Item 9A. Controls and Procedures
Item 9A. Controls and Procedures .
Evaluation of disclosure controls and procedures .
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms and (2) accumulated and communicated to our management, including our principal executive and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
As of December 31, 2021, our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of our disclosure controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2021.
Management’s Annual Report on Internal Control Over Financial Reporting
This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) or an attestation report of our independent registered public accounting firm due to a transition period established by rules of the SEC for newly public companies.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our 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 our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Because of these 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. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become ineffective because of changes in conditions or that the degree of compliance with established policies or procedures may deteriorate.
Changes in Internal Control over Financial Reporting
There were no material changes in our internal control over financial reporting during the quarter ended December 31, 2021, that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Attestation Report of the Registered Public Accounting Firm
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to a transition period established by rules of the SEC for newly public companies. Additionally, our independent registered public accounting firm will not be required to opine on our internal control over financial reporting until we are no longer an emerging growth company.
106
Item 9B. Other Information .
2022 Annual Stockholder Meeting
The Company currently plans to hold its 2022 Annual Meeting of Stockholders (the “Annual Meeting”) on June 15, 2022 at 10:30 a.m. local time virtually. Pursuant to the provisions of the Company’s Bylaws, for any stockholder to propose business (other than pursuant to and in compliance with Exchange Act Rule 14a-8) or make a nomination before the annual meeting, the stockholder must have given timely notice in writing to the secretary and any such nomination or proposed business must constitute a proper matter for stockholder action. Under the Company’s Bylaws, to be timely, a stockholder’s notice must be received by the secretary at the principal executive offices of the Company later than the close of business on the 90th day before the 2022 Annual Meeting nor earlier than the close of business on the 10th day following the day on which public announcement of the date of 2022 Annual Meeting is first made by the Company. Because the Company did not hold an annual meeting last year, the Company has determined that the date by which stockholders must deliver such notice for the purposes of the 2022 Annual Meeting is April 2, 2022, which is 10 days after the filing of this Annual Report on Form 10-K. Pursuant to Rule 14a-8, for a stockholder to submit a proposal for inclusion in the Company’s proxy materials for the 2022 Annual Meeting, the stockholder must comply with the requirements set forth in Rule 14a-8 including with respect to the subject matter of such proposal and must deliver the proposal and all required documentation to the Company a reasonable time before the Company begins to print and send its proxy materials for the meeting. For the purposes of the 2022 Annual Meeting of Stockholders, the Company has determined that April 18, 2022 is a reasonable time before the Company plans to begin printing and mailing its proxy materials. The public announcement of an adjournment or postponement of the 2022 Annual Meeting date will not commence a new time period (or extend any time period) for giving such notice under the Company’s Bylaws or submitting a proposal pursuant to Rule 14a-8.
Item 9C. Disclosure Regarding Forei gn Jurisdictions that Prevent Inspections.
None.
107
PART III
Item 10. Directors, Executive Offic ers and Corporate Governance.
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2021.
Item 11. Executive Compensation .
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2021.
Item 12. Security Ownership of Certain Beneficial Own e rs and Management and Related Stockholder Matters.
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2021.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2021.
Item 14. Principal Accoun ting Fees and Services.
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2021.
108
PART IV
Item 15. Exhibits, Financial Statement Schedules .
(1) For a list of the consolidated financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report on Form 10-K, incorporated into this Item by reference.
(2) Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the financial statements or the notes thereto.
(3) Exhibits:
Exhibit
Number
Description
3.1*
Tenth Amended and Restated Certificate of Incorporation of Registrant
3.2*
Amended and Restated Bylaws of Registrant
4.1*
Description of Securities
4.2
Fifth Amended and Restated Investors’ Rights Agreement (incorporated by reference to Exhibit 4.2 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 8, 2021)
10.1#
2009 Amended and Restated Stock Option and Restricted Stock Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.1 of the Registrant’s Registration Statement on Form S-8 (File No. 333-260589) filed on October 29, 2021)
10.2#
2018 Equity Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.2 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.3#
2021 Stock Option and Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.3 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.4#
2021 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.4 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.5#
Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.5 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.6#
Senior Executive Cash Bonus Plan (incorporated by reference to Exhibit 10.6 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.7#
Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (incorporated by reference to Exhibit 10.7 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.8#
Employment Agreement between the Registrant and Elisabet de los Pinos, dated January 1, 2015, as amended on October 13, 2017 (incorporated by reference to Exhibit 10.8 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.9#
Employment Offer Letter between the Registrant and Julie Feder, dated August 10, 2018 (incorporated by reference to Exhibit 10.9 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.10#
Employment Offer Letter between the Registrant and Cadmus Rich, dated October 14, 2017 (incorporated by reference to Exhibit 10.10 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 25, 2021)
10.11
Exclusive Patent License Agreement with the National Institutes of Health, dated September 3, 2013 as amended (incorporated by reference to Exhibit 10.11 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 8, 2021)
10.12
Exclusive License and Supply Agreement with LI-COR, Inc., dated January 31, 2014, as amended (incorporated by reference to Exhibit 10.12 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 8, 2021)
109
10.13
License Agreement with Clearside Biomedical, Inc., dated July 3, 2019 (incorporated by reference to Exhibit 10.13 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 8, 2021)
10.14
Lease Agreement with Bolton Street Partners, LLC, dated June 9, 2011, as amended (incorporated by reference to Exhibit 10.14 of the Registrant’s Registration Statement on Form S-1 (File No. 333-260156) filed on October 8, 2021)
21.1*
List of Subsidiaries of Registrant
23.1*
Consent of Ernst & Young, independent registered public accounting firm.
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Filed herewith.
Item 16. Form 10-K Summary
None.
110
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .
Aura Biosciences, Inc.
Date: March 23, 2022
By:
/s/ Elisabet de los Pinos
Elisabet de los Pinos
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ Elisabet de los Pinos
President and Chief Executive Officer
March 23, 2022
Elisabet de los Pinos
/s/ Julie Feder
Chief Financial Officer
March 23, 2022
Julie Feder
/s/ David Johnson
Chairman of the Board of Directors
March 23, 2022
David Johnson
/s/ Giovanni Mariggi
Director
March 23, 2022
Giovanni Mariggi
/s/ Antony Mattessich
Director
March 23, 2022
Anthony Mattessich
/s/ Raj Parekh
Director
March 23, 2022
Raj Parekh
/s/ Sapna Srivastava
Director
March 23, 2022
Sapna Srivastava
/s/ Karan Takhar
Director
March 23, 2022
Karan Takhar
111
Index to CONSOLIDATED Financial Statements
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 42 )
F- 2
Consolidated Balance Sheets
F- 3
Consolidated Statements of Operations and Comprehensive Loss
F- 4
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
F- 5
Consolidated Statements of Cash Flows
F- 6
Notes to Consolidated Financial Statements
F- 7
F- 1
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Aura Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Aura Biosciences, Inc. (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ deficit and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, 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 the Company’s 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.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2016.
Boston, Massachusetts
March 23, 2022
F- 2
Aura Biosciences, Inc.
C onsolidated Balance Sheets
(in thousands, except share and per share amounts)
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
149,063
$
17,393
Restricted cash and deposits
23
19
Prepaid expenses and other current assets
4,618
1,043
Total current assets
153,704
18,455
Restricted cash and deposits, net of current portion
125
75
Right of use assets - operating lease
950
—
Property and equipment, net
5,251
3,574
Total Assets
$
160,030
$
22,104
Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
2,401
611
Short-term operating lease liability
615
—
Accrued expenses and other current liabilities
4,256
2,050
Total current liabilities
7,272
2,661
Deferred rent
—
8
Long-term operating lease liability
360
—
Warrant liability
83
72
Total Liabilities
7,715
2,741
Commitments and Contingencies (Note 12)
Convertible preferred stock (Note 7)
—
128,076
Stockholders’ Equity (Deficit):
Common stock, $ 0.00001 par value, 150,000,000 and 232,697,999 authorized at December 31, 2021, and December 31, 2020, and 29,211,643 and 381,123 shares issued and outstanding at December 31, 2021, and December 31, 2020, respectively
—
—
Additional paid-in capital
304,452
8,173
Accumulated deficit
( 152,137
)
( 116,886
)
Total Stockholders’ Equity (Deficit)
152,315
( 108,713
)
Total Liabilities, Convertible Preferred Stock, and Stockholders’ Deficit
$
160,030
$
22,104
The accompanying notes are an integral part of these consolidated financial statements.
