The following management's discussion and analysis should be read in conjunction
with the unaudited consolidated financial statements included elsewhere in this
Quarterly Report and with our historical consolidated financial statements, and
the related notes thereto, included in our Annual Report on Form 10-K for the
year ended December 31, 2019 (the "2019 Annual Report"). The management's
discussion and analysis contains forward-looking statements within the meaning
of the safe harbor provisions under Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934, as amended
(the "Exchange Act"). These statements include statements made regarding our
commercialization strategy, future operations, cash requirements and liquidity,
capital requirements, and other statements on our business plans and strategy,
financial position, and market trends. In some cases, you can identify
forward-looking statements by terms such as "may," "might," "will," "should,"
"believe," "plan," "intend," "anticipate," "target," "estimate," "expect," and
other similar expressions. These forward-looking statements are subject to risks
and uncertainties that could cause actual results or events to differ materially
from those expressed or implied by the forward-looking statements in this
Quarterly Report, including factors such as our ability to raise substantial
additional capital to finance our planned operations and to continue as a going
concern; our ability to execute our strategy and business plan; our ability to
obtain regulatory approvals for our products, including the Neuro-Spinal
Scaffold™; our ability to successfully commercialize our current and future
product candidates, including the Neuro-Spinal Scaffold; the progress and timing
of our development programs; market acceptance of our products; our ability to
retain management and other key personnel; our ability to promote, manufacture,
and sell our products, either directly or through collaborative and other
arrangements with third parties; the impact of the COVID-19 outbreak and our
response to it; and other factors detailed under "Risk Factors" in Part II,
Item 1A of this Quarterly Report. These forward-looking statements speak only as
of the date hereof. We do not undertake any obligation to update forward-looking
statements to reflect events or circumstances occurring after the date of this
Quarterly Report, except as required by law.
The discussion and analysis of our financial condition and results of operations
are based on our consolidated financial statements, which we have prepared in
accordance with U.S. generally accepted accounting principles. The preparation
of these consolidated financial statements requires us 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 consolidated
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 we believe
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.
All share amounts presented in this Item 2 are retroactively adjusted to give
effect to the 1-for-30 reverse stock split of our outstanding shares of common
stock, par value $0.00001 per share ("common stock"), that occurred on February
11, 2020.
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 Boston Children's Hospital, or BCH, and the Massachusetts
Institute of Technology, or MIT. We also plan to evaluate other technologies and
therapeutics that may be complementary to our development of the Neuro-Spinal
Scaffold implant, such as stem cells, therapeutics or electrical stimulation,
including in combination with learnings applied from our Neuro-Spinal Scaffold
implant or technologies that offer the potential to bring us closer to our goal
of redefining the life of the SCI patient.
The current standard of care for acute management of spinal cord injuries
focuses on preventing further injury to the spinal cord. However, the current
standard of care does not address repair of the spinal cord.
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Our Clinical Program
We currently have one clinical development program for the treatment of acute
SCI.
Neuro-Spinal Scaffold Implant for acute SCI
Our Neuro-Spinal Scaffold implant is an investigational bioresorbable polymer
scaffold that is designed for implantation at the site of injury within a spinal
cord. The Neuro-Spinal Scaffold implant is intended to promote appositional, or
side-by-side, healing by supporting the surrounding tissue after injury,
minimizing expansion of areas of necrosis, and providing a biomaterial substrate
for the body's own healing/repair processes following injury. We believe this
form of appositional healing may spare white matter, increase neural sprouting,
and diminish post-traumatic cyst formation.
The Neuro-Spinal Scaffold implant is composed of 2 biocompatible and
bioresorbable polymers that are cast to form a highly porous investigational
product:
Poly lactic-co-glycolic acid, a polymer that is widely used in resorbable
? sutures and provides the biocompatible support for Neuro-Spinal Scaffold
implant; and
? Poly-L-Lysine, a positively charged polymer commonly used to coat surfaces in
order to promote cellular attachment.
