UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
(Mark One)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2015
OR
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-36781
Juno Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 46-3656275 | |
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
|
307 Westlake Avenue North, Suite 300 Seattle, WA |
98109 | |
| (Address of principal executive offices) | (Zip Code) | |
(206) 582-1600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
Name of each exchange on which registered |
|
| Common stock, par value $0.0001 per share | The NASDAQ Global Select Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
| Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
| Non-accelerated filer | x (Do not check if a smaller reporting company) | Smaller reporting company | ¨ | |||
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act). Yes ¨ No x
The number of shares outstanding of the registrant’s common stock as of August 7, 2015 was 100,556,371.
Explanatory Note
This Amendment No. 1 on Form 10-Q/A (this “Amendment”) amends the Quarterly Report on Form 10-Q of Juno Therapeutics, Inc. (the “Company”) for the fiscal quarter ended June 30, 2015, which was originally filed on August 14, 2015 (the “Q2 2015 Form 10-Q”). The Company is filing this Amendment for the purpose of re-filing Exhibit 10.7 thereto in connection with a request for confidential treatment for certain of the terms in such exhibit. This Amendment does not modify or update any part of or information set forth in the Q2 2015 Form 10-Q other than Exhibit 10.7 and the Exhibit Index.
PART II. OTHER INFORMATION
| ITEM 6. | EXHIBITS |
See the Exhibit Index on the page immediately following the signature page to this Amendment for a list of the exhibits filed as part of this Quarterly Report, which Exhibit Index is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Juno Therapeutics, Inc. | ||||||
| Date: November 23, 2015 | By: |
/s/ Steven D. Harr |
||||
|
Steven D. Harr
Chief Financial Officer &
(principal financial and accounting officer) |
||||||
EXHIBIT INDEX
|
Exhibit Number |
Incorporated by Reference |
Filed Herewith |
||||||||||
|
Exhibit Description |
Form |
Date |
Number |
|||||||||
| 2.1#‡ D | Share Purchase Agreement, dated May 11, 2015, by and among Dr. Herbert Stadler, Dr. Lothar Germeroth, Prof. Dr. Dirk Busch, and the registrant | 8-K | 05/11/2015 | 2.1 | ||||||||
| 2.2#‡ D | Agreement and Plan of Merger, dated June 1, 2015, by and among X Acquisition Corporation, X-Body, Inc., Brant Binder as stockholder representative, certain principal stockholders of X-Body, Inc., and the registrant | 8-K | 06/05/2015 | 2.1 | ||||||||
| 3.1 | Amended and Restated Certificate of Incorporation | 8-K | 12/29/2014 | 3.1 | ||||||||
| 3.2 | Amended and Restated Bylaws | S-1/A | 12/09/2014 | 3.2 | ||||||||
| 4.1 | Fourth Amended and Restated Investors’ Rights Agreement, dated December 5, 2014, by and among the registrant and the investors named therein | S-1/A | 12/09/2014 | 4.1 | ||||||||
| 4.2 | Amendment and Waiver of Fourth Amended and Restated Investors’ Rights Agreement, dated July 27, 2015 | 10-Q | 08/14/2015 | 4.2 | ||||||||
| 4.3 | Form of Common Stock Certificate | S-1/A | 12/09/2014 | 4.2 | ||||||||
| 10.1+ | Amendment #2 to License Agreement, dated April 4, 2015, by and between St. Jude Children’s Research Hospital, Inc. and the registrant | 10-Q | 08/14/2015 | 10.1 | ||||||||
| 10.2+ | Non-Exclusive Sublicense Agreement, effective April 7, 2015, by and among Novartis Institutes for Biomedical Research, Inc., The Trustees of the University of Pennsylvania, and the registrant | 10-Q | 08/14/2015 | 10.2 | ||||||||
| 10.3 | Lease Agreement, dated as of April 6, 2015, by and between ARE-Seattle No. 16, LLC and the registrant | 8-K | 04/07/2015 | 10.1 | ||||||||
| 10.4 | First Amendment to Lease Agreement, dated May 21, 2015, by and between ARE-Seattle No. 16, LLC and the registrant | 10-Q | 08/14/2015 | 10.4 | ||||||||
| 10.5 | 2015 Non-Employee Director Compensation Program, adopted April 3, 2015 | 10-Q | 05/12/2015 | 10.3 | ||||||||
| 10.6 | Amendment No. 1 to Sponsored Research Agreement, effective April 1, 2015, by and between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute and the registrant | 10-Q | 05/12/2015 | 10.4 | ||||||||
| 10.7+ | Amendment No. 2 to Exclusive License Agreement, dated June 15, 2015, by and between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute and the registrant | X | ||||||||||
| 10.8 | Offer Letter with Hyam Levitsky, dated May 27, 2015 | 10-Q | 08/14/2015 | 10.8 | ||||||||
| 10.9#‡ | Share Purchase Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant | 8-K | 06/29/2015 | 10.1 | ||||||||
| 10.10 | Voting and Standstill Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant | 8-K | 06/29/2015 | 10.2 | ||||||||
| 10.11 | Registration Rights Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant | 8-K | 06/29/2015 | 10.3 | ||||||||