F- 3
Aura Biosciences, Inc.
C onsolidated Statements of Operations and Comprehensive Loss
(in thousands except for share and per share data)
Year Ended
December 31,
2021
2020
Operating Expenses:
Research and development
25,161
18,042
General and administrative
10,089
4,164
Total operating expenses
35,250
22,206
Total operating loss
( 35,250
)
( 22,206
)
Other income (expense):
Change in fair value of warrant liability
( 11
)
3
Interest income (expense), including amortization of discount
13
( 3
)
Loss on disposal of assets
( 3
)
—
Total other expense
( 1
)
—
Net loss and comprehensive loss
$
( 35,251
)
$
( 22,206
)
Net loss attributable to common stockholders—basic and diluted (Note 13)
$
( 46,193
)
$
( 30,132
)
Net loss per share attributable to common stockholders—basic and diluted
( 8.95
)
( 82.06
)
Weighted average common stock outstanding—basic and diluted
5,159,973
367,204
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
Aura Biosciences, Inc.
C onsolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except share data)
Convertible Preferred Stock
Additional
Total
Series A
Series A-1
Series A-2
Series B
Series C-1 and C-2
Series D-1 and D-2
Series E
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balance, December
31, 2019
1,701,141
$ 3,368
3,298,732
$ 7,837
4,324,998
$ 5,373
22,531,819
$ 20,806
91,327,903
$ 41,099
57,878,742
$ 39,686
—
$—
340,591
$-
$ 7,274
$( 94,680 )
$( 87,406 )
Issuance of Series D convertible preferred stock, net of issuance costs of $ 93
—
—
—
—
—
—
—
—
—
—
14,469,710
9,907
—
—
—
—
—
—
—
Stock-based compensation expense
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
736
—
736
Stock options exercises
—
—
—
—
—
—
—
—
—
—
—
—
—
—
40,532
—
163
—
163
Net loss
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
( 22,206 )
( 22,206 )
Balance, December
31, 2020
1,701,141
$ 3,368
3,298,732
$ 7,837
4,324,998
$ 5,373
22,531,819
$ 20,806
91,327,903
$ 41,099
72,348,452
$ 49,593
—
$—
381,123
$-
$ 8,173
$( 116,886 )
$( 108,713 )
Issuance of Series D convertible preferred stock, net of issuance costs of $ 18
—
—
—
—
—
—
—
—
—
—
10,128,771
6,982
—
—
—
—
—
—
—
Issuance of Series E convertible preferred stock, net of issuance costs of $ 237
—
—
—
—
—
—
—
—
—
—
—
—
102,671,041
80,246
—
—
—
—
—
Issuance of common stock - as a result of IPO, net of issuance costs $ 8,620
—
—
—
—
—
—
—
—
—
—
—
—
—
—
6,210,000
—
78,320
—
78,320
Conversion of convertible preferred stock to common stock upon closing of IPO
( 1,701,141 )
( 3,368 )
( 3,298,732 )
( 7,837 )
( 4,324,998 )
( 5,373 )
( 22,531,819 )
( 20,806 )
( 91,327,903 )
( 41,099 )
( 82,477,223 )
( 56,575 )
( 102,671,041 )
( 80,246 )
22,550,561
—
215,304
—
215,304
Stock-based compensation expense
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
2,307
—
2,307
Stock options exercises
—
—
—
—
—
—
—
—
—
—
—
—
—
—
69,959
—
348
—
348
Net loss
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
( 35,251 )
( 35,251 )
Balance, December
31, 2021
—
$—
—
$—
—
$—
—
$—
—
$—
—
$—
—
$—
29,211,643
$-
$ 304,452
$( 152,137 )
$ 152,315
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
Aura Biosciences, Inc.
C onsolidated Statements of Cash Flows
(in thousands)
Year ended December 31,
2021
2020
Cash flows from operating activities:
Net loss
$
( 35,251
)
$
( 22,206
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
831
831
Change in fair value of warrant liability
11
( 3
)
Stock-based compensation expense
2,307
736
Gain on disposal of property and equipment
3
—
Operating lease expense
4
—
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 3,575
)
( 165
)
Accounts payable
1,054
( 1,721
)
Accrued expenses and other liabilities
2,206
( 1,793
)
Net cash used in operating activities
( 32,410
)
( 24,321
)
Cash flows from investing activities:
Purchases of property and equipment
( 2,125
)
( 771
)
Net cash used in investing activities
( 2,125
)
( 771
)
Cash flows from financing activities:
Proceeds from issuance of common stock upon IPO, net of issuance costs
78,697
—
Proceeds from exercise of stock options
349
163
Proceeds from issuance of Series E convertible preferred stock, net of issuance costs
80,246
—
Proceeds from issuance of Series D convertible preferred stock, net of
issuance costs
6,982
9,907
Other
( 15
)
( 34
)
Net cash provided by financing activities
166,259
10,036
Net increase (decrease) in cash, cash equivalents and restricted cash
131,724
( 15,056
)
Cash, cash equivalents and restricted cash at beginning of period
17,487
32,543
Cash, cash equivalents and restricted cash at end of period
$
149,211
$
17,487
Supplemental disclosure of cash flow information:
Purchases of property and equipment in accounts payable and accrued expenses and other liabilities
$
386
$
—
Initial measurement of operating lease right-of-use assets and liabilities
$
536
$
—
Right-of-use assets obtained in exchange for operating lease liabilities
$
516
$
—
Remeasurement of operating lease right-of-use assets and liabilities for lease modification
$
390
$
—
Deferred offering costs in accounts payable
$
377
$
—
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands):
Year ended December 31,
2021
2020
Cash and cash equivalents, end of period
$
149,063
$
17,393
Short-term restricted cash, end of period
23
19
Long-term restricted cash, end of period
125
75
Cash, cash equivalents and restricted cash at end of period
$
149,211
$
17,487
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
Aura Biosciences, Inc.
Notes to Consolidated Financial Statements
1. Description of Business
Aura Biosciences, Inc. (the “Company” or “Aura”) is a clinical-stage biotechnology company leveraging its novel targeted oncology platform to develop a potential new standard of care across multiple cancer indications, with an initial focus on ocular and urologic oncology. Within these consolidated financial statements, unless the context otherwise requires, references to the Company or Aura refer to Aura Biosciences, Inc. The Company’s proprietary platform enables the targeting of a broad range of solid tumors using Virus-Like Particles, or VLPs, that can be conjugated with drugs or loaded with nucleic acids to create Virus-Like Drug Conjugates, or VDCs. The Company’s VDCs are largely agnostic to tumor type and can recognize a surface marker, known as HSPGs, that are specifically modified and more broadly expressed on many tumors. The Company is developing AU-011, its first VDC product candidate for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. The Company is also developing AU-011 for additional ocular oncology indications and in non-muscle invasive bladder cancer. Aura’s team combines expertise in cancer cell biology, ophthalmology, and targeted therapies together with experience in the development and commercialization of orphan products for significant unmet medical needs. Aura’s headquarters are located in Cambridge, Massachusetts.
The Company’s operations to date have consisted primarily of conducting research and development and raising capital.
The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, the successful development and commercialization of products, fluctuations in operating results and financial risks, need for additional financing or alternative means of financial support or both to fund its current operating plan, protection of proprietary technology and patent risks, compliance with government regulations, dependence on key personnel and collaborative partners, competition, customer demand, management of growth, and the effectiveness of marketing by the Company.
Reverse Stock Split
On October 22, 2021, the Company effected a reverse stock split of the Company’s common stock on a 1-for-13.7 basis, or the Reverse Stock Split. In connection with the Reverse Stock Split, the conversion ratio for the Company’s convertible preferred stock was proportionately adjusted such that the common stock issuable upon conversion of such preferred stock was decreased in proportion to the Reverse Stock Split. Accordingly, all common stock share and per share amounts, for all periods presented in these consolidated financial statements, have been retroactively adjusted, to reflect this reverse stock split and adjustment of the convertible preferred stock conversion ratios.