Because of the complexity of SCIs, it is likely that multi-modal therapies will
be required to maximize positive outcomes in SCI patients. In the future, we may
attempt to further enhance the performance of our Neuro-Spinal Scaffold implant
by multiple combination strategies involving electrostimulation devices,
additional biomaterials, drugs approved by the U.S. Food and Drug
Administration, or FDA, or growth factors. We expect the Neuro-Spinal Scaffold
implant to be regulated by the FDA as a Class III medical device.
INSPIRE 2.0 Study
Our Neuro-Spinal Scaffold implant has been approved to be studied under our
approved Investigational Device Exemption, or IDE, in the INSPIRE 2.0 Study,
which is titled the "Randomized, Controlled, Single-blind Study of Probable
Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in
Subjects with Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard
of Care." The purpose of the INSPIRE 2.0 Study is to assess the overall safety
and probable benefit of the Neuro-Spinal Scaffold for the treatment of
neurologically complete thoracic traumatic acute SCI. The INSPIRE 2.0 Study is
designed to enroll 10 subjects into each of the 2 study arms, which we refer to
as the Scaffold Arm and the Comparator Arm. Patients in the Comparator Arm will
receive the standard of care, which is spinal stabilization without dural
opening or myelotomy. The INSPIRE 2.0 Study is a single blind study, meaning
that the patients and assessors are blinded to treatment assignments. The FDA
approved the enrollment of up to 35 patients in this study so that there would
be at least 20 evaluable patients (10 in each study arm) at the primary endpoint
analysis, accounting for events such as screen failures or deaths that would
prevent a patient from reaching the primary endpoint visit. As of August 9,
2020, eight patients in the INSPIRE 2.0 Study have been enrolled and 17 sites
are activated for enrollment. We are aware that a significant number of our
clinical sites have temporarily suspended enrollment into the INSPIRE 2.0 Study
at their institution due to the coronavirus pandemic. We estimate that
enrollment in the INSPIRE 2.0 Study will be complete in the second quarter of
2021, with the final patient enrolled in the INSPIRE 2.0 study reaching their
six-month primary endpoint visit in the fourth quarter of 2021.
The primary endpoint is defined as the proportion of patients achieving an
improvement of at least 1 American Spinal Injury Association Impairment Scale
("AIS") grade at 6 months post-implantation. Assessments of AIS grade are at
hospital discharge, 3 months, 6 months, 12 months and 24 months. The definition
of study success for INSPIRE 2.0 is that the difference in the proportion of
subjects who demonstrate an improvement of at least 1 grade on AIS assessment at
the 6-month primary endpoint follow-up visit between the Scaffold Arm and the
Comparator Arm must be equal to or greater than 20%. In one example, if 50% of
subjects in the Scaffold Arm have an improvement of AIS grade at the 6-month
primary endpoint and 30% of subjects in the Comparator Arm have an improvement,
then the difference in the proportion of subjects who demonstrated an
improvement is equal to 20% (50% minus 30% equals 20%) and the definition of
study success would be met. In another example, if 40% of subjects in the
Scaffold Arm have an
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improvement of AIS grade at the 6-month primary endpoint and 30% of subjects in
the Comparator Arm have an improvement, then the difference in the proportion of
subjects who demonstrated an improvement is equal to 10% (40% minus 30% equals
10%) and the definition of study success would not be met. Additional endpoints
include measurements of changes in neurological level of injury, sensory levels
and motor scores, bladder, bowel and sexual function, pain, Spinal Cord
Independence Measure, and quality of life.
Our Neuro-Spinal Scaffold was previously studied in The INSPIRE Study: the
"InVivo Study of Probable Benefit of the Neuro- Spinal Scaffold for Safety and
Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord
Injury," under an IDE application for the treatment of neurologically complete
thoracic traumatic acute SCI. Although The INSPIRE Study was structured with an
Objective Performance Criterion, or the OPC as the primary component for
demonstrating probable benefit, the OPC is not the only variable that the FDA
would evaluate when reviewing a future human device exemption, or HDE,
application. Similarly, while our INSPIRE 2.0 Study is structured with a
definition of study success requiring a minimum difference between study arms in
the proportion of subjects achieving improvement, that success definition is not
the only factor that the FDA would evaluate in the future HDE
application. Approval is not guaranteed if the OPC is met for The INSPIRE Study
or the definition of study success is met for the INSPIRE 2.0 Study, and even if
the OPC or definition of study success are not met, the FDA may approve a
medical device if probable benefit is supported by a comprehensive review of all
clinical endpoints and preclinical results, as demonstrated by the sponsor's
body of evidence.
