The following discussion should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements as a result of many important factors, including those set forth in Part I of this Annual Report on Form 10-K under the caption "Risk Factors". Please see also the "Special Note Regarding Forward-Looking Statements" in Part I above. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Annual Report on Form 10-K.

All share amounts presented in this Item 7 give effect to the 1-for-30 reverse stock split of the outstanding shares of our common stock that occurred on February 11, 2020.





Introduction


This Management's Discussion and Analysis of our financial condition and results of operations is based on our financial statements, which management has prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base our estimates on historical experience and on various other factors that management believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.





Business Overview


We are a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries, or SCIs. Our approach to treating acute SCIs is based on our investigational Neuro-Spinal Scaffold™ implant, a bioresorbable polymer scaffold that is designed for implantation at the site of injury within a spinal cord and is intended to treat acute SCI. The Neuro-Spinal Scaffold implant incorporates intellectual property licensed under an exclusive, worldwide license from BCH and MIT. We also plan to evaluate other technologies and therapeutics that may be complementary to our development of the Neuro-Spinal Scaffold implant or offer the potential to bring us closer to our goal of redefining the life of the SCI patient.

Overall, we expect our research and development expenses to be substantial and to increase for the foreseeable future as we continue the development and clinical investigation of our current and future products. However, expenditures on research and development programs are subject to many uncertainties, including whether we develop our products with a partner or independently, or whether we acquire products from third parties. At this time, due to the uncertainties and inherent risks involved in our business, we cannot estimate in a meaningful way the duration of, or the costs to complete, our research and development programs or whether, when or to what extent we will generate revenues or cash inflows from the commercialization and sale of any of our products. While we are currently focused on advancing our Neuro-Spinal Scaffold implant, our future research and development expenses will depend on the determinations we make as to the scientific and clinical prospects of each product candidate, as well as our ongoing assessment of regulatory requirements and each product's commercial potential. In addition, we may make acquisitions of businesses, technologies or intellectual property rights that we believe would be necessary, useful or complementary to our current business. Any investment made in a potential acquisition could affect our results of operations and reduce our limited capital resources, and any issuance of equity securities in connection with a potential acquisition could be substantially dilutive to our stockholders.

There can be no assurance that we will be able to successfully develop or acquire any product, or that we will be able to recover our development or acquisition costs, whether upon commercialization of a developed product or otherwise. We cannot provide assurance that any of our programs under development or any acquired technologies or products will result in products that can be marketed or marketed profitably. If our development-stage programs or any acquired products or technologies do not result in commercially viable products, our results of operations could be materially adversely affected.



                                       43

--------------------------------------------------------------------------------

Table of Contents

We were incorporated on April 2, 2003, under the name of Design Source, Inc. On October 26, 2010, we acquired the business of InVivo Therapeutics Corporation, which was founded in 2005, and continued the existing business operations of InVivo Therapeutics Corporation as our wholly-owned subsidiary.

Critical Accounting Policies and Estimates

Our consolidated financial statements, which appear in Item 8 of this Annual Report on Form 10-K, have been prepared in accordance with accounting principles generally accepted in the United States, which require that our management make certain assumptions and estimates and, in connection therewith, adopt certain accounting policies. Our significant accounting policies are set forth in Note 2, "Significant Accounting Policies", in the Notes to Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K. Of those policies, we believe that the policies discussed below may involve the highest degree of judgment and may be the most critical to an accurate reflection of our financial condition and results of operations.





Stock-Based Compensation


Our stock options are granted with an exercise price set at the fair market value of our common stock on the date of grant. Our stock options generally expire 10 years from the date of grant and vest upon terms determined by our Board of Directors.

We recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in our statements of operations over the service period based on a measure of fair value for each stock-based award. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option pricing model and the fair value of each restricted stock award or restricted stock unit, which we refer to collectively as restricted securities, is determined based on the fair market value of our common stock on the date of grant. The fair value is amortized as a compensation cost on a straight-line basis over the requisite service period of the award, which is generally the vesting period. The expected term of any options granted under our stock plans is based on the average of the contractual term (generally, 10 years) and the vesting period (generally, 48 months). The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the expected term of the option. The restricted securities generally vest over a three-year period, contingent on the recipient's continued employment. See Note 9, "Shared-Based Compensation, Stock Options and Restricted Securities," in the Notes to Consolidated Financial Statements in Item 8 of this Annual Report on Form 10 K for more information about the assumptions underlying these estimates.

