3 unchanged sentences
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
−Removed: Under the supervision and with the participation of our principal executive officer, principal financial officer, and other senior management personnel, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K.
−Removed: Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K.
+Added: Under the supervision and with the participation of our principal executive officer, principal financial officer, and other senior management personnel, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report.
+Added: Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report.
Management’s Report on Internal Control Over Financial Reporting
−Removed: Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal officer and principal financial officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:
−Removed: (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets, (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors, and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
+Added: Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal officer and principal financial officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S.
+Added: GAAP, and includes those policies and procedures that:
+Added: (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets, (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
+Added: GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors, and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations.
5 unchanged sentences
Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act.
−Removed: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of the end of the period covered by this Annual Report on Form 10-K.
+Added: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of the end of the period covered by this Annual Report.
Management used the framework set forth in the report entitled “Internal Control — Integrated Framework (2013 Framework)” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting.
Based on its evaluation, management concluded that our internal control over financial reporting was effective at a reasonable level of assurance as of December 31, 2020, the end of our most recent fiscal year.
−Removed: Our independent registered public accounting firm, KPMG LLP, has audited the effectiveness of our internal control over financial reporting as of December 31, 2019 , which accompanies this Annual Report .
Changes in Internal Control Over Financial Reporting
1 unchanged sentence
OTHER INFORMATION
−Removed: Not applicable.
DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
−Removed: The information required by this Item 10 will be set forth under the headings “Proposal 1 - Election of Directors,” “Executive Officers,” “Information Regarding the Board of Directors and Corporate Governance” and “Section 16(a) Beneficial Ownership Reporting Compliance” in our definitive proxy statement for our 2020 annual meeting of stockholders, or the proxy statement, which will be filed with the SEC within 120 days after December 31, 2019, and is incorporated herein by reference.
−Removed: We have adopted a written code of business conduct and ethics that applies to our directors, officers, and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.
−Removed: A current copy of the code is posted on our website, which is located at www.miragen.com .
+Added: The information required by this Item is incorporated by reference to our 2021 Proxy Statement to be filed with the SEC within 120 days after December 31, 2020.
+Added: Our board of directors has adopted a written code of business conduct and ethics that applies to our directors, officers, and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.
+Added: A current copy of the code is posted on our website, which is located at www.viridiantherapeutics.com .
If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a Current Report on Form 8-K.
EXECUTIVE COMPENSATION
−Removed: The information required by this Item 11 will be set forth under the headings “Executive Compensation” and “Information Regarding the Board of Directors and Corporate Governance” in our proxy statement and is incorporated herein by reference.
+Added: The information required by this Item is incorporated by reference to our 2021 Proxy Statement to be filed with the SEC within 120 days after December 31, 2020.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
−Removed: The information required by this Item 12 will be set forth under the headings “Security Ownership of Certain Beneficial Owners and Management” and “Securities Authorized for Issuance under the Equity Compensation Plans” in the proxy statement and is incorporated herein by reference.
+Added: The information required by this Item is incorporated by reference to our 2021 Proxy Statement to be filed with the SEC within 120 days after December 31, 2020.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
−Removed: The information required by this Item 13 will be set forth under the headings “Information Regarding the Board of Directors and Corporate Governance” and “Transactions with Related Persons” in the proxy statement and is incorporated herein by reference.
+Added: The information required by this Item is incorporated by reference to our 2021 Proxy Statement to be filed with the SEC within 120 days after December 31, 2020.
PRINCIPAL ACCOUNTING FEES AND SERVICES
−Removed: The information required by this Item 14 will be set forth under the proposal with the heading “Ratification of Selection of Independent Registered Public Accounting Firm” in the proxy statement and is incorporated herein by reference.
+Added: The information required by this Item is incorporated by reference to our 2021 Proxy Statement to be filed with the SEC within 120 days after December 31, 2020.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
5 unchanged sentences
See Exhibit Index, which is incorporated herein by reference.
−Removed: FORM 10-K SUMMARY
+Added: EXHIBIT INDEX
The exhibits listed in the Exhibit Index are required by Item 601 of Regulation S-K.
1 unchanged sentence
Incorporated by Reference
−Removed: Description of Exhibit
−Removed: Filed Herewith
+Added: Description of Exhibit Form Filing Date Number
+Added: 2.1^ Agreement and Plan of Merger, dated October 27, 2020, by and among the Registrant, Oculus Merger Sub I, Inc., Oculus Merger Sub II, LLC, and Viridian Therapeutics, Inc.
+Added: 8-K 10/28/2020 2.1
3.1 Certificate of Incorporation of the Registrant.
+Added: 10-Q 08/14/2014 3.1
3.2 Certificate of Amendment of Certificate of Incorporation of the Registrant.
+Added: S-4 12/02/2016 3.3
3.3 Certificate of Amendment of Certificate of Incorporation of the Registrant.
+Added: 8-K 02/13/2017 3.1
3.4 Certificate of Amendment of Certificate of Incorporation of the Registrant.
−Removed: Amended and Restated Bylaws of the Registrant.
+Added: 8-K 02/13/2017 3.2
+Added: 3.5 Certificate of Amendment of Certificate of Incorporation of Registrant.
+Added: 8-K 11/13/2020 3.4
+Added: 3.6 Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant, effective as of January 4, 2021.
+Added: 8-K 01/04/2021 3.1
+Added: 3.7 Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant, effective as of January 20, 2021.
+Added: 8-K 01/20/2021 3.1
+Added: 3.8 Restated Certificate of Incorporation of the Registrant , effective as of January 20, 2021.
+Added: 8-K 01/20/2021 3.2
+Added: 3.9 Amended and Restated Bylaws of the Registrant , effective as of January 20, 2021.
+Added: 8-K 01/20/2021 3.3
3.10 Amendment to the Amended and Restated Bylaws of the Registrant.
+Added: 8-K 02/13/2017 3.3
3.11 Certificate of Ownership and Merger of the Registrant.
+Added: 8-K 02/13/2017 3.4
+Added: 3.12 Certificate of Designation of Series A Non-Voting Convertible Preferred Stock.
+Added: 8-K 10/28/2020 3.1
4.1 Specimen Common Stock Certificate.
+Added: S-1 03/19/2014 4.1
4.2 Warrant to Purchase Stock between Miragen Therapeutics, Inc.
and Silicon Valley Bank, dated April 30, 2015.
+Added: 10-K 03/14/2019 4.2
4.3 Warrant to Purchase Stock between Miragen Therapeutics, Inc.
and Silicon Valley Bank, dated November 14, 2017.
+Added: 8-K 11/15/2017 10.2
4.4 Form of Warrant to Purchase Common Stock.
+Added: 8-K 02/07/2020 4.1
4.5 Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
+Added: 10.1^ License Agreement, by and between the Registrant and ImmunoGen, dated as of October 12, 2020.
+Added: 8-K 12/09/2020 10.1
+Added: 10.2^ Technology License Agreement, by and between the Registrant and Xencor, Inc., dated as of December 16, 2020.
+Added: 10.3 Subscription Agreement, by and between the Registrant and Xencor, Inc., dated as of December 16, 2020.
10.4 Form of Indemnification Agreement between Registrant and each of its directors and executive officers.
+Added: S-1 03/19/2014 10.14
10.5* Form of Indemnity Agreement between the Registrant and each of its directors and executive officers.
−Removed: Form of 2016 Equity Incentive Plan.
−Removed: Form of Stock Option Grant Notice and Stock Option Agreement under 2016 Equity Incentive Plan.
−Removed: Form of Restricted Stock Award Agreement under the 2016 Equity Incentive Plan.
−Removed: Form of 2008 Equity Incentive Plan.
−Removed: Form of Stock Option Grant Notice and Stock Option Agreement under the Registrant 2008 Equity Incentive Plan.
−Removed: 2016 Employee Stock Purchase Plan
−Removed: Amended and Restated Non-Employee Director Compensation Policy.
+Added: S-4 12/02/2016 10.32
+Added: 10.6* Employment Agreement by and between the Registrant and Jonathan Violin, dated as of January 15, 2021.
+Added: 8-K 01/20/2021 10.1
+Added: 10.7* Amended and Restated Employment Agreement, dated as of September 14, 2020, by and between the Registrant and Lee Rauch.
+Added: 8-K 09/17/2020 10.3
+Added: 10.8* Separation and Release Agreement by and between the Registrant and Lee Rauch, dated as of January 15, 2021.
+Added: 8-K 01/20/2021 10.2
10.9* Employment Agreement by and between the Registrant and William S.
Marshall, Ph.D., dated as of December 2, 2016.
+Added: S-4 12/02/2016 10.33
+Added: 10.10* Separation Agreement, dated as of October 15, 2020, by and between the Registrant and William S.
+Added: Marshall, Ph.D.
+Added: 10-Q 11/12/2020 10.2
+Added: 10.11* Consulting Agreement, dated as of October 16, 2020, by and between the Registrant and William S.
+Added: Marshall, Ph.D.
+Added: 10-Q 11/12/2020 10.3
10.12* Employment Agreement by and between the Registrant and Jason A.
Leverone, dated as of December 2, 2016.
+Added: S-4 12/02/2016 10.34
+Added: 10.13* Bonus Agreement, dated as of September 14, 2020, by and between the Registrant and Jason Leverone.
+Added: 10-Q 11/12/2020 10.4
+Added: 10.14* Employment Agreement by and between the Registrant and Barrett Katz, M.D., dated as of January 18, 2021.
10.15* Employment Agreement by and between the Registrant and Diana Escolar, M.D., dated as of February 20, 2020.
−Removed: Employment Agreement by and between the Registrant and Paul D.
−Removed: Rubin, M.D., dated as of December 2, 2016.
+Added: 10-K 03/13/2020 10.1
+Added: 10.16* Bonus Agreement, dated as of September 27, 2020, by and between the Registrant and Diana Escolar, M.D.
+Added: 8-K/A 10/01/2020 10.5
+Added: 10.17* Separation and Release Agreement, dated as of September 27, 2020 by and between the Registrant and Diana Escolar, M.D.
+Added: 10.18* Amended and Restated 2016 Equity Incentive Plan.
+Added: 10.19* Form of Stock Option Grant Notice and Stock Option Agreement under 2016 Equity Incentive Plan.
+Added: S-4 12/02/2016 10.38
+Added: 10.20* Form of Restricted Stock Award Agreement under the 2016 Equity Incentive Plan.
+Added: 10-Q 05/11/2017 10.12
+Added: 10.21* 2016 Employee Stock Purchase Plan.
+Added: S-4 12/02/2016 10.39
+Added: 10.22* Viridian Therapeutics, Inc.
+Added: 2020 Stock Incentive Plan.
+Added: S-8 11/24/2020 99.1
+Added: 10.23* Form of 2020 Incentive Stock Option Grant Notice under Viridian Therapeutics, Inc.
+Added: 2020 Stock Incentive Plan.
+Added: 10.24* Form of 2008 Equity Incentive Plan.
+Added: S-4 12/02/2016 10.48
+Added: 10.25* Form of Stock Option Grant Notice and Stock Option Agreement under the Registrant 2008 Equity Incentive Plan.
+Added: S-4 12/02/2016 10.49
10.26 Lease by and between Registrant and Crestview, LLC, dated as of December 16, 2010.
+Added: S-4 12/02/2016 10.40
10.27 First Addendum to Lease by and between Registrant and Crestview, LLC, dated as of February 18, 2015.
+Added: S-4 12/02/2016 10.40.1
10.28 Second Addendum to Lease by and between Registrant and Crestview, LLC, dated as of October 23, 2015.
+Added: S-4 12/02/2016 10.40.2
10.29 Third Addendum to Lease by and between Registrant and Crestview, LLC, dated as of January 17, 2020.
−Removed: Exclusive Patent License Agreement, dated as of April 16, 2008, by and between Registrant and Board of Regents of The University of Texas System.
−Removed: License and Collaboration Agreement, dated as of October 20, 2010, by and between Registrant and T2Cure GmbH.
−Removed: Amendment No.
−Removed: 1 to License and Collaboration Agreement, dated as of July 8, 2014, by and between Registrant and T2cure GmbH.
−Removed: Amended and Restated License Agreement, dated as of December 31, 2012, by and between Registrant and Santaris Pharma A/S.
−Removed: Amendment No.
−Removed: 1 to Amended and Restated License Agreement, effective as of August 8, 2019, by and between Registrant and Roche Innovation Center Copenhagen A/S.
−Removed: License and Collaboration Agreement, dated as of October 12, 2011, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: First Amendment of the License and Collaboration Agreement, effective as of May 13, 2013, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Second Amendment of the License and Collaboration Agreement, effective as of April 10, 2014, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Third Amendment of the License and Collaboration Agreement, effective as of May 28, 2015, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Fourth Amendment of the License and Collaboration Agreement, effective as of September 22, 2016, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Fifth Amendment of the License and Collaboration Agreement, effective as May 2, 2017, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Sixth Amendment of the License and Collaboration Agreement, effective as September 27, 2017, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Seventh Amendment of the License and Collaboration Agreement, entered into as of April 3, 2018 and effective as of March 26, 2018, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Eighth Amendment of the License and Collaboration Agreement, entered into as of January 21, 2019 and effective as of January 7, 2019, by and between Registrant and Les Laboratoires Servier, on the first part, and Institut de Recherches Servier, on the second part.
−Removed: Research Subaward Agreement, dated as of October 1, 2016, by and between Registrant and Yale University, as amended.
−Removed: Amendment to Research Subaward Agreement, effective as of October 27, 2016, by and between Registrant and Yale University.
−Removed: Amendment to Research Subaward Agreement, effective as of July 1, 2017, by and between Registrant and Yale University.
−Removed: Amendment to Research Subaward Agreement, entered into as of May 30, 2018 and effective as of May 17, 2018, by and between Registrant and Yale University, as amended.
−Removed: Amendment to Research Subaward Agreement, entered into as of June 29, 2018 and effective as of July 1, 2018, by and between Registrant and Yale University, as amended.
−Removed: Amendment to Research Subaward Agreement, entered into as of March 7, 2019 and effective as of September 1, 2018, by and between Registrant and Yale University, as amended.
−Removed: Amendment to Research Subaward Agreement, entered into as of October 11, 2019 and effective as of August 12, 2019, by and between Registrant and Yale University, as amended.
+Added: 10-K 03/13/2020 10.12.3
+Added: 10.30 Fourth Addendum to Lease by and between Registrant and Crestview, LLC, dated as of April 7, 2020.
+Added: 10-Q 05/08/2020 10.2
10.31^ Loan and Security Agreement, dated as of April 30, 2015, by and between the Registrant and Silicon Valley Bank.
+Added: S-4 12/02/2016 10.47
10.32 First Loan Modification Agreement, dated as of December 22, 2016, by and between the Registrant and Silicon Valley Bank.
+Added: S-4 01/04/2017 10.47.1
10.33 Amended and Restated Loan and Security Agreement between Miragen Therapeutics, Inc.
and Silicon Valley Bank, dated November 14, 2017.
+Added: 8-K 11/15/2017 10.1
+Added: 10.34 Deferral Agreement between Silicon Valley Bank and the Registrant effective as of April 6, 2020.
+Added: 10-Q 05/08/2020 10.4
+Added: Small Business Administration Paycheck Protection Program Note, by and between the Registrant and Silicon Valley Bank, dated April 21, 2020.
+Added: 8-K 04/27/2020 10.1
10.36 Common Stock Sales Agreement, dated March 31, 2017, by and between the Registrant and Cowen and Company, LLC.
−Removed: Common Stock Purchase Agreement, dated August 6, 2018, by and between the Registrant and The Leukemia & Lymphoma Society, Inc.
