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xbrli:pure utr:sqft
UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For the
quarterly period ended
September 30, 2021
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:
001-15911
CELSION CORPORATION
(Exact name
of Registrant as specified in its charter)
Delaware |
|
52-1256615 |
(State or
other jurisdiction of
incorporation or
organization)
|
|
(I.R.S.
Employer
Identification
Number)
|
997 Lenox Drive,
Suite 100,
Lawrenceville,
NJ
08648
(Address of
principal executive offices)
(609)
896-9100
(Registrant’s telephone
number, including area code)
NA
(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 |
Common stock, par value $0.01 per share |
|
CLSN |
|
Nasdaq Capital Market |
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.
Yes ☒ No ☐
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).
Yes ☒ No ☐
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 (Check One):
|
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
|
Non-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 Exchange Act). Yes ☐
No ☒
As of
November 12, 2021, the Registrant had
86,557,736 shares of common stock, $0.01 par value per
share, outstanding.
CELSION
CORPORATION
QUARTERLY
REPORT ON
FORM
10-Q
TABLE OF
CONTENTS
Cautionary Note
Regarding Forward-Looking Statements
This report
includes “forward-looking statements” within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). All statements other than statements
of historical fact are “forward-looking statements” for purposes of
this Quarterly Report on Form 10-Q, including, without limitation,
any projections of earnings, revenue or other financial items, any
statements of the plans and objectives of management for future
operations (including, but not limited to, pre-clinical
development, clinical trials, manufacturing and commercialization),
uncertainties and assumptions regarding the impact of the COVID-19
pandemic on our business, operations, clinical trials, supply
chain, strategy, goals and anticipated timelines, any statements
concerning proposed drug candidates, potential therapeutic
benefits, or other new products or services, any statements
regarding future economic conditions or performance, any changes in
the course of research and development activities and in clinical
trials, any possible changes in cost and timing of development and
testing, capital structure, financial condition, working capital
needs and other financial items, and any statements of assumptions
underlying any of the foregoing. In some cases, forward-looking
statements can be identified by the use of terminology such as
“may,” “will,” “expects,” “plans,” “anticipates,” “estimates,”
“potential” or “continue,” or the negative thereof or other
comparable terminology. Although we believe that our expectations
are based on reasonable assumptions within the bounds of our
knowledge of our industry, business, and operations, we cannot
guarantee that actual results will not differ materially from our
expectations.
Our future
financial condition and results of operations, as well as any
forward-looking statements, are subject to inherent risks and
uncertainties, including, but not limited to, the inherent
uncertainty in the drug development process, our ability to raise
additional capital to fund our planned future operations, our
ability to obtain or maintain FDA and foreign regulatory approvals
for our drug candidates, potential impact of the outbreak, duration
and severity of the COVID-19 pandemic on our business, our ability
to enroll patients in our clinical trials, risks relating to third
parties conduct of our clinical trials, risks relating to
government, private health insurers and other third-party payers
coverage or reimbursement, risks relating to commercial potential
of a drug candidate in development, changes in technologies for the
treatment of cancer, impact of development of competitive drug
candidates by others, risks relating to intellectual property,
volatility in the market price of our common stock, potential
inability to maintain compliance with The Nasdaq Marketplace Rules
and the impact of adverse capital and credit market conditions.
These and other risks, assumptions are described in Item 1A. Risk
Factors in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in other documents that we file or furnish
with the SEC. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those indicated or
anticipated by such forward-looking statements. All forward-looking
statements speak only as of the date they are made and we do not
intend to update any forward-looking statements, except as required
by law or applicable regulations. We operate in a highly
competitive, highly regulated, and rapidly changing environment and
our business is in a state of evolution. Therefore, it is likely
that new risks will emerge, and that the nature and elements of
existing risks will change, over time. It is not possible for
management to predict all such risk factors or changes therein, or
to assess either the impact of all such risk factors on our
business or the extent to which any individual risk factor,
combination of factors, or new or altered factors, may cause
results to differ materially from those contained in any
forward-looking statement.
Except where
the context otherwise requires, in this Quarterly Report on Form
10-Q, the “Company,” “Celsion,” “we,” “us,” and “our” refer to
Celsion Corporation, a Delaware corporation and its wholly owned
subsidiary CLSN Laboratories, Inc., also a Delaware
corporation.
Trademarks
The Celsion
brand and product names, including but not limited to
Celsion® and ThermoDox® contained in this
document are trademarks, registered trademarks or service marks of
Celsion Corporation or its subsidiary in the United States (“U.S.”)
and certain other countries. This document also contains references
to trademarks and service marks of other companies that are the
property of their respective owners.
PART I: FINANCIAL
INFORMATION
Item 1. FINANCIAL
STATEMENTS
CELSION
CORPORATION
CONDENSED
CONSOLIDATED
BALANCE
SHEETS
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
BALANCE
SHEETS
(Continued)
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
|
|
|
(Unaudited) |
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable – trade |
|
$ |
2,615,992 |
|
|
$ |
2,244,847 |
|
Other
accrued liabilities |
|
|
2,824,788 |
|
|
|
2,458,532 |
|
Notes
payable – current portion, net of deferred financing
costs |
|
|
– |
|
|
|
1,116,663 |
|
Operating
lease liability - current portion |
|
|
534,256 |
|
|
|
433,413 |
|
Deferred
revenue - current portion |
|
|
500,000 |
|
|
|
500,000 |
|
Total
current liabilities |
|
|
6,475,036 |
|
|
|
6,753,455 |
|
|
|
|
|
|
|
|
|
|
Earn-out
milestone liability |
|
|
7,345,000 |
|
|
|
7,018,000 |
|
Notes
payable – non-current portion, net of deferred financing
costs |
|
|
5,808,774 |
|
|
|
3,934,497 |
|
Operating
lease liability - non-current portion |
|
|
373,526 |
|
|
|
710,305 |
|
Deferred
revenue - non-current portion |
|
|
125,000 |
|
|
|
500,000 |
|
Total
liabilities |
|
|
20,127,336 |
|
|
|
18,916,257 |
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies |
|
|
– |
|
|
|
– |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
Stock - $0.01 par value
(100,000
shares authorized, and no
shares issued or outstanding at September 30, 2021 and December 31,
2020) |
|
|
– |
|
|
|
– |
|
Common stock
- $0.01 par value
(112,500,000
shares authorized; 86,558,070 and 40,701,356 shares issued
at September 30, 2021 and December 31, 2020, respectively, and
86,557,736 and
40,701,022 shares
outstanding at September 30, 2021 and December 31, 2020,
respectively) |
|
|
865,581 |
|
|
|
407,014 |
|
Additional
paid-in capital |
|
|
387,106,934 |
|
|
|
330,289,596 |
|
Accumulated
other comprehensive loss |
|
|
2,139 |
|
|
|
– |
|
Accumulated
deficit |
|
|
(328,548,285 |
) |
|
|
(312,000,341 |
) |
Total
stockholders’ equity before treasury stock |
|
|
59,426,369 |
|
|
|
18,696,269 |
|
|
|
|
|
|
|
|
|
|
Treasury
stock, at cost (334 shares at
September 30, 2021 and December 31, 2020) |
|
|
(85,188 |
) |
|
|
(85,188 |
) |
Total
stockholders’ equity |
|
|
59,341,181 |
|
|
|
18,611,081 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
79,468,517 |
|
|
$ |
37,527,338 |
|
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF
OPERATIONS
(Unaudited)
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF
COMPREHENSIVE LOSS
(Unaudited)
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF CASH
FLOWS
(Unaudited)
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF CASH
FLOWS (continued)
(Unaudited)
|
|
Nine
Months Ended
September
30,
|
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information: |
|
|
|
|
|
|
|
|
Interest
paid |
|
$ |
(307,985 |
) |
|
$ |
(685,913 |
) |
|
|
|
|
|
|
|
|
|
Cash paid
for amounts included in measurement of lease
liabilities: |
|
|
|
|
|
|
|
|
Operating
cash flows from lease payments |
|
$ |
418,696 |
|
|
$ |
393,947 |
|
|
|
|
|
|
|
|
|
|
Common stock
issued to settle accrued bonuses |
|
$ |
– |
|
|
$ |
498,632 |
|
|
|
|
|
|
|
|
|
|
Fair value
of warrants issued in connection with debt facility, net of
cancelled warrants |
|
$ |
– |
|
|
$ |
81,102 |
|
|
|
|
|
|
|
|
|
|
Realized and
unrealized gains (losses), net, on investment
securities |
|
$ |
2,139 |
|
|
$ |
(42,778 |
) |
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF CHANGES
IN STOCKHOLDERS’ EQUITY
(Unaudited)
THREE
MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
Three Months
Ended |
|
Common
Stock
Outstanding
|
|
|
Additional
Paid
in
|
|
|
Treasury
Stock |
|
|
Accumulated
Other Comprehensive |
|
|
Accumulated |
|
|
|
|
September 30,
2020 |
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
July 1, 2020 |
|
|
33,229,380 |
|
|
$ |
332,297 |
|
|
$ |
324,869,780 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
7,866 |
|
|
$ |
(300,916,593 |
) |
|
$ |
24,208,162 |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(8,071,596 |
) |
|
|
(8,071,596 |
) |
Sale of
equity through equity financing facilities |
|
|
2,927,400 |
|
|
|
29,274 |
|
|
|
2,038,553 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,067,827 |
|
Common stock
warrants issued in exchange for services |
|
|
- |
|
|
|
- |
|
|
|
44,798 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
44,798 |
|
Issuance of
restricted stock |
|
|
3,000 |
|
|
|
30 |
|
|
|
(30 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Realized and
unrealized gains and losses, net, on investments
securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(7,866 |
