Full Press Release Details
Allarity Therapeutics
Reports Fourth Quarter and Full Year
2021 Financial Results and Provides a Corporate Update
Cambridge, MA U.S.A. (May 16, 2022) -
Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing
novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, today reported financial
results for the fourth quarter and year ended December 31, 2021, and provided a corporate update.
"2021 was a momentous year for Allarity
Therapeutics," said Steve Carchedi, President and Chief Executive Officer. "We advanced our clinical-stage assets, raised
a record amount of new investment for the Company, and completed our listing on the U.S. Nasdaq stock exchange. We are grateful for the
collective support of our internal team, shareholders, and advisors, who are enabling the further development of our prioritized programs
to address significant unmet needs within difficult-to-treat cancers. As we await further feedback from the United States Food and Drug
Administration (FDA) regarding our NDA application for dovitinib, we remain steadfast in our mission to pair promising cancer therapeutics
with our proprietary companion diagnostic technology to help significantly improve treatment outcomes for patients suffering from cancer.
We look forward to sharing further updates on dovitinib and our other two priority clinical programs throughout the year."
A delay in filing the Company's Form 10-K
triggered a notification of non-compliance by Nasdaq concerning Listing Rule 5250(c)(1), as announced on April 22, 2022. Issuing a promissory
note to Novartis to replace an unenforceable note issued by one of the Company's Danish subsidiaries in 2018 and an error in the
calculation of a tax Net Operating Loss allowance led to a restatement of the Company's Form 10-Q dated September 30, 2021, and
financial statements for the twelve months ended December 31, 2020, were the primary cause of the delay. The Company has filed the restated
Form 10-Q for September 30, 2021, and its Form 10-K for 2021 today with the U.S. Securities and Exchange Commission (SEC). With these
filings completed, the Company expects to regain compliance with Nasdaq Listing Rule 5250(c)(1) in the near future. The restatement of
our financial statements for the year ended December 31, 2020, also resulted in a "Triggering Event" under our Certificate
of Designations for our Series A Preferred Stock (the "Preferred Stock") because of the requirement to file a post-effective
amendment to the Company's Form S-1 registration statement that registers shares of our common stock issuable upon conversion of
the Preferred Stock. As previously disclosed, the Investor that holds all of our Preferred Stock and the Company entered into a Forbearance
Agreement and Waiver, dated April 27, 2022, providing the Company a forbearance period until June 4, 2022, in order to have the post-effective
amendment declared effective by the SEC.
Full Year 2021 and Recent Highlights
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
Anticipated Milestones in 2022
Fourth Quarter and Full Year 2021 Financial
Balance Sheet: As of December 31, 2021,
Allarity's cash was $19.6 million, as compared to $298 thousand as of December 31 2020. This includes net proceeds from the Company's
December 2021 initial public offering in the U.S. The Company's current cash, are expected to fund operations through 2022.
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
R&D Expenses: Research and Development
(R&D) expenses were $9.5 million for the three months ended December 31, 2021, and $14.2 million for the full year 2021, compared
to $1.7 million and $4.2 million for comparable periods in 2020, respectively.
G&A Expenses: General and Administrative
(G&A) expenses were $6.2 million for the three months ended December 31, 2021, and $12.4 million for the full year 2021, compared
to $856 thousand and $4.1 million for comparable periods in 2020, respectively.
Net Loss: Net loss was $16.8 million for
the three months ended December 31, 2021, and $26.6 million for the full year 2021, compared to $1.7 million and $6.6 million for comparable
periods in 2020, respectively.
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
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/
Twitter: https://twitter.com/allaritytx
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
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, all statements under the heading "Anticipated
Milestones in 2022," 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