UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification Number) | |
(Address of principal executive offices) | (Zip code) |
(
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol(s) | Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ◻ |
| Accelerated filer ◻ |
Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Act). Yes
As of November 4, 2021,
INVIVO THERAPEUTICS HOLDINGS CORP.
Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2021
TABLE OF CONTENTS
2
Risk Factors Summary
Our business is subject to a number of risks of which you should be aware before making an investment decision. Below we summarize what we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information in this Quarterly Report.
● | We have found it difficult and may continue to find it difficult to enroll patients in our clinical studies, which could delay or prevent clinical studies of our product candidates, and due to such enrollment delays, we may need to make a determination as to the next steps for our clinical program that could significantly impact our future operations and financial position. |
● | The COVID-19 pandemic has delayed and may continue to delay our ability to complete our ongoing INSPIRE 2.0 clinical trial or may delay the initiation of future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on our business and operations. |
● | We will need additional funding before achieving potential profitability. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts, engage in one or more potential transactions, or cease our operations entirely. |
● | Increases in authorized shares will be required for future financings or other strategic transactions. We have experienced difficulties obtaining quorum for our annual meetings of stockholders and achieving the number of votes required for increases in authorized shares. If we continue to experience such difficulties, we will be limited in our efforts to raise additional capital, and our operations, financial condition and our ability to continue as a going concern may be materially and adversely affected. |
● | We anticipate that we will continue to incur substantial losses for the foreseeable future and may never achieve or maintain profitability. |
● | We are wholly dependent on the success of one product candidate, the Neuro-Spinal Scaffold implant. Even if we are able to complete clinical development and obtain favorable clinical results, we may not be able to obtain regulatory approval for, or successfully commercialize, our Neuro-Spinal Scaffold implant. |
● | If we cannot protect, maintain and, if necessary, enforce our intellectual property rights, our ability to develop and commercialize products will be adversely impacted. |
● | We will depend upon strategic relationships to develop and manufacture our products. If these relationships are not successful, we may not be able to capitalize on the market potential of these products. |
● | Our success depends on our ability to retain our management and other key personnel. |
● | We may face, and in the past have faced, lawsuits, which could divert management’s attention and harm our business. |
● | The price of our common stock has been and may continue to be volatile, which could lead to losses by investors and costly securities litigation. |
3
PART I — FINANCIAL INFORMATION
Item 1.Financial Statements.
InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per-share data)
(Unaudited)
As of | |||||||
| September 30, |
| December 31, |
| |||
2021 | 2020 | ||||||
ASSETS: |
|
| |||||
Current assets: | |||||||
Cash and cash equivalents | $ | | $ | | |||
Prepaid expenses and other current assets |
| |
| | |||
Total current assets |
| |
| | |||
Property, equipment and leasehold improvements, net |
| |
| | |||
Restricted cash - non-current | | | |||||
Operating lease right-of-use assets | | | |||||
Prepaid clinical trial expenses |
| |
| | |||
Other assets |
| — |
| | |||
Total assets | $ | | $ | | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |||||||
Current liabilities: | |||||||
Accounts payable | $ | | $ | | |||
Operating lease liabilities | | | |||||
Accrued expenses |
| |
| | |||
Total current liabilities |
| |
| | |||
Other liabilities | | | |||||
Operating lease liabilities - non-current | | | |||||
Total liabilities |
| |
| | |||
Commitments and contingencies (Note 5) | |||||||
Stockholders’ equity: | |||||||
Common stock, $ |
| |
| | |||
Additional paid-in capital |
| |
| | |||
Accumulated deficit | ( | ( | |||||
Total stockholders’ equity |
| |
| | |||
Total liabilities and stockholders’ equity | $ | | $ | |
See notes to the unaudited consolidated financial statements.
