0001590750-20-000138.txt : 20201217 0001590750-20-000138.hdr.sgml : 20201217 20201217070739 ACCESSION NUMBER: 0001590750-20-000138 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20201216 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20201217 DATE AS OF CHANGE: 20201217 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MIRAGEN THERAPEUTICS, INC. CENTRAL INDEX KEY: 0001590750 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 471187261 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36483 FILM NUMBER: 201394215 BUSINESS ADDRESS: STREET 1: 6200 LOOKOUT ROAD CITY: BOULDER STATE: CO ZIP: 80301 BUSINESS PHONE: 303-531-5952 MAIL ADDRESS: STREET 1: 6200 LOOKOUT ROAD CITY: BOULDER STATE: CO ZIP: 80301 FORMER COMPANY: FORMER CONFORMED NAME: MIRAGEN THERAPEUTICS, INC. DATE OF NAME CHANGE: 20170213 FORMER COMPANY: FORMER CONFORMED NAME: SIGNAL GENETICS, INC. DATE OF NAME CHANGE: 20140710 FORMER COMPANY: FORMER CONFORMED NAME: SIGNAL GENETICS LLC DATE OF NAME CHANGE: 20131031 8-K 1 mgen-20201216.htm 8-K mgen-20201216
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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): December 17, 2020 (December 16, 2020)

mgen-20201216_g1.jpg
MIRAGEN THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)

Delaware 001-36483 47-1187261
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

6200 Lookout Rd.
Boulder CO80301
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (720) 643-5200 
Not Applicable
(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 obligations of the registrant under any of the following provisions:
☐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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.01 par valueMGENThe 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.
License Agreement
On December 16, 2020, Miragen Therapeutics, Inc. (the “Company”) entered into a technology license agreement (the “License Agreement”) with Xencor, Inc. (“Xencor”) under which the Company gained exclusive rights to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc technology from Xencor. Under the terms of the License Agreement, the Company will be solely responsible for the activities and costs related to research, development, and if successful, the potential commercialization of product candidates incorporating technologies licensed from Xencor. Xencor will receive an upfront payment (“Upfront Payment”), payable in shares of common stock of the Company, and is eligible to receive certain development and commercial milestone payments, as well as royalties, in each case, payable in cash.
Subscription Agreement
Concurrently with the execution of the License Agreement, on December 16, 2020, the Company and Xencor entered into a subscription agreement (“Subscription Agreement”) pursuant to which the Company agreed to issue Xencor 322,407 shares of the Company’s common stock (the “Shares”) in a private placement transaction as the Upfront Payment under the License Agreement.
The foregoing descriptions of the License Agreement and the Subscription Agreement are not complete and are qualified in their entirety by reference to the License Agreement and the Subscription Agreement, each of which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2020.
Item 3.02. Unregistered Sales of Equity Securities.
The description of the Subscription Agreement and the issuance and sale of the Shares thereunder set forth in Item 1.01 above is incorporated by reference into this Item 3.02. The Shares are being offered and sold to Xencor in a private placement that is exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).
Item 7.01. Regulation FD Disclosure.
On December 17, 2020, the Company issued a press release announcing obtaining exclusive rights to develop and commercialize antibody therapeutics targeting insulin-like growth factor-1 receptor (IGF-1R) using Xencor’s XtendTM half-life extension technology and its expectation to file an Investigational New Drug (IND) application for VRDN-002, including half-life extension, by the end of 2021. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it deemed to be incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Forward-Looking Statement
Statements in this Current Report on Form 8-K contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: half-life extension and expected IND filings and expected clinical development plans. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.