Research and Development Expense

Our research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:

? employee related expenses, including salaries, benefits, travel, and stock

based compensation expense;

? expenses incurred under agreements with contract research organization

("CROs"), and clinical sites that conduct our clinical studies;

facilities, depreciation, and other expenses, which include direct and

? allocated expenses for rent and maintenance of facilities, insurance, and other


   supplies;



? costs associated with our research platform and preclinical activities;

? costs associated with our regulatory, quality assurance, and quality control


   operations; and



? amortization of intangible assets.

Our research and development costs are expensed as incurred. We are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed



                                       44

--------------------------------------------------------------------------------

Table of Contents

and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrued expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. To date, we have not made any material adjustments to our prior estimates of accrued research and development expenses.

Recently Adopted Accounting Standards

In June 2016, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update ("ASU") No. 2016-13, "Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments" and subsequent amendments to the initial guidance: ASU 2018-19 "Codification Improvements to Topic 326, Financial Instruments-Credit Losses", ASU 2019-04 "Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments", ASU 2019-05 "Financial Instruments-Credit Losses", ASU 2019-11 "Codification Improvements to Topic 326, Financial Instruments - Credit Losses", ASU 2020-02 Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) and ASU 2020-03 Codification Improvements to Financial Instruments, (collectively, "Topic 326"). Topic 326 requires measurement and recognition of expected credit losses for financial assets held. Topic 326 is effective for all public business entities, excluding smaller reporting companies, for periods beginning after December 15, 2019 and all other entities beginning after December 15, 2022. We early adopted ASU No. 2016-13 and the related amending ASU's on January 1, 2020, and the adoption did not have a material effect on our financial position, results of operations or disclosures.

In August 2018, the FASB issued ASU No. 2018-13 - Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement which improves the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this ASU. We adopted ASU No. 2018-13 on January 1, 2020, and the adoption did not have a material effect on our financial position, results of operations or disclosures.

In November 2019, the FASB issued ASU No. 2019-08 "Compensation - Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Codification Improvements - Share-Based Consideration Payable to a Customer." ASU No. 2019-08 amends and clarifies ASU No. 2018-07, which we adopted on January 1, 2019, to require that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. For entities that have already adopted the amendments in ASU No. 2018-07, the amendments in this ASU are effective for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. We adopted ASU No. 2019-08 on January 1, 2020, and the adoption did not have any impact on our financial position, results of operations or disclosures.

In December 2019, the FASB issued ASU No. 2019-12, Simplifications to Accounting for Income Taxes (Topic 740). The amendments in this ASU removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation, and calculating income taxes in interim periods. This ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. This ASU is effective for all entities for fiscal years beginning after December 15, 2020, and early adoption is permitted. We adopted ASU No. 2019-12 on January 1, 2020, and the adoption did not have any impact on our financial position, results of operations or disclosures.

New Accounting Pronouncements Not Yet Adopted

In January 2020, the FASB issued ASU No. 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). The



                                       45

--------------------------------------------------------------------------------

Table of Contents

amendments in this ASU clarify the interaction between the accounting for investments in equity securities, investment in equity method and certain derivatives instruments. The ASU is expected to reduce diversity in practice and increase comparability of the accounting for these interactions. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2021. ASU No. 2020-01 is effective for us beginning in fiscal 2022. We are currently in the process of evaluating the effects of this pronouncement on our financial statements.

In August 2020, the FASB issued ASU No. 2020-06 "Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity's Own Equity", related to the measurement and disclosure requirements for convertible instruments and contracts in an entity's own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity's own equity. This pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning in fiscal 2022. We are currently in the process of evaluating the effects of this pronouncement on our financial statements.





