Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 159

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 159
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 several companies
that are targeting the same rare diseases as us. Below is a description of a selection of those companies that we see as our closest competitors.
However, it is possible that another company, that is not listed below, can potentially have a successful product approved before us and
have a more effective treatment.

In the MPS-1 space, several
companies offer competitive products to Jupiter. Sanofi Genzyme’s Aldurazyme has been the standard enzyme replacement therapy for
nearly 20 years. RegenexBio is developing RGX-111, a gene therapy designed to deliver a functional copy of the IDUA gene to the central
nervous system. Sigilon Therapeutics, Inc. is working on SIG-005, which uses a genetically modified human cell line to express the IDUA
enzyme, with an IND application for Phase I submitted to the FDA. Additionally, Sangamo Therapeutics, Inc. is exploring gene editing products,
although no positive results have been published yet. These developments represent significant competition in the treatment of MPS-1.

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In the treatment of Friedreich’s
ataxia, several products compete with Jupiter’s offerings. Reata Pharmaceuticals’ Omaveloxolone, branded as SKYCLARYS, received
approval in 2023 following successful Phase II and pivotal trials. Despite its effectiveness, Jupiter anticipates conducting future studies
in Europe and Australia due to market competition in the USA, especially after Biogen’s acquisition of Reata. Minoryx Therapeutics
has completed a Phase II trial for MIN-102, a selective PPAR gamma agonist, showing promise in this space. Additionally, Larimar Therapeutics
is developing CTI-1601, a recombinant fusion protein intended to deliver human frataxin to mitochondria, currently in Phase I trials.
These advancements highlight the competitive landscape in Friedreich’s ataxia treatment.

In the treatment of MELAS,
several products present competition to Jupiter’s offerings. Cyclerion Therapeutics is advancing CY643, currently in Phase 1B, which
evaluates safety and its impact on mitochondrial dysfunction and cognition. Abliva AB is developing KL1333, which has been granted orphan
drug designation in both the United States and Europe. This product has been tested in healthy volunteers and patients, with a registrational
Phase 2/3 study initiated in December 2022. These developments underscore the competitive landscape in the search for effective MELAS
treatments