Corbus Pharmaceuticals Holdings, INC. 8-K Filing

Ticker: CRBP · Form: 8-K · Filed: Dec 11, 2025 · CIK: 1595097

Sentiment: neutral

Filing Stats: 1,010 words · 4 min read · ~3 pages · Grade level 11.1 · Accepted 2025-12-11 07:22:10

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 11, 2025, Corbus Pharmaceuticals Holdings, Inc. (the "Company") issued a press release announcing data from its Phase 1a study of oral CB1 inverse agonist CRB-913. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference. The Company also updated its presentation used by management to describe its business. A copy of the presentation is furnished as Exhibit 99.2 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 and 99.2, 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.

01 Other Events

Item 8.01 Other Events. On December 11, 2025, the Company announced the completion of the single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 and the initiation of a Phase 1b dose-range finding study ("CANYON-1"), with completion expected in summer 2026. CRB-913 is a highly peripherally restricted oral small molecule CB1 inverse agonist targeting chronic obesity management. The double-blinded placebo-controlled SAD/MAD Phase 1a study, conducted in the United States, assessed the safety, tolerability, and pharmacokinetics (PK) of escalating once-daily doses of CRB-913. The SAD portion of the study (n=64) comprised 8 cohorts that received ascending doses of CRB-913 (maximal dose of 600 mg/day) or placebo orally once daily (2 placebo and 6 CRB-913 per cohort). Seven of the SAD cohorts enrolled healthy participants (mean BMI=28), and one enrolled people with obesity (mean BMI=36). The MAD portion of the study (n=48) comprised 4 cohorts who received ascending doses of CRB-913 (25 mg, 75 mg or 150 mg) or placebo orally once daily (3 placebo and 9 CRB-913-treated per cohort) over 7 days and followed by a further 7 days of continuous, in-clinic observation. Three of the MAD cohorts enrolled healthy participants and one enrolled people with obesity. No serious treatment-emergent adverse events were reported in the SAD/MAD study. CRB-913 was not associated with GI intolerability. There were no reported cases of nausea, vomiting, or constipation and only a single case of mild diarrhea. Daily neuropsychiatric assessments using the Columbia-Suicide Severity Rating Scale (CSSRS), the Patient Health Questionnaire-9 (PHQ-9), and the General Anxiety Disorder-7 (GAD-7) questionnaires remained stable and negative at all time points for all participants. No cases of suicidality, depression, or insomnia were reported. No neuropsychiatric adverse events were noted in any of the cohorts of non-obese participants. Three adverse events of mild a

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated December 11, 2025. 99.2 Investor Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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: December 11, 2025 By: /s/ Yuval Cohen Name: Yuval Cohen Title: Chief Executive Officer

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