In 2016, the FDA accepted our proposed HDE modular shell submission and review
process for the Neuro-Spinal Scaffold implant. The HDE modular shell is
comprised of 3 modules: a preclinical studies module, a manufacturing module,
and a clinical data module. As part of its review process, the FDA reviews each
module, which are individual sections of the HDE submission, on a rolling basis.
Following the submission of each module, the FDA reviews and provides feedback,
typically within 90 days, allowing the applicant to receive feedback and
potentially resolve any deficiencies during the review process. Upon receipt of
all 3 modules, which constitutes the complete HDE submission, the FDA makes a
filing decision that may trigger the review clock for an approval decision. We
submitted the first module in March 2017 and received feedback in June 2017. We
submitted an updated first module in the fourth quarter of 2019. The HDE
submission will not be complete until the manufacturing and clinical modules are
also submitted.
Impact of COVID-19 Outbreak
On January 30, 2020, the World Health Organization, or the WHO, announced a
global health emergency because of a new strain of coronavirus originating in
Wuhan, China, or the COVID-19 outbreak, and the risks to the international
community as the virus spreads globally beyond its point of origin. In March
2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid
increase in exposure globally. We are aware that a significant number of our
clinical sites have temporarily suspended enrollment into the INSPIRE 2.0 Study
at their institution due to the COVID-19 outbreak, and as such, the COVID-19
outbreak has affected and may continue to affect the potential for enrollment in
our INSPIRE 2.0 Study as clinical sites suspend studies in order to manage the
pandemic. Aside from the impact on enrollment in our INSPIRE 2.0 Study, we did
not experience any significant impact from the COVID-19 outbreak on our
financial condition, liquidity, other operations, suppliers, industry, and
workforce for the quarter ended June 30, 2020. The full impact of the COVID-19
outbreak continues to evolve as of the date of filing this Quarterly Report on
Form 10-Q. We are actively monitoring the impact of the global situation on our
financial condition, liquidity, operations, suppliers, industry, and workforce,
although there remains significant uncertainty related to the public health
situation globally. Given the daily evolution of the COVID-19 outbreak and the
global responses to curb its spread, we are not able to estimate the ultimate
effects of the COVID-19 outbreak on our results of operations, financial
condition, or liquidity in the future. However, as the COVID-19 outbreak
continues, it will likely continue to have an adverse effect on enrollment in
our INSPIRE 2.0 Study, and may also have an adverse effect on our results of
future operations, financial position, and liquidity, and even after the
COVID-19 outbreak has subsided, we may continue to experience adverse impacts to
our business as a result of any economic recession or depression that has
occurred or may occur in the future.
Critical Accounting Policies and Estimates
Our consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of America. The
preparation of these consolidated financial statements requires
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management to make estimates and assumptions and, in connection therewith, adopt
certain accounting policies that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the consolidated financial statements and the reported amounts of revenues
and expenses during the reporting period.
On an ongoing basis, we evaluate our estimates and judgments for all assets and
liabilities, stock-based compensation expense, and the fair value determined for
stock purchase warrants classified as derivative liabilities. We base our
estimates and judgments on historical experience, current economic and industry
conditions, and on various other factors that we believe to be reasonable under
the circumstances. Such factors form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different
assumptions or conditions. There have been no changes in our critical accounting
policies and estimates from the disclosure provided in our 2019 Annual Report.
We believe that the consolidated financial statements accurately reflect our
best estimate of the results of operations, financial position, and cash flows
for the periods presented.