Results of Operations


Comparison of the Years Ended December 31, 2020 and 2019

Research and Development Expenses

Research and development expenses decreased by $1.7 million to $3.9 million for the year ended December 31, 2020 from $5.6 million for the year ended December 31, 2019. The decrease in research and development expenses for the year ended December 31, 2020 is attributable to a decrease in clinical trial costs of $1.0 million due to lower startup costs in our INSPIRE 2.0 Study in the current year as compared to the prior year, a decrease in scaffold manufacturing costs of $0.2 million primarily as a result of lower clinical demand, a decrease in incentive compensation costs of $0.3 million, a decrease in legal costs of $0.1 million primarily due to fewer regulatory tasks requiring legal assistance and a decrease in other net immaterial balances of $0.1 million mainly due to cost containment initiatives.

General and Administrative Expenses

General and administrative expenses decreased by $0.7 million to $5.2 million for the year ended December 31, 2020 from $5.9 million for year ended December 31, 2019. The decrease in general and administrative expenses for the year ended December 31, 2020 is due to lower incentive compensation costs in the current year of $0.3 million as well as lower consulting costs of $0.4 million. In the prior year, the Company conducted a one-time market analysis which did not recur in the current year resulting in lower consulting costs in the current year.

Interest Income / (Expense), Net

Interest income decreased by $235 thousand to $19 thousand for the year ended December 31, 2020 from $254 thousand for the year ended December 31, 2019. The decrease in interest income was primarily due to lower yields in our cash and cash equivalents in 2020.

Warrant Modification Expense

The Company did not incur any Warrant Modification Expenses during the year ended December 31, 2020. During the year ended December 31, 2019, the Company incurred $0.7 million in expense related to the Second Ladenburg Warrant Amendment (defined below).





Other Income


Other income for the year ended December 31, 2020 was $4 thousand. Other income for the year ended December 31, 2019 was $79 thousand mainly attributed to income related to the sale of lab equipment.





                                       46

--------------------------------------------------------------------------------

Table of Contents

Liquidity and Capital Resources

Since inception, we have devoted substantially all of our efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, and raising capital. At December 31, 2020, our accumulated deficit was $228.2 million.

At December 31, 2020, we had total assets of $21.9 million, total liabilities of $2.7 million, and total stockholders' equity of $19.2 million. We recorded a net loss of $9.1 million for the year ended December 31, 2020. We have not achieved profitability and may not be able to realize sufficient revenue to achieve or sustain profitability in the future. We do not expect to be profitable in the next several years, but rather expect to incur additional operating losses. We believe that our cash and cash equivalents at December 31, 2020 combined with the proceeds from the exercise of certain of the October 2020 Series A Warrants subsequent to December 31, 2020, will provide necessary funding to fund operations through the second quarter of 2023. This estimate is based on assumptions that may prove to be wrong; expenses could prove to be significantly higher, leading to a more rapid consumption of our existing resources. We have limited liquidity and capital resources and must obtain significant additional capital resources in order to fund our operations and sustain our product development efforts, for acquisition of technologies and intellectual property rights, for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, for selling, general and administrative expenses and for other working capital requirements. We also expect that we will need to raise additional capital through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additionally, the COVID-19 pandemic could have a continued adverse impact on economic and market conditions and extend the period of global economic slowdown, which would impair our ability to raise needed funds.

We may pursue various other dilutive and non­dilutive funding alternatives depending upon our clinical path forward and the extent to which we require additional capital to proceed with development of some or all of our product candidates on expected timelines. The source, timing and availability of any future financing will depend principally upon market conditions and the status of our clinical development programs, both of which may be negatively impacted by the COVID-19 pandemic. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us to, among other things, delay, scale back or eliminate some or all of our research and product development programs, planned clinical trials, and capital expenditures or to license our potential products or technologies to third parties. We may alternatively engage in cost-cutting measures in an attempt to extend our cash resources as long as possible. If we are unable to raise additional capital, we may be forced to cease operations entirely.