−Removed: Assignment and Assumption Agreement, dated as of October 28, 2019, by and between the Registrant, The Leukemia & Lymphoma Society, Inc.
−Removed: and LLS TAP miRagen, LLC.
+Added: 8-K 03/31/2017 10.1
10.37 Common Stock Purchase Agreement, dated December 11, 2019 between the Registrant and Aspire Capital Fund, LLC.
+Added: 8-K 12/11/2019 10.1
10.38 Registration Rights Agreement, dated December 11, 2019, by and between the Registrant and Aspire Capital Fund, LLC.
+Added: 8-K 12/11/2019 4.1
+Added: 10.39^ Securities Purchase Agreement, dated as of October 27, 2020, by and among the Registrant and each purchaser identified on Annex A thereto.
+Added: 8-K 10/28/2020 10.1
+Added: 10.40^ Registration Rights Agreement, dated as of October 30, 2020, by and among the Registrant and certain purchasers.
+Added: 10-Q 11/12/2020 4.2
21.1 Subsidiaries of the Registrant.
5 unchanged sentences
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: XBRL Instance Document
−Removed: XBRL Taxonomy Extension Schema Document
−Removed: XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: XBRL Taxonomy Extension Definition Linkbase Document
−Removed: XBRL Taxonomy Extension Label Linkbase Document
−Removed: XBRL Taxonomy Extension Presentation Linkbase Document
+Added: 101.INS** XBRL Instance Document x
+Added: 101.SCH** XBRL Taxonomy Extension Schema Document x
+Added: 101.CAL** XBRL Taxonomy Extension Calculation Linkbase Document x
+Added: 101.DEF** XBRL Taxonomy Extension Definition Linkbase Document x
+Added: 101.LAB** XBRL Taxonomy Extension Label Linkbase Document x
+Added: 101.PRE** XBRL Taxonomy Extension Presentation Linkbase Document x
+Added: 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) x
____________________
+Added: ^ Schedules have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K.
+Added: Viridian agrees to furnish supplementally a copy of any omitted schedule to the SEC upon its request;
+Added: provided, however, that Viridian may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any schedule so furnished.
Certain portions of the exhibit, identified by the mark, “[*],” have been omitted because such portions contained information that is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
* This certification is being furnished pursuant to 18 U.S.C.
−Removed: Section 1350 and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof.
−Removed: In accordance with Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: Section 1350 and is not being filed for purposes of Section 18 of the Exchange Act and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof.
+Added: ** In accordance with Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act are deemed not filed for purposes of Section 18 of the Exchange Act and otherwise are not subject to liability under these sections.
+Added: x Filed herewith.
+Added: FORM 10-K SUMMARY
+Added: VIRIDIAN THERAPEUTICS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
6 unchanged sentences
Report of Independent Registered Public Accounting Firm
−Removed: To the Stockholders and Board of Directors Miragen Therapeutics, Inc.:
+Added: To the Stockholders and Board of Directors
+Added: Viridian Therapeutics, Inc.:
Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Miragen Therapeutics, Inc.
−Removed: and subsidiaries (the Company) as of December 31, 2019 and 2018, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2019, and the related notes (collectively, the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2019, in conformity with U.S.
+Added: We have audited the accompanying consolidated balance sheets of Viridian Therapeutics, Inc.
+Added: and subsidiaries (the Company) as of December 31, 2020 and 2019, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively, the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for the years then ended, in conformity with U.S.
generally accepted accounting principles.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission,” and our report dated March 12, 2020 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
Change in Accounting Principle
−Removed: As discussed in note 2 to the consolidated financial statements, the Company has changed its method of accounting for revenue as of January 1, 2019 due to the adoption of ASC Topic 606, Revenue from Contracts with Customers.
+Added: As discussed in Note 2 to the consolidated financial statements, the Company has changed its method of accounting for Leases as of January 1, 2020 due to the adoption of ASU No.
+Added: 2016-02, Leases (Topic 842).
Basis for Opinion
1 unchanged sentence
Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
5 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Accounting acquirer in the merger with Viridian Therapeutics, Inc.
+Added: As discussed in Notes 1 and 3 to the consolidated financial statements, the Company completed a merger with Viridian Therapeutics, Inc.
+Added: (Private Viridian) on October 28, 2020.
+Added: The merger was accounted for as an asset acquisition, with the Company being identified as the accounting acquirer.
+Added: We identified the evaluation of identified accounting acquirer in the Company’s merger with Private Viridian as a critical audit matter.
+Added: Subjective auditor judgment was required to evaluate the Company’s determination of the accounting acquirer due to the subjectivity inherent in assessing the reasonableness of the accounting conclusion.
+Added: The following are the primary procedures we performed to address this critical audit matter.
+Added: We evaluated the design of certain internal controls related to the merger with Private Viridian, including a control related to
+Added: management’s determination of the accounting acquirer.
+Added: We read and evaluated the Company’s accounting memorandum that documented the factors the Company considered in determining the accounting acquirer, including voting interests held by the former shareholder groups and the composition of the board of directors and senior management of the combined Company.
+Added: We obtained and read the Merger Agreement and Purchase Agreement to identify factors relevant to the accounting acquirer determination and compared them to the Company’s accounting memorandum.
We have served as the Company’s auditor since 2009.
1 unchanged sentence
March 26, 2021
−Removed: Report of Independent Registered Public Accounting Firm
−Removed: To the Stockholders and Board of Directors Miragen Therapeutics, Inc.:
−Removed: Opinion on the Internal Control Over Financial Reporting
−Removed: We have audited Miragen Therapeutics, Inc.
−Removed: and subsidiaries (the Company) internal control over financial reporting as of December 31, 2019, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2019, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: We have also audited in accordance with the standards of the Public Company Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2019 and 2018, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2019, and the related notes (collectively, the consolidated financial statements), and our report dated March 12, 2020 expressed an unqualified opinion on those consolidated financial statements.
−Removed: Basis for Opinion
−Removed: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Controls over Financial Reporting.
−Removed: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective control over financial reporting was maintained in all material respects.
−Removed: Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating design and operating effectiveness of internal control based on the assessed risk.
−Removed: Our audits also included performing such other procedures as we considered necessary in the circumstances.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Definition and Limitations of Internal Control Over Financial Reporting
−Removed: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company;
−Removed: (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company;
−Removed: and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on financial statements.
−Removed: Because of inherent limitation, internal control over financial reporting may not prevent or detect misstatements.
−Removed: Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
−Removed: Boulder, Colorado March 12, 2020
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
3 unchanged sentences
Short-term investments 81,742 1,999
−Removed: Accounts receivable
Prepaid expenses and other current assets 1,972 2,894
1 unchanged sentence
Property and equipment, net 309 523
−Removed: Liabilities and Stockholders’ Equity
+Added: Operating lease right-of-use asset, net 478 —
+Added: Other assets 857 —
+Added: Total assets $ 131,255 $ 30,262
+Added: Liabilities, Convertible Preferred Stock, and Stockholders’ Equity
Current liabilities:
1 unchanged sentence
Accrued liabilities 9,703 5,108
−Removed: Current portion of note payable
+Added: Current portion of notes payable — 3,976
+Added: Current portion of deferred revenue 301 —
Total current liabilities 10,674 10,180
−Removed: Note payable, net of current portion
+Added: Notes payable, net of current portion — 4,328
Other liabilities 544 —
2 unchanged sentences
Stockholders’ equity:
+Added: Preferred stock, series A non-voting convertible preferred stock, $ 0.01 par value;
+Added: 435,000 shares authorized;
+Added: 398,487 and no shares issued and outstanding at December 31, 2020 and 2019, respectively
+Added: Preferred stock, $ 0.01 par value;
+Added: 5,000,000 shares authorized;
+Added: 0 shares issued and outstanding at December 31, 2020 and 2019, respectively
Common stock, $ 0.01 par value;
5 unchanged sentences
Total stockholders’ equity 120,037 15,754
−Removed: Total liabilities and stockholders’ equity
+Added: Total liabilities, preferred stock, and stockholders’ equity $ 131,255 $ 30,262
See accompanying notes to these consolidated financial statements.
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
6 unchanged sentences
General and administrative 13,265 11,646
+Added: Acquired in-process research and development 69,861 —
Total operating expenses 111,430 46,440
3 unchanged sentences
Interest and other expense ( 508 ) ( 835 )
+Added: Net loss ( 110,715 ) ( 41,873 )
Change in unrealized gain (loss) on investments ( 8 ) 3
Comprehensive loss $ ( 110,723 ) $ ( 41,870 )
+Added: Net loss $ ( 110,715 ) $ ( 41,873 )
Net loss per share, basic and diluted $ ( 31.13 ) $ ( 20.04 )
1 unchanged sentence
See accompanying notes to these consolidated financial statements.
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share data)
−Removed: Accumulated Other Comprehensive Gain (Loss)
+Added: Series A Non-Voting Convertible Preferred Stock Common Stock Additional
+Added: Capital Accumulated Other Comprehensive Gain (Loss) Accumulated
+Added: Deficit Total
Stockholders’
−Removed: Balance as of Balance at December 31, 2017
−Removed: Issuance of common stock in a public offering, net of issuance costs
+Added: Shares Amount Shares Amount
+Added: Balance as of December 31, 2018 — $ — 2,055,964 $ 21 $ 177,622 $ ( 3 ) $ ( 126,296 ) $ 51,344
+Added: Issuance of common stock pursuant to a 2019 stock purchase agreement, net of issuance costs 170,503 2 888 — — 890
Issuance of common stock under the 2017 ATM, net of issuance costs — — 43,867 — 758 — — 758
Issuance of common stock pursuant to a 2018 stock purchase agreement, net of issuance costs 40,424 — 483 — — 483
−Removed: Shares issued for cash upon the exercise of stock options under an equity incentive plan
+Added: Issuance of common stock for cash upon the exercise of stock options under equity incentive plans — — 9,617 — 87 — — 87
Issuance of common stock for cash under employee stock purchase plan — — 3,751 — 110 — — 110
Share-based compensation expense — — — — 3,970 — — 3,970
−Removed: Change in unrealized loss on investments
+Added: Reclassification of warrant liability from equity — — ( 18 ) — — ( 18 )
+Added: Change in unrealized gain on investments — — — — — 3 — 3
+Added: Net loss — — — — — — ( 41,873 ) ( 41,873 )
Balance as of December 31, 2019 — — 2,324,126 23 183,900 — ( 168,169 ) 15,754
+Added: Adjustment from adoption of ASC 842 — — — — — — ( 3 ) ( 3 )
+Added: Issuance of convertible preferred stock and common stock and warrants in a public offering, net of issuance costs 195,290 86,122 1,000,000 10 13,857 — — 99,989
+Added: Issuance of preferred and common stock upon acquisition of Viridian 203,197 94,682 72,131 1 678 — — 95,361
+Added: Adjustment for fractional shares resulting from reverse stock split and acquisition of Viridian — ( 3 ) ( 2,756 ) — ( 44 ) — — ( 47 )
Issuance of common stock pursuant to a 2019 stock purchase agreement, net of issuance costs — — 412,187 4 8,782 — — 8,786
Issuance of common stock under the 2017 ATM, net of issuance costs — — 65,004 1 669 — — 670
−Removed: Issuance of common stock pursuant to a 2018 stock purchase agreement, net of issuance costs
−Removed: Shares issued for cash upon the exercise of stock options under an equity incentive plan
+Added: Issuance of common stock to settle accrued liabilities — — 322,407 3 5,997 — — 6,000
+Added: Issuance of common stock upon exercise of warrants — — 33,333 — 550 — — 550
+Added: Issuance of common stock for cash upon the exercise of stock options under equity incentive plans — — 2,203 — 29 — — 29
Issuance of common stock for cash under employee stock purchase plan — — 2,500 — 26 — — 26
Share-based compensation expense — — — — 3,645 — — 3,645
−Removed: Reclassification of warrant liability from equity
−Removed: Change in unrealized gain on investments
+Added: Change in unrealized loss on investments — — — — — ( 8 ) — ( 8 )
+Added: Net loss — — — — — — ( 110,715 ) ( 110,715 )
Balance as of December 31, 2020 398,487 $ 180,801 4,231,135 $ 42 $ 218,089 $ ( 8 ) $ ( 278,887 ) $ 120,037
See accompanying notes to these consolidated financial statements.
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
1 unchanged sentence
Cash flows from operating activities:
+Added: Net loss $ ( 110,715 ) $ ( 41,873 )
Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Non-cash portion of acquired IPR&D 65,990 —
+Added: Issuance of common stock under license agreement 6,000 —
Share-based compensation expense 3,645 3,970
+Added: Amortization of financing issuance costs 281 —
Non-cash interest expense 263 340
9 unchanged sentences
Purchases of short-term investments ( 81,807 ) ( 32,690 )
+Added: Cash acquired in acquisition of Viridian 29,371 —
Maturities of short-term investments 2,000 61,000
−Removed: Purchases of property and equipment
−Removed: Net cash provided by (used in) investing activities
+Added: Purchases of property and equipment, net ( 42 ) ( 84 )
+Added: Other ( 3 ) —
+Added: Net cash provided by investing activities ( 50,481 ) 28,226
Cash flows from financing activities:
−Removed: Payments of principal on note payable
−Removed: Proceeds from the sale of common stock
−Removed: Payment of issuance costs associated with the sale of common stock
−Removed: Proceeds from stock purchases under employee stock purchase plan
−Removed: Proceeds from the exercise of stock options
+Added: Proceeds from the issuance of Series A preferred stock 90,997 —
+Added: Payment of issuance costs associated with the issuance of preferred stock ( 4,875 ) —
+Added: Proceeds from the issuance of common stock and warrants 25,104 2,480
+Added: Payment of issuance costs associated with the issuance of common stock and warrants ( 1,304 ) ( 77 )
+Added: Payments of principal of notes payable ( 10,293 ) ( 2,333 )
+Added: Proceeds from the issuance of notes payable 1,726 —
+Added: Fractional share payment – reverse split ( 44 ) —
Net cash provided by financing activities 101,311 70
−Removed: Net decrease in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents 21,051 ( 7,760 )
Cash and cash equivalents at beginning of period 24,846 32,606
3 unchanged sentences
Supplemental disclosure of non-cash investing and financing activities
−Removed: Change in unrealized gain (loss) on investments
Amortization of public offering costs $ 32 $ 3
See accompanying notes to these consolidated financial statements.
−Removed: MIRAGEN THERAPEUTICS, INC.
+Added: VIRIDIAN THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DESCRIPTION OF BUSINESS
−Removed: Miragen Therapeutics, Inc., a Delaware corporation (the “Company” or “miRagen”), is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need.
−Removed: The Company has three clinical stage product candidates:
−Removed: cobomarsen, remlarsen, and MRG-110.
−Removed: The Company is developing cobomarsen for the treatment of patients with certain cancers that have elevated microRNA-155, including cutaneous T-cell lymphoma and adult T-cell leukemia/lymphoma.
−Removed: Cobomarsen is an inhibitor of microRNA-155, which is found at abnormally high levels in malignant cells of several blood cancers.
−Removed: The Company is also developing remlarsen and MRG-229, which are product candidates being developed for the treatment of patients with pathological fibrosis, including idiopathic pulmonary fibrosis.
−Removed: These product candidates are replacements for microRNA-29 (“miR-29”), which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as in systemic sclerosis.
−Removed: MRG-110, an inhibitor of microRNA-92, is the Company’s product candidate for the treatment of heart failure, wound healing, and other ischemic disease.
−Removed: The Company believes its experience in microRNA biology and chemistry, drug discovery, bioinformatics, translational medicine, and drug development allows it to identify and develop microRNA-targeted drugs that are designed to regulate gene pathways to return diseased tissues to a healthy state.
