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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): February 1, 2023

 

Unicycive Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40582   81-3638692
(State or other jurisdiction   (Commission File Number)   IRS Employer
of incorporation or organization)       Identification No.)

 

4300 El Camino Real, Suite 210

Los Alto, CA 94022

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (650) 351-4495

 

 

(Former name or former address, if changed since last report)

 

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   UNCY   Nasdaq Capital Market

 

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 communication 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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 1.01 Entry into a Material Definitive Agreement

 

Unicycive Therapeutics, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) effective as of February 1, 2023 with Lotus International Pte Ltd. (“Lotus”) pursuant to which the Company licensed the exclusive right to develop, market and commercialize Renazorb® to Lotus in the Republic of Korea. Under the terms of the agreement, Lotus will be responsible for development, registration filing and approval for Renazorb® in the licensed territory. In addition, Lotus will have sole responsibility for the importation of the drug product from Unicycive and for the costs of commercialization of Renazorb® in the licensed territory.

 

The Company will receive an upfront payment of $750,000 upon execution of the Agreement and up to $3.7 million in milestone payments and will be eligible for tiered royalties upon achievement of prespecified commercial achievements. The term of the Agreement shall continue in effect until ten (10) years from the date of the first product purchase order. Thereafter the Agreement shall be renewed automatically for succeeding terms of two years each unless either party provides ninety (90) days prior written notice of termination.

 

The foregoing summary of the Agreement is qualified in its entirety by reference to the Agreement attached as Exhibit 10.1 hereto and is incorporated herein by reference.

 

Item 8.01 Other Events.

 

On February 2, 2023, the Company issued a press release announcing that the Company entered into the Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits.

 

10.1*   License Agreement effective as of February 1, 2023 by and between Unicycive Therapeutics, Inc. and Lotus International Pte Ltd.
99.1   Press Release of Unicycive Therapeutics, Inc. dated February 2, 2023.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document

 

*Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).

 

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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.

 

Dated: February 2, 2023

 

  UNICYCIVE THERAPEUTICS, INC.
   
  By: /s/ Shalabh Gupta
    Shalabh Gupta
    Chief Executive Officer

 

 

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