false 0001835022 0001835022 2024-06-04 2024-06-04

 

 

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): June 4, 2024

 

 

Coya Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41583   85-4017781
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

 

5850 San Felipe St., Suite 500  
Houston, Texas   77057
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (800) 587-8170

N/A

(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:

 

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 $0.0001 per share   COYA   The Nasdaq Stock Market LLC

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.

 

 

 


Item 1.01 Entry into a Material Definitive Agreement.

On June 4, 2024, Coya Therapeutics, Inc. (the “Company”) entered into the First Amendment to Development and License Agreement (the “First Amendment”) with Dr. Reddy’s Laboratories Ltd. and its affiliate, Dr. Reddy’s Laboratories SA (collectively, “Dr. Reddy’s”), pursuant to which the parties agreed to amend that certain Development and License Agreement by and between the Company and Dr. Reddy’s, dated December 5, 2023 (the “DRL Development Agreement”), to provide that (i) Dr. Reddy’s will make a one-time payment to the Company of $3.85 million to be used solely for the purposes of funding the first phase 2 clinical trial of COYA 302 (a proprietary co-pack kit containing low dose IL-2 and CTLA-4 Ig) in the amyotrophic lateral sclerosis field in the United States and (ii) Dr. Reddy’s will have no obligation to pay the Company the first $6 million in royalty payments that otherwise would have been payable to the Company under the DRL Development Agreement.

The foregoing summary of the First Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the First Amendment, which is filed as Exhibit 10.1 hereto.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.   

Description

10.1    First Amendment to DRL Development Agreement, dated June 4, 2024.
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.

 

      COYA THERAPEUTICS, INC.
Date: June 5, 2024     By:  

/s/ Howard Berman

      Howard Berman
Chief Executive Officer

Exhibit 10.1

FIRST AMENDMENT TO DEVELOPMENT AND LICENSE AGREEMENT

This First Amendment to Development and License Agreement (this “First Amendment”) is made and entered into effective as of June 4, 2024 (the “First Amendment Effective Date”) by and between Coya Therapeutics, Inc., a Delaware corporation having its registered office at 5850 San Felipe St., Suite 500, Houston, Texas 77057, USA (“Coya”) and Dr. Reddys Laboratories SA, a Swiss company having its place of business at Elisabethenanlage 11, CH—4051, Basel, Switzerland (“DRL”). Capitalized terms used but not defined in this First Amendment shall have meanings ascribed to such terms in the Agreement (as defined below).

RECITALS

WHEREAS, Coya, DRL and, solely for the purposes of certain provisions as set forth therein, Dr. Reddy’s Laboratories Ltd. (“DRL Ltd.”), which is an Affiliate of DRL, entered into that certain Development and License Agreement dated as of December 5, 2023 (the “Agreement”) pursuant to which, inter alia, Coya granted DRL an exclusive license to exploit Final Product in the DRL Field in the DRL Transferred Territory; and

WHEREAS, the Parties desire to amend certain provisions of the Agreement related to Development Funding and Royalty Payments, as set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Additional Development Milestone Payment. Within five (5) Business Days after receipt of an invoice from Coya, which shall be issuable by Coya on or after the First Amendment Effective Date, DRL shall make a one-time payment to Coya of USD 3.85 million (the “Additional Development Funding Payment”). The Additional Development Funding Payment shall be deemed to be included in the definition of Development Funding for the purposes of the Agreement. Coya shall use the Additional Development Funding Payment solely for purposes of funding the first phase 2 clinical trial of the Final Product in the DRL Field in the United States in accordance with the Development Plan. The Parties acknowledge and agree that the Additional Development Funding Payment is not in consideration for any of the license rights granted under the Agreement, and combined with the other Development Funding, is not in excess of fair market value for services provided by Coya to Develop the Final Product.

2. Amendment to Royalty Payments. Section 8.5.1 of the Agreement is hereby amended to add the following to the end thereof:

“Notwithstanding anything to the contrary, DRL will have no obligation to pay Coya the first USD 6 million in Royalty Payments that otherwise would be payable under this Agreement.”

3. Miscellaneous. Except as expressly modified by this First Amendment, the Agreement remains in full force and effect. This First Amendment may be executed in counterparts, each of which shall be deemed an original but all of which shall constitute a single instrument.

[Signature Page Follows]

 

1


IN WITNESS WHEREOF, this First Amendment is executed by the duly authorized representative of each Party as of the First Amendment Effective Date.

 

Coya Therapeutics, Inc.     Dr. Reddy’s Laboratories SA
By:   /s/ Howard Berman     By:   /s/ Samin Ahmed Ranju
Name:   Howard Berman     Name:   Samin Ahmed Ranju
Title:   CEO     Title:   Head of Legal & Compliance, Europe
      By:   /s/ Sameer
      Name:   Sameer
      Title:   Director

 

2

v3.24.1.1.u2
Document and Entity Information
Jun. 04, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001835022
Document Type 8-K
Document Period End Date Jun. 04, 2024
Entity Registrant Name Coya Therapeutics, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-41583
Entity Tax Identification Number 85-4017781
Entity Address, Address Line One 5850 San Felipe St.
Entity Address, Address Line Two Suite 500
Entity Address, City or Town Houston
Entity Address, State or Province TX
Entity Address, Postal Zip Code 77057
City Area Code (800)
Local Phone Number 587-8170
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.0001 per share
Trading Symbol COYA
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false

Coya Therapeutics (NASDAQ:COYA)
Historical Stock Chart
From May 2024 to Jun 2024 Click Here for more Coya Therapeutics Charts.
Coya Therapeutics (NASDAQ:COYA)
Historical Stock Chart
From Jun 2023 to Jun 2024 Click Here for more Coya Therapeutics Charts.