Allarity Therapeutics, Inc., a clinical-stage biopharmaceutical company, engages in developing oncology therapeutics using drug-specific companion diagnostics generated by its drug response predictor technology. Its drug candidates include Stenoparib, a poly-ADP-ribose polymerase inhibitor that is in Phase 2 clinical trials for ovarian cancer; Dovitinib, a pan- tyrosine kinase inhibitor for the treatment of renal cell carcinoma; IXEMPRA, a microtubule inhibitor for the treatment of metastatic breast cancer; LiPlaCis, a liposomal formulation of cisplatin, which is in Phase 2 clinical trials for metastatic breast cancer; and 2X-111, a liposomal formulation of doxorubicin that is in Phase 2 clinical trials for metastatic breast cancer and glioblastoma multiforme. The company was incorporated in 2004 and is headquartered in Cambridge, Massachusetts.
IPO Year:
Exchange: NASDAQ
Website: https://www.allarity.com
8-K - Allarity Therapeutics, Inc. (0001860657) (Filer)
8-K - Allarity Therapeutics, Inc. (0001860657) (Filer)
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- Phase 2 Trial of Stenoparib Concluded Early due to Clear Clinical Benefits Achieved - On Track to Regain Compliance with All Nasdaq Listing Requirements - No Variable Priced Securities are Outstanding - Warrant Overhang Near Elimination - Allarity Withdraws its Form S-1 - Establishes Equity of $15 Million - Cash Balance of $14 Million Boston (May 14, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today reported financial results and provided an update on recent operational highlights for the first quarter that ended March 31, 2024. "The s
Press release Cambridge, MA U.S.A. (November 15, 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 today reported financial results for the third quarter ended September 30, 2022. Balance Sheet: As of September 30, 2022, Allarity's cash was $3.9 million, as compared to $19.6 million as of December 31, 2021. R&D Expenses: Research and Development (R&D) expenses were $3.0 million for the three months ended September 30, 2022, as compared to $1.4 million for the three months ended September 30, 2021. G&A Expenses:
Press release 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 clini
Former Eli Lilly Research Fellow Jeremy R. Graff, Ph.D., appointed as President and Chief Development Officer to lead the Company's clinical development programsEli Lilly and Celgene veteran Jose Iglesias, M.D., joins as Consultant Chief Medical Officer to drive the stenoparib program toward regulatory approvalFormer President of Novo Nordisk's U.S. Operations, Jesper Høiland, appointed as Strategic Advisor to guide strategic initiatives and optimize commercial potential Boston (October 3, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced seve
- New CFO Brings Multiple Years of Experience from Biotech Companies- As Part of the New Hire, the Company Issues Inducement Grants Boston (September 13, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the appointment of Alex Epshinsky as the Company's new Chief Financial Officer (CFO), and that the Company has granted equity awards on September 12, 2024 as a material inducement to the employment of Mr. Epshinsky. Mr. Epshinsky is a Chartered Public Accountant (CPA) and brings nearly a decade of financial leadership experience in the biotech and
Leadership Changes Led by Appointment of Co-Founder Thomas Jensen as Interim CEO and Jeremy Graff, Ph.D., former Eli Lilly Executive, as Executive AdvisorReduced Net Loss from Operations by 50% and Reduced Net Loss by 26%Announced Data in December 2023 from Advanced Ovarian Cancer Phase 2 Stenoparib Study Showing Significant Clinical Benefit Boston (March 8, 2024) — Allarity Therapeutics, Inc. ("Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today reported financial results for the year ended December 31, 2023, and provided a general business update. The Company's Interim Chief Executive Officer, Thomas Jensen, sta
Boston (December 12, 2023) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, today announced a transition in its leadership. Effective immediately, James G. Cullem is no longer President and CEO. The Company also announced that Thomas H. Jensen, co-founder and member of the Board of Directors of Allarity Therapeutics, has been appointed as Interim Chief Executive Officer. The Company has also engaged Jeremy R. Graff, Ph.D., as an Executive Advisor. Dr. Graff will work closely with Mr. Jensen and the Board
Cambridge, MA U.S.A. (October 11, 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, today reported 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 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 Com
