In February, when the first coronavirus-infected cruise goers came home to the U.S., the biodefense lab in Galveston pulled from its freezer one of five antiviral drug candidates developed by Celgene spinoff Trek Therapeutics.
Its test on COVID-19 patients yielded a 98.6% response rate.
It was then that Dr. Jerome Zeldis, the founder of Trek and a board member at BioSig Technologies Inc BSGM, urged BioSig CEO Ken Londoner to buy and advance the candidate, Londoner told Benzinga.
“He called to say he believed he had a cure for COVID,” the BioSig CEO said.
“We saw in vitro data from the Galveston biodefense lab and said, ‘wow, this drug is really far along.’”
BioSig — a medtech company specializing in electrophysiology devices — took eight days to analyze the drug before completing the purchase in late March. By mid-April, it had filed to initiate a Phase 2 study.
From Medtech To Biotech
Vicromax is a broad-spectrum oral antiviral that demonstrated safety in humans and activity in Hepatitis B and C, herpes and other diseases in 12 prior clinical trials. The drug was originally developed by Vertex Pharmaceuticals for hepatitis C. “We don’t know how much money went into it, but we think at least $100 million or more,” Londoner said.
Celgene bought it for Trek, but the program stalled. Now, the drug formula — and 67 kilograms of active ingredients — are in the hands of BioSig. “We thought this could be developed very quickly,” Londoner said.
Pharmaceutical development is not exactly in BioSig’s wheelhouse, but Londoner said he hopes to leverage the company’s partner network, financing, infrastructure and employee expertise to get Vicromax on its feet.
BioSig launched ViralClear, a new division of subsidiary NeuralClear, to run the program with the guidance of 30-some consultants.
“We’ve provided a unique apparatus to speed their drug development along,” Londoner said.
In April, ViralClear partnered with Mayo Clinic as the principal investigator for a Phase 2 clinical trial. Londoner expects a 30-patient placebo trial to be underway by mid-May, with results about 30 daysout from the start.
“It may get approved by early fall if we see consistent results,” he said.
ViralClear has also begun provisioning and signing contracts for scaled production.
"We’re lining up a global manufacturing supply in Europe and the U.S. and think we’ll be in a position to make millions of doses so we can start getting this product if it’s approved out into the country."
ViralClear should be completing private financing in the weeks to come, and BioSig intends to spin off the entity as a publicly traded Nasdaq company in late summer, the CEO said.
At that point, BioSig will retain a stake in ViralClear and shareholders will receive a stock dividend.
That’s the plan regardless of Vicromax’s success against the coronavirus, Londoner said.
“The team feels there are other applications for this drug,” Londoner said. “Measles [and] other forms of coronavirus.”
And even if there are no other indications, the CEO’s recent string of 18-hour days haven’t necessarily been wasted.
“We feel like we’ve done our duty as citizens,” he said of contributing to the coronavirus fight.
The Heart Of BioSig's Business
When it’s not trying to tackle the coronavirus, BioSig is busy marketing its PureEP system — an electrophysiology device that assists surgeons with cardiac ablations.
The computer system helps identify electric malfunctions in hearts that are beating irregularly or too quickly.
“We saw an unmet need technically and clinically,” Londoner said of the impetus for BioSig’s founding.
The technology earned FDA approval in 2018, and BioSig began to build its inventory in 2019. Now it’s in its first year of commercialization.
“We’ve been pushed back maybe three to six months given the hiatus when hospitals are no longer doing these ablation surgeries, but people are sick, they need these surgeries, [so the market will pick up],” Londoner said.
“In about five years, our tech will improve the way they do those procedures probably meaningfully and become the standard of care.”
BioSig seeks to address a $6-billion U.S. market that boasts double-digit growth before it goes global. The company is aiming for EU approval in 2021 and a launch there in 2022.
Altogether, Londoner estimates $600 million to $800 million in revenue potential for the first version of the system, with BioSig taking five to seven years to reach its potential.
BioSig's Pipeline, Partners, Financials
In the meantime, BioSig is building out other products to penetrate additional markets, including various conditions associated with neurological issues.
“Our core competency is to see biomedical signals more clearly than others do,” Londoner said. “It’s a big market, bioelectronic medicine. It’s an established market growing double digits.”
BioSig is three years into a 10-year partnership with Mayo Clinic to develop its technology and explore new applications, but it has “no corporate partnership that we want to discuss at this point,” the CEO said.
For the time being — and in spite of the coronavirus disruptions — BioSig is comfortable with its balance sheet as it continues to develop its pipeline, he said.
“We have enough cash on hand to ride the BioSig programs forward well into next year.”
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