4
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per-share data)
(Unaudited)
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| |||||
Operating expenses: |
|
|
|
| |||||||||
Research and development | $ | | $ | | $ | | $ | | |||||
General and administrative |
| |
| |
| |
| | |||||
Total operating expenses |
| |
| |
| |
| | |||||
Operating loss |
| ( |
| ( |
| ( |
| ( | |||||
Other income: | |||||||||||||
Interest income |
| |
| |
| |
| | |||||
Other income | | | | | |||||||||
Other income |
| |
| |
| |
| | |||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per share, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average number of common shares outstanding, basic and diluted |
| |
| |
| |
| |
See notes to the unaudited consolidated financial statements.
5
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Changes in Stockholders’ Equity
(In thousands, except share and per-share data)
(Unaudited)
Three Months Ended September 30, 2020 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance as of June 30, 2020 | | $ | | $ | | $ | ( | $ | | |||||
Share-based compensation expense |
| — | — | | — | | ||||||||
Net loss |
| — | — | — | ( | ( | ||||||||
Balance as of September 30, 2020 |
| | $ | | $ | | $ | ( | $ | |
Three Months Ended September 30, 2021 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance as of June 30, 2021 | | $ | | $ | | $ | ( | $ | | |||||
Share-based compensation expense |
| — | — | | — | | ||||||||
Net loss |
| — | — | — | ( | ( | ||||||||
Balance as of September 30, 2021 |
| | $ | | $ | | $ | ( | $ | |
Nine Months Ended September 30, 2020 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance as of December 31, 2019 | | $ | | $ | | $ | ( | $ | | |||||
Share-based compensation expense |
| — | — | | — | | ||||||||
Issuance of common stock upon vesting of restricted stock units | | — | — | — | — | |||||||||
Fractional shares issued due to 1 for reverse stock split | | — | — | — | — | |||||||||
Issuance of common stock and warrants in public offering | | — | | — | | |||||||||
Issuance of common stock upon exercise of warrants | | — | | — | | |||||||||
Net loss |
| — | — | — | ( | ( | ||||||||
Balance as of September 30, 2020 |
| | $ | | $ | | $ | ( | $ | |
Nine Months Ended September 30, 2021 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance as of December 31, 2020 | | $ | | $ | | $ | ( | $ | | |||||
Share-based compensation expense |
| — | — | | — | | ||||||||
Issuance of common stock upon vesting of restricted stock units | | — | — | — | — | |||||||||
Issuance of common stock upon exercise of warrants |
| | — | | — | | ||||||||
Net loss |
| — | — | — | ( | ( | ||||||||
Balance as of September 30, 2021 |
| | $ | | $ | | $ | ( | $ | |
See notes to the unaudited consolidated financial statements.
6
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Nine Months Ended | |||||||
September 30, | |||||||
| 2021 |
| 2020 |
| |||
Cash flows from operating activities: |
|
| |||||
Net loss | $ | ( | ( | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization |
| | | ||||
Amortization of operating lease right-of-use assets | | | |||||
Share-based compensation expense |
| | | ||||
Changes in operating assets and liabilities: | |||||||
Prepaid expenses and other current assets |
| ( | ( | ||||
Accounts payable |
| | ( | ||||
Operating lease liability | ( | ( | |||||
Accrued expenses and other liabilities |
| ( | ( | ||||
Net cash used in operating activities |
| ( | ( | ||||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | ( | ( | |||||
Net cash used in investing activities |
| ( | ( | ||||
Cash flows from financing activities: | |||||||
Proceeds from exercise of warrants | | | |||||
Proceeds from issuance of common stock and warrants, net of commissions and issuance costs |
| — | | ||||
Net cash provided by financing activities |
| | | ||||
Increase in cash and cash equivalents and restricted cash |
| | | ||||
Cash, cash equivalents and restricted cash at beginning of period |
| | | ||||
Cash, cash equivalents and restricted cash at end of period | $ | | | ||||
Supplemental disclosure of cash flow information and non-cash investing and financing activities: | |||||||
Fair value of warrants issued in connection with financing activities | $ | — | $ | | |||
Increase in operating right-of-use assets and liabilities related to lease modifications | $ | | $ | — |
See notes to the unaudited consolidated financial statements.