Results of Operations
Comparison of the Three Months Ended June 30, 2020 and 2019
Research and Development Expenses
Research and development expenses consisted primarily of expenses related to
contract research organizations and clinical sites, professional services, and
payroll. Research and development expenses for the three months ended
June 30, 2020 were $0.9 million, a decrease of $776 thousand compared to the
three months ended June 30, 2019. The decrease in research and development
expenses for the three months ended June 30, 2020 is attributable to a decrease
clinical trial costs of $592 thousand, a decrease in compensation related
expenses of $179 thousand, a decrease in scaffold manufacturing costs of $43
thousand and a decrease in other net immaterial balances of $11 thousand. These
decreases were partially offset by an increase in facilities and rent expense of
$49 thousand.
General and Administrative Expenses
General and administrative expenses consisted primarily of payroll, rent, and
professional services. General and administrative expenses for the three months
ended June 30, 2020 were $1.3 million, a decrease of $277 thousand compared to
the three months ended June 30, 2019. The decrease in general and administrative
expenses for the three months ended June 30, 2020 is attributable primarily due
to a decrease in compensation related expenses of $279 thousand. This decrease
was partially offset by increases in other net immaterial balances of $2
thousand.
Other Income and Expense
Other income for the three months ended June 30, 2020 was $6 thousand, which was
comprised primarily of interest income. Other income for the three months ended
months ended June 30, 2019 was $104 thousand, which was comprised of
miscellaneous income of $32 thousand and interest income of $72 thousand.
Comparison of the Six Months Ended June 30, 2020 and 2019
Research and Development Expenses
Research and development expenses consisted primarily of expenses related to
contract research organizations and clinical sites, professional services, and
payroll. Research and development expenses for the six months ended
June 30, 2020 were $2.0 million, a decrease of $835 thousand compared to the six
months ended June 30, 2019. The decrease in research and development expenses
for the six months ended June 30, 2020 is attributable primarily due to a
decrease in compensation related expenses of $268 thousand and a decrease
clinical trial costs of $639 thousand. These decreases were partially offset by
an increase in facilities and rent expense of $72 thousand.
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General and Administrative Expenses
General and administrative expenses consisted primarily of payroll, rent, and
professional services. General and administrative expenses for the six months
ended June 30, 2020 were $2.6 million, a decrease of $568 thousand compared to
the six months ended June 30, 2019. The decrease in general and administrative
expenses for the six months ended June 30, 2020 is attributable to a decrease in
consulting costs of $360 thousand, a decrease compensation related expenses of
$317 thousand and decreases in other net immaterial balances of $10 thousand.
These decreases were partially offset by an increase in investor relations
expenses of $119 thousand.
Other Income and Expense
Other income for the six months ended June 30, 2020 was $20 thousand, which was
comprised primarily of interest income. Other income for the six months ended
June 30, 2019 was $247 thousand, which was comprised of interest income of $171
thousand and other income of $76 thousand.
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 June 30, 2020, our
accumulated deficit was $223.8 million. Since our inception, we have
historically financed our operations primarily through the sale of
equity-related securities.
At June 30, 2020, we had total assets of $12.7 million, total liabilities of
$2.7 million, and total stockholders' equity of $10.0 million. During the six
months ended June 30, 2020, we recorded a net loss of $4.6 million. 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 on hand which
includes proceeds from the two offerings that occurred in 2020 and described in
more detail below, will provide necessary funding to fund operations into the
second quarter of 2021. 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 outbreak could have a
continued adverse impact on economic and market conditions and trigger a period
of global economic slowdown, which would impair our ability to raise needed
funds to continue as a going concern. Based on these factors, as of
June 30, 2020, management determined that there is substantial doubt regarding
our ability to continue as a going concern.
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 outbreak. 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.
Financings Transactions
On April 15, 2020, we entered into a securities purchase agreement, or the April
2020 Purchase Agreement, with certain institutional investors, or the April 2020
Purchasers, pursuant to which we agreed to sell and issue, in a registered
direct offering, an aggregate of 1,715,240 of common stock, at a purchase price
per share of $1.75, or the
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April 2020 Shares, for net proceeds to us of approximately $2.6 million, after
deducting fees payable to Wainwright, the placement agent for the offering, and
other offering expenses payable by us, or the April 2020 Registered Offering.
