SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2018
AIMMUNE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of incorporation)||(Commission File Number)||(IRS Employer Identification Number)|
8000 Marina Blvd, Suite 300
Brisbane, CA 94005
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (650) 614-5220
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 1.01||Entry into a Material Definitive Agreement.|
On January 10, 2018, Aimmune Therapeutics, Inc., a Delaware corporation (Aimmune or the Company), entered into an Amended and Restated Supply Agreement with Golden Peanut Company, LLC (GPC), a Georgia Limited Liability Company, to, among other things, expand the scope of the product and geographical exclusivity and extend the term provided in its existing supply agreement with GPC (the Restated Supply Agreement). In connection with the entry into the Restated Supply Agreement, Aimmune issued to Archer Daniels Midland Company, a Delaware corporation (ADM), which is an affiliate and the parent company of GPC, 300,000 shares of Aimmune common stock, par value $0.0001 (Common Stock), pursuant to a Securities Issuance Agreement dated January 10, 2018 (the Securities Issuance Agreement) with ADM.
Under the terms of the Restated Supply Agreement, Aimmune is obligated to purchase peanut flour exclusively from GPC, provided that GPC is able to supply the peanut flour in a timely manner with the quantity of peanut flour that Aimmune requires. GPC is not allowed to sell several peanut flour products to any third party worldwide for use in oral immunotherapy (OIT) for the treatment or cure of peanut allergy, provided that Aimmune is in compliance with its exclusive purchase obligation and meets specified annual purchase commitments. The Restated Supply Agreement remains in effect until ten years after the first delivery to Aimmune of peanut flour for commercial use and includes an option for Aimmune to extend the term for an additional five years. The Restated Supply Agreement requires GPC to notify its wholesalers and distributors that the peanut flour products subject to the Restated Supply Agreement cannot be used in OIT for the treatment or cure of peanut allergy. Aimmune has a right of first refusal to obtain rights to new or existing GPC peanut flour products that are not already covered by the Restated Supply Agreement if a third party intends to use the new or existing GPC product in OIT for the treatment of or cure of peanut allergy. Subject to certain exceptions, in the event that the price per share of Aimmunes Common Stock were to fall below a specified level, the Restated Supply Agreement provides that GPC would only be prohibited from selling one peanut flour product to any third party in the United States, Mexico, Canada, the European Union or Japan for use in OIT for the treatment or cure of peanut allergy. Aimmune may terminate the Restated Supply Agreement at any time for any reason upon providing 60 days written notice to GPC. Either party may terminate the Restated Supply Agreement if the other party fails to cure their material breach within 30 days of receiving notice of such breach from the non-breaching party or if the other party fails to perform their obligations under the agreement for a continuous period of 120 days due to a force majeure event or an insolvency or bankruptcy-related events.
In connection with the entry into the Restated Supply Agreement, Aimmune issued 300,000 shares of its Common Stock (the Shares) as consideration for the covenants and obligations of GPC set forth in the Restated Supply Agreement. The Securities Issuance Agreement provides that all of the Shares shall initially be subject to forfeiture, which forfeiture restriction shall lapse as to 25% of the Shares on the date that is six months prior to each yearly anniversary of the effective date of the Restated Supply Agreement, such that all Shares shall be released and no Shares shall be subject to forfeiture as of July 10, 2021, provided that on each vesting date Aimmune has not terminated the Restated Supply Agreement due to GPCs uncured material breach, GPCs insolvency or the occurrence of a force majeure event that prevents GPCs performance for 120 days.
The foregoing summary of the material terms and conditions of the Restated Supply Agreement is qualified in its entirety by the full agreement, which will be filed as an exhibit to the Companys Annual Report on Form 10-K for the year ended December 31, 2017 and are incorporated by reference herein. The Company intends to request confidential treatment for portions of the Restated Supply Agreement.
A copy of the Companys related press release announcing the transactions is attached hereto as Exhibit 99.1.
|Item 3.02||Unregistered Sales of Equity Securities.|
Reference is made to the disclosures set forth in Item 1.01 with regard to the issuance of the Shares, which disclosures are incorporated by reference into this Item 3.02.