Initial Public Offering
On November 2, 2021, the Company completed its initial public offering or the IPO, in which it issued and sold 6,210,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $ 14.00 per share for aggregate gross proceeds of $ 86.9 million. The Company received approximately $ 78.3 million in net proceeds after deducting underwriting discounts, commissions and offering expenses.
F- 7
Liquidity and Going Concern
Through December 31, 2021, the Company has funded its operations primarily with proceeds from the initial closing and additional closings of its convertible preferred stock financings, through its license agreements, and through its IPO. On November 2, 2021, the Company completed its IPO, in which it issued and sold 6,210,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $ 14.00 per share for aggregate gross proceeds of $ 86.9 million. The Company received approximately $ 78.3 million in net proceeds after deducting underwriting discounts, commissions and offering expenses. The Company has incurred recurring losses and negative operating cash flows from operations since its inception, including net losses of $ 35.3 million and $ 22.2 million for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company had cash and cash equivalents of $ 149.1 million and an accumulated deficit of $ 152.1 million. The Company expects to continue to generate operating losses for the foreseeable future.
As of the issuance date of these consolidated financial statements for the year ended December 31, 2021, the Company expects that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance of these consolidated financial statements. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations.
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include those accounts of the Company and its subsidiaries after elimination of all intercompany accounts and transactions.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant items subject to such estimates and assumptions include the fair value of stock-based compensation and accrued research and development costs. Management bases its estimates on historical experience and on various other market-specific relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Segment Information
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment operating exclusively in the United States.
Cash and Restricted Cash
Cash consists of standard checking accounts. As of December 31, 2021 and 2020, the restricted cash account is comprised of a $ 0.1 million security deposit held by the lessor for the Company’s facility lease, and a $ 0.02 million deposit that is collateral for the Company’s corporate credit card.
Cash Equivalents
Cash equivalents are highly liquid investments with an original maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds that invest in U.S. Treasury obligations and government funds with commercial banks and financial institutions.
Fair Value Measurements
Accounting Standards Codification 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs).
F- 8
Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following:
▪ Level 1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.
▪ Level 2—Inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
▪ Level 3—Inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash.
Property and Equipment
Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of the assets. Upon sale or retirement, the cost and accumulated depreciation is eliminated from their respective accounts and the resulting gain or loss is included in income or loss for the period. Repair and maintenance expenditures are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows:
Estimated Useful Life
Leasehold improvements
2 years
IT equipment
3 years
Laboratory equipment
5 years
Office furniture
7 years
Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation are removed from the consolidated balance sheet and any gain or loss is reflected in the consolidated statements of operations and comprehensive loss.
Impairment of Long-Lived Assets
The Company reviews all long-lived assets for impairment whenever events or circumstances indicate the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying value of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such asset is considered to be unrecoverable, the impairment recognized is measured by the difference between the estimated fair value of the asset and its carrying value. The Company did not recognize any material impairments during the years ended December 31, 2021 or 2020.
F- 9
Research and Development
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs, depreciation, third-party license fees, and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as to manufacture research and development materials. The Company accrues costs for clinical trial activities and contract manufacturers based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the contract research organizations, clinical study sites, contract manufacturers, laboratories, consultants, or other vendors that perform the activities.
Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are expensed as the goods are delivered or the related services are performed or until it is no longer expected that the goods will be delivered, or the services rendered.
Costs incurred in obtaining technology licenses are recognized as research and development expense as incurred if the technology licensed has not reached technological feasibility and has no alternative future uses.
Patent and Trademark Costs
All patents and trademark related costs incurred in connection with filing and prosecuting patent and trademark applications are expensed as incurred due to uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Leases
Prior to January 1, 2021, the Company accounted for leases in accordance with ASC 840, Leases ("ASC 840"). At lease inception, the Company determined if an arrangement was an operating or capital lease. For operating leases, the Company recognized rent expense, inclusive of rent escalation, holidays and lease incentives, on a straight-line basis over the lease term. The difference between rent expense recorded and the amount paid was charged to deferred rent. The Company presented lease incentives as deferred rent and amortized the incentives as a reduction to rent expense on a straight-line basis over the lease term. The Company classified deferred rent as current and noncurrent liabilities based on the portion of the deferred rent that was scheduled to mature within the proceeding twelve months.
Effective January 1, 2021, the Company accounts for leases in accordance with ASU No. 2016-02, Leases (Topic 842) (“ASC 842”). At contract inception, the Company determines if an arrangement is or contains a lease. A lease conveys the right to control the use of an identified asset for a period of time in exchange for consideration. If determined to be or contain a lease, the lease is assessed for classification as either an operating or finance lease at the lease commencement date, defined as the date on which the leased asset is made available for use by the Company, based on the economic characteristics of the lease. For each lease with a term greater than twelve months, the Company records a right-of-use asset and lease liability.
The Company adopted the new leasing standard effective January 1, 2021 , using the modified retrospective transition approach which uses the effective date, or January 1, 2021, as the date of initial application. As a result, prior periods are presented in accordance with the previous guidance in ASC 840. ASC 842 provides several optional practical expedients in transition. The Company has elected to apply the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or the capitalization of initial direct costs for any existing leases.
F- 10
A right-of-use asset represents the economic benefit conveyed to the Company by the right to use the underlying asset over the lease term. A lease liability represents the obligation to make lease payments arising from the lease. The Company elected the practical expedient to not separate lease and non-lease components for all classes of underlying assets and therefore measures each lease payment as the total of the fixed lease and associated non-lease components. Lease liabilities are measured at lease commencement and calculated as the present value of the future lease payments in the contract using the rate implicit in the contract, when available. If an implicit rate is not readily determinable, the Company uses an incremental borrowing rate measured as the rate at which the Company could borrow, on a fully collateralized basis, a commensurate loan in the same currency over a period consistent with the lease term at the commencement date. Right-of-use assets are measured as the lease liability plus initial direct costs and prepaid lease payments, less lease incentives granted by the lessor. The lease term is measured as the noncancelable period in the contract, adjusted for any options to extend or terminate when it is reasonably certain the Company will extend the lease term via such options based on an assessment of economic factors present as of the lease commencement date. The Company elected the practical expedient to not recognize leases with a lease term of twelve months or less.
Components of a lease are split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) are allocated, based on the respective relative fair values, to the lease components and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only.
The Company’s operating leases are presented in the consolidated balance sheet as operating lease right-of-use assets, classified as noncurrent assets, and operating lease liabilities, classified as current and noncurrent liabilities. Operating lease expense is recognized on a straight-line basis over the lease term. Variable costs associated with a lease, such as maintenance and utilities, are not included in the measurement of the lease liabilities and right-of-use assets but rather are expensed when the events determining the amount of variable consideration to be paid have occurred.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and/or tax returns. Deferred tax assets and liabilities are based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all the deferred tax asset will not be realized.
The Company provides reserves related to uncertain tax positions when management determines the related tax benefit is not more likely than not to be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as the consideration of the available facts and circumstances. The Company has no reserves related to uncertain tax positions as of December 31, 2021 and 2020.
Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expense in the accompanying consolidated statements of operations and comprehensive loss. As of December 31, 2021, and 2020, the Company had no accrued interest related to uncertain tax positions.
Deferred Offering Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. After the closing of the IPO, these costs were recorded in stockholders' equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering.
F- 11
Convertible Preferred Stock Classification
The Company records all convertible preferred stock upon issuance at its respective fair value or original issuance price less issuance costs. The Company classifies its convertible preferred stock outside of stockholders’ deficit as the redemption of such shares is outside the Company’s control. The Company does not adjust the carrying values of the convertible preferred stock to redemption value unless and until it becomes probable that the instrument will become redeemable. As of December 31, 2020, the Company’s convertible preferred stock was no t adjusted to redemption value. After the closing of the IPO, all of the Company's outstanding shares of convertible preferred stock automatically converted into shares of common stock.
Stock-Based Compensation
The Company recognizes stock-based compensation expense for all stock-based awards based on their grant date fair value.
