forward-looking statements. Risks and uncertainties include, but are not limited to: the expected benefits of, and opportunities related to, the strategic partnership between Crescent and Kelun-Biotech may not be realized or may take longer to realize than anticipated; 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, run its clinical trials, and manufacture its product candidates; significant disruptions of information technology systems or breaches of data security, litigation and regulatory risks; risks related to the current macroeconomic environment, including fluctuating interest rates, barriers to trade, changes to fiscal and monetary policy or government budget dynamics, geopolitical factors, including the ongoing conflicts in Iran and between Russia and Ukraine and the responses thereto, and supply chain disruptions, 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. Should one or more of these risks or uncertainties materialize, or should any of Crescent’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by law, Crescent does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements.
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Crescent Biopharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
Three Months Ended September 30, 2026 | Nine Months Ended September 30, 2026 | Three Months Ended September 30, 2025 | Nine Months Ended September 30, 2025 | ||||||||||||||||||||
License agreement revenue | $ | 3,117 | $ | 4,156 | $ | — | $ | — | |||||||||||||||
Operating expenses | |||||||||||||||||||||||
Research and development | 34,305 | 71,598 | 20,347 | 43,059 | |||||||||||||||||||
General and administrative | 8,719 | 25,328 | 5,538 | 18,081 | |||||||||||||||||||
Total operating expenses | 43,024 | 96,926 | 25,885 | 61,140 | |||||||||||||||||||
Other income | — | 1,770 | — | — | |||||||||||||||||||
Loss from operations | (39,907) | (91,000) | (25,885) | (61,140) | |||||||||||||||||||
Other income (expense) | 2,181 | 5,154 | 1,278 | (405) | |||||||||||||||||||
Net loss and comprehensive loss | $ | (37,726) | $ | (85,846) | $ | (24,607) | $ | (61,545) | |||||||||||||||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.90) | $ | (2.37) | $ | (1.27) | $ | (7.89) | |||||||||||||||
Net loss per share attributable to Series A non-voting convertible preferred shareholders, basic and diluted | $ | (899.31) | $ | (2,368.17) | $ | (1,266.44) | $ | (7,891.38) | |||||||||||||||
Weighted-average ordinary shares outstanding used in computing net loss per share to ordinary shareholders, basic and diluted | 39,056,224 | 33,360,473 | 16,540,771 | 6,640,402 | |||||||||||||||||||
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 | 2,890 | 2,890 | 1,160 | |||||||||||||||||||
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Summary Balance Sheet Data
(in thousands)
(Unaudited)
(in thousands)
(Unaudited)
September 30, 2026 | December 31, 2025 | ||||||||||
Assets | |||||||||||
Cash | $ | 289,357 | $ | 213,192 | |||||||
Other assets | 10,146 | 27,101 | |||||||||
Total Assets | $ | 299,503 | $ | 240,293 | |||||||
Liabilities and Shareholders' Equity | |||||||||||
Liabilities | $ | 25,224 | $ | 37,281 | |||||||
Shareholders' equity | 274,279 | 203,012 | |||||||||
Total liabilities and shareholders' equity | $ | 299,503 | $ | 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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