−Removed: The Company believes its drug discovery and development strategy will enable it to progress its product candidates from preclinical discovery to confirmation of mechanism of action in humans quickly and efficiently.
−Removed: The elements of this strategy include identification of mechanistic biomarkers, in early-stage clinical trials to assess target engagement in humans, as well as monitoring outcomes in these early-stage clinical trials to help guide later clinical development.
−Removed: The Company has funded its operations to date principally through proceeds received from the sale of the Company’s common stock (“Common Stock”) and other equity securities, debt financings, up-front milestones, and reimbursements received under a license and collaboration agreement.
+Added: Viridian Therapeutics, Inc., a Delaware corporation (the “Company” or “Viridian”), is a biotechnology company advancing new treatments for patients with diseases that are underserved by current therapies.
+Added: The Company’s most advanced program, VRDN-001, is an intravenously administered anti-IGF-1R monoclonal antibody being developed for thyroid eye disease, a debilitating condition caused by an autoimmune reaction that causes the immune system to attack tissues in the orbital socket.
+Added: Agreement and Plan of Merger
+Added: On October 27, 2020, the Company acquired a private company, Viridian Therapeutics, Inc.
+Added: (“Private Viridian”) in accordance with the terms of the Agreement and Plan of Merger, dated October 27, 2020 (the “Merger Agreement”).
+Added: Pursuant to the Merger Agreement, Oculus Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub”), merged with and into Private Viridian, pursuant to which Private Viridian was the surviving corporation and became a wholly-owned subsidiary of the Company (the “First Merger”).
+Added: Immediately following the First Merger, Private Viridian merged with and into Oculus Merger Sub II, LLC, a Delaware limited liability company and wholly-owned subsidiary of the Company (“Second Merger Sub”), pursuant to which Second Merger Sub was the surviving entity (together with the First Merger, the “Merger”).
+Added: The Merger is intended to qualify as a tax-free reorganization for U.S.
+Added: federal income tax purposes.
+Added: On October 27, 2020, the Company completed a short-form merger under which the Second Merger Sub merged with Viridian Therapeutics, Inc (then Miragen Therapeutics, Inc.) pursuant to which Viridian Therapeutics, Inc was the surviving entity.
+Added: Under the terms of the Merger Agreement, at the closing of the Merger, the Company issued 72,131 shares of the Company’s common stock (“Common Stock”) and 203,197 shares of Series A Non-Voting Convertible Preferred Stock (the “Series A Preferred Stock”) to securityholders of Private Viridian.
+Added: Each share of Series A Preferred Stock is convertible into 66.67 shares of Common Stock, subject to certain conditions described below.
+Added: Private Placement and Securities Purchase Agreement
+Added: Concurrent with the acquisition of Private Viridian, on October 27, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers named therein, pursuant to which the Company sold an aggregate of approximately 195,290 shares of Series A Preferred Stock for an aggregate purchase price of approximately $ 91.0 million (collectively, the “Financing”).
+Added: Each share of Series A Preferred Stock is convertible into 66.67 shares of Common Stock, as described below.
+Added: The powers, preferences, rights, qualifications, limitations, and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation filed in connection with the Financing.
+Added: Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock.
+Added: Except as otherwise required by law, the Series A Preferred Stock does not have voting rights.
+Added: However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (d) increase the number of authorized shares of Series A Preferred Stock, (e) at any time while at least 30 % of the originally issued Series A Preferred Stock remains issued and outstanding, consummate a Fundamental Transaction (as defined in the Certificate of Designation) or (f) enter into any agreement with respect to any of the foregoing.
+Added: The Series A Preferred Stock does not have a preference upon any liquidation, dissolution, or winding-up of the Company.
+Added: Following stockholder approval of the conversion of the Series A Preferred Stock into shares of Common Stock in December 2020, each share of Series A Preferred Stock is convertible into 66.67 shares of Common Stock at any time at the option of the holder thereof, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.99 % and 19.99 %) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
+Added: As of December 31, 2020, no Series A Preferred Stock had been converted.
+Added: As of March 26, 2021, 43,664 shares of Series A Preferred Stock had been converted into 2,911,078 shares of Common Stock.
+Added: On October 30, 2020, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”), pursuant to which the Company agreed to register for resale the shares of Common Stock sold to investors in the Financing.
+Added: The registration statement that was filed pursuant to the Registration Rights Agreement was declared effective by the SEC on December 22, 2020 (File No.
+Added: The accompanying consolidated financial statements have been prepared on a basis that assumes the Company is a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to its ability to continue as a going concern.
+Added: The Company has funded its operations to date principally through proceeds received from the sale of the Company’s Common Stock, its Series A Preferred Stock, and other equity securities, debt financings, up-front milestones, and reimbursements received under a prior license and collaboration agreement.
Since its inception and through December 31, 2020, the Company has generated an accumulated deficit of $ 278.9 million.
+Added: The Company expects to continue to generate operating losses in the foreseeable future.
+Added: The Company has no products approved for commercial sale, has not generated any revenue from product sales, and cannot guarantee when or if it will generate any revenue from product sales.
+Added: Substantially all of the Company’s operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations.
+Added: The Company expects to incur significant expenses and operating losses for at least the next several years as it continues the clinical development of, and seeks regulatory approval for, its product candidates.
+Added: It is expected that operating losses will fluctuate significantly from quarter to quarter and year to year due to timing of clinical development programs and efforts to achieve regulatory approval.
As of December 31, 2020, the Company had approximately $ 127.6 million in cash, cash equivalents, and short-term investments.
−Removed: Based on its current operating plans, management believes that the Company’s cash, cash equivalents, and short-term investments, after giving effect to the proceeds received in sales of Common Stock subsequent to December 31, 2019 and through the date of these consolidated financial statements, will be sufficient to fund the Company’s operations into the third quarter of 2021 .
−Removed: The Company will continue to require additional capital beyond the third quarter of 2021 to continue its operations.
+Added: As of the issuance date of these consolidated financial statements, the Company expects that its current resources will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2023.
+Added: The Company will continue to require additional capital in order to continue to finance its operations.
The amount and timing of future funding requirements will depend on many factors, including the pace and results of the Company’s clinical development efforts, equity financings, entering into license and collaboration agreements, and issuing debt or other financing vehicles.
−Removed: The Company’s ability to secure additional capital is dependent upon a number of factors, some of which are outside of the Company’s control, including success in developing its technology and drug product candidates, operational performance, and market conditions.
+Added: The Company’s ability to secure additional capital is dependent upon a number of factors, some of which are outside of the Company’s control, including success in developing its technology and drug product candidates, operational performance, and market conditions, including resulting from the ongoing COVID-19 pandemic.
+Added: Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on the Company’s financial condition and its ability to develop its product candidates.
+Added: Changing circumstances may cause the Company to consume capital significantly faster or slower than currently anticipated.
+Added: If the Company is unable to acquire additional capital or resources, it will be required to modify its operational plans.
+Added: The estimates included herein are based on assumptions that may prove to be wrong, and the Company could exhaust its available financial resources sooner than currently anticipated.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
2 unchanged sentences
The Company’s subsidiaries have no employees or operations.
+Added: In February 2021, the names of these subsidiaries were changed to Viridian Therapeutics Europe Limited and Viridian Therapeutics S.à.r.l., respectively.
The consolidated financial statements have been prepared in accordance with U.S.
2 unchanged sentences
All significant intercompany balances have been eliminated in consolidation.
−Removed: The Company’s management performed an evaluation of its activities through the date of filing of these financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed.
+Added: The Company’s management performed an evaluation of its activities through the date of filing of these consolidated financial statements and concluded that there are no subsequent events requiring disclosure, other than as disclosed.
+Added: Risk and Uncertainties – Impact of the COVID-19 Pandemic
+Added: The Company is subject to risks and uncertainties as a result of the ongoing COVID-19 pandemic.
+Added: The virus continues to spread globally and has been declared a pandemic by the World Health Organization.
+Added: The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.
+Added: The spread of COVID-19 has caused the Company to modify its business practices, including implementing a work-from-home policy for all employees who are able to perform their duties remotely and restricting all nonessential travel, and it expects to continue to take actions as may be required or recommended by government authorities or as the Company determines are in the best interests of its employees, the patients it serves, and other business partners in light of COVID-19.
+Added: Potential impacts to the Company’s business include temporary closures of its facilities or those of its vendors, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing laboratory experiments and operations, and the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, and its ability to raise capital.
+Added: As of December 31, 2020, there have been no material impacts to the Company as a result of the COVID-19 pandemic.
+Added: As the impacts of COVID-19 continue to unfold, the Company will continually assess the impacts, as the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity, or results of operations in the future is uncertain.
Going Concern
8 unchanged sentences
Revenue Recognition
−Removed: Effective January 1, 2019, the Company adopted the provisions set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method.
−Removed: Under this method, there was no cumulative effect of initially applying ASC 606 to all contracts as of the date of the adoption.
+Added: The Company accounts for revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).
The Company enters into collaboration agreements and certain other agreements that are within the scope of ASC 606, under which the Company licenses, may license, or grants an option to license rights to certain of the Company’s product candidates and performs research and development services in connection with such agreements.
19 unchanged sentences
The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received.
−Removed: The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to
−Removed: the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
+Added: The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
The Company’s contracts often include development and regulatory milestone payments that are assessed under the most likely amount method and constrained if it is probable that a significant revenue reversal would occur.
26 unchanged sentences
Payments under the Company’s agreements with external service providers depend on a number of factors, such as site initiation, patient screening, enrollment, delivery of reports, and other events.
−Removed: In accruing for these activities, the Company
−Removed: obtains information from various sources and estimates the level of effort or expense allocated to each period.
+Added: In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period.
Adjustments to the Company’s research and development expenses may be necessary in future periods as its estimates change.
+Added: Acquired In-Process Research and Development
+Added: The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the assets, which includes transaction costs.
+Added: Goodwill is not recognized in asset acquisitions.
+Added: In an asset acquisition, the cost allocated to acquire in-process research and development (“IPR&D”) with no alternative future use is charged to expense at the acquisition date.
+Added: Refer to Note 3.
+Added: Acquisition of Private Viridian for a more detailed description of the accounting policy utilized for the recent asset acquisition.
Restructuring and Other Charges
2 unchanged sentences
Business restructuring charges include (i) one-time termination benefits related to employee separations, (ii) contract termination costs, and (iii) other related costs associated with exit or disposal activities including.
−Removed: In 2019, t he Company implemented two phases of a restructuring plan to streamline the organization, reduce costs, and direct resources to advance the Company’s primary operating goals.
+Added: In 2020 and 2019, t he Company implemented two phases of a restructuring plan to streamline the organization, reduce costs, and direct resources to advance the Company’s primary operating goals in place at that time.
The Company recognizes and measures a liability for one-time termination benefits, for which no future service is required, once the plan of termination meets all of the following criteria for an established communication date:
3 unchanged sentences
Share-Based Compensation
−Removed: The Company accounts for share-based compensation expense related to stock options granted to employees and members of its board of directors under its 2008 Equity Incentive Plan (the “2008 Plan”) and under its 2016 Equity Incentive Plan (the “2016 Plan”) by estimating the fair value of each stock option or award on the date of grant using the Black-Scholes option pricing model.
+Added: The Company accounts for share-based compensation expense related to stock options granted to employees, members of its board of directors, and non-employees under its 2008 Equity Incentive Plan (the “2008 Plan”), its amended and restated 2016 Equity Incentive Plan (the “2016 Plan”), and the Viridian 2020 Equity Incentive Plan (the “2020 Plan”) (collectively, the
+Added: “Equity Incentive Plans”) by estimating the fair value of each stock option or award on the date of grant using the Black-Scholes option pricing model.
The Company recognizes share-based compensation expense on a straight-line basis over the vesting term.
−Removed: The Company adopted ASU 2018-07 on January 1, 2019.
−Removed: Prior to 2019, the Company determined the value of Common Stock options issued to non-employees (other than members of its board of directors) using the Black-Scholes option pricing model and adjusting the value of such awards to current fair value each reporting period until the awards were vested or a performance commitment had otherwise been reached.
−Removed: After adoption of ASU 2018-07, non-employee stock options are valued at the award’s inception using grant-date fair value, in the same manner of stock options granted to employees.
−Removed: Any outstanding and partially vested non-employee stock option shares were remeasured on January 1, 2019.
−Removed: The adoption of this standard had an immaterial impact on the Company’s consolidated financial statements.
Cash and Cash Equivalents
9 unchanged sentences
An impairment charge would occur when a decline in the fair value of the investments below the cost basis is judged to be other-than-temporary.
−Removed: As of December 31, 2019 , the Company’s short-term available-for-sale securities had an amortized cost of $2.0 million and fair value of $2.0 million .
−Removed: As of December 31, 2018 , the Company’s short-term available-for-sale securities had an amortized cost of
−Removed: $29.9 million , fair value of $29.9 million , and an unrealized loss of $3 thousand .
−Removed: The Company had no long-term investments as of December 31, 2019 or December 31, 2018 .
Fair Value Measurements
1 unchanged sentence
In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities.
−Removed: Fair value determined by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices, for similar assets or liabilities, quoted market prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.
+Added: Fair value determined by Level 2 inputs utilizes observable inputs other than Level 1 prices, such as quoted prices, for similar assets or liabilities, quoted market prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.
Fair values determined by Level 3 inputs are unobservable data points for the asset or liability and include situations where there is little, if any, market activity for the asset or liability.
−Removed: December 31, 2019
−Removed: December 31, 2018
+Added: Level 1 Level 3 Level 1 Level 3
(in thousands)
1 unchanged sentence
treasury securities (included in short-term investments) 81,742 — 1,999 —
+Added: Total assets $ 127,702 $ — $ 27,262 $ —
Common Stock warrants (included in accrued and other liabilities) $ — $ 100 $ — $ 100
−Removed: ____________________
−Removed: Amounts presented for each period above differ from cash and cash equivalents reported in the consolidated balance sheets due to uninvested cash balances and outstanding disbursements and deposits.
−Removed: The change in the balance was due to changes in fair value.
−Removed: This adjustment was reflected in interest expense and other related expenses.
Fair Value of Financial Instruments
Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to the short-term nature of their maturities, such as cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses.
−Removed: The carrying amount of the Company’s note payable approximates its fair value (a Level 2 fair value measurement), reflecting interest rates currently available to the Company.
+Added: The carrying amount of the Company’s note payable approximated its fair value (a Level 2 fair value measurement), reflecting interest rates currently available to the Company.
The Company accounts for warrants to purchase its stock pursuant to ASC Topic 470, Debt , and ASC Topic 480, Distinguishing Liabilities from Equity , and classifies warrants for Common Stock as liabilities or equity.
−Removed: The warrants classified as liabilities are reported at their estimated fair value and any changes in fair value are reflected in interest expense and other related expenses.
+Added: The warrants classified as liabilities are reported at their estimated fair value and any changes in fair value are reflected in interest and other expense.
The warrants classified as equity are reported at their estimated fair value with no subsequent remeasurement.
+Added: The Company’s outstanding warrants are discussed in more detail in Note 11.
Concentrations of Credit Risk
6 unchanged sentences
Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally three to five years .
−Removed: Leasehold improvements are amortized over the shorter of the life of the lease (including any renewal periods that are deemed to be reasonably assured) or
−Removed: the estimated useful life of the assets.
+Added: Leasehold improvements are amortized over the shorter of the life of the lease (including any renewal periods that are deemed to be reasonably assured) or the estimated useful life of the assets.
Construction in progress is not depreciated until placed in service.
Repairs and maintenance costs are expensed as incurred and expenditures for major improvements are capitalized.