The Company recognizes compensation expense over the requisite service period, which is generally the vesting period of the award. For awards that include performance-based vesting conditions, expense is recognized using the accelerated attribution method when the performance condition is deemed to be probable of being satisfied. As of December 31, 2021, the Company has no performance-based awards. The Company accounts for forfeitures as they occur. The Company determines the fair value of restricted stock awards in reference to the fair value of its common stock less any applicable purchase price.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option and the Company’s expected dividend yield. The Company determines the volatility for awards granted based on an analysis of reported data for a group of guideline companies that have issued options with substantially similar terms. The expected volatility has been determined using a weighted-average of the historical volatility measures of this group of guideline companies. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options granted to employees has been determined utilizing the “simplified” method, using the midpoint between the vesting date and the contractual term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero .
Before the IPO, as there has been no public market for the Company's common stock, the estimated fair value of its common stock was been determined by its Board of Directors, with input from management, considering third-party valuations of the common stock as well as the Board of Directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the option grant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The Company's common stock valuations were prepared using either an option pricing method, or OPM, or a hybrid method, both of which used market approaches to estimate the Company's enterprise value. The hybrid method is a probability-weighted expected return method, or PWERM, where the equity value in one or more of the scenarios is calculated using an OPM. The PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for the company, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock is then applied to arrive at an indication of value for the common stock. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger.
F- 12
In addition to considering the results of these third-party valuations, the Company's Board of Directors considered various objective and subjective factors to determine the fair value of the Company's common stock as of each grant date, including:
∎
The prices at which the Company sold shares of preferred stock and the superior rights and preferences of the preferred stock relative to its common stock at the time of each grant;
∎
The progress of Aura's research and development programs, including the status and results of preclinical studies for its product candidates;
∎
The Company's stage of development and commercialization and its business strategy;
∎
External market conditions affecting the biotechnology industry and trends within the biotechnology industry;
∎
The Company's financial position, including cash on hand, and its historical and forecasted performance and operating results;
∎
The lack of an active public market for Aura's common stock and convertible preferred stock;
∎
The likelihood of achieving a liquidity event, such as an IPO, or sale of the Company in light of prevailing market conditions; and
∎
The analysis of an IPO and the market performance of similar companies in the biotechnology industry.
The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used different assumptions or estimates, the fair value of its common stock and stock-based compensation expense could have been materially different.
The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s cash compensation costs are classified.
Warrants
The Company accounts for warrants on capital stock based on guidelines provided in ASC Topic 815, Derivatives and Hedging—Contracts in Entity’s Own Equity (“ASC 815”), which provides guidance on contracts that are settled in the Company’s own shares as either a liability or as an equity instrument depending on the warrant agreement. The Company's warrants are all classified as equity instruments. As such, the Company uses the Black-Scholes pricing model, depending on the applicable terms of the warrant agreement, to value the warrants.
Net Loss per Share
Net loss per share attributable to common stockholders is computed by using the two-class method, which is an earnings allocation formula that determines loss per share for the holders of the Company’s common stock and participating securities. All series of preferred stock contain participation rights in any dividend declared or accumulated by the Company and are deemed to be participating securities. Income available to common stockholders and participating convertible preferred stock is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities do not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss.
Diluted net income per share is computed using the more dilutive of (a) the two-class method, or (b) the if-converted method. The Company allocates earnings first to preferred stockholders based on dividend rights and then to common and preferred stockholders based on ownership interests. The weighted-average number of common stock included in the computation of diluted loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, and convertible preferred stock. Common stock equivalent shares are excluded from the computation of diluted loss per share if their effect is antidilutive.
F- 13
The Company’s convertible preferred stock contractually entitles the holders of such shares to participate in dividends. Accordingly, in periods in which the Company reports a net loss, such losses are not allocated to such participating securities. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2021 and 2020, respectively.
Comprehensive Loss
Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. For the years ended December 31, 2021 and 2020, comprehensive loss was equal to net loss.
Recently Adopted Accounting Pronouncements
Upon adoption of ASC 842, the Company recorded lease liabilities and their corresponding right-of-use assets based on the present value of lease payments over the remaining lease term. The adoption of ASC 842 resulted in the recognition of operating lease liabilities of $ 0.6 million and operating lease right-of-use assets of $ 0.5 million and the derecognition of deferred rent liabilities of $ 0.02 million on the Company’s consolidated balance sheet as of January 1, 2021. The adoption impact relates to the Company’s existing operating lease for operating and laboratory space. The adoption of ASC 842 did not have a material impact on the Company’s consolidated statements of operations and comprehensive loss or consolidated statements of cash flows.
Recently Issued Accounting Pronouncements Not Yet Adopted
The Company reviewed recently issued accounting pronouncements for the year end December 31, 2021 and noted no pronouncements would have a material impact on the Company's consolidated financial statements.
3. Fair Value of Assets and Liabilities
The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2021 and 2020 (in thousands):
Description
December 31,
2021
Quoted prices
active markets
for identical
assets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
other
observable
inputs
(Level 3)
Assets
Money market funds
$
24,063
$
24,063
$
—
$
—
Total financial assets
$
24,063
$
24,063
$
—
$
—
Liability
Warrant Liability
$
83
$
—
$
—
$
83
Total financial liabilities
$
83
$
—
$
—
$
83
Description
December 31,
2020
Quoted prices
active markets
for identical
assets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
other
observable
inputs
(Level 3)
Liability
Warrant Liability
$
72
$
—
$
—
$
72
Total financial liabilities
$
72
$
—
$
—
$
72
At December 31, 2021, the fair value of the warrant liability was determined based on Level 3 inputs and utilizing the Black-Scholes option pricing model (see Note 10).
F- 14
During the years ended December 31, 2021 and 202 0 , there were no transfers into or out of Level 3.
The following table set forth a summary of changes in the fair value of the common stock warrants, which represents a recurring fair value measurement that is classified within Level 3 of the fair value hierarchy. Changes in fair value are recognized in other (expense) income as “Change in fair value of warrant liability” in the Company’s consolidated statements of operations and comprehensive loss (in thousands):
Common Stock ( 12,686 warrants)
Fair value at December 31, 2019
$
75
Change in fair value
( 3
)
Fair value at December 31, 2020
72
Change in fair value
11
Fair value at December 31, 2021
$
83
4. Property and Equipment, Net
At December 31, 2021 and 2020, property and equipment consisted of the following (in thousands):
December 31,
2021
December 31,
2020
Assets under construction
$
2,365
$
1,154
IT equipment
85
—
Leasehold improvements
13
—
Lab equipment
5,489
4,708
Office furniture
63
64
$
8,015
$
5,926
Less—accumulated depreciation
( 2,764
)
( 2,352
)
Property and equipment, net
$
5,251
$
3,574
For the years ended December 31, 2021 and 2020, depreciation expense was $ 0.8 million.
5. Prepaid Expenses and Other Current Assets
At December 31, 2021 and 2020, prepaid expenses and other current assets consisted of the following (in thousands):
December 31,
2021
December 31,
2020
Prepaid insurance
$
2,734
$
51
Prepaid research and development expenses
1,754
915
Prepaid license agreements
64
61
Other
66
16
Prepaid expenses and other current assets
$
4,618
$
1,043
6. Accrued Expenses and Other Current Liabilities
At December 31, 2021 and 2020, accrued expenses and other current liabilities consisted of the following (in thousands):
December 31,
2021
December 31,
2020
Accrued research and development expenses
$
1,686
$
750
Accrued compensation
2,147
1,023
Other
423
277
Accrued expenses and other current liabilities
$
4,256
$
2,050
F- 15
7. Convertible Preferred Stock
As of December 31, 2020, the Company had 1,701,141 authorized, issued and outstanding shares of Series A convertible preferred stock, 3,298,732 authorized, issued and outstanding shares of Series A-1 convertible preferred stock, 4,325,021 authorized shares and 4,324,998 issued and outstanding shares of Series A-2 convertible preferred stock and, 22,705,646 authorized shares and 22,531,819 issued and outstanding shares of Series B convertible preferred stock, 58,109,711 authorized, issued and outstanding shares of Series C-1 convertible preferred stock, 33,218,192 authorized, issued and outstanding shares of Series C-2 convertible preferred stock, 57,878,742 authorized, issued and outstanding shares of Series D-1 convertible preferred stock and 24,598,481 authorized shares and 14,469,710 issued and outstanding shares of Series D-2 convertible preferred stock. All series of convertible preferred stock are collectively referred to as Preferred Stock, each with a par value of $ 0.00001 per share.
