Crescent Biopharma Reports Third Quarter 2026 Financial Results and Recent Business Highlights

Rhea-AI Summary

Crescent Biopharma (CBIO) reported third-quarter 2026 financial results and completed dose escalation in its Phase 1/2 ASCEND cancer trial. Quarterly net loss widened to $37.7 million from $24.6 million a year earlier, while ordinary-share loss narrowed to $0.90 from $1.27. Cash and cash equivalents were $289.4 million at September 30, including July offering proceeds; Crescent expects funding into the second half of 2028.

More than 125 patients have received CR-001 in ASCEND. Crescent expects initial monotherapy results in Q1 2027 and chemotherapy-combination data in Q2/Q3 2027. Partner Kelun-Biotech expects initial CR-001/sac-TMT lung cancer data in Q2/Q3 2027. The first patient received CR-002 in APOLLO, with initial results expected in the second half of 2027. CR-003 proof-of-concept data from its China trial are expected in Q1 2027.

16 points · 1 major

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0 major · 5 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point$133.4 million in net proceeds came from the July 2026 public offering. 24% of market cap
• Moderate pointCash of $289.357 million at September 30, 2026 exceeded $213.192 million at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Existing cash is expected to fund operations into the second half of 2028.
• Moderate pointASCEND dose escalation completed, with more than 125 patients dosed across the United States, Europe and South Korea.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Q1 2027 monotherapy data expected, including preliminary tumor responses in up to 12 first-line lung cancer patients.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ASCEND chemotherapy-combination dosing commenced; Crescent expects initial data from hundreds of patients in Q2/Q3 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CR-001/sac-TMT Phase 2 studies ongoing in China; initial lung cancer data expected in Q2/Q3 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CR-003 China trial ongoing, with proof-of-concept data expected in Q1 2027 to support global development.

8 minor points

• Minor pointQuarterly license revenue reached $3.117 million, versus none a year earlier; nine-month revenue reached $4.156 million.
• Minor pointNine investigational new drug clearances achieved through the Kelun-Biotech partnership this year.
• Minor point. Forward-looking: it has not happened yet and may not happen.CR-001/CR-003 combination trial is expected to commence in the first half of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.First APOLLO patient dosed; Crescent anticipates initial CR-002 data in the second half of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Portfolio dosing is expected to exceed 2,000 patients by mid-2027.
• Minor pointLiabilities fell to $25.224 million from $37.281 million at December 31, 2025.
• Minor pointShareholders’ equity rose to $274.279 million from $203.012 million at December 31, 2025.
• Minor pointNine-month other income reached $5.154 million, versus $0.405 million in other expense a year earlier.

Negative

• Moderate pointQuarterly net loss widened to $37.726 million from $24.607 million; ordinary-share loss narrowed to $0.90 from $1.27.
• Moderate pointQuarterly research spending increased to $34.305 million from $20.347 million; nine-month spending rose to $71.598 million from $43.059 million.
• Minor pointNine-month net loss widened to $85.846 million from $61.545 million; ordinary-share loss narrowed to $2.37 from $7.89.
• Minor pointQuarterly administrative spending increased to $8.719 million from $5.538 million; nine-month spending rose to $25.328 million from $18.081 million.
• Minor point. Forward-looking: it has not happened yet and may not happen.First CR-001 Phase 3 trial planned for early 2028 depends on results and further regulator interactions.

News Explained

At September 30, 2026, Crescent reported approximately 44.1 million ordinary shares and ordinary-share equivalents, including shares underlying pre-funded warrants and non-voting convertible preferred stock. If the warrants are exercised into shares, those additional shares would reduce existing holders’ percentage ownership absent offsetting changes.

Key Figures

Cash and cash equivalents: $289.4 million Expected cash runway: Into the second half of 2028 R&D expenses: $34.3 million vs. $20.3 million +5 more

Cash and cash equivalents

$289.4 million

As of September 30, 2026

Expected cash runway

Into the second half of 2028

Based on existing cash and cash equivalents

R&D expenses

$34.3 million vs. $20.3 million

Three months ended September 30, 2026 vs. 2025

Net loss

$37.7 million vs. $24.6 million

Three months ended September 30, 2026 vs. 2025

ASCEND patients

More than 125 patients

Safety, tolerability, pharmacokinetic and pharmacodynamic data

First-line NSCLC cohort

Up to 12 patients

ASCEND preliminary antitumor response cohort

ASCEND initial monotherapy data

Q1 2027

Expected; includes first-line NSCLC cohort

APOLLO initial data

Second half of 2027

Expected; includes safety, tolerability and preliminary antitumor activity

Previous Earnings Reports

1 past event · Latest: Jul 30

Same Type 1 event

1. Jul 30

   Quarterly results

   24h Move

   +1.7%

   Reported pro forma cash supporting runway into second half 2028 and ongoing ASCEND enrollment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

overall response rate, pharmacokinetic, pharmacodynamic, antibody-drug conjugate

4 terms

overall response rate medical

"Preliminary antitumor response as measured by overall response rate (ORR)"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

pharmacokinetic medical

"Safety, tolerability, pharmacokinetic and pharmacodynamic data"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamic medical

"Safety, tolerability, pharmacokinetic and pharmacodynamic data"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

antibody-drug conjugate medical

"its investigational PD-1 x VEGF bispecific, with patients enrolled"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

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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., Nov. 12, 2026 (GLOBE NEWSWIRE) -- 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.
  • 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 38^th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held November 18-20, 2026 in Barcelona, Spain.
  

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.

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.

Crescent Biopharma, Inc. 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

Summary Balance Sheet Data (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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much cash does Crescent Biopharma have, and how long is it expected to last?

Crescent had $289.4 million in cash and cash equivalents at September 30, 2026, and expects those funds to support operations into the second half of 2028. The balance includes $133.4 million in net proceeds from the July 2026 public offering.

When will Crescent Biopharma report initial ASCEND CR-001 results?

Crescent expects initial ASCEND monotherapy results in Q1 2027, including preliminary tumor-response results from up to 12 patients with previously untreated non-small cell lung cancer. Initial chemotherapy-combination results from hundreds of patients are expected in Q2/Q3 2027.

What must happen before Crescent starts Phase 3 trials of CR-001?

Crescent plans to initiate the first of multiple CR-001 Phase 3 trials in early 2028, pending results and further interactions with regulators. Monotherapy and chemotherapy-combination expansion data from ASCEND will inform future development.

How many patients will Crescent Biopharma enroll in the APOLLO CR-002 trial?

APOLLO’s dose-escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants, with the opportunity for additional participants in expansion cohorts. The global Phase 1/2 trial is designed to enroll patients with advanced solid tumors in the United States, Europe and Asia Pacific.

What CR-001 and CR-003 development rights do Crescent and Kelun-Biotech hold?

Kelun-Biotech holds exclusive CR-001 development and commercialization rights in Greater China, while Crescent holds exclusive CR-003 rights in the United States, Europe and all markets outside Greater China. Both companies may independently develop CR-001 combinations, including combinations with their respective antibody-drug conjugates, which deliver drugs using targeted antibodies.