Corbus Pharmaceuticals (NASDAQ: CRBP) reaches key Phase 1b obesity trial milestone for CRB-913

Rhea-AI Filing Summary

Corbus Pharmaceuticals Holdings, Inc. reports that the last patient has been enrolled and completed the first clinical visit in its CANYON-1 Phase 1b trial of CRB-913 for obesity, keeping the study on track for completion in summer 2026. CANYON-1 is a 16-week, double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic participants at multiple U.S. sites. The trial tests once-daily oral CRB-913 at 20 mg, 40 mg, and 60 mg with dose titration from 20 mg, followed by one month of post-dosing monitoring. Earlier Phase 1a data showed CRB-913-treated obese participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14 at 150 mg/day and the drug was reported as safe and well-tolerated, with a favorable gastrointestinal and neuropsychiatric profile.

Insights

Biotech clinical development analyst

Corbus hits a key enrollment milestone for its obesity candidate CRB-913 with supportive early data.

The company has completed Last Patient First Visit in the 240-participant CANYON-1 Phase 1b obesity study of oral CB1 inverse agonist CRB-913, with completion targeted for summer 2026. This marks a notable operational milestone in advancing its obesity pipeline.

Phase 1b is 16 weeks, placebo-controlled and dose-ranging (20, 40, 60 mg once daily) with three months of dosing and one month follow-up, designed to refine dosing and safety. It builds on Phase 1a data where obese participants on 150 mg/day achieved a mean 2.9% placebo-adjusted weight loss by Day 14 and reported favorable gastrointestinal and neuropsychiatric profiles.

Actual impact will depend on the forthcoming Phase 1b readout, which the company notes will help inform CRB-913’s potential as a non-incretin option for weight loss and long-term weight management. Subsequent company disclosures are expected to provide the detailed Phase 1b efficacy and safety results.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

CANYON-1 participants: 240 participants Phase 1b duration: 16 weeks CRB-913 dose levels: 20 mg, 40 mg, 60 mg +5 more

8 metrics

CANYON-1 participants 240 participants Obese, non-diabetic participants in Phase 1b trial

Phase 1b duration 16 weeks Double-blind, placebo-controlled, dose-ranging study period

CRB-913 dose levels 20 mg, 40 mg, 60 mg Once-daily oral dosing cohorts in CANYON-1

Phase 1a SAD enrollment 64 participants Single ascending dose portion across 8 cohorts

Phase 1a MAD enrollment 48 participants Multiple ascending dose portion across 4 cohorts

Placebo-adjusted weight loss 2.9% Mean reduction by Day 14 in obese MAD cohort at 150 mg/day

Highest SAD dose tested 600 mg/day CRB-913 single ascending dose Phase 1a

Highest MAD dose tested 150 mg/day CRB-913 multiple ascending dose Phase 1a

Key Terms

Phase 1b clinical trial, CB1 inverse agonist, double-blind, placebo-controlled, single ascending dose (SAD), +2 more

6 terms

Phase 1b clinical trial medical

"CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity"

A phase 1b clinical trial is an early-stage human study that follows initial safety tests and checks how a new drug or treatment works at different doses in the target patient group. It matters to investors because it is one of the first steps showing whether a therapy is tolerable and shows any sign of benefit in real patients — like a small proof-of-concept test that can significantly raise or lower a drug’s commercial prospects.

CB1 inverse agonist medical

"a once-daily highly peripherally restricted oral CB1 inverse agonist"

A CB1 inverse agonist is a drug that binds to the brain and nervous system’s CB1 cannabinoid receptor and pushes its activity below its normal resting level, producing effects opposite to those of cannabis-like stimulation. For investors, these drugs matter because altering appetite, mood, pain or addiction pathways can create significant market opportunities or regulatory risks—think of it as turning a dimmer switch lower than the factory setting to achieve a different therapeutic outcome.

double-blind, placebo-controlled medical

"a 16-week, double-blind, placebo-controlled, dose-ranging study"

A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.

single ascending dose (SAD) medical

"completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study"

A single ascending dose (SAD) is a type of test where a new medicine is given to a small group of people in increasing amounts to see how the body responds. This process helps determine the safest and most effective dose for future use. For investors, understanding SAD studies can provide insight into a drug's development progress and potential approval prospects.

multiple ascending dose (MAD) medical

"The MAD portion enrolled 48 participants across 4 cohorts"

Multiple ascending dose (MAD) is a research process used to test how a new medicine affects the body when given in increasing amounts over several doses. It helps researchers find the safest and most effective dose before the drug is widely used. For investors, understanding MAD studies is important because successful results can signal progress toward new treatments and potential future profits.

forward-looking statements regulatory

"This press release contains certain forward-looking statements within the meaning of Section 27A"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Understanding 8-K Material Events →

0001595097false00015950972026-04-142026-04-14

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 14, 2026

CORBUS PHARMACEUTICALS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-37348	46-4348039
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
500 River Ridge Drive
Norwood, Massachusetts				02062
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 963-0100

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:

☐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
Common Stock, par value $0.0001 per share		CRBP		The Nasdaq Capital Market

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 ☐

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. ☐

Item 7.01 Regulation FD Disclosure.

On April 14, 2026, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing the last patient has been enrolled and completed the first clinical visit ("Last Patient First Visit") in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1, is being furnished to the Securities and Exchange Commission (the “SEC”), and shall not be deemed to be “filed” for the 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, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

Item 8.01 Other Events.

On April 14, 2026, the Company announced Last Patient First Visit in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study is on track to be completed in the summer of 2026. CRB-913 is a once-daily highly peripherally restricted oral CB1 inverse agonist potentially offering an orthogonal approach to weight loss and long-term weight management.

