ImmunSYS, a Fort Lauderdale company developing technology to treat prostate cancer and other solid tumors, was the top winner in BioPitch, a Shark Tank for life science companies that highlighted the 2019 BioFlorida annual conference.
The company won $10,000 after besting 15 other seed-stage and early-stage life science firms that also pitched at the Oct. 22 conference in Tampa.
More than 20 investor judges worked over the past several months to review a record-breaking number of applications for BioPitch, and they determined the 16 semi-finalists who presented at the conference, said Jane Teague, who organized the pitch competition and is executive director of the Institute for Commercialization of Florida Technology.
In addition to the pitch competition, the conference featured biotech leaders presenting research updates, and panels discussing the state of the industry in Florida.
ImmunSYS is developing an immunotherapy designed to empower the immune system to recognize and selectively attack cancer throughout the body.
The company just received approval from the Food & Drug Administration for a clinical development plan, said Eamonn Hobbs, chairman and CEO. He expects accelerated or full approval from the FDA for its therapy after a Phase 2 trial. ImmunSYS has drawn $14 million in investment so far and plans to pursue an initial public offering in the first half of 2020.
“In the meantime, we’re setting up for that with a cross-over round of $3 million plus that we expect to close before December, and a SAFE note [a convertible security] that leads into that,” Hobbs said.
One of the factors that made ImmunSYS stand out likely was the story of its chief medical officer, Dr. Gary Onik, who invented the technology. He was diagnosed with metastatic prostate cancer in October 2018, and after treatment in December, he has had a complete response, which is complete absence of the disease, Hobbs said.
ImmunSYS’ technology, which empowers the patient’s own immune system to recognize and fight cancer, has response rates similar to those of CAR T treatment developed for liquid cancers, such as lymphoma and leukemia, but without requiring weeks in an intensive care unit, Hobbs said.
“We do everything in the tumor in a relatively non-toxic way in an outpatient setting with very low cost, repeatable results and much faster benefit for the patient,” he said.
Other semi-finalists that presented on Tuesday were:
AireHealth, an Orlando company that has developed a nebulizer specifically for children. A nebulizer is a medical device for a person with asthma or other respiratory conditions used to deliver medication quickly and directly to the lungs.
“AireHealth is a connected nebulizer company serving 29 million wheezy kids,” said Stacie Ruth, co-founder and CEO. A wheezy kid is a child who has had respiratory difficulty but has not necessarily been diagnosed with a specific condition.
“Today’s problem is that a nebulizer is large, about the size of a pizza box. It’s loud. It’s scary for children and it’s not portable,” Ruth said. Inhalers are smaller and more portable, but less effective and more costly for children, she said. “What AireHealth is bringing to market is a completely silent, portable, small – it’s smaller than a deck of cards — very child-friendly device. Our claim we can make with our FDA clearance, and we are a Class 2 cleared device, is that we deliver 98 percent of the drug.”
DermaSensor, a Miami company with a team of physicians, scientists and entrepreneurs leading the fight to solve skin cancer. Skin cancer is more common than all other cancers combined, with 5.5 million skin cancers diagnosed annually, said CEO Cody Simmons.
“Because of poor access to dermatologists, only 15 percent of Americans get an annual skin cancer check, and access to dermatologists is only getting worse, with larger costs and longer wait times,” Simmons said. “The good news is that 99 percent of skin cancers are curable if detected early. There are 330,000 front line providers that could do a better job of detecting skin cancer early, but they’re not dermatologists. They don’t have that expertise, so they don’t do a good job at assessing those lesions and catching them early … DermaSensor is an affordable hand-held tool that uses spectroscopy machine learning to empower those front-line providers to better assess skins cancer. We want to be the eyes of dermatologists in the hands of all clinicians.”
Regenerative Processing Plant LLC, a Palm Harbor company focused on treating dry eye disease. Dry eye disease has been described as similar to putting an eyelid over a piece of sandpaper, said co-founder Marissa Morris, and the drugs currently in the market don’t get good results.
The company’s product, Regener-Eyes, is a biologic eye drop. “It’s more biocompatible. We have less side effects .. and most important it is more efficacious,” Morris said.
Regener-Eyes was capitalized with $7 million in founders’ money, and an additional $2.7 million from family and friends.
“We are seeking a $2 million investment to obtain an FDA BLA, which is a biologics license application. That will help us accelerate sales. We are already on the market, but this will allow us to compete with the big boys,” Morris said. “We believe that once we are on our way to the BLA, even before we complete it, that a strategic investment partner will pluck us up because this is such as huge market. That allows for our investors a partial or complete exit, and we believe that may occur within the next 12 to 24 months. Or, we then do a Series B round and continue the commercialization to obtain what we believe conservatively will be 25 percent of the market, $500 million plus.”