Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosures. 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. 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. 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
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. GAAP, and includes those policies and procedures that: (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. 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.
67
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
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. 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, 2022, the end of our most recent fiscal year.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially effect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTION
Not applicable.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
The information required by this Item is incorporated by reference to our 2023 Proxy Statement to be filed with the SEC within 120 days after December 31, 2022.
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. 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.
68
PART III
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item 11 is incorporated herein by reference to our 2023 Proxy Statement, including under headings “Executive Compensation” and “Directors, Executive Officers and Corporate Governance.”
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this Item 12 is incorporated herein by reference to our 2023 Proxy Statement, including under headings “Security Ownership of Certain Beneficial Owners and Management” and “Securities Authorized for Issuance Under Equity Compensation Plans.”
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The information required by this Item 13 is incorporated herein by reference to our 2023 Proxy Statement, including under headings “Directors, Executive Officers and Corporate Governance” and “Transactions with Related Persons.”
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item 14 is incorporated herein by reference to our 2023 Proxy Statement, including under the heading “Ratification of Selection of Independent Registered Accounting Firm.”
69
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)(1) Financial Statements
The financial statements required by this item are submitted in a separate section beginning on page F-1 of this Annual Report.
(a)(2) Financial Statement Schedules
Financial statement schedules have been omitted because they are either not required, not applicable, or the information is otherwise included.
(a)(3) Exhibits
See Exhibit Index, which is incorporated herein by reference.
EXHIBIT INDEX
The exhibits listed in the Exhibit Index are required by Item 601 of Regulation S-K. The SEC file number for all items incorporated by reference herein from reports on Forms 10-K, 10-Q, and 8-K is 001-36483.
Incorporated by Reference
Exhibit No. Description of Exhibit Form Filing Date Number
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.
8-K 10/28/2020 2.1
3.1 Second Restated Certificate of Incorporation of the Registrant, effective as of March 9, 2022
10-K 03/11/2022 3.1
3.2 Amended and Restated Bylaws of the Registrant, effective as of May 11, 2022.
10-Q 05/13/2022 3.2
3.3 Certificate of Designation of Series A Non-Voting Convertible Preferred Stock.
8-K 10/28/2020 3.1
3.4 Certificate of Designation of Series B Non-Voting Convertible Preferred Stock.
8-K 09/23/2021 3.1
4.1 Specimen Common Stock Certificate.
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.
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.
8-K 11/15/2017 10.2
4.4 Form of Warrant to Purchase Common Stock.
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.
x
10.1^ License Agreement, by and between the Registrant and ImmunoGen, dated as of October 12, 2020.
8-K 12/09/2020 10.1
10.2^ Technology License Agreement, by and between the Registrant and Xencor, Inc., dated as of December 16, 2020.
10-K 03/26/2021 10.2
10.3 Subscription Agreement, by and between the Registrant and Xencor, Inc., dated as of December 16, 2020.
10-K 03/26/2021 10.3
10.4 Subscription Agreement, by and between the Registrant and Xencor, dated as of December 2, 2021.
10-K 03/11/2022 10.4
10.5+ Form of Indemnity Agreement between the Registrant and each of its directors and executive officers.
S-4 12/02/2016 10.32
10.6+ Barre t t Katz, M.D. Employment Agreement , dated January 18, 2021.
10-K 03/26/2021 10.14
10.7+ Kristian Humer Employment Agreement, dated June 9, 2021
8-K 07/26/2021 10.1
10.8+ Carrie Melvin Employment Agreement, dated May 25, 2022.
8-K 06/23/2022 10.1
70
10.9+ Scott Myers Employment Agreement, dated December 29, 2022
8-K 02/06/2023 10.1
10.10+ Jonathan Violin General Release and Separation and Consulting Agreement, dated February 6, 2023
8-K 02/06/2023 10.2
10.11+ Viridian Therapeutics, Inc. Amended & Restated 2016 Equity Incentive Plan.
10-Q 08/15/2022 10.3
10.12+ Form of Stock Option Grant Notice and Stock Option Agreement under 2016 Equity Incentive Plan.
S-4 12/02/2016 10.38
10.13+ Form of Restricted Stock Award Agreement under the 2016 Equity Incentive Plan.
10-Q 05/11/2017 10.12
10.14+ 2016 Employee Stock Purchase Plan.
S-4 12/02/2016 10.39
10.15+ Viridian Therapeutics, Inc. 2020 Stock Incentive Plan.
S-8 11/24/2020 99.1
10.16+ Form of 2020 Incentive Stock Option Grant Notice under Viridian Therapeutics, Inc. 2020 Stock Incentive Plan.
10-K 03/26/2021 10.23
10.17+ Form of 2008 Equity Incentive Plan.
S-4 12/02/2016 10.48
10.18+ Form of Stock Option Grant Notice and Stock Option Agreement under the Registrant 2008 Equity Incentive Plan.
S-4 12/02/2016 10.49
10.19 Lease by and between Registrant and Crestview, LLC, dated as of December 16, 2010.
S-4 12/02/2016 10.40
10.20 First Addendum to Lease by and between Registrant and Crestview, LLC, dated as of February 18, 2015.
S-4 12/02/2016 10.40.1
10.21 Second Addendum to Lease by and between Registrant and Crestview, LLC, dated as of October 23, 2015.
S-4 12/02/2016 10.40.2
10.22 Third Addendum to Lease by and between Registrant and Crestview, LLC, dated as of January 17, 2020.
10-K 03/13/2020 10.12.3
10.23 Fourth Addendum to Lease by and between Registrant and Crestview, LLC, dated as of April 7, 2020.
10-Q 05/08/2020 10.2
10.24 Fifth Addendum to Lease by and between Registrant and Crestview LLC, dated as of March 26, 2021.
10-Q 08/12/2021 10.4
10.25 Waltham Lease between Registrant and Watch City Ventures MT, LLC dated as of January 13, 2020 .
10-Q 11/05/2021 10.1
10.26 First Amendment to Waltham Lease between Registrant and Watch City Ventures MT, LLC dated as of July 6, 2021.
10-Q 11/05/2021 10.4
10.27 Second Amendment to Lease by and between the Registrant and Watch City Ventures MT, LLC dated as of April 13, 2022.
10-Q 08/15/2022 10.2
10.28 Third Amendment to Lease by and between Registrant and Watch City Ventures MT, LLC dated as of July 29, 2022.
10-Q 11/14/2022 10.1
10.29 Registration Rights Agreement, dated December 11, 2019, by and between the Registrant and Aspire Capital Fund, LLC.
8-K 12/11/2019 4.1
10.30^ Securities Purchase Agreement, dated as of October 27, 2020, by and among the Registrant and each purchaser identified on Annex A thereto.
8-K 10/28/2020 10.1
10.31^ Registration Rights Agreement, dated as of October 30, 2020, by and among the Registrant and certain purchasers.
10-Q 11/12/2020 10.8
10.32 Open Market Sale Agreement SM , dated as of November 8, 2021, by and among the Registrant and Jefferies LLC
S-3 11/08/2021 1.2
10.33 Open Market Sale Agreement SM , dated as of September 9, 2022 by and between the Registrant and Jefferies LLC.
S-3 09/09/2022 1.2
10.34^ Loan and Security Agreement, dated as of April 1, 2022, among the Viridian Therapeutics, Inc., certain of its subsidiaries from time to time party thereto, the Lenders from time to time party thereto and Hercules Capital, Inc., as Agent.
8-K 04/05/2022 10.1
21.1 Subsidiaries of the Registrant.
x
23.1 Consent of Independent Registered Public Accounting Firm.
x
24.1 Power of Attorney (included on signature page hereto).
x
31.1 Certification of Principal Executive Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.
x
71
31.2 Certification of Principal Financial Officer pursuant to Rule13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.
x
32.1* Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
x
101.INS XBRL Instance Document x
101.SCH XBRL Taxonomy Extension Schema Document x
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document x
101.DEF XBRL Taxonomy Extension Definition Linkbase Document x
101.LAB XBRL Taxonomy Extension Label Linkbase Document x
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document x
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) x
____________________
^ Schedules have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. Viridian agrees to furnish supplementally a copy of any omitted schedule to the SEC upon its request; 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, “[***],” may have been omitted because such portions contained information that is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
+ Indicates management contract or compensatory plan
* This certification is being furnished pursuant to 18 U.S.C. 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.