The sale and issuance of the Shares is being made in reliance upon exemptions from registration pursuant to Section 4(2) under the Securities Act of 1933, as amended (the Securities Act), and Rule 506 promulgated thereunder, and ADM represented to the Company that it is an accredited investor within the meaning of Rule 501 under the Securities Act. Accordingly, the Shares have not been registered under the Securities Act, and until so registered, these securities may not be offered or sold in the United States absent registration or availability of an applicable exemption from registration. No underwriting discounts or commissions or similar fees are payable in connection with the issuance.
|Item 9.01||Financial Statements and Exhibits.|
|Exhibit No.|| |
|99.1||Press release titled Aimmune Therapeutics Broadens and Extends Supply Agreement with Golden Peanut and Tree Nuts for AR101 for Peanut Allergy dated January 10, 2018.|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|AIMMUNE THERAPEUTICS, INC.|
|Date: January 10, 2018||By:|
Douglas T. Sheehy
General Counsel and Secretary
Aimmune Therapeutics Broadens and Extends Supply Agreement with
Golden Peanut and Tree Nuts for AR101 for Peanut Allergy
Newly Expanded Global Agreement Secures Exclusive Supply Relationship
BRISBANE, California, January 10, 2018 Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced an expansion and extension of its exclusive supply agreement with Golden Peanut and Tree Nuts (Golden), a subsidiary of Archer Daniels Midland Company (ADM), to support the anticipated potential commercialization of AR101. Golden is a leading handler, processor and exporter of peanuts and tree nuts and exclusively supplies the starting material for AR101, Aimmunes investigational biologic oral immunotherapy (OIT) for desensitization of patients with peanut allergy. AR101 is currently in Phase 3 clinical trials, with pivotal topline data expected in February.
The expanded agreement secures Aimmunes exclusive global use of the starting material of AR101 for the oral treatment of peanut allergy for 10 years, with an option to extend the agreement up to an additional five years, through 2033. Further, it gives Aimmune exclusive access to additional Golden products that could be developed into peanut oral immunotherapies. As part of the agreement, Aimmune has granted ADM a 300,000-share equity stake in Aimmune.
Were honored and delighted to strengthen our alliance with Golden Peanut, said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. As drug developers, we have a responsibility to thoroughly secure our supply chain, and this exclusive agreement, with the largest and most established supplier in the industry, fulfills that very well. Golden Peanut shares our mission to protect people with peanut allergies and has been a great partner for ensuring that we have a consistent, stable, reliable source for our clinical trials and our potential future commercial requirements.
The batch-to-batch consistency of the AR101 starting material Aimmune receives from Golden is an essential component of the AR101 manufacturing process, as Aimmune controls for both the quantity of peanut protein and the relative concentrations of key peanut proteins in the final drug product. Additionally, the Golden peanut production process takes place in a peanut-only environment, from field to shipment. This is an important safeguard for Aimmunes manufacture of an investigational peanut allergy treatment that is free from other common food allergens, such as tree nuts, as some people with peanut allergy are allergic to tree nuts as well.
From the beginning of Goldens involvement with Aimmune, our companies have been aligned in wanting to see a successful treatment to protect people with peanut allergy, said Greg Mills, President, Golden Peanut and Tree Nuts. We are proud that our high-quality products and processes can be part of a potential solution, and we are excited to deepen our relationship with Aimmune in support of helping peanut allergy patients.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for potentially life-threatening food allergies. The companys Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmunes first investigational biologic product using CODIT, AR101 for the treatment of peanut allergy, has received the FDAs Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 417 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.
About Golden Peanut and Tree Nuts
Golden Peanut and Tree Nuts, a subsidiary of Archer Daniels Midland Company, is a leading handler and processor of peanuts and tree nuts. Headquartered in Alpharetta, Georgia, the company has 13 processing facilities in the United States and one in Argentina. In South Africa, Golden Peanut is the majority owner of peanut processing plants in Hartswater, Hoopstad and Jan Kempdorp, and is 51-percent owner of pecan processor and marketer GPC Pecan S.A.
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: Aimmunes expectations regarding the potential benefits of the expanded and extended supply agreement with Golden Peanut Company for the starting material for AR101; the ability of Golden Peanut Company to supply batch-to-batch consistency of the starting material for AR101; the potential benefits of AR101; and Aimmunes 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; the companys ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmunes clinical trials will not be successful; Aimmunes dependence on the success
of AR101; the companys reliance on third parties for the manufacture of the companys product candidates; possible regulatory developments in the United States and foreign countries; and the companys ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmunes most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. 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.
# # #
Laura Hansen, Ph.D.