The April 2020 Shares were offered 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 "Series C Warrants") to purchase up to
1,715,240 shares of common stock (the "Private Placement" and together with the
April 2020 Registered Offering, the "April 2020 Offerings"). The 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
designees of Wainwright, warrants to purchase an aggregate of 111,491 shares of
our common stock, which represents a number of shares of common stock equal to
6.50% 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. During the three months ended June 30, 2020, we
issued an aggregate of 35,000 shares of common stock upon the exercise of
certain of the Series C Warrants for aggregate proceeds of $57 thousand.
In March 2020, we completed a registered public offering, or the March 2020
Offering, in which we sold an aggregate of (i) 955,613 shares of common stock,
or the Shares, at a combined public offering price of $2.75 per share and 2020
Series A Warrant (as defined below), (ii) 2020 Series B Warrants exercisable for
an aggregate of 1,589,842 shares of common stock at a combined public offering
price of $2.74999 per share and 2020 Series A Warrant and (iii) 2020 Series A
Warrants exercisable for an aggregate of 2,545,455 shares of common stock. The
Shares and the 2020 Series B Warrants were each offered together with the 2020
Series A Warrants, but the Shares and 2020 Series B Warrants were issued
separately from the Series A Warrants. Each 2020 Series A warrant has an
exercise price of $2.75 per share, is exercisable immediately and expires in
March 2025. Each 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
Wainwright, the placement agent for the March 2020 Offering, the Wainwright
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 2020 Series B
Warrants sold in the March 2020 Offering. The Wainwright 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 three months ended June 30, 2020, we
issued an aggregate of 560,577 shares of common stock upon the exercise of
certain of the pre-funded 2020 Series B warrants for an immaterial amount.
During the six months ended June 30, 2020, we issued an aggregate of 1,577,114
shares of common stock upon the exercise of certain of the pre-funded 2020
Series B warrants for an immaterial amount.
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 designees of Wainwright, the placement agent for the
2019 Offering, warrants, or the "Placement Agent Warrants", to purchase an
aggregate of 15,168 shares of our common stock. The Placement Agent Warrants
have an exercise price of $4.50 per share, are immediately exercisable and
expire in November 2024. During the three and six months ended June 30, 2020,
there was no exercise activity related to the Placement Agent Warrants.
In June 2018, we closed an underwritten public offering of an aggregate of
45,950 Common Units, at an offering price of $60.00 each, each comprised of 1
share of our common stock, and 1 Series A warrant to purchase 1 share of common
stock. The public offering also included 208,096 pre-funded units at an offering
price of $59.70 each, each comprised of 1 pre-funded Series B Warrant and 1
Series A warrant to purchase 1 share of common stock. Each Series A warrant had
an exercise price of $60.00 per share, was exercisable immediately from the date
of issuance and expired 5 years from the date of issuance. Each Series B warrant
had an exercise price of $0.30 per share, was exercisable immediately and would
have expired 20 years from the date of issuance. The net proceeds to us, after
deducting the underwriting discounts and commissions and other offering
expenses, were $13.5 million. We did not issue any shares as a result of either
the Series A or Series B warrant exercise activity during the three months ended
June 30, 2020. During the six months ended June 30, 2020 we issued an aggregate
of 40,975 shares of common stock upon the exercise of certain of the Series A
warrants for aggregate proceeds of $286 thousand. We did not issue any shares as
a result of either the Series A or Series B warrant exercise activity during the
three and six months ended June 30, 2019. There are no outstanding Series B
warrants as of June 30, 2020.
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In September 2018, we entered into an Amendment to Warrant Agency Agreement and
Warrants, or the Ladenburg Warrant Amendment, with Continental Stock Transfer &
Trust Company, or Continental, that amended the Warrant Agency Agreement, by and
between us and Continental, as Warrant Agent, dated June 25, 2018, and the
Series A common stock Purchase Warrant, and the Series B Pre-Funded common stock
Purchase Warrant both dated June 25, 2018, and we refer to the Series A and
Series B Warrant collectively as the 2018 Warrants. See Note 10 to our
Consolidated Financial Statements in Item 1 of this report for more information
about the Ladenburg Warrant Amendment.