Series D-2 Offering
On June 25, 2020, the Company entered into the Series D-2 Purchase Agreement (the "Series D-2 Agreement”) with certain investors to sell up to 24,598,481 shares of Series D-2 convertible preferred stock at a purchase price of $ 0.6911 per share. The Series D-2 Agreement provides for two closings, the first on October 1, 2020 and the second upon the achievement or waiver of certain milestone events. The Company sold 14,469,710 shares of the Series D-2 convertible preferred stock on October 1, 2020 at the first tranche closing for gross proceeds of $ 10.0 million.
On March 5, 2021, the Company completed the second tranche of the Series D-2 convertible preferred stock offering and issued 10,128,771 shares of the Series D-2 convertible preferred stock, $ 0.00001 par value per share, at a purchase price of $ 0.6911 per share for gross proceeds of $ 7.0 million.
Costs incurred in connection with the Series D-2 convertible preferred stock offering totaled $ 0.1 million and were recorded as a reduction to the Series D-2 convertible preferred stock. The majority of offering costs were incurred during the year ended December 31, 2020. Offering costs incurred during the year ended December 31, 2021 was $ 0.02 million.
The Company evaluated the tranche rights pursuant to the Series D-2 Agreement and determined the tranche rights did not represent a freestanding financial instrument as they are not legally detachable from the Series D-2 convertible preferred stock issued in the first tranche.
As of December 31, 2021, all the Series D-2 convertible preferred stock have been converted to shares of common stock upon closing of the IPO.
Series E Offering
On March 18, 2021, the Company completed its Series E Stock offering and issued 102,671,041 shares of Series E convertible preferred stock, $ 0.00001 par value per share, at a purchase price of $ 0.7839 per share for gross proceeds of $ 80.5 million.
Costs incurred in connection with the Series E convertible preferred stock offering totaled $ 0.2 million during the year ended December 31, 2021 and were recorded as a reduction to Series E convertible preferred stock.
As of December 31, 2021, all Series E convertible preferred stock have been converted to shares of common stock upon closing of the IPO.
The rights and privileges of the Company’s Preferred Stock for the year ended December 31, 2020, and the period January 1, 2021 through November 2, 2021, are as follows:
Voting
Except as otherwise required by law or by other provisions, holders of the Preferred Stock vote together with the holders of common stock as a single class. Holders of Preferred Stock may cast the number of votes equal to the number of shares of common stock to which such shares of Preferred Stock are convertible into.
F- 16
Dividends
Series C, D and E Dividend:
From and after the date of the issuance of any shares of Series C-1, Series C-2, Series D-1, Series D-2, and Series E, dividends at the annual rate of seven percent ( 7 %) per annum of the original share price per share accrue on such shares of Series C-1, Series C-2, Series D-1, Series D-2, and Series E. Dividends accrue from day to day, whether or not declared, and are cumulative, but not compounding. Such dividends are only payable when and if declared by the Board or in the event of a Deemed Liquidation Event (as defined in the amended and restated Certificate of Incorporation). No other dividends may be declared or paid on any other class of stock unless the holders of the shares of Series E then outstanding first receive, or simultaneously receive, their applicable dividend. For the year ended December 31, 2020, $ 5.9 million, $ 2.6 million, $ 3.9 million, and $ 0.2 million of cumulative dividends on Series C-1, Series C-2, Series D-1, and Series D-2, respectively, are included in the liquidation preference amount indicated on the consolidated balance sheet. For the year ended December 31, 2020, there were no Series E convertible preferred stock shares issued or outstanding.
Series B Dividends:
From and after the date of the issuance of any shares of Series B, dividends at the annual rate of $ 0.0869645 per share accrue on such shares of Series B. Dividends accrue from day to day, whether or not declared, and are cumulative, but not compounding. Such dividends are only payable when and if declared by the Company’s Board or in the event of a Deemed Liquidation Event (as defined in the amended and restated Certificate of Incorporation). No other dividends may be declared or paid on any other class of stock unless the holders of the shares of Series B then outstanding first receive, or simultaneously receive, their applicable dividend. For the year ended December 31, 2020, $ 9.4 million of cumulative dividends on Series B are included in the liquidation preference amount indicated on the consolidated balance sheet.
Series A Dividends:
From and after the date of the issuance of Series A, Series A-1, and Series A-2, if the Company declares, pays or sets aside, on the same date, a dividend on shares of more than one class or series of capital stock of the Company, the dividend payable to the holders of Series A, Series A-1, and Series A-2 convertible preferred stock shall be calculated based upon the dividend on the class or series of capital stock that would result in the highest dividend. No other dividends, or dividends on common stock payable in shares of common stock, may be declared or paid unless the holders of Series A, Series A-1, and Series A-2 then outstanding first receive, or simultaneously receive, their applicable dividend. As of December 31, 2020, no dividends have been declared on the common stock or the convertible preferred stock.
F- 17
Liquidation Rights
In the event of a Deemed Liquidation Event, as defined in the Company’s amended and restated Certificate of Incorporation, the assets of the Company will be distributed first to the holders of Series E convertible preferred stock. The holders of Series E convertible preferred stock will receive, in preference to all other stockholders, and amount equal to the sum of the Series E original issue price (equal to the cash price paid per share of $ 0.783900 ), plus unpaid dividends on such shares. Next, the holders of Series D convertible preferred stock will receive, in preference to all other stockholders other than Series E, an amount equal to the sum of the Series D original issue price, plus unpaid dividends on such shares. Next, the holders of Series C will receive, in preference to all stockholders other than the Series E and D convertible preferred stock holders, an amount equal to the sum of the Series C original issue price plus unpaid dividends on such shares. Next, the holders of Series B will receive, in preference to the holders of Series A, Series A-1, Series A-2 and common stock, an amount equal to the sum of the Series B original issue price plus unpaid dividends on such shares. Next, the holders of Series A, Series A-1, and Series A-2 will receive, in preference to the holders of common stock, an amount equal to the greater of their applicable liquidation preference or what they would have received had their shares converted into common stock. If the proceeds available are not sufficient to satisfy the full liquidation preference, the entire proceeds are to be distributed pro-rata among the Series E convertible preferred stock holders in proportion to the full preferential amount the Series E convertible preferred stock holders are entitled to receive.
Conversion
The Series E, together with the Series D, the Series C and the Series B convertible preferred stock, collectively the "Senior Preferred Stock", c onverts into common stock on a one-for-one basis . Each share of Series B, Series C-1, Series C-2, Series D-1, Series D-2, and Series E convertible preferred stock is convertible into the number of shares of common stock as is determined by dividing the respective original issue price by the conversion price in effect at the time of conversion. The Series E conversion price is set at $ 0.7839 per share, the Series D-1 and Series D-2 conversion price is set at $ 0.6911 per share, the Series C-1 conversion price is set at $ 0.5213 per share, the Series C-2 conversion price is set at $ 0.36491 per share, and the Series B conversion price is set at $ 1.24235 per share; none represents a beneficial conversion feature. Subject to certain exceptions, the Senior Preferred Stock has the benefit of anti- dilution protection on a weighted-average basis in the event that the Company sells stock at less than the applicable conversion price per share.
Each share of Series A and Series A-1 was originally convertible into the number of shares of common stock determined by dividing the respective Series A and Series A-1 original issue price by the conversion price in effect at the time of conversion. The Series A conversion price was originally equal to $ 2.00 per share and the Series A-1 conversion price was originally equal to $ 2.4847 per share. As Series A-2 was sold at $ 1.24235 per share, less than the per share prices of Series A and Series A-1, anti-dilution protections were triggered. Pursuant to the anti-dilution protection terms, on February 24, 2015, the Series A conversion price was reduced from $2.00 to $ 1.8191 per share of common stock and the Series A-1 conversion price was reduced from $2.4847 to $ 2.1898 per share of common stock and, therefore, the Series A conversion ratio was changed from 1:1 to 1: 1.099 and the Series A-1 conversion ratio was changed from 1:1 to 1: 1.135 . The Company evaluated Series A and Series A-1 with the updated conversion ratios and determined that there was no beneficial conversion feature.
