RALEIGH – First disclosed in a recent SEC filing, Raleigh startup Bryn Pharma on Tuesday confirmed its latest funding news – $11 million.
The firm has now raised $26 million in a round dating back to October 2019.
The money will be used “to fund the remaining development and regulatory approval activities, and pre-launch commercialization program for BRYN-NDS1C, its bi-dose epinephrine nasal spray,” Bryn said.
“Participants included existing and new investors comprised of investment funds, family offices and private investors.”
“This financing provides us further resources to continue building the value of Bryn Pharma and to bring our disruptive nasal epinephrine product to the large number of patients requiring protection from anaphylactic events,” said David Dworaczyk, CEO of Bryn Pharma, in the announcement.
“We are pleased with the enthusiastic response to this offering and to the continued support of investors as we forge ahead with this important initiative for anaphylactic patients.”
The company’s first reported raise was for $9.2 million in July 2018. It raised $17.2 million in February 2019 and $15 million in October 2019.
It is estimated that 49 million Americans with severe, possibly life-threatening allergies are at risk for anaphylaxis. For 30 years, the standard of care has been for patients to carry two epinephrine auto-injectors with them at all times. Studies show, however, that less than half of patients diagnosed with anaphylaxis carry one auto-injector and a much smaller percentage carry the recommended two.
Bryn Pharma’s Bryn Intranasal Epinephrine Spray (BRYN-NDS1C) is a needle-free, portable and easy-to-use device for administering epinephrine. The U.S. Food and Drug Administration granted BRYN-NDS1C Fast Track designation early last year.
Investors aren’t the only ones recognizing BRYN-NDS1C’s promise. Over the past few months, three peer-reviewed scientific journals have published the results of preclinical studies in support of the device – Respiratory Research, Pharmacology Research and Perspectives and Pharmaceutical Research.
In April 2020, results of the latest human clinical trial were presented at the American Academy of Asthma, Allergy and Immunology annual meeting. Trial researchers concluded that intranasal delivery of epinephrine from the needle-free, bi-dose device was comparable to intramuscular injection in pharmacokinetics, pharmacodynamics and safety.
More human clinical trials continue as the company moves closer to commercialization.
(The NC Biotech Center contributed to this report.)