Corbus Pharmaceuticals Holdings, INC. 8-K Filing

Ticker: CRBP · Form: 8-K · Filed: Jun 3, 2024 · CIK: 1595097

Sentiment: neutral

Filing Stats: 1,108 words · 4 min read · ~4 pages · Grade level 9.2 · Accepted 2024-06-03 07:08:54

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 1, 2024, Corbus Pharmaceuticals Holdings, Inc. (the "Company") issued a press release announcing data from the ongoing Phase 1 clinical trial for SYS6002 (CRB-701) conducted by the Company's development partner, CSPC Pharmaceutical Group, that was presented at the American Society of Clinical Oncology Annual Conference (the "ASCO Annual Conference") on June 1, 2024. A copy of the press release is attached hereto as Exhibit 99.1. 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 June 1, 2024, the Company announced data from the ongoing Phase 1 clinical trial of SYS6002 (CRB-701) conducted by the Company's development partner, CSPC Pharmaceutical Group, that was presented at the ASCO Annual Conference on June 1, 2024. The Phase 1 dose escalation study is being conducted in China and is enrolling patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive. The study opened for enrollment in January 2023 and the data presented is through April 2024 from 25 patients reflective of seven dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg). Emerging clinical safety profile: SYS6002 (CRB-701) was generally well tolerated with mainly grade 1 or 2 AEs. No DLTs or grade 4 or 5 AEs have been observed to date. Anemia and eye-related treatment emergent AEs (TEAEs) were the most common. One patient exhibited a grade 3 rash which lasted for eight days and did not result in a reduction or interruption in dosing (2.7 mg/Kg). Two milder cases of skin rash were recorded (grade 1 and grade 2). Both also resolved with no need for change or interruption in dosing. No new drug-related SAEs have been encountered since the January 2024 data update. To date, a single case of peripheral neuropathy (grade 1) has been reported (numb hands) associated with hypokalemia (grade 3). It resolved in parallel with the hypokalemia after ten days of combined oral and/or parenteral K + replacement therapy. Two grade 3 corneal disorders were reported in patients who received 2.7 mg/Kg and 3.6 mg/Kg, respectively. Preventative eye measures have been introduced and no such cases have been seen so far at the 4.5 mg/Kg dose. Over 50% of patients enrolled had corneal disorders or dry eye at baseline. Emergi

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated June 1, 2024 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 hereunto duly authorized. Corbus Pharmaceuticals Holdings, Inc. Date: June 3, 2024 By: /s/ Yuval Cohen Name: Yuval Cohen Title: Chief Executive Officer

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