Series A-2 converts into common stock on a one-for- one basis. The Series A-2 conversion price is set at $ 1.24235 per share and does not represent a beneficial conversion feature.
According to the terms of the Company’s amended and restated Certificate of Incorporation, in the event that the applicable conversion price for any series of Senior Preferred Stock is reduced, then the applicable conversion price for each series of Series A convertible preferred stock shall be uniformly and concurrently reduced.
Each share of Preferred Stock will automatically convert into common stock upon (a) the occurrence of an event, specified by vote or written consent of certain stockholders or (b) the completion of a public stock offering involving a price per share of common stock of not less than $ 1.554975 per share, subject to certain adjustments, where such offering results in aggregate gross proceeds to the Company of at least $ 50.0 million and the common stock is listed for trading on either the New York Stock Exchange or the Nasdaq Stock Market.
The Company must reserve and keep available out of its authorized but unused capital stock such number of authorized shares of common stock to sufficiently effect the conversion of all outstanding Preferred Stock.
F- 18
In considering the features of the convertible preferred stock, the Company determined that none of the features, including the conversion features, requires bifurcation during the year ended December 31, 2020.
The conversion ratios for the Series A stock was changed to 13.700 to 1.099 , Series A-1 stock was changed to 13.7 to 1.135 , and the Series A-2 stock through Series E stock was changed to 13.7 to 1 upon the Company’s filing of its amendment to its amended and restated Certificate of Incorporation on October 22, 2021.
Upon closing of the IPO on November 2, 2021, all of the Company's outstanding shares of convertible preferred stock automatically converted into 22,550,561 shares of common stock. In addition, the Company authorized 10,000,000 shares of preferred stock, par value $ 0.00001 per share, all of which shares of preferred stock will be undesignated.
8. C ommon Stock
The Company has 150,000,000 and 232,697,999 authorized shares of common stock, par value $ 0.00001 per share, of which 29,211,643 and 381,123 shares were issued and outstanding as of December 31, 2021 and 2020, respectively.
9. Stock-Based Compensation
2018 Stock Option and Incentive Plan
On December 12, 2018, the Company adopted the Aura Biosciences, Inc. 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan will expire in 2028. Under the 2018 Plan, Aura may grant incentive stock options, non-qualified stock options, restricted and unrestricted stock awards and stock right. The Board has determined not to make any further awards under the 2018 Plan as of November 2, 2021. However, the 2018 Plan will continue to govern outstanding equity awards granted thereunder.
2021 Stock Option and Incentive Plan
The 2021 Stock Option and Incentive Plan, (the "2021 Plan"), was adopted by the Board on October 7, 2021, approved by the Company’s stockholders on October 22, 2021 and became effective on November 1, 2021. The 2021 Plan permits the granting of both options to purchase common stock intended to qualify as incentive stock options under Section 422 of the Code and options that do not so qualify. The number of shares initially reserved for issuance under the 2021 Plan was 3,352,166 , which will automatically increase on January 1, 2022 and each January 1 thereafter, by 5 % of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the Company’s compensation committee. The maximum number of shares of common stock that may be issued in the form of incentive stock options shall not exceed the initial limit, cumulatively increased on January 1, 2022 and on each January 1 thereafter by the lesser of the annual increase for such year or 3,352,166 shares of common stock.
2021 Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan, (the "ESPP"), was adopted by the Board on October 7, 2021, approved by the Company’s stockholders on October 22, 2021 and became effective on November 1, 2021. A total of 335,217 shares of common stock were initially reserved for issuance under this plan, which will automatically increase on January 1, 2022 and each January 1 thereafter through January 1, 2031, by the least of (i) 335,217 shares of common stock, (ii) 1 % of the outstanding number of shares of common stock on the immediately preceding December 31 or (iii) such lesser number of shares of common stock as determined by the administrator of the ESPP.
F- 19
On March 18, 2021, the Board approved an increase to the 2018 Plan available option pool of 2,346,228 options. As mentioned above, the 2021 Plan was initiated in November 2021. With the transfer of the available options from the 2018 Plan to the 2021 Plan, there were 2,042,774 options available for grant under the 2021 Plan at December 31, 2021.
The Board is authorized to administer the 2021 Plan. In accordance with the provisions of the 2021 Plan, the Board determines the terms of Aura options and other awards issued pursuant thereto, including the following:
▪ which employees, directors and consultants shall be granted awards;
▪ the number of shares of common stock subject to options and other awards;
▪ the exercise price of each option, which generally shall not be less than fair market value of the common stock on the date of grant;
▪ the termination or cancellation provisions applicable to options;
▪ the terms and conditions of other awards, including conditions for repurchase, termination or cancellation, issue price and repurchase price; and
▪ all other terms and conditions upon which each award may be granted in accordance with the 2018 Plan.
In addition, the Board may award restricted shares of common stock and restricted stock units to participants subject to such conditions and restrictions as it may determine. The Board or any committee to which the Board delegates authority may, with the consent of the affected plan participants, re-price or otherwise amend outstanding awards consistent with the terms of the 2021 Plan.
The following table summarizes stock option activity under the 2021 Plan for the year ended December 31, 2021:
Options
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term
(years)
Aggregate Intrinsic
Value
Outstanding at December 31, 2020
1,512,129
$
3.84
7.77
$
1,174
Granted
2,970,708
9.03
Exercised
( 69,959
)
4.99
Cancelled/Forfeited
( 179,887
)
4.59
Outstanding at December 31, 2021
4,232,991
$
7.43
8.66
$
40,437
Exercisable at December 31, 2021
1,174,871
$
3.95
6.82
$
15,304
Unvested as of December 31, 2021
3,058,120
$
8.78
9.30
$
25,133
The weighted-average grant date fair value of stock options granted during the years ended December 31, 2021 and 2020 was $ 5.84 and $ 2.74 per share, respectively. The total intrinsic value of options exercised was $ 0.1 million and $ 0.02 million for the years ended December 31, 2021 and 2020, respectively.
The Company has elected to use the Black-Scholes option pricing model to determine the fair value of options granted and generally recognizes the compensation cost of stock-based awards on a straight-line basis over the vesting period of the award.
The determination of the fair value of stock-based payment awards utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s common stock and a number of other assumptions, including expected volatility, expected life, risk-free interest rate, and expected dividends.
F- 20
The fair value of the stock options issued as of December 31, 2021 and 2020 was measured with the following weighted-average assumptions:
December 31,
2021
December 31,
2020
Risk-free interest rate, %
1.15
%
0.55
%
Expected term
6.03
6.02
Expected volatility of the underlying stock, %
73.87
%
74.04
%
Expected dividend rate, %
—
%
—
%
Restricted Stock Units
The Company has granted restricted stock units with service vesting based conditions. Unvested shares of restricted common stock may not be sold or transferred by the holder. They are legally issued and outstanding. These restrictions lapse accordingly to the time-based vesting of each award.
A summary of the restricted stock unit activity during the year ended December 31, 2021 is as follows:
Restricted Stock Units
Weighted-
Average
Grant Date Fair Value
Granted at December 31, 2020
—
$
—
Granted
232,111
14.00
Forfeited
( 191
)
14.00
Granted at December 31, 2021
231,920
$
14.00
As a result of the 2021 Equity Incentive Plan, the Company granted restricted stock units which vest in increments of 25 % annually over a period of four years. No restricted stock units vested during the year ended December 31, 2021.
Stock-based Compensation Expense
The Company recorded stock-based compensation as follows (in thousands):
Year Ended December 31,
2021
2020
Research and development
$
702
$
193
General and administrative
1,605
543
Total
$
2,307
$
736
As of December 31, 2021, there was $ 16.5 million of unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 3.33 years.
As of December 31, 2021, there was $ 3.1 million of unrecognized compensation expense related to restricted stock units, which is expected to be recognized over a weighted-average period of 3.82 years.
10. Common Stock Warrants
In February 2015 and May 2015, the Company issued warrants to purchase 1,650,098 and 887,536 shares of Series B convertible preferred stock, respectively, at an exercise price of $ 1.24235 per share (the "Series B Warrants"). Each Series B Warrant was immediately exercisable and expires ten years from the original date of issuance. Pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity, the Series B Warrants were classified as a liability and are re-measured to fair value at each balance sheet date and immediately prior to exercise. The Series B Warrants were converted into warrants to purchase 12,686 shares of common stock upon the completion of the IPO in November 2021.
