Allarity Stock Price, News & Analysis

Allarity Therapeutics (NASDAQ: ALLR) presented new Phase 2 clinical data for stenoparib in advanced ovarian cancer at the SGO 2025 Annual Meeting. The trial focused on heavily pre-treated patients, with 14 out of 15 participants being platinum-resistant and one having primary platinum-refractory disease.

Key findings show that five patients maintained therapy beyond 4 months, with four exceeding 20 weeks. Notable outcomes include:

• One patient achieved a confirmed complete response lasting over 10 months
• Two patients remain on therapy after 17+ months
• The platinum-refractory patient stayed on therapy beyond 40 weeks

Significantly, stenoparib showed benefit in patients without BRCA mutations, potentially due to its unique dual mechanism inhibiting both PARP and Wnt pathway. The drug demonstrated good tolerability without typical bone marrow toxicity seen in first-generation PARP inhibitors.

Allarity Therapeutics (NASDAQ: ALLR) has reached a final settlement with the SEC regarding its past disclosures about FDA interactions concerning its New Drug Application for Dovitinib. The settlement follows the January 30, 2025 agreement in principle.

Key terms include:

• A $2.5 million civil penalty payment
• A cease-and-desist order without admitting or denying SEC findings
• Findings of violations under Securities Act Sections 17(a)(2) and (3) and Exchange Act Section 13(a)

The company confirms this penalty won't impact its financial outlook or ability to execute planned Phase 2 clinical trials. Allarity's cash position is expected to support operations into 2026. The settlement resolves all outstanding legal matters, including the recently dismissed securities class action lawsuit.

Allarity Therapeutics (NASDAQ: ALLR) has announced plans for a Phase 2 trial evaluating the combination of stenoparib with temozolomide for treating recurrent Small Cell Lung Cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration through the Special Emphasis Panel on Precision Oncology, will be conducted across 11 VA medical centers.

The study will enroll approximately 65 extensive-stage SCLC patients who have failed frontline treatment. Stenoparib, a dual PARP/Wnt pathway inhibitor, combined with temozolomide aims to improve upon previous PARP inhibitor combinations that showed ~40% response rates but had dose-limiting toxicity.

Key advantages of stenoparib include its ability to cross the blood-brain barrier, potentially treating both systemic tumors and brain metastases, and its unique tankyrase inhibition affecting the Wnt pathway involved in SCLC progression and treatment resistance. The trial will assess progression-free survival and determine the recommended Phase 2 dose during an initial safety lead-in phase.

Allarity Therapeutics (NASDAQ: ALLR) has announced a $5 million share repurchase program authorized by its Board of Directors, running through February 28, 2026. The company, currently in Phase 2 clinical trials, is developing stenoparib—a dual PARP/Wnt pathway inhibitor—for personalized cancer treatment using its Drug Response Predictor (DRP®) technology.

The repurchase program, which will be executed through open market transactions, reflects management's confidence in the company's direction and its commitment to shareholder value. As disclosed in November 2024, Allarity's cash position extends into 2026, allowing the company to proceed with the buyback without impacting its financial runway.

The company is preparing to initiate patient enrollment for stenoparib trials in advanced ovarian cancer, focusing on investigating its dual mechanisms as both a PARP inhibitor and Wnt pathway modulator.

Allarity Therapeutics (NASDAQ: ALLR) announced the complete dismissal of a securities class action lawsuit filed against the company in the United States District Court for the Southern District of New York. The lawsuit, originally filed on September 13, 2024, alleged false or misleading statements regarding the Dovitinib New Drug Application (NDA) regulatory prospects.

The case was dismissed with each party bearing its own legal costs, and notably, no settlement or payment was required from Allarity or its officers. The company, which is currently in Phase 2 clinical trials, is developing stenoparib—a dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary Drug Response Predictor (DRP®) technology.

Allarity Therapeutics (NASDAQ: ALLR) announced the initiation of a new Phase 2 protocol for stenoparib in ovarian cancer, with patient enrollment ready to begin at U.S. clinical sites. The protocol was developed following review of ongoing Phase 2 data and consultation with ovarian cancer experts and FDA input.

The current Phase 2 study has shown promising results, including a complete confirmed response and two patients maintaining treatment without progression for over 17 months. The new protocol aims to provide critical data by summer 2026 for a pivotal registration trial.

The trial will evaluate stenoparib's impact on the Wnt pathway in the $9B+ PARP inhibitor market. The study will assess both the current twice-daily dosing and an additional dose level to optimize clinical benefit. Allarity plans to pursue expedited regulatory pathways for approval in the first half of 2025, advancing both stenoparib and its companion diagnostic stenoparib-DRP simultaneously.

Allarity Therapeutics (NASDAQ: ALLR) announced plans to expand its Phase 2 clinical trial for stenoparib in advanced ovarian cancer. The expanded protocol aims to optimize dosing and refine patient selection criteria using their proprietary Drug Response Predictor (DRP®) technology.

The new trial will focus specifically on patients with advanced, recurrent, platinum-resistant disease, a group that has shown durable clinical benefit from stenoparib in current trials, with some patients continuing therapy for over 14 months. The study will also investigate stenoparib's impact on the Wnt pathway, which is involved in advanced ovarian and colon cancers.

Patient enrollment is expected to begin in the first half of 2025 at U.S. trial sites, with potential expansion to U.K. locations. The trial will assess DRP scores for all enrolled patients to generate data supporting the companion diagnostic approval alongside stenoparib.

Allarity Therapeutics (NASDAQ: ALLR) has announced an agreement in principle with the SEC to resolve a previously disclosed investigation. The settlement concerns the company's disclosures made during or before 2022 regarding FDA meetings about their New Drug Application for Dovitinib/Dovitinib-DRP submitted in 2021.

The agreement remains subject to final language approval and SEC confirmation. CEO Thomas Jensen highlighted that some patients in their Phase 2 stenoparib trial have exceeded 14 months of treatment, expressing optimism about the molecule's prospects. The company plans to design a follow-on trial aimed at FDA registration for stenoparib.

Allarity confirms it maintains sufficient financial positioning to continue core operations, including stenoparib development, into 2026.

Allarity Therapeutics (NASDAQ: ALLR) reported significant progress in its Phase 2 stenoparib trial for advanced ovarian cancer, with two patients exceeding 14 months of treatment. The company maintains a strong financial position with $18.5 million cash balance as of September 30, 2024, enabling advancement toward FDA approval. Additionally, Allarity's Medical Laboratory has expanded into revenue-generating services for external biotech clients, offering Drug Response Predictor (DRP®) analysis and gene expression services. The ongoing Phase 2 trial involves prescreening patients using Allarity's DRP® companion diagnostic, with a revised dosing protocol implemented in Q1 2023.