| 10.12+ | Amended and Restated Master Research and Collaboration Agreement, dated August 13, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant | 10-Q | 08/14/2015 | 10.12 | ||||||||||||||
| 10.13 | First Amendment to Lease, dated July 31, 2015, by and between BMR-217 th Place LLC and the registrant | 10-Q | 08/14/2015 | 10.13 | ||||||||||||||
| 31.1 | Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended | X | ||||||||||||||||
| 31.2 | Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended | X | ||||||||||||||||
| 32.1* | Certification of Principal Executive Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350 | 10-Q | 08/14/2015 | 32.1 | ||||||||||||||
| 32.2* | Certification of Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350 | 10-Q | 08/14/2015 | 32.2 | ||||||||||||||
| 101 | The following materials from Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, formatted in eXtensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets at June 30, 2015 (unaudited) and December 31, 2014, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three and six months ended June 30, 2015 and 2014, (iii) Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2015 and 2014, and (iv) Notes to the Condensed Consolidated Financial Statements. | 10-Q | 08/14/2015 | 101 | ||||||||||||||
| * | The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Juno Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing. |
| + | Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the Securities and Exchange Commission. |
| # | Confidential treatment has been granted for certain information contained in this exhibit. Such information has been omitted and filed separately with the Securities and Exchange Commission. |
| ‡ | The representations and warranties contained in this agreement were made only for purposes of the transactions contemplated by the agreement as of specific dates and may have been qualified by certain disclosures between the parties and a contractual standard of materiality different from those generally applicable under securities laws, among other limitations. The representations and warranties were made for purposes of allocating contractual risk between the parties to the agreement and should not be relied upon as a disclosure of factual information about the registrant or the transactions contemplated thereby. |
| D | The exhibits and schedules to this agreement have been omitted in reliance on Item 601(b)(2) of Regulation S-K promulgated by the Securities and Exchange Commission, and a copy thereof will be furnished supplementally to the Securities and Exchange Commission upon its request. |
Exhibit 10.7
| [***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
AMENDMENT NO. 2
to
EXCLUSIVE LICENSE AGREEMENT
This Amendment No. 2 (this “ Amendmen t No. 2 ”), dated as of June 15, 2015, is entered into between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute, a Washington non-profit corporation (“ Licensor ”) and Juno Therapeutics, Inc., a Delaware corporation (“ Licensee ”).
BACKGROUND
A. Licensee and Licensor are parties to that certain Exclusive License Agreement dated as of February 13, 2014, as amended by Amendment No. 1 thereto dated August 4, 2014 (the “ License Agreement ”).
B. The parties wish to amend the License Agreement as set forth below.
C. All terms used in this Amendment No. 2 with initial letters capitalized but not defined herein shall have the meaning set forth in the License Agreement.
AGREEMENT
Accordingly, the parties agree as follows:
Section 1. Amendments to License Agreement
1.1 Reservation of Rights. Section 2.3 of the License Agreement is hereby deleted in its entirety and replaced with the following:
“Licensor reserves the right to use and otherwise exploit the Licensed Patents solely for Licensor’s (a): internal non-commercial (i) research, teaching and other education-related purposes, (ii) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations), and (iii) development, manufacture and use of products for children and young adults solely in support of the foregoing; in each case, at the facilities of (and under the supervision of) Licensor and its Affiliates; and (b) non-commercial manufacture, at the facilities of (and under the supervision of) Licensor and its Affiliates, of products for the treatment of children and young adults for supply to any other not-for-profit entity solely for use by such not–for-profit entity solely for such not-for-profit entity’s internal non-commercial (i) research, teaching and education-related purposes and (ii) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations), provided Licensor covenants that any such supply
will (A) be in writing, and (B) either (i) contain an express written prohibition on the filing by the not-for-profit licensee of any patent application(s) on any invention first conceived and/or reduced to practice by such not-for-profit entity as a result of using such product that would limit any practice of any of the Licensed Patents under this Agreement, or (ii) require that such not-for-profit assign to Licensor any patent application or patent filed on any such invention.