A total of 12,686 of the common stock warrants remained outstanding at December 31, 2021 and 2020.
F- 21
The warrants were valued using the Black-Scholes option pricing model. The fair value of the warrants and the significant assumptions used were as follows:
Common Stock Warrants
December 31,
2021
December 31,
2020
Fair value
$
16.98
$
16.03
Volatility
80.38
%
74.00
%
Expected term (years)
3.15
4.2
Risk free rate
0.97
%
0.27
%
Dividend yield
7.00
%
7.00
%
11. Compensation
In January 2012, the Company adopted the Aura Biosciences 401(K) Profit Sharing Plan and Trust (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company makes matching contributions of 100 % of the first 6 % of employee contributions. The Company made matching contributions in the amount of $ 0.3 million and $ 0.2 million for the years ended December 31, 2021 and 2020, respectively.
12. Commitments and Contingencies
Lease Commitments
The Company has historically entered into lease arrangements for its facilities. As of December 31, 2021 and 2020, respectively, the Company had one operating lease for its office and laboratory facility with required future minimum payments. The lease does not contain any options to renew, terminate, or purchase the underlying asset, and was set to expire on July 31, 2022 . As part of its adoption of ASC 842, the Company recorded a right-of-use asset and operating lease liability for this lease as of the effective date.
On March 31, 2021, the Company executed an amendment to the facility lease which included an extension of the expiration date of the original leased premises, the addition of 4,516 square feet of laboratory space with an expected commencement date of May 1, 2021 , and the addition of 1,000 square feet of laboratory space with an expected commencement date of June 15, 2021 . The lease term for the original and new spaces will expire on July 31, 2023 , with an option to renew for an additional 12 months .
Upon the execution of the amendment, which was deemed to be a lease modification, the Company re-evaluated the assumptions made at the original lease commencement date. The Company determined the amendment consists of two separate contracts under ASC 842. One contract is related to the modification of term for the original space, and the other is related to a new right-of-use for the two additional spaces, which are to be accounted for as new leases. The Company remeasured the lease liability and corresponding right-of-use asset for the original space as of the effective date of the amendment to reflect the extended term and recorded in the second quarter of 2021 an additional right-of-use asset and lease liability upon lease commencement of each of the additional space.
The Company also leases office and laboratory equipment for which the related expense is immaterial.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s leases for the year ended December 31, 2021 (in thousands):
Year Ended
December 31, 2021
Lease Cost
Amortization of finance right-of-use assets
$
11
Operating lease costs
524
Variable lease costs
322
Short-term lease costs
4
Total lease costs
$
861
F- 22
Cash paid for amounts included in the measurement of lease liability—finance leases
$
15
Cash paid for amounts included in the measurement of lease liability—operating leases
$
519
Weighted-average remaining lease term—operating leases (years)
1.58
Weighted-average discount rate—finance leases
7.94
%
Weighted-average discount rate—operating leases
3.51
%
The following table reconciles the future minimum commitments to the Company’s operating lease liabilities at December 31, 2021 (in thousands):
Operating lease payments as of December 31, 2021
2022
$
625
2023
377
Thereafter
—
Total lease payments
1,002
Less: interest
( 27
)
Total operating lease liabilities at December 31, 2021
975
Less: current portion of lease liabilities
615
Lease liabilities, net of current portion
$
360
In May 2021, the Company paid in full its finance lease.
Laser Purchasing Commitment
On April 5, 2019, the Company entered into a purchase agreement for equipment with future commitments payable in three installments of € 0.2 million each. The first two installments of € 0.2 million were paid by the Company in April 2019 and August 2019. Upon receipt of the laser systems, the Company will assess whether the laser systems have an alternative future use and, if so, will capitalize the lasers as a component of fixed assets.
License Agreements
The Company has entered into the following key agreements that relate to the core technology under development:
LI-COR Exclusive License and Supply Agreement
In January 2014, the Company entered into an Exclusive License and Supply Agreement, or the LI-COR Exclusive License agreement with LI-COR, Inc. (LI-COR) for the license of IRDye 700DC and related licensed patents for the treatment and diagnosis of ocular cancers in humans as amended in January 2016, July 2017, April 2018 and April 2019. The LI-COR Exclusive License Agreement required a one-time upfront license issue fee of $ 0.1 million and aggregate milestone payments of up to $ 0.2 million upon certain regulatory and development milestones. The Company is also required to pay LI-COR low-single digit royalties on net sales. The term of the LI-COR Exclusive Agreement expires on a country-by-country basis, until the longer of (i) ten years from the first commercial sale of a licensed product in such country and (ii) the last to expire valid claim in such country.
For the years ended December 31, 2021, and December 31, 2020, the Company incurred, respectively, $ nil and $ 0.1 million of expenses related to this agreement.
LI-COR Non-Exclusive License and Supply Agreement
In December 2014, the Company entered into a Non-Exclusive License Agreement with LI-COR for the supply of IRDye 700DX to the Company for the treatment and diagnosis of non-ocular solid tumor cancers in humans. Under the 2014 Non-Exclusive, the Company paid a license issue fee of $ 0.03 million on the effective date. The Company must also pay LI-COR a non-refundable, non-creditable fee of $ 0.03 million per each licensed product upon pre-IND designation, as defined of such licensed product, aggregate milestone payments of up to $ 0.3 million upon certain regulatory and development milestones; and during the term, the Company must pay LI-COR a low-single digit percentage royalty on net sales. LI-COR receives 10% of all sublicensee income within 30 days of the Company’s receipt from the sublicensee. The 2014 Non-Exclusive Agreement also required the Company to make certain payments upon the achievement of specified development and commercial milestones of up to $ 0.4 million in aggregate.
F- 23
Life Technologies Corporation
In December 2014, the Company entered into a non-exclusive, perpetual license agreement with Life Technologies Corporation (“Life Technologies”), which allows for five licensed products. Under this agreement the Company is required to pay an initial license fee of $ 0.1 each product. An annual development fee of $ 0.1 million is due within a year from payment of the initial license fee and due annually or earlier of (i) payment of a commercialization fee or (ii) all development work is terminated. The commercialization fee is a one-time, non-refundable, non-creditable fee of $ 0.3 million due upon receipt of approval of a licensed product. In the event of a change of control, there will be a change of control fee of $ 0.2 million.
For the years ended December 31, 2021 and December 31, 2020, the Company incurred $ 0.1 million of expenses related to this agreement.
National Institute of Health (NIH)-Biologic Materials License Agreement
In December 2010, the Company entered into a Biologic Materials License Agreement with NIH for a non-exclusive right to use materials described in Schiller et al., Virology 2004 Apr.10, 321(2):205-16. This agreement required a one-time non-refundable license issuance fee of $ 0.02 million. No future milestone payments or royalties are due under this agreement.
National Institute of Health (NIH)-Collaboration Research and Development Agreement
In July 2011, the Company entered into a Collaboration Research and Development Agreement (CRADA), with Dr. John Schiller at the NIH, for a period of two years with the rights to an exclusive license to all technology generated within the collaboration. Under this agreement, the Company is required to make annual payments of $ 0.03 million to fund the research activities, the first payment of which was paid within 30 days of the effective date. Subsequent payments are due within 30 days of the anniversary of the effective date. This agreement was first amended in 2012, 2013, 2014, 2015, 2016, 2018 and most recently in September of 2020. During 2011-2021, the Company paid an aggregate of $ 0.4 million in research collaboration fees, $ 0.03 million and 0.04 million of which was paid in 2021 and 2020, respectively.
A seventh amendment was made in October 2020, requiring payment of $ 0.04 million within 30 days of October 1, 2020, and another $ 0.03 million within 30 days of the 10th anniversary of the CRADA, which was paid in July 2021. This seventh amendment extended the term of the CRADA to September 30, 2022.
