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): | July 28, 2021 |
Adhera Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | | 000-13789 | | 11-2658569 |
| (State or other jurisdiction | | (Commission | | (I.R.S. Employer |
| of incorporation) | | File Number) | | Identification No.) |
8000 Innovation Parkway Baton Rouge, LA | | 70820 |
| (Address of principal executive offices) | | (Zip Code) |
| Registrant’s telephone number, including area code: | 919-518-3748 |
Former name or former address, if changed since last report
Securities registered pursuant to Section 12(b) of the Act: None
| Title of each class | | Trading Symbol | | Name of each exchange on which registered |
| — | | — | | — |
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)) |
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| ☐ | 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 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 July 28, 2021, Adhera Therapeutics, Inc. (the “Company”) and Melior Pharmaceuticals II, LLC (“MP”) entered into an exclusive license agreement for the development, commercialization and exclusive license of MLR-1019. MLR-1019 is being developed as a new class of therapeutic for Parkinson’s disease (PD) and is, to the best of the Company’s knowledge, the only drug candidate today to address both movement and non-movement aspects of PD. Under the Agreement, the Company was granted an exclusive license to use the MP Patents and know-how to develop products in consideration for cash payments upon meeting certain performance milestones (described in the table below), as well as a royalty of 5% of gross sales.
Additionally, the Company and MP agreed to form a joint steering committee consisting of three Company representatives and two MP representatives. The purpose of the JSC is to oversee the commercialization of MLR-1019.
| Milestone | | Milestone Payment | |
| Last patient enrolled into the Phase 2a study | | $ | 250,000 | |
| Positive outcome of the Phase 2a study | | $ | 1,500,000 | |
| Initiation of a Phase 3 study | | $ | 10,000,000 | |
| New Drug Application approval | | $ | 10,000,000 | |
| Total Milestone Payments | | $ | 21,750,000 | |
The license terminates upon the last expiration of the patents licensed by the Company, which is presently 2034 subject extensions and renewals of any of such patents. If the Company fails to get its common stock listed on Nasdaq or the NYSE (an “Uplisting Event”) within 12 months after the Company receives a Clinical Trial Authorization from the European Medicines Agency, then the Company’s commercial license and rights for using MP’s data shall terminate. Additionally, if the Company has completed the necessary steps to affect an Uplisting Event, the Company will have the option to purchase the all rights held by MP on the MLR-1019 licensed products in consideration for 10% of the outstanding shares of the Company’s common stock (immediately post Uplisting Event) and 2.5% royalty of future gross product sales.
The foregoing summary of the material terms of the form of the License Agreement is not complete and is qualified in its entirety by reference to the full text thereof, a copy of which is filed herewith as Exhibit 10.1, and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | ADHERA THERAPEUTICS, INC. |
| | | |
| August 3, 2021 | By: | /s/ Andrew Kucharchuk |
| | Name: | Andrew Kucharchuk |
| | Title: | Chief Executive Officer |