Press release Cambridge, MA U.S.A. (September 26, 2022) — Allarity Therapeutics, Inc. (NASDAQ:ALLR) ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, today announced the appointment of Jerry McLaughlin as a new member of its Board of Directors, effective October 1, 2022. Mr. McLaughlin is a highly accomplished biotechnology executive with extensive experience in financing, drug development, licensing, commercialization, and product lifecycle management. Mr. McLaughlin is expected to serve on the compensation, and audit committees as an independent
Press release Cambridge, MA U.S.A. (September 12, 2022) — Allarity Therapeutics, Inc. (NASDAQ:ALLR) ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, announced today the appointment of Wolf & Company, P.C. (Boston, MA) ("Wolf & Company") as the Company's independent registered public accounting firm effective immediately. The appointment of Wolf & Company has been approved by both the audit committee and the Board of Directors (the "Board") of the Company. The appointment of Wolf & Company has no immediate effect on the Company's status as bei
Interim CEO James G. Cullem, J.D. and Co-Founder Thomas Jensen also joining the Board Press ReleaseCambridge, MA, U.S.A. (July 11, 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, today announced the appointment of David A. Roth, M.D., as well as Company Interim CEO James G. Cullem, J.D., and Company Co-Founder and Senior Vice President of Investor Relations Thomas Jensen, as new members of its Board of Directors, effective July 7, 2022. Dr. Roth will bring to Allarity deep experience and exper
Board Appoints James G. Cullem, J.D., to Interim Chief Executive Officer,Joan Y. Brown, CPA, to Interim Chief Financial Officer Press release Cambridge, MA, U.S.A. (June 29, 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, today announced an executive leadership transition. Effective immediately, the Company's Board of Directors has appointed James G. Cullem, J.D., current Chief Business Officer, as interim Chief Executive Officer (CEO) and Joan Y. Brown, CPA, current Director of Financial Reporting, as
Cambridge, MA U.S.A. (June 15, 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, today announced the appointment of Roberto Pili, M.D., as a member of the Company's Scientific Advisory Board (SAB). Dr. Pili is a highly respected oncologist and brings to Allarity deep expertise in renal cancers, as well as the development of targeted therapies for personalized medicine. "Dr. Pili is a highly respected doctor and researcher, with a proven record of helping improve outcomes for cancer patients through personalized m
Former Eli Lilly Research Fellow Jeremy R. Graff, Ph.D., appointed as President and Chief Development Officer to lead the Company's clinical development programsEli Lilly and Celgene veteran Jose Iglesias, M.D., joins as Consultant Chief Medical Officer to drive the stenoparib program toward regulatory approvalFormer President of Novo Nordisk's U.S. Operations, Jesper Høiland, appointed as Strategic Advisor to guide strategic initiatives and optimize commercial potential Boston (October 3, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced seve
- Durable Clinical Benefit Observed Beyond a Year on Treatment in Heavily Pre-Treated Patients Boston (September 16, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded one year on therapy. The patients had been pre-screened using Allarity's Drug Response Predictor (DRP®) companion diagnostic, which identified them as having a high likelihood of benefiting from stenoparib, the Company's novel dual PARP/Tankyrase inhibitor. T
- New CFO Brings Multiple Years of Experience from Biotech Companies- As Part of the New Hire, the Company Issues Inducement Grants Boston (September 13, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the appointment of Alex Epshinsky as the Company's new Chief Financial Officer (CFO), and that the Company has granted equity awards on September 12, 2024 as a material inducement to the employment of Mr. Epshinsky. Mr. Epshinsky is a Chartered Public Accountant (CPA) and brings nearly a decade of financial leadership experience in the biotech and
Boston (September 11, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that the Company is taking a decisive step toward regaining compliance with Nasdaq's listing requirements, as outlined by the Nasdaq Hearings Panel during a meeting on August 15, 2024. At the meeting, the Nasdaq Hearings Panel approved Allarity's plan to maintain its listing, contingent upon the Company securing shareholder approval for a reverse stock split by September 6, 2024. This approval was granted by Allarity's shareholders at the Company's Annual Meeting of Stockholders