* 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.
x Filed/furnished herewith.
ITEM 16. FORM 10-K SUMMARY
None.
72
VIRIDIAN THERAPEUTICS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Reports of Independent Registered Public Accounting Firm (KPMG LLP, Boulder CO, Auditor Firm ID: 185 )
2
Consolidated Balance Sheets
4
Consolidated Statements of Operations and Comprehensive Loss
5
Consolidated Statements of Changes in Stockholders’ Equity
6
Consolidated Statements of Cash Flows
7
Notes to Consolidated Financial Statements
9
1
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
Viridian Therapeutics, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Viridian Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2022 and 2021, 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). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. 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.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
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: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. 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.
Accrued outsourced clinical trials and preclinical studies
As discussed in Notes 2 and 5 to the consolidated financial statements, accrued expenses for clinical trials and preclinical studies are based on estimates of costs incurred for services provided by clinical research organizations, manufacturing organizations, and other providers. In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period. The estimates consider a number of factors such as site initiation, patient screening, enrollment, delivery of reports, and other events.
Accrued liabilities for outsourced clinical trials and preclinical studies were $12.6 million as of December 31, 2022.
We identified the evaluation of accrued outsourced clinical trials and preclinical studies as a critical audit matter. Specifically, evaluating the sufficiency of audit evidence obtained over the estimates of costs incurred by third
2
parties, including the factors described above, required subjective auditor judgment due to the nature of available evidence. Such evidence included communications from third parties regarding tasks completed, invoices received from third parties, and management’s analysis of expenses incurred against budgeted and contractual amounts.
The following are the primary procedures we performed to address this critical audit matter. For a selection of accrued liabilities for outsourced clinical trials and preclinical studies, we compared the relevant factors used by management to estimate the accrued expenses to contracts, invoices and third-party confirmations of contractual milestones and project status. We compared the Company’s estimate of costs accrued as of year-end to a selection of third-party invoices received after year-end, but prior to the issuance of the Company’s financial statements. We assessed the sufficiency of audit evidence obtained related to accrued outsourced clinical trials and preclinical studies by assessing the cumulative results of the audit procedures.
/s/ KPMG LLP
We have served as the Company’s auditor since 2009.
Boulder, Colorado
March 9, 2023
3
VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
2022 2021
Assets
Current assets:
Cash and cash equivalents $ 155,579 $ 42,299
Short-term investments 268,971 154,666
Prepaid expenses and other current assets 6,521 2,747
Unbilled revenue - related party 102 451
Total current assets 431,173 200,163
Property and equipment, net 1,326 375
Operating lease right-of-use asset 1,610 1,680
Other assets 982 1,491
Total assets $ 435,091 $ 203,709
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 14,234 $ 2,329
Accrued liabilities 18,827 11,018
Current portion of deferred revenue - related party 288 289
Total current liabilities 33,349 13,636
Long-term debt, net 4,645 —
Deferred revenue - related party 861 1,149
Other liabilities 1,172 1,208
Total liabilities 40,027 15,993
Commitments and contingencies
Stockholders’ equity:
Preferred stock, series A non-voting convertible preferred stock, $ 0.01 par value; 435,000 shares authorized; 188,381 and 260,437 shares issued and outstanding as of December 31, 2022 and 2021, respectively
85,470 118,164
Preferred stock, series B non-voting convertible preferred stock, $ 0.01 par value; 500,000 shares authorized; 51,210 and 23,126 shares issued and outstanding as of December 31, 2022 and 2021, respectively
56,677 15,669
Common stock, $ 0.01 par value; 200,000,000 shares authorized; 41,305,947 and 23,924,004 shares issued and outstanding as of December 31, 2022 and 2021, respectively
414 239
Additional paid-in capital 741,067 412,101
Accumulated other comprehensive loss ( 390 ) ( 157 )
Accumulated deficit ( 488,174 ) ( 358,300 )
Total stockholders’ equity 395,064 187,716
Total liabilities and stockholders’ equity $ 435,091 $ 203,709
See accompanying notes to these consolidated financial statements.
4
VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Year Ended
December 31,
2022 2021
Revenue:
Collaboration revenue - related party $ 1,772 $ 2,963
Operating expenses:
Research and development (related party - $ 5,619 and $ — at December 31, 2022 and 2021, respectively)
100,894 56,886
General and administrative 35,182 25,805
Total operating expenses 136,076 82,691
Loss from operations ( 134,304 ) ( 79,728 )
Other income (expense):
Interest and other income 4,916 318
Interest and other expense ( 486 ) ( 3 )
Other income, net 4,430 315
Net loss $ ( 129,874 ) $ ( 79,413 )
Net loss per share, basic and diluted $ ( 4.05 ) $ ( 6.66 )
Weighted-average shares used to compute basic and diluted net loss per share 32,087,293 11,918,712
Comprehensive loss:
Net loss $ ( 129,874 ) $ ( 79,413 )
Other comprehensive loss:
Change in unrealized loss on investments ( 233 ) ( 149 )
Total other comprehensive loss ( 233 ) ( 149 )
Total comprehensive loss $ ( 130,107 ) $ ( 79,562 )
See accompanying notes to these consolidated financial statements.
5
VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share data)
Preferred Stock Common Stock Additional
Paid-in
Capital Accumulated Other Comprehensive Loss Accumulated
Deficit Total
Stockholders’
Equity
Series A Convertible Preferred Stock Series B Convertible Preferred Stock
Shares Amount Shares Amount Shares Amount
Balance as of December 31, 2020 398,487 $ 180,801 — $ — 4,231,135 $ 42 $ 218,089 $ ( 8 ) $ ( 278,887 ) $ 120,037
Issuance of common stock upon the conversion of convertible preferred stock ( 138,050 ) ( 62,637 ) — — 9,203,732 92 62,545 — — —
Issuance of Series B preferred stock and common stock in the 2021 Public Offering, net of issuance costs of $ 1,291 and $ 5,983 , respectively
— — 23,126 15,669 7,344,543 73 74,734 — — 90,476
Issuance of common stock upon exercises of warrants — — — — 77,871 1 1,284 — — 1,285
Issuance of common stock for exercises of stock options — — — — 106,831 1 1,026 — — 1,027
Issuance of common stock upon the vesting of restricted stock units — — — — 10,574 — — — — —
Issuance of common stock, 2021 ATM, net of issuance costs of $ 1,004
— — — — 2,551,269 26 32,423 — — 32,449
Issuance of common stock under license agreement — — — — 394,737 4 7,496 7,500
Issuance of common stock for cash under employee stock purchase plan — — — — 3,312 — 39 — — 39
Share-based compensation expense — — — — — — 14,465 — — 14,465
Change in unrealized loss on investments — — — — — — — ( 149 ) — ( 149 )
Net loss — — — — — — — — ( 79,413 ) ( 79,413 )
Balance as of December 31, 2021 260,437 118,164 23,126 15,669 23,924,004 239 412,101 $ ( 157 ) ( 358,300 ) 187,716
Issuance of common stock upon the conversion of convertible preferred stock ( 72,056 ) ( 32,694 ) — — 4,803,965 48 32,646 — — —
Issuance of Series B preferred stock and common stock, 2022 Public Offering, net of issuance costs of $ 2,992 and $ 18,146 , respectively
— — 28,084 41,008 11,352,640 114 248,528 — — 289,650
Issuance of common stock, September 2022 ATM, net of issuance costs of $ 926
— — — — 964,357 10 24,150 — — 24,160
Issuance of common stock upon exercises of warrants — — — — 56,666 1 934 — — 935
Issuance of common stock for exercises of stock options — — — — 191,291 2 2,760 — — 2,762
Issuance of common stock for cash under employee stock purchase plan — — — — 13,024 — 183 — — 183
Share-based compensation expense — — — — — — 19,765 — — 19,765
Change in unrealized loss on investments — — — — — — — ( 233 ) — ( 233 )
Net loss — — — — — — — — ( 129,874 ) ( 129,874 )
Balance as of December 31, 2022 188,381 $ 85,470 51,210 $ 56,677 41,305,947 $ 414 $ 741,067 $ ( 390 ) $ ( 488,174 ) $ 395,064
See accompanying notes to these consolidated financial statements.
