Aurinia Pharmaceuticals

2024 was a challenging year for the biopharma industry, with companies like Bayer, Bristol Myers Squibb, and Johnson & Johnson cutting hundreds to thousands of jobs. Cassava Sciences announced layoffs of 10 employees, 33% of its workforce, following a failed Phase III trial for its Alzheimer's drug. CytomX Therapeutics cut 40% of its staff to focus on clinical programs. Velia, a San Diego biotech, is shutting down, affecting 47 employees. Regeneron's acquisition of Oxular led to layoffs, with no Oxular employees joining Regeneron. Javara, Ring Therapeutics, Outlook Therapeutics, Editas, Bavarian Nordic, BenevolentAI, Chroma Medicine and Nvelop Therapeutics, Cellectar Biosciences, Carisma Therapeutics, Belharra Therapeutics, National Resilience, AmplifyBio, Agenus, Alligator Bioscience, Idorsia Pharmaceuticals, Kronos Bio, Novartis, Recursion Therapeutics, Medigene, Alector, Bristol Myers Squibb, Sonata Therapeutics, 23andMe, Johnson & Johnson, Merck, Gilead Sciences, Adaptimmune, Sensei Biotherapeutics, Marinus Pharmaceuticals, Orna Therapeutics, Thermo Fisher Scientific, Charles River Laboratories, Aurinia Pharmaceuticals, Viracta Therapeutics, Astellas Gene Therapies, Sana Biotechnology, Sage Therapeutics, Compass Pathways, Spero Therapeutics, ICON, Pfizer, Takeda, SalioGen Therapeutics, Evonik, Medtronic, CareFusion Resources, Turnstone Biologics, Leo Pharma, Astellas Pharma, Prime Medicine, Kaléo, Stryker, Relay Therapeutics, ImmunityBio, Shattuck Labs, Inventprise, bluebird bio, Athira Pharma, AGC Biologics, Oncternal Therapeutics, Biosense Webster, Vesigen Therapeutics, Connect Biopharma, BioMarin, IN8bio, Edwards Lifesciences, DermTech, Repare Therapeutics, Genentech, Tome Biosciences, Aadi Bioscience, Lykos Therapeutics, Evotec, Galera Therapeutics, Grail, Ovid Therapeutics, Lexicon Pharmaceuticals, Acelyrin, Boundless Bio, FibroGen, Ajinomoto Bio-Pharma Services, AN2 Therapeutics, Entero Therapeutics, Precigen, Sumitomo Pharma America, uniQure, Vir Biotechnology, Arbutus Biopharma, HilleVax, and Bayer also announced significant layoffs, reflecting a tough year for the industry.

Noema Pharma appoints Volker Knappertz, M.D., as EVP of R&D, leveraging his 25+ years in drug development, including key roles at Aurinia Pharmaceuticals and GW Pharmaceuticals. Knappertz aims to advance Noema's Phase 2 clinical trials targeting CNS disorders, with results expected in 2025.

Aurinia Pharmaceuticals plans to cut 45% of its workforce, saving over $40m annually, to focus on Lupkynis and AUR200 development. Lupkynis sales drove a 24% revenue increase to $67.8m in Q3 2024. AUR200, an immune modulator, is in a Phase I study with data expected in H1 2025. The restructuring aims to address investor dissatisfaction and strengthen financial position.

Lupkynis (voclosporin) approved in Japan for lupus nephritis, used with mycophenolate mofetil. Otsuka Pharmaceutical filed for approval in Nov 2023. Aurinia eligible for $10M payment and royalties. Lupkynis also approved in U.K., EU, Switzerland, and U.S. Based on AURORA Clinical Program, Lupkynis better than placebo at stabilizing kidney function.

Aurinia Pharmaceuticals has initiated a Phase Ia single ascending dose clinical trial of AUR200, targeting autoimmune diseases. The trial aims to assess safety, tolerability, pharmacokinetics, and biomarker changes in healthy volunteers, with results expected in H1 next year. AUR200, an IgG4 Fc-fusion protein, inhibits B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), crucial for B-cell regulation. The company plans to develop AUR200 for disease states with limited market options, funded by available cash flow.