7
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
1. | NATURE OF OPERATIONS AND GOING CONCERN, BASIS OF PRESENTATION AND RECENT ACCOUNTING PRONOUNCEMENTS |
Business
InVivo Therapeutics Holdings Corp., including its subsidiary, (the “Company”) is a biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (“SCIs”). The Company’s proprietary technologies incorporate intellectual property that is licensed under an exclusive, worldwide license from Boston Children’s Hospital (“BCH”) and the Massachusetts Institute of Technology (“MIT”), as well as intellectual property that has been developed internally in collaboration with its advisors and partners.
Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company has historically financed its operations primarily through the sale of equity-related securities. As of September 30, 2021, the Company had unrestricted consolidated cash and cash equivalents of $
As a result of the COVID-19 pandemic, a significant number of the Company’s clinical sites temporarily suspended enrollment into the INSPIRE 2.0 Study at their institution in 2020. As such, the COVID-19 pandemic did affect and may continue to affect the potential for enrollment in the Company’s INSPIRE 2.0 Study in the event that clinical sites may again suspend our study in the future in order to manage the pandemic. Aside from the impact on enrollment in the Company’s INSPIRE 2.0 Study, the Company did not experience any significant impact from the COVID-19 pandemic on its financial condition, liquidity, other operations, suppliers, industry, and workforce during the three and nine months ended September 30, 2021. As of November 2, 2021, the Company has
8
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
Going Concern
The Company’s consolidated financial statements as of September 30, 2021 were prepared under the assumption that the
The Company’s ability to continue as a going concern depends on its ability to obtain additional equity or debt financing, attain further operating efficiencies, manage expenditures, and, ultimately, to generate revenue. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on its audited financial statements, and it is likely that investors will lose all or part of their investment.
Reverse Stock Split
All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these consolidated financial statements were adjusted, on a retroactive basis to reflect the 2020 Reverse Stock Split.
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”) consistent with those applied in, and should be read in conjunction with, the Company’s audited consolidated financial statements and related footnotes for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K as filed with the United States Securities and Exchange Commission (“SEC”) on March 1, 2021. The unaudited consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the Company’s financial position as of September 30, 2021 and its results of operations and cash flows for the interim periods presented, and are not necessarily indicative of results for subsequent interim periods or for the full year. The interim consolidated financial statements do not include all of the information and footnotes required by U.S. GAAP for complete financial statements, as allowed by the relevant SEC rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading.
New Accounting Pronouncements Not Yet Adopted
In May 2021 the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the Emerging Issues Task Force, which amends the FASB Accounting Standards Codification (“ASC”) to provide explicit guidance, and, thus, reduce diversity in practice, on accounting
9
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
by issuers for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after the modification or exchange. This amendment provides that for an entity that presents earnings per share (EPS) in accordance with Topic 260, the effects of a modification or an exchange of a freestanding equity-classified written call option that is recognized as a dividend should be an adjustment to net income (or net loss) in the basic EPS calculation. The amended guidance becomes mandatorily effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years, and should be applied prospectively to modifications or exchanges occurring on or after the effective date. The Company will adopt ASU 2021-04 effective January 1, 2022, and it is expected that the adoption will not have a material impact to the Company's Condensed Consolidated Financial Statements.
No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s consolidated financial statements upon adoption.
2. | CASH AND CASH EQUIVALENTS |
The Company considers only those investments that are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. From time to time, the Company may have cash balances in financial institutions in excess of insurance limits. The Company has not experienced any losses related to these balances. Management believes it is not exposed to significant credit risk.