6
VIRIDIAN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended
December 31,
2022 2021
Cash flows from operating activities:
Net loss $ ( 129,874 ) $ ( 79,413 )
Adjustments to reconcile net loss to net cash (used in) operating activities:
Issuance of common stock under license agreement — 7,500
Share-based compensation expense 19,765 14,465
Non-cash interest expense and amortization of debt issuance costs 228 87
Depreciation and amortization 255 120
Accretion and amortization of premiums and discounts on available-for-sale securities ( 210 ) 965
Realized gain on investments — ( 4 )
Loss on sale of equipment — 77
Non-cash lease expenses 36 ( 102 )
Changes in operating assets and liabilities:
Prepaid expenses and other assets ( 3,339 ) ( 1,496 )
Accounts payable 11,524 1,655
Accrued and other liabilities 7,716 1,380
Unbilled revenue 349 ( 451 )
Deferred revenue ( 288 ) 636
Net cash used in operating activities ( 93,838 ) ( 54,581 )
Cash flows from investing activities:
Purchases of short-term investments ( 223,264 ) ( 188,431 )
Proceeds from sales and maturities of short-term investments 108,935 114,398
Proceeds from sale of property and equipment — 79
Purchases of property and equipment ( 797 ) ( 338 )
Net cash used in investing activities ( 115,126 ) ( 74,292 )
Cash flows from financing activities:
Proceeds from the issuance of common stock, pursuant to 2022 Public Offering and September 2022 ATM Agreement 291,874 —
Proceeds from the issuance of common stock, pursuant to 2021 Public Offering and April 2021 ATM Agreement — 114,242
Payments of issuance costs associated with the sale of common stock ( 19,072 ) ( 6,987 )
Proceeds from the issuance of Series B preferred stock 44,000 16,960
Payment of issuance costs associated with the sale of preferred stock ( 2,992 ) ( 1,291 )
Proceeds from the exercise of warrants 935 1,285
Proceeds from issuance of long-term debt 5,000 —
Payment of debt issuance costs ( 446 ) —
Proceeds from issuance of common stock upon the exercise of stock options 2,762 1,027
Proceeds from the issuance of common stock for cash under employee stock purchase plan 183 39
Net cash provided by financing activities 322,244 125,275
Net increase (decrease) in cash and cash equivalents 113,280 ( 3,598 )
Cash and cash equivalents at beginning of period 42,299 45,897
Cash and cash equivalents at end of period $ 155,579 $ 42,299
Supplemental disclosure of cash flow information
Interest paid $ 293 $ —
Supplemental disclosure of non-cash investing and financing activities
7
Purchase of property and equipment in accounts payable and accrued liabilities $ 380 $ 4
Amortization of public offering costs $ 75 $ 87
See accompanying notes to these consolidated financial statements.
8
VIRIDIAN THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS
Viridian Therapeutics, Inc., a Delaware corporation (the “Company” or “Viridian”), is a biopharmaceutical company advancing new treatments for patients suffering from serious diseases that are underserved by today’s therapies. The Company’s most advanced program, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (“IGF-1R”), a clinically and commercially validated target for the treatment of thyroid eye disease (“TED”). The Company’s second product candidate, VRDN-002, is a distinct anti-IGF-1R antibody that incorporates half-life extension technology. VRDN-003 is an extended half-life version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as convenient, low-volume, subcutaneous pen injections. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids. In addition to developing therapies for TED, the Company is executing a similar strategic approach to identify opportunities in other rare and/or serious disease indications.
Liquidity
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. 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, Series B Preferred Stock, and other equity securities, debt financings, license fees, and reimbursements received under collaboration agreements. Since its inception and through December 31, 2022, the Company has generated an accumulated deficit of $ 488.2 million. The Company expects to continue to generate operating losses for the foreseeable future.
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. 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. The Company expects to incur significant expenses and operating losses for at least the next several years as it continues the development of, and seeks regulatory approval for, its product candidates. It is expected that operating losses will fluctuate significantly from quarter to quarter and year to year due to timing of development programs and efforts to achieve regulatory approval.
As of December 31, 2022, the Company had approximately $ 424.6 million in cash, cash equivalents, and short-term investments. 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 for at least the next twelve months from the issuance date of these financial statements.
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. 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 those resulting from the current inflationary and broader macroeconomic environment.
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. Changing circumstances may cause the Company to consume capital significantly faster or slower than currently anticipated. If the Company is unable to acquire additional capital or resources, it will be required to modify its operational plans. 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.
9
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Viridian Therapeutics Europe Limited and Viridian Therapeutics S.à.r.l., both of which were formed for the sole purpose of submitting regulatory filings in Europe, and Viridian Securities Corporation, which was formed in July 2021. The Company’s subsidiaries have no employees or operations.
The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods presented. All significant intercompany balances have been eliminated in consolidation. 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.
Global Economic Considerations
The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the rising tensions between China and Taiwan and other political tensions, and lingering effects of the COVID-19 pandemic. Such challenges have caused, and may continue to cause, recession fears, concerns regarding potential sanctions, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects of this economic instability on its future operations.
Going Concern
At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern.
The Company’s evaluation entails, among other things, analyzing the results of the Company’s clinical development efforts, license and collaboration agreements as well as the entity’s current financial condition including conditional and unconditional obligations anticipated within a year, and related liquidity sources at the date the financial statements are issued. This is reflected in the Company’s prospective operating budgets and forecasts and compared to the current cash, cash equivalents and short-term investments balance.
Use of Estimates
The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for clinical trial costs and other outsourced research and development expenses and the valuation of share-based awards. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions.
Revenue Recognition
The Company accounts for revenue in accordance with 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. The terms of these agreements typically include payment of one or more of the following: non-refundable, up-front fees; reimbursement of research and development costs; developmental, clinical, regulatory, and commercial sales milestone payments; and royalties on net sales of licensed products.
10
In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services.
To determine the appropriate amount of revenue to be recognized, for agreements within the scope of ASC 606, the Company performs the following five steps: (i) identification of the goods or services within the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct within the terms of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the identified performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.
The promised goods or services in the Company’s agreements typically consist of a license, or option to license, rights to the Company’s intellectual property or research and development services. Performance obligations are promises in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available, and whether the goods or services are integral or dependent to other goods or services in the contract.
The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. At the inception of each agreement that includes variable consideration, the Company evaluates the amount of potential payment and the likelihood that the payments will be received. 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. 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. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such development and clinical milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration and other research and development revenue in the period of adjustment.
For agreements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue 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). To date, the Company has not recognized any royalty revenue resulting from any of the Company’s collaboration or strategic alliance agreements.
The Company allocates the transaction price based on the estimated standalone selling price. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, and the estimated costs. Variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts the Company would expect to receive for the satisfaction of each performance obligation.
The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
11
The Company receives payments from its customers based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.
Research and Development
Research and development costs are expensed as incurred in performing research and development activities. The costs include employee-related expense including salaries, benefits, share-based compensation, restructuring charges, fees for acquiring and maintaining licenses under third-party license agreements, consulting fees, costs of research and development activities conducted by third parties on the Company’s behalf, costs to manufacture or have manufactured clinical trial materials, laboratory supplies, depreciation, and facilities and overhead costs. The Company records research and development expense in the period in which the Company receives or takes ownership of the applicable goods or when the applicable services are performed. In circumstances where amounts have been paid in excess of costs incurred, the Company records a prepaid expense.
The Company records up-front and milestone payments to acquire and retain contractual rights to licensed technology as research and development expenses when incurred if there is uncertainty in the Company receiving future economic benefit from the acquired contractual rights. Such expenses are included within operating activities in the consolidated statements of cash flows. The Company considers future economic benefits from acquired contractual rights to licensed technology to be uncertain until such a drug candidate is approved for sale by the U.S. Food and Drug Administration (“FDA”) or when other significant risk factors are abated.