+Added: Operating Lease Right-of-Use Asset
+Added: The Company determines if an arrangement is, or contains, a lease at contract inception and during modifications or renewal of existing leases.
+Added: Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease.
+Added: The Company’s existing operating lease assets and liabilities were recognized upon the date of transition to ASC 842, on January 1, 2020.
+Added: After January 1, 2020, the Company’s operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term.
+Added: The lease payments used to determine the Company’s operating lease assets may include lease incentives, stated rent increases, and escalation clauses and are recognized in the Company’s operating lease assets in the Company’s consolidated balance sheets.
+Added: The Company’s operating leases are reflected in operating lease right-of-use asset and operating lease liability within accrued and other liabilities in the Company’s consolidated balance sheets.
+Added: Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
+Added: Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease.
+Added: Refer to Note 9.
+Added: Commitments and Contingencies - Lease Obligations Payable for additional information related to the Company’s operating leases.
+Added: Convertible Preferred Stock
+Added: The Company records shares of non-voting convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs.
+Added: The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement:
+Added: Classification and Measurement of Redeemable Securities , and at issuance classified the Series A Preferred Stock outside of shareholders’ equity because, if conversion to common stock was not approved by the shareholders, the Series A Preferred Stock would be redeemable at the option of the holders for cash equal to the closing price of the common stock on last trading day prior to the holder’s redemption request.
+Added: On December 31, 2020, the shareholders approved the conversion of the Series A Preferred Stock into common stock and as such, the Company reclassified the Series A Preferred Stock to permanent equity.
Impairment of Long-Lived Assets
3 unchanged sentences
Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of Common Stock outstanding during the period without consideration of Common Stock equivalents.
−Removed: Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods, as the inclusion of all potential common shares outstanding is antidilutive.
+Added: Since the Company was in a loss position
+Added: for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods, as the inclusion of all potential common shares outstanding is antidilutive.
Comprehensive Loss
Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on investments.
−Removed: Unrealized accumulated comprehensive gains or losses are reflected as a separate component in the statement of stockholders’ equity.
−Removed: The Company had an accumulated other comprehensive loss of $3 thousand as of December 31, 2018 , and no unrealized gain or loss as of December 31, 2019.
−Removed: The Company had no realized gains or losses during the years ended December 31, 2019 and 2018 .
+Added: Unrealized accumulated comprehensive gains or losses are reflected as a separate component in the consolidated statements of changes in stockholders’ equity.
+Added: The Company had an unrealized loss of $ 8 thousand and an unrealized gain $ 3 thousand during the years ended December 31, 2020 and 2019, respectively, and no realized gains or losses during the same corresponding periods.
The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes.
8 unchanged sentences
No such expenses have been recognized during the years ended December 31, 2020 and 2019.
−Removed: The legislation informally titled the Tax Cuts and Jobs Act of 2017 (“Tax Act”) was signed into law on December 22, 2017.
−Removed: The Tax Act includes significant changes to the U.S.
−Removed: corporate income tax system, including:
−Removed: (i) a federal corporate rate reduction from 35% to 21%;
−Removed: (ii) limitations on the deductibility of interest expense and executive compensation;
−Removed: (iii) elimination of the corporate alternative minimum tax (“AMT”) and a change in how existing AMT credits can be realized;
−Removed: (iv) change in the rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017;
−Removed: (v) reduction of the orphan drug credit from 50% to 25%;
−Removed: and (vi) transition of U.S.
−Removed: international taxation from a worldwide tax system to a territorial tax system.
−Removed: The Tax Act did not have a material impact on the Company’s consolidated financial statements primarily due to the valuation allowance recorded against its net deferred tax assets.
Segment Information
3 unchanged sentences
Recent Accounting Pronouncements – Adopted
−Removed: Revenue Recognition
−Removed: In May 2014, the FASB issued Accounting Standards Update ( “ ASU”) No.
−Removed: 2014-09 , Revenue from Contracts with Customers (Accounting Standards Codification Topic 606) , and has issued a number of clarifying ASUs subsequently, all of which outline a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance.
−Removed: The core principle of the revenue model is that “an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.” The standard provides enhancements to the quality and consistency of how revenue is reported by companies, while also improving comparability in the financial statements of companies reporting using International Financial Reporting Standards or U.S.
−Removed: The new standard requires enhanced revenue disclosures, provides guidance for transactions that were not previously addressed comprehensively, and improves guidance for multiple-element arrangements.
−Removed: Effective January 1, 2019, the Company adopted ASC 606 using the modified retrospective method approach, which consists of applying and recognizing the cumulative effect of ASC 606 at the date of initial application and providing certain additional disclosures defined per ASC 606.
−Removed: As part of this adoption, the Company completed its assessment of the Servier Collaboration Agreement under ASC 606.
−Removed: The adoption of ASC 606 did not have a material impact on the Company’s consolidated financial statements, and it did not result in a cumulative adjustment of initially applying ASC 606 to all contracts as of the date of the adoption.
−Removed: Share-based Compensation
−Removed: In June 2018, the FASB issued ASU No.
−Removed: 2018-07, Compensation — Stock Compensation (Topic 718):
−Removed: Improvements to Non-employee Share-Based Payment Accounting , which simplifies the accounting for share-based payments to non-employees by aligning it with the accounting for share-based payments to employees, with specified exceptions.
−Removed: The Company adopted this standard on January 1, 2019.
−Removed: The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
−Removed: Recent Accounting Pronouncements – Not Yet Adopted
−Removed: In February 2016, the FASB issued ASU No.
+Added: In February 2016, the FASB issued Accounting Standards Update (“ASU”) No.
2016-02 , Leases (Topic 842), and subsequent amendments to the initial guidance:
1 unchanged sentence
2018-10, and ASU No.
−Removed: 2018-11 (collectively, “Topic 842”).
−Removed: The Company adopted Topic 842 on January 1, 2020 using a modified retrospective approach.
−Removed: The Company’s building operating lease commitments are subject to the new standard, which will result in an operating lease liability of $0.3 million and a right-of-use asset of $0.3 million , with no material effect on the consolidated statements of operations and comprehensive loss.
−Removed: RESTRUCTURING PLAN
−Removed: In 2019, the Company began implementing two phases of a cost restructuring plan to streamline the organization, reduce costs, and direct resources to advance cobomarsen and miR-29 mimics, including remlarsen, while reducing investments in new discovery research.
−Removed: The restructuring plan identified approximately 44 positions for elimination, or approximately 50% of our total workforce, primarily associated with research and development and corresponding project, general, and administrative support, and other costs related to these areas.
−Removed: At December 31, 2019 , the Company had recorded approximately $2.0 million in restructuring expense and expects to incur another $0.2 million during the first half of 2020 .
−Removed: Of the $2.0 million in restructuring charges recorded during the year ended December 31, 2019 , $1.7 million was recorded in research and development expenses and $0.3 million in general and administrative expenses on the consolidated statements of operations and comprehensive loss.
−Removed: The majority of the restructuring expense related to severance and retention transactions.
−Removed: The following table summarizes the Company’s accrued restructuring liability balance and associated activity (in thousands):
−Removed: December 31, 2018
−Removed: Cash Payments
−Removed: December 31, 2019
−Removed: Severance and severance-related expenses
−Removed: Total restructuring liability
−Removed: STRATEGIC ALLIANCE AND COLLABORATION WITH SERVIER
−Removed: In October 2011, the Company entered into a license and collaboration agreement (the “Servier Collaboration Agreement”) with Les Laboratoires Servier and Institut de Recherches Servier (collectively, “Servier”) for the research, development, and commercialization of RNA-targeting therapeutics in cardiovascular disease.
+Added: 2018-11 (collectively, “ASC 842”).
+Added: The Company adopted ASC 842 on January 1, 2020, using the optional transition method permitted by ASU No.
+Added: 2018-11 in which an immaterial prior-period cumulative adjustment was recorded on January 1, 2020.
+Added: The Company’s building operating lease commitments are subject to the new standard, which resulted in an operating lease liability of $ 0.4 million and a right-of-use asset of $ 0.4 million, with no material effect on the Company’s consolidated statements of operations and comprehensive loss.
+Added: Recent Accounting Pronouncements – To Be Adopted
+Added: From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date.
+Added: The Company does not believe that the adoption of recently issued standards have or may have a material impact on the Company’s consolidated financial statements or disclosures.
+Added: ACQUISITION OF PRIVATE VIRIDIAN
+Added: On October 27, 2020, the Company completed its acquisition of Private Viridian in accordance with the terms of the Merger Agreement as discussed in Note 1.
+Added: Description of Business.
+Added: Under the terms of the Merger Agreement, the Company issued
+Added: 72,131 shares of Common Stock and 203,197 shares of Series A Preferred Stock.
+Added: Each share of Series A Preferred Stock is convertible into 66.67 shares of Common Stock, subject to certain conditions.
+Added: The Company concluded that the acquisition of Private Viridian did not result in the acquisition of a business, as substantially all of the fair value of the non-monetary assets acquired was concentrated in a single identifiable asset, the exclusive license agreement with ImmunoGen, which includes the Company’s lead program VRDN-001.
+Added: The Company determined that the cost to acquire the assets was $ 97.4 million, based on the fair value of the equity consideration issued and including direct costs of the acquisition of $ 2.0 million.
+Added: The net assets acquired in connection with the Merger were recorded at their estimated fair values as of October 27, 2020, the date the Merger was completed.
+Added: The following table summarizes the net assets acquired based on their estimated fair values as of October 27, 2020 (in thousands):
+Added: Acquired IPR&D $ 69,861
+Added: Cash and cash equivalents 29,371
+Added: Accrued liabilities ( 1,843 )
+Added: Net acquired tangible assets $ 97,389
+Added: In the estimation of fair value of the asset purchase consideration, the Company used the carrying value of the cash and cash equivalents and accrued liabilities as the most reliable indicator of fair value based on the associated short-term nature of the balances.
+Added: The remaining fair value was attributable to the acquired IPR&D.
+Added: As the asset had not yet received regulatory approval in any territory, the cost attributable to the license agreement was expensed in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2020 as the acquired IPR&D had no alternative future use, as determined by the Company in accordance with U.S.
+Added: RESTRUCTURING
+Added: In August 2019, the Company began implementing two phases of cost restructuring to streamline the organization, reduce costs, and redirect resources towards prioritized initiatives and product candidates, which provided a reduction of approximately 50 % of the Company’s workforce in place at that time, primarily associated with research and development and related administrative positions.
+Added: From August 2019 and through December 31, 2020, the Company recorded cumulative restructuring expense of $ 2.4 million.
+Added: As of December 31, 2020, the Company’s restructuring was completed, and no additional expense under the restructuring plan is expected.
+Added: The Company recorded restructuring expense of $ 0.3 million and $ 2.0 million during the years ended December 31, 2020 and 2019, respectively, which was primarily related to retention transactions and was recorded in research and development expenses on the consolidated statements of operations and comprehensive loss.
+Added: COLLABORATION AGREEMENTS
+Added: License Agreement with Zenas BioPharma
+Added: In October 2020, Private Viridian entered a license agreement with Zenas BioPharma (Cayman) Limited (“Zenas BioPharma”) to license technology comprising certain materials, patent rights, and know-how to Zenas BioPharma.
+Added: On October 27, 2020, in connection with the closing of the Private Viridian acquisition, the Company became party to the license agreement with Zenas BioPharma.
+Added: In February 2021, the Company entered into a letter agreement with Zenas BioPharma in which the Company agreed to provide assistance to Zenas BioPharma with certain manufacturing activities.
+Added: The license agreement and letter agreement (collectively, the “Zenas Agreements”) were negotiated with a single commercial objective and are treated as a combined contract for accounting purposes.
+Added: Under the terms of the Zenas Agreements, the Company granted Zenas BioPharma an exclusive license to develop, manufacture, and commercialize certain IGF-1R directed antibody products for non-oncology indications in the greater area of China.
+Added: As consideration for the Zenas Agreements, the transaction price included upfront non-cash consideration and variable consideration in the form of payment for the Company’s goods and services and milestone payments due upon the achievement of specified events.
+Added: Under the Zenas Agreements, the Company can receive non-refundable milestone payments upon achieving specific milestone events during the contract term.
+Added: Additionally, the Company may receive royalty payments based on a percentage of the annual net sales of any licensed products sold on a country-by-country basis in the greater area of China.
+Added: The royalty percentage may vary based on different tiers of annual net sales of the licensed products made.
+Added: Zenas BioPharma is obligated to make royalty payments to the Company for the royalty term in the Zenas Agreements.
+Added: The Zenas Agreements would qualify as a collaborative arrangement under the scope of Accounting Standards Codification, Topic 808, Collaborative Arrangements (“ASC 808”).
+Added: While this arrangement is in the scope of ASC 808, the Company analogized to ASC 606 to account for certain aspects of this arrangement.
+Added: The Company analogized to ASC 606 for certain activities within the arrangement associated with the Company’s transfer of a good or service (i.e., a unit of account) that is part of the Company’s ongoing major or central operations.
+Added: The Company allocated the transaction price based on the relative estimated standalone selling prices of each performance obligation or, in the case of certain variable consideration, to one or more performance obligations.
+Added: Research and development activities are priced generally at cost.
+Added: The Company’s license of goods and services to Zenas BioPharma during the contract term was determined to be a single performance obligation satisfied over time.
+Added: The Company will recognize the transaction price from the license agreement over the Company’s estimated period to complete its activities.
+Added: At the inception of the arrangement, the Company evaluated whether the milestones were considered probable of being reached and estimated the amount to be included in the transaction price using the most likely amount method.
+Added: As it was not probable that a significant revenue reversal would not occur, none of the associated milestone payments were included in the transaction price at contract inception.
+Added: For the sales-based royalties included in the arrangement, the license was deemed to be the predominant item to which the royalties relate.
+Added: The Company will recognize royalty revenues at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
+Added: During the year ended December 31, 2020, the Company recognized $ 0.1 million of collaboration revenue related to the Zenas Agreements.
+Added: The Zenas Agreements may be considered related party transactions because Tellus BioVentures, a 5% or greater stockholder of the Company (on an as-converted basis, assuming that only the shares of Series A Preferred Stock held by Tellus BioVentures are converted into shares of Common Stock), is also a 5% or greater stockholder of Zenas BioPharma and has a seat on Zenas BioPharma’s board of directors.
+Added: Servier License and Collaboration Agreement
+Added: In 2011, the Company entered into a license and collaboration agreement (the “Servier Collaboration Agreement”) with Les Laboratoires Servier and Institut de Recherches Servier (collectively, “Servier”) for the research, development, and commercialization of RNA-targeting therapeutics in cardiovascular disease.
Under the Servier Collaboration Agreement, the Company granted Servier an exclusive license to research, develop, manufacture, and commercialize RNA-targeting therapeutics for certain microRNA targets in the cardiovascular field.
−Removed: In August 2019, Servier terminated the Servier Collaboration Agreement effective in February 2020.
−Removed: During the period from receipt of notice from Servier in August 2019 and termination in February 2020, the Company completed certain activities under its development plan with Servier, which included finalizing the two Phase 1 clinical trials of MRG-110.
−Removed: The activities for which the Company is eligible for reimbursement under the Servier Collaboration Agreement are considered a research and development performance obligation and revenue are recognized in accordance with ASC 606 through the termination date.
−Removed: Accounting Analysis
+Added: In August 2019, Servier terminated the Servier Collaboration Agreement, with such termination becoming effective in February 2020.
+Added: During the period from receipt of notice from Servier in August 2019 and termination in February 2020, the Company completed certain activities under its development plan with Servier, which included finalizing two Phase 1 clinical trials of a legacy product candidate.
