Allarity Therapeutics, Inc 8-K/A, filed May 19, 2022
Allarity Therapeutics, Inc. (ALLR)
About this 8-K/A
Allarity Therapeutics, Inc filed this 8-K/A on May 19, 2022, reporting on events of May 16, 2022.
Items reported
- Item 2.02: Financial results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Amendment No. 1)
CURRENT REPORT
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Explanatory Note
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Item 2.02 Results of Operations and Financial Condition.
On May 16, 2022, the Company issued a press release announcing, among other things, limited financial and operational information for its fourth quarter and full fiscal year ended December 31, 2021 and provided a corporate update including certain forward-looking performance estimates and anticipated milestones in 2022 (the “Earnings Release”).
On May 18, 2022, the Company issued a press release announcing a correction of a typographical error incorrectly referencing “$971 million” instead of “$971 thousand” in connection with the description of the size of a debt cancellation in the section titled “Full Year 2021 and Recent Highlights” of the Earnings Release. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
The information under Item 2.02 above is incorporated herein by reference.
The information reported under Items 2.02 and 7.01 in this Current Report on Form 8-K, including Exhibit 99.1, is being “furnished” and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Exhibit Index
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit | Exhibit Description | |
| 99.1 | Press Release dated May 18, 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on our behalf by the undersigned hereunto duly authorized.
| Allarity Therapeutics, Inc. | ||
| By: | /s/ Jens Erik Knudsen | |
|
Jens Erik Knudsen Chief Financial Officer | ||
| Dated: May 18, 2022 | ||
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Exhibit 99.1
Correction Notice to Press Release
Announcing Financial Results For the
Fourth Quarter and Full Year 2021 Financial Results and Corporate Update
Cambridge, MA U.S.A. (May 18, 2022) — Allarity Therapeutics, Inc. (NASDAQ: ALLR) announced today that its press release issued under the headline “Allarity Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update” on May 16, 2022, included a typographical error in the section titled “Full Year 2021 and Recent Highlights”, describing the size of the debt cancellation which should have read “$971 thousand” instead of “$971 million.” The corrected paragraph is set forth below:
Full Year 2021 and Recent Highlights
| · | In March 2022, entered into two agreements amending the LiPlaCis® program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis®, including the cancellation of outstanding liability of $971 thousand. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million |
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 five drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; dovitinib, a post-Phase 3 pan-tyrosine kinase inhibitor; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. for the treatment of second-line metastatic breast cancer and in Phase 2 development in Europe for the same indication; and 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. LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP® is 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. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | 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
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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 relating to the Company’s NDA submission for dovitinib and its PMA submission for the drug-specific DRP® companion diagnostic for dovitinib, any statements related to ongoing clinical trials for stenoparib 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 10-K for the year ended December 31, 2021 filed today 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.
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
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Company Contact:
Jens Knudsen
Chief Financial Officer 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. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
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