Item 9.01. Financial Statements and Exhibits.
(d) Exhibits

* * *


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.
 Miragen Therapeutics, Inc.
Date: December 17, 2020 By: /s/ Jason A. Leverone
  Jason A. Leverone
  Chief Financial Officer, Treasurer , and Secretary


 EX-99.1 2 a202012178kexhibit991.htm EX-99.1 Document

Exhibit 99.1
mgen1.jpg


miRagen Enters into License Agreement with Xencor for use of Xtend™ Antibody Technology for Investigational Antibodies to Treat Thyroid Eye Disease

Company obtains exclusive rights to develop and commercialize antibody therapeutics targeting insulin-like growth factor-1 receptor (IGF-1R) using Xencor’s Xtend™ half-life extension technology
miRagen expects to file an Investigational New Drug (IND) application for VRDN-002, including half-life extension, by the end of 2021

BOULDER, Colo, Dec. 17, 2020 -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a development-stage biotechnology company, today announced an agreement under which miRagen gains exclusive rights to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc technology from Xencor, Inc. This clinically validated technology provides for improved antibody half-life, which miRagen intends to leverage in its product candidate VRDN-002 to reduce dose and/or dosing frequency. The Company expects to file an IND for VRDN-002 by the end of 2021.
“We are excited to leverage the Xtend technology in our next-generation IGF1R antibody program VRDN-002.” said Jonathan Violin, Ph.D., President and Chief Operating Officer of miRagen. “We believe that Xtend-enabled half-life extension will facilitate our efforts to reduce dose and/or dose frequency of VRDN-002 to achieve a convenient subcutaneous injection product, and that these features will provide a valuable new option for patients suffering from Thyroid Eye Disease.”
miRagen is developing multiple product candidates to treat patients who suffer from thyroid eye disease (TED). The Company’s most advanced product candidate is intravenous VRDN-001, which pending feedback from the Food and Drug Administration, may be able to proceed directly to a phase 2 trial. VRDN-002 is a second-generation product candidate, distinct from VRDN-001, which incorporates half-life extension technology and is intended for subcutaneous administration. The Company expects in 2021 to file Investigational New Drug (IND) applications for both VRDN-001 and VRDN-002 and to initiate a Phase 2 clinical trial of VRDN-001.
Under the terms of the exclusive license agreement, miRagen will be solely responsible for the activities and costs related to research, development, and if successful, the potential commercialization of product candidates incorporating technologies licensed from Xencor. Xencor will receive an upfront payment, payable in shares of common stock of miRagen, and is eligible to receive certain development and commercial milestone payments, as well as royalties.


About Xencor's Xtend™ Fc Technology
Xtend™ Fc technology is part of Xencor’s proprietary XmAb® protein engineering platform. Xtend™ Fc domains increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexion’s Ultomiris® (ravulizumab-cwvz). For more information, please visit www.xencor.com. XmAb® is a registered trademark of Xencor, Inc.
About miRagen Therapeutics
miRagen Therapeutics is a biotechnology company advancing new treatments for patients with diseases that are underserved by today’s therapies. miRagen’s most advanced program, VRDN-001, is a clinical-stage anti-IGF-1R monoclonal antibody in development for thyroid eye disease (TED). miRagen is headquartered in Boulder, Colo., with research and development operations in Waltham, Mass.
Follow miRagen Therapeutics on social media: @miRagenRx and LinkedIn. Additional details are available at www.miragen.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: half-life extension and expected IND filings release of clinical data. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in miRagen’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information,
2




future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Investor Relations contact:
Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
617.430.7576

Media contact:
Darby Pearson
Verge Scientific Communications
dpearson@vergescientific.com
703.587.0831
3



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Boulder CO 80301 720 643-5200 false false false false Common Stock, $0.01 par value MGEN NASDAQ false XML 11 R1.htm IDEA: XBRL DOCUMENT v3.20.4
Cover
Dec. 16, 2020
Cover [Abstract]  
Document Type 8-K
Document Period End Date Dec. 16, 2020
Entity Registrant Name MIRAGEN THERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36483
Entity Tax Identification Number 47-1187261
Entity Address, Address Line One 6200 Lookout Rd.
Entity Address, City or Town Boulder
Entity Address, State or Province CO
Entity Address, Postal Zip Code 80301
City Area Code 720
Local Phone Number 643-5200
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.01 par value
Trading Symbol MGEN
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001590750
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