0001016169false00010161692021-10-182021-10-18

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): October 18, 2021
_________________________________________________________________
ANTARES PHARMA, INC.
(Exact name of registrant specified in its charter)
_________________________________________________________________
Delaware 001-32302 41-1350192
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
100 Princeton South, Suite 300, Ewing, NJ
08628
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (609) 359-3020
Not Applicable
(Former Name or Former Address, if Changed Since 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):
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 $0.01 per share ATRS NASDAQ
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.    o



Item 8.01    Other Events
On October 18, 2021, Antares Pharma, Inc. (“Antares”) announced that it had entered into an exclusive license agreement (the “License Agreement”) with Lipocine Inc. (“Lipocine”) for TLANDO® (testosterone undecanoate), an oral treatment for testosterone replacement therapy in the United States.

TLANDO® was granted tentative approval from the U.S. Food and Drug Administration (“FDA”) as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022.

Under the terms of the License Agreement, Lipocine received an upfront payment of $11.0 million and is eligible for additional milestone payments up to $10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO® in the United States. Antares shall be responsible for the manufacturing and commercialization of TLANDO®.

The License Agreement also grants Antares the option to license and develop LPCN 1111 (“Tlando XR”). Upon the exercise of the option, Antares shall pay an additional $4.0 million in license fees in two installments. Antares shall also be responsible for additional development and commercial milestone payments as well as tiered royalties on net sales of Tlando XR in the United States.

Tlando XR (testosterone tridecanoate) is a potential once daily oral testosterone product in development for the treatment of hypogonadism in adult males. Results of the Phase 2b study for Tlando XR met its primary endpoints, including identifying the dose expected to be tested in a Phase 3 study. Tlando XR was well tolerated with no drug-related severe or serious adverse events reported and the target Phase 3 dose also met its primary and secondary endpoints in the Phase 2b study. Tlando XR is an investigational drug and has not been approved by the FDA. If Antares exercises the option for Tlando XR, Antares shall be responsible for completing the development program including the conduct of a phase 3 clinical trial and applying for regulatory approval in the United States.

The License Agreement contains customary terms and conditions for agreements of like type, including representations, warranties and covenants.

A copy of the press release announcing the entry into the License Agreement is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01    Financial Statements and Exhibits.
(d)     Exhibits

The following exhibits are being furnished herewith:
Exhibit
No.
Description
 
99.1
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)



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.
ANTARES PHARMA, INC.
(Registrant)
Date:
October 18, 2021 By:
/s/ Peter J. Graham
Name:
Peter J. Graham
Title:
Executive Vice President, General Counsel, Chief Compliance Officer, Human Resources and Secretary

Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Nov 2021 to Dec 2021 Click Here for more Antares Pharma Charts.
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Dec 2020 to Dec 2021 Click Here for more Antares Pharma Charts.