KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On January 27, 2021, KemPharm, Inc., or the Company, issued a press release to announce that the U.S. Food and Drug Administration, or the FDA, has completed its review of the Investigational New Drug, or IND, application for KP879, or KP879 IND, concluding that the Company may proceed with its planned clinical investigation of the product candidate. The Company expects to initiate the clinical program for KP879 in 2021. In addition, the Company reported that it has completed its multi-phase process to regain its Nasdaq listing and to restructure its balance sheet. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, and the press release furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
On January 27, 2021, the Company announced that the FDA completed its review of the KP879 IND, concluding that the Company may proceed with its planned clinical investigation of the product candidate. In addition, the Company reported that it has completed its multi-phase process to regain its Nasdaq listing and to restructure its balance sheet.
On January 26, 2021, the Company reported that it entered into a warrant exchange and inducement transaction with certain of holders of the warrants from the January 8, 2021 offering, the Offering Warrants, whereby such holders agreed to exercise for cash the Offering Warrants to purchase 6,620,358 shares of the Company’s common stock in exchange for the Company’s agreement to issue new warrants to purchase up to 7,944,430 shares of the Company’s common stock, which is equal to 120% of the number of shares of the Company’s common stock issued upon exercise of the Offering Warrants. As a result of this transaction, the Company will receive gross proceeds of approximately $44.0 million. The Company intends to use approximately $8.0 million of the proceeds from the warrant exchange and inducement transaction to repay the remaining debt, including the related prepayment premium.
Item 9.01 Financial Statements and Exhibits.
KEMPHARM, INC Exhibit
EX-99.1 2 ex_222841.htm EXHIBIT 99.1 ex_165063.htm Exhibit 99.1 KemPharm Receives FDA Clearance to Initiate KP879 Clinical Program for the Treatment of Stimulant Use Disorder Financial Restructuring and Nasdaq Re-Listing Process Completed Celebration,…
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About KemPharm, Inc. (NASDAQ:KMPH)
KemPharm, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in the discovery and development of prodrugs. The Company uses its Ligand Activated Therapy (LAT) platform technology to create prodrugs. The Company’s product candidate, KP201/APAP, consists of KP201, its prodrug of hydrocodone, which is combined with acetaminophen (APAP). The Company is developing KP201/APAP as an immediate release (IR), a product candidate for the short-term, or no longer than 14 days for the management of acute pain. The Company has designed KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse in the United States. The Company also focuses on developing the pipeline of additional prodrug product candidates that targets pain and attention deficit hyperactivity disorder (ADHD). The Company’s products include KP201/IR (APAP-free), KP511/ER, KP415, KP606/IR and KP746.