Licensor may also provide non-exclusive, non-sublicensable, non-transferable licenses under the Licensed Patents to any other not-for-profit entity solely for such not-for-profit entity’s internal non-commercial (A) research, teaching and other educational-related purposes, and (B) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations); provided Licensor covenants that any such license will (X) be in writing and (Y) either (i) contain an express written prohibition on the filing by the not-for-profit licensee of any patent application(s) on any invention first conceived and/or reduced to practice by such not-for-profit entity as a result of the practice of the Licensed Patents that would limit any practice of any of the Licensed Patents under this Agreement, or (ii) require that the licensee assign to Licensor any patent application or patent filed on any such invention. Any patent application or patent filed in violation of any restriction described in subsection (B)(i) or (Y)(i) above, and/or any patent application or patent described in subsection (B)(ii) and/or (Y)(ii) above, shall, at Licensee’s option, be deemed to be a Licensed Patent.
Licensor shall not exploit the Licensed Patents except as expressly described above in this Section 2.3.”
1.2 Development Milestone Cap. The preamble to Section 3.2 of the License Agreement is hereby deleted and replaced in its entirety with the following language:
“Licensee shall pay Licensor milestone payments in the amounts set forth in this Section 3.2, whether the milestone is met by Licensee, its Affiliates or Sublicensee, payable according to the following schedule for the development milestone payment for each particular Licensed Product (i.e., distinct biological entity) (provided, however, the aggregate milestone payments under this Section 3.2 shall not exceed a total of five million dollars ($5,000,000) to Licensor for any Licensed Product that is covered only by a Valid Claim of a patent or patent application that is co-owned by Licensor and FHCRC but not any Valid Claim of any other patent application or patent within the Licensed Patents (“ Development Milestones Fee Cap ”) per Licensed Product, regardless of [***])”
1.3 New Milestone. Section 3.2 of the License Agreement is hereby amended to add a new clause (i) to Section 3.2 that reads as follows:
“A payment of [***] for first achievement [***].”
1.4 Exhibit A Patent List. Exhibit A is hereby amended to add the following patent applications:
|
SERIAL NUMBER |
DESCRIPTION | FILING DATE | ||||||
|
[***] |
[*** | ] | [*** | ] | ||||
| [***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
Accordingly, Exhibit A, in full, now reads as follows:
|
SERIAL NUMBER |
DESCRIPTION | FILING DATE | ||||||
|
[***] |
[*** | ] | [*** | ] | ||||
| [***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
3
Section 2. Full Force and Effect
Except as modified by this Amendment No. 2, all other terms and provisions of the License Agreement shall remain in full force and effect. In the event of a conflict between the terms of this Amendment No. 2 and the License Agreement, the terms of this Amendment No. 2 shall control.
|
SEATTLE CHILDREN’S HOSPITAL D/B/A SEATTLE CHILDREN’S RESEARCH INSTITUTE |
JUNO THERAPEUTICS, INC. | |||||||
| By: | /s/ James B. Hendricks | By: | /s/ Hans Bishop | |||||
| James B. Hendricks, Ph.D. | Print: | Hans Bishop | ||||||
| President | Its: | CEO | ||||||
4
Exhibit 31.1
CERTIFICATIONS
I, Hans E. Bishop, certify that:
| 1. | I have reviewed this Amendment No. 1 to the Quarterly Report on Form 10-Q of Juno Therapeutics, Inc.; and |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Date: November 23, 2015
|
/s/ Hans E. Bishop |
| Hans E. Bishop |
|
President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATIONS
I, Steven D. Harr, certify that:
| 1. | I have reviewed this Amendment No. 1 to the Quarterly Report on Form 10-Q of Juno Therapeutics, Inc.; and |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Date: November 23, 2015
|
/s/ Steven D. Harr |
|
Steven D. Harr Chief Financial Officer |
| (Principal Financial and Accounting Officer) |