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Form 8-K Allarity Therapeutics, For: May 27

May 27, 2022 5:49 PM EDT

Exhibit 99.1

 

 

Allarity Therapeutics Reports First Quarter 2022 Financial Results

 

Cambridge, MA U.S.A. (May 27, 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 first quarter ended March 31, 2022.

 

First Quarter Financial Results

 

Balance Sheet: As of March 31, 2022, Allarity’s cash was $14.5 million, as compared to $19.6 million as of December 31, 2021.

 

R&D Expenses: Research and Development (R&D) expenses were $1.3 million for the three months ended March 31, 2022, compared to $1.3 million for the quarter ended March 31, 2021.

 

Impairment of Intangible Assets: Impairment of Intangible Assets was $14.0 million for the three months ended March 31, 2022, compared to nil for the quarter ended March 31, 2021.

 

G&A Expenses: General and Administrative (G&A) expenses were $3.0 million for the three months ended March 31, 2022, as compared to $1.2 million for the three months ended March 31, 2021.

 

Net Loss: Net loss was $3.1 million for the three months ended March 31, 2022, compared to $3.1 million for the comparable period in 2021.

 

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

 

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, 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 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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ALLARITY THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

   March 31,
2022
$
   December 31,
2021
$
 
         
ASSETS        
Current assets:        
Cash   14,544    19,555 
Other current assets   147    625 
Prepaid expenses   1,249    36 
Tax credit receivable   1,271    838 
Total current assets   17,211    21,054 
Investment in Lantern Pharma Inc. stock   314    350 
Property, plant and equipment, net   6    8 
Operating lease right of use assets   65    86 
Intangible assets, net   13,694    28,135 
Total assets   31,290    49,633 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   5,799    698 
Accrued liabilities   1,342    8,590 
Warrant liability   3,081    11,273 
Derivative liabilities   2,265     
Income taxes payable   52    60 
Operating lease liabilities, current   82    98 
Total current liabilities   12,711    20,719 
Convertible promissory note and accrued interest, net   1,005    979 
Derivative liabilities       7,181 
Operating lease liabilities, noncurrent       9 
Deferred tax   700    1,961 
Total liabilities   14,416    30,849 
Redeemable convertible preferred stock          
Series A Convertible Preferred stock   2,142    632 
Stockholders’ equity          
Common stock   885    810 
Additional paid-in capital   84,233    84,434 
Accumulated other comprehensive (loss)   (814)   (600)
Accumulated deficit   (69,572)   (66,492)
Total stockholders’ equity   14,732    18,152 
Total liabilities, redeemable convertible preferred stock & stockholders’ equity   31,290    49,633 

 

Allarity Therapeutics, Inc.   |  210 Broadway, #201  |   Cambridge, MA   |   U.S.A.   |   NASDAQ: ALLR  |  www.allarity.com

 

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ALLARITY THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(unaudited)

 

   Three months ended
March 31,
 
   2022$   2021$ 
Operating expenses:        
Research and development   1,289    1,185 
Impairment of intangible assets   14,007     
General and administrative   3,013    1,277 
Total operating expenses   18,309    2,462 
Loss from operations   (18,309)   (2,462)
Other income (expense), net   14,002    (590)
Net loss for the period before tax benefit (expense)   (4,307)   (3,052)
Income tax benefit (expense)   1,227    (33)
Net loss   (3,080)   (3,085)
Deemed 8% dividend on Preferred Stock   (1,572     
Net loss attributable to common stockholders   (4,652)   (3,085)
Basic and diluted net loss per common share  $(0.56)  $(0.68)
Weighted-average number of common shares outstanding, basic and diluted   8,288,371    4,533,430 

 

###

 

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

[email protected]

 

Investor Relations:

 

Chuck Padala

LifeSci Advisors

+1 (646) 627-8390

[email protected]

 

U.S. Media Contact:

 

Mike Beyer
Sam Brown, Inc.
+1 (312) 961-2502
[email protected]

 

EU Media Contact:

 

Thomas Pedersen

Carrotize PR & Communications

+45 6062 9390

[email protected]

 

Allarity Therapeutics, Inc.   |  210 Broadway, #201  |   Cambridge, MA   |   U.S.A.   |   NASDAQ: ALLR  |  www.allarity.com

 

 

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