On October 12, 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, reported financial results for the second quarter ended June 30, 2022 (Press release, Allarity Therapeutics, OCT 12, 2022, View Source [SID1234621956]).
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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 has addressed the cause of the non-compliant status with Nasdaq Listing Rule 5250(c)(1), as previously announced on August 26, 2022. On October 10, 2022, Nasdaq provided confirmation that upon the filing of the Company’s Form 10-Q has regained compliance with Nasdaq Listing Rule 5250(c)(1) and the matter is now closed.
" We are very pleased to have completed the necessary Q2 filings and to have regained compliance with Nasdaq’s listing requirements ," said James G. Cullem, Chief Executive Officer at Allarity. "We are now eagerly looking forward to focusing on advancing the important work of leveraging DRP companion diagnostics to develop truly personalized medicines for cancer patients who need better options."
Second Q uarter and R ecent O perational H ighlights
The Company announced an executive leadership transition with James G. Cullem, J.D. named as interim Chief Executive Officer, and Joan Y. Brown, CPA, named as interim Chief Financial Officer; Mr. Cullem previously served as Chief Business Officer, and Ms. Brown previously served as the Company’s Director of Financial Reporting.
Distinguished oncologist, Roberto Pili, M.D., Associate Dean for cancer research and integrative oncology and Professor and Chief of the Division of Hematology/Oncology in the Department of Medicine at the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo (New York), joined the Company’s Scientific Advisory Board.
The Company appointed prominent clinical researcher and oncology drug developer David A. Roth, M.D. to the Company’s Board of Directors; Dr. Roth is the Chief Medical Officer of Syros Pharmaceuticals, Inc. Mr. Cullem and Thomas Jensen, Company Co-Founder and Senior V.P. of Investor Relations, were also appointed to the Board.
The Company appointed seasoned biotechnology executive Jerry McLaughlin to the Company’s Board of Directors; Mr. McLaughlin is currently serving as CEO and Board Member of Life Biosciences, LLC.
Allarity rolled out a new combination therapy focused strategy, aligning the Company with the ongoing shift in oncology standard-of-care towards combination therapies while at the same time improving the Company’s future funding and commercial prospects.
The Company announced the appointment of a new auditor Wolf & Company, P.C. The appointment of Wolf & Company has been approved by both the audit committee and the Board of Directors of the Company. The selection of Wolf & Company follows the resignation of Marcum LLP, which previously was the independent registered public accounting firm of Allarity.
OncoHeroes Biosciences, Allarity’s partner for the development of dovitinib and stenoparib in pediatric indications, announced that the FDA had granted a Rare Pediatric Disease Designation to dovitinib for development in pediatric osteosarcoma.
Second Quarter Financial Results
Balance Sheet: As of June 30, 2022, Allarity’s cash was $7.7 million, as compared to $19.6 million as of December 31, 2021.
R&D Expenses: Research and Development (R&D) expenses were $1.7 million for the three months ended June 30, 2022 as compared to $2.3 million for the three months ended June 30, 2021.
Impairment of Intangible Assets : Impairment of Intangible Assets was zero for the three months ended June 30, 2022, and June 30, 2021.
G&A Expenses: General and Administrative (G&A) expenses were $3.1 million for the three months ended June 30, 2022, as compared to $2.1 million for the three months ended June 30, 2021.
Net Loss: Net loss was $5.1 million for the three months ended June 30, 2022, compared to $5.4 million for the comparable period in 2021.
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 cancers, may have a high likelihood of responding to a specific drug. By screening patients before treatment, and treating those patients with sufficiently high DRP scores, 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.