Algorae Pharmaceuticals Advances AI-Driven Drug Pipeline with Strong Preclinical Wins

Preclinical Breakthroughs in Cardiovascular and Dementia Therapies

Algorae Pharmaceuticals Ltd (ASX: 1AI) has unveiled compelling advancements in its research and development pipeline for the December 2024 quarter. The cardiovascular drug candidate Al-168 demonstrated a remarkable 94% restoration of endothelial cell proliferation in preclinical assays, outperforming FDA-approved beta blockers in multiple disease models. These results, generated at the Victorian Heart Institute, underpin the recent filing of an International Patent Cooperation Treaty (PCT) application and set the stage for upcoming in vivo studies.

Meanwhile, the dementia-focused candidate Al-116 showed superior neuroprotective effects compared to Donepezil Hydrochloride, the current first-line treatment. This promising data has also led to a PCT filing and the initiation of Phase 2 clinical trial planning, signaling Algorae’s commitment to addressing unmet needs in neurodegenerative disorders.

AI Platform Expansion Fuels Oncology Drug Discovery

Central to Algorae’s innovation is its proprietary AI drug discovery platform, Algorae Operating System (AlgoraeOS). Since its launch in September 2024, AlgoraeOS has identified 24 novel oncology drug targets, focusing on challenging cancers such as breast cancer, leukemia, and glioblastoma. The company has commenced development of AlgoraeOS Version 2.0, leveraging the computational power of the Gadi supercomputer to enhance data integration and algorithmic sophistication. This upgrade aims to accelerate the identification of synergistic drug combinations and streamline candidate validation.

Strategic Leadership and Operational Efficiency

Algorae has bolstered its scientific advisory capabilities with the appointment of Dr. Sarah Siggins, a seasoned pharmaceutical executive with over 14 years of experience at Johnson & Johnson and Bristol-Myers Squibb. Dr. Siggins’ expertise in regulatory affairs and commercialisation across the Asia-Pacific region is expected to guide the company’s pipeline advancement and partnership strategies.

In a move to simplify its capital structure and reduce fixed costs, Algorae discontinued its OTCQB American Depositary Share (ADS) program during the quarter. This strategic streamlining aligns with the company’s focus on maximising shareholder value and directing resources toward core growth initiatives.

Financial Position and Outlook

Financially, Algorae closed the quarter with a solid cash balance of $2.4 million, supporting ongoing R&D activities and operational expenses. The company reported operating cash outflows of approximately $360,000, primarily driven by research and development expenditures. Algorae is also positioned to benefit from the Australian Research and Development Tax Incentive, with an application submitted in January 2025.

Looking ahead, the company plans to initiate in vivo studies for Al-168, continue evaluating AlgoraeOS-derived drug targets, and advance clinical trial preparations for Al-116. With a strengthened leadership team, enhanced AI capabilities, and a focused strategic direction, Algorae is well placed to drive innovation and growth in the competitive pharmaceutical landscape.