Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

v3.23.2
Subsequent Events
6 Months Ended
Jun. 30, 2023
Subsequent Events [Abstract]  
Subsequent Events

Note 11—Subsequent Events

 

Shareholder approval for changing the Company’s state of domicile

 

On July 31, 2023 the shareholders approved the Agreement and Plan of Merger between the Company and its wholly owned Delaware subsidiary, MyMD Pharmaceuticals, Inc. (“MyMD Delaware”), pursuant to which the Company will merge with and into MyMD Delaware for the sole purpose of changing the Company’s state of domicile, including the approval of the Certificate of Incorporation of MyMD Delaware.

 

FDA Acceptance of IND for Phase 2 Study of MYMD-1® in Rheumatoid Arthritis

 

On August 14, 2023 the Company announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug Application (IND) for a Phase 2 study for evaluating the safety, efficacy, pharmacodynamics and pharmacokinetics of MYMD-1® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept). The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication. The approval triggered a milestone event for the vesting of 50,000 stock options for a key employee.