Post by prokofiev on Oct 14, 2016 22:35:02 GMT
I have been following this little Canadian company (HSDT is the US ticker) for over two years now, initiated a position early this year and added on to my position on two occasions (full disclosure). Helius Medical is probably the most interesting story I have come across in the last few years and has the potential to become a very large company (C$124M market cap) if it is not acquired before, which is the most likely outcome.
Helius Medical is not an easy story to understand, although investors that are familiar with biotech stocks should have an easier time. It personally took me a while to fully understand the story, and meeting with management on numerous occasions has been really helpful.
The company is developing and commercializing an oral device called the PoNS device delivering nerve impulses to the patient's brain through the tongue and is focused on treatment of neurological symptoms of disease or trauma. The indications HSM is currently pursuing are multiple sclerosis, traumatic brain injury and cerebral palsy, but others such as Parkinson’s and Alzheimer’s disease will likely follow shortly after.
Results from various studies (different indications) have been very encouraging so far, and have reached statistical significance in a small pool of patients (cerebral palsy & multiple sclerosis).
Helius is currently in its Phase 3 trial for the treatment of traumatic brain injury and expects to have the results published sometime in 1Q17. If successful, I expect the stock to trade north of C$4.00 (C$1.47 last close) and much higher if PoNS is approved by the FDA in 2Q-3Q17.
To get up to speed on the story I suggest you go through the following documents/videos in order:
CBC Documentary preview: Electrical stimulation a new treatment for multiple sclerosis
The documentary will air October 27 at 8pm on CBC.
Introduction Video: Helius Medical Presentation at Small Cap Stars
Latest investor presentation: Investor Presentation
There are handful of catalysts that I expect to lift the stock prior to the release of the results of the Phase 3 TBI trial. Below is a comprehensive list of the catalysts as I see them:
I am happy to answer any additional questions you might have.
Best,
Prokofiev
Helius Medical is not an easy story to understand, although investors that are familiar with biotech stocks should have an easier time. It personally took me a while to fully understand the story, and meeting with management on numerous occasions has been really helpful.
The company is developing and commercializing an oral device called the PoNS device delivering nerve impulses to the patient's brain through the tongue and is focused on treatment of neurological symptoms of disease or trauma. The indications HSM is currently pursuing are multiple sclerosis, traumatic brain injury and cerebral palsy, but others such as Parkinson’s and Alzheimer’s disease will likely follow shortly after.
Results from various studies (different indications) have been very encouraging so far, and have reached statistical significance in a small pool of patients (cerebral palsy & multiple sclerosis).
Helius is currently in its Phase 3 trial for the treatment of traumatic brain injury and expects to have the results published sometime in 1Q17. If successful, I expect the stock to trade north of C$4.00 (C$1.47 last close) and much higher if PoNS is approved by the FDA in 2Q-3Q17.
To get up to speed on the story I suggest you go through the following documents/videos in order:
CBC Documentary preview: Electrical stimulation a new treatment for multiple sclerosis
The documentary will air October 27 at 8pm on CBC.
Introduction Video: Helius Medical Presentation at Small Cap Stars
Latest investor presentation: Investor Presentation
There are handful of catalysts that I expect to lift the stock prior to the release of the results of the Phase 3 TBI trial. Below is a comprehensive list of the catalysts as I see them:
- CBC Documentary on PoNS device (October 27, 2016)
- Publication of the Cerebral Palsy results in a scientific magazine (December 2016)
- Press release of long-term TBI study interim results (4Q16)
- Possibility of a placebo study – might not get published if results are positive (4Q16)
- Possibility of an MRI study to confirm link between PoNS device and brain stimulation (4Q16 or 1Q17)
- Two interim analysis that are planned for the TBI pivotal study (4Q16 & 1Q17)
- Parkinson’s feasibility study results (4Q16 or 1Q17)
- Press release of Phase 3 Traumatic Brain Injury Pivotal Trial results (1Q17)
- Potential FDA approval (2Q17 or 3Q17)
I am happy to answer any additional questions you might have.
Best,
Prokofiev