In November 2019, we entered into a Second Amendment to Warrant Agency Agreement
and Warrants, or "the Second Ladenburg Warrant Amendment", by and between us and
Continental, as Warrant Agent, dated November 21, 2019, that amended the Series
A warrants to reflect a reduced exercise price per share of $6.98 from $60.00.
See Note 10 to our Consolidated Financial Statements in Item 1 of this report
for more information about the Second Ladenburg Warrant Amendment.
In January 2018, we entered into a purchase agreement (the "Purchase Agreement")
and a registration rights agreement (the "RRA") with Lincoln Park Capital Fund,
LLC, which we refer to as Lincoln Park, under which we had the right to sell up
to $15 million in shares of our common stock to Lincoln Park over a 24-month
period, subject to certain limitations and conditions set forth in the Purchase
Agreement and RRA. On May 30, 2018 at our 2018 Annual Meeting of Stockholders,
our stockholders approved an increase to the number of shares of common stock
available for issuance and sale by us to Lincoln Park, including our prior
issuances and sales of shares of common stock to Lincoln Park since January
2018, up to 40,000 shares of common stock. In accordance with the terms of the
Purchase Agreement, at the time we signed the Purchase Agreement and the RRA, we
issued 574 shares to Lincoln Park as consideration for its commitment to
purchase shares of our common stock under the purchase agreement and recorded
$627 thousand in deferred offering costs of which the full amount was
capitalized into additional paid-in capital as of December 31, 2018. In May
2019, we terminated the Purchase Agreement with Lincoln Park.
Facility Changes
In May 2018, we assigned the Cambridge Lease to a third party, who assumed from
us all of our remaining rights and obligations under the lease. Concurrently
with the lease assignment, we entered into a sublease for 5,104 square feet of
the space, originally part of the Cambridge Lease, from the third party to which
we assigned the lease. The sublease ends on October 31, 2023 and contains rent
holidays and rent escalation clauses. In order to obtain the consent of our
lender for these facility changes and the sale of certain assets, we repaid $300
thousand of principal on our loan and recorded an impairment charge of $48
thousand. On January 1, 2019 we adopted ASU No. 2016-02, Leases (Topic 842). The
adoption of this standard resulted in the recognition of operating lease
liabilities and right-of-use assets of $1.5 million and $1.5 million,
respectively, on our consolidated balance sheet. For more information, see Notes
1 and 5 to the notes to our unaudited Consolidated Financial Statements in Item
1 of this report.
Cashflows
Net cash used in operating activities for the six months ended June 30, 2020 was
$5.7 million, as compared to net cash used in operating activities of $6.7
million for the six months ended June 30, 2019. The change in net cash used in
operating activities for the six months ended June 30, 2020, as compared to the
same period in the prior year was primarily due to a decrease in our net loss of
$1.2 million, an increase in the change in accrued expenses and other
liabilities of $15 thousand, an increase in the change in operating lease
liability of $134 thousand, an increase in the change in accounts payable of
$394 thousand and a decrease in the change in prepaid expenses and other assets
of $365 thousand. In addition to the above operating activity, there was a net
decrease in the change in non-cash activity of $22 thousand.
Net cash used in investing activities for the six months ended June 30, 2020 was
$23 thousand related to the purchase of computer equipment. The Company did not
generate or use cash in investing activities during the six months ended
June 30, 2019.
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Net cash generated by financing activities for the six months ended
June 30, 2020, was $8.9 million consisting of $8.6 million in proceeds from the
issuance of common stock associated with the Offerings in 2020 and $343 thousand
in proceeds from the exercise of warrants. This compares to net cash used by
financing activities of $99 thousand for the six months ended June 30, 2019
consisting primarily $100 thousand in loan repayments and offset by employee
stock purchase plan issuances of $1 thousand.
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.
Contractual Obligations
As of June 30, 2020, there were no material changes to our contractual
obligations and commitments described under Management's Discussion and Analysis
of Financial Condition and Results of Operations in the 2019 Annual Report.
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INVIVO THERAPEUTICS HOLDINGS CORP. 
