Hørsholm, Denmark (31 March 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announces the issuance of its Annual Report for 2020. The report is available as an attached document and on the Company’s website.
Comment from CEO Steve Carchedi
Steve Carchedi, CEO of Allarity Therapeutics, stated, “2020 was a year filled with unforeseen challenges, but despite that, I pleased to report that we continue to advance our three priority programs as 2021 progresses. Two of them, IXEMPRA® and stenoparib, are in Phase 2 clinical trials with enrollment of patients expanding during this year. Our lead program, dovitinib, is advancing towards filing of a New Drug Application (NDA) with the U.S. FDA this year seeking approval for the treatment of renal cell carcinoma (RCC). Looking beyond our cancer pipeline, we are now awaiting the outcome of the preclinical testing of stenoparib’s anti-viral properties against the British and South African variants of Coronavirus. All this is a result of the great effort we made in 2020 to align the Company’s efforts with our strategy, mapped out in the end of 2019. Those efforts included implementing robust financial controls, simplifying the ownership structure of our key assets, and out-licensing two other assets, LiPlaCis® and 2X-111, to Smerud Medical Research. We also relaunched the Company with a suitable name and corporate identity. As a result, today Allarity is positioned as one of the key future contributors to realizing the promise of personalized cancer care.”
Fourth quarter (2020-10-01 to 2020-12-31)
- Consolidated group revenue amounted to 0 MDKK (0.3 MDKK).
- Consolidated group loss before depreciation amounted to -24.7 MDKK (-20.4 MDKK).
- Consolidated group loss before net financials amounted to -24.9 MDKK (-35.1 MDKK).
- Consolidated group loss before taxes amounted to -27.4 MDKK (-110.4 MDKK)
- Consolidated net result amounted to -20.2 MDKK (-79.1 MDKK).
Full year 2020 (2020-01-01 to 2020-12-31)
- Consolidated group revenue amounted to 0 MDKK (0.8 MDKK).
- Consolidated group loss before depreciation amounted to -59.0 MDKK (-66.5 MDKK).
- Consolidated group loss before taxes amounted to -59.1 MDKK (-174.9 MDKK).
- Consolidated net loss amounted to -47.7 MDKK (-138.1 MDKK).
- Consolidated earnings per share (EPS) amounted to -0.29 DKK (-2.08 DKK).
2019 numbers in brackets.
Key events during first quarter 2020
- On January 10, the Company announced a directed share issue of 287,500 new shares to Colliander & Partners, who have assisted the company in HR activities. The transaction was a debt conversion of DKK 632,500.
- On February 24, the Company announced the termination of the financing agreement with European High Growth Opportunities Securitization Fund (EHGO) and its investment manager, Alpha Blue Ocean.
- On March 20, the Company announced that it had received feedback from its pre-NDA meeting with the U.S. FDA regarding a potential path to approval for Dovitinib. The FDA provided additional guidance to the Company regarding the submission process.
- On March 31, the Company announced the establishment of a convertible note program of 100 million SEK with Negma Group LTD and Park Partners GP, a program where the Company will remain in full control of the degree of utilization of this source of financing.
- On March 31, the Company’s Annual Report was published.
Key events during second quarter 2020
- On April 3, the Company announced a draw-down of the first tranche of SEK 10 million under its convertible note agreement with Negma Group LTD and Park Partners GP.
- On April 7, the Company announced a notice to convene Annual General Meeting 2020, to be held on April 22, 2020.
- On April 22, the Company announced that it would pre-clinically test the activity of its PARP inhibitor, Stenoparib (formerly 2X-121), as a potential therapy for Coronavirus. The testing would be conducted by the Pathogen and Microbiome Institute at Northern Arizona University.
- On April 22, the minutes from the Annual General Meeting 2020 were published.
- On May 6, the Company announced that it had entered into a USD 5 million equity investment agreement with a new US based investor, Global Corporate Finance. The agreement runs for 36 months, during which time the Company can solely decide to exercise investments by GCF, sequentially, in a number of tranches.
- On May 7, the Company announced a directed share issue of 1,952,475 new shares in connection with debt conversion directed to Global Corporate Finance and a consultant.
- On May 29, the Company published its Q1 2020 report, covering the period January – March 2020.
- On June 8, the Company announced that it had acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS and thereby had gained full control of its Dovitinib program.
- On June 9, the Company calls the first investment tranche under its share subscription agreement with Global Corporate Finance.
- On June 11, the Company announced the termination of the agreement with its liquidity provider Sedermera Fondkommission.
- On June 29, the Company announced that it had signed an agreement to out-license two pipeline assets to Smerud Medical Research International. The deal concerned two clinical pipeline assets, LiPlaCis® and 2X-111. As a part of the terms of the deal, the Company is eligible to receive significant milestone payments as well as royalties.