Clinical Trial and Preclinical Study Accruals
The Company makes estimates of accrued expenses as of each balance sheet date in its consolidated financial statements based on certain facts and circumstances at that time. The Company’s accrued expenses for clinical trials and preclinical studies are based on estimates of costs incurred for services provided by clinical research organizations, manufacturing organizations, and other providers. 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. 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.
Share-Based Compensation
The Company accounts for share-based compensation expense to employees and non-employees based on the fair value of each stock option or award on the date of the grant. The Company uses the Black-Scholes option pricing model to determine the fair value of stock options. The use of the Black-Scholes option-pricing model requires the Company to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. The Company recognizes share-based compensation expense for awards with service-based conditions using the straight-line method over the requisite service period, net of any actual forfeitures.
Cash and Cash Equivalents
All highly-liquid investments that have maturities of 90 days or less at the date of purchase are classified as cash equivalents. Cash equivalents are reported at cost, which approximates fair value due to the short maturities of these instruments.
Investments
The Company’s investments consist of highly-rated corporate and U.S. Treasury securities and have been classified as available-for-sale securities. Accordingly, these investments are recorded at their respective fair values, as determined based on quoted market prices. The Company may hold securities with stated maturities greater than one year. All available-for-sale securities are considered available to support current operations, and thus investments with maturities beyond one year are generally classified as current assets.
Unrealized gains and losses are reported as a component of stockholders’ equity until their disposition. Realized gains and losses are included as a component of other income (expense), net based on the specific identification method. The securities are subject to a periodic impairment review. 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.
12
Fair Value Measurements
Certain assets and liabilities are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
• Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities.
• 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.
• 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.
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.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, which include short-term investments that have maturities of less than three months. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts. The Company invests its excess cash primarily in deposits and money market funds held with one financial institution.
Property and Equipment
The Company carries its property and equipment at cost, less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally three to five years . 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.
Operating Lease Right-of-Use Assets and Liabilities
The Company determines if an arrangement is, or contains, a lease at contract inception and during modifications or renewal of existing leases. 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. The Company has recorded operating lease assets and liabilities pursuant to the guidance in Accounting Standards Update (“ASU”) No. 2016-02 , Leases (Topic 842), and subsequent amendments to the initial guidance: ASU No. 2017-13, ASU No. 2018-10, and ASU No. 2018-11 (collectively, “ASC 842”). These 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. 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. 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. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. 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. Refer to Note 8. Commitments and Contingencies - Lease Obligations for additional information related to the Company’s operating leases.
Debt and Debt Issuance Costs
Debt issuance costs and expenses paid by the Company to its lenders are presented on the consolidated balance sheet as a direct deduction from the related debt liability rather than capitalized as an asset in accordance with ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . Debt issuance costs represent
13
legal and other direct costs incurred in connection with the Company’s Term Loan (as defined in Note 6. Debt ). These costs are amortized as a non-cash component of interest expense using the effective interest method over the term of the loan.
Convertible Preferred Stock
The Company records shares of non-voting convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities , and at issuance classified the Series A Preferred Stock outside of stockholders’ equity because, if convertibility of Series A Preferred Stock into common stock was not approved by the stockholders, 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. On December 31, 2020, the stockholders approved the convertibility of the Series A Preferred Stock into common stock and as such, the Company reclassified the Series A Preferred Stock to permanent equity. In September 2021, the Company issued Series B Preferred Stock with conversion rights which the Company has classified as permanent equity in its consolidated balance sheets.
Impairment of Long-Lived Assets
The Company assesses the carrying amount of its property and equipment whenever events or changes in circumstances indicate the carrying amount of such assets may not be recoverable. No impairment charges were recorded during the years ended December 31, 2022 and 2021.
Net Loss per Share
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. 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.
Comprehensive Loss
Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on investments. Unrealized accumulated comprehensive gains or losses are reflected as a separate component in the consolidated statements of changes in stockholders’ equity. The Company had unrealized losses on investments of $ 0.2 million and $ 0.1 million during the years ended December 31, 2022 and 2021, respectively.
Income Taxes
The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that a deferred tax asset will not be realized. 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 be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.
The Company’s significant deferred tax assets are for net operating loss carryforwards, tax credits, accruals and reserves, and capitalized start-up costs. The Company has provided a valuation allowance for its entire net deferred tax assets since inception as, due to its history of operating losses, the Company has concluded that it is more likely than not that its deferred tax assets will not be realized.
The Company has no unrecognized tax benefits. The Company classifies interest and penalties arising from the underpayment of income taxes in the consolidated statements of operations and comprehensive loss as general and administrative expenses. No such expenses have been recognized during the years ended December 31, 2022 and 2021.
Warrants
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,
14
Compensation - Stock Compensation , and classifies warrants for common stock as liabilities or equity. 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.
Segment Information
The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. All equipment, leasehold improvements, and other fixed assets are physically located within the United States and all agreements with the Company’s partners are denominated in U.S. dollars, except where noted.
Accounting Pronouncements – To Be Adopted
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. 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.
3. INVESTMENTS AND FAIR VALUE MEASUREMENTS
Investments
The Company’s investments consisted of the following as of December 31, 2022 and December 31, 2021:
(in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value
December 31, 2022
Money market funds $ 137,903 $ — $ — $ 137,903
U.S. treasury securities 85,578 123 ( 96 ) 85,605
U.S. corporate paper and bonds 199,350 1 ( 385 ) 198,966
International corporate bond holdings 2,009 — ( 33 ) 1,976
Total $ 424,840 $ 124 $ ( 514 ) $ 424,450
December 31, 2021
Money market funds $ 42,199 $ — $ — $ 42,199
U.S. treasury securities 22,215 — ( 54 ) 22,161
U.S. corporate paper and bonds 128,005 6 ( 94 ) 127,917
International corporate bond holdings 4,603 — ( 15 ) 4,588
Total $ 197,022 $ 6 $ ( 163 ) $ 196,865
The Company considers the unrealized losses in its investment portfolio to be temporary in nature and not due to credit losses. The Company has the intent and ability to hold such investments until their recovery at fair value. The Company had realized gains of zero and $ 4 thousand in its available for sale securities for the years ended December 31, 2022 and 2021, respectively. The contractual maturity dates of all of the Company’s investments are all less than 24 months.
Fair Value Measurements
The following tables summarize the Company’s assets and liabilities that are measured at fair value on a recurring basis:
15
(in thousands) Quoted Prices in Active Markets
(Level 1) Significant Other Observable Inputs
(Level 2) Significant Unobservable Inputs
(Level 3) Total
December 31, 2022
Assets:
Cash equivalents:
Money market funds $ 137,903 $ — $ — $ 137,903
U.S. corporate paper and bonds — 17,576 — 17,576
Short-term investments:
U.S. treasury securities — 85,605 — 85,605
U.S. corporate paper and bonds — 181,390 — 181,390
International corporate bond holdings — 1,976 — 1,976
Total cash equivalents and short-term investments $ 137,903 $ 286,547 $ — $ 424,450
December 31, 2021
Assets:
Cash equivalents:
Money market funds $ 42,199 $ — $ — $ 42,199
Short-term investments:
U.S. treasury securities — 22,161 — 22,161
U.S. corporate paper and bonds — 127,917 — 127,917
International corporate bond holdings — 4,588 — 4,588
Total cash equivalents and short-term investments $ 42,199 $ 154,666 $ — $ 196,865
4. PROPERTY AND EQUIPMENT
Property and equipment, net, consisted of the following:
December 31,
2022 2021
(in thousands)
Lab equipment $ 1,160 $ 775
Leasehold improvements 1,113 749
Computer hardware and software 725 430
Furniture and fixtures 332 197
Property and equipment, gross 3,330 2,151
Less: accumulated depreciation and amortization ( 2,004 ) ( 1,776 )
Property and equipment, net $ 1,326 $ 375
During the year ended December 31, 2021, certain lab equipment met the criteria to be classified and were reclassified as held for sale and included in prepaid expenses and other current assets. The assets held for sale totaled $ 0.1 million, which was the net book value on the date of transfer. During the year ended December 31, 2021, the Company sold the equipment, received proceeds of approximately $ 0.1 million and recorded a loss of approximately $ 0.1 million.
