8-K 1 a8-kinexia.htm 8-K Document


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

Date of Report (Date of earliest event reported): January 31, 2019
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optinoselogorgb.jpg
OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________________________________________________________________________________________
DELAWARE
001-38241
42-1771610

(State or Other Jurisdiction of Incorporation or Organization)
(Commission File No.)
(I.R.S. Employer Identification No.)

1020 Stony Hill Road, Suite 300
Yardley, Pennsylvania 19067
(Address of principal executive offices and zip code)

(267) 364-3500
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)
____________________________________________________________________________________________

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 (see General Instruction A.2. below):
 
 
q
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))
 
 
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).
 
 
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Emerging growth company
 
 
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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 January 31, 2019, OptiNose AS (the "Company"), a wholly owned subsidiary of OptiNose, Inc., entered into a License Agreement (the "License Agreement") with Inexia Limited ("Inexia").
  
Under the terms of the License Agreement, the Company has granted Inexia an exclusive, royalty-bearing, worldwide, non-transferable, sublicensable license to the Company's exhalation delivery system (“EDS”) and other intellectual property for the use, sale, import and manufacture of products containing orexin receptor agonist and/or orexin receptor positive modulator molecule(s) as the sole active pharmaceutical ingredient(s) for the treatment, diagnosis or prevention of human diseases or conditions associated primarily with orexin receptor agonism and orexin receptor positive modulation. The license excludes the treatment of any disease or condition affecting the ear, nose or throat, or the treatment of any disease or condition associated primarily with another receptor, other than the Orexin 1 and Orexin 2 receptors. Inexia is solely responsible for all costs and activities related to its identification, development and commercialization of products under the License Agreement.

Under the terms of the License Agreement, Inexia is required to pay the Company a $500,000 upfront payment (the "Upfront Payment"). For each product developed under the License Agreement, the Company is eligible to receive up to $8 million of development milestone payments and up to $37 million of sales milestone payments. In addition, the Company is eligible to receive tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the License Agreement. Other than the Upfront Payment, the Company does not anticipate the receipt of any milestone or royalty payments from Inexia in the near term.

As a result of the License Agreement, the Company will discontinue its internal OPN-021 program, which combined the Company’s EDS with orexin-A for the treatment of narcolepsy and symptoms of other diseases potentially amenable to the same pharmacologic activity, such as Parkinson's disease.

On February 4, 2019, OptiNose issued a press release announcing the License Agreement with Inexia. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.








Item 9.01 Financial Statements and Exhibits.

(d)    Exhibits
 
 
 
 
Exhibit No.
 
Description
99.1
 





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.
 
 
 
 
 
 
 
 
 
 
OptiNose, Inc.
 
 
By: /s/ Keith A. Goldan
 
 
Keith A. Goldan
 
 
Chief Financial Officer
Date: February 4, 2019