Cash and cash equivalents consisted of the following:
September 30, | December 31, | ||||||
(In thousands) |
| 2021 |
| 2020 |
| ||
Cash | $ | ( | $ | ( | |||
Money market funds |
| |
| | |||
Total cash and cash equivalents | $ | | $ | |
3. | RESTRICTED CASH |
Restricted cash as of September 30, 2021 and December 31, 2020 was $
4. | FAIR VALUES OF ASSETS AND LIABILITIES |
The Company groups its assets and liabilities generally measured at fair value into three levels based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value.
Level 1 — Valuation is based on quoted prices in active markets for identical assets or liabilities. Level 1 assets and liabilities generally include debt and equity securities that are traded in an active exchange market. Valuations are obtained from readily available pricing sources for market transactions involving identical assets or liabilities.
Level 2 — Valuation is based on observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 — Valuation is based on unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments
10
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation.
Assets and liabilities measured at fair value on a recurring basis are summarized below:
As of September 30, 2021 | |||||||||||||
(In thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | |
As of December 31, 2020 | |||||||||||||
(In thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | |
During the three and nine months ended September 30, 2021 and 2020, there were
The Company believes the carrying amounts of its prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these amounts.
5. | COMMITMENTS AND CONTINGENCIES |
Operating Leases
On May 3, 2018, the Company entered into a sublease for
Concurrent with the Sublease Termination, the Company entered into a new lease for the same space with ARE-MA (the “Cambridge Lease”). The Cambridge Lease commenced on June 1, 2021 and is scheduled to expire on December 31, 2023. The Cambridge Lease contains rent escalation clauses. In connection with the Cambridge Lease, a new standby letter of credit was established for $
The Sublease Termination and concurrent execution of the Cambridge Lease was determined to be a lease modification that qualified as a change of accounting on the existing lease and not a separate contract. As such, the right-of-use assets and operating lease liabilities were remeasured using an incremental borrowing rate at the date of modification of
The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:
11
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
● | As the Cambridge Lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. |
● | Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component. |
● | The expected lease terms include noncancelable lease periods. |
The elements of lease expense are as follows:
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
Lease cost (In thousands) | 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Operating lease cost | $ | | $ | | $ | | $ | | |||
Short-term lease cost | — | | | | |||||||
Variable lease cost | | | | | |||||||
Total lease cost | $ | | $ | | $ | | $ | | |||
Other information (In thousands) | |||||||||||
Increase in operating right-of-use assets and liabilities related to lease modifications | $ | — | $ | — | $ | | $ | — | |||
Cash paid for amounts included in the measurement of lease liabilities: | |||||||||||
Operating cash flows from short term leases | $ | — | $ | | $ | | $ | | |||
Operating cash flows from operating leases | | | | | |||||||
Total cash paid for leases | $ | | $ | | $ | | $ | | |||
Weighted-average remaining lease term - operating leases | |||||||||||
Weighted-average discount rate - operating leases |
Maturities of the lease liability due under the Cambridge Lease as of September 30, 2021 are as follows:
Leases (In thousands) | As of September 30, 2021 |
| |
2021 (excluding the nine months ended September 30, 2021) | $ | | |
2022 | | ||
2023 | | ||
Total lease payments | | ||
Less: imputed interest | ( | ||
Present value of lease liabilities | $ | |
Right-of-use lease assets and lease liabilities are reported in the Company’s consolidated balance sheets as follows:
Leases (In thousands) | Classification |
| September 30, 2021 | December 31, 2020 | ||||
Assets | ||||||||
Operating | $ | | $ | | ||||
Total lease assets | $ | | $ | | ||||
Liabilities | ||||||||
Operating | $ | | $ | | ||||
Operating | | | ||||||
$ | | $ | |
12
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
Clinical Trial Commitments
