Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for potentially life-threatening food allergies, announced that it has entered into a $170 million loan agreement with an affiliate of KKR, a leading global investment firm.
“The addition of the KKR loan financing to Aimmune’s capital resources is expected to fully fund the commercialization of AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy,” said Eric Bjerkholt, Chief Financial Officer of Aimmune Therapeutics. “In addition, this financing secures resources to support the continued advancement of our pipeline of additional food allergy treatments, including the Phase 2 trial of AR201 for egg allergy, which is anticipated to commence this year.”
In December 2018, Aimmune submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for AR101 for the treatment of peanut allergy in children and adolescents ages 4–17 years based on data from the landmark Phase 3 PALISADE trial, which met its primary and key secondary endpoints, and from additional ongoing and completed AR101 clinical trials. The FDA has granted Breakthrough Therapy Designation to AR101 for the desensitization of peanut-allergic patients 4–17 years of age.
The loan agreement provides Aimmune with an up to $170 million term loan in three tranches. Forty million dollars was funded at close, with $85 million to follow upon FDA approval of AR101 and satisfaction of other customary borrowing conditions, and $45 million at the company’s option in 2020 upon the satisfaction of certain borrowing conditions. The loan can be prepaid at Aimmune’s discretion, at any time, subject to prepayment fees. Further information with respect to the term loan is set forth in a Form 8-K filed by Aimmune with the Securities and Exchange Commission on January 4, 2019.
Aimmune reported September 30, 2018, cash, cash equivalents and short-term investments of $255 million. With the $98 million equity investment from Nestlé Health Science announced in November 2018 and the $170 million KKR loan, assuming full borrowings under all tranches, Aimmune’s capital resources as of September 30, 2018, would have exceeded $500 million.
For KKR, the investment is part of the firm’s Health Care Royalty and Income strategy, which is focused on providing non-dilutive capital to companies for which KKR can help reach scale and achieve strategic objectives.
“Aimmune is leading the way in meeting the critical, growing need to offer treatment to the millions of people affected by food allergies,” said Emily Janvey, M.D., Head of Health Care Royalty and Income strategy at KKR. “We’re proud to help support Aimmune’s important work, especially as the company prepares to launch what could be the world’s first approved medical treatment for peanut allergy.”