National Institute of Health (NIH)-Exclusive Patent License Agreement
In September 2013, the Company entered into an exclusive patent license agreement (the “NIH Exclusive License Agreement”) with the NIH, that required the Company to pay a license issue royalty of $ 0.1 million and reimburse the NIH for any patent expenses incurred. Under the agreement, the Company is required to make low single-digit percentage royalty payments based on specified levels of annual net sales of licensed products subject to certain specified reductions. The Company is required to make development and regulatory milestone payments of up to $ 0.7 million in aggregate and sales milestone payments up to $ 0.6 million in the aggregate. The Company is also required to pay NIH a mid-single to low teen-digit percentage of any sublicensing revenue the Company receives. Additionally, the Company’s payment obligations to the NIH are subject to an annual minimum royalty payment of low five figures. As of December 31, 2021, the Company has paid NIH approximately $ 0.4 million in aggregate milestones under the NIH license agreement. The Company accrued $ 0.03 million and $ 0.02 million in patent licensing reimbursement fees as of December 31, 2021, and 2020, respectively.
In 2015, 2018 and 2019, the Company amended its exclusive patent license to include updates on the status of the commercial development and update/expand the list of licensed patents and patent applications. Each of those amendments required a $ 0.03 million payment that the Company paid.
F- 24
Inserm-Transfert License Agreement
In November 2009, the Company entered into an exclusive, royalty-bearing patent license agreement with Inserm-Transfert of France. The agreement expires on a country by country basis based on the last to expire any patent encompassed within the scope of the patent rights or 10 years from the date of the first commercial sales by the Company, whichever is later. There are potential milestone The IND filing milestone of € 0.01 million was accrued in 2016 and paid in 2017 by the Company. The milestones for the successful Phase I, II and III clinical trials are based on receiving a final report and achieving the primary endpoints defined in that trial, and those milestones have not been achieved as of December 31, 2021. Upon the sublicense by the Company of a product for which royalties are payable under the agreement, low- to mid-single-digit royalty payments would be due by the Company. The non-milestone payments in this agreement are subject to an anti-stacking clause. The Company did no t incur any expense in the years ended December 31, 2021, and 2020.
Clearside
In July 2019, the Company entered into an exclusive license agreement with Clearside Biomedical, Inc. (“Clearside”), for the license of Clearside’s Suprachoroidal Microneedle Technology for use in the treatment of indeterminate lesions and choroidal tumors. Upon execution of the License Agreement, the Company paid Clearside an upfront payment of $ 0.1 million which was expensed as incurred. Under the Clearside License Agreement, the Company is required to pay milestones up to $ 21.0 million in the aggregate upon the achievement of specified regulatory and development milestones, and upon the achievement of certain commercial sales milestones. The Company is also required to pay low to mid-single digit royalties on net sales. If the Company sublicenses a product for which royalties are payable, then the Company is required to pay the greater of 20 % received or low single digit royalties on net sales.
The Clearside License agreement expires on a country-by-country basis upon the later of the last to expire patent or ten years from the date of the first commercial sale of a product.
13. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for the periods presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company.
The Company has calculated basic and diluted loss per share for the years ended December 31, 2021 and 2020 as follows (in thousands, except share and per share data):
December 31,
2021
December 31,
2020
Numerator:
Net loss
$
( 35,251
)
$
( 22,206
)
Less: Accruals of dividends of preferred stock
( 10,942
)
( 7,926
)
Net loss attributable to common stockholders—basic and diluted
$
( 46,193
)
$
( 30,132
)
Denominator:
Weighted-average common stock outstanding
5,159,973
367,204
Net loss per share attributable to common stockholders—basic and diluted
$
( 8.95
)
$
( 82.06
)
The following potentially dilutive securities were excluded from the computation of the diluted net loss per share for the periods presented because their effect would have been antidilutive:
December 31,
2021
December 31,
2020
Convertible preferred stock on an if converted basis
—
14,317,032
Stock options to purchase common stock
4,232,991
1,512,129
Restricted stock units that vest into common stock
231,920
—
Warrants to purchase preferred stock
—
12,686
Warrants to purchase common stock
12,686
—
Total potential dilutive shares
4,477,597
15,841,847
F- 25
14. Income Taxes
The Company has no t recorded any net tax provision for the periods presented due to the losses incurred and the need for a full valuation allowance on net deferred tax assets. The difference between the income tax expense at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance provided on all deferred tax assets. The Company’s loss before income tax for the periods presented was generated entirely in the United States:
A reconciliation of the federal statutory income tax rate to the Company’s effective tax rate as of December 31, 2021 and 2020 is as follows:
2021
2020
Tax provision at statutory rate
21.0
%
21.0
%
State taxes, net of federal benefit
5.3
%
5.4
%
Federal tax credits
2.6
%
3.8
%
Permanent items
( 0.4
)%
( 0.3
)%
Other
( 0.3
)%
( 0.4
)%
Decrease in valuation reserve
( 28.2
)%
( 29.5
)%
Total
0.0
%
0.0
%
Temporary differences that give rise to significant deferred tax assets (liabilities) as of December 31, 2021 and 2020 are as follows (in thousands):
2021
2020
Deferred tax assets:
Net operating loss carryforwards
$
36,287
$
27,921
Stock-based compensation expense
635
328
Tax credit carryforwards
5,821
4,675
Accrued expenses
517
418
Lease liability
248
—
Other
194
168
Total deferred tax assets
43,702
33,510
Deferred tax liabilities:
Right of use asset
( 241
)
Depreciable assets
( 182
)
( 157
)
Valuation allowance
( 43,279
)
( 33,353
)
Net deferred tax asset
$
—
$
—
As of December 31, 2021, the Company had federal gross operating loss carryforwards of approximately $ 138.7 million which may be available to offset future taxable income, of which $ 44.2 million begin to expire in 2029 and go through 2037 , and $ 94.5 million do not expire. The Company had state gross operating loss carryforwards of $ 113.6 million, which may be available to offset future taxable income and which would begin to expire in 2030 . As of December 31, 2021, the Company had federal and state research and experimentation credit carryforwards of $ 4.7 million and $ 1.4 million, respectively, which may be available to offset future income tax liabilities and which would begin to expire in 2029 and 2028 , respectively.
F- 26
The Company’s ability to use its operating loss carryforwards and tax credit carryforwards to offset taxable income is subject to restrictions under Sections 382 and 383 of the United States Internal Revenue Code (the “Internal Revenue Code”). Under the Internal Revenue Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, have limited and may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. The Company has not yet completed an analysis of ownership changes. The Company may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside the Company’s control. As a result, the Company’s ability to use our pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to the Company. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. All Federal NOLs generated post tax reform have an indefinite life, are not subject to carryback provisions, and limited to 80 % of income in any year.
The Company has not conducted a study of its research and development credit carryforwards. A study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known, no amounts will be presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credit carryforwards and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheet or consolidated statement of operations and comprehensive loss at this time, if an adjustment were required.
Management has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are principally comprised of NOL carryforwards and tax credit carryforwards. Management has determined that it is more likely than not that the Company will not realize the benefits of its deferred tax assets, and as a result, a valuation allowance of $ 43.3 million has been recorded at December 31, 2021. The increase in the valuation allowance of $ 9.9 million during the year ended December 31, 2021 was primarily due to the increase in net operating loss generated by the Company.
As of December 31, 2021 and 2020, the Company had no unrecognized tax benefits. Interest and penalty charges, if any, related to income taxes would be classified as a component of the provision for income taxes in the consolidated statements of operations. The Company does not expect any significant change in its uncertain tax positions in the next twelve months.
The Company files income tax returns in the United States federal tax jurisdiction and several state tax jurisdictions. Since the Company is in a loss carryforward position, it is generally subject to examination by federal and state tax authorities for all tax years in which a loss carryforward is available.
15. Related Parties
During the years ended December 31, 2021 and 2020, the Company incurred $ 0.04 million and $nil million in expenses to a legal firm whose partner is also an investor and former officer of the Company. As of December 31, 2021, and 2020, none of these amounts were included in accounts payable.
During the years ended December 31, 2021 and 2020, the Company incurred $ 0.3 million and $ 0.5 million in expenses to a stockholder that provided research and development related services. Of these amounts, $nil and $ 0.1 million were in accrued expenses as of December 31, 2021 and 2020.
16. Subsequent Events
The Company has not identified any subsequent events that require disclosure.
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