+Added: The activities for which the Company was eligible for reimbursement under the Servier Collaboration Agreement were considered a research and development performance obligation and revenue was recognized in accordance with ASC 606 through the termination date.
The Company evaluated the Servier Collaboration Agreement in accordance with the provisions in ASC 606.
1 unchanged sentence
The Company combined the amendments with the original agreement due to the modifications not resulting in increased promised goods or services that were distinct, and the price of the contract did not increase by an amount of consideration that reflects the Company’s standalone selling prices.
−Removed: The Company identified the following performance obligations under the Servier Collaboration Agreement:
−Removed: (i) up-front license fee for a multiple-year research collaboration, under which it jointly performed agreed upon research activities directed to the identification and characterization of named targets and oligonucleotides in the cardiovascular field (the “Research Collaboration”);
−Removed: (ii) research and development activities;
−Removed: (iii) transfer of materials;
−Removed: (iv) developmental, clinical, regulatory, and commercial sales milestone payments;
−Removed: and (v) royalties on net sales of licensed products.
−Removed: The Company acts as a principal as it controls the goods or services prior to transfer to the customer.
−Removed: The Company performed the research and development activities specified in the contracts and controlled the laboratories and resources that performed the research and development activities.
−Removed: The Company concluded that the up-front license fees were not distinct from the Research Collaboration as Servier cannot obtain the benefit of the license without the Research Collaboration.
−Removed: This performance obligation represented the licensing of Company‑owned intellectual property related to the Company’s knowledge of microRNA therapeutics for certain specific diseases, together with research activities that were interdependent with licensed intellectual property to determine feasibility of commercialization.
−Removed: As of January 1, 2019, the date of the initial application of ASC 606 by the Company, the remaining total transaction price associated with the Servier Collaboration Agreement was determined to be approximately $3.1 million consisting of maximum reimbursements of development costs under the development plan.
−Removed: During February 2019, the Joint Steering Committee approved an additional $1.0 million of development plan activities.
−Removed: As of January 1, 2019, the Company identified up to $60.4 million in development and regulatory milestones under the Servier Collaboration agreement, and the Company had recognized $7.5 million in milestone revenue through the initial application date.
−Removed: The Company utilizes the most likely amount method to estimate any development and regulatory milestone payments to be received.
−Removed: The Company considered the stage of development and the risks associated with the remaining development required to achieve these milestones, as well as whether the achievement of the milestones is outside the control of the Company.
−Removed: The Company determined that the remaining milestone payments were fully constrained, as a result of the uncertainty whether the milestones would be achieved by December 31, 2019 .
−Removed: The Company also determined that any commercial milestones and sales-based royalties will be recognized when the related sales occur and, therefore, these payments have also been excluded from the transaction price.
−Removed: The Company re-evaluates the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur.
−Removed: As of December 31, 2019 , no adjustments to the transaction price were noted.
−Removed: The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation or, in the case of certain variable consideration, to one or more performance obligations.
−Removed: Research and development activities are priced generally at the standard labor rates for the respective activity and transfer of materials are generally priced at cost.
+Added: The Company identified several performance obligations under the Servier Collaboration Agreement and allocated the transaction price to these performance obligations based on the relative estimated standalone selling prices of each performance obligation or, in the case of certain variable consideration, to one or more performance obligations.
+Added: Research and development activities are priced generally at the standard labor rates for the respective activity, and the transfer of materials is generally priced at cost.
Milestone payments are individually negotiated and because of the unique nature of each milestone, there are no comparable transactions to compare to;
therefore, the negotiated amounts of the milestones in the agreement are the standalone selling price.
−Removed: Amounts incurred and billable, but not billed to Servier, for research and related intellectual property activities totaled $0.3 million and $0.5 million as of December 31, 2019 and December 31, 2018 , respectively.
−Removed: These amounts are included in prepaid expenses and other current assets in the Company’s consolidated balance sheets.
+Added: Amounts incurred and billable, but not billed to Servier, for research and related intellectual property activities totaled $ 0.3 million as of December 31, 2019, which are included in prepaid expenses and other current assets in the Company’s consolidated balance sheets.
+Added: No amounts were incurred and billable, but not billed to Servier, for research and related intellectual property activities as of December 31, 2020.
As of December 31, 2020 and 2019, the Company had no accounts receivable balances outstanding for Servier research and related intellectual property activities.
−Removed: The amounts recognized in 2019 under ASC 606 did not differ from what the Company would have recognized under ASC 605.
Collaboration revenue under the Servier Collaboration Agreement consisted of the following:
(in thousands)
−Removed: Milestone payments
Research and development reimbursable costs $ 681 $ 4,308
−Removed: Total collaboration revenue
PROPERTY AND EQUIPMENT
8 unchanged sentences
Property and equipment, net $ 309 $ 523
−Removed: During the years ended December 31, 2019 and 2018 , depreciation and amortization expense was $0.3 million .
+Added: During the years ended December 31, 2020 and 2019, depreciation and amortization expense was $ 0.2 million and $ 0.3 million, respectively.
Depreciation and amortization expense is recorded primarily in research and development expense on the consolidated statements of operations and comprehensive loss.
3 unchanged sentences
Accrued outsourced clinical trials and preclinical studies $ 5,400 $ 2,259
−Removed: Restructuring liability
Accrued employee compensation and related taxes 1,963 508
−Removed: Accrued legal fees and expenses
Accrued other professional service fees 796 254
+Added: Operating lease liability 455 —
+Added: Accrued legal fees and expenses 380 284
Value of liability-classified stock purchase warrants 100 100
+Added: License agreement liability 86 —
+Added: Restructuring liability — 1,515
Deferred and accrued facility lease obligations — 66
−Removed: Accrued equipment and lab materials
Other accrued liabilities 523 122
3 unchanged sentences
In November 2017, the Company entered into a loan and security agreement with Silicon Valley Bank (the “2017 SVB Loan Agreement”).
−Removed: Upon entry into the 2017 SVB Loan Agreement, the Company borrowed $10.0 million with a 30 -month payment period following an 18 -month interest-only payment period ending in November 2021.
−Removed: Amounts outstanding bear interest at the prime rate ( 4.75% and 5.50% at December 31, 2019 and December 31, 2018 , respectively), with a final payment fee equal to $0.9 million due upon maturity.
−Removed: As of December 31, 2019 , no additional amounts are available under the 2017 SVB Loan Agreement.
−Removed: The Company may elect to prepay prior to maturity all or any portion of the outstanding principal amounts under the 2017 SVB Loan Agreement, subject to a prepayment charge, depending on the date of prepayment or upon the occurrence of an event of default in which the Company’s obligations to repay the outstanding principal is accelerated.
−Removed: The Company’s obligations under the 2017 SVB Loan Agreement are secured by a first-priority security interest, right, and title in all business assets, excluding the Company’s intellectual property, which is subject to a negative pledge.
−Removed: The 2017 SVB Loan Agreement includes customary representations, warranties, and covenants (affirmative and negative), including restrictive covenants that limit the Company’s ability to:
−Removed: encumber or dispose of the collateral securing the loan;
−Removed: change the business of the Company;
−Removed: transfer a material portion of the Company’s assets;
−Removed: acquire other businesses;
−Removed: and merge or consolidate with or into any other business organization;
−Removed: incur additional indebtedness;
−Removed: declare or pay any cash dividend or make a cash distribution on any class of stock or other equity interest;
−Removed: enter into specified material transactions with Company affiliates;
−Removed: make non-ordinary course payments or enter into any amendment regarding subordinated debt of the Company;
−Removed: or become an “investment company” under the Investment Company Act of 1940, as amended;
−Removed: in each case subject to specified exceptions.
−Removed: The 2017 SVB Loan Agreement also includes standard events of default, including payment defaults;
−Removed: breaches of covenants following any applicable cure period;
−Removed: material breaches of representations or warranties;
−Removed: the occurrence of a material adverse change (as defined in the 2017 SVB Loan Agreement);
−Removed: events relating to bankruptcy or insolvency;
−Removed: breaches of material third-party agreements;
−Removed: the occurrence of an unsatisfied material judgment against the Company;
−Removed: and specified governmental actions against the Company, including specified actions by the U.S.
−Removed: Food and Drug Administration.
−Removed: Upon the occurrence of an event of default, Silicon Valley Bank may declare all outstanding obligations immediately due and payable, including a prepayment charge, and take such other actions as are set forth in the 2017 SVB Loan Agreement.
−Removed: Upon the occurrence of an event of default, at the Silicon Valley Bank’s discretion, interest on the 2017 SVB Loan Agreement will accrue at 5.0% above the rate that is otherwise applicable thereto until the earlier of the repayment of the Company’s obligations under the 2017 SVB Loan Agreement or the cure of such event of default.
−Removed: Amounts outstanding under the 2017 SVB Loan Agreement were as follows:
−Removed: (in thousands)
−Removed: Principal amount outstanding
−Removed: Unamortized debt discount
−Removed: Accreted final payment fee
−Removed: Total note payable
−Removed: current maturities
−Removed: Note payable, net of current portion
−Removed: Future annual minimum principal payments under the 2017 SVB Loan Agreement as of December 31, 2019 for the respective calendar years are as follows (in thousands):
+Added: Upon entry into the 2017 SVB Loan Agreement, the Company borrowed $ 10.0 million bearing interest at the prime rate with a 30 -month payment period following an 18 -month interest-only payment period ending in November 2021.
+Added: In April 2020, the 2017 Loan Agreement was amended to extend the interest-only payment period and extended the maturity date
+Added: by an additional six months .
+Added: On December 18, 2020, the Company repaid the full outstanding loan balance, including accrued interest and a final payment fee equal to $ 0.9 million that was due upon maturity.
+Added: As of December 31, 2020, no additional amounts were outstanding under the 2017 SVB Loan Agreement.
+Added: Paycheck Protection Program Loan
+Added: In April 2020, the Company received approximately $ 1.7 million in loan funding under the Paycheck Protection Program (the “PPP”), which was established pursuant to the recently enacted Coronavirus Aid, Relief, and Economic Security Act and is administered by the U.S.
+Added: Small Business Administration.
+Added: The unsecured loan (the “PPP Loan”) was evidenced by a promissory note of the Company (the “Note”) in the principal amount of approximately $ 1.7 million to Silicon Valley Bank (the “Bank”).
+Added: Under the terms of the Note and the PPP Loan, interest accrued on the outstanding principal at the rate of 1.0 % per annum.
+Added: On December 18, 2020, the PPP Loan, including accrued interest, was repaid to the Bank.
+Added: As of December 31, 2020, there were no amounts outstanding under the PPP Loan.
COMMITMENTS AND CONTINGENCIES
−Removed: Indemnification Agreements
−Removed: The Company has entered into indemnification agreements with each of its directors and officers whereby it has agreed to indemnify such persons for certain events or occurrences while the individual is, or was, serving as a director, officer, employee, or other agent of the Company.
−Removed: The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited.
−Removed: Employment Agreements
−Removed: The Company has entered into agreements with its executives and the majority of its employees that provide for base salary, severance, eligibility for bonuses, and other generally available benefits.
−Removed: The agreements provide that the Company may terminate the employment of its employees, including executives, at any time, with or without cause.
−Removed: If an employee under an employment agreement is terminated without cause, as defined in the employment agreements, or an employee under an employment agreement resigns for good reason, as defined in the employment agreements, then the employee under the employment agreement is entitled to receive, upon the execution of a release agreement, a severance package consisting of one or more of the following provisions:
−Removed: (i) the equivalent of up to 12 months of the employee’s base salary in effect immediately prior to date of termination;
−Removed: (ii) acceleration of vesting of the equivalent of up to 12 months of vesting of the executive’s outstanding unvested stock options or other equity awards that were outstanding as of the effective date of the executive’s employment agreement;
−Removed: and (iii) up to 12 months of continued health coverage.
−Removed: If an executive is terminated without cause or resigns for good reason within one month prior to or 12 months following a change of control, as defined in the employment agreements, the executive is entitled to receive, upon the execution of a release agreement, a severance package consisting of:
−Removed: (i) the equivalent of 12 months of the executive’s base salary in effect immediately prior to date of termination;
−Removed: (ii) the vesting in full of the executive’s then-outstanding stock options or other equity awards subject to time-based vesting;
−Removed: and (iii) 12 months of continued health coverage.
−Removed: Solely in the case of the Company’s Chief Executive Officer, if such termination occurs one month before or 12 months following a change of control, then, upon the execution of a release agreement, the executive is entitled to:
−Removed: (i) the equivalent of 24 months of the executive’s base salary in effect immediately prior to the date of termination;
−Removed: (ii) the vesting in full of the executive’s outstanding stock options or other equity awards subject to time-based vesting;
−Removed: and (iii) 12 months of continued health coverage.
−Removed: License Agreement with the University of Texas
−Removed: As of December 31, 2019 , the Company had one exclusive patent license agreement (the “UT License Agreement”) with the Board of Regents of The University of Texas System (the “University of Texas”).
−Removed: Under the UT License Agreement, the University of
−Removed: Texas granted the Company exclusive and nonexclusive licenses to certain patent and technology rights.
−Removed: At the time the UT License Agreement was entered into, the University of Texas was a minority stockholder of the Company.
−Removed: In consideration of rights granted by the University of Texas, the Company is required to:
−Removed: (i) pay a nonrefundable up-front license documentation fee in the amount of $10 thousand ;
−Removed: (ii) pay an annual license maintenance fee in the amount of $10 thousand starting one year from the date of the agreement;
−Removed: (iii) reimburse the University of Texas for actual costs incurred in conjunction with the filing, prosecution, enforcement, and maintenance of patent rights prior to the effective date;
−Removed: and (iv) bear all future costs of and manage the filing, prosecution, enforcement, and maintenance of patent rights.
−Removed: During the years ended December 31, 2019 and 2018 , the Company incurred immaterial up-front and maintenance fees, which were recorded as research and development expense.
−Removed: All costs related to the filing, prosecution, and maintenance of patent and technology rights are recorded as general and administrative expense when incurred.
−Removed: Under the terms of the UT License Agreement, the Company may be obligated to make the following future milestone payments for each licensed product candidate:
−Removed: (i) up to approximately $0.6 million upon the initiation of defined clinical trials;
−Removed: (ii) $2.0 million upon regulatory approval in the United States;
−Removed: and (iii) $0.5 million per region upon regulatory approval in other specified regions.
−Removed: Additionally, if the Company or any of its sublicensees successfully commercializes any product candidate subject to the UT License Agreement, it is responsible for royalty payments in the low-single digits based upon net sales of such licensed products and payments at a percentage in the mid-teens of any sublicense income, subject to specified exceptions.
−Removed: The University of Texas’s right to these royalty payments will expire upon the expiration of the last patent claim subject to the UT License Agreement.
−Removed: During the year ended December 31, 2019 , the Company did not incur any milestone payments.
−Removed: During the year ended December 31, 2018 , the Company incurred $0.1 million in milestone payments.
−Removed: The license term extends on a product-by-product and country-by-country basis until the expiration of the last to expire of the licensed patents that covers such product in such country.
−Removed: Upon expiration of the royalty payment obligation, the Company will have a fully-paid license in such country.
−Removed: The Company may also terminate each UT License Agreement for convenience upon a specified number of days’ prior notice to the University of Texas.
−Removed: The University of Texas also has the right to earlier terminate the UT License Agreement after a defined date under specified circumstances where the Company has effectively abandoned its research and development efforts or has no sales.
−Removed: The UT License Agreement will terminate under customary termination provisions including automatic termination upon the Company’s bankruptcy or insolvency, upon notice of an uncured material breach, and upon mutual written consent.