Boston (July 26, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, announced that its Board of Directors has decided to postpone the Annual Meeting of Stockholders, which was originally scheduled for 10:00 AM Eastern Time today, July 26, 2024. On July 25, 2024, the Board, exercising its authority under the Company's bylaws, opted to delay the meeting to a future date, which will be determined and announced in due course. The Company will provide updated information regarding the new date for the Annual Meeting and, if necessary, a new record date, as soon a
Boston (July 24, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, encourages its stockholders to participate actively in the upcoming annual meeting of stockholders scheduled on July 26, 2024. The Company's Board of Directors has put a proposal before stockholders for a reverse stock split. Allarity has requested approval of the reverse stock split to regain and sustain compliance with Nasdaq requirements. The reverse stock split is essential to enabling compliance with this objective. If the reverse stock split is not approved by the Company's stockholders
Current Cash Balance of $20 million Expected to Provide Runway Into 2026Allarity to Pause Use of ATMCap Table Successfully Cleaned UpAllarity's Stenoparib Shows Extended Duration of Phase 2 Clinical Benefit Boston (July 22, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today outlines the Company's progress in 2024 and future objectives. Led by New Management Allarity has Materially Strengthened its Finances The Company's overall financial situation significantly improved as the Company today announced a new, strong cash balanc
Boston (June 27, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that it received notice from the NASDAQ Stock Market ("NASDAQ") that it was granted a hearing before a Nasdaq Hearings Panel (the "Panel"). This upcoming hearing, occurring in approximately 5 weeks, is scheduled for the Company to present its plan for regaining compliance following Nasdaq's notification, disclosed in Allarity's Form 8-K filed with the SEC on June 21, 2024, of Allarity's non-compliance with Nasdaq Listing Rule 5550(a)(2), also known as the Bid-Price Rule. This
Multiple patients have now exceeded 30 weeks on treatment Boston (June 25, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have been on treatment for more than 30 weeks. The continued durability of clinical benefit further bolsters the Company's announcement in early May 2024 that stenoparib had shown clear clinical benefit, including significant tumor shrinkage and long-term disease stability, in patients who had been heavily pre-treat
Boston (May 20, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that it has received formal written notice from The Nasdaq Stock Market, LLC's Office of General Counsel ("Nasdaq") that the Company has regained compliance with the minimum stockholders' equity requirement as set forth in Nasdaq Listing Rule 5550(b)(1) (the "Equity Rule"). This confirmation follows the Company's successful efforts to cut operation costs and improve its balance sheet, including raising new equity and reducing outstanding liabilities. As a result, Allarity Therape
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-SEC Filing
Allarity Therapeutics Inc (NASDAQ:ALLR) revealed on Monday it received a “Wells Notice” from the U.S. Securities and Exchange Commission (SEC). This notice pertains to the company’s disclosures about meetings with the Federal Drug Administration (FDA) regarding their New Drug Application (NDA) for Dovitinib or Dovitinib-DRP, submitted in 2021. In December 2021, Allarity Therapeutics submitted a marketing application to the FDA seeking approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients. The company’s NDA filing was supported by its prior pre-market approval (PMA) submission with the FDA for using Dovitinib-DRP, its companion diagnostic for th
Current Cash Balance of $20 million Expected to Provide Runway Into 2026 Allarity to Pause Use of ATM Cap Table Successfully Cleaned Up Allarity's Stenoparib Shows Extended Duration of Phase 2 Clinical Benefit
On July 19, 2024, Allarity Therapeutics, Inc. (the “Company”) received a “Wells Notice” from the Staff of the U.S. Securities and Exchange Commission (the “SEC”) relating to the Company’s previously disclosed SEC investigation. The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the “FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. The Company understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022. Allarity also understands that three of its former officers received Wells Notices from the SEC relating to the sam
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Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that it received notice from the NASDAQ Stock Market ("NASDAQ") that it was granted a hearing before a Nasdaq Hearings Panel (the "Panel").