) |
|
|
- |
|
|
|
(7,866 |
) |
Stock-based
compensation expense |
|
|
- |
|
|
|
- |
|
|
|
417,476 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
417,476 |
|
Balance at
September 30, 2020 |
|
|
36,159,780 |
|
|
$ |
361,601 |
|
|
$ |
327,370,577 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
- |
|
|
$ |
(308,988,189 |
) |
|
$ |
18,658,801 |
|
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
CONDENSED
CONSOLIDATED
STATEMENTS OF CHANGES
IN STOCKHOLDERS’ EQUITY (continued)
(Unaudited)
NINE
MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
Nine Months
Ended |
|
Common
Stock
Outstanding
|
|
|
Additional
Paid
in
|
|
|
Treasury
Stock |
|
|
Accumulated
Other Comprehensive |
|
|
Accumulated |
|
|
|
|
September 30,
2021 |
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
January 1, 2021 |
|
|
40,701,022 |
|
|
$ |
407,014 |
|
|
$ |
330,289,596 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
- |
|
|
$ |
(312,000,341 |
) |
|
$ |
18,611,081 |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(16,547,944 |
) |
|
|
(16,547,944 |
) |
Sale of
equity through equity financing facilities |
|
|
44,632,547 |
|
|
|
446,326 |
|
|
|
52,242,619 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
52,688,945 |
|
Shares issued
upon exercise of common stock warrants, net of fees |
|
|
1,216,667 |
|
|
|
12,166 |
|
|
|
1,496,500 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,508,666 |
|
Shares issued
upon exercise of options to purchase common stock |
|
|
7,500 |
|
|
|
75 |
|
|
|
4,650 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,725 |
|
Realized and
unrealized gains and losses, net, on investments
securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,139 |
|
|
|
- |
|
|
|
2,139 |
|
Stock-based
compensation expense |
|
|
- |
|
|
|
- |
|
|
|
3,073,569 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,073,569 |
|
Balance at
September 30, 2021 |
|
|
86,557,736 |
|
|
$ |
865,581 |
|
|
$ |
387,106,934 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
2,139 |
|
|
$ |
(328,548,285 |
) |
|
$ |
59,341,181 |
|
Nine Months
Ended |
|
Common
Stock
Outstanding
|
|
|
Additional
Paid
in
|
|
|
Treasury
Stock |
|
|
Accumulated
Other Comprehensive |
|
|
Accumulated |
|
|
|
|
September 30,
2020 |
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
January 1, 2020 |
|
|
23,255,818 |
|
|
$ |
232,562 |
|
|
$ |
304,885,663 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
42,778 |
|
|
$ |
(290,516,780 |
) |
|
$ |
14,559,035 |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(18,471,409 |
) |
|
|
(18,471,409 |
) |
Sale of
equity through equity financing facilities |
|
|
12,330,243 |
|
|
|
123,301 |
|
|
|
20,127,125 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
20,250,426 |
|
Issuance of
common stock upon exercise of options |
|
|
140,864 |
|
|
|
1,409 |
|
|
|
370,486 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
371,895 |
|
Common stock
warrants issued in exchange for services |
|
|
- |
|
|
|
- |
|
|
|
44,798 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
44,798 |
|
Issuance of
restricted stock |
|
|
3,000 |
|
|
|
30 |
|
|
|
(30 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Realized and
unrealized gains and losses, net, on investments
securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(42,778 |
) |
|
|
- |
|
|
|
(42,778 |
) |
Stock-based
compensation expense |
|
|
- |
|
|
|
- |
|
|
|
1,448,202 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,448,202 |
|
Common stock
issued to settle accrued bonuses |
|
|
429,855 |
|
|
|
4,299 |
|
|
|
494,333 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
498,632 |
|
Balance at
September 30, 2020 |
|
|
36,159,780 |
|
|
$ |
361,601 |
|
|
$ |
327,370,577 |
|
|
|
334 |
|
|
$ |
(85,188 |
) |
|
$ |
- |
|
|
$ |
(308,988,189 |
) |
|
$ |
18,658,801 |
|
See
accompanying notes to the condensed consolidated financial
statements.
CELSION CORPORATION
NOTES TO
THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS
(UNAUDITED)
FOR THE
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021 AND
2020
Note 1.
Business
Description
Celsion
Corporation (“Celsion” and the “Company”) is a fully integrated,
clinical stage biotechnology company focused on advancing a
portfolio of innovative treatments including DNA-based
immunotherapies, next generation vaccines and directed
chemotherapies through clinical trials and eventual
commercialization. The Company’s product pipeline includes GEN-1, a
DNA-based immunotherapy for the localized treatment of ovarian
cancer and ThermoDox®, a proprietary heat-activated
liposomal encapsulation of doxorubicin, currently under
investigator-sponsored development for several cancer indications.
Celsion has two feasibility stage platform technologies for the
development of novel nucleic acid-based immunotherapies and next
generation vaccines and other anti-cancer DNA or RNA therapies.
Both are novel synthetic, non-viral vectors with demonstrated
capability in nucleic acid cellular transfection.
Note 2.
Basis of
Presentation
The
accompanying unaudited condensed consolidated financial statements,
which include the accounts of the Company and its wholly owned
subsidiaries, CLSN Laboratories, Inc. and Celsion, GmbH, have been
prepared in accordance with generally accepted accounting
principles in the United States (GAAP) for interim financial
information and with the instructions to Form 10-Q and Article 10
of Regulation S-X. All significant intercompany balances and
transactions have been eliminated in consolidation. Certain
information and disclosures normally included in financial
statements prepared in accordance with GAAP have been condensed or
omitted pursuant to such rules and regulations.
In the
opinion of management, all adjustments, consisting only of normal
recurring accruals considered necessary for a fair presentation,
have been included in the accompanying unaudited condensed
consolidated financial statements. Operating results for the
three-month and nine-month periods ended September 30, 2021 and
2020 are not necessarily indicative of the results that may be
expected for any other interim period(s) or for any full year. For
further information, refer to the consolidated financial statements
and notes thereto included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2020 filed with the
Securities and Exchange Commission (SEC) on March 19,
2021.
The
preparation of financial statements in conformity with GAAP
requires management to make judgments, estimates, and assumptions
that affect the amount reported in the Company’s financial
statements and accompanying notes. Actual results could differ
materially from those estimates. Events and conditions arising
subsequent to the most recent balance sheet date have been
evaluated for their possible impact on the financial statements and
accompanying notes. The Company continues to monitor the impact of
the COVID-19 pandemic on its financial condition and results of
operations, along with the valuation of its long-term assets,
intangible assets, and goodwill. The effect of this matter could
potentially have an impact on the valuation of such assets in the
future. The COVID-19 pandemic is discussed in more detail in Note 3
to the financial statements.
Note 3.
Financial Condition
and Business Plan
Since
inception, the Company has incurred substantial operating losses,
principally from expenses associated with the Company’s research
and development programs, clinical trials conducted in connection
with the Company’s product candidates, and applications and
submissions to the U.S. Food and Drug Administration. The Company
has not generated significant revenue and has incurred significant
net losses in each year since our inception. As of September 30,
2021, the Company has incurred approximately $329 million of cumulative net
losses and had approximately $60.6
million in cash and cash equivalents, restricted cash, short-term
investments and interest receivable. We have substantial future
capital requirements to continue our research and development
activities and advance our product candidates through various
development stages. The Company believes these expenditures are
essential for the commercialization of its technologies.
The Company
expects its operating losses to continue for the foreseeable future
as it continues its product development efforts, and when it
undertakes marketing and sales activities. The Company’s ability to
achieve profitability is dependent upon its ability to obtain
governmental approvals, manufacture, and market and sell its
product candidates. There can be no assurance that the Company will
be able to commercialize its technology successfully or that
profitability will ever be achieved. The operating results of the
Company have fluctuated significantly in the past.
In January
2020, the WHO declared an outbreak of coronavirus, COVID-19, to be
a “Public Health Emergency of International Concern,” and the U.S.
Department of Health and Human Services declared a public health
emergency to aid the U.S. healthcare community in responding to
COVID-19. This virus has spread to over 100 countries, including
the U.S. Governments and businesses around the world have taken
unprecedented actions to mitigate the spread of COVID-19,
including, but not limited to, shelter-in-place orders,
quarantines, significant restrictions on travel, as well as
restrictions that prohibit many employees from going to work.
Uncertainty with respect to the economic impacts of the pandemic
has introduced significant volatility in the financial markets. The
Company did not observe significant impacts on its business or
results of operations during 2020 and into 2021 due to COVID-19.
While the extent to which COVID-19 impacts the Company’s future
results will depend on future developments, the pandemic and
associated economic impacts could result in a material impact to
the Company’s future financial condition, results of operations and
cash flows. The Company’s ability to raise additional capital may
be adversely impacted by potential worsening global economic
conditions and the recent disruptions to, and volatility in,
financial markets in the U.S. and worldwide resulting from the
ongoing COVID-19 pandemic. The disruptions caused by COVID-19 may
also disrupt the clinical trials process and enrolment of patients.
This may delay commercialization efforts. The Company continues to
monitor its operating activities in light of these events. The
specific impact, if any, is not readily determinable as of the date
of these financial statements.
