Morphogenesis, a Tampa biotechnology company developing treatments for cancer, has raised $2.7 million in equity capital.
The funding came from 24 investors and is part of an ongoing $11 million offering, according to a Dec. 17 filing with the U.S. Securities and Exchange Commission.
The latest capital raise is occurring as Morphogenesis continues trials on an immunotherapeutic treatment called IFx-Hu2.0. The U.S. Food and Drug Administration last month granted orphan drug designation to IFx-Hu2.0 for the treatment of late-stage melanoma.
That’s a huge win, said Patricia Lawman, co-founder and CEO.
“When we go to register our product, when we finally get approval, it will save us several million in fees and it adds to the length of time we can have exclusive marketing as well,” she said.
The FDA grants orphan drug designation to drug sponsors for medications that are intended for use in diseases which affect fewer than 200,000 persons in the United States. Late stage melanoma affects as many as 62,748 Americans, according to a press release from Morphogenesis.
The treatment, if it wins final approval, could be a “game-changer,” Lawman said.
There are several types of skin cancer, according to the American Academy of Dermatology Association. Melanoma is often called the most serious type because it has a tendency to spread.
Morphogenesis has completed a Phase 1 trial for cutaneous melanoma and initial findings substantiate the treatment’s mechanism of action and safety, the company said. A second Phase 1 trial for cutaneous squamous cell carcinoma and Merkel cell carcinoma began in the first quarter of 2020. The company plans to begin a Phase 2 skin cancer basket trial in the first half of 2021, starting with melanoma.
The ongoing Phase 1 trial is at Moffitt Cancer Center in Tampa as well as at sites in California and Boston. The Phase 2 study likely will be at 15 sites.
That gets expensive, Lawman said.
She could not address the ongoing capital raise directly, but did say funding is vital for the company’s progress.
“Our only constraint is not the science, it’s not the people, it’s not the regulatory hurdles, even. It’s the money to get through it,” she said.
Morphogenesis has raised several rounds of funding previously, including a 2018 round led by Tampa healthcare entrepreneur Dr. Kiran Patel, who is chairman of the Morphogenesis board.
Related: Startup Report
Morphogenesis also was profiled in Forbes on Thursday. Read that profile here.