Apr. 27, 2020 – ViralClear Pharmaceuticals CEO Nick Spring discusses how the company is working closely with the Mayo Clinic to plan clinical trials for Vicromax, a drug given orally.
All of our reports starting from February, 2020 to present on Biosig can be found below
Good day everyone,
Breaking news out this morning from ViralClear / BioSig (NASDAQ: BSGM)
Mayo Clinic preparing to Commence Phase II FDA clinical trial for the treatment of COVID-19 with Vicromax
The Traders News Group
Original BioSig reports below
There is much more to this story than meets the eye
Read this newsletter in its entirety
ViralClear Spinoff and the Team Behind the Scenes
Good day everyone,
We are continuing our coverage of BioSig Technologies, Inc. (NASDAQ: BSGM), a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace.
Price $5.17 per share
BSGM has created a new subsidiary, ViralClear to develop the drug candidate Vicromax and its development and proposed path through the FDA.
Vicromax, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The pharmaceutical is currently undergoing extensive pre-clinical testing. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020.
Vicromax was owned by Trek Pharmaceuticals and BSGM purchased the assets from Trek. BSGM has seeded ViralClear with a seasoned drug development team.
Vicromax was being developed for treatment of Hepatitis C by Trek and went through phase 1 and phase 2 trials for that indication. Due to the urgency of finding a treatment for Covid 19 the company decided to try a lab test against the coronavirus.
It was tested and showed great promise with market reduction and viral production in cell culture. ViralClear hopes to be able to bring it to market quickly, as it had already been through Phase I and Phase II trials.
The company expect to file the IND round in the next few weeks. This means that they could be in human trials in May.
Biosig has a relationship with the Mayo Clinic through its PURE EP product program. This link to a Viromax conference call transcript mentions the Mayo clinic in a reference to Vicromax.
The strategy is to fund ViralClear through direct investment into the subsidiary, ViralClear, and not through sales of BioSig stock, and then spin ViralClear out onto the public market on the NASDAQ pending approval as its own entity with BioSig’s shareholders getting an ownership in this newly formed public company.
This additional asset that BioSig has acquired and the team they have assembled is developing rapidly.
Look at Dr. Badley’s credentials – he is a top Doc at the Mayo Clinic in this area, immunovirology for 25 years and now the Enterprise Chair of the COVID Task Force.
And then Jerry Zeldis’s – Celgene was one of the most successful biotechs ever (it was bought for $74 billion by Bristol Meyers) – Jerry was the Chief Medical Officer there. Look at what these guys are saying and doing as they drop other projects to take this one because they see the promise it represents.
Highlights from the Recent Conference Call
Dr. Andrew Badley
Good morning everyone, and thank you, Ken and team for inviting me. By way of background, I’m a Physician Scientist at Mayo Clinic. I’m the Professor and Chair of the Department of Molecular Medicine. I am a Professor and Associate Chair of the Department of Medicine, where I see patients in the Infectious Disease Division. I run an immunovirology lab for the past 25 years and continually NIH funded during that period of time.
Relating to the current COVID outbreak, I am the Enterprise Chair of the COVID task force. We are tasked with overseeing all domains of research associated with COVID from clinical trials to translational studies to epidemiology and everything else. In that capacity, I’ve reviewed over 50 therapeutic protocols and I am tasked with prioritizing those and determining which ones we should enter into the clinic.
By way of further background, Mayo Clinic Enterprise consists of four dominant sites, Mayo Clinic Rochester, Mayo Clinic Arizona, Mayo Clinic Florida, and the Mayo Clinic Health System, which is a series of smaller hospitals throughout the Midwest. It is our goal as we recruit trials to Mayo Clinic to enroll them across all four sites. I’ve been involved in discussions with Ken and Jerry and the team and, quite familiar with MMPD.
It is a valuable therapeutic target. It targets RNA-dependent-RNA polymerase. It’s shown activity against a broad cross section of RNA viruses including hepatitis C. It has satisfactory safety data from about 350 patients treated with hepatitis C. And importantly, it’s shown in vitro activity against the SARS-CoV-2, coronavirus 2 at doses which are achievable in humans, specifically around 3.3 micromolar.
In my capacity overseeing the task force at Mayo Clinic, we review patient every day to determine which studies are open and available and which studies pace individual patients could be eligible for, and I think that there’s an opportunity for the development of an oral antiviral, which is not yet met. And so, I think that the MMPD compounds, when tested in clinical trials, if successful could fill an important niche, and I’ll end my comments there.
Thank you Dr. Badley. Operator we’ll be ready to take questions. Thank you.
A – Nick Spring
While we’re waiting for questions, that is Nick Spring again here. From the audience, we’ll answer a couple of more common questions that have come up since we announced this news on March 25th. The first that we get common news this drug has been sitting on the shelf since 2004. So what makes it so good now? I’ll turn that question into Jerry.
