The Dawson James Securities Fourth Annual Small Cap Growth Conference in Jupiter, Florida, brought together some of the most dynamic companies in the US and Canada, showcasing the latest biotech and tech innovations and making their cases directly to investors.
Jack Stover, CEO of Interpace Diagnostics Group Inc (NASDAQ:IDGX) was among five panelists in the kick-off panel presentation exploring the impact of Artificial Intelligence and Bioinformatics -- the science of collecting and analyzing complex biological and genetic data -- on the future of health care.
Interpace, which focuses on developing molecular diagnostics for cancers of the thyroid and pancreas, is exploring new ways to use the bioinformatics data it collects, Stover explained.
“We have 10 years’ worth of data and hundreds of thousands of data points on patients, and ultimately what we’re doing is looking at those patients against a publicly available database to make determinations not only to where that patient is today, but where they’re going to be in five years,” Stover told moderator David Weinstein, managing partner of Dawson James.
Stover also gave a simple example of how bioinformatics data can be used to reduce the number of unnecessary cancer surgeries as a means of containing spiraling health care costs.
“That data is extremely important and extremely valuable to us,” Stover said. “We see it as a bridge to the pharmaceutical and biopharmaceutical world.”
Stover told Proactive Investors separately that the Parsippany, New Jersey, company experienced a huge turnaround over the past year and a half, punctuated by its acquisition of rival Rosetta Genomics earlier this year.
With a growing sales force, Stover said the company is on track for full-year 2018 revenue above $20 million, a more than 26% increase over 2017.
Going all in on Ampligen
Another compelling rebound story is Hemispherx BioPharma Inc (NYSEAMERICAN:HEB), an Orlando, Florida, developer of therapeutics to treat multiple cancers, as well as immune-deficiency disorders. Its lead drug Ampligen is the only approved therapy for Chronic Fatigue Syndrome, or CFS.
Its other drug, Alferon N, is approved by the US Food and Drug Administration to treat genital warts.
Despite having two approved drugs, the company had to overcome what CEO Thomas Equels calls a “life or death scenario.”
“When I took over as CEO a little over two years ago we had a problem,” Equels told Proactive Investors. “We had no money, we had no Ampligen, and our Alferon facility had a flood and was shut down.”
Under Equels the company quickly pivoted from Alferon to focus on developing Ampligen as a potential treatment for multiple cancers. He restructured, raised money, and used that money to manufacture commercial-sized lots of Ampligen.
Meanwhile, he signed up major cancer research institutes in the US and Europe to work with Ampligen as an immuno-oncology agent.
Edward Woo, an analyst with Ascendiant Capital Markets, sees the upside.
“Though we acknowledge that Hemispherx’s oncology drugs still have long development roads left (about two years), we believe the [billion-dollar] market potential presents a high reward for the risk.”
The analyst started coverage Monday with a Buy rating and a $0.75 price target. The shares closed Thursday at $0.34 per share.
Surgery at the cutting edge
Another company at the conference, Titan Medical Inc (NASDAQ:TMDI), is literally at the cutting edge of innovation in the field of surgery. It designs and manufactures robotic surgical systems.
A restructuring in 2017 brought CEO David McNally to the Toronto-based company, and after some key hires, he said it’s now on a fast-track to commercialization.
Titan Medical expects to have applications for its SPORT Surgical System submitted to the FDA and European regulators for a CE Mark in 2019, with a rollout in mid-2020.
While robotic surgery is nothing new, McNally told Proactive Investors that SPORT will not only be the most advanced but the most user-friendly robotic system for abdominal surgery on the market.
By concentrating on the abdominal area, the system will be able to support a wide range of minimally invasive surgeries, such as gynecological, urological and colorectal other procedures.
“Our system is designed to reduce trauma to the body while being easy to operate for the surgeon and the operating room staff,” McNally said.
The first goal, to reduce patient trauma, is achieved by making only a single incision. McNally said that numerous studies on live animals and human cadavers have shown positive results thus far.
“It’s a red-hot space and the problems covered by robotics are only beginning to be solved,” McNally said. “Market penetration is only 10% globally.”