The actual
amount of funds the Company will need to operate is subject to many
factors, some of which are beyond the Company’s control. These
factors include the following:
● |
the progress
of research activities; |
|
|
● |
the number
and scope of research programs; |
|
|
● |
the progress
of preclinical and clinical development activities; |
|
|
● |
the progress
of the development efforts of parties with whom the Company has
entered into research and development agreements; |
|
|
● |
the costs
associated with additional clinical trials of product
candidates; |
|
|
● |
the ability
to maintain current research and development licensing arrangements
and to establish new research and development and licensing
arrangements; |
|
|
● |
the ability
to achieve milestones under licensing arrangements; |
|
|
● |
the costs
involved in prosecuting and enforcing patent claims and other
intellectual property rights; and |
|
|
● |
the costs
and timing of regulatory approvals. |
On July 13,
2020, the Company announced that it has received a recommendation
from the independent Data Management Committee (“DMC”) to consider
stopping the global Phase III OPTIMA Study of ThermoDox®
in combination with RFA for the treatment of HCC, or primary liver
cancer. The recommendation was made following the second
pre-planned interim safety and efficacy analysis by the DMC on July
9, 2020. The DMC’s analysis found that the pre-specified boundary
for stopping the trial for futility of 0.900 was crossed with an
actual value of 0.903. The Company followed the advice of the DMC
and considered its options to either stop the study or continue to
follow patients after a thorough review of the data, and an
evaluation of the probability of success. On February 11, 2021, the
Company issued a letter to shareholders stating that the Company
was notifying all clinical sites to discontinue following patients
in the OPTIMA Study.
During 2020,
2019 and 2018, the Company submitted applications to sell a portion
of the Company’s State of New Jersey net operating losses as part
of the Technology Business Tax Certificate Program sponsored by The
New Jersey Economic Development Authority. Under the program,
emerging biotechnology companies with unused NOLs and unused
research and development credits are allowed to sell these benefits
to other New Jersey-based companies. In 2018 and 2019, the Company
sold cumulative NOL’s from 2011 to 2018 NOLs totaling $13
million receiving net proceeds of $12.2
million. In June 2020 and as updated in September 2020, the Company
filed an application with the New Jersey Economic Development
Authority to sell substantially all of its remaining State of New
Jersey net operating losses totaling $2.0
million available under the program. On February 12, 2021, the New
Jersey Economic Development Authority approved the full amount of
the Company’s application. In February of 2021, the Company entered
into an agreement to sell the net operating losses from the 2020
application and the Company received net proceeds of approximately
$1.85
million on May 10, 2021. During 2021, the New Jersey State
Legislature increased the maximum lifetime benefit per company from
$15
million to $20
million, which will allow the Company to participate in this
program in future years. On June 16, 2021, the Company filed
another application to sell approximately $1.6
million of net operating losses during 2021 and expects to receive
up to approximately $1.4
million under the current year program.
In June
2018, the Company entered into a Credit Agreement with Horizon
Technology Finance Corporation (“Horizon”) that provided $10 million in
capital (the “Horizon Credit Agreement”). The obligations under the
Horizon Credit Agreement are secured by a first-priority security
interest in substantially all assets of Celsion other than
intellectual property assets. Payments under the loan
agreement are interest only (calculated based on one-month LIBOR
plus 7.625%)
for the first 24 months through July 2020, followed by a 21-month
amortization period of principal and interest starting on August 1,
2020 and ending through the scheduled maturity date on April
1, 2023. On August 28, 2020, in connection with an Amendment to the
Horizon Credit Agreement, Celsion repaid $5 million of the
$10 million loan and
$0.2 million
in related end of term charges, and the remaining $5 million in
obligations were restructured. As more fully discussed in Note 11
to these condensed consolidated financial statements, in June 2021,
the Company entered into a $10
million loan facility with Silicon Valley Bank. The Company
immediately used $6
million from this facility to retire all outstanding indebtedness
with Horizon Technology Finance Corporation. The remaining
$4
million will be available to be drawn down up to 12 months after
closing and will be used for working capital and to fund the
advancement of the Company’s product pipelines. The funding is in
the form of money market secured indebtedness bearing interest at a
calculated WSJ Prime-based variable rate of 3.25%.
Payments under the loan agreement are interest only for the first
24 months after loan closing, followed by a 24-month amortization
period of principal and interest through the scheduled maturity
date.
As more
fully discussed in Note 12, during 2021 through the date of the
filing of this Quarterly Report on Form 10-Q, the Company has
raised approximately $6.9 million in
gross proceeds from the use of its JonesTrading Capital on
DemandTM financing facility, $35 million from a
registered direct financing completed in January 2021, $15 million from a
registered direct financing completed on April 5, 2021, and
$1.5 million from
warrant exercises. With $60.6
million in cash and cash equivalents, restricted cash, short-term
investments and interest receivable, the Company believes it has
sufficient capital resources to fund its operations through the end
of 2024.
The Company
has based its estimates on assumptions that may prove to be wrong.
The Company may need to obtain additional funds sooner or in
greater amounts than it currently anticipates. Potential sources of
financing include strategic relationships, public or private sales
of the Company’s shares or debt, the sale of the Company’s State of
New Jersey net operating losses and other sources. If the Company
raises funds by selling additional shares of common stock or other
securities convertible into common stock, the ownership interest of
existing stockholders may be diluted.
Note 4.
New Accounting
Pronouncements
From time to
time, new accounting pronouncements are issued by the Financial
Accounting Standards Board (FASB) and are adopted by us as of the
specified effective date. Unless otherwise discussed, we believe
that the impact of recently issued accounting pronouncements will
not have a material impact on the Company’s condensed consolidated
financial position, results of operations, and cash flows, or do
not apply to our operations.
In June
2016, the FASB issued ASU No. 2016-13, “Financial Instruments –
Credit Losses (Topic 326): Measurement of Credit Losses on
Financial Instruments”, which modifies the measurement of
expected credit losses on certain financial instruments. The
Company adopted ASU 2016-13 in the first quarter of 2021 utilizing
the modified retrospective transition method. Based on the
composition of the Company’s investment portfolio and current
market conditions, the adoption of ASU 2016-13 did not have a
material impact on its consolidated financial
statements.
In December
2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic
740). The standard simplifies the accounting for incomes taxes
by removing certain exceptions to the general principles in Topic
740 related to the approach for intra-period tax allocation and the
recognition of deferred tax liabilities for outside basis
differences. The standard also clarifies the accounting for
transactions that result in a step-up in the tax basis of goodwill.
The standard also improves consistent application of and simplifies
GAAP for other areas of Topic 740 by clarifying and amending
existing guidance. The amendment is effective for fiscal years, and
interim periods within those fiscal years, beginning after December
15, 2020. The Company adopted this standard during the first
quarter of 2021. The adoption of ASU 2019-12 did not have a
material impact on its consolidated financial
statements.
In
connection with the upcoming elimination of the London Inter-bank
Offered Rate, (“LIBOR”) and other reference interest rates, the
FASB issued ASU 2020-04, Reference Rate Reform (Topic 848)
Facilitation of the Effects of Reference Reform on Financial
Reporting. ASU 2020-04, which is available for contract
modifications and hedging relationship modifications entered into
or evaluated before December 31, 2022, provides certain practical
expedients related to simplifying the accounting for contract
modifications resulting from the change in terms from LIBOR to a
new required interest rate benchmark. The Company is currently
evaluating the effects of adopting this accounting standards
update.
In May 2021,
the FASB issued ASU 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 FASB Emerging Issues Task Force)”. This ASU is intended to
clarify and reduce diversity in an issuer’s accounting for
modifications or exchanges of freestanding equity-classified
written call options (for example, warrants) that remain equity
classified after modification or exchange. The guidance clarifies
whether an issuer should account for a modification or an exchange
of a freestanding equity-classified written call option that
remains equity classified after modification or exchange as (1) an
adjustment to equity and, if so, the related earnings per share
effects, if any, or (2) an expense and, if so, the manner and
pattern of recognition. The amendments in this ASU affect all
entities that issue freestanding written call options that are
classified in equity. The amendments do not apply to modifications
or exchanges of financial instruments that are within the scope of
another Topic and do not affect a holder’s accounting for
freestanding call options. The amendments in this ASU are effective
for all entities for fiscal years beginning after December 15,
2021, including interim periods within those fiscal years. An
entity should apply the amendments prospectively to modifications
or exchanges occurring on or after the effective date of the
amendments. Early adoption is permitted for all entities, including
adoption in an interim period. The Company is currently evaluating
the impact of adopting ASU 2021-04 on its consolidated financial
statements.
Note 5.
Restricted
Cash
As a
condition of the $10
million loan
facility with Silicon Valley Bank (“SVB”) entered into on June 18,
2021 as further discussed in Note 11,
the Company is required at all times to maintain on deposit with
SVB as cash collateral in a segregated money market bank account in
the name of the Company, unrestricted and unencumbered cash (other
than a lien in favor of SVB) in an amount of at least 100% of the
aggregate outstanding amount of the SVB loan facility. SVB may
restrict withdrawals or transfers by or on behalf of the Company
that would violate this requirement. The required reserve
totaled $6.0
million as
of September 30, 2021. This amount is presented in part as
restricted cash in other non-current assets on the accompanying
condensed consolidated balance sheets.
The
following table reconciles cash and cash equivalents and restricted
cash per the balance sheet to the condensed statements of cash
flows:
Schedule
of Cash and Cash Equivalents and Restricted Cash
|
|
September 30, 2021 |
|
|
September 30, 2020 |
|
Cash and cash
equivalents |
|
$ |
25,648,849 |
|
|
$ |
18,339,728 |
|
Money market
investments, restricted |
|
|
6,000,000 |
|
|
|
- |
|
Total |
|
$ |
31,648,849 |
|
|
$ |
18,339,728 |
|
Note 6.
Net Loss per Common
Share
Basic loss
per share is calculated based upon the net loss available to common
shareholders divided by the weighted average number of common
shares outstanding during the period. Diluted loss per share is
calculated after adjusting the denominator of the basic earnings
per share computation for the effects of all dilutive potential
common shares outstanding during the period. The dilutive effects
of preferred stock, options and warrants and their equivalents are
computed using the treasury stock method.