Financing Transactions


In October 2020, we completed a registered public offering (the "October 2020 Offering") in which we sold an aggregate of (i) 11,785,000 shares of our common stock, (the "October 2020 Shares") and Series A Warrants exercisable for an aggregate of 11,785,000 shares of our common stock (the "October 2020 Series A Warrants") at a combined public offering price of $0.80 per share and associated warrant and (ii) pre-funded Series B warrants exercisable for an aggregate of 6,965,000 shares of common stock (the "October 2020 Series B Pre-funded Warrants") and Series A Warrants exercisable for an aggregate of 6,965,000 shares of our common stock (also the "October 2020 Series A Warrants") at a combined public offering price of $0.80 per pre-funded warrant and associated warrant. Each October 2020 Series A Warrant has an exercise price of $0.80 per share, is exercisable immediately and expires in October 2025. Each October 2020 Series B Pre-funded Warrant has an exercise price of $0.00001 per share, is exercisable immediately, and expires when exercised in full, subject to certain conditions. In connection with the October 2020 Offering, we issued, to designees of H.C. Wainwright & Co., LLC ("Wainwright"), the placement agent for the October 2020 Offering, warrants (the "October 2020 Placement Agent Warrants") to purchase an aggregate of 1,218,750 shares of our common stock, which represents a number of shares of common stock equal to 6.5% of the aggregate number of shares of common stock and October 2020 Series B Pre-funded Warrants sold in the October 2020 Offering. The October 2020 Placement Agent Warrants have an exercise price of $1.00 per share, are immediately exercisable and expire in October 2025. The net proceeds to us, after deducting Wainwright's placement agent fees and other offering expenses payable by us, were approximately $13.5 million. During the year ended December 31, 2020, we issued an aggregate of 6,965,000 shares of our common stock upon the exercise of all of the October 2020 Series B Pre-funded Warrants for an immaterial amount, as they were substantially pre-funded. During the year ended December 31, 2020, we did not issue any shares as a result of October 2020 Series A Warrants or October 2020 Placement Agent Warrants exercise activity.





                                       47

--------------------------------------------------------------------------------

Table of Contents

In April 2020, we entered into a securities purchase agreement (the "April 2020 Purchase Agreement") with certain institutional investors (the "April 2020 Purchasers"), pursuant to which we agreed to sell and issue, in a registered direct offering, an aggregate of 1,715,240 shares of our common stock, at a purchase price per share of $1.75 (the "April 2020 Shares"). The April 2020 Shares were offered by us pursuant to a shelf registration statement on Form S-3, which was declared effective by SEC on November 14, 2019 (File No. 333-234353) and a prospectus supplement thereunder. Pursuant to the April 2020 Purchase Agreement, in a concurrent private placement, we also issued to the April 2020 Purchasers warrants (the "April 2020 Series C Warrants") to purchase up to 1,715,240 shares of our common stock (the "Private Placement" and together with the April 2020 Registered Offering, the "April 2020 Offerings"). The April 2020 Series C Warrants are exercisable immediately at an exercise price of $1.62 per share of common stock, subject to adjustment in certain circumstances, and expire on October 17, 2025. In connection with the April 2020 Offerings, we also issued to Wainwright warrants to purchase an aggregate of 111,491 shares of our common stock (the "April 2020 Placement Agent Warrants") which represents a number of shares of common stock equal to 6.5% of the aggregate number of April 2020 Shares sold in the April 2020 Registered Offering, at an exercise price of $2.1875 per share with a term expiring on April 15, 2025. The net proceeds to us, after deducting Wainwright's placement agent fees and other offering expenses payable by us, were approximately $2.6 million. During the year ended December 31, 2020, we issued an aggregate of 35,000 shares of our common stock upon the exercise of certain of the April 2020 Series C Warrants for aggregate proceeds of $57 thousand. During the year ended December 31, 2020, we did not issue any shares as a result of April 2020 Placement Agent Warrants exercise activity.

