Lawsuit filed for Investors who lost money with shares of Allarity Therapeutics, Inc. (NASDAQ: ALLR)

An investor, who purchased shares of Allarity Therapeutics, Inc. (NASDAQ: ALLR), filed a lawsuit over alleged violations of Federal Securities Laws by Allarity Therapeutics, Inc.

Investors who purchased shares of Allarity Therapeutics, Inc. (NASDAQ: ALLR) have certain options and for certain investors are short and strict deadlines running. Deadline: November 12, 2024. NASDAQ: ALLR investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Boston, MA based Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP."
On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA").

On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA").

On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic."

On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities."

The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same.

On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy.

On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP."

On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date.

On July 22, 2024, before market hours Allarity Therapeutics, Inc. filed a current report on Form 8-K with the Securities and Exchange Commission ("SEC"), in which the Company disclosed that: "Allarity Therapeutics, Inc. (the 'Company') received a 'Wells Notice' from the Staff of the U.S. Securities and Exchange Commission (the 'SEC') relating to the Company's previously disclosed SEC investigation."
Allarity Therapeutics, Inc. also revealed that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the United States Food and Drug Administration (the 'FDA') regarding the Company's NDA [New Drug Application] for Dovitinib or Dovitinib-DRP," and that "Allarity also understands that three of its former officers received Wells Notices from the SEC relating to the same conduct." Further, "[t]he Wells Notice informed the Company that the SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege certain violations of the federal securities laws."

Shares of Allarity Therapeutics, Inc. (NASDAQ: ALLR) declined to $0.138 per share on August 07, 2024.

Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from Brown, its [CFO], effective September 12, 2024."

The plaintiff claims that between May 17, 2022 and July 19, 2024, the Defendants made false and/or misleading statements and/or failed to disclose tha Defendants had overstated the Dovitinib NDA's continued regulatory prospects, that Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, that the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm, that following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation, and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Allarity Therapeutics, Inc. (NASDAQ: ALLR) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.