The total
number of shares of common stock issuable upon exercise of
warrants, stock option grants and equity awards were
9,250,354 and
8,507,041 shares for the three-month and nine-month periods
ended September 30, 2021 and 2020, respectively. Warrants with an
exercise price of $0.01
exercisable for
200,000 shares of common stock were considered issued in
calculating basic loss per share during the first nine-months of
2020. These warrants were exercised in October 2020. For the
three-month and nine-month periods ended September 30, 2021 and
2020, diluted loss per common share was the same as basic loss per
common share as the other warrants and equity awards that were
convertible into shares of the Company’s common stock were excluded
from the calculation of diluted loss per common share as their
effect would have been anti-dilutive. The Company did not pay any
dividends during the first nine months of 2021 or 2020.
Note 7.
Investment in Debt
Securities-Available for Sale
Investments
in debt securities available for sale with a fair value of
$28,864,364 as
of September 30, 2021, consisted of government backed debt
securities and commercial paper. These investments are valued at
estimated fair value, with unrealized gains and losses reported as
a separate component of stockholders’ equity in accumulated other
comprehensive loss. The Company only had investments in cash and
cash equivalents on December 31, 2020.
Investments
in debt securities available for sale are evaluated periodically to
determine whether a decline in their value is other than temporary.
The term “other than temporary” is not intended to indicate a
permanent decline in value. Rather, it means that the prospects for
near term recovery of value are not necessarily favorable, or that
there is a lack of evidence to support fair values equal to, or
greater than, the carrying value of the security. Management
reviews criteria such as the magnitude and duration of the decline,
as well as the reasons for the decline, to predict whether the loss
in value is other than temporary. Once a decline in value is
determined to be other than temporary, the value of the security is
reduced and a corresponding charge to earnings is
recognized.
A summary of
the cost, fair value and maturities of the Company’s short-term
investments is as follows:
Schedule
of Cost, Fair Value and Maturities of Short Term
Investments
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
|
|
Cost |
|
|
Fair
Value |
|
|
Cost |
|
|
Fair
Value |
|
Short-term
investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial
paper |
|
$ |
7,784,165 |
|
|
$ |
7,784,894 |
|
|
$ |
- |
|
|
|
- |
|
Government
backed debt securities |
|
|
21,078,059 |
|
|
|
21,079,470 |
|
|
|
- |
|
|
|
- |
|
Total |
|
$ |
28,862,224 |
|
|
$ |
28,864,364 |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
|
|
Cost |
|
|
Fair
Value |
|
|
Cost |
|
|
Fair
Value |
|
Short-term
investment maturities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Within 3
months |
|
$ |
11,998,304 |
|
|
$ |
11,999,400 |
|
|
$ |
- |
|
|
$ |
- |
|
Between 3-12
months |
|
|
16,863,920 |
|
|
|
16,864,964 |
|
|
|
- |
|
|
|
- |
|
Total |
|
$ |
28,862,224 |
|
|
$ |
28,864,364 |
|
|
$ |
- |
|
|
$ |
- |
|
The
following table shows the Company’s investment in debt securities
available for sale gross unrealized gains (losses) and fair value
by investment category and length of time that individual
securities have been in a continuous unrealized loss position at
September 30, 2021 and December 31, 2020. The Company has reviewed
individual securities to determine whether a decline in fair value
below the amortizable cost basis is other than
temporary.
Summary
of Investment Securities Gross Unrealized Gains
(Losses)
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
Available
for sale securities (all unrealized holding gains and losses are
less than 12 months at date of measurement) |
|
Fair
Value |
|
|
Unrealized
Holding
Gains
(Losses)
|
|
|
Fair
Value |
|
|
Unrealized
Holding
Gains
(Losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments
with unrealized gains |
|
$ |
21,029,520 |
|
|
$ |
3,055 |
|
|
$ |
- |
|
|
$ |
- |
|
Investments
with unrealized losses |
|
|
7,834,844 |
|
|
|
(916 |
) |
|
|
- |
|
|
|
- |
|
Total |
|
$ |
28,864,364 |
|
|
$ |
2,139 |
|
|
$ |
- |
|
|
$ |
- |
|
Investment
(loss) income, which includes net realized losses on sales of
available for sale securities and investment income interest and
dividends, is summarized as follows:
Summary
of Net Realized Losses on Sales of Available for Sale Securities
and Investment Income Interest and Dividends
|
|
2021 |
|
|
2020 |
|
|
|
Three
Months Ended
September
30,
|
|
|
|
2021 |
|
|
2020 |
|
Interest and dividends
accrued and paid |
|
$ |
6,288 |
|
|
$ |
2,857 |
|
Realized
(losses) gains |
|
|
(2,736 |
) |
|
|
7,257 |
|
Investment
income, net |
|
$ |
3,552 |
|
|
$ |
10,114 |
|
|
|
2021 |
|
|
2020 |
|
|
|
Nine
Months Ended
September
30,
|
|
|
|
2021 |
|
|
2020 |
|
Interest and dividends
accrued and paid |
|
$ |
10,135 |
|
|
$ |
66,029 |
|
Realized
(losses) gains |
|
|
(4,521 |
) |
|
|
53,354 |
|
Investment
income, net |
|
$ |
5,614 |
|
|
$ |
119,383 |
|
Note 8.
Fair Value
Measurements
FASB ASC
Section 820, Fair Value Measurements and Disclosures
establishes a three-level hierarchy for fair value measurements
which requires an entity to maximize the use of observable inputs
and minimize the use of unobservable inputs when measuring fair
value. The three levels of inputs that may be used to measure fair
value are as follows:
Level 1:
Quoted prices (unadjusted) or identical assets or liabilities in
active markets that the entity has the ability to access as of the
measurement date;
Level 2:
Significant other 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; and
Level 3:
Significant unobservable inputs that reflect a reporting entity’s
own assumptions that market participants would use in pricing an
asset or liability.
Cash and
cash equivalents, other current assets, accounts payable and other
accrued liabilities are reflected in the condensed consolidated
balance sheet at their approximate estimated fair values primarily
due to their short-term nature. The fair values of securities
available for sale is determined by relying on the securities’
relationship to other benchmark quoted securities and classified
its investments as Level 2 items in both 2021 and 2020. There were
no transfers of assets or liabilities between Level 1 and Level 2
and no transfers in or out of Level 3 during the nine-months ended
September 30, 2021 or during the year ended December 31, 2020. The
changes in Level 3 liabilities were the result of changes in the
fair value of the earn-out milestone liability included in earnings
and in-process R&D. The earnout milestone liability is valued
using a risk-adjusted assessment of the probability of payment of
each milestone, discounted to present value using an estimated time
to achieve the milestone (see Note 14).
Assets and
liabilities measured at fair value are summarized below:
Schedule
of Fair Value, Assets and Liabilities Measured on Recurring
Basis
|
|
Total Fair Value |
|
|
Quoted Prices in Active Markets for Identical Assets/Liabilities
(Level 1) |
|
|
Significant Other
Observable Inputs
(Level
2)
|
|
|
Significant
Unobservable Inputs
(Level
3)
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recurring items as of September 30, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment in debt securities - available for sale, at fair
value |
|
$ |
28,864,364 |
|
|
$ |
– |
|
|
$ |
28,864,364 |
|
|
$ |
– |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-recurring items as of September 30, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process R&D
(Note 9) |
|
$ |
13,366,234 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
13,366,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-recurring items as of December 31, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process R&D
(Note 9) |
|
$ |
13,366,234 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
13,366,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recurring items as of September 30, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earn-out milestone
liability (Note 14) |
|
$ |
7,345,000 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
7,345,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recurring items as of December 31, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earn-out milestone
liability (Note 14) |
|
$ |
7,018,000 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
7,018,000 |
|
Note 9.
Intangible
Assets
In June
2014, we completed the acquisition of substantially all of the
assets of EGEN, Inc., an Alabama corporation, which has changed its
company name to EGWU, Inc. after the closing of the acquisition
(“EGEN”). We acquired all of EGEN’s right, title and interest in
and to substantially all of the assets of EGEN, including cash and
cash equivalents, patents, trademarks and other intellectual
property rights, clinical data, certain contracts, licenses and
permits, equipment, furniture, office equipment, furnishings,
supplies and other tangible personal property. In addition, CLSN
Laboratories assumed certain specified liabilities of EGEN,
including the liabilities arising out of the acquired contracts and
other assets relating to periods after the closing date.
Acquired
In-process Research and Development
Acquired
in-process research and development (IPR&D) consists of EGEN’s
drug technology platforms: TheraPlas and TheraSilence. The fair
value of the IPR&D drug technology platforms was estimated to
be $24.2
million as of the acquisition date. As of the closing of the
acquisition, the IPR&D was considered indefinite lived
intangible assets and will not be amortized. IPR&D is reviewed
for impairment at least annually as of our third quarter ended
September 30, and whenever events or changes in circumstances
indicate that the carrying value of the assets might not be
recoverable. The Company’s IPR&D consisted of three core
elements, its RNA delivery system, its glioblastoma multiforme
cancer (GBM) product candidate and its ovarian cancer
indication.
The
Company’s ovarian cancer indication, with original value of
$13.3
million, has not been impaired since its acquisition. At September
30, 2021, the Company evaluated its IPR&D of the ovarian cancer
indication and concluded that it is not more likely than not that
the asset is impaired. As no other indicators of impairment existed
during the fourth quarter of 2020 or first nine months of 2021,
no
impairment charges were recorded during the three or nine-months
ended September 30, 2021 and 2020.
The
Company’s GBM candidate, with original value of $9.4 million, had cumulative
impairments through 2018 of $7 million, with remaining
carrying value of $2.4 million at December 31,
2019. On September 30, 2020, the Company evaluated its IPR&D
for the (GBM) product candidate and concluded that it is more
likely than not that the asset is further impaired. After this
assessment on September 30, 2020, the Company wrote off the
remaining $2.4 million of this asset,
thereby recognizing a non-cash charge of $2.4 million in the third quarter of
2020.
