Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 96

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 96
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. Revelation’s pipeline is summarized in the figure below: The Gemini Platform Our current therapeutic candidates are all based on our proprietary Gemini formulation of PHAD ®, a synthetic version of monophosphoryl lipid A (“MPLA”), that is known to stimulate TLR4. Stimulation of TLR4 via Gemini leads to a more controlled production of varied cytokines and chemokines which modulate the activity of the innate and adaptive immune response, relative to a lipopolysaccharide, a traditional TLR4 agonist. This “Immunostimulatory Preconditioning” with Gemini prepares the body to better guard against a rapid upregulation of multiple pro-inflammatory and microbial gene products and proteins, such as pathogen-associated molecular patterns (“PAMPS”) and damage-associated molecular patterns (“DAMPS”) (damage-associated molecular proteins) (Zwirner 2017, Hernandez 2019, Ismaeli 2002). Modulated activities may include stimulation and recruitment of infection fighting immune cells, reduction of inflammation, and/or regulation of inflammation depending on the degree and nature of the stimulation, which enables the multiple potential product candidates in development. Figure 1: Interaction of PHAD with TLR4 56 Gemini-AKI The Gemini-AKI program is being developed as a potential therapy for the prevention of AKI due to external stress or insult (e.g. surgical procedure, chemotherapy toxicity). We believe immunologic preconditioning with Gemini prepares the body to handle biologic stress by redirecting the body’s immune system to have an attenuated response to the stress. Preclinical studies have demonstrated that preconditioning with PHAD significantly reduces the severity and duration of AKI following an ischemia of the kidney. Additional data from these preclinical studies have been accepted for presentation at The International Conference on Advances in Critical Care Nephrology on March 12, 2024. During 2024 we conducted a Phase 1 clinical study. safety and biomarker activity data from our Phase 1 clinical study was announced in June of 2024, showing a significant increase in anti-inflammatory cytokines including IL-1RA and IL-10. In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients. The Phase 1b clinical study will support further development of Gemini-AKI. We expect data from our Phase 1b clinic study in the first half of this year. Gemini-CKD The Gemini-CKD program is being developed as a potential