The CANYON-1 Phase 1b clinical trial is a 16-week, double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic participants, and is being conducted at multiple clinical sites in the United States. The trial includes a placebo cohort and three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily (QD). A dose titration regimen is included in the design, with all CRB-913 participants commencing at 20 mg/day and then titrating up to either 40 mg/day or beyond that to 60 mg/day, depending on their respective cohorts. Participants are dosed for 3 months and are then monitored for an additional month post-dosing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

Exhibit No.		Description
99.1		Press Release dated April 14, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			Corbus Pharmaceuticals Holdings, Inc.
Date:	April 14, 2026	By:	/s/ Yuval Cohen
			Name: Yuval Cohen Title: Chief Executive Officer

Exhibit 99.1

Corbus Pharmaceuticals Announces Last Patient First Visit in CANYON-1 Study of CRB-913 for the Treatment for Obesity

On track to complete 16-week, dose-finding Phase 1b study (n=240) in summer 2026

Phase 1b data will build upon Phase 1a findings that demonstrated weight loss of nearly

3% at 14 days in individuals with obesity

CRB-913 is a non-incretin daily oral small molecule with the potential to deliver a therapeutic option for weight loss and long-term weight management

Norwood, MA, April 14, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today announced the last patient has been enrolled and completed the first clinical visit (Last Patient First Visit) in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study is on track to be completed in the summer of 2026. CRB-913 is a once-daily highly peripherally restricted oral CB1 inverse agonist potentially offering an orthogonal approach to weight loss and long-term weight management.

The CANYON-1 Phase 1b clinical trial is a 16-week, double-blind, placebo-controlled, dose-ranging study in 240 obese, non-diabetic participants, and is being conducted at multiple clinical sites in the United States. The trial includes a placebo cohort and three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily (QD). A dose titration regimen is included in the design, with all CRB-913 participants commencing at 20 mg/day and then titrating up to either 40 mg/day or beyond that to 60 mg/day, depending on their respective cohorts. Participants are dosed for 3 months and are then monitored for an additional month post-dosing.

“Despite the remarkable success of GLP-1s and the incretin class, significant treatment gaps exist for millions of people struggling with obesity. In the real-world setting, over 40% of those who try incretin therapy turn out to be either intolerant or non-responsive to these drugs. These factors contribute to the high discontinuation rate of over 60% for this class. These statistics underscore the need for new, additional mechanisms to address obesity,” said Yuval Cohen, PhD, Chief Executive Officer of Corbus. “We look forward to our upcoming Phase 1b data readout that will help further inform CRB-913's potential to deliver a novel, non-incretin drug and therapeutic option for weight loss and long-term weight management.”

About the CRB-913 Phase 1a Study Findings

Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 in December 2025. The SAD portion of the trial enrolled 64 participants across

8 cohorts. The MAD portion enrolled 48 participants across 4 cohorts, including a dedicated obese cohort. The highest SAD dose tested was 600 mg/day, and the highest MAD dose tested was 150 mg/day. In the dedicated obese MAD cohort (150 mg/day), all CRB-913-treated participants (n=9), and none in the placebo group (n=3), experienced weight loss. The CRB-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Weight loss started early and deepened with time. CRB-913 was safe and well-tolerated across all cohorts and all doses studied, including demonstrating a very favorable GI profile with no reports of vomiting, constipation or nausea. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative.

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on promising new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

INVESTOR CONTACTS:

Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

MEDIA CONTACT:

Liz Melone

Founder & Principal

Melone Communications, LLC

liz@melonecomm.com

FAQ

What milestone did Corbus Pharmaceuticals (CRBP) report for the CANYON-1 study?

Corbus reported that the last patient has been enrolled and completed the first clinical visit in the CANYON-1 Phase 1b trial of CRB-913. This Last Patient First Visit milestone confirms the 240-participant study is fully enrolled and on track for completion in the summer of 2026.

What is the design of Corbus (CRBP) CANYON-1 Phase 1b trial of CRB-913?

CANYON-1 is a 16-week, double-blind, placebo-controlled, dose-ranging Phase 1b study in 240 obese, non-diabetic participants. It includes placebo and three CRB-913 cohorts (20 mg, 40 mg, 60 mg once daily), with three months of dosing followed by one month of post-dosing monitoring.

What did earlier Phase 1a data show for Corbus (CRBP) obesity candidate CRB-913?

In the Phase 1a multiple ascending dose obese cohort at 150 mg/day, all CRB-913-treated participants and none on placebo lost weight, achieving a mean 2.9% placebo-adjusted weight loss by Day 14. CRB-913 was described as safe, well-tolerated and showed a favorable gastrointestinal and neuropsychiatric profile.

How is CRB-913 positioned versus incretin drugs in obesity treatment for Corbus (CRBP)?

CRB-913 is a once-daily, highly peripherally restricted oral CB1 inverse agonist, offering a non-incretin mechanism for weight loss and long-term weight management. Management highlighted real-world gaps with incretins, citing over 40% intolerance or non-response and more than 60% discontinuation in this drug class.

What dosing strategy is used in Corbus (CRBP) CANYON-1 trial for CRB-913?

All CRB-913 participants start at 20 mg per day and then titrate up to either 40 mg or 60 mg daily depending on their cohort. This dose-titration approach is built into the 16-week, placebo-controlled Phase 1b design to better assess tolerability and dose-response.

What other programs are in Corbus Pharmaceuticals (CRBP) pipeline besides CRB-913?

Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate targeting Nectin-4-expressing tumors in oncology, and CRB-913 for obesity. The company describes itself as a clinical-stage firm focused on promising new therapies in oncology and obesity using innovative approaches to known biological pathways.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 22.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 30.5 KB