During the years ended December 31, 2022 and 2021, depreciation and amortization expense was $ 0.3 million and $ 0.1 million, respectively.
16
5. ACCRUED LIABILITIES
Accrued liabilities consisted of the following:
December 31,
2022 2021
(in thousands)
Accrued outsourced clinical trials and preclinical studies $ 12,576 $ 6,316
Accrued employee compensation and related taxes 4,772 3,652
Operating lease liability, short-term 613 520
Accrued legal fees and expenses 177 80
Accrued other professional service fees 392 140
Value of liability-classified stock purchase warrants 100 100
Other accrued liabilities 197 210
Total accrued liabilities $ 18,827 $ 11,018
6. DEBT
Loan and Security Agreement with Hercules Capital, Inc.
In April 2022, the Company entered into a loan and security agreement (the “Hercules Loan and Security Agreement”) among the Company, certain of its subsidiaries from time to time party thereto (together with the Company, collectively, the “Borrower”), Hercules Capital, Inc. (“Hercules”) and certain other lenders named therein (the “Lenders”). Under the Hercules Loan and Security Agreement, the Lenders provided the Company with access to a term loan with an aggregate principal amount of up to $ 75.0 million, in four tranches (collectively the “Term Loan”), consisting of (1) an initial tranche of $ 25.0 million, available to the Company through June 15, 2023; (2) a second tranche of $ 10.0 million, subject to the achievement of certain regulatory milestones, available through June 15, 2023; (3) a third tranche of $ 15.0 million, subject to the achievement of certain regulatory milestones, available through March 15, 2024; and (4) a fourth tranche of $ 25.0 million, subject to approval by the Lenders’ investment committee(s), available through December 15, 2024. The milestones for the second and third tranches have not yet been achieved. The obligations of the Borrower under the Loan Agreement are secured by substantially all of the assets of the Borrower, excluding the Borrower’s intellectual property. The Term Loan has a maturity date of October 1, 2026.
The Term Loan bears interest at a floating per annum rate equal to the greater of (i) 7.45 % and (ii) 4.2 % above the Prime Rate, provided that the Term Loan interest rate shall not exceed a per annum rate of 8.95 %. Interest is payable monthly in arrears on the first day of each month. The interest rate as of December 31, 2022 was 8.95 % based upon an increase in the prime rate in June 2022.
Per the terms of the Hercules Loan and Security Agreement, the Company was originally obligated to make interest-only payments through April 1, 2024. However, upon the achievement of a development milestone in August 2022 the interest-only period was extended to October 1, 2024. If additional development milestones are met, the interest-only period will be further extended to April 1, 2025. The Borrower is required to repay the Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, the Borrower is required to pay an end-of-term fee equal to 6 % of the principal amount of funded Term Loan advances at maturity, which are being accreted as additional interest expense over the term of the loan.
Upon signing the Hercules Loan and Security Agreement, the Company drew an initial principal amount of $ 5.0 million. The Company incurred debt issuance costs of $ 0.2 million in connection with the Term Loan. In addition, in connection with the initial draw, the Company paid to the Lenders a facility fee of $ 0.1 million, as well as $ 0.1 million of other expenses incurred by the Lenders and reimbursed by the Company (“Lender Expenses”). The debt issuance costs and the Lender Expenses are being amortized as additional interest expense over the term of the loan. Debt issuance costs and the Lender Expenses are presented on the consolidated balance sheet as a direct deduction from the related debt liability rather than capitalized as an
17
asset in accordance with ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs .
The total cost of all items (cash interest, the amortization/accretion of the debt issuance costs and the end-of-term fee) is being recognized as interest expense using an effective interest rate of approximately 9.3 %. The Company recorded interest expense of $ 0.5 million during the year ended December 31, 2022.
The following table summarizes the impact of the Term Loan, on the Company’s consolidated balance sheet at December 31, 2022:
December 31, 2022
(in thousands)
Gross proceeds 5,000
Unamortized debt issuance costs ( 355 )
Carrying value $ 4,645
Future principal payments, which exclude the end of term charge, in connection with the Hercules Loan and Security Agreement as of December 31, 2022 are as follows (in thousands):
Fiscal Year
2023 —
2024 551
2025 2,331
2026 2,118
Total $ 5,000
7. COLLABORATION AGREEMENTS
License Agreement with Zenas BioPharma
In October 2020, the Company became party to a license agreement with Zenas BioPharma (Cayman) Limited (“Zenas BioPharma”) to license technology comprising certain materials, patent rights, and know-how to Zenas BioPharma. Since February 2021, the Company has entered into several letter agreements with Zenas BioPharma pursuant to which the Company agreed to provide assistance to Zenas BioPharma with certain development activities, including manufacturing. In May 2022, the Company entered into a Manufacturing Development and Supply Agreement with Zenas BioPharma (the “Supply Agreement”) to manufacture and supply, or to have manufactured and supplied, clinical drug product for developmental purposes. The license agreement and subsequent letter agreements and supply agreement (collectively, the “Zenas Agreements”) were negotiated with a single commercial objective and are treated as a combined contract for accounting purposes. 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.
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. Under the Zenas Agreements, the Company can receive non-refundable milestone payments upon achieving specific milestone events during the contract term. 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. The royalty percentage may vary based on different tiers of annual net sales of the licensed products made. Zenas BioPharma is obligated to make royalty payments to the Company for the royalty term in the Zenas Agreements.
The Zenas Agreements would qualify as a collaborative arrangement under the scope of Accounting Standards Codification, Topic 808, Collaborative Arrangements (“ASC 808”). While this arrangement is in the scope of ASC 808, the Company applied ASC 606 to account for certain aspects of this arrangement. The Company applied 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. The Company allocated the transaction price based on the relative estimated
18
standalone selling prices of each performance obligation or, in the case of certain variable consideration, to one or more performance obligations. Research and development activities are priced generally at cost. 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. The Company will recognize the transaction price from the license agreement over the Company’s estimated period to complete its activities.
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. 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. For the sales-based royalties included in the arrangement, the license was deemed to be the predominant item to which the royalties relate. 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). During the years ended December 31, 2022 and 2021, the Company recognized $ 1.8 million and $ 3.0 million, respectively, of collaboration revenue related to the Zenas Agreements.
As of December 31, 2022, the Zenas Agreements are considered related party transactions because Fairmount Funds Management LLC beneficially owns more than 5 % of the Company’s common stock and is also a 5 % or greater stockholder of Zenas BioPharma and has a seat on Zenas BioPharma’s board of directors.
Antibody and Discovery Option Agreement with Paragon Therapeutics, Inc.
In January 2022, the Company and Paragon Therapeutics, Inc. (“Paragon”) entered into an antibody and discovery option agreement (the “Paragon Agreement”) under which the Company and Paragon will cooperate to develop one or more antibodies. Under the terms of the Paragon Agreement, Paragon will perform certain development activities in accordance with an agreed upon research plan, and the Company will pay Paragon agreed upon development fees in exchange for Paragon’s commitment of the necessary personnel and resources to perform these activities. The Paragon Agreement stipulates a final deliverable to the Company comprising of a report summarizing the experiments and processes performed under the research plan (the “Final Deliverable”).
Additionally, Paragon agreed to grant the Company an option for an exclusive license to all of Paragon’s right, title and interest in and to certain antibody technology and the Final Deliverable, and a non-exclusive license to certain background intellectual property owned by Paragon solely to research, develop, make, use, sell, offer for sale and import of the licensed intellectual property and resulting products worldwide (each, an “Option” and together, the “Options”). Paragon also granted to the Company a limited, exclusive, royalty-free license, without the right to sublicense, to certain antibody technology and the Final Deliverable, and a non-exclusive, royalty-free license without the right to sublicense, under certain background intellectual property owned by Paragon, solely to evaluate the antibody technology and Option and for the purpose of allowing the Company to determine whether to exercise the Option with respect to certain programs. The Company may, at its sole discretion, exercise the Option with respect to specified programs at any time until the date that is 90 days after the Company’s receipt of the Final Deliverable the applicable program, or such longer period as agreed upon by the parties (“Option Period”) by delivering written notice of such exercise to Paragon. If the Company fails to exercise an Option prior to expiration of the applicable Option Period, such Option for such Program will terminate. In consideration for Paragon’s grant of the Options to the Company, the Company paid to Paragon a non-refundable, non-creditable one-time fee of $ 2.5 million, which was recorded as research and development expense during the three months ended March 31, 2022. In December 2022, the Company and Paragon entered into a first amendment to the Paragon Agreement, under which the Company obtained an additional limited license for the purpose of conducting certain activities. In consideration for the rights and licenses obtained under the first amendment, Viridian paid Paragon a non-refundable fee of $ 2.3 million (the “First Amendment Payment”), which was recorded as research and development expense during the three months ended December 31, 2022. The non-refundable upfront fee and the First Amendment Payment are separate from any development costs or cost advance paid or owing with respect to the specified program. During the year ended December 31, 2022, the Company recorded $ 5.6 million in research and development costs related to the Paragon Agreement.