Covenants
Not to Compete
Pursuant to
the EGEN Purchase Agreement, EGEN provided certain covenants
(“Covenant Not To Compete”) to the Company whereby EGEN agreed,
during the period ending on the seventh anniversary of the closing
date of the acquisition on June 20, 2014, not to enter into any
business, directly or indirectly, which competes with the business
of the Company, nor will it contact, solicit or approach any of the
employees of the Company for purposes of offering employment. The
Covenant Not to Compete which was valued at approximately
$1.6 million
at the date of the EGEN acquisition has a definitive life and is
amortized on a straight-line basis over its life of 7 years.
The Company recognized the remaining carrying value of $113,660 as amortization
expense in the first half of 2021. The carrying value of the
Covenant Not to Compete was fully amortized as of June 30, 2021 and
had a carrying value of $113,660, net of
$1,477,554
accumulated amortization, as of December 31, 2020. The Company
recognized amortization expense of $56,830 and
170,487 in the three-month and nine-month periods ended
September 30, 2020.
Goodwill
The purchase
price exceeded the estimated fair value of the net assets acquired
by approximately $2.0 million which
was recorded as Goodwill. Goodwill represents the difference
between the total purchase price for the net assets purchased from
EGEN and the aggregate fair values of tangible and intangible
assets acquired, less liabilities assumed. Goodwill is reviewed for
impairment at least annually as of our third quarter ended
September 30 or sooner if we believe indicators of impairment
exist. As of September 30, 2021, we concluded that the Company’s
fair value exceeded its carrying value therefore “it is not more
likely than not” that the Goodwill was impaired.
Following is
a summary of the net fair value of the assets acquired in the EGEN
asset acquisition for the nine-month period ended September 30,
2021:
Schedule
of Fair Value of Assets Acquired
|
|
IPR&D |
|
|
Goodwill |
|
|
Covenant Not
To Compete |
|
For the nine-months ended September
30, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1,
2021, net |
|
$ |
13,366,234 |
|
|
$ |
1,976,101 |
|
|
$ |
113,660 |
|
Amortization |
|
|
- |
|
|
|
- |
|
|
|
(113,660 |
) |
Balance at
September 30, 2021, net |
|
$ |
13,366,234 |
|
|
$ |
1,976,101 |
|
|
$ |
- |
|
Note 10.
Accrued
Liabilities
Other
accrued liabilities at September 30, 2021 and December 31, 2020
include the following:
Schedule
of Accrued Liabilities
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
Amounts due to contract
research organizations and other contractual agreements |
|
$ |
1,276,317 |
|
|
$ |
636,000 |
|
Accrued payroll and related
benefits |
|
|
1,247,460 |
|
|
|
1,736,271 |
|
Accrued professional fees |
|
|
265,350 |
|
|
|
66,850 |
|
Accrued interest |
|
|
16,250 |
|
|
|
- |
|
Other |
|
|
19,411 |
|
|
|
19,411 |
|
Total |
|
$ |
2,824,788 |
|
|
$ |
2,458,532 |
|
Note 11.
Notes
Payable
The SVB
Loan Facility
On June 18,
2021, the Company entered into a $10
million loan facility (the “SVB Loan Facility”) with Silicon Valley
Bank (“SVB”). Celsion immediately used $6 million from the SVB
Loan Facility to retire all outstanding indebtedness with Horizon
Technology Finance Corporation as further discussed below.
Concurrently with this transaction, the Company used $6.0 million of other available funds
to establish a restricted cash account which serves as security for
the SVB Loan Facility. The remaining $4
million will be available to be drawn down up to 12 months after
closing and will be used for working capital and to fund the
advancement of the Company’s product pipeline, including GEN-1 for
the treatment of newly diagnosed advanced ovarian cancer, as well
as other strategic initiatives intended to broaden its product
pipeline.
The SVB Loan
Facility is in the form of money market secured indebtedness
bearing interest at a calculated WSJ Prime-based variable rate
(currently 3.25%).
A final payment equal to 3% of the total $10 million commitment
amount is due upon maturity or prepayment of the SVB Loan Facility.
There was no facility commitment fee and no stock or warrants were
issued to SVB. Payments under the loan
agreement are interest only for the first 24 months after loan
closing, followed by a 24-month amortization period of principal
and interest through the scheduled maturity date.
In
connection with the SVB Loan Facility, the Company incurred
financing fees and expenses totaling $243,370 which is recorded
and classified as debt discount and are being amortized as interest
expense using the effective interest method over the life of the
loan. Also, in connection with the SVB Loan Facility, the Company
is required to pay an end-of-term fee equal to 3.0% of the original
loan amount at time of maturity. Therefore, these amounts totaling
$300,000 are
being amortized as interest expense using the effective interest
method over the life of the loan. During the three-month and
nine-month periods ended September 30, 2021, the Company incurred
interest expense of $49,883 and $56,875, respectively, and
amortized $45,687
and $52,144,
respectively, as interest expense for debt discounts and
end-of-term fee in connection with the SVB Financing
Facility.
Following is
a schedule of future principal payments, net of unamortized debt
discounts and amortized end-of-term fee, due on the SVB Loan
Facility:
Schedule
of Future Principle Payments, Net of Unamortized Debt
Discounts
|
|
As
of
September
30,
|
|
2022 |
|
$ |
– |
|
2023 |
|
|
750,000 |
|
2024 |
|
|
3,000,000 |
|
2025 and
thereafter |
|
|
2,250,000 |
|
Subtotal of future
principal payments |
|
|
6,000,000 |
|
Unamortized debt
premium, net |
|
|
(191,226 |
) |
Total |
|
$ |
5,808,774 |
|
Horizon
Credit Agreement
On June 27,
2018, the Company entered into a loan agreement with Horizon
Technology Finance Corporation (“Horizon”) that provided $10
million in new capital (the “Horizon Credit Agreement”). The
Company drew down $10 million upon
closing of the Horizon Credit Agreement on June 27, 2018. On August
28, 2020, Horizon and the Company amended the Horizon Credit
Agreement (the “Amendment”) whereby Celsion repaid $5
million of the $10 million loan and $0.2
million in related end of term charges, and the remaining
$5
million in obligations were restructured as set forth
below.
Pursuant to
the Amendment, the remaining $5 million in
obligations of Celsion under the Horizon Credit Agreement was
secured by a first-priority security interest in substantially all
assets of Celsion other than intellectual property assets.
The obligations bore
interest at a rate calculated based an amount by which the
one-month LIBOR exceeds 2% plus 7.625%. In no event shall the
interest rate be less than 9.625%. Payments pursuant to the
Amendment were interest only for the first twelve (12) months after
August 1, 2020, followed by a 21-month amortization period of
principal and interest through the scheduled maturity date on April
1, 2023. In addition, the remaining $5
million in obligations was subject to an end of term fee equal, in
the aggregate, to $275,000, which amount
was payable upon the maturity of the obligations or upon the date
of final payment or default, as applicable. In connection with
the Amendment, Celsion agreed to a liquidity covenant which
provides that, at all times, Celsion shall maintain unrestricted
cash and/or cash equivalents on deposit in accounts over which the
applicable Lenders maintain an account control agreement in an
amount not less than $2.5 million. In addition, pursuant to the
Amendment, Celsion agreed to provide evidence to Horizon on or
before March 31, 2021, that it received aggregate cash proceeds of
not less than $5 million from the sale of equity, debt, its New
Jersey net operating losses, or a combination thereof, subsequent
to the date of the Amendment. The Company met this requirement
during the fourth quarter of 2020.
In
connection with the Horizon Credit Agreement, the Company incurred
financing fees and expenses totaling $175,000
which were recorded and classified as debt discount. In addition,
the Company paid loan origination fees of $ which were recorded and
classified as debt discount. These debt discount amounts totaling
$782,116 were
being amortized as interest expense using the effective interest
method over the life of the loan. Also, in connection with each of
the Horizon Credit Agreement, the Company was required to pay an
end of term charge equal to
4.0% of the original loan amount at time of maturity.
Therefore, those amounts totaling $400,000 were being
amortized as interest expense using the effective interest method
over the life of the loan.
As a fee in
connection with the Horizon Credit Agreement, Celsion issued
Horizon warrants exercisable for a total of
190,114 shares of Celsion’s common stock (the “Existing
Warrants”) at a per share exercise price of $2.63.
The Horizon Warrants were immediately exercisable for cash or by
net exercise from the date of grant and will expire after ten years
from the date of grant. The Company valued the Horizon Warrants
issued using the Black-Scholes option pricing model and recorded a
total of $507,116
as a direct deduction from the debt liability, consistent with the
presentation of debt discounts, and are being amortized as interest
expense using the effective interest method over the life of the
loan. Pursuant to the Amendment, one-half of the aggregate Existing
Warrants, exercisable for a total of 95,057 shares
of Celsion’s common stock, have been canceled, and, in connection
with the Amendment, Celsion issued Horizon new warrants exercisable
at a per share exercise price equal to $1.01
for a total of
247,525 shares of Celsion’s common stock (the “New Warrants”
and, together with the Existing Warrants, the “Warrants”). The
remaining 95,057 Existing Warrants issued
in connection with the Horizon Credit Agreement remain outstanding
at a per share exercise price of $2.63.
The New
Warrants were immediately exercisable for cash or by net exercise
from the date of grant and will expire after ten years from the
date of grant. The Horizon Credit Agreement contains customary
representations, warranties and affirmative and negative covenants
including, among other things, covenants that limit or restrict
Celsion’s ability to grant liens, incur indebtedness, make certain
restricted payments, merge, or consolidate and make dispositions of
assets.
