Allarity Therapeutics, Inc 8-K, filed Sep 12, 2022
Allarity Therapeutics, Inc. (ALLR)
About this 8-K
Allarity Therapeutics, Inc filed this 8-K on September 12, 2022, reporting on events of September 9, 2022.
Items reported
- Item 4.01: Change of auditor
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
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| Item 4.01 | Changes in Registrant’s Certifying Accountant |
(b) On September 9, 2022, the Audit Committee of the Board of Directors of the Allarity Therapeutics, Inc. (the “Company”) approved the engagement of Wolf & Company, P.C. (“Wolf & Company”) as its independent registered public accounting firm for the fiscal year ending December 31, 2022, effective immediately.
During the two most recent fiscal years ended December 31, 2020 and December 31, 2021 and through the subsequent interim period to September 9, 2022, neither the Company, nor anyone on its behalf, consulted with Wolf & Company regarding any accounting or auditing issues involving the Company, including (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered with respect to the consolidated financial statements of the Company; or (ii) any matter that was the subject of a “disagreement” (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) or a “reportable event” (as that term is defined in Item 304(a)(1)(v) of Regulation S-K).
| Item 7.01 | Regulation FD Disclosure |
On September 12, 2022, the Company issued a press release announcing the engagement of Wolf & Company. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
This information is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, unless we specifically incorporate it by reference in a document filed under the Securities Act of 1933 or the Securities Exchange Act of 1934. By furnishing this information on this Current Report on Form 8-K, we make no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit | Exhibit Descri5ption | |
| 99.1 | Press Release dated September 12, 2022 | |
| 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.
| Allarity Therapeutics, Inc. | ||
| By: | /s/ James G. Cullem | |
| James G. Cullem | ||
| Chief Executive Officer | ||
| Dated: September 12, 2022 | ||
Exhibit 99.1
Press release
Allarity Therapeutics Announces Appointment of New Auditor
Cambridge, MA U.S.A. (September 12, 2022) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity” or the “Company”), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, announced today the appointment of Wolf & Company, P.C. (Boston, MA) (“Wolf & Company”) as the Company’s independent registered public accounting firm effective immediately. The appointment of Wolf & Company has been approved by both the audit committee and the Board of Directors (the “Board”) of the Company.
The appointment of Wolf & Company has no immediate effect on the Company’s status as being non-compliant with Nasdaq Listing Rule 5250(c)(1). However, it is a pivotal part of the Company’s efforts to regain compliance. Allarity is already working with Wolf & Company to file the Quarterly Report on Form 10-Q for the quarter that ended June 30, 2022 as soon as it is practically feasible, and it is anticipated that following the filing of the Form 10-Q with the SEC, Nasdaq compliance will be regained.
The appointment of Wolf & Company follows the resignation of Marcum LLP (“Marcum”), which previously was the independent registered public accounting firm of Allarity, effective as of August 5, 2022, and as disclosed by Allarity in a Form 8-K filed with the SEC on August 12, 2022, and in a Form 8-K/A filed with the SEC on August 24, 2022.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; dovitinib, a post-Phase 3 pan-tyrosine kinase inhibitor; and the European rights to IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with Chosa ApS, an affiliate of Smerud Medical Research International, for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com.
Allarity Therapeutics, Inc. I 210 Broadway, #201 I Cambridge, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
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About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP® score, the therapeutic response rate can be significantly increased. The DRP® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP® is based on messenger RNA from patient biopsies. The DRP® platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA®. The DRP® platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer reviewed literature.
Follow Allarity on Social Media
Facebook: https://www.facebook.com/AllarityTx/
LinkedIn: https://www.linkedin.com/company/allaritytx/
Twitter: https://twitter.com/allaritytx
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allarity’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements related to the Company’s ability to regain compliance with the Nasdaq Listing Rule, statements relating to the timing of the filing of the Form 10-Q with the SEC, statements related to the expected availability capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination with another therapeutic candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA® for the treatment of metastatic breast cancer, and statements relating to the effectiveness of the Company’s DRP® companion diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the risk that the current COVID-19 pandemic will impact the Company’s current and future clinical trials and the timing of the Company’s preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form S-1 registration statement on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
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Allarity Therapeutics, Inc. I 210 Broadway, #201 I Cambridge, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
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Company Contact:
Thomas Jensen
Senior V.P. of Investor Relations
investorrelations@allarity.com
Investor Relations:
Chuck Padala
LifeSci Advisors
+1 (646) 627-8390
chuck@lifesciadvisors.com
U.S. Media Contact:
Mike Beyer
Sam Brown, Inc.
+1 (312) 961-2502
mikebeyer@sambrown.com
EU Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Allarity Therapeutics, Inc. I 210 Broadway, #201 I Cambridge, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
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