As of December 31, 2022, the Paragon Agreement is considered a related party transaction because Fairmount beneficially owns more than 5 % of the Company’s capital stock and has two seats on the Company’s board of directors, and beneficially owns more than 5 % of Paragon, which is a joint venture between Fairmount and FairJourney Biologics, and has appointed the sole director on Paragon’s board of directors and has the contractual right to approve the appointment of any executive officers.
19
8. COMMITMENTS AND CONTINGENCIES
License Agreement with ImmunoGen, Inc.
In October 2020, the Company became party to a license agreement (the “ImmunoGen License Agreement”) with Immunogen, Inc. (“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. In consideration for rights granted by ImmunoGen, the Company is obligated to make certain future development milestone payments of up to $ 48.0 million upon the achievement of specified clinical and regulatory milestones. In December 2021, the Company paid a $ 2.5 million milestone payment to ImmunoGen upon the submission of an investigational new drug (“IND”) application for VRDN-001 with the FDA. In May 2022, the Company paid a $ 3.0 million milestone payment to ImmunoGen related to the first patient dosed in the clinical trial for VRDN-001. In December 2022, the Company recorded $ 10.0 million as research and development expense related to a milestone owed to ImmunoGen related to the first patient dosed in a Pivotal Clinical Trial for VRDN-001, amount which was paid in January 2023 and which was included in accounts payable in the consolidated balance sheet as of December 31, 2022. 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. 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.
License Agreements with Xencor, Inc.
In December 2021, the Company entered into a subsequent technology license agreement (the “2021 Xencor License Agreement”) with Xencor for a non-exclusive license to certain antibody libraries developed by Xencor. Under the 2021 Xencor License Agreement, the Company received a one-year research license to review the antibodies and the right to select up to three antibodies for further development. In consideration for rights granted by Xencor, the Company issued 394,737 shares of our common stock to Xencor in December 2021. The shares were valued at $ 7.5 million and recorded as research and development expense during the year ended December 31, 2021. Under the terms of the 2021 Xencor License Agreement, if successful, for each licensed product, the Company would be obligated to make future milestone payments of up to $ 27.75 million, which includes development milestone payments of up to $ 4.75 million, special milestone payments of up to $ 3.0 million, and commercial milestone payments of up to $ 20.0 million. Additionally, for each licensed product that the Company successfully commercializes, it would be responsible for royalty payments equal to a percentage in the mid-single digits of net sales.
In December 2020, the Company entered into a license agreement (the “Xencor License Agreement”) with 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. In consideration for rights granted by Xencor, the Company issued 322,407 shares of its common stock in December 2020. The shares were valued at $ 6.0 million and recorded as research and development expense in 2020. Under the terms of the Xencor License Agreement, the Company is obligated to make future development milestone payments of up to $ 30.0 million. 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. 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.
Contingent Value Rights Agreement
In accordance with the merger agreement with miRagen Therapeutics, Inc., on November 4, 2020, the Company and the Rights Agent (as defined therein) executed and delivered a contingent value rights agreement (the “CVR Agreement”), pursuant to which each holder of the Company’s common stock as of November 6, 2020, other than former stockholders of Private Viridian, was 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 its common stock held by such holder. No CVRs have been or may in the future be issued pursuant to the terms of the CVR Agreement as of December 31, 2022.
20
Lease Obligations
Colorado-based Office and Lab Space
The Company is party to a multi-year, non-cancelable lease agreement 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 three terms of three years each. 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. The lease term was amended in March 2021 to extend the lease maturity date to December 31, 2024. Upon adoption of ASC 842 and upon subsequent modification of the lease in 2020 and in March 2021, the Company recognized a right-of-use asset and corresponding lease liability for the lease agreement of approximately $ 1.6 million 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.
Massachusetts-based Office Space
The Company is party to a multi-year, non-cancelable lease agreement for its Massachusetts-based office space (as subsequently amended, the “Original Lease”). The Original Lease included rent escalation clauses through the lease term. Minimum base lease payments under the lease agreement are recognized on a straight-line basis over the full term of the lease. Upon assumption of the Original Lease, the Company recognized a right-of-use asset and corresponding lease liability for the Original Lease of $ 0.1 million by calculating the present value of lease payments, discounted at 6 %, the Company’s estimated incremental borrowing rate, over the expected remaining term. In July 2021, the Company entered into an amendment to the Original Lease to increase its Massachusetts-based office space (the “First Amendment”). In April 2022, the Company entered into a second amendment to the Original Lease of its Massachusetts-based office space (the “Second Amendment”). The Second Amendment made certain modifications to both the Original Lease and First Amendment, including (i) the addition of 2,432 square feet of office space in the same building and (the “April 2022 Expansion Premises”), (ii) the termination of the 1,087 square feet of leased space under the Original Lease seven days after the delivery of the April 2022 Expansion Premises, which occurred in the fourth quarter of 2022, and (iii) the extension of the expiration date of the 3,284 square feet of leased space under the First Amendment from October 2024 through November 2026.
Under the Second Amendment, the Company has the option to extend the lease term for an additional period of three years upon notice to the landlord. The Second Amendment provides for annual base rent for the April 2022 Expansion Premises of approximately $ 0.4 million during the lease term. The Company is also obligated to pay the landlord certain costs, taxes and operating expenses.
In July 2022, the Company entered into a third amendment to the Original Lease of its Massachusetts-based office space (the “Third Amendment”). The Third Amendment makes certain modifications to the Original Lease, including (i) the addition of 5,240 square feet of office space in the same building (the “July 2022 Expansion Premises”), (ii) the termination of the 1,087 square feet of leased space under the Original Lease, and (iii) the extension of the expiration date of the 3,284 square feet of leased space under the First Amendment to four years from the delivery of the July 2022 Expansion Premises.
Under the Third Amendment, the Company has the option to extend the lease term for an additional period of three years upon notice to the landlord. The Third Amendment provides for annual base rent for the July 2022 Expansion Premises of approximately $ 0.9 million during the lease term. The Company is also obligated to pay the landlord certain costs, taxes and operating expenses.
Future lease payments under noncancellable leases as of December 31, 2022 are as follows:
(in thousands)
2023 $ 717
2024 748
2025 245
2026 230
Total future minimum lease payments 1,940
Less: imputed interest ( 217 )
Total $ 1,723
21
As of December 31, 2022, the Company’s operating lease obligations were reflected as short-term operating lease liabilities of $ 0.6 million within accrued liabilities and $ 1.1 million of long-term lease obligations as other liabilities in the Company’s consolidated balance sheets.
Amortization of the operating lease right-of-use assets, and corresponding reduction of operating lease obligations, amounted to $ 0.5 million for both the years ended December 31, 2022 and 2021, and which was included in operating expense in the consolidated statements of operations and comprehensive loss.
The Company is also required to pay for operating expenses related to the leased space, which were $ 0.3 million for both the years ended December 31, 2022 and 2021. The operating expenses are incurred separately and were not included in the present value of lease payments.
9. CAPITAL STOCK
Common Stock
Under the Company’s second 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. Each share of common stock is entitled to one vote. The holders of common stock are entitled to receive dividends when and as declared or paid by its board of directors.