−Removed: All charges incurred under the UT License Agreement have been expensed to date due to the uncertainty as to future economic benefit from the acquired rights.
−Removed: License Agreement with Roche Innovation Center Copenhagen A/S (formerly Santaris Pharma A/S)
−Removed: The Company is party to a license agreement with Santaris Pharma A/S, which subsequently changed its name to Roche Innovation Center Copenhagen A/S (“RICC”), which was acquired by F.
−Removed: Hoffmann-La Roche Ltd (“Roche”), in 2014.
−Removed: The agreement was entered into in June 2010, was amended in October 2011, amended and restated in December 2012, and further amended in August 2019 (the “RICC License Agreement”).
−Removed: At the time the RICC License Agreement was entered into, Roche was a minority stockholder of the Company.
−Removed: Under the RICC License Agreement, the Company has received exclusive and nonexclusive licenses from RICC to use specified technology of RICC (the “RICC Technology”) for specified uses, including research, development, and commercialization of pharmaceutical products using this technology worldwide.
−Removed: Under the RICC License Agreement, the Company has the right to develop and commercialize the RICC Technology directed to four specified targets and the option to obtain exclusive product licenses for up to six additional targets.
−Removed: The acquisition of Santaris Pharma A/S by Roche was considered a change of control under the RICC License Agreement, and as such, certain terms and conditions of the RICC License Agreement changed, as contemplated and in accordance with the RICC License Agreement.
−Removed: These changes primarily relate to milestone payments reflected in the disclosures below.
−Removed: If the Company exercises its option to obtain additional product licenses or to replace the target families, it will be required to make additional payments to RICC.
−Removed: Under the terms of the RICC License Agreement, milestone payments were previously decreased by a specified percentage as a result of the change of control by RICC referenced above.
−Removed: The Company is obligated to make milestone payments for each licensed product of up to $5.2 million , which is inclusive of a potential product license option fee.
−Removed: Certain of these milestones will be increased by a specified percentage if the Company undergoes a change of control as defined under the RICC License Agreement.
−Removed: If the Company grants a third party a sublicense to the RICC Technology, it is required to remit to Roche up to a specified percentage of the up-front, milestone, and other specified payments it receives under its sublicense, and if such sublicense covers use of the RICC Technology in the United States or the entire European Union, the Company will not have any further obligation to pay the fixed milestone payments noted above.
−Removed: During the years ended December 31, 2019 and 2018 , the Company incurred $0.1 million and $0.7 million , respectively, of expense related to a milestone reached under the RICC License Agreement, which is included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss.
−Removed: If the Company or its sublicensee successfully commercializes any product candidate subject to the RICC License Agreements, then RICC is entitled to royalty payments in the mid-single digits on the net sales of such product, provided that if such net sales are made by a sublicensee under the RICC License Agreement, RICC is entitled to royalty payments equal to the lesser of a percentage in the mid-single digits on the net sales of such product or a specified percentage of the royalties paid to the Company by such sublicensee, subject to specified restrictions.
−Removed: The Company is obligated to make any such royalty payments until the later of:
−Removed: (i) a specified anniversary of the first commercial sale of the applicable product or (ii) the expiration of the last valid patent claim licensed by RICC under the RICC License Agreement underlying such product.
−Removed: Upon the occurrence of specified events, the royalty owed to RICC will be decreased by a specified percentage.
−Removed: The RICC License Agreement will terminate upon the latest of the expiration of all of RICC’s royalty rights, the termination of the last miRagen target, or the expiration of its right to obtain a product license for a new target under the RICC License Agreement.
−Removed: The Company may also terminate the RICC License Agreement for convenience upon a specified number of days’ prior notice to RICC, subject to specified terms and conditions.
−Removed: Either party may terminate the RICC License Agreement upon an uncured material breach by the other party and RICC may terminate the RICC License Agreement upon the occurrence of other specified events immediately or after such event is not cured within a specified number of days, as applicable.
−Removed: All charges incurred under the RICC License Agreement have been expensed to date due to the uncertainty as to future economic benefit from the acquired rights.
−Removed: During the year ended December 31, 2019 , the Company made no payments to RICC for raw materials to be used in its drug manufacturing process.
−Removed: During the year ended December 31, 2018 , the Company made $0.3 million in payments to RICC for raw materials.
−Removed: Subcontract Agreement with Yale University
−Removed: The Company is party to a subcontract agreement that began in October 2014 and a subaward agreement that began in March 2015 (the “Yale Agreements”) with Yale University (“Yale”), which were subsequently amended.
−Removed: Under the Yale Agreements, the Company is providing specified services regarding the development of a proprietary compound that targets miR-29 in the indication of idiopathic pulmonary fibrosis.
−Removed: Yale entered into the Yale Agreements in connection with a grant that Yale received from the National Institutes of Health (“NIH”) for the development of a miR-29 mimic as a potential therapy for pulmonary fibrosis.
−Removed: In consideration of the Company’s services under the Yale Agreements, Yale has agreed to reimburse the Company up to a specified amount over five years , subject to the availability of funds under the grant and continued eligibility.
−Removed: Under the terms of the Yale Agreements, the Company retains all rights to any and all intellectual property developed solely by the Company in connection with the Yale Agreements.
−Removed: Yale has also agreed to provide the Company with an exclusive option to negotiate in good faith for an exclusive, royalty-bearing license from Yale for any intellectual property developed by Yale or jointly by the parties under the Yale Agreements.
−Removed: Yale is responsible for filing, prosecuting, and maintaining foreign and domestic patent applications and patents on all inventions jointly developed by the parties under the Yale Agreements.
−Removed: Through December 31, 2019 , the Company received $0.9 million under the Yale Agreements.
−Removed: The Yale Agreements terminate automatically on the date that Yale delivers its final research report to the NIH under the terms of the grant underlying the Yale Agreements.
−Removed: Each party may also terminate the Yale Agreements upon a specified number of days’ notice in the event that the NIH’s grant funding is reduced or terminated or upon material breach by the other party.
−Removed: License Agreements with the t2cure GmbH
−Removed: The Company is party to a license and collaboration agreement (the “t2cure Agreement”) that began in October 2010 with t2cure GmbH (“t2cure”), which was subsequently amended.
−Removed: Under the t2cure Agreement, the Company received a worldwide, royalty-bearing, and exclusive license to specified patent and technology rights relating to microRNA-92.
−Removed: In consideration of rights granted by t2cure, the Company paid an up-front fee of $46 thousand and the Company is obligated to:
−Removed: (i) pay an annual license maintenance fee in the amount of €3 thousand ( $3 thousand as of December 31, 2019 );
−Removed: and (ii) reimburse t2cure for costs incurred in conjunction with the filing, prosecution, enforcement, and maintenance of patent rights.
−Removed: Under the terms of the t2cure Agreement, the Company is obligated to make the following future milestone payments for each licensed product, as defined in the t2cure Agreement:
−Removed: (i) up to approximately $0.7 million upon the initiation of certain defined clinical trials;
−Removed: (ii) $2.5 million upon regulatory approval in the United States;
−Removed: and (iii) up to $1.5 million per region upon regulatory approval in the European Union or Japan.
−Removed: Additionally, if the Company or any of its sublicensees successfully commercialize any product candidate subject to the t2cure Agreement, it is responsible for royalty payments equal to percentages in the low-single digits upon net sales of licensed products, and under specified circumstances, sublicense fees equal to a percentage in the low twenties of sublicense income received by it.
−Removed: The Company is obligated to make any such royalty payment until the later of:
−Removed: (i) the tenth anniversary of the first commercial sale of the applicable product or (ii) the expiration of the last valid claim to a patent licensed by t2cure under the t2cure Agreement covering such product.
−Removed: If such patent claims expire prior to the end of the ten -year term, then the royalty owed to t2cure will be decreased by a specified percentage.
−Removed: The Company also has the right to decrease its royalty payments by a specified percentage for royalties paid to third parties for licenses to certain third-party intellectual property.
−Removed: The license term extends on a country-by-country basis until the later of:
−Removed: (i) the tenth anniversary of the first commercial sale of a licensed product in a country and (ii) the expiration of the last to expire valid claim that claims such licensed product in such country.
−Removed: Upon expiration of the royalty payment obligation, the Company will have a fully-paid license in such country.
−Removed: The Company has the right to terminate the t2cure Agreement at will, on a country-by-country basis, after 60 days’ written notice.
−Removed: The t2cure Agreement will also automatically terminate upon the Company’s bankruptcy or insolvency or upon notice of an uncured material breach.
−Removed: All charges incurred under the t2cure Agreement have been expensed to date, due to the uncertainty as to future economic benefit from the acquired rights.
−Removed: License Agreement with The Brigham and Women’s Hospital
−Removed: The Company was party to an exclusive patent license agreement (the “BWH License Agreement”) with The Brigham and Women’s Hospital (“BWH”).
−Removed: The BWH License Agreement began in May 2016 and provided the Company with an exclusive, worldwide license, including a right to sublicense, to specified patent rights and a nonexclusive, worldwide license, including a right to sublicense, to specified technology rights of BWH, each related to certain microRNAs believed to be involved in various neurodegenerative disorders.
−Removed: In December 2019, the Company delivered notice of termination to BWH of the BWH License Agreement, effective March 8, 2020.
−Removed: Per the terms of the BWH License Agreement, the Company is responsible to pay to BWH any unreimbursed, accrued or due patent costs due to BWH as of the termination date.
−Removed: Upon termination of the BWH License Agreement, the Company ceased all use of any licensed patent rights under the BWH License Agreement.
−Removed: Facility Lease
−Removed: The Company is party to a multi-year, noncancelable lease agreement that began in December 2010 for its current office and lab space.
−Removed: In January 2020, the agreement was subsequently amended to extend the term through December 2020.
+Added: License Agreement with ImmunoGen, Inc.
+Added: On October 27, 2020, in connection with the closing of the Private Viridian acquisition, the Company became party to a license agreement (the “ImmunoGen License Agreement”) with Immunogen, Inc.
+Added: (“ImmunoGen”), under which the Company obtained an exclusive, sublicensable, worldwide license to certain patents and other intellectual property rights to develop, manufacture, and commercialize certain products for non-oncology and non-radiopharmaceutical indications.
+Added: In consideration for rights granted by ImmunoGen, the Company is obligated to make certain development milestone payments of up to $ 48.0 million.
+Added: Additionally, if the Company successfully commercializes any product candidate subject to the ImmunoGen License Agreement, it is responsible for royalty payments equal to a percentage in the mid-single digits of net sales and commercial milestone payments of up to $ 95.0 million.
+Added: The Company is obligated to make any such royalty payments on a product-by-product and country-by-country basis from the first commercial sale of a specified product in each country until the later of (i) the expiration of the last patent claim subject to the ImmunoGen License Agreement in such country, (ii) the expiration of any applicable regulatory exclusivity obtained for each product in such country, or (iii) the 12th anniversary of the date of the first commercial sale of such product in such country.
+Added: License Agreement with Xencor, Inc.
+Added: On December 16, 2020, the Company entered into a license agreement (the “Xencor License Agreement”) with Xencor, Inc.
+Added: (“Xencor”), under which Xencor granted the Company rights to an exclusive, worldwide, sublicensable, non-transferable, royalty-bearing license to use specified Xencor technology for the research, development, manufacturing, and commercialization of therapeutic antibodies targeting IGF-1R indications.
+Added: In consideration for rights granted by Xencor, the Company issued 322,407 shares of its Common Stock in December 2020.
+Added: The shares were valued at $ 6.0 million and recorded as research and development expense in 2020.
+Added: Under the terms of the Xencor License Agreement, the Company is obligated to make future development milestone payments of up to $ 30.0 million.
+Added: Additionally, if the Company successfully commercializes any product candidate subject to the Xencor License Agreement, it is responsible for royalty payments equal to a percentage in the mid-single digits of net sales and commercial milestone payments of up to $ 25.0 million.
+Added: The Company is obligated to make any such royalty payments on a product-by-product and country-by-country basis from the first commercial sale of products containing the licensed technology in each country until the later of (i) the expiration of the last patent claim subject to the Xencor License Agreement in such country, (ii) the expiration of any applicable regulatory exclusivity obtained, or (iii) the 12 th anniversary of the date of the first commercial sale.
+Added: Contingent Value Rights Agreement
+Added: Pursuant to the Merger Agreement, on November 4, 2020, the Company and the Rights Agent (as defined therein) executed a contingent value rights agreement (the “CVR Agreement”), pursuant to which each holder of Common Stock as of November 6, 2020, other than former stockholders of Private Viridian, is entitled to one contractual contingent value right issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Common Stock held by such holder.
+Added: Each contingent value right entitles the holder thereof to receive certain cash payments equal to 80 % of the net proceeds, if any, related to the disposition of the Company’s legacy programs to develop product candidates that modulate microRNAs within five years following the date of the Merger.
+Added: The contingent value rights are not transferable, except in certain limited circumstances as provided in the CVR Agreement, will not be certificated or evidenced by any instrument, and will not be registered with the SEC or listed for trading on any exchange.
+Added: Lease Obligations
+Added: The Company is party to a multi-year, noncancelable lease agreement that began in December 2010 for its Colorado-based office and lab space.
The lease agreement includes rent escalation clauses through the lease term and a Company option to extend the lease term for up to two terms of three years each.
−Removed: Minimum base lease payments, including the impact of tenant improvement allowances, under the operating lease are recognized on a straight-line basis over the full term of the lease.
−Removed: During the years ended December 31, 2019 and 2018 , rent expense was $0.3 million .
−Removed: The Company is also required to pay for operating expenses related to the leased space, which were $0.3 million for the years ended December 31, 2019 and 2018 .
−Removed: Future annual minimum payments under the lease as of December 31, 2019 are $0.3 million through December 31, 2020.
+Added: Minimum base lease payments under the lease agreement, including the impact of tenant improvement allowances, are recognized on a straight-line basis over the full term of the lease.
+Added: The lease term was amended in April 2020, which extended the lease term.
+Added: As of December 31, 2020, the lease was scheduled to mature on December 31, 2021.
+Added: Upon adoption, the Company recognized a right-of-use asset and corresponding lease liability for the lease agreement of $ 0.4 million as of January 1, 2020, by calculating the present value of lease payments, discounted at 6 %, the Company’s estimated incremental borrowing rate, over the 12 months expected remaining term.
+Added: As a result of the transition to ASC 842, the Company recorded an immaterial prior-period adjustment, as a cumulative-effect adjustment, on January 1, 2020.
+Added: In April 2020, when the lease was amended, the Company accounted for the amendment as a lease modification in accordance with ASC 842, which resulted in an immaterial adjustment to the right-of-use asset and corresponding lease liability.
+Added: The interest rate implicit in the lease contract is not readily determinable and as such, the Company uses an incremental borrowing rate, based on prior borrowing rates, at the implementation date.
+Added: This is an internally developed rate that would be incurred to borrow, with similar collateral, over the term of the lease.
+Added: In connection with the acquisition of Private Viridian, the Company became party to a multi-year, noncancelable lease agreement in October 2020 for its Massachusetts-based office space.
+Added: The lease agreement included rent escalation clauses through the lease term.
+Added: Minimum base lease payments under the lease agreement are recognized on a straight-line basis over the full term of the lease.
+Added: As of December 31, 2020, the lease was scheduled to mature on February 28, 2023.
+Added: Upon assumption of the lease, the Company recognized a right-of-use asset and corresponding lease liability for the lease agreement of $ 0.1 million by calculating the present value of lease payments, discounted at 6 %, the Company’s estimated incremental borrowing rate, over the 26 months expected remaining term.
+Added: Consolidated future minimum lease payments as of December 31, 2020 were approximately $ 0.5 million through December 31, 2022.
