UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §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 1.01. Entry into a Material Definitive Agreement.
On February 19, 2021, SCYNEXIS, Inc. entered into an agreement (the “Agreement”) with Amplity, Inc. (“Amplity”), a leading global contract commercialization organization, to support the anticipated commercialization of BrexafemmeTM (ibrexafungerp) in the United States. Brexafemme is the expected trade name for ibrexafungerp, an oral antifungal product candidate, for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The New Drug Application (NDA) for Brexafemme is currently under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021.
Provided that Brexafemme is approved by the FDA, during the 5-year term of the Agreement SCYNEXIS will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services. SCYNEXIS will maintain full ownership of Brexafemme and control of all strategic aspects of the launch. Amplity is deferring a portion of its direct service costs in the first two years (2021 and 2022), up to a cap, which SCYNEXIS will repay over three years starting in 2023. Amplity has the potential to earn a performance-based success fee, up to a cap, in the 2023-2025 timeframe by exceeding certain revenue targets. Each party retains the right to terminate the Agreement upon notice to the other party.
Signature
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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SCYNEXIS, Inc. |
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Date: February 23, 2021 |
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By: |
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/s/ Marco Taglietti |
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Name: |
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Marco Taglietti, M.D. |
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Its: |
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Chief Executive Officer |