In March 2020, we completed a registered public offering (the "March 2020 Offering") in which we sold an aggregate of (i) 955,613 shares of our common stock, (the "March 2020 Shares") and Series A Warrants exercisable for an aggregate of 955,613 shares of our common stock (the "March 2020 Series A Warrants") at a combined public offering price of $2.75 per share and associated warrant and (ii) pre-funded Series B warrants exercisable for an aggregate of 1,589,842 shares of our common stock (the "March 2020 Series B Warrants") and Series A Warrants exercisable for an aggregate of 1,589,842 shares of our common stock (also the "March 2020 Series A Warrants") at a combined public offering price of $2.75 per pre-funded warrant and associated warrant. Each March 2020 Series A Warrant has an exercise price of $2.75 per share, is exercisable immediately and expires in March 2025. Each March 2020 Series B Warrant has an exercise price of $0.00001 per share, is exercisable immediately, and expires when exercised in full, subject to certain conditions. In connection with the March 2020 Offering, we issued, to Wainwright, the placement agent for the March 2020 Offering, warrants (the "March 2020 Placement Agent Warrants") to purchase an aggregate of 165,455 shares of our common stock, which represents a number of shares of common stock equal to 6.5% of the aggregate number of shares of common stock and March 2020 Series B Warrants sold in the March 2020 Offering. The March 2020 Placement Agent Warrants have an exercise price of $3.4375 per share, are immediately exercisable and expire in March 2025. The net proceeds to us, after deducting Wainwright's placement agent fees and other offering expenses payable by us, were approximately $6.0 million. During the year ended December 31, 2020, we did not issue any shares as a result of the March 2020 Placement Agent Warrants or March 2020 Series A Warrants exercise activity. During the year ended December 31, 2020, we issued an aggregate of 1,577,114 shares of our common stock upon the exercise of certain of the pre-funded March 2020 Series B warrants for an immaterial amount, as they were substantially pre-funded.

In November 2019, we closed a public offering of an aggregate of 233,341 shares of our common stock, at an offering price of $3.60 per share (the offering, the "2019 Offering"). The net proceeds to us after deducting the placement agent fees and other offering expenses, were $367 thousand. In connection with the 2019 Offering, we issued to Wainwright, warrants (the "2019 Placement Agent Warrants") to purchase an aggregate of 15,168 shares of our common stock. The 2019 Placement Agent Warrants have an exercise price of $4.50 per share, are immediately exercisable and expire in November 2024. During the year ended December 31, 2020, we did not issue any shares of common stock as a result of exercise activity related to the 2019 Placement Agent Warrants.

In November 2019, we entered into a Second Amendment to Warrant Agency Agreement and Warrants, ("the Second Ladenburg Warrant Amendment"), by and between us and Continental, as Warrant Agent, dated November 21, 2019, that amended the 2018 Series A warrants issued by us in the June 2018 underwritten public offering to reflect a reduced exercise price per share of $6.98 from $60.00. See Note 10 to our Consolidated Financial Statements for more information about the Second Ladenburg Warrant Amendment. During the year ended December 31, 2020 we issued an aggregate of 40,975 shares of common stock upon the exercise of certain of the 2018 Series A warrants for aggregate proceeds of $286 thousand.





                                       48

--------------------------------------------------------------------------------

Table of Contents

Cashflows

Net cash used in operating activities is comprised of our net losses, adjusted for non-cash expenses, and working capital requirements. Net cash used in operating activities for the year ended December 31, 2020 was $9.5 million compared to $10.3 million for the year ended December 31, 2019. The $0.8 million decrease in net cash used in operating activities for the year ended December 31, 2020 as compared to the same period in the prior year was primarily due to a decrease in our net loss of $2.8 million, a decrease in warrant modification expense of $0.7 million, a decrease in the change in accrued expenses and other liabilities of $0.4 million, a decrease in the change in accounts payable of $0.6 million and a decrease in the change in operating lease right-of-use liability of $0.2 million.

Net cash used in investing activities for the years ended December 31, 2020 and 2019, was $41 thousand and $12 thousand, respectively attributable to purchases of capital equipment.

Net cash provided by financing activities for the year ended December 31, 2020 was $22.4 million consisting of $22.1 million in proceeds from the issuance of common stock associated with the offerings in 2020 and $0.3 million in proceeds from the exercise of warrants. This compares to net cash of $0.3 million provided by financing activities for the year ended December 31, 2019 consisting primarily of $0.4 million in proceeds from the issuance of common stock associated with the November 2019 underwritten public offering, offset by $0.1 million in loan repayments.

Off Balance Sheet Arrangements

We do not have any off balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.





Inflation and Changing Prices


We do not believe that inflation has had, or will have, a material impact on our operating costs and earnings.





Commitments


See Note 13, "Commitments and Contingencies," in the Notes to Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K for information regarding our commitments.

© Edgar Online, source Glimpses