On November 14, 2024 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, reported financial results for the third quarter ended September 30, 2024, and provided an update on recent operational highlights (Press release, Allarity Therapeutics, NOV 14, 2024, View Source [SID1234648419]).

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"This quarter’s progress marks a steady period of advancement for Allarity as we have maintained a strong cash position, achieved record patient duration on stenoparib treatment, and welcomed new members to our leadership team who bring the expertise needed to shape a successful future for the Company," said Thomas Jensen, CEO of Allarity Therapeutics. "We continue to drive the development of our promising, novel dual PARP/tankyrase inhibitor, stenoparib, forward, and we remain optimistic that our efforts will ultimately bring new hope to ovarian cancer patients, especially those who currently have few or no treatment options."

Third Quarter 2024 and Recent Operational Highlights

Encouraging Patient Outcomes in Phase 2 Stenoparib Trial: On September 16, 2024, the Company announced that two patients in its Phase 2 trial for stenoparib in advanced ovarian cancer had exceeded one year on treatment, demonstrating durable clinical benefit in this heavily pre-treated population and highlighting the potential of stenoparib as a meaningful treatment option for patients with limited or no alternatives.
New Leadership to Drive Clinical Development: The Company, led by President and Chief Development Officer Jeremy R. Graff, Ph.D., and Consultant Chief Medical Officer Jose Iglesias, M.D., both appointed in October 2024, is working closely with its scientific advisors to prepare a follow-on trial aimed at FDA regulatory intent. Dr. Graff—a distinguished oncology expert with over 25 years in drug development who previously served as a consultant to Allarity—and Dr. Iglesias—a seasoned leader in oncology clinical trials and former Celgene executive—bring invaluable experience and strategic insight to advance Allarity’s clinical trial efforts.
Appointment of New CFO: In September 2024, Allarity appointed Alexander Epshinsky as Chief Financial Officer. With nearly a decade of financial leadership experience in the biotech sector, Mr. Epshinsky brings valuable expertise to support the Company’s financial strategy as it advances the development of stenoparib.
European Patent Secured for Stenoparib DRP: The Company was granted a European patent in October 2024 for its proprietary DRP companion diagnostic specific to stenoparib, strengthening Allarity’s market position by securing critical IP protection for this unique diagnostic in an important market. Patent applications are also pending in other key regions, including the U.S., Japan, and China.
Regained NASDAQ Compliance: In October 2024, the Company received formal notice from The Nasdaq Stock Market LLC confirming that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, effectively concluding the previously disclosed listing matter.
Third Quarter 2024 Financial Highlights

Cash Position: As of September 30, 2024, Allarity had cash and cash equivalents of $18.5 million, compared to $0.2 million at December 31, 2023. The Company maintains a financial runway extending into 2026.

R&D Expenses: Research and development expenses for the third quarter of 2024 were $1.0 million, compared to $1.9 million for the third quarter of 2023. Additionally, the Company recorded a $9.7 million intangible asset impairment charge (non-cash) for the third quarter of 2024.

G&A Expenses: General and administrative expenses for the third quarter of 2024 were $1.6 million, compared to $2.5 million for the third quarter of 2023.

Net Loss: Net loss attributable to common stockholders for the third quarter of 2024 was $12.2 million (primarily due to the aforementioned $9.7 million intangible asset impairment charge), compared to a net loss of $5.6 million for the third quarter of 2023.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may 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 expression profiles 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 dozens of clinical studies (both retrospective and prospective). 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 the peer-reviewed literature.