UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 25, 2020
Regulus Therapeutics Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-35670 | 26-4738379 | ||
(State of incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
10628 Science Center Drive, Suite 225 San Diego, CA |
92121 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (858) 202-6300
(Former name or former address, if changed since last report.)
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 Instruction 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)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Common Stock, par value $0.001 per share | RGLS | The Nasdaq Stock Market LLC |
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. |
Second Amendment to Second Amended and Restated Collaboration and License Agreement
On August 25, 2020, Regulus Therapeutics Inc. (the Company) entered into a second amendment (the Sanofi Second Amendment) to the Second Amended and Restated Collaboration and License Agreement with Sanofi, dated February 4, 2014 (the Sanofi License). The Sanofi License was previously amended pursuant to a first amendment, dated November 5, 2018, which the first amendment, among other things, provided that the Company would be eligible to receive up to $40.0 million in development milestones related to Sanofis development of miR-21 compounds (collectively, the First Amendment Milestones), including a $10.0 million payment for an interim enrollment milestone (the Enrollment Milestone).
Under the terms of the Sanofi Second Amendment, the Company has agreed to transfer to Sanofi additional RG-012 development program materials (the Materials) in exchange for a payment from Sanofi of $1.0 million (the Transfer Payment).
In addition, upon the completion of the transfer and verification of the Materials, Sanofi will be obligated to pay the Company a $4.0 million milestone payment (the Materials Transfer Milestone). The Company is also eligible to receive an additional $5.0 million upon the achievement of the Enrollment Milestone. In the event the Enrollment Milestone occurs before the Materials Transfer Milestone, Sanofi is obligated to pay the Company $9 million in satisfaction of both milestones. In addition, the Company is eligible to receive $25.0 million upon the achievement of an additional development milestone related to Sanofis development of miR-21 compounds. The milestones and milestone payments provided for under the Sanofi Second Amendment, as summarized in this paragraph, replace in their entirety the First Amendment Milestones.
Tenth Amendment to Loan and Security Agreement
On August 25, 2020, and in connection with the Sanofi Second Amendment, the Company entered into a tenth amendment to its Loan and Security Agreement (the Tenth Amendment) with Oxford Finance LLC, as the collateral agent and a lender (the Lender), dated June 17, 2016, as amended, pursuant to which the Lender lent the Company $20.0 million in a term loan (Term Loan).
Under the terms of the Tenth Amendment, the Companys required monthly payments to the Lender are to be comprised of interest only through and including (i) April 1, 2021, if the Principal Paydown Event (as defined below) does not occur by April 30, 2021 or (ii) the payment date immediately preceding January 1, 2022 (the Second Amortization Date), if the Principal Paydown Event occurs by April 30, 2021. The Company is required to use 100% of the proceeds from the Transfer Payment, the Materials Transfer Milestone and/or the Enrollment Milestone (collectively, License Amendment Payments) to prepay the Term Loan. The Principal Paydown Event means the prepayment by the Company to the Lender, after August 25, 2020 and on or before July 31, 2021, of an aggregate principal amount of at least $10.0 million pursuant to the Companys receipt of License Amendment Payments.
If the Principal Paydown Event does not occur by April 30, 2021, then commencing on May 1, 2021 until the occurrence of the Principal Paydown Event on or before July 31, 2021, the Company will be required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to the Lender.
If the Principal Paydown Event does not occur by July 31, 2021, then commencing on August 1, 2021 and continuing on each successive payment date thereafter through and including the maturity date of May 1, 2022, the Company will be required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to the Lender.
If the Principal Paydown Event does occur (i) after April 30, 2021, but on or before July 31, 2021, commencing on the first payment date after the date of the occurrence of the Principal Paydown Event and continuing on each successive payment date thereafter through and including the payment date immediately preceding the Second Amortization Date, the Company shall make monthly payments of interest only; and (ii) commencing on the Second Amortization Date, and continuing on each successive payment date thereafter, the Company will be required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to the Lender.
The Tenth Amendment also provides that the Company is required to maintain cash in a collateral account controlled by the Lender of (i) $5.0 million if the Company has not yet made the License Amendment Payments or (ii) $3.0 million if the Company has made the License Amendment Payments.
The Tenth Amendment also provides that the Lenders positive lien on the Companys intellectual property will continue regardless of whether the Company makes its required prepayments related to the License Amendment Payments.
In addition, the Tenth Amendment provides that, upon the occurrence of certain events related to the discontinuation of the LIBOR rate by certain governmental bodies, the Lender may amend the Term Loan to replace the existing interest rate under the Term Loan with an alternative benchmark rate selected by the Lender.
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 hereunto duly authorized.
Regulus Therapeutics Inc. | ||||||
Date: August 31, 2020 | By: | /s/ Joseph Hagan | ||||
Joseph Hagan | ||||||
President and Chief Executive Officer |