The
Amendment was evaluated in accordance with FASB ASC 470-50,
Debt-Modifications and Extinguishments, for debt
modification and extinguishment accounting. We accounted for the
$5
million we repaid as a debt extinguishment thereby reducing the
principal obligations accordingly. Also, in connection with the $5
million repayment, we recognized as interest expense, approximately
$0.2
million of unamortized debt discount, deferred financing and end of
term fees related to the repaid obligation in August
2020.
We accounted
for the remaining $5 million of obligation
under the Amendment as a debt modification to the initial agreement
with respect to the minor changes in cash flows. Also, in
connection with the $5 million remaining obligations, we recorded
$5,000
of financing fees and the New Warrant fair value of $247,548
as additional debt discount on the $5 million remaining obligation.
Therefore, approximately $109,706
of unamortized debt discount will be amortized over the remaining
life of the new obligations. The $275,000 of end of term fees, net of
previously amortized end of term fees totaling $142,605
previously accrued on the original note associated with the $5
million remaining obligation, will be amortized as interest expense
over the remaining life of the new obligations.
No interest expense was recognized during the three months
ended September 31, 2021 as the amounts owed under the Horizon
Credit agreement were paid off in June 2021. During the nine-month
period ended September 30, 2021, the Company incurred $225,920
in interest expense and amortized $139,428 as
interest expense for debt discounts and end of term charges in
connection with the Horizon Credit Agreement. During the
three-month period ended September 30, 2020, the Company incurred
$198,738
in interest expense and amortized $251,993
as interest expense for debt discounts and end of term charges in
connection with the Initial Horizon Credit Agreement and Amendment.
During the nine-month period ended September 30, 2020, the Company
incurred $685,913
in interest expense and amortized $444,786
as interest expense for debt discounts and end of term charges in
connection with the Initial Horizon Credit Agreement and
Amendment.
On June 18,
2021, as a condition of entering into the SVB Loan Facility, the
Company paid the outstanding principal balance, an early
termination fee and the end of term charges in full satisfaction of
the Horizon Credit Agreement, as amended. Following is a schedule
of the amounts paid to Horizon on June 18, 2021.
Schedule
of Debt
|
|
|
|
|
Principal balance at June 18, 2021 |
|
$ |
5,000,000 |
|
Early termination fees |
|
|
150,000 |
|
End of term
charges |
|
|
275,000 |
|
Total |
|
$ |
5,425,000 |
|
During the
nine months ended September 30, 2021, the Company recorded a loss
of $234,419 on the
termination of the Horizon Credit Agreement, as amended, which
represented the early termination fee and the end of term fees, net
of previously amortized interest expense totaling $190,581
on the date of its payoff.
Note 12.
Stockholders’
Equity
In September
2018, the Company filed with the SEC a $75 million shelf
registration statement on Form S-3 (the 2018 Shelf Registration
Statement) that allows the Company to issue any combination of
common stock, preferred stock or warrants to purchase common stock
or preferred stock. This shelf registration was declared effective
on October 12, 2018 and was fully utilized by the end of January
2021.
On March 19,
2021, the Company filed with the SEC a new $100 million
shelf registration statement on Form S-3 (the “2021 Registration
Statement”) that allows the Company to issue any combination of
common stock, preferred stock or warrants to purchase common stock
or preferred stock. This shelf registration was declared effective
on March 30, 2021.
Capital on DemandTM Sales
Agreement
On December
4, 2018, the Company entered into the Capital on Demand Agreement
with JonesTrading, pursuant to which the Company may offer and
sell, from time to time, through JonesTrading shares of Common
Stock having an aggregate offering price of up to $16.0
million.
During 2020
through September 30, 2020, the Company sold and issued an
aggregate of 2.1
million shares under the Capital on Demand Agreement, receiving
approximately $4.3 million
in gross proceeds. During the first nine months of 2021, the
Company sold 7.2
million shares under the Capital on Demand Agreement, receiving
approximately $6.9 million
in gross proceeds under the Capital on Demand Agreement.
Registered Direct
Offering
On February
27, 2020, we entered into a Securities Purchase Agreement (the
“February 2020 Purchase Agreement”) with several institutional
investors, pursuant to which we agreed to issue and sell, in a
registered direct offering (the “February 2020 Offering”), an
aggregate of 4,571,428
shares of our common stock at an offering price of $1.05 per Share for
gross proceeds of approximately $4.8 million
before the deduction of the Placement Agent fees and offering
expenses. In a concurrent private placement (the “Private
Placement”), the Company issued to the investors that participated
in the February 2020 Offering, for no additional consideration,
warrants to purchase up to
2,971,428 shares of common stock (the “Original Warrants”).
The Original Warrants were initially exercisable six months
following their date of issue and were set to expire on the
five-year anniversary of such initial exercise date.
The Original Warrants had an exercise price of $1.15
per share subject to adjustment as provided therein. On March 12,
2020, the Company entered into private exchange agreements (the
“Exchange Agreements”) with holders of the Original Warrants.
Pursuant to the Exchange Agreements, in return for a higher
exercise price of $1.24
per share of common stock, the Company issued new warrants to the
Investors to purchase up to
3,200,000 shares of common stock (the “Exchange Warrants”)
in exchange for the Original Warrants. The Exchange Warrants, like
the Original Warrants, are initially exercisable six months
following their issuance (the “Initial Exercise Date”) and expire
on the
five-year anniversary of their Initial Exercise Date.
Other than having a higher exercise price, different issue date,
Initial Exercise Date and expiration date, the terms of the
Exchange Warrants are identical to those of the Original Warrants.
On July 31, 2020, the Company filed a Form S-3 Registration
Statement to register the shares of common stock issuable under the
Exchange Warrants; the Registration Statement was declared
effective by the SEC on August 13, 2020. No Exchange Warrants were
exercised during 2020. During 2021 through the date of this
Quarterly Report on Form 10-Q, the Company issued
1.2 million shares pursuant to investors exercising Exchange
Warrants, receiving approximately $1.5 million in
net proceeds.
Underwritten
Offering
On June 22,
2020, the Company entered into an underwriting agreement (the
“Underwriting Agreement”) with Oppenheimer & Co. Inc. (the
“Underwriter”), relating to the issuance and sale (the
“Underwritten Offering”) of 2,666,667
shares of the Company’s common stock. Pursuant to the terms of the
Underwriting Agreement, the Underwriter agreed to purchase the
shares at a price of $3.4875 per share. The Underwriter
offered the shares at a public offering price of $3.75 per share,
reflecting an underwriting discount equal to $0.2625,
or 7.0% of the public
offering price. The net proceeds to the Company from the
Underwritten Offering, after deducting the underwriting discount
and estimated offering expenses payable by the Company, were
approximately $9.1
million.
Pursuant to
the Underwriting Agreement, until December 31, 2020, the
Underwriter had a right of first refusal to act as sole
underwriter, initial purchaser, placement/selling agent, or
arranger, as the case may be, on any new financing for the Company
(excluding equipment lease financings, loans or grants from
governmental authorities or in connection with government programs
and financings relating to or sales of tax attributes) during such
period. The Underwriter had the sole right to determine whether or
not any other broker dealer could participate in any such offering
and the economic terms of any such participation.
January 2021 Registered Direct
Offering
On January
22, 2021, the Company entered into a Securities Purchase Agreement
(the “January 2021 Purchase Agreement”) with several institutional
investors, pursuant to which the Company agreed to issue and sell,
in a registered direct offering (the “January 2021 Offering”), an
aggregate of 25,925,925
shares of the Company’s common stock at an offering price of
$1.35 per share for gross proceeds of
approximately $35 million
before the deduction of the January 2021 Placement Agents (as
defined below) fee and offering expenses. The January 2021 Purchase
Agreement contains customary representations, warranties and
agreements by the Company and customary conditions to closing. The
closing of the January 2021 Offering occurred on January 26,
2021.
In connection with the
January 2021 Offering, the Company entered into a placement agent
agreement (the “January 2021 Placement Agent Agreement”) with
A.G.P./Alliance Global Partners (together with Brookline Capital
Markets, the “January 2021 Placement Agents”) pursuant to which the
Company agreed to pay the January 2021 Placement Agents a cash fee
equal to 7% of the aggregate gross proceeds raised from the sale of
the securities sold in the January 2021 Offering and reimburse the
January 2021 Placement Agents for certain of their expenses in an
amount not to exceed $82,500.
March 2021 Registered Direct
Offering
On March 31,
2021, the Company entered into a Securities Purchase Agreement (the
“March 2021 Purchase Agreement”) with several institutional
investors, pursuant to which the Company agreed to issue and sell,
in a registered direct offering (the “March 2021 Offering”), an
aggregate of 11,538,462
shares of the Company’s common stock, at an offering price of
$1.30 per share for gross proceeds of
approximately $15 million
before the deduction of the placement agents fee and offering
expenses. The shares were offered by the Company pursuant to the
2021 Registration Statement. The closing of the Offering occurred
on April 5, 2021.
In connection with the
March 2021 Offering, the Company entered into a placement agent
agreement (the “March 2021 Placement Agent Agreement”) with
A.G.P./Alliance Global Partners, as lead placement agent (“AGP,”
and together with JonesTrading Institutional Services LLC and
Brookline Capital Markets, a division of Arcadia Securities, LLC,
serving as co-placement agents, the “March 2021 Placement Agents”),
pursuant to which the Company agreed to pay the March 2021
Placement Agents an aggregate cash fee equal to 7% of the aggregate
gross proceeds raised from the sale of the securities sold in the
Offering and reimburse the Placement Agents for certain of their
expenses in an amount not to exceed $82,500.
