Dear Sir, Dear Madam,

GeNeuro was founded in 2006 with the scientific vision that autoimmune diseases could be better understood, and thus also controlled, through pathogenic proteins encoded by viral sequences present within human DNA (or “HERVs”). The results we have obtained in recent months lend weight to this new approach and have opened up the possibility of new types of treatment—in other autoimmune and neurodegenerative diseases as well as in multiple sclerosis.

For the first time, a therapy has successfully demonstrated a major impact in a large-scale clinical trial (270 patients) on three key neuroprotection markers known to be linked to disease progression, without affecting the patients’ immune system. The results were achieved by neutralizing solely a pathogenic protein produced by patients called pHERV-W Env, demonstrating its causal role in neurodegeneration—the key unmet medical need in multiple sclerosis.

We are currently looking at how best to leverage this success for temelimab’s clinical development. Multiple possibilities are open to us in the various forms of multiple sclerosis, both as a monotherapy for patients with progressive forms of the disease, and in combination with existing drugs for its remitting forms.

These results open up the way for other applications of GeNeuro’s approach to pathogenic HERV proteins. We are also currently evaluating our technology in the treatment of type 1 diabetes and amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease.

In type 1 diabetes, the pHERV-W Env protein was found in the pancreas of over half the patients with the disease, and we are currently conducting a Phase IIa trial for which 60 adult patients were enrolled. 6-month results obtained in the fall 2018 confirmed the safety of this approach, the primary endpoint of the study in this new patient population, as well as pharmacodynamic markers such as a reduction in the number of hypoglycemic episodes. Full one-year results are expected in 2Q2019, as a stepping stone to entering the juvenile T1D population, where there are currently no disease modifying therapies and a very high unmet medical need. 

In ALS, we entered into a Cooperative Research and Development Agreement in 2017 with the US National Institutes of Health, and preclinical results obtained in 2018 motivated GeNeuro to acquire all IP related to the project from the NIH, and launch a formal preclinical plan with the objective of obtaining an IND by mid 2020.

2019 is shaping up to be another important year, and we are working tirelessly to continue our work in multiple sclerosis and related applications so that we can realize the full potential of our technology and offer new therapeutic options to millions of patients around the world.

Yours sincerely,

Jesús Martin-Garcia
Chairman and CEO