Eton Pharmaceuticals Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits

false 0001710340 0001710340 2024-11-22 2024-11-22

 

 

 

 

 

 

 

 

 

 

 

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:

 

 

 

 

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. ☐

 

 

 

On November 22, 2024, Eton Pharmaceuticals, Inc. (the “Company”) entered into a Licensing Agreement (the “Licensing Agreement”) with AMMTeK. (the “Seller”), pursuant to which the Company has agreed to acquire the U.S. rights to Amglidia (glyburide oral suspension) from the Seller. Amglidia is being developed for the treatment of neonatal diabetes mellitus, a rare condition estimated to impact approximately 300 patients in the U.S. The product was approved by the European Medicines Agency in 2018 and has been granted Orphan Drug Designation by the U.S. FDA. The Seller has conducted a post-approval study tracking five years of real-world safety and efficacy in European patients, which will be used to support Eton’s New Drug Application (“NDA”) submission.

 

The Company intends to hold a meeting with the FDA in the first quarter of 2025 and retains the option to terminate the licensing agreement within 30 days of receiving FDA meeting minutes without liability for any milestone payments to the Seller. Under the terms of the Licensing Agreement, the Company will not make any upfront payments to Seller and could pay up to $2.35 million as follows:

 

 

In addition, the Company would pay a royalty of 14% of net sales to the Seller.

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

 

 

 

 

 

 

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.