Under the
March 2021 Purchase Agreement and March 2021 Placement Agent
Agreement, the Company and its subsidiaries were prohibited, for a
period of 90 days after the closing, from entering into any
agreement to issue or announcing any issuance or proposed issuance
of common stock or any other securities that are at any time
convertible into, or exercisable or exchangeable for, or otherwise
entitle the holder thereof to receive common stock without the
prior written consent of AGP or the investors participating in the
offering. For purposes of this offering, AGP and the investors from
the Company’s January 2021 Offering waived a similar 90-day
restriction in the placement agent agreement and purchase agreement
for that transaction.
LPC Purchase
Agreement
On September
8, 2020, the Company entered into a purchase agreement (the “LPC
Purchase Agreement”) and a Registration Rights Agreement (the
“Registration Rights Agreement”) with Lincoln Park Capital Fund,
LLC (“Lincoln Park”), pursuant to which, upon the terms and subject
to the conditions and limitations set forth therein, the Company
has the right to sell to Lincoln Park up to $26.0
million of shares of the Company’s common stock at the Company’s
discretion as described below (the “LPC Offering”). During 2020,
the Company sold and issued an aggregate of 3.3
million shares, including the 437,828
commitment shares, under the LPC Purchase Agreement, receiving
approximately $2.2 million
in gross proceeds. On January 21, 2021, the Company terminated the
LPC Purchase Agreement. The Company did not sell any shares under
the LPC Purchase Agreement in 2021.
Note 13.
Stock-Based
Compensation
The Company
has long-term compensation plans that permit the granting of
equity-based awards in the form of stock options, restricted stock,
restricted stock units, stock appreciation rights, other stock
awards, and performance awards.
At the 2018
Annual Stockholders Meeting of the Company held on May 15, 2018,
stockholders approved the Celsion Corporation 2018 Stock Incentive
Plan (the “2018 Plan”). The 2018 Plan, as adopted, permits the
granting of
2,700,000 shares of Celsion common stock as equity awards in
the form of incentive stock options, nonqualified stock options,
restricted stock, restricted stock units, stock appreciation
rights, other stock awards, performance awards, or in any
combination of the foregoing. At the 2019 Annual Stockholders
Meeting of the Company held on May 14, 2019, stockholders approved
an amendment to the 2018 Plan whereby the Company increased the
number of common stock shares available by
1,200,000 to a total of
3,900,000 under the 2018 Plan, as amended. Prior to the
adoption of the 2018 Plan, the Company had maintained the Celsion
Corporation 2007 Stock Incentive Plan (the “2007 Plan”). At the
2020 Annual Stockholders Meeting of the Company held on June 15,
2020, stockholders approved an amendment to the 2018 Plan, as
previously amended, whereby the Company increased the number of
shares of common stock available by
2,500,000 to a total of
6,400,000 under the 2018 Plan, as amended. At the 2021
Annual Stockholders Meeting of the Company held on June 10, 2020,
stockholders approved an amendment to the 2018 Plan, as previously
amended, whereby the Company increased the number of shares of
common stock available by
7,700,000 to a total of
14,100,000 under the 2018 Plan, as amended.
The Company
has issued stock awards to employees and directors in the form of
stock options and restricted stock. Options are
generally granted with strike prices equal to the fair market value
of a share of Celsion common stock on the date of grant. Incentive
stock options may be granted to purchase shares of common stock at
a price not less than 100% of the fair market value of the
underlying shares on the date of grant, provided that the exercise
price of any incentive stock option granted to an eligible employee
owning more than 10% of the outstanding stock of Celsion must be at
least 110% of such fair market value on the date of grant. Only
officers and key employees may receive incentive stock
options.
Option and
restricted stock awards vest upon terms determined by the
Compensation Committee of the Board of Directors and are subject to
accelerated vesting in the event of a change of control or certain
terminations of employment. The Company issues new shares to
satisfy its obligations from the exercise of options or the grant
of restricted stock awards.
On September
28, 2018, and again on February 19, 2019, the Compensation
Committee of the Board of Directors approved the grant of (i)
inducement stock options (the “Inducement Option Grants”) to
purchase a total of 164,004 and 140,004 shares of Celsion common
stock, respectively, and (ii) inducement restricted stock awards
(the “Inducement Stock Grants”) totaling 19,000 and 13,000 shares of Celsion common stock
to five new employees collectively. Each award has a grant date of
the date of grant. Each Inducement Option Grant has an exercise
price per share equal to $2.77
and $2.18
which represents the closing price of Celsion’s common stock as
reported by Nasdaq on September 28, 2018 and February 19, 2019,
respectively. Each Inducement Option Grant will vest over
three years, with one-third vesting on the one-year
anniversary of the employee’s first day of employment with the
Company and one-third vesting on the second and third anniversaries
thereafter, subject to the new employee’s continued service
relationship with the Company on each such date. Each Inducement
Option Grant has a ten-year term and is subject to the terms and
conditions of the applicable stock option agreement. Each of
Inducement Stock Grant vested on the one-year anniversary of the
employee’s first day of employment with the Company is subject to
the new employee’s continued service relationship with the Company
through such date and is subject to the terms and conditions of the
applicable restricted stock agreement.
As of
September 30, 2021, there were a total of 14,198,424
shares of Celsion common stock reserved for issuance under the 2018
Plan, which were comprised of 6,473,451
shares of Celsion common stock subject to equity awards previously
granted under the 2018 Plan and 2007 Plan and 7,724,973
shares of Celsion common stock available for future issuance under
the 2018 Plan. As of September 30, 2021, there were a total of
140,004
shares of Celsion common stock subject to outstanding inducement
awards.
A summary of
stock option awards and restricted stock grants for the nine-months
ended September 30, 2021 is presented below:
Summary
of Stock Option Awards and Restricted Stock
Grants
|
|
Stock Options |
|
|
Restricted Stock Awards |
|
|
Weighted
Average
|
|
|
|
Options
Outstanding
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Non-vested
Restricted
Stock
Outstanding
|
|
|
Weighted
Average
Grant
Date
Fair
Value
|
|
|
Contractual
Terms
of
Equity
Awards
(in
years)
|
|
Equity awards outstanding
at January 1, 2021 |
|
|
4,624,725 |
|
|
$ |
2.77 |
|
|
|
2,750 |
|
|
$ |
0.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity awards granted |
|
|
2,171,250 |
|
|
$ |
2.17 |
|
|
|
9,000 |
|
|
$ |
1.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity awards exercised or vested and
issued |
|
|
(7,500 |
) |
|
$ |
0.63 |
|
|
|
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity awards
forfeited, cancelled or expired |
|
|
(185,770 |
) |
|
$ |
2.59 |
|
|
|
(1,000 |
) |
|
$ |
2.22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity awards
outstanding at September 30, 2021 |
|
|
6,602,705 |
|
|
$ |
2.58 |
|
|
|
10,750 |
|
|
$ |
1.33 |
|
|
|
7.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate
intrinsic value of outstanding equity awards at September 30,
2021 |
|
$ |
2,538 |
|
|
|
|
|
|
$ |
12,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity awards
exercisable at September 30, 2021 |
|
|
4,291,685 |
|
|
$ |
2.73 |
|
|
|
|
|
|
|
|
|
|
|
7.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate
intrinsic value of equity awards exercisable at September 30,
2021 |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
compensation cost related to stock options and restricted stock
awards amounted to $700,624 and
$417,476 for
the three-month periods ended September 30, 2021 and 2020,
respectively. Of these amounts, $241,288 and
$164,035 was
charged to research and development during the three-month periods
ended September 30, 2021 and 2020, respectively, and $459,336 and
$253,441 was
charged to general and administrative expenses during the
three-month periods ended September 30, 2021 and 2020,
respectively.
Total
compensation cost related to stock options and restricted stock
awards amounted to $3,073,569
and $1,448,202
for the nine-month periods ended September 30, 2021 and 2020,
respectively. Of these amounts, $1,123,376
and $542,157 was
charged to research and development during the nine-month periods
ended September 30, 2021 and 2020, respectively, and $1,950,193
and $906,045 was
charged to general and administrative expenses during the
nine-month periods ended September 30, 2021 and 2020,
respectively.
As of
September 30, 2021, there was $2.4
million of total unrecognized compensation cost related to
non-vested stock-based compensation arrangements. That cost is
expected to be recognized over a weighted-average period of
1.0 years. The weighted average grant date fair values of
the stock options granted was $1.97
and $3.07
during the nine-month periods ended September 30, 2021 and 2020,
respectively.
The fair
values of stock options granted were estimated at the date of grant
using the Black-Scholes option pricing model. The Black-Scholes
model was originally developed for use in estimating the fair value
of traded options, which have different characteristics from
Celsion’s stock options. The model is also sensitive to changes in
assumptions, which can materially affect the fair value estimate.
The Company used the following assumptions for determining the fair
value of options granted under the Black-Scholes option pricing
model:
Schedule
of Assumptions Used to Determine Fair Value of Options
Granted
|
|
Nine
Months Ended
September 30, |
|
|
|
2021 |
|
|
2020 |
|
Risk-free interest
rate |
|
|
1.54 to
1.74 |
% |
|
|
0.66 to
1.33 |
% |
Expected volatility |
|
|
106.8 to
113.2 |
% |
|
|
100.4 to
104.8 |
% |
Expected life (in years) |
|
|
7.5 to
10.0 |
|
|
|
8.0
to
10.0 |
|
Expected dividend yield |
|
|
- |
% |
|
|
- |
% |
Expected
volatilities utilized in the model are based on historical
volatility of the Company’s stock price. The risk-free interest
rate is derived from values assigned to U.S. Treasury bonds with
terms that approximate the expected option lives in effect at the
time of grant.
Note 14.