Dr. Jerry Zeldis
Thank you, Nick. MMPD’s pharmacological action is ideally suited to stop the propagation of rapidly expanding viral infections. The drug has been shown to be very active for a number of viruses than the acute phase of the infection are manifested by rapid spread of the disease in the body including viruses that caused Ebola, Zika and Lassa Fever. MMPD’s pharmacology is not suited for chronic viral infections. Although some activity was observed for chronic hepatitis C, the real sweet spot for this agent is retrieving an infection caused by the novel coronavirus.
Fox News Coverage
Connecticut company BioSig acquires rights to potential coronavirus cure
We will keep you apprised of developments and catalysts as they occur.
The Traders News Group
View our first two reports from this year below
New Report, Vicromax a Viable Covid -19 Therapy
Potential for a special dividend / spin-off
Tuesday’s tele-breifing mention a Viralclear subsidiary spin-off. The spin-off and the details of that spin-off are yet to be announced. These type of announcements are usually well received by investors as current shareholders of BioSig will likely receive shares in the new company as a type of dividend.
News out Today
Positive Data Generated by Biosig (NASDAQ: BSGM) Subsidiary ViralClear on Covid-19 Coronavirus Published in bioRxiv
“Vicromax shown to decrease viral production of Covid -19 coronavirus by over 98% Article highlights recent work done in laboratory studies of Covid -19 with Vicromax(tm) at the Galveston National Laboratory at The University”
Recent Telebriefing features a lead Dr. from the Mayo Clinic. More information on the Mayo Clinic and Covid-19 https://www.mayoclinic.org/coronavirus-covid-19
Today’s news release from Biosig April 9th, 2020
Tuesday’s tele-briefing – replay will be available for two weeks starting on April 7, 2020 at approximately 2:00 P.M. ET. To access the replay, please dial 1- 877-660-6853 in the U.S. and 1- 201-612-7415 for international callers. The conference ID# is 13701652.
The Traders News Group
Original report below, issued February 19th, 2020
Undervalued Shares in the Bioelectronic Sector
Potential treatment for a multitude of diseases
Good day everyone,
We are initiating coverage on BioSig Technologies, Inc. (NASDAQ: BSGM), a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace.
Current price $4.19 per share
Float (est.) 15.9 million shares
52-week range $4.02 to $9.97 per share
BSGM shares are trading near their 52-week low and we want to examine if that low price is warranted or if the shares are oversold.
Bioelectronic medicine is a field that could deliver treatment breakthroughs for many diseases including neurology, auto-immune diseases, diabetes, arthritis, hypertension, pain management, cancer, and others.
BSGM is targeting the $4.6 billion electrophysiology (EP) market with their bioelectonic technology. The electrophysiology sector is growing at more than 10% annually.
BSGM’s first product, PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EPTM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
These devices are roughly the size of a household dehumidifer that plug into the machines used by cardiac physicians during procedures to correct irregular heartbeats. The BioSig Pure EP system filters out “noise” in the readings on electrical activity in the heart that physicians are monitoring, giving them the best odds of completing the procedure to restore normal heart rhythms.
BSGM received FDA 510(k) clearance for the PURE EP System in August 2018.
BioSig’s clinical trial titled “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” has installed units at Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin, Texas and the Mayo Clinic in Florida. The company expects to increase that number to 9 installations in H1 this year.
The company has been awarded 5 patents and eleven additional worldwide utility patent applications are pending covering various aspects of its PURE EPTM System.
In December, BioSig announced a partnership with Reified Capital, a provider of advanced artificial intelligence-focused technical advisory services to the private sector. Integration of AI can open new avenues for improved diagnosis and more effective therapy delivery for bioelectronic medicine and healthcare in general.
BSGM has a subsidiary named NeuroClear Technologies, formed in 2018, to pursue additional applications of BioSig’s PURE EP signal processing technology outside of the field of electrophysiology. NeuroClear has received independent funding.
Video interview with CEO Ken Londoner. It’s a must see as part of your due diligence.
Now, why are BSGM shares seemingly oversold?
BioSig is at the leading edge of electrophysiology and bioelectric medicine (a pacemaker is a rudimentary example). Their initial product, PURE EP for application in cardiac arrhythmia treatment could be the tip of the iceberg in their product development.
The company balance sheet (as at 9-30-19) shows zero debt and there are only 15.9 million shares in the public float. The company has been conservative in financing operations, given the scope of its technology’s potential.
The current market cap is under $100 million. A cursory scan of development stage biotech companies will yield dozens of examples with market caps exceeding $200 million.
Insiders hold 28% of the outstanding shares and institutions hold 16%. In the past six months insiders have purchased shares in 20 different transactions, there have been no insider sales. There are several institutions holding and buying shares in BSGM, and The Mayo Clinic is one of them.
Bioelectronic medicine is growing quickly and attracting interest and investment from major players in technology and healthcare, such as Verily Life Sciences, Medtronic, and Johnson & Johnson.
As the chart below indicates, BSGM shares are trading below their 50 DMA and 200 DMA of $5.59 and $7.04 respectively. The current RSI (14) is only 29.59. These data can indicate shares that are oversold considering the absence of adverse events.
Further, BSGM shares are trading at 57.97% below their 52-week high, again absent any adverse events.
Updated report coming soon.
The Traders News Group