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
January 14, 2021
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 incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
21925 W. Field Parkway, Suite 235
Deer Park, Illinois 60010-7208
(Address of principal executive offices) (Zip code)
(847) 787-7361
(Registrant’s 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 [X]
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. [X]
Item 8.01 Other Events.
On January 14, 2021, Eton Pharmaceuticals, Inc. issued a press release announcing that it has acquired Canadian rights to ALKINDI® SPRINKLE from Diurnal Group plc. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits
| Exhibit 99.1 | Press Release dated January 14, 2021 |
| 2 |
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: | January 14, 2021 | By: | /s/ W. Wilson Troutman |
| W. Wilson Troutman | |||
| Chief Financial Officer and Secretary | |||
| (Principal Financial Officer) |
| 3 |
Exhibit 99.1
Eton Pharmaceuticals Announces Acquisition of Canadian Rights for ALKINDI® SPRINKLE
DEER PARK, Ill., Jan. 14, 2021 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that it has acquired Canadian rights to ALKINDI® SPRINKLE from Diurnal Group plc (LSE AIM: DNL). Eton Pharmaceuticals currently commercializes ALKINDI® SPRINKLE in the United States as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.
“Since launching ALKINDI® SPRINKLE in the United States, we have been overwhelmed by the strong interest we have received from endocrinologists and caregivers in Canada,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We are pleased to be expanding our partnership with Diurnal to include the Canadian market. This exciting acquisition will allow us to leverage the early success we have experienced with ALKINDI® SPRINKLE in the United States market and will further advance us towards our goal of becoming an industry leading orphan drug company.”
“We continue to be impressed by Eton’s enthusiasm and vision for ALKINDI® SPRINKLE,” said Martin Whitaker, CEO of Diurnal Group plc. “We are pleased to extend our collaboration with Eton to potentially bring the product to pediatric patients in Canada suffering with adrenal insufficiency, where there is a significant unmet patient need.”
About ALKINDI SPRINKLE
ALKINDI® SPRINKLE is an immediate-release oral hydrocortisone granule preparation that has been specifically designed to meet the dosing needs of pediatric patients with adrenocortical insufficiency. ALKINDI® SPRINKLE is manufactured using commercially proven technology in four strengths: 0.5 mg, 1 mg, 2 mg and 5 mg, to give greater dosing flexibility to clinicians. Taste-masking excipients that are acceptable for pediatric use eliminate the bitter taste of hydrocortisone. ALKINDI® SPRINKLE has a shelf -life of three years at ambient temperature and does not require refrigeration. Additional information for U.S. patients and healthcare professionals is available at www.alkindisprinkle.com.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to the FDA.
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.
Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740