The Company has engaged and executed contracts with clinical research organizations (“CROs”) to assist with the administration of its ongoing INSPIRE 1.0 and INSPIRE 2.0 clinical trials. As of September 30, 2021, approximately $
6. FIXED ASSETS
Property, equipment, and leasehold improvements, net consisted of the following:
September 30, | December 31, | ||||||
(In thousands) |
| 2021 |
| 2020 |
| ||
Computer software and hardware | $ | | $ | | |||
Research and lab equipment |
| |
| | |||
Leasehold improvements |
| |
| | |||
Property and equipment | | | |||||
Less accumulated depreciation |
| ( |
| ( | |||
Property and equipment, net | $ | | $ | |
Depreciation expense for the three and nine months ended September 30, 2021 was $
7. INTANGIBLE ASSETS
Intangible assets, included in “other assets,” consisted of patent licensing fees paid to license intellectual property. In July 2007, the Company entered into a worldwide exclusive license (the “BCH License”) for patents co-owned by BCH and MIT initially covering the use of biopolymers to treat spinal cord injuries, and to promote the survival and proliferation of human stem cells in the spinal cord. During 2011, the BCH License was amended, and the Company obtained additional rights for use in the field of peripheral nerve injuries. The BCH License, as amended, has a
Intangible assets, net consisted of the following:
September 30, | December 31, | ||||||
(In thousands) |
| 2021 |
| 2020 |
| ||
Patent licensing fee | $ | | $ | | |||
Accumulated amortization |
| ( |
| ( | |||
Other assets | $ | — | $ | |
13
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
The Company did not record any amortization expense during the three months ended September 30, 2021 as the license fee was fully amortized during the previous quarter. Amortization expense during the nine months ended September 30, 2021 was $
8. ACCRUED EXPENSES
Accrued expenses consisted of the following:
September 30, | December 31, | ||||||
(In thousands) |
| 2021 |
| 2020 |
| ||
Compensation | $ | | $ | | |||
Clinical |
| | | ||||
Legal | | | |||||
Other accrued expenses |
| | | ||||
Total accrued expenses | $ | | $ | |
9. | EMPLOYEE BENEFIT PLAN |
In November 2006, the Company adopted a 401(k) plan (the “Plan”) covering all employees. Employees must be
10. | COMMON STOCK |
On January 21, 2020, the Company held its 2019 Annual Meeting of Stockholders (the “2019 Annual Meeting”). At the 2019 Annual Meeting, the Company’s stockholders approved an amendment to the Company’s Articles of Incorporation to increase the number of shares of authorized common stock from
In October 2020, the Company completed a registered public offering (the “October 2020 Offering”) in which it sold an aggregate of (i)
14
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
common stock, which represents a number of shares of common stock equal to
In April 2020, the Company entered into a securities purchase agreement (the "April 2020 Purchase Agreement") with certain institutional investors (the "April 2020 Purchasers"), pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of
15
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
September 30, 2020, the Company issued an aggregate of
In March 2020, the Company completed a registered public offering (the “March 2020 Offering”) in which it sold an aggregate of (i)
During the three and nine months ended September 30, 2021, there was
During the nine months ended September 30, 2020, as part of the adjustment to reflect the 2020 Reverse Stock Split, the Company issued an aggregate of
The Company did not issue any shares as a result of the vesting of restricted stock units during the three months ended September 30, 2021. During nine months ended September 30, 2021 the Company issued an aggregate of
16
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
months ended September 30, 2020, the Company issued an aggregate of
11. | STOCK-BASED COMPENSATION |
On October 26, 2010, the Company’s Board of Directors adopted, and the Company’s shareholders subsequently approved, the 2010 Equity Incentive Plan (as subsequently amended, the “2010 Plan”). The 2010 Plan provided for grants of incentive stock options to employees, and nonqualified stock options and restricted common stock to employees, consultants, and non-employee directors of the Company.
In April 2015, the Company’s Board of Directors adopted, and the Company’s shareholders subsequently approved, the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for grants of incentive stock options to employees, and nonqualified stock options, restricted common stock, restricted stock units (“RSUs”), and stock appreciation rights to employees, consultants, and non-employee directors of the Company.
