— Nestlé Health Science to Invest $98 Million in Aimmune through the
Purchase of 3.24 Million Shares of Aimmune Stock at $30.27 per Share —
— Companies Extend Existing Strategic Collaboration Agreement Focused
on Offering Innovative Food Allergy Therapies —
— Nestlé Health Science CEO Greg Behar Continues as Aimmune Director —
BRISBANE, Calif.--(BUSINESS WIRE)--Nov. 12, 2018--
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company
developing treatments for potentially life-threatening food allergies,
today announced that Nestlé Health Science will make an additional
equity investment in Aimmune of $98 million, increasing Nestlé Health
Science’s ownership of Aimmune to approximately 19 percent.
This $98 million investment brings Nestlé Health Science’s total
investment in Aimmune to $273 million. Nestlé Health Science first
invested $145 million in Aimmune in November 2016, followed by $30
million as part of Aimmune’s public offering in February 2018.
Aimmune and Nestlé Health Science also entered into a two-year extension
of their original two-year strategic collaboration agreement, focused on
offering innovative food allergy therapies. The agreement does not
contain any partnership, collaboration, or negotiation restrictions on
Aimmune. Aimmune retains all rights to its current and future pipeline
assets, and Aimmune and Nestlé Health Science will collaborate towards
successful development of such assets.
“We’re extremely pleased to continue this valuable collaboration with
Nestlé Health Science,” said Jayson Dallas, M.D., President and CEO of
Aimmune. “Nestlé Health Science has been a tremendous ally as we lead
the way into the new field of food allergy treatment. Their expertise in
the pediatric space and their insights as a premier consumer health and
medical nutrition products company have advanced our thinking and will
help with critical planning as we anticipate launching AR101. We’re
especially grateful to have Greg on our board and to be able to continue
to benefit from his guidance and vision in service of our shared
commitment to improving the lives of people affected by food allergies.
Combined with our $255 million of cash, as of the end of the third
quarter, this $98 million investment finances the company well beyond
the anticipated approval and launch of AR101 in the United States.
Additionally, it gives us the ability to bring AR101 to patients in
Europe and to develop our pipeline of treatments for other food
Greg Behar, CEO of Nestlé Health Science, stated: “With this investment,
Nestlé Health Science continues to be the largest investor in Aimmune.
We’re proud to reaffirm our strong strategic interest in Aimmune and the
important progress they have made toward addressing the significant
unmet needs in pediatric food allergy. The imminent U.S. regulatory
filing for AR101 and the anticipated launch to follow in the coming year
will be great news for people with peanut allergy, who need robust,
reliable protection from accidental-exposure reactions. This
collaboration exemplifies Nestlé Health Science’s commitment to food
allergy and our excitement to continue an alliance with a leading
innovator in the development of food allergy therapeutics.”
The investment adds a two-year extension to the original two-year
strategic collaboration between Aimmune and Nestlé Health Science
launched in November 2016. Through the continuation of the Strategic
Collaboration Committee, Aimmune and Nestlé Health Science will engage
broadly on Aimmune’s current and future development programs, leveraging
Nestlé Health Science’s scientific, regulatory, and commercial expertise.
Upon closing of the equity investment, Aimmune will receive a payment of
$98 million in connection with Nestlé Health Science’s purchase of
3,237,529 newly issued shares of Aimmune’s common stock at $30.27 per
share, priced at a five-day volume adjusted trading average. After the
completion of the transaction, Nestlé Health Science’s total investments
in Aimmune will correspond to an 18.9-percent stake in the company.
The companies expect to close the equity investment by the end of 2018,
subject to the expiration or termination of applicable waiting periods
under all applicable antitrust laws and satisfaction of other usual and
customary closing conditions.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing
treatments for life-threatening food allergies. The company’s
Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is
intended to provide meaningful levels of protection against allergic
reactions resulting from accidental exposure to food allergens by
desensitizing patients with defined, precise amounts of key allergens.
Aimmune’s first investigational biologic product using CODIT™, AR101 for
the treatment of peanut allergy, has received the FDA’s Breakthrough
Therapy Designation for the desensitization of peanut-allergic patients
4–17 years of age. Aimmune plans to submit regulatory filings for
marketing approval of AR101 in the United States and Europe based on
data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in
4–17-year-old subjects met its primary and key secondary endpoints, and
additional ongoing and completed AR101 clinical trials. For more
information, please see www.aimmune.com.
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s expectations regarding the potential
benefits of AR101; Aimmune’s expectations on regulatory submissions for
marketing approval of AR101 for peanut allergy in the United States and
Europe, including the timing of these submissions; and Aimmune’s
expectations regarding potential applications of the CODIT™ approach to
treating life-threatening food allergies. Risks and uncertainties that
contribute to the uncertain nature of the forward-looking statements
include: the expectation that Aimmune will need additional funds to
finance its operations; Aimmune’s or any of its collaborative partners’
ability to initiate and/or complete clinical trials; the
unpredictability of the regulatory process; the possibility that
Aimmune’s or any of its collaborative partners’ clinical trials will not
be successful; Aimmune’s dependence on the success of AR101; Aimmune’s
reliance on third parties for the manufacture of Aimmune’s product
candidates; possible regulatory developments in the United States and
foreign countries; and Aimmune’s ability to attract and retain senior
management personnel. These and other risks and uncertainties are
described more fully in Aimmune’s most recent filings with the
Securities and Exchange Commission, including its Quarterly Report on
Form 10-Q for the quarter ended September 30, 2018. All forward-looking
statements contained in this press release speak only as of the date on
which they were made. Aimmune undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
This press release concerns a product that is under clinical
investigation and that has not yet been approved for marketing by the
U.S. Food and Drug Administration (FDA) or the European Medicines Agency
(EMA). It is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181112005233/en/
Source: Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc.
Laura Hansen, Ph.D.,