Public Offerings
In August 2022, the Company entered into an underwriting agreement (the “2022 Underwriting Agreement”) with Jefferies LLC (“Jefferies”), SVB Securities LLC and Evercore Group L.L.C. (“Evercore”) relating to the offer and sale (the “2022 Offering”) of 11,352,640 shares of the Company’s common stock, which includes 1,725,000 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares at a public offering price of $ 23.50 per share, and 28,084 shares of Series B Non-Voting Convertible Preferred Stock, par value $ 0.01 per share, at a public offering price of $ 1,566.745 per share (collectively the “2022 Public Offering”). The aggregate gross proceeds to the Company from the 2022 Public Offering, including the exercise of the option were approximately $ 311.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.
In September 2021, the Company entered into an underwriting agreement (the “2021 Underwriting Agreement”) with Jefferies, SVB Leerink LLC and Evercore for the sale and issuance of 7,344,543 shares of common stock, which includes 1,159,089 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares at a public offering price of $ 11.00 per share and 23,126 shares of Series B Non-Voting Convertible Preferred Stock at a public offering price of $ 733.37 per share (collectively the “2021 Public Offering”). The aggregate gross proceeds to the Company from the 2021 Public Offering, including the exercise of the option, were approximately $ 97.7 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
Common Stock Sales Agreements - Jefferies LLC
In September 2022, the Company entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies, pursuant to which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $ 175.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as its sales agent. Jefferies will receive a commission of 3.0 % of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement. During the quarter ended December 31, 2022, 964,357 shares have been sold under the September 2022 ATM Agreement with Jefferies at a weighted average price of $ 26.01 per share, for aggregate net proceeds of approximately $ 24.2 million, including commissions to Jefferies as a sales agent.
In November 2021, the Company entered into an Open Market Sale Agreement SM (the “November 2021 ATM Agreement”) with Jefferies, pursuant to which the Company could offer and sell shares of its common stock having an aggregate offering price of up to $ 75.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as its sales agent. The November 2021 ATM Agreement was terminated in connection with the September 2022 ATM Agreement. No shares were sold under the November 2021 ATM Agreement.
22
In April 2021, the Company entered into an Open Market Sale Agreement SM (the “April 2021 ATM Agreement”) with Jefferies pursuant to which the Company could offer and sell shares of its common stock having an aggregate offering price of up to $ 50.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies as its sales agent. Jefferies could receive a commission equal to 3.0 % of the gross sales proceeds of any common stock sold through Jefferies under the April 2021 ATM Agreement. The April 2021 ATM Agreement was terminated in connection with the November 2021 ATM Agreement. An aggregate of 2,551,269 shares of common stock were sold pursuant to the April 2021 ATM Agreement prior to its termination, at a volume weighted average price of $ 13.13 per share, for aggregate net proceeds of approximately $ 32.4 million, including commissions to Jefferies as sales agent.
Common Stock Purchase Agreement - Aspire Capital Fund, LLC
In December 2019, the Company entered into a common stock purchase agreement (the “Aspire Stock Purchase Agreement”), with Aspire Capital Fund, LLC (“Aspire Capital”), which provides that, subject to the terms, conditions, and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $ 20.0 million of shares of common stock over the 30-month term of the Aspire Stock Purchase Agreement.
Through December 31, 2020, the Company sold 412,187 shares of common stock to Aspire Capital at a weighted-average price of $ 21.35 per share for aggregate net proceeds of $ 8.8 million. The Company did not sell any shares to Aspire Capital during the years ended December 31, 2021 or 2022. As of December 31, 2022, the Company has the ability to 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. The Company also has the right to require Aspire Capital to purchase up to an additional 30 % of the trading volume of the shares for the next business day at a purchase price (the “VWAP Purchase Price”), equal to the lesser of: (i) the closing sale price of the shares on the purchase date, or (ii) ninety-seven percent ( 97 %) of the next business day’s volume weighted average-price (each such purchase, a “VWAP Purchase”). The Company shall have the right, in its sole discretion, to determine a maximum number of shares and set a minimum market price threshold for each VWAP Purchase. The Company can only require a VWAP Purchase if the Company has also submitted a regular purchase on the notice date for the VWAP Purchase. There are no limits on the number of VWAP purchases that the Company may require.
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.
Preferred Stock
Under the Company’s second 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.
Series A Preferred Stock
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. Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. 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, (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (ii) alter or amend the Certificate of Designation, (iii) 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, (iv) increase the number of authorized shares of Series A Preferred Stock, (v) 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 (vi) enter into any agreement with respect to any of the foregoing. The Series A Preferred Stock does not have a preference upon any liquidation, dissolution, or winding-up of the Company. 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
23
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.
As of December 31, 2022 and 2021, there were 188,381 and 260,437 shares of Series A Preferred Stock outstanding, respectively.
Series B Preferred Stock
Each share of Series B Preferred Stock is convertible into 66.67 shares of common stock, subject to certain limitations, including that a holder of Series B Preferred Stock is prohibited from converting shares of Series B 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 4.9 % and 19.9 %) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. The powers, preferences, rights, qualifications, limitations, and restrictions applicable to the Series B Preferred Stock are set forth in the Certificate of Designation filed in connection with the Offering.
Holders of Series B Preferred Stock are entitled to receive dividends on shares of Series B 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. Except as otherwise required by law, the Series B Preferred Stock does not have voting rights. However, as long as any shares of Series B 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 B Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (ii) alter or amend the Certificate of Designation, or (iii) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock. The Series B Preferred Stock does not have a preference upon any liquidation, dissolution, or winding-up of the Company. As of December 31, 2022 and 2021, there were 51,210 and 23,126 shares of Series B Preferred Stock outstanding, respectively.
10. WARRANTS
The following table presents information about the Company’s outstanding warrants:
Number of Underlying Shares (1) Weighted-Average Exercise Price at December 31, 2022 Remaining Contractual Life at December 31, 2022
(No. Years)
December 31,
2022 2021
Liability-classified warrants
Issued April 2017 781 781 $ 127.95 2.33
Equity-classified warrants
Acquired October 2020 29,446 29,446 $ 0.01 7.73
Issued February 2020 (2) 332,130 388,796 $ 15.09 2.12
Issued November 2017 1,606 1,606 $ 0.47 1.87
Subtotal 363,182 419,848 $ 15.57
Total warrants 363,963 420,629 $ 15.82
____________________
(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. 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.
(2) Subject to specified conditions, the Company may voluntarily reduce the warrant exercise price of the warrants issued in February 2020.
24
A summary of the Company’s warrant activity during the year ended December 31, 2022 is as follows:
Common Stock Warrants
Number Weighted-Average Exercise Price
Outstanding at December 31, 2021 420,629 $ 15.82
Exercised ( 56,666 ) $ 16.50
Outstanding at December 31, 2022 363,963 $ 15.82
11. SHARE-BASED COMPENSATION
Equity Incentive Plans
The Company has grants outstanding 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” and collectively with the 2008 Plan and the 2016 Plan, the “Equity Incentive Plans”). Additionally, beginning in July 2021, the Company granted stock options outside of its Equity Incentive Plans to certain employees to induce them to accept employment with the Company (the “Inducement Awards”). The terms and conditions of the Inducement Awards are substantially similar to those awards granted under the Company’s Equity Incentive Plans.
On June 8, 2022 (the “Effective Date”), the Company’s stockholders approved the amendment and restatement of the 2016 Plan (the “Amended 2016 Plan”), which increased the number of shares reserved for issuance under the Amended 2016 Plan by 3,050,000 shares and transferred the number of shares that remain available for issuance under the 2020 Plan as of the Effective Date into the Amended 2016 Plan so that the Company operates from a single equity plan going forward. The term of the Amended 2016 Plan is 10 years following the Effective Date.
As of December 31, 2022, the Company had the following balances by plan:
Stock Options Outstanding Shares Available for Issuance
Inducement Awards 1,513,174 —
2020 Plan 930,332 —
2016 Plan 3,278,757 3,781,888
2008 Plan 186 —
Total 5,722,449 3,781,888
Options granted under the Equity Incentive Plans and the Inducement Awards have an exercise price equal to the market value of the common stock at the date of grant and expire 10 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. The Company has also granted options that vest in equal monthly or quarterly amounts over periods up to 48 months.
The Company does not currently hold any treasury shares. Upon stock option exercise, the Company issues new shares and delivers them to the participant.