Earn-Out Milestone
Liability
On March 28,
2019, the Company and EGWU, Inc. entered into an amendment to its
purchase agreement (“Amended Asset Purchase Agreement”), whereby
payment of the earnout milestone liability related to the Ovarian
Cancer Indication of $12.4 million had been
modified. The Company has the option to make the payment as
follows:
a) |
$7.0 million in cash
within 10 business days of achieving the milestone; or |
b) |
$12.4 million in cash,
common stock of the Company, or a combination of either, within one
year of achieving the milestone. |
As of
September 30, 2021, June 30, 2021, and December 31, 2020, the
Company calculated the fair value of the earn-out milestone
liability at $7.3
million, $7.1
million and $7.0
million, respectively, and recognized a non-cash charge of
$0.3
million and for each of the three-months and nine months ended
September 30, 2021. In assessing the
earnout milestone liability at September 30, 2021 and June 30,
2021, the Company determined the fair value of each of the two
payment options per the Amended Asset Purchase Agreement and
weighted them at 50% and 50% probability for the $7.0 million and
the $12.4 million payments, respectively.
As of
September 30, 2020, June 30, 2020 and December 31, 2019, the
Company calculated the fair value of the earn-out milestone
liability at $7.1
million, $6.0
million, and $5.7
million, respectively, and recognized a non-cash charge of
$1.1
and $1.4
million for the three-month and nine-month periods ended September
30, 2020, respectively. In assessing the
earnout milestone liability at September 30, 2020, the Company fair
valued each of the two payment options per the Amended Asset
Purchase Agreement and weighted them at 50% and 50% probability for
the $7.0 million and the $12.4 million payments, respectively, and
at June 30, 2020, the Company determined the fair value of each of
the two payment options per the Amended Asset Purchase Agreement
and weighted them at 80% and 20% probability for the $7.0 million
and the $12.4 million payments, respectively.
The
following is a summary of the changes in the earn-out milestone
liability for the nine-month period ended September 30,
2021:
Schedule
of Changes in Earn-out Milestone Liability
Balance at January 1, 2021 |
|
$ |
(7,018,000 |
) |
Non-cash loss
from the change in fair value |
|
|
(327,000 |
) |
Balance at September 30,
2021 |
|
$ |
(7,345,000 |
) |
The
following is a schedule of the Company’s risk-adjustment assessment
of each milestone:
Schedule
of Risk Adjustment Assessment
Date |
|
Risk-adjustment
Assessment
of
Achieving Each Milestone
|
|
|
Discount
Rate |
|
|
Estimated
Time
to
Achieve
|
|
|
|
|
|
|
|
|
|
September 30, 2021 |
|
|
80 |
% |
|
|
6.54% to
6.60 |
% |
|
0.29 to
1.29 years |
June 30, 2021 |
|
|
80 |
% |
|
|
9 |
% |
|
0.42 to
1.42
years |
December 31, 2020 |
|
|
80 |
% |
|
|
9 |
% |
|
0.54 to
1.54
years |
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
|
80 |
% |
|
|
9 |
% |
|
0.38 to
1.38
years |
June 30, 2020 |
|
|
80 |
% |
|
|
9 |
% |
|
0.54 to
1.54
years |
December 31, 2019 |
|
|
80 |
% |
|
|
9 |
% |
|
1.12 to
2.12 years |
Note 15.
Warrants
Following is
a summary of all warrant activity for the nine-months ended
September 30, 2021:
Warrants |
|
Number
of
Warrants
Issued
|
|
|
Weighted
Average
Exercise
Price
|
|
|
|
|
|
|
|
|
Warrants outstanding at
December 31, 2020 |
|
|
3,853,566 |
|
|
$ |
1.35 |
|
|
|
|
|
|
|
|
|
|
Warrants
exercised during the nine months ended September 30, 2021 (see Note
12) |
|
|
(1,216,667 |
) |
|
$ |
1.24 |
|
|
|
|
|
|
|
|
|
|
Warrants
outstanding at September 30, 2021 |
|
|
2,636,899 |
|
|
$ |
1.40 |
|
|
|
|
|
|
|
|
|
|
Aggregate
intrinsic value of outstanding warrants at September 30, 2021 |
|
$ |
159,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average remaining contractual
terms at September 30, 2021 |
|
|
4.1
years |
|
|
|
|
|
Note 16.
Leases
In 2011, the Company
executed a lease (the “Lease”) with Brandywine Operating
Partnership, L.P. (Brandywine), a Delaware limited partnership, for
a 10,870 square foot premises located in
Lawrenceville, New Jersey and relocated its offices to
Lawrenceville, New Jersey from Columbia, Maryland. The Lease
had an initial term of 66 months.
In late 2015, Lenox Drive Office Park LLC purchased the real estate
and office building and assumed the Lease. This Lease was set to
expire on April 30, 2017. In April 2017,
the Company and the landlord amended the Lease effective May 1,
2017. The 1st Lease Amendment extended the term of the
agreement for an additional 64 months, reduced the premises to
7,565 square feet, reduced the monthly rent and provided four
months free rent. The monthly rent ranged from approximately
$18,900 in the first year to
approximately $20,500 in the final year of the
1st Lease Amendment. Effective January 9, 2019, the
Company amended the current terms of the 1st Lease
Amendment to increase the size of the
premises by 2,285 square feet to 9,850 square feet and also
extended the lease term by one year to September 1, 2023.
The monthly rent ranges from approximately $25,035 in the first year to
approximately $27,088 in the final year of the
2nd Lease Amendment.
In connection with the
EGEN Asset Purchase Agreement in June 2014, the Company assumed the
existing lease with another landlord for an 11,500 square foot premises located in
Huntsville Alabama. In January 2018, the Company and the
Huntsville landlord entered into a new 60-month lease which reduced
the premises to 9,049 square feet with rent payments of
approximately $18,100 per month. On June 9, 2021
and, as amended on July 7, 2021, the Company and the Huntsville
landlord entered into a 22-month lease for an additional
2,197 square foot premises with rent payments of
approximately $5,500
per month.
We adopted
ASC Topic 842 on January 1, 2019 using the modified retrospective
transition method for all lease arrangements at the beginning of
the period of adoption. Results for reporting periods beginning
January 1, 2019 are presented under ASC 842, while prior period
amounts were not adjusted and continue to be reported in accordance
with our historic accounting under Topic 840, Leases. The standard
had a material impact on our Condensed Consolidated Balance Sheet
but had no impact on our condensed consolidated net earnings and
cash flows. The most significant impact of adopting ASC Topic 842
was the recognition of the right-of-use (ROU) asset and lease
liabilities for operating leases, which are presented in the
following three-line items on the Consolidated Condensed Balance
Sheet: (i) operating lease right-of-use asset; (ii) current
operating lease liabilities; and (iii) operating lease liabilities.
Therefore, on date of adoption of ASC Topic 842, the Company
recognized a ROU asset of $1.4 million,
operating lease liabilities, current and non-current collectively,
of $1.5 million and reduced
other liabilities by approximately $0.1 million. We elected the
package of practical expedients for leases that commenced before
the effective date of ASC Topic 842 whereby we elected to not
reassess the following: (i) whether any expired or existing
contracts contain leases; (ii) the lease classification for any
expired or existing leases; and (iii) initial direct costs for any
existing leases. In addition, we have lease agreements with lease
and non-lease components, and we have elected the practical
expedient for all underlying asset classes and account for them as
a single lease component. We have no finance leases. We determine
if an arrangement is a lease at inception. We have operating leases
for office space and research and development facilities. Neither
of our leases include options to renew, however, one contains an
option for early termination. We considered the option of early
termination in measurement of right-of-use assets and lease
liabilities and we determined it is not reasonably certain to be
terminated. In connection with the 2nd Lease Amendment
for the New Jersey office lease in January 2019, the Company
considered this as one modified lease and not as two separate
leases. Therefore, in January 2019, the Company determined this
lease was an operating lease and remeasured the ROU asset and lease
liability. Therefore, the Company increased the ROU asset and
operating lease liabilities by $0.4 million to
$1.8
million and $1.9 million,
respectively. In connection with the 2021 lease, as amended, the
Company determined this lease should be treated as a separate
contract. Therefore, during the third quarter of 2021, the Company
increased the ROU assets and operating lease liabilities by
$0.1
million.
Following is
a table of the lease payments and maturity of our operating lease
liabilities as of September 30, 2021:
Schedule
of Lease Payments and Maturity of Operating Lease
Liabilities
|
|
For
the
year
ending
September 30,
|
|
Remainder of 2021 |
|
$ |
149,573 |
|
2022 |
|
|
601,495 |
|
2023 |
|
|
238,609 |
|
2024 and
thereafter |
|
|
- |
|
Subtotal future lease payments |
|
|
989,677 |
|
Less
imputed interest |
|
|
(81,895 |
) |
Total lease
liabilities |
|
$ |
907,782 |
|
|
|
|
|
|
Weighted average remaining
life |
|
|
1.7
years |
|
|
|
|
|
|
Weighted average discount
rate |
|
|
8.28 |
% |
For the
three-month and nine-month periods ended September 30, 2021,
operating lease expense was $146,936 and $413,577, respectively and cash
paid for operating leases included in operating cash flows was
$149,115 and $418,696, respectively. For
the three-month and nine-month periods ended September 30, 2020,
operating lease expense was $130,595 and $391,785, respectively and cash
paid for operating leases included in operating cash flows was
$131,863 and $393,947,
respectively.
Note 17.
Technology Development
and Licensing Agreements
On May 7,
2012, the Company entered into a long-term commercial supply
agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for
the production of ThermoDox® in the China territory. In
accordance with the terms of the agreement, Hisun will be
responsible for providing all of the technical and regulatory
support services, including the costs of all technical transfer,
registration and bioequivalence studies, technical transfer costs,
Celsion consultative support costs and the purchase of any
necessary equipment and additional facility costs necessary to
support capacity requirements for the manufacture of
ThermoDox®. Celsion will repay Hisun for the aggregate
amount of these development costs and fees commencing on the
successful completion of three registration batches of
ThermoDox®. Hisun is