Item 1.01 Entry into a Material Definitive Agreement.

On January 13, 2023, we entered into an external sponsored collaborative clinical research agreement with Erasmus University Medical Center Rotterdam and AstraZeneca BV, pursuant to which Erasmus is sponsoring and planning to perform an investigator-initiated clinical study, entitled Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect (the "Study") in which it will use both study drugs provided by AstraZeneca and us. We also have entered into an Investigator Initiated Study Support Agreement (the "Support Agreement") with Erasmus regarding the Study. We anticipate that the Study will be a phase II, non-randomized, open-label, single-arm, single center study with two subsequent phases pursuant to the protocol set forth in the Support Agreement. We will supply Erasmus with a sufficient supply of rintatolimod to conduct the Study and AstraZeneca will supply the durvalumab. We retain all rights to our intellectual property. Erasmus will own all right to the Study data but shall permit us to use the Study Data for any purpose. We shall own all rights and titles to inventions arising from the Study related to rintatolimod. The Study Agreement is terminable upon the completion of the Study or upon the happening of certain events including the insolvency of a party, a material breach which is not remedied within 30 days after notice, the Study not receiving official approval from the Ethics Committee or competent authorities or the approval being permanently revoked, or force majeure.





Cautionary Statement

This Current Report on Form 8-K and the exhibit filed herewith, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. Any forward-looking statements set forth herein speak only as of the date hereof. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. No assurance can be given as to whether the Study will be successful, yield favorable data or not require additional funding, and the Study is subject to many factors. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

Item 9.01. Financial Statements and Exhibits.





(d) Exhibits.



Exhibit No.   Description

99.1            January 17, 2023 Press Release.
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document).

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