Cambridge, Massachusetts, United States (October 11, 2022) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”), a clinical-stage pharmaceutical company developing novel oncology treatments with drug-specific DRPs® companion diagnostics for personalized cancer care, today announced its financial results for the second quarter ended June 30, 2022.
On October 7, 2022, Allarity filed its Quarterly Report on Form 10-Q for the second quarter ended June 30, 2022. With this filing, the Company addressed the cause of the Nasdaq Listing Rule Non-Compliance Status. 5250(c)(1), as previously announced on August 26, 2022. On October 10, 2022, Nasdaq confirmed that upon filing the company’s Form 10-Q, the company had regained compliance with the listing rule Nasdaq 5250(c)(1) and the issue is now closed.
“We are very pleased to have completed the necessary filings in Q2 and regained compliance with Nasdaq listing requirements.“, said James G. Cullem, president and CEO of Allarity. “Wearand now looking forward to focus on advancing the important work of take advantage of DRP® companion diagnosis for to develop truly personalized medicines for cancer patients who need better options.”
Second Qquarter and Rdecent Ooperational Hstrong points
- The company announced a leadership transition with James G. Cullem, JD, named interim chief executive officer, and Joan Y. Brown, CPA, named interim chief financial officer; Mr. Cullem was previously chief commercial officer and Ms. Brown was previously chief financial reporting officer for the company.
- Distinguished Oncologist, Roberto Pili, MD, Associate Dean for Cancer Research and Integrative Oncology and Professor and Division Chief of Hematology/Oncology in the Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo (New York), joined the Scientific Council of the Society.
- The Company Named David A. Roth, MD, a Distinguished Clinical Researcher and Developer of Oncology Drugs, to the Company’s Board of Directors; Dr. Roth is the chief medical officer of Syros Pharmaceuticals, Inc. Mr. Cullem and Thomas Jensen, the company’s co-founder and senior vice president of investor relations, were also appointed to the board.
- The company named veteran biotech executive Jerry McLaughlin to the company’s board of directors; Mr. McLaughlin is currently CEO and a member of the Board of Directors of Life Biosciences, LLC.
- Allarity has deployed a new strategy focused on combination therapies, aligning the Company with the ongoing shift in oncology care standards towards combination therapies, while improving the Company’s future funding and business prospects.
- Company Announces Appointment of New Auditor Wolf & Company, PC Wolf & Company’s appointment has been approved by both the Company’s Audit Committee and Board of Directors. The selection of Wolf & Company follows the resignation of Marcum LLP, which was previously Allarity’s independent registered accounting firm.
- OncoHeroes Biosciences, Allarity’s development partner for dovitinib and stenoparib in pediatric indications, announced that the FDA has granted rare pediatric disease designation to dovitinib for development in pediatric osteosarcoma.
Second Quarterly financial results
Balance sheet: As of June 30, 2022, Allarity had cash of $7.7 million, compared to $19.6 million as of December 31, 2021.
Impairment of intangible assets: Impairment of intangible assets was nil for the three months ended June 30, 2022 and June 30, 2021.
General and administrative costs: General and administrative (G&A) expenses were $3.1 million for the quarter ended June 30, 2022, compared to $2.1 million for the quarter ended June 30, 2021.
Net loss: Net loss was $5.1 million for the quarter ended June 30, 2022, compared to $5.4 million for the comparable period of 2021.
About the Drug Response Predictor – DRP® Companion diagnosis
Allarity uses its drug-specific DRP® select patients who, by the genetic signature of their cancers, may have a high probability of responding to a specific drug. By screening patients before treatment and treating patients with a sufficiently high DRP® scores, the rate of therapeutic response can be significantly increased. DRP® The method relies on the comparison of susceptible and resistant human cancer cell lines, including transcriptomic information from the cell lines combined with clinical tumor biology filters and results from previous clinical trials. PRD® is based on messenger RNA from patient biopsies. DRP® demonstrated its ability to provide a statistically significant prediction of clinical outcome of drug treatment in cancer patients in 37 of 47 clinical studies reviewed (both retrospective and prospective), including the ongoing prospective phase 2 trials of Stenoparib and IXEMPRA®. DRP® platform, which can be used in all types of cancer and is patented for more than 70 cancer drugs, has been widely published in peer-reviewed literature.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) is developing medicines for personalized cancer treatment guided by its proprietary and highly validated companion diagnostic technology, 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 United States 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 under discussion for a license overhaul at Smerud Medical Research International AS . LiPlaCis®a liposomal formulation of cisplatin and its accompanying DRP® is developed through a partnership with Chosa ApS, a subsidiary of Smerud Medical Research International, for advanced metastatic breast cancer. The company is headquartered in the United States and has an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com
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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 “plans”, “believes”, “continues”, “could”, “estimates”, “expects”, “intends”, “may”, “could”, “plans”, ” possible”, “potential”, “predicted”, “plans”, “should”, “would” and similar expressions may identify forward-looking statements, but the absence of such words does not mean that a statement is not prospective. These forward-looking statements include, but are not limited to, statements regarding the clinical and commercial potential of the Company advancing dovitinib in combination with another therapeutic candidate or other approved drug, any statements regarding ongoing clinical trials for stenoparib as monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA® for the treatment of metastatic breast cancer, and related statements the effectiveness of the Company’s DRP® companion diagnostic platform in predicting whether a particular patient is likely to respond to a specific drug. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. These risks and uncertainties include, but are not limited to, the risk that the results of a clinical study will not necessarily predict the final results and that one or more of the clinical results could change materially as a result of examinations. more complete data and as patients become available, the risk that the results of a clinical study will be subject to interpretation and that additional analyzes will be necessary and/or may contradict these results, obtaining regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of termination or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that results of previously conducted studies may not be repeated or observed in ongoing or future studies involving our product candidates t therapeutics, and the risk that the current COVID-19 pandemic will impact the Company’s current and future clinical trials and the Company’s schedule of preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, each of which could cause our actual results to differ materially from those contained in the forward-looking statements, see the section titled “Risk Factors” in our statement of registration of Form S-1. filed with the Securities and Exchange Commission, available on the Securities and Exchange Commission’s website at www.sec.gov, together with discussions of potential risks, uncertainties and other important factors in the filings of the Company with the Securities and Exchange Commission. All information contained in this press release is as of the date of publication, and the Company assumes no obligation to update such information except as required by law.
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Allarity Press Release Q2 2022 Report