Current Report Filing (8-k)
October 18 2021 - 07:56AM
Edgar (US Regulatory)
0001016169false00010161692021-10-182021-10-18
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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
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ANTARES PHARMA, INC.
(Exact name of registrant specified in its charter)
_________________________________________________________________
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Delaware |
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001-32302 |
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41-1350192 |
(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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100 Princeton South, Suite
300, Ewing, NJ
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08628 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code:
(609) 359-3020
Not Applicable
(Former Name or Former Address, if Changed Since Last
Report)
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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):
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☐ |
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-4(c)) |
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading
Symbol(s)
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Name of each exchange on which registered |
Common Stock, par value $0.01 per share |
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ATRS |
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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:
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Exhibit
No. |
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Description |
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99.1 |
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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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.
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ANTARES PHARMA, INC. |
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(Registrant) |
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Date:
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October 18, 2021 |
By: |
/s/ Peter J. Graham
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Name: |
Peter J. Graham
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Title: |
Executive Vice President, General Counsel, Chief Compliance
Officer, Human Resources and Secretary
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