The development-stage company has invested more than $140 million in the system, has about $30 million in cash on hand and no debt on its books.
Running with the big dogs
In the red-hot immuno-therapy space, Canadian company IMV Inc (NASDAQ:IMV) is making its presence known by attracting two giant players as partners – without giving up the rights to its clinical assets.
The Halifax-based company uses lipid-based, injectable nanoparticle technology to create artificial T-cells that kill cancer. CEO Frederic Ors describes it as a new way to deliver active ingredients to the immune system.
“We’ve already made clinical demonstrations that we can shrink solid tumors,” Ors told Proactive Investors. “Nobody yet in immuno-oncology has been able to prove they can shrink solid tumors.”
With reductions of more than 30% in solid tumors such as the kind found in ovarian cancer, IMV was able to attract and partner with Merck (NYSE:MRK) and Incyte (NASDAQ:INCY) and now has eight ongoing Phase 2 trials -- seven with Merck, which has invested more than US$50 million, and one with Incyte.
Ors pointed out that IMV still retains the rights on its lead clinical asset DPX-Survivac.
The company, formerly known as Immunovaccine Inc, is well funded through the end of 2019, he said, with C$25 million in cash as of June 30. The company listed on the Nasdaq because the future of the company is in the US, Ors said, and he wants its flow of milestones to be accessible to investors through Nasdaq.
Betting on the nose
Altimmune Inc. (NASDAQ:ALT) is a clinical-stage vaccine maker that’s raised $40 million in the last few weeks to develop its internasal flu vaccine, NasoVAX, which CEO Bill Enright told Proactive will enter $2 billion flu market that he says is not well-served.
“About the same number of people die every year from the flu as from breast cancer,” Enright told Proactive. “We’ve got a vaccine that we believe will significantly improve vaccines on the market.”
Every year millions of doses of flu vaccine are created using chicken eggs, one egg per dose, at a huge cost to maintain a chicken population for a strategic supply in the event of a pandemic. And they take months to produce.
But Altimmune has come up with a faster and cheaper process using cell cultures that covers more strains of flu than traditional vaccines and minimizes mismatched strains. And the company can get a new flu vaccine to market in half the time.
A Phase 2A trial of 60 people has just been completed with 100% protection.
The key is the delivery system. Traditional flu vaccines are injected, whereas Altimmune’s vaccine is administered nasally. This increases absorption by the body because there’s a mucosal response in the nose that also stimulates a rapid T-cell response.
So Altimmune’s internasal dose will be effective in just days versus weeks via injectables.
Not to be overlooked is its anthrax vaccine, NasoShield, which is also internasal, and funded by a US government contract for $130 million in reimbursements for the research. It’s currently in Phase 1 trials.
Though Enright announced last week that he’ll be stepping down as CEO after 10 years of running the Gaithersburg, Maryland, company, he will continue to be a shareholder.
The mouse that roars
Cyclacel Pharmaceuticals Inc. (NAS:CYCC) CEO Spiro Rombotis describes his biopharma company as “a mouse in a ballroom full of elephants” because its main competitors include Merck and Bayer AG.
Rather than scurry about to avoid being stomped, the Berkeley Heights, New Jersey, company wants to dance. Cyclacel employs what it calls a “triple-hit strategy.” Hit the patient early, Rombotis said, before the disease goes off the rails and then hit twice more by combining its development drug with an already approved drug from an established player.
He compares it to playing Whack-A-Mole.
“If you hit the mole only once, it raises its head somewhere else," he told Proactive Investors. "But if you hit it twice, you have a better chance to get the patient to a prolonged period without disease recurrence and a higher quality of life.”
From a business perspective, the strategy is appealing because the companies selling the approved drug have an interest in owning the new molecule and extending the life of their product in the market, he explained.
“So, this idea of taking the approved drug, plus the new drug to make the approved drug better has caught on and we are one of the pioneers in this area,” he said.
Contact Paul Curcio at email@example.com
Follow him on Twitter at @GoCurcioGo