Allarity Therapeutics Inc. filed SEC Form 8-K: Other Events

false 0001860657 0001860657 2025-01-30 2025-01-30

 

 

 

 

 

 

Date of Report (Date of earliest event reported) January 30, 2025

 

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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:

 

 

 

 

 

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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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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As previously disclosed, Allarity Therapeutics, Inc. (the “Company”) has been the subject of an investigation (the “Investigation”) by the Securities and Exchange Commission (the “SEC”) which relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the “FDA”) regarding the Company’s New Drug Application ("NDA") for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. 

 

The Company has reached an agreement in principle with the SEC staff to resolve the Investigation with respect to the Company. Under the terms of the settlement, the Company would consent, without admitting or denying the SEC’s findings, to the entry of an administrative cease-and-desist order.  This order would resolve the SEC’s investigation with findings of violations of non-scienter based charges under Sections 17(a)(2) and (3) of the Securities Act of 1933, and Section 13(a) of the Securities Exchange Act of 1934 and Rules 12b-20, 13a-11, and 13a-13 under the Exchange Act. As part of the settlement, the Company would also pay a one-time civil penalty of $2,500,000 and the Company would agree to fully cooperate with the SEC in any litigation going forward. This agreement in principle with the SEC staff remains subject to mutual agreement on the final language of the settlement documents and approval by the SEC. Accordingly, the Company emphasizes that there is no assurance that the settlement will be finalized or approved on the terms set forth above, or at all. The Company will file additional updates as appropriate once the settlement process is finalized.

 

As disclosed previously, Allarity understands that three of its former officers received Wells Notices. The three former officers who received a Wells Notice related to this matter are no longer with the Company, nor were they at the time of receipt of the Wells Notice. While the Company has reached an agreement in principle on its own behalf it may have certain potential indemnification obligations with respect to these individuals for their costs incurred for the SEC investigation and any subsequent litigation by the SEC directly against the former officers. The Company, however, has insurance coverage in place once up to $3.5 million has been incurred. Through the end of 2024, the Company has accrued or paid in cash an aggregate of approximately $1.8 million in fees and expenses for the representation of former officers and the Company will seek to apply this amount to that $3.5 million retention.

 

 

 

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.