Bryn Pharma Raises $17.5 Million in Financing as it Advances Toward U.S. Application to Market Bidose Epinephrine Nasal Spray for Anaphylaxis
RALEIGH, N.C., Oct. 24, 2019 /PRNewswire/ -- Bryn Pharma, LLC ("Bryn" or the "Company"), a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, today announced that it has raised $17.5 million in financing to fund U.S. approval and to prepare for commercialization of BRYN-NDS1C, its bidose epinephrine nasal spray. This was the fourth financing series completed by the Company, and it included $15.0 million in proceeds from existing and new investors comprised of investment funds, family offices and private investors. An additional $2.5 million in financing was provided by a corporate collaborator.
"We formed the Company with the singular goal of bringing an easy-to-use, needle-free, and convenient-to-carry solution to patients and their loved ones at risk of anaphylaxis," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "This financing follows our rapid advancement of the development and clinical testing of BRYN-NDS1C. The additional capital will be used to prepare for the rapid commercialization of the product once approved by the FDA."
An estimated 49 million Americans are at risk for anaphylaxis, and epinephrine auto-injectors are the only option currently available to protect this at-risk community. Current practice parameters recommend that two epinephrine auto-injectors be carried by patients at all times because up to 30 percent of patients who develop anaphylaxis require a second dose of epinephrine to control symptoms.(1) However, studies have shown that the majority of people at risk for anaphylaxis often do not carry two epinephrine auto-injectors due in part to size and cost of the products, putting patients at greater risk of severe complications during an allergic reaction.
The Bryn Intranasal Epinephrine Spray (BRYN-NDS1C) product candidate is designed to provide patients with a life-saving treatment that fits in a pocket, is easy-to-use and complies with practice parameters by containing two doses of epinephrine in one portable device, replacing the need to carry two emergency auto-injectors.
Over the last three years, Bryn has conducted extensive preclinical and clinical trials of BRYN-NDS1C designed to support regulatory submission and approval to market the product candidate. In early 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BRYN-NDS1C. The Company has successfully completed pilot studies demonstrating the proof of concept of the innovative treatment, and in October 2019 completed dosing in the pivotal human trial designed to support U.S. approval to market the product candidate.
About Bryn Pharma
Bryn Pharma, founded in 2016, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine auto-injectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. BRYN-NDS1C is not currently approved for sale by the FDA or any international regulatory authority. For more information visit www.brynpharma.com.
Forward-Looking Statements
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the Company's products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company's securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
1. Anaphylaxis - a practice parameter update 2015; Lieberman, Phillip et al.; Annals of Allergy, Asthma & Immunology, Volume 115, Issue 5, 341-384.
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