eton20240426c_8k.htm
false 0001710340 0001710340 2024-04-30 2024-04-30


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

 
FORM 8-K
 

 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
April 30, 2024

Date of Report (Date of earliest event reported)
 

 
ETON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
001-38738
37-1858472
(State of
(Commission
(I.R.S. Employer
incorporation)
File Number)
Identification Number)
 
21925 W. Field Parkway, Suite 235
Deer Park, Illinois 60010-7208
(Address of principal executive offices) (Zip code)
 
(847) 787-7361
(Registrants telephone number, including area code)
 

 
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:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.001 per share
 
ETON
 
NASDAQ Global Market
 
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. ☐
 
 

 
Item 8.01: Other Events
 
On April 30, 2024, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, the Company's proprietary patented formulation of hydrocortisone oral solution.
 
2

 
Item 9.01: Financial Statements and Exhibits
 
Exhibit No.
 
Description
     
Exhibit 99.1   Press Release dated April 30, 2024
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 
3

 
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.
 
Date: April 30, 2024
By:
/s/ James R. Gruber
   
James R. Gruber
   
Chief Financial Officer and Secretary
   
(Principal Financial Officer)
 
4
ex_661653.htm

Exhibit 99.1

 

Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

 

 

Company anticipates 10-month review for potential approval in Q1 2025

 

Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than $50 million annually

 

Product has patent protection through 2043

 

DEER PARK, Ill., April 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton’s proprietary patented formulation of hydrocortisone oral solution. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.

“With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need. We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than $50 million annually,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

 

Eton has been issued a patent by the U.S. Patent and Trademark Office on ET-400, which expires in 2043 and has additional patent applications under review.

 

About Eton Pharmaceuticals

 

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

 

Forward-Looking Statements

 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Investor Relations:

Lisa M. Wilson, In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

 

Source: Eton Pharmaceuticals.