As of September 30, 2021, the total number of shares authorized for issuance under the 2015 Plan was
Options issued under the
Stock-based compensation
For the three and nine month periods ended September 30, 2021 and 2020, stock-based compensation recognized was classified in the consolidated statements of operations as follows:
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
(In thousands) | 2021 | 2020 | 2021 | 2020 | |||||||
Research and development | $ | | $ | | $ | | $ | | |||
General and administrative | | | | | |||||||
Total | $ | | $ | | $ | | $ | |
The fair value of each option award is estimated on the date of grant using the Black‑Scholes option pricing model, which uses the following assumptions; (i) Risk-free interest rate, (ii) Expected dividend yield, (iii) Expected term and (iv) Expected volatility. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercises within the valuation model. The expected term of options granted under the Plans, all of which qualify as “plain vanilla,” is based on the average of the contractual term (
The Company grants RSUs and restricted stock awards (“RSAs”), collectively referred to as restricted securities under the 2015 Equity Incentive Plan. These restricted securities generally vest over a
17
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
dividends under the 2015 Equity Incentive Plan; however, the Company’s form of Restricted Stock Agreement provides that the payment of dividends on unvested RSAs shall be deferred until such time as the shares vest. The grant date fair value of these awards is based on the fair market value of our common stock on the date of grant.
The Company did
September 30, |
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| 2021 |
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Risk-free interest rate |
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Expected dividend yield |
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Expected term (employee grants) |
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Expected volatility |
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Stock options
A summary of option activity as of September 30, 2021 and changes for the nine month period then ended are presented below:
Weighted | |||||||||||
Weighted | Average | ||||||||||
Average | Remaining | Aggregate | |||||||||
Exercise | Contractual | Intrinsic | |||||||||
Options |
| Shares |
| Price |
| Term in Years | Value | ||||
Outstanding as of December 31, 2020 |
| | $ | |
| $ | — | ||||
Granted |
| | $ | | |||||||
Cancelled/Forfeited | ( | $ | | ||||||||
Outstanding as of September 30, 2021 |
| | $ | | $ | — | |||||
Vested and Exercisable as of September 30, 2021 |
| | $ | | $ | — | |||||
Vested and expected to vest as of September 30, 2021 |
| | $ | |
| $ | — |
The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2021 was $
During the three and nine months ended September 30, 2021, the Company recorded stock-based compensation expense of $
18
InVivo Therapeutics Holdings Corp.
Notes to Consolidated Financial Statements for the Quarter Ended September 30, 2021 (Unaudited)
(Continued)
Restricted Securities
The following table summarizes the restricted securities activity under the 2015 Plan during the nine month period ended September 30, 2021:
Weighted-Average | |||||
Restricted Securities |
| Number of Grants |
| Grant Date Fair Value | |
Unvested balance as of December 31, 2020 | | $ | | ||
Vested | ( | $ | | ||
Unvested balance as of September 30, 2021 | | $ | |
During the three and nine months ended September 30, 2021, the Company recorded stock-based compensation expense of $
12. WARRANTS
The following table presents information about warrants to purchase common stock issued and outstanding as of September 30, 2021:
|
|
| Number of |
| Exercise Price as of |
| ||||||
Year Issued | Defined Name | Classification | Warrants | September 30, 2021 | Date of Expiration | |||||||
2018 Series A Warrants | Equity | | $ | | ||||||||
2019 Placement Agent Warrants | Equity | | $ | | ||||||||
March 2020 Series A Warrants | Equity | | $ | | ||||||||
March 2020 Placement Agent Warrants | Equity | | $ | | ||||||||
March 2020 Series B Warrants | Equity | | $ | | Until Fully Exercised | |||||||
April 2020 Series C Warrants | Equity | | $ | | ||||||||
April 2020 Placement Agent Warrants | Equity | | $ | | ||||||||
October 2020 Placement Agent Warrants | Equity | | $ | | ||||||||
October 2020 Series A Warrants | Equity | | $ | | ||||||||
Total |