Allarity Therapeutics, Inc 8-K, filed Jan 6, 2022
Allarity Therapeutics, Inc. (ALLR)
About this 8-K
Allarity Therapeutics, Inc filed this 8-K on January 6, 2022, reporting on events of January 2, 2022.
Items reported
- Item 1.01: Entered into a material agreement
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
On January 2, 2022, Allarity Therapeutics A/S, an Aktieselskab organized under the laws of Denmark (“Allarity A/S”) entered into certain exclusive license agreements (collectively, the “License Agreements”) with Oncoheroes Biosciences, Inc. (“Oncoheroes”). As previously disclosed, on December 20, 2021 and in connection with the Plan of Reorganization and Asset Purchase Agreement which was amended and restated on September 23, 2021 (the “Recapitalization Share Exchange”), between Allarity Therapeutics, Inc. (“us,” “we,” “our,” or the “Company”), Allarity Acquisition Subsidiary, Inc., a Delaware corporation and our wholly owned subsidiary (“Acquisition Sub”), and Allarity A/S, we consummated the transactions contemplated in the Asset Purchase Agreement among us, Acquisition Sub and Allarity A/S (the “Purchase Agreement”), pursuant to which Acquisition Sub acquired substantially all of the assets and assumed substantially all of the liabilities of Allarity A/S. In accordance with Section 13.03 of the Purchase Agreement, effective as of January 2, 2022, we entered into an Assignment and Assumption Agreement with Allarity A/S, pursuant to which Allarity A/S assigned the License Agreements to us (the “Assignment”).
Under the License Agreements, Oncoheroes will acquire exclusive, global development rights to our therapeutic candidates Dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and Stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in the field of pediatric cancers. As part of the License Agreements, Oncoheroes will receive commercialization rights for pediatric cancers, subject to our first buy-back option for each program, and we will receive upfront license fees and regulatory milestones for each program. If we do not re-acquire the pediatric field rights, we will further receive certain clinical/regulatory milestone payments and royalties on sales of Stenoparib and Dovitinib in the pediatric cancer market from Oncoheroes.
Development Milestone Payments
Under the License Agreements, we would also be entitled to receive certain milestone payments relating to the development and commercialization of Dovitinib and Stenoparib upon the occurrence of the following events: (i) upon the regulatory approval of a product in the United States, and (ii) upon the regulatory approval of a product in the European Union. Each milestone payment is payable one time only, regardless of the number of times the corresponding milestone event is achieved by a product and regardless of the number of products to achieve such milestone event. If all milestones are achieved, then we would be entitled to receive up to $2 million in milestone payments under each respective License Agreement.
Royalty Payments
In addition to the milestone payments described above, Oncoheroes has agreed to pay us royalties based on aggregate annual net sales of all products derived from Dovitinib and Stenoparib during the royalty term which is determined on a country-by-country and product-by-product basis, as the period of time commencing on the first commercial sale of any product in such country and expiring upon the latest of (a) the expiration of the last valid claim of a patent within (i) our intellectual property and/or (ii) the joint intellectual property in such country (if, but only if, such joint intellectual property arose from activities under the clinical development plan defined in the agreement), or (b) the fifteenth (15th) anniversary of the date of first commercial sale of such licensed drug in such country. We will be entitled to royalty payments of between three percent (3%) and eight percent (8%) of annual net sales of between $0 and $100 million, between six percent (6%) and eleven percent (11%) of annual net sales between $100 million and $200 million, and between eight percent (8%) and thirteen percent (12%) of annual net sales in excess of $200 million. The royalty amounts we are entitled to receive may be subject to reduction in the event a product is not covered by a valid claim of a licensed patent in such country.
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The License Agreements with Oncoheroes will continue on a product-by-product and country-by-country basis until the expiration of the applicable royalty term described above. However, the License Agreements may be terminated by Oncoheroes at any time after the first anniversary of the effective date of each License Agreement for any or no reason upon (i) ninety (90) days’ written notice if such notice is provided prior to first commercial sale, and (ii) one hundred eighty (180) days’ written notice if such notice is provided on or after the first commercial sale. We may also terminate the License Agreements upon sixty (60) days’ written notice if Oncoheroes challenges any of our licensed patents included under the License Agreements. The License Agreements may also be terminated by either party upon the material breach of the agreement by the other party if such breach is not cured within sixty (60) days, or in the event that either party files for bankruptcy.
The foregoing summary of the terms of the License Agreements and Assignment do not purport to be complete. Copies of the License Agreements (in redacted form subject to a confidential treatment request submitted to the Securities and Exchange Commission (the “SEC”)) and Assignment will be filed as Exhibits to the Company’s Form 10-K to be filed for the year ended December 31, 2021.
Item 7.01 Regulation FD Disclosure
On January 3, 2022, the Company issued a joint press release announcing the signing of the License Agreements. A copy of the full text of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
The information reported Item 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.
Cautionary Note Regarding Forward-Looking Statements
This Report on Form 8-K contains certain statements that are, or may be deemed to be, “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements that are purely historical are forward-looking statements. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose,” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees for future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | Exhibit Description | |
| 99.1 | Press Release dated January 3, 2022 – Allarity Therapeutics and Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib and Stenoparib | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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/ Steve R. Carchedi | |
| Steve R. Carchedi | ||
| Chief Executive Officer | ||
| Dated: January 6, 2022 | ||
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Exhibit 99.1
 |
Press release
Allarity
Therapeutics and Oncoheroes Biosciences Sign
Agreements to Advance Pediatric Cancer Development
of Dovitinib and Stenoparib
Oncoheroes will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers, utilizing Allarity’s DRP® companion diagnostics
Allarity has submitted a new drug application (NDA) for the U.S. approval of dovitinib in renal cell carcinoma (RCC) together with the Dovitinib-DRP® companion diagnostic
Cambridge, MA U.S.A. (January 3, 2022) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity” or the “Company”), a clinical-stage biopharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, and Oncoheroes Biosciences, Inc. (“Oncoheroes”), a clinical-stage biotechnology company advancing new therapies for childhood cancers, today announced that they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancers.
Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to fund and conduct further clinical development of both dovitinib and stenoparib in pediatric cancers. Oncoheroes will take responsibility for pediatric cancer clinical development activities for both clinical-stage therapeutics. Allarity will support Oncoheroes’ pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP® companion diagnostic screening of pediatric patients for each drug. Under the licenses, Oncoheroes will receive commercialization rights for pediatric cancers, subject to Allarity’s first buy-back option for each program, and Allarity will receive an undisclosed upfront license fee and regulatory milestones for each program. If Allarity does not re-acquire the pediatric field rights, it will further receive certain clinical/regulatory milestone payments and royalties on sales of stenoparib and dovitinib in the pediatric cancer market from Oncoheroes. Further financial terms of the licenses were not disclosed.
Steve R. Carchedi, CEO of Allarity Therapeutics, commented, “We are very pleased to partner with Oncoheroes Biosciences to advance both dovitinib and stenoparib as potential new therapeutic options for the personalized treatment of children and adolescents with cancer. Oncoheroes is a leader in advancing new therapeutics to help address historically underserved, rare childhood cancers, and an ideal partner for Allarity in the pediatric cancer market. Our out-licensing of these pediatric development programs enables Allarity to remain focused on our top priority programs in adult cancers, while at the same time leveraging Oncoheroes’ resources, capabilities, and commitment to clinically advancing dovitinib and stenoparib in childhood cancers, together with our DRP® companion diagnostics, in a true personalized cancer care approach.”
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
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In December 2021, Allarity submitted an NDA, to the U.S. Food and Drug Administration (FDA), for marketing approval for dovitinib for the treatment of third line RCC. In April 2021, the Company submitted a premarket approval (PMA) application for use of its Dovitinib-DRP® companion diagnostic to select and treat patients most likely to respond to dovitinib. In support of its NDA filing, and in accordance with FDA requirements, the Company is also planning a clinical trial of dovitnib in pediatric patients with osteosarcoma, in partnership with Oncoheroes, where the patients will be selected with the Dovitinib-DRP® companion diagnostic. Allarity’s focus on pediatric osteosarcoma development is based on the results of two previously reported preclinical studies in which treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time of mouse models of osteosarcoma by 50% and antitumor growth activity was observed for dovitinib as a single agent.
Ricardo Garcia, CEO & Founder of Oncoheroes Biosciences, further commented, “Oncoheroes is a mission-driven company committed to deliver more effective and safer treatments for children and adolescents with cancer. We are excited to partner with Allarity on these co-development programs. These fit perfectly with our goal of becoming the partner of choice for life sciences companies with drug candidates that have the potential to treat pediatric cancers. We are confident that this collaborative model will create powerful synergies to accelerate pediatric drug development and bring tangible benefits to younger cancer patients.”
Allarity is currently evaluating stenoparib for the treatment of advanced ovarian cancer in a Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.), and additional U.S. and European trial sites, using the Stenoparib-DRP® companion diagnostic to guide patient enrollment and improve therapeutic outcome. In prior clinical testing of more than 60 patients, stenoparib was well tolerated with a demonstrated acceptable safety profile. Through use of DRP® patient selection, Allarity aims to provide a superior clinical benefit to ovarian cancer patients receiving stenoparib as compared to other approved PARP inhibitors. Moreover, there is increasing evidence pointing to the potential use of PARP inhibitors in the treatment of various pediatric cancers.
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, including: Stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; Dovitinib, a pan-TKI submitted for NDA review by the FDA for the 3rd line treatment of renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. for the 2nd line treatment of metastatic breast cancer and in Phase 2 development, in Europe, for the treatment of the same indication; LiPlaCis®, a liposomal formulation of cisplatin in Phase 2 development for metastatic breast cancer; and 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM). The LiPlaCis® and 2X-111 programs are partnered, via out-license, to Smerud Medical Research International AS. In 2021, Allarity sold the global rights to Irofulven, a DNA-damaging agent in Phase 2 for prostate cancer, back to Lantern Pharma, Inc. The Company 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
About Oncoheroes Biosciences
Oncoheroes is a ground-breaking biotech company exclusively focused on the discovery and development of better drugs for children and adolescents with cancer. Our vision is to deliver benefits to young cancer patients and create value in the process. The company is headquartered in Boston, US, with a discovery lab in Barcelona, Spain. Oncoheroes is actively looking for in-licensing opportunities in the pediatric oncology space while working to generate new proprietary assets for a number of pediatric cancer indications with high unmet medical needs. For more information please visit: oncoheroes.com
Follow Oncoheroes on social media
Facebook: https://www.facebook.com/Oncoheroes
LinkedIn: https://www.linkedin.com/company/oncoheroes
Twitter: https://twitter.com/oncoheroesbio
Instagram: https://www.instagram.com/oncoheroesbio
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 submitted NDA for dovitinib and PMA for the drug-specific DRP® companion diagnostic for dovitinib, future clinical trials for dovitinib in pediatric cancers, development of dovitinib with an indication for osteosarcoma based on preclinical studies, ongoing clinical trials for stenoparib for the treatment of advanced ovarian 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, the drug-specific DRP® companion diagnostic 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. | 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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