Good day everyone,
We are re-initiating our coverage of BioSig Technologies, Inc. (NASDAQ: BSGM)
Current price $10.21 per share
Outstanding shares (est.) 26.16M
Shares in float (est.) 19.82M
Insider ownership 24.57%
Institutional ownership 14.02%
We once again reported on BSGM in mid-February when it was at $4.19/share. In the ensuing months, BSGM shares offered the potential for gains multiple times. However, there are now some additional and substantial, potential near-term catalysts.
The last time we talked about BioSig was in April when the shares were at $4.92 and we led with this exciting news: BioSig subsidiary ViralClear acquires license for a broad-spectrum anti-viral agent that may treat COVID-19. That news has been expanded quickly into clinical trial’s by a major player in the search for a Covid 19 treatment.
On May 18, 2020, ViralClear announced the FDA’s clearance of its IND to proceed with a proposed Phase II study of merimepodib in COVID-19 patients. On June 5th, the company stated the phase II trial would begin in a few weeks. The human clinical trial is planned to be conducted under the leadership of Dr. Andrew D. Badley, Professor and Chair of the Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force at the Mayo Clinic. The study will be a randomized, placebo-controlled trial. BSGM expects to announce the data from the planned Phase II trial within three months of its commencement.
BSGM has two potential verticals, a treatment for Covid 19 currently in development and their PURE EP system to enhance the success of cardio catheter ablation procedures.
The race for an effective treatment(s) for Covid 19 is a high stakes endeavor with the potential for substantial rewards. Their PURE EP system could end up in every cardiac operating room.
BioSig’s subsidiary, ViralClear Pharmaceuticals, Inc., is working towards developing an orally administered, broad-spectrum anti-viral agent, merimepodib, a drug originally developed by Vertex Pharmaceuticals to treat hepatitis C. The safety of the drug was confirmed in hundreds of patients.
On May 14, 2020, an article titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro” was published. The article cites that merimepodib in combination with remdesivir decreases viral production of SARS-CoV-2 to undetectable levels in pre-clinical testing.
The pre-clinical results of decreasing SARS-CoV-2 to undetectable levels is an amazing development. It means that the drug combo has eliminated the virus in the pre-clinical scenario.
The entry into development of a Covid 19 treatment has been a driver for the company shares. BSGM has indicated it could be in a phase III trial by the fall. Only a couple months away.
On June 9th, the company hosted a conference call to discuss the development of merimepodib. As part of your due diligence you may want to read the transcript here: https://d1io3yog0oux5.cloudfront.net/biosigtech/files/pages/biosigtech/db/349/content/ViralClear+Update+Call+06.09.2020.pdf
BioSig will continue to place emphasis on the development of its PURE EP system to enhance the success of cardio catheter ablation procedures. PURE EP is an FDA approved device in the marketing stage. The devices are roughly the size of a household dehumidifier that plug into the machines used by cardiac physicians during procedures to correct irregular heartbeats.
Recent PURE EP milestones:
• Receiving new commercial units of PURE EP, which are being allocated to leading centers of excellence across the country.
• Conducting over 50 patient enrollments into the first clinical trial at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Mayo Clinic Florida Campus.
• Being formally invited to be featured in live cases during EPLive 2020.
• Finalizing protocols for upcoming installations at new medical centers.
BSGM is targeting the $4.6 billion electrophysiology (EP) market with their bioelectonic technology. The electrophysiology sector is growing at more than 10% annually.
Sales of the PURE EP system may likely be the first revenue stream for BSGM. The units could sell for $250,000 with additional revenues from product support. Cardiac operating rooms can cost up to $20 million to equip and with the defined advantages of PURE EP, the cost of the units could be easily justified.
Insider activity is a statistic worth looking at when considering BSGM shares. In the past two years there have been 37 “buy” transactions by insiders and there have been no insider sales. During the week before Memorial Day, Insiders bought 8,600 shares at an average price of $10.14 per share bringing the total insider holdings to 24.7% of the outstanding shares. That recent insider buying spree seems to indicate a lot of confidence in the company.
BSGM shares have had a nice gain since we first discussed them, but we believe there could be another surge in the share price. The company has, in PURE EP, an FDA approved, and widely lauded biomedical device currently being marketed to hospitals. They are initiating clinical trials with a drug combo, to be conducted under the leadership of the Chair of the COVID-19 Task Force at Mayo Clinic.
It is crucially important that the pre-clinical testing indicated merimepodib in combination with remdesivir decreased viral production of SARS-CoV-2 to undetectable levels.
Both the potential advancement of merimepodib in clinical trials and the marketing of PURE EP may generate catalysts that could positively impact the BSGM share price in the near to mid-term.
We will be back with a full report soon.
The Traders News Group
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