Under an agreement with Accelerated growth Venture Group (AGVG) a company controlled by Ramy El-Batrawi is assisting NeurMedix to go public through a Regulation A+ offering. Mr. El-Batrawi also holds a 10% stake in the company. The company is going out at a $500M pre-money market cap.
NeurMedix, Inc. is a clinical-stage biopharmaceutical company that engages in developing products for the treatment of neurological and neuro-degenerative disorders. The company’s product candidates have successfully completed 17 pre-clinical, Phase I, Phase I/II, and Phase II clinical studies, and is entering clinical trials for the treatment of patients with severe Parkinson’s disease, migraine, post operative cognitive dysfunction (POCD), and inclusion-body myositis (IBM). Further studies are contemplated for ALS, Huntington’ Diseases, Alzheimer’s disease, and Encephalitis. Nearly $100 million has been invested on developing NE3107. The company’s focus is on diseases with tremendous unmet medical needs in order to expedite FDA approvals and commercialization, minimize capital requirement and optimize shareholder value.
Scientific literature states that neuro-inflammation causes neuro-degeneration. The scientific literature also indicates that ERK 1/2’s (Extra-cellular signaling Regulated Kinase) and NF-kB’s hyper-activation causes the inflammation. NeurMedix’s NE3107 binds to ERK 1/2 and inhibits these hyper-activation mechanisms. The drug uniquely inhibits ERK 1/2’s hyper-activated signaling throughout the body while allowing it to maintain its homeostatic function. The Company currently owns the entire space and mechanism of action (MOA). Moreover, the Company has retained all worldwide rights, thereby enhancing shareholder value. The Company’s intellectual property is protected up to 2034, and will be lengthened by extensions and successor molecules in development.
NE3107 is an orally administered pill that penetrates the blood-brain barrier, stays in the brain long enough to register its desired effect, and has not demonstrated toxicity in animal studies at up to 40 times the human dose. There appears no significant side-effect profile. These qualities are unique in neuro-active compounds where toxicity and side-effects can be quite significant. The ease of administration and safety of daily use qualifies it as an ideal medication for neuro-degenerative and neurological disorders. It appears that unlike most compounds in development for neurological and neuro-degenerative diseases, NE3107 appears to be disease modifying. Most others are limited to targeting the symptoms and side-effects. Neuro-degenerative and neurologic diseases are the result of neuro-inflammation. The Company halts the neuro-inflammation, and thereby results in disease non-progression.
NeurMedix is targeting 4 distinct diseases. Two of which, POCD and IBM, may receive the FDA’s “Breakthrough” designation. This designation is applicable when there aren’t any drugs approved to treat the disease and represents a significant unmet medical need. It is possible that with one study’s efficacy could lead to commercial approval with follow-up studies post approval. The third, LID has received Orphan drug status. ERK’s hyper activation is necessary for LID; hence NE3107 efficacy in LID in the primate study.
NeurMedix is doing a Phase II prophylactic migraine study. ERK’s hyper activation is implicated in the scientific literature to cause migraine. If efficacious, it will be the first oral, safe, non-toxic, prophylactic migraine medication. Teva recently paid $825 million for Phase 1b data drug.
Another Comparable worth noting in the neurological space is Sarepta Therapeutics:
What is particularly interesting is that the Sarepta drug actually didn’t show statistical significance in a 20 patient study, however the FDA still approved the drug despite the FDA’s Advisory Board recommending that the FDA reject their application. Sarepta’s market-value has traded at approximately a $3.0 billion market cap since approval. Just on speculation of the FDA overriding the Advisory Board because it did help a few of the 20 patients, it traded at an $850 million market cap. This points out the value of having a “breakthrough” designation and the value of having a treatment when no alternative is available for patients.
Sarepta’s drug targets one neurological disease, Duchenne Muscular Dystrophy (DMD). Like NeurMedix’s targeted IBM disease, DMD is a neuro-muscular disease. NeurMedix’s NE3107 is targeting initially four neurological diseases, with further disease indications thereafter.
“This is a very exiting company to be part of with the potential of really coming out with a drug that can help cure some major diseases” says Mr. El-Batrawi Ramy El Batrawi.