25
A summary of common stock option activity is as follows:
Number of Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term
(years) Aggregate Intrinsic Value
(in thousands)
Outstanding as of December 31, 2021 3,683,839 $ 16.94 8.94 $ 15,969
Granted 2,545,500 17.72
Exercised ( 191,291 ) 14.44
Forfeited or expired ( 315,599 ) 19.48
Outstanding as of December 31, 2022 5,722,449 17.23 8.64 $ 68,977
Vested or expected to vest as of December 31, 2022 5,722,449 $ 17.23 8.64 $ 68,977
Exercisable as of December 31, 2022 1,697,616 $ 16.95 8.07 $ 21,258
Vested as of December 31, 2022 1,697,616 $ 16.95 8.07 $ 21,258
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. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility, and expected lives of the options. Because the Company has a limited history of stock purchase and sale activity, expected volatility is based on a blend of historical data from public companies that are similar to the Company in size and nature of operations, as well as the Company’s own volatility. The Company will continue to use similar entity volatility information until its historical volatility is relevant to measure expected volatility for option grants. The Company accounts for forfeitures as they occur. The risk-free rate for periods within the contractual life of each option is based on the U.S. Treasury yield curve in effect at the time of the grant for a period commensurate with the expected term of the grant. The expected term (without regard to forfeitures) for options granted represents the period of time that options granted are expected to be outstanding and is derived from the contractual terms of the options granted, and actual and expected option-exercise behaviors. The fair value of the underlying common stock is based on the closing price of the common stock on The Nasdaq Capital Market at the date of grant.
The weighted-average grant-date fair value of options granted to the Company’s employees and members of its board of directors during the years ended December 31, 2022 and 2021 was $ 12.95 and $ 17.50 , respectively. The fair value was determined by the Black-Scholes option pricing model using the following weighted-average assumptions:
Year Ended
December 31,
2022 2021
Expected term, in years 5.81 5.92
Expected volatility 87.8 % 117.7 %
Risk-free interest rate 2.5 % 0.8 %
Expected dividend yield — % — %
Weighted average exercise price $ 17.72 $ 20.56
Employee Stock Purchase Plan
The 2016 Employee Stock Purchase Plan (“ESPP”) allows qualified employees to purchase shares of common stock at a price equal to 85 % of the lower of: (i) the closing price at the beginning of the offering period or (ii) the closing price at the end of the offering period. New six-month offering periods begin each August 22 and February 22. As of December 31, 2022, the Company had 309,541 shares available for issuance, and 27,074 cumulative shares had been issued under the ESPP.
26
Share-Based Compensation Expense
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:
Year Ended
December 31,
2022 2021
(in thousands)
Research and development $ 7,298 $ 4,701
General and administrative 12,467 9,764
Total share-based compensation expense $ 19,765 $ 14,465
As of December 31, 2022, the Company had $ 54.9 million of total unrecognized employee and non-employee share-based compensation costs, which the Company expects to recognize over a weighted-average remaining period of 2.77 years.
12. NET LOSS PER SHARE
Basic net loss per share is computed by dividing the net loss available to common stockholders by the weighted-average number of common stock outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional shares of common stock were dilutive. Diluted net loss per share is the same as basic net loss per share of common stock, as the effects of potentially dilutive securities are antidilutive.
Potentially dilutive securities include the following:
December 31,
2022 2021
(in thousands)
Series A Preferred Stock, as converted to shares of common stock 12,559 17,363
Series B Preferred Stock, as converted to shares of common stock 3,414 1,542
Options to purchase common stock 5,722 3,684
Warrants to purchase common stock 364 421
Total 22,059 23,010
13. INCOME TAXES
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.
Since its inception, the Company has incurred net taxable losses, and accordingly, no current provision for income taxes has been recorded. This amount differs from the amount computed by applying the U.S. federal income tax rate of 21% to pretax loss due to the provision of a valuation allowance to the extent of the Company’s net deferred tax asset, as well as to state income taxes and nondeductible expenses.
27
The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows:
Year Ended December 31,
2022 2021
Federal statutory income tax rate 21.0 % 21.0 %
Federal and state tax credits 1.6 1.5
State income taxes, net of federal benefit 4.2 8.3
Change in valuation allowance ( 24.5 ) ( 28.5 )
Other permanent items ( 0.8 ) —
Section 382 limit — —
Stock-based compensation ( 1.5 ) ( 2.3 )
Effective income tax rate — % — %
The tax effects of temporary differences that give rise to significant portions of the deferred income tax assets and liabilities are presented below:
Year Ended December 31,
2022 2021
(in thousands)
Deferred tax assets:
Net operating loss carryforwards $ 46,000 $ 40,992
Tax credits 3,803 1,686
Accruals and reserves 4,986 3,055
Stock-based expense 4,161 3,123
Start-up costs and amortized costs 9,460 5,013
IRC § 174 capitalized costs 18,252 —
Operating lease right-of-use asset, net 22 —
Total deferred tax assets 86,684 53,869
Valuation allowance ( 86,602 ) ( 53,430 )
Net deferred tax assets 82 439
Deferred tax liabilities:
Unrealized gains/losses ( 82 ) —
Operating lease right-of-use asset, net — ( 439 )
Total deferred tax liabilities ( 82 ) ( 439 )
Total deferred tax assets, net $ — $ —
At December 31, 2022, the Company had approximately $ 175.6 million and $ 3.5 million of federal net operating loss and research and experimentation tax carryforwards, respectively, which will begin to expire in 2029. At December 31, 2022 ,the Company had approximately $ 196.7 million of state net operating loss carryforwards which will begin to expire in 2030. In addition, the realization of net operating losses to offset potential future taxable income and related income taxes that would otherwise be due is subject to annual limitations under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state provisions, which may result in the expiration of additional net operating losses before future utilization as a result of ownership changes. As a result of these ownership change provisions during 2020, the Company estimated an aggregate limitation on the utilization of net operating loss carryforwards of $ 59.0 million. In addition to the limitation of net operating losses of $ 59.0 million, approximately $ 15.3 million of research and development tax credits were derecognized with the inability of the Company to ever realize a benefit from those credits in the future. The Company determines on an annual basis whether net operating loss carryforwards will be limited. An IRC 382 analysis has been completed through December 31, 2022 and determined that there were no additional ownership changes. The Company will continue to evaluate changes in ownership and the related limitations on a go forward basis.
As of December 31, 2022 and 2021, the Company’s net deferred tax assets before valuation allowance was $ 86.6 million and $ 53.4 million, respectively. In assessing the realizability of its deferred tax assets, the Company considers whether it is more likely than not that some portion or all of its deferred tax assets will not be realized. The ultimate realization of deferred tax
28
assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. 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, 2022 and 2021. The change in valuation allowance was an increase of $ 33.2 million in 2022 and an increase of $ 24.4 million in 2021.
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 2022 and 2021. As of December 31, 2022 and 2021, the Company had no accrued interest related to uncertain tax positions.
The Company’s federal and state returns for 2018 through 2022 remain open to examination by tax authorities.
14. SUBSEQUENT EVENTS
None.
29
SIGNATURES
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.
VIRIDIAN THERAPEUTICS, INC.
Date: March 9, 2023 By: /s/ Scott Myers
Scott Myers
President, Chief Executive Officer, and Director
(Principal Executive Officer)
Date: March 9, 2023 By: /s/ Kristian Humer
Kristian Humer
Chief Financial Officer
(Principal Financial Officer; Principal Accounting Officer)
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Scott Myers and Kristian Humer, 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.
Signature Title Date
/s/ Scott Myers President, Chief Executive Officer, and Director March 9, 2023
Scott Myers (Principal Executive Officer)
/s/ Kristian Humer Chief Financial Officer March 9, 2023
Kristian Humer (Principal Financial Officer; Principal Accounting Officer)
/s/ Tomas Kiselak Chairman of the Board March 9, 2023
Tomas Kiselak
/s/ Peter Harwin Director March 9, 2023
Peter Harwin
/s/ Arlene Morris Director March 9, 2023
Arlene Morris
/s/ Jennifer Moses Director March 9, 2023
Jennifer Moses
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.