+Added: As of December 31, 2020, the Company’s operating lease obligations were reflected as operating lease liabilities of $ 0.5 million as accrued liabilities and $ 43 thousand as other liabilities in the Company’s consolidated balance sheets.
+Added: Amortization of the operating lease right-of-use assets, and corresponding reduction of operating lease obligations, amounted to $ 0.3 million for the year ended December 31, 2020, which was included in operating expense in the consolidated statements of operations and comprehensive loss.
+Added: During the year ended December 31, 2019, lease rental expense, and the corresponding cash outflow, was approximately $ 0.3 million.
+Added: The Company is also required to pay for operating expenses related to the leased space, which were $ 0.3 million for both of the years ended December 31, 2020 and 2019.
+Added: The operating expenses are incurred separately and were not included in the present value of lease payments.
CAPITAL STOCK
−Removed: The Company is authorized to issue 105,000,000 shares of its stock, of which 100,000,000 shares have been designated as Common Stock and 5,000,000 shares have been designated as preferred stock with a par value of $0.01 per share.
+Added: Under the Company’s amended and restated certificate of incorporation, the Company is authorized to issue 205,000,000 shares of its stock, of which 200,000,000 shares have been designated as Common Stock and 5,000,000 shares have been designated as preferred stock, both with a par value of $ 0.01 per share.
The number of authorized shares of Common Stock may be increased or decreased by the affirmative vote of the holders of a majority of the Company’s stock who are entitled to vote.
1 unchanged sentence
The holders of Common Stock are entitled to receive dividends when and as declared or paid by its board of directors.
+Added: Reverse Stock Split
+Added: On November 12, 2020, the Company effected a reverse stock split of its shares of Common Stock at a ratio of 1-for-15, and trading of the Common Stock began on a split-adjusted basis on November 13, 2020.
+Added: The Common Stock continued to trade on the Nasdaq Capital Market under the ticker symbol “VRDN.” The Company’s stockholders approved the reverse stock split and granted the Company’s board of directors the authority to effect a reverse stock split at the Company’s annual meeting of shareholders held on May 21, 2020.
+Added: As a result of the reverse stock split, every 15 shares of the Company’s pre-reverse split Common Stock were combined and reclassified into one share of Common Stock.
+Added: No fractional shares were issued in connection with the reverse stock split.
+Added: In the result of any stockholders owning a fractional share, such stockholders received a cash payment in lieu of any fractional shares.
+Added: The reverse stock split did not modify any rights of the Company’s Common Stock.
+Added: The reverse stock split reduced the number of shares of Common Stock issuable upon the conversion of the Company’s outstanding shares of Series A Preferred Stock to a ratio of 66.67 and the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and caused a proportionate increase in the conversion and exercise prices of such preferred stock, stock options, and warrants.
+Added: The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the exchange ratio for all periods presented.
Common Stock Purchase Agreement - Aspire Capital Fund, LLC
1 unchanged sentence
Upon execution of the Aspire Stock Purchase Agreement, the Company sold to Aspire Capital 106,564 shares of Common Stock at $ 9.38 per share for proceeds of $ 1.0 million (the “Initial Purchase Shares”).
−Removed: As consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement and the Initial Purchase Shares, the Company issued to 959,079 shares of Common Stock to Aspire Capital as a non-refundable commitment fee, for a total issuance of 2,557,544 shares.
−Removed: In January 2020, the Company sold to Aspire Capital 2,200,000 shares Common Stock at a weighted-average price of $1.84 per share for proceeds of $4.1 million .
−Removed: As of March 13, 2020 , the Company may sell an additional $14.9 million of shares of Common Stock to Aspire Capital.
+Added: As consideration for entering into the Aspire Stock Purchase Agreement, concurrently with the execution of the Aspire Stock Purchase Agreement and the Initial Purchase Shares, the Company issued 63,938 shares of Common Stock to Aspire Capital as a non-refundable commitment fee, for a total issuance of 170,502 shares.
+Added: During the year ended December 31, 2020, the Company sold to Aspire Capital 412,187 shares of Common Stock at a weighted-average price of $ 21.35 per share for aggregate net proceeds of $ 8.8 million.
+Added: As of December 31, 2020, the Company may sell an additional $ 10.2 million of shares of Common Stock to Aspire Capital.
Under the Aspire Stock Purchase Agreement, the Company has the right, in its sole discretion, on any trading day selected by it, and within certain specified limitations, to present Aspire Capital with a purchase notice, directing Aspire Capital (as principal) to purchase up to 13,333 shares of Common Stock per business day at a per share price equal to the lesser of (i) the lowest sale price of Common Stock on the purchase date or (ii) the average of the three lowest closing sale prices for the Common Stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date.
4 unchanged sentences
There are no limits on the number of VWAP purchases that the Company may require.
−Removed: The Aspire Stock Purchase Agreement may be terminated by us at any time, at the Company’s discretion, without any cost to the Company.
+Added: The Aspire Stock Purchase Agreement may be terminated by the Company at any time, at the Company’s discretion, without any cost to the Company.
There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties, or liquidated damages in the Aspire Stock Purchase Agreement.
1 unchanged sentence
In August 2018, the Company and The Leukemia & Lymphoma Society, Inc.
−Removed: (“LLS”) entered into a Common Stock Purchase Agreement (the “LLS Stock Purchase Agreement”), which was subsequently assigned to LLS TAP miRagen, LLC (“LLS TAP”) pursuant to an Assignment and Assumption Agreement, effective October 28, 2019 (the “Assignment Agreement”), for the sale of up to $5.0 million of shares of Common Stock to LLS and its affiliates in a private placement (the “Offering”).
−Removed: Under the terms of the LLS Stock Purchase Agreement, the Company may raise up to approximately $5.0 million in gross proceeds by selling shares of Common Stock to LLS and its affiliates in up to five separate closings.
−Removed: The initial closing of the Offering was held on August 6, 2018 .
−Removed: At the initial closing, the Company issued 150,987 shares of Common Stock at a price per share equal to $ 6.62 .
−Removed: On October 31, 2019, the Company issued an additional 606,364 shares of Common Stock to LLS TAP at a price per share of approximately $0.82 .
−Removed: The Company has received aggregate net proceeds of approximately $1.4 million after expenses incurred in connection with the Offering.
−Removed: The price per share of Common Stock to be sold in any subsequent closing will be equal to the average of the volume weighted-average prices of a share of Common Stock on the Nasdaq Capital Market for the three trading days beginning with the first trading day after the date of achievement of the relevant milestone for each such closing.
−Removed: Each closing is subject to the Company’s achievement of specified operational milestones under the LLS Stock Purchase Agreement and other customary closing conditions, provided, however, that each such closing must be completed prior to December 31, 2021.
−Removed: Based on the modifications to its Phase 2 clinical trial of cobomarsen in CTCL in December 2019, the Company does not anticipate it will achieve any of the remaining milestones under the LLS Stock Purchase Agreement.
+Added: (“LLS”) entered into a Common Stock Purchase Agreement (the “LLS Stock Purchase Agreement”), which was subsequently assigned to LLS TAP Miragen, LLC (“LLS TAP”) pursuant to an Assignment and Assumption Agreement, effective October 28, 2019, for the sale of up to $ 5.0 million of shares of Common Stock to LLS and its affiliates in a private placement.
+Added: Under the terms of the LLS Stock Purchase Agreement, the Company could raise up to approximately $ 5.0 million in gross proceeds by selling shares of Common Stock to LLS and its affiliates.
+Added: From inception and through December 31, 2020, the Company issued 50,490 shares of Common Stock for net proceeds of approximately $ 1.4 million, after deducting expenses incurred in connection with the private placement.
+Added: The LLS Stock Purchase Agreement was terminated on December 11, 2020.
Common Stock Sales Agreement
1 unchanged sentence
Cowen may sell the Common Stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended, including without limitation sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company.
−Removed: Cowen will use commercially-reasonable efforts to sell the Common Stock from time to time, based
−Removed: upon instructions from the Company (including any price, time, or size limits or other customary parameters or conditions the Company may impose).
+Added: Cowen will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time, or size limits or other customary parameters or conditions the Company may impose).
The Company will pay Cowen a commission equal to 3.0 % of the gross sales proceeds of any Common Stock sold through Cowen under the ATM Agreement.
5 unchanged sentences
Since March 2017 and through December 31, 2020, the Company sold, pursuant to the terms of the ATM Agreement, an aggregate of 189,763 shares of Common Stock, at a weighted average price of $ 63.71 per share, for aggregate net proceeds of approximately $ 11.6 million, including initial expenses for executing the “at the market offering” and commissions to Cowen as sales agent.
−Removed: Common Stock Public Offerings
−Removed: In February 2018, the Company entered into an underwriting agreement relating to a public offering of its Common Stock, pursuant to which the Company sold 7,414,996 shares of Common Stock at a price of $5.50 per share, which resulted in net proceeds of approximately $37.9 million after deducting underwriting commissions and discounts and other offering expenses payable by the Company.
+Added: Common Stock Public Offering
In February 2020, the Company entered into an underwriting agreement with Oppenheimer & Co.
−Removed: (“Oppenheimer”) as the underwriter relating to a public offering of Common Stock, pursuant to which Oppenheimer purchased 15,000,000 shares of Common Stock and warrants to purchase 7,500,000 shares of Common Stock.
−Removed: Each whole warrant has an exercise price of $1.10 per share, was exercisable immediately, and expires on the fifth anniversary of the date of issuance.
+Added: (“Oppenheimer”) as the underwriter relating to a public offering of Common Stock, pursuant to which Oppenheimer purchased 1,000,000 shares of Common Stock and warrants to purchase 500,000 shares of Common Stock (the “2020 Public Offering”).
+Added: Each whole warrant has an exercise price of $ 16.50 per share and expires on the fifth anniversary of the date of issuance.
The shares of Common Stock and warrants were sold together as a fixed combination, each consisting of one share of Common Stock and one-half warrant, with each whole warrant exercisable to purchase one whole share of Common Stock but were issued separately and were immediately separable upon issuance.
−Removed: The combined price to the public in the offering for each share of Common Stock and accompanying half warrant was $1.00 , which resulted in approximately $14.0 million of net proceeds to the Company after deducting underwriting commissions and discounts and other estimated offering expenses payable by the Company and excluding.
−Removed: Series Preferred
−Removed: As of December 31, 2019 , the Company had no shares of preferred stock outstanding and had not designated any class or series of preferred stock.
+Added: The combined price to the public in the offering for each share of Common Stock and accompanying half warrant was $ 15.00 , which resulted in approximately $ 13.9 million of net proceeds to the Company after deducting underwriting commissions and discounts and other estimated offering expenses payable by the Company and excluding the proceeds from the exercise of the warrants.
+Added: Series A Preferred
+Added: As of December 31, 2020, the Company had 398,487 shares of preferred stock outstanding.
Under the Company’s amended and restated certificate of incorporation, the Company’s board of directors has the authority to designate and issue up to 5,000,000 shares of preferred stock, at its discretion, in one or more classes or series and to fix the powers, preferences and rights, and the qualifications, limitations, or restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption, and liquidation preferences, without further vote or action by the Company’s stockholders.
−Removed: As of December 31, 2019 , the Company had 46,522 Common Stock warrants outstanding at a weighted average exercise price of $17.93 .
−Removed: A summary of outstanding Common Stock purchase warrants as of December 31, 2019 is as follows:
−Removed: Number of Underlying Shares
−Removed: Exercise Price
−Removed: Expiration Date
−Removed: Stock purchase warrant activity is as follows:
+Added: Refer to Note 1.
+Added: Description of Business regarding the issuance of Series A Preferred Stock in October 2020.
+Added: Upon the issuance of warrants to purchase shares of Common Stock, the Company evaluates the terms of the warrant issue to determine the appropriate accounting and classification of the warrant issue pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity , FASB ASC Topic 505, Equity , FASB ASC 815, Derivatives and Hedging, and ASC 718, Compensation - Stock Compensation .
+Added: Warrants are classified as liabilities when the Company may be required to settle a warrant exercise in cash and classified as equity when the Company settles a warrant exercise in shares of its Common Stock.
+Added: Liability-classified warrants are valued at fair value at the date of issue and at each reporting date pursuant to FASB ASC 820, Fair Value Measurement , and are reflected as a warrant liability on the Company’s consolidated balance sheets.
+Added: Any changes in the warrant liability during each reporting period would be reflected as other expense in the consolidated statement of operations and comprehensive loss.
+Added: Number of Underlying Shares (1) Weighted-Average Exercise Price at December 31, 2020 Remaining Contractual Life at December 31, 2020
+Added: Liability-classified warrants
+Added: Issued April 2017 781 781 $ 127.95 4.33
+Added: Equity-classified warrants
+Added: Acquired October 2020 29,446 — $ 0.15 9.73
+Added: Issued February 2020 (2) 466,667 — $ 16.50 4.11
+Added: Issued November 2017 1,606 1,606 $ 107.25 3.87
+Added: Acquired February 2017 — 714 $ 787.50 —
+Added: Subtotal 497,719 2,320 $ 15.82
+Added: Total warrants 498,500 3,101 $ 16.00
+Added: ____________________
+Added: (1) If the Company subdivides (by any stock split, stock dividend, recapitalization, or otherwise) its outstanding shares of its Common Stock into a smaller number of shares, the warrant exercise price is proportionately reduced and the number of shares under outstanding warrants is proportionately increased.
+Added: Additionally, if the Company combines (by combination, reverse stock split, or otherwise) its outstanding shares of common stock into a smaller number of shares, the warrant exercise price is proportionately increased and the number of shares under outstanding warrants is proportionately decreased.
+Added: (2) Subject to specified conditions, the Company may voluntarily reduce the warrant exercise price of the warrants issued in February 2020.
+Added: A summary of the Company’s warrant activity during the year ended December 31, 2020 is as follows:
Common Stock Warrants
−Removed: Weighted Average Exercise Price
+Added: Number Weighted-Average Exercise Price
Outstanding at December 31, 2019 3,101 $ 268.95
+Added: Granted 500,000 $ 16.50
+Added: Acquired in Merger 29,446 $ 0.15
+Added: Exercised ( 33,333 ) $ 16.50
+Added: Expired ( 714 ) $ 787.50
Outstanding at December 31, 2020 498,500 $ 16.00
+Added: Equity-Classified Warrants
+Added: In connection with the Merger in 2020, the Company assumed 29,446 outstanding warrants to purchase shares of Common Stock at an exercise price of $ 0.15 per share that expire ten years from the date of issuance.
+Added: At the time of the Merger, the warrants were classified as equity and recorded at fair value with no subsequent remeasurement.
+Added: In connection with the Company’s 2020 Public Offering, the Company issued warrants to purchase 500,000 shares of its Common Stock at a price of $ 16.50 per share that expire five years from the date of issuance (the “Warrants”).
+Added: The terms of the warrants include certain provisions related to fundamental transactions, a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions.
+Added: Therefore, the Warrants were classified as equity with no subsequent remeasurement as long as the warrants continued to be classified as equity.
+Added: On November 6, 2020, warrants were exercised to purchase 33,333 shares of Common Stock for proceeds of approximately $ 0.5 million.
+Added: In connection with a debt financing in 2017, the Company issued detachable warrants to purchase up to 1,606 shares of the Company’s Common Stock at an exercise price of $ 107.25 per share that expire seven years from the date of issuance.
+Added: At issuance, the warrants were classified as equity and recorded at fair value with no subsequent remeasurement.
SHARE-BASED COMPENSATION
Equity Incentive Plans
−Removed: As of December 31, 2019 , there were 1,305,678 options outstanding and no remaining equity awards available for future issuances under the 2008 Plan.