Key events during third quarter 2020
- On July 13, the Company announced that it had acquired full ownership of its PARP inhibitor program (at the time known as 2X-121, now stenoparib) by acquiring all outstanding shares in Oncology Venture US Inc., formerly 2X Oncology, Inc., from its external shareholders and warrant holders.
- On August 21, the Company published that it would offer 1,619,912 new shares, each with a subscription price of DKK 0.05, to a small number of recipients as part of the clean-up of outstanding incentive commitments and obligations made by prior management.
- On August 21, the Company announced that it had called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF. A total of 5,980,020 shares at a price per share of SEK 1.3420441 was issued to Global Corporate Finance.
- On August 26, the Company announced that its PARP inhibitor stenoparib (formerly known as 2X-121) had shown in vitro anti-viral activity against Coronavirus in pre-clinical studies.
- On August 28, the Company published the Interim Report for the period January – June 2020.
- On September 21, the Company published a notice to convene an Extraordinary General Meeting on 7 October 2020.
- On September 21, the Company announced its plans to change its name to Allarity Therapeutics and restructure its Board of Directors subject to approval of shareholders at the upcoming EGM.
Key events during fourth quarter 2020
- On October 6, the Company announced that it has called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF. A total of 5,370,617 shares was issued to Global Corporate Finance.
- On October 6, the Company announced that a small group of recipients had received a total of 1,619,912 shares in exchange for previously annulled warrants.
- On October 7, the Company announced that the Extraordinary General Meeting had approved the adoption of its new name, Allarity Therapeutics, as well as the restructuring of its Board of Directors, and a revision of the Company’s Articles of Association.
- On October 9, the Company published that following its name change to Allarity Therapeutics A/S, it will be trading under its new short name (ticker code) ALLR from Monday, October 12, 2020.
- On October 23, Allarity Therapeutics announced several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dovitinib, one of Allarity’s priority programs.
- On October 26, Allarity Therapeutics announced that the United States Patent and Trademark Office (USPTO) had issued Notices of Allowance to the Company for three new DRP® biomarker patents in conjunction with use of several of its clinical pipeline drugs.
- On November 4, the Company announced that Jens Erik Knudsen, CPA, MBA, had been appointed as its new Chief Financial Officer (CFO), effective immediately, replacing outgoing CFO Henrik Moltke.
- On November 5, the Company announced that it had drawn down a second tranche under its convertible note agreement with Negma Group LTD and Park Partners GP.
- On November 30, the Company published the Interim Report for the period January – September 2020.
- On December 14, the Company announced that it had expanded its stenoparib license rights to include anti-viral uses.
- On December 22, the Company announced that it had drawn down a third tranche under its convertible note agreement with Negma Group LTD and Park Partners GP.
Subsequent events during 2021
- On January 26, Allarity Therapeutics announced that it would test its PARP inhibitor, stenoparib, as a potential therapy for new highly infectious Strain B.1.1.7 of Coronavirus in preclinical studies.
- On February 11, the Company announced that it had drawn down a fourth tranche under its convertible note agreement with Negma Group LTD and Park Partners GP.
- On February 24, the Company provided an update on the pre-clinical testing of stenoparib’s antiviral activity against new variants of Coronavirus.
- On March 3, the Company published that it had initiated a Phase 2 trial of IXEMPRA® in Europe for the treatment of metastatic breast cancer.
- On March 9, the Company announced positive data from a preclinical study of dovitinib in osteosarcoma.
- On March 23, the Company announced plans of fully guaranteed rights issue of approximately SEK 100 million.
The report is available on:
Online webcast/conference call
Allarity Therapeutics A/S will host a live webcast on 31 March 2021, at 5:00 p.m. CEST to discuss the Company’s full year 2020 results and provide a business and financial update.
Attendees are encouraged to pre-register in order to be able to watch the presentation slides using this link:
Attendees who would wish to call in may use the following:
Attendee Dial-in Number: +1 (312) 248-9348
Attendee Dial-in ID Number: 821771#
Attendee Dial-in Passcode: 7041#
About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: Stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; Dovitinib, a pan-TKI in post-Phase 3 for renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer; LiPlaCis®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer.
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, the response rate can be significantly increased. The DRP® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP® is based on messenger RNA from the patient’s biopsies. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP® platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.
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This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning Allarity’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. Allarity undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Jens Knudsen, CFO
+45 8874 2415
Email inquiries: [email protected]
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Svensk Kapitalmarknadsgranskning AB, Email: [email protected]. Tel: +46 11 32 30 732
This information is information that Allarity A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 31 March 2021.