Founded by current management in 2014, Newtown, Pennsylvania-based Helius’s corporate focus is bringing to market innovative, non-invasive treatments that promote healing of various brain-related maladies. These treatments are based on research carried out at the Tactile Communication and Neurohabilitation Laboratory (TCNL) at the University of Wisconsin related to electrochemical stimulation of the human brain to encourage the brain’s own ability to create or rehabilitate damaged neural pathways and sensory capabilities.
The company’s flagship product is its Portable Neuromodulation Stimulation (PoNS™) non-invasive medical treatment technology, which an increasing number of studies are showing can produce significant improvement for patients suffering from brain-related maladies as diverse as the difficulty sufferers of mild-to-moderate brain trauma have walking and the balance disorders associated with multiple sclerosis. The PoNS™ device, in combination with the company’s proprietary Cranial Nerve – Non-Invasive Neuromodulation (CNNIN) physical therapy protocol, promotes the human brain’s own ability to heal itself (commonly referred to as “neurostimulation”) after suffering from traumatic, degenerative, chemical and other dysfunctions.
Four major universities in the US and Canada are each currently involved in two separate feasibility studies and two separate Phase III clinical trials of the company’s technology with reportable results expected to be made available to Health Canada and the US Food and Drug Administration (FDA) during 2015 or 2016. A fifth multi-site, double-blind, randomized study of PoNS™ and CNNIN has received approval from the FDA and will begin shortly.
US Armed Forces – Brain trauma is a common element of armed conflict. The US Army’s Medical Research and Materiel Command is actively partnering with Helius (including providing development funding) in developing Helius’s technology for future use in treating armed forces troops and veterans for illnesses as diverse as tinnitus, post-traumatic stress disorder and general pain relief. In return for not-yet-specified financial support for the continued development of PoNS™, the US government will have certain rights to use any related FDA-approved technology under a non-exclusive license.
TCNL – By providing Helius with access to high quality insights and knowledge gained via brain-related research carried out since the 1970s, TCNL’s partnership gives the company information that is indispensable in maximizing efficient use of corporate assets and management efforts at new product development.
Ximedica – ISO 13485 certified, FDA-approved and experienced in manufacturing medical devices for US and global customers, Providence, Rhode Island-based Ximedica is primarily responsible for designing, manufacturing and distributing Helius’s PoNS™ device.
The potential near-term market for Helius’s technology is substantial. For example, since 2000 members of the US armed forces have sustained nearly 300,000 traumatic brain injuries. And in the US alone approximately 250,000 – 350,000 people suffer from multiple sclerosis. These two initial applications, which company management estimates could generate combined revenues of approximately US$5.5 billion, are a subset of the total potential applications the company’s neurostimulation expertise could be applied to. Beyond these specific applications, management expects additional applications will be investigated in due course, including muscular dystrophy, spina bifida, Parkinson’s and Alzheimer’s.
Helius currently has three full-time employees and 15 full-time equivalent outside consultants.
For the nine months ending December 31, 2014 the company reported a net loss of US$9.2 million. As of the same date, the company had cumulative losses of US$18.7 million, reflecting losses incurred before the company’s reverse merger with a firm that had incurred previous losses. As of 12/31/14 the company’s cash balance was US$2.9 million.
April 30, 2015 – Company raised C$2.2 million/US$1.8 million selling 849,273 units (1 common share, ½ warrant to purchase additional common share for C$3.62/US$3.00 for three years).
April 14, 2015 – US Patent and Trademark Office issued Helius its third patent related to the PoNS™ device.
April 13, 2015 – Company received FDA approval to carry out new study of PoNS™/CN-NINM training in three sites (two in the US, one in Canada).
February 19, 2015 – Company began subject enrollments for multiple sclerosis study at Montreal Neurological Institute and Hospital.
February 10, 2015 – Company’s common shares began trading on the US OTCQB trading platform. (Note: The company has made application for listing on the NASDAQ Capital Market.)
As with any small, innovative medical device company with products not yet cleared by regulators for public sale, Helius’s current shareholders face a variety of risks, including:
Commercial sales of products not yet allowed - To date, the clinical trials of the PoNS™ technology’s efficacy in providing safe treatment have not been sufficient to support clearance by the FDA for the device’s general use or commercial distribution. As a result, Helius has no operating revenues or profits.
Additional funds will be required to commercial the company’s products – To date, the company has been able to execute various private placements of common shares and warrants to fund its operating losses, but it is not possible at this time to forecast when the company will generate operating cash flow and reduce or eliminate the need for such funding.
Additional funding may create dilution for existing shareholders – As of May 1, 2015, the company had 63.9 million shares outstanding, To date, Helius’s private placements of common shares have included warrants. To the extent such placements provide shares to investors in these private placements at prices below the public price of such shares or warrants, existing shareholders face some level of dilution of their interest in the company. (As of May 1, 2015 the company had 4.9 million stock options and 8.9 million warrants outstanding.)
“Going concern” qualification by company auditors – Helius’s need for additional future funding in order to achieve its goal of commercializing one or more of its products is substantial. Without the cash on hand to continue to fund all the activities required for such commercialization, the company’s auditors have issued an opinion that “there is substantial doubt that (the company) can continue as an on-going business for the next twelve months unless (it) can obtain additional capital to pay (its) expenditures.
Complex corporate structure – Helius’s corporate structure includes multiple entities, including various persons identified as “inventors” and “background patent owners” by the company. Certain such entities are entitled to royalties based on Helius’s future revenues.
Concentrated share ownership – Two shareholders – MPG Healthcare and ANR – whose own shareholders include Helius management, own 50.1 percent of Helius’s common shares outstanding. With this majority ownership, these two entities control the company’s management and shareholder-related actions and decision making. Under the company’s shareholder rules, these two entities can effectively control the company as long as their aggregate ownership interest in the company is greater than 33.33 percent.
Although Helius has not yet completed the necessary testing and clinical trials required before its PoNS™ device could be approved by US and/or Canadian regulators for commercial applications, the results provided by testing and trials of the technology at the University of Wisconsin-Madison and other sites since 2007 have been positive and encouraging. With further clinical trials to be carried out by various independent parties and clear ongoing interest from the US military in PoNS™ (since 2013), successful future clinical trials will likely generate substantial excitement among clinicians and medical professionals and broader investor interest in the company.
Treatments currently available to sufferers of brain-related trauma and multiple sclerosis are expensive and invasive (creating additional physical trauma for patients). As a non-invasive treatment, PoNS™ is potentially substantially less expensive than these existing treatments, as well as being much less traumatic for patients—two very significant advantages in today’s medical environment.
Expansion of active trading in the company’s common shares in the US market via the OTCQB platform gives Helius additional credibility among US investors, while also allowing any US investor to easily trade the company’s shares. The resulting additional trading liquidity will be a positive for such a young company whose share price will typically experience wide swings in trading price and volume due to limited trading liquidity and the involvement of one or more market makers. Knowing that its OTCQB qualification includes a requirement for the company to adhere to US securities regulations and standards also gives Helius additional credibility among knowledgeable investors in the US and abroad.