Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 105

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 105
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 the safety and tolerability of GIGA-2339, the company’s first recombinant polyclonal antibody candidate for treating hepatitis B virus (HBV) infection, following its FDA clearance as an investigational new drug (IND). GIGA-2339 includes more than 1,000 recombinant human antibodies targeting HBV to mimic the body’s natural immune response, with the potential to eliminate the virus and activate the immune system. There is presently no cure for HBV, which affects more than 296 million people globally and causes over 800,000 deaths every year. Additionally, in May 2024, GigaGen announced first patient dosing in a Phase 1 clinical trial evaluating the safety and tolerability of its anti-CTLA-4 monoclonal antibody, GIGA-564, for the treatment of metastatic or locally advanced solid tumors in collaboration with the U.S. National Cancer Institute.
In 2024, we initiated a strategic partnership with the Biomedical Advanced Research and Development Authority (“BARDA”), part of the U.S. Department of Health and Human Services, to evaluate the nonclinical efficacy of ocular surface immunoglobulin (“OSIG”) eye drops for the treatment of sulfur mustard-induced ocular injury. This proof-of-concept study aims to assess the anti-inflammatory and immunomodulatory potential of OSIG in neutralizing the long-term effects of exposure to sulfur mustard — a chemical warfare agent known to cause debilitating corneal damage. The investigational OSIG therapeutic is being repurposed from an ongoing development program targeting dry eye disease (“DED”), for which a Phase 2 clinical trial is planned to begin in 2025. This initiative represents a significant step in expanding the applications of our IG platform into ophthalmology and biodefense.
During 2024, we discontinued the Grifols Pyrenees Research Center, SL, which we held under a joint venture with the Government of Andorra, as well as the AlbaJuna Therapeutics S.L initiative and the Trimodulin study 1,001 due to the termination of the applicable agreements and following a strategic realignment of R&D resources toward higher-priority programs. The discontinuation did not, and is not expected to, have a material impact on our financial position or long-term growth strategy.
Seasonality
Our businesses are not significantly affected by seasonal trends.
Raw Materials
Plasma is the key raw material we use to make our products and therapies. We obtain our plasma primarily from our