−Removed: All awards granted under the 2008 Plan that, after February 13, 2017, expire or terminate for any reason prior to exercise or settlement, are forfeited, or are reacquired, withheld, or not issued to satisfy a tax withholding obligation or to satisfy the exercise price of a stock award, will become available for grant under the 2016 Plan in accordance with its terms.
+Added: Upon closing of the Merger, the Company assumed all outstanding options issued under the 2020 Plan.
+Added: The terms and conditions for each assumed option were substantially the same as prior to the Merger, including that the assumed options remained subject to the terms and conditions of the 2020 Plan, provided that each assumed option are exercisable for shares of the Company’s Common Stock and the number of shares issuable upon exercise of, and the exercise price per share for, each assumed option has been appropriately adjusted to give effect to the Merger.
+Added: As of December 31, 2020, the Company had the following balances by plan:
+Added: Stock Options Outstanding Restricted Stock Units Outstanding Shares Available for Issuance
+Added: 2020 Plan 659,028 — 1,151,920
+Added: 2016 Plan 304,438 — 3,419,368
+Added: 2008 Plan 69,790 — —
+Added: Total 1,033,256 — 4,571,288
The 2016 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, other stock awards, and performance awards that may be settled in cash, stock, or other property.
All employees and non-employee directors are eligible to participate in the 2016 Plan and may receive all types of awards other than incentive stock options.
−Removed: Incentive stock options may be granted under the 2016 Plan only to employees (including officers) and employees of the Company’s affiliates.
−Removed: The aggregate number of shares of Common Stock that may be issued under the 2016 Plan will not exceed 4,182,404 shares, which number is the sum of:
−Removed: (i) 1,681,294 shares, plus (ii) the number of shares subject to outstanding stock awards that were granted under the 2008 Plan, that, from and after February 13, 2017, expire or terminate for any reason prior to exercise or settlement, are forfeited because of the failure to meet a contingency or condition required to vest such shares, or are reacquired, withheld, or not issued to satisfy a tax withholding obligation in connection with an award or to satisfy the purchase price or exercise price of a stock award, if any, as such shares become available from time to time, plus (iii) shares from automatic increases to the share reserve, as described in more detail below.
−Removed: In accordance with the 2016 Plan, the share reserve will automatically increase on January 1 of each year, for a period of not more than ten years , commencing on January 1 of the year following the year in which the effective date of the 2016 Plan occurs, and ending on (and including) January 1, 2026, in an amount equal to 4% of the shares of Common Stock outstanding on December 31 of the preceding calendar year;
−Removed: however, the board of directors or compensation committee may act prior to January 1 of a given year to provide that there will be no January 1 increase in the share reserve for such year or that the increase in the share reserve for such year will be a lesser number of shares of Common Stock than would otherwise occur pursuant to the automatic increase.
−Removed: On January 1, 2020 , the share reserve automatically increased by 1,394,475 shares.
−Removed: Cumulative increases to the share reserve through January 1, 2020 consisted of 3,530,773 shares.
−Removed: As of December 31, 2019 , there were outstanding stock options to purchase 2,190,922 shares of Common Stock and 1,826,218 shares of Common Stock available for issuance pursuant to the terms under the 2016 Plan.
−Removed: Options granted under the 2008 Plan and the 2016 Plan have an exercise price equal to the market value of the Common Stock at the date of grant and expire ten years from the date of grant.
+Added: Incentive stock options may be granted under the 2016 Plan only to employees and employees of the Company’s affiliates.
+Added: Pursuant to the 2016 Plan, the aggregate number of shares of Common Stock that may be issued will not exceed 3,419,368 shares.
+Added: Subsequent to December 31, 2020, any awards granted under the 2016 Plan that expire or terminate subsequent to December 31, 2020, for any reason prior to exercise or settlement, are forfeited, or are reacquired, withheld, or not issued to satisfy a tax withholding obligation or to satisfy the exercise price of a stock award, will become available for grant under the 2016 Plan in accordance with its terms.
+Added: Similarly, any shares of Common Stock issued pursuant to a stock award under the 2020 Plan that are forfeited, repurchased by the Company, or reacquired by the Company in satisfaction of tax withholding obligations will become available for grant under the 2020 Plan.
+Added: Options granted under the Equity Incentive Plans have an exercise price equal to the market value of the Common Stock at the date of grant and expire ten years from the date of grant.
Generally, options vest 25 % on the first anniversary of the vesting commencement date and 75 % ratably in equal monthly installments over the remaining 36 months.
1 unchanged sentence
A summary of Common Stock option activity is as follows:
−Removed: Number of Options
−Removed: (in thousands)
−Removed: Weighted Average Exercise Price
−Removed: Weighted Average Remaining Contractual Term
−Removed: Aggregate Intrinsic Value
+Added: Number of Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term
+Added: (years) Aggregate Intrinsic Value
(in thousands)
Outstanding at December 31, 2019 233,173 $ 77.85 5.91 $ —
−Removed: Forfeited or expired
−Removed: Outstanding at December 31, 2018
+Added: Granted 889,243 $ 3.59
+Added: Exercised ( 2,203 ) $ 12.98
Forfeited or expired ( 86,957 ) $ 62.92
Outstanding at December 31, 2020 1,033,256 $ 15.34 8.56 $ 11,427
−Removed: Vested or expected to vest at December 31, 2019
+Added: Vested or expected to vest as of December 31, 2020 1,033,256 $ 15.34 8.56 $ 11,427
Exercisable as of December 31, 2020 181,160 $ 66.75 4.79 $ 84
Vested as of December 31, 2020 181,160 $ 66.75 4.79 $ 84
−Removed: The total intrinsic value of stock options exercised during the year ended December 31, 2019 and 2018 was $0.1 million and $1.6 million , respectively.
−Removed: Cash received from the exercise of stock options during the year ended December 31, 2019 and 2018 was approximately $0.1 million and $0.2 million , respectively.
Fair Value Assumptions
The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options granted under its equity compensation plans.
−Removed: The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility, and expected lives of the options.
+Added: The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility, and expected
+Added: lives of the options.
Because the Company has a limited history of stock purchase and sale activity, expected volatility is based on historical data from public companies that are similar to the Company in size and nature of operations.
16 unchanged sentences
(i) the closing price at the beginning of the offering period or (ii) the closing price at the end of the offering period.
−Removed: The Company expects that a new 6 -month offering period will begin each August 22 and February 22.
−Removed: As of December 31, 2019 , the Company had 622,346 shares available for issuance and 121,890 shares had been issued under the ESPP.
+Added: New six-month offering periods begin each August 22 and February 22.
+Added: As of December 31, 2020, the Company had 62,231 shares available for issuance and 10,626 cumulative shares had been issued under the ESPP.
Share-Based Compensation Expense
−Removed: Share-based compensation related to all equity awards issued pursuant to the 2008 Plan and 2016 Plan and for estimated shares to be issued under the ESPP for the purchase periods active during each respective period is included in the consolidated statements of operations and comprehensive loss as follows:
+Added: Share-based compensation related to all equity awards issued pursuant to the Equity Incentive Plans and for estimated shares to be issued under the ESPP for the purchase periods active during each respective period is included in the consolidated statements of operations and comprehensive loss as follows:
(in thousands)
9 unchanged sentences
(in thousands)
+Added: Series A Preferred Stock 26,567 —
Options to purchase Common Stock 1,033 233
Warrants to purchase Common Stock 499 3
+Added: Total 28,099 236
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse.
8 unchanged sentences
Change in valuation allowance 15.8 ( 31.3 )
+Added: IPR&D ( 12.9 ) 0.0
Other permanent items ( 0.9 ) ( 3.9 )
−Removed: Change in tax rate
+Added: Section 382 limit ( 24.9 ) —
+Added: Other, net 0.2 0.4
Effective income tax rate — % — %
2 unchanged sentences
(in thousands)
+Added: Deferred tax assets:
Net operating loss carryforwards $ 22,622 $ 32,792
+Added: Tax credits 494 10,812
Accruals and reserves 2,037 829
1 unchanged sentence
Start-up costs 2,467 605
−Removed: Gross deferred tax assets
+Added: Total deferred tax assets 29,191 46,240
Valuation allowance ( 29,073 ) ( 46,240 )
Net deferred tax assets 118 —
+Added: Deferred tax liabilities:
+Added: Operating lease right-of-use asset, net ( 118 ) —
+Added: Total deferred tax liabilities ( 118 ) —
+Added: Total deferred tax assets, net $ — $ —
At December 31, 2020, the Company had approximately $ 104.1 million and $ 0.5 million of net operating loss and research and experimentation tax carryforwards, respectively, which will begin to expire in 2029.
6 unchanged sentences
The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment.
−Removed: As the Company does not have any historical taxable income or projections of future taxable
−Removed: income over the periods in which the deferred tax assets are deductible, and after consideration of its history of operating losses, the Company does not believe it is more likely than not that it will realize the benefits of its net deferred tax assets, and accordingly, has established a valuation allowance equal to 100% of its net deferred tax assets at December 31, 2019 and 2018 .
+Added: As the Company does not have any historical taxable income or projections of future taxable income over the periods in which the deferred tax assets are deductible, and after consideration of its history of operating losses, the Company does not believe it is more likely than not that it will realize the benefits of its net deferred tax assets, and accordingly, has established a valuation allowance equal to 100 % of its net deferred tax assets at December 31, 2020 and 2019.
The change in valuation allowance was an increase of $ 17.2 million in 2020 and an increase of $ 13.1 million in 2019.
−Removed: The Company has concluded that there were no significant uncertain tax positions relevant to the jurisdictions where it is required to file income tax returns requiring recognition in the consolidated financial statements for the years ended 2019 and 2018 .
+Added: The Company concluded that there were no significant uncertain tax positions relevant to the jurisdictions where it is required to file income tax returns requiring recognition in the consolidated financial statements for the years ended 2020 and 2019.
As of December 31, 2020 and 2019, the Company had no accrued interest related to uncertain tax positions.
The Company’s federal and state returns for 2014 through 2020 remain open to examination by tax authorities.
−Removed: SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
−Removed: The tables below summarize the Company’s unaudited quarterly operating results for the year ended December 31, 2019 :
−Removed: For the Quarters Ended
−Removed: (unaudited, in thousands)
−Removed: Research and development expenses
−Removed: General and administrative expenses
−Removed: Other income (expense), net
−Removed: Comprehensive loss
−Removed: Net loss per share, basic and diluted
−Removed: ____________________
−Removed: Restructuring charges of $1.1 million were recorded during the quarter, of which $0.9 million was recorded in research and development expenses and $0.2 million recorded in general and administrative expenses.
−Removed: Restructuring charges of $0.9 million were recorded during the quarter, of which $0.8 million was recorded in research and development expenses and $0.1 million recorded in general and administrative expenses.
−Removed: The tables below summarize the Company’s unaudited quarterly operating results for the year ended December 31, 2018 :
−Removed: For the Quarters Ended
−Removed: (unaudited, in thousands)
−Removed: Research and development expenses
−Removed: General and administrative expenses
−Removed: Other income (expense), net
−Removed: Comprehensive loss
−Removed: Net loss per share, basic and diluted
+Added: SUBSEQUENT EVENTS
+Added: Conversion of Series A Preferred Stock
+Added: Subsequent to December 31, 2020, a total of 43,664 shares of Series A Preferred Stock were converted by certain holders into 2,911,078 shares of Common Stock.
+Added: As a result, the Company’s total shares of Common Stock outstanding on an as-converted
+Added: basis as of March 26, 2021 was approximately 30,886,700 , which includes 7,230,651 shares of Common Stock outstanding and 23,656,049 shares of Common Stock issuable upon the conversion of 354,823 shares of Series A Preferred Stock.
+Added: Resignation of Chief Executive Officer and Director
+Added: On January 20, 2021, the Company announced that Lee Rauch resigned from her positions as chief executive officer and principal executive officer of the Company, effective as of January 15, 2021 (the “Separation Date”).
+Added: Pursuant to the separation agreement, Ms.
+Added: Rauch will be entitled to receive severance and other benefits in accordance with her agreements.
+Added: Following her separation from the Company, Ms.
+Added: Rauch has been serving as a consultant to the Company.
+Added: Appointment of new Chief Executive Officer and Director
+Added: On January 15, 2021, the board of directors appointed Jonathan Violin as the Company’s chief executive officer, president, and principal executive officer, effective as of January 15, 2021.
+Added: Additionally, the board of directors appointed Dr.
+Added: Violin as a member of the board of directors of the Company, effective as of January 15, 2021.
+Added: In connection with his appointment as chief executive officer, Dr.
+Added: Violin entered into a new employment agreement with the Company and resigned from his role as chief operating officer.
Pursuant to the requirements of Section 13 or 15(d) 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.
−Removed: MIRAGEN THERAPEUTICS, INC.
−Removed: March 13, 2020
−Removed: /s/ William S.
−Removed: Marshall, Ph.D.
−Removed: Chief Executive Officer
+Added: VIRIDIAN THERAPEUTICS, INC.
+Added: March 26, 2021 By:
+Added: /s/ Jonathan Violin
+Added: Jonathan Violin
+Added: President, Chief Executive Officer, and Director
(Principal Executive Officer)
−Removed: March 13, 2020
+Added: March 26, 2021 By:
+Added: /s/ Jason Leverone
+Added: Jason Leverone
Chief Financial Officer
−Removed: (Principal Financial Officer;
−Removed: Principal Accounting Officer)
−Removed: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints William S.
−Removed: Marshall and Jason A.
−Removed: Leverone, and each of them, as his or her attorneys-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, and each of them, or his substitute or substitutes may do or cause to be done by virtue hereof.
+Added: (Principal Financial and Accounting Officer)
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jonathan Violin and Jason Leverone, and each of them, as his or her attorneys-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, and each of them, or his substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of l934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
−Removed: /s/ William S.
−Removed: President, Chief Executive Officer, and Director
−Removed: March 13, 2020
−Removed: Marshall, Ph.D.
−Removed: (Principal Executive Officer)
−Removed: Chief Financial Officer, Treasurer, and Secretary
−Removed: March 13, 2020
−Removed: (Principal Financial Officer;
−Removed: Principal Accounting Officer)
−Removed: /s/ Jeffrey S.
−Removed: Chairman of the Board
−Removed: March 13, 2020
−Removed: /s/ Christopher Bowden
−Removed: March 13, 2020
−Removed: Christopher Bowden, M.D.
−Removed: /s/ Thomas E.
−Removed: March 13, 2020
−Removed: Hughes, Ph.D.
−Removed: /s/ Kevin Koch
−Removed: March 13, 2020
−Removed: Kevin Koch, Ph.D.
−Removed: /s/ Arlene M.
−Removed: March 13, 2020
−Removed: /s/ Joseph L.
−Removed: March 13, 2020
+Added: Signature Title Date
+Added: /s/ Jonathan Violin President, Chief Executive Officer, and Director March 26, 2021
+Added: Jonathan Violin (Principal Executive Officer)
+Added: /s/ Jason Leverone Chief Financial Officer, Treasurer, and Secretary March 26, 2021
+Added: Jason Leverone (Principal Financial and Accounting Officer)
+Added: /s/ Jeffrey Hatfield Chairman of the Board March 26, 2021
+Added: Jeffrey Hatfield
+Added: /s/ Peter Harwin Director March 26, 2021
+Added: /s/ Tomas Kiselak Director March 26, 2021
+Added: Tomas Kiselak
+Added: /s/ Arlene Morris Director March 26, 2021
+Added: Arlene Morris
+Added: /s/ Joseph Turner Director March 26, 2021
+Added: Joseph Turner
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.