Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Par Value and Share Amounts)
March
31,
December
31,
2021
2020
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
164,214
$
77,068
Prepaid expenses and
other
8,951
10,921
Total
current assets
173,165
87,989
Property and equipment,
net
9,070
8,571
Right of use assets,
net
921
1,258
Security deposit
5
5
Restricted cash
240
240
Intangible asset
120
120
Total
assets
$
183,521
$
98,183
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
2,859
$
4,598
Accrued expenses and
other current liabilities
2,783
4,626
Lease liability, current
386
595
Total
current liabilities
6,028
9,819
Lease liability, net
of current
577
716
Total liabilities
6,605
10,535
Commitments (See Note
15)
Stockholders’
equity:
Preferred
stock, $0.001 par value; 5,000,000 shares authorized
Series
B Convertible Preferred stock, $0.001 par value; 5,313 shares designated as of March 31,
2021 and December 31, 2020 issued and outstanding - None
Series
A Convertible Preferred stock, $0.001 par value; 7,938 shares designated as of March 31,
2021 and December 31, 2020 issued and outstanding - None
—
—
Common
stock, $0.001 par value; 800,000,000 and 400,000,000 shares authorized as of March 31, 2021 and December 31, 2020, respectively;
323,917,731 and 206,008,683 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively, and 54,447 shares
to be issued as of December 31, 2020
324
206
Additional paid in capital
464,841
355,037
Accumulated deficit
(288,186
)
(267,533
)
Accumulated other comprehensive
loss
(63
)
(62
)
Total
stockholders’ equity
176,916
87,648
Total
liabilities and stockholders’ equity
$
183,521
$
98,183
See
the accompanying notes to the condensed consolidated financial statements
3
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Three
Months Ended March 31,
2021
2020
COSTS
AND EXPENSES:
Research
and development
$
15,327
$
4,676
General
and administrative
5,409
2,621
20,736
7,297
Operating
loss
(20,736
)
(7,297
)
Interest and other income, net
83
24
Net loss
(20,653
)
(7,273
)
Warrant deemed dividend
—
451
Preferred stock deemed
dividend
—
1,260
Net loss available to
common stockholders
$
(20,653
)
$
(8,984
)
Net loss per common
share, basic and diluted
$
(0.07
)
$
(0.37
)
Weighted average common
shares outstanding, basic and diluted
290,106,510
24,028,970
See
the accompanying notes to the condensed consolidated financial statements
4
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In Thousands)
(unaudited)
Three
Months Ended March 31,
2021
2020
Net loss
$
(20,653
)
$
(7,273
)
Other comprehensive
loss:
Foreign
currency translation loss
(1
)
(14
)
Total other comprehensive
loss
(1
)
(14
)
Comprehensive loss
$
(20,654
)
$
(7,287
)
See
the accompanying notes to the condensed consolidated financial statements
5
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
THREE
MONTHS ENDED MARCH 31, 2021 AND 2020
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
Accumulated
Series B
Convertible
Additional
Other
Preferred
stock
Common
stock
Paid
in
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Capital
Gain
(loss)
Deficit
Total
Balance,
December 31, 2020
—
$
—
206,008,683
$
206
$
355,037
$
(62
)
$
(267,533
)
$
87,648
Issuance
of common stock upon exercise of warrants in March 2021 ($0.57 per share)
—
—
3,400
—
2
—
—
2
Issuance
of common stock in January 2021 ($0.80 per share), net of transactional expenses of $3,096
—
—
50,000,000
50
36,854
—
—
36,904
Issuance
of common stock in February 2021 ($1.20 per share), net of transactional expenses of $5,002
—
—
58,333,334
58
64,939
—
—
64,997
Issuance
of common stock under at-the-market offering, net of transactional expenses of $230
—
—
9,517,867
10
6,769
—
—
6,779
Employee
stock purchase plan
—
—
54,447
—
28
—
—
28
Stock-based
compensation
—
—
—
—
1,212
—
—
1,212
Foreign
currency transaction gain
—
—
—
—
—
(1)
—
(1)
Net
loss
—
—
—
—
—
—
(20,653
)
(20,653
)
Balance,
March 31, 2021
—
$
—
323,917,731
$
324
$
464,841
$
(63
)
$
(288,186
)
$
176,916
See
the accompanying notes to the condensed consolidated financial statements
6
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
THREE MONTHS ENDED MARCH 31, 2021 AND 2020
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Accumulated
Series B
Convertible
Additional
Other
Preferred
stock
Common
stock
Paid
in
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Capital
Gain
(loss)
Deficit
Total
Balance,
December 31, 2019
—
$
—
8,531,504
$
9
$
226,524
$
(46
)
$
(217,070
)
$
9,417
Issuance
of common stock in exchange for exercise of warrants in February and March 2020 ($0.57 per share)
—
—
13,111,999
13
7,461
—
—
7,474
Deemed
dividend in connection with repricing of November 2019 warrants
—
—
—
—
451
—
—
451
Warrant
deemed dividend
—
—
—
—
(451
)
—
—
(451
)
Issuance
of Series B Convertible preferred stock and common stock warrants in February 2020 ($1,000.00 per share, net of transactional expenses
of $711)
5,313
—
—
—
4,602
—
—
4,602
Beneficial
conversion feature in connection with issuance of Series B Convertible preferred stock
—
—
—
—
1,260
—
—
1,260
Preferred
stock deemed dividend
—
—
—
—
(1,260
)
—
—
(1,260
)
Issuance
of common stock and common stock warrants in February 2020 ($0.57 per share, net of transactional expenses of $292)
—
—
3,837,000
4
1,891
—
—
1,895
Issuance
of common stock upon conversion of
Series B Convertible preferred stock
(5,313
)
—
9,321,053
9
(9
)
—
—
—
Issuance
of common stock in March 2020 ($1.10 per share, net of transactional expenses of $1,221)
—
—
14,550,000
14
14,770
—
—
14,784
Employee
stock purchase plan
—
—
1,578
—
2
—
—
2
Stock-based
compensation
—
—
—
—
360
—
—
360
Foreign
currency transaction gain
—
—
—
—
—
(14
)
—
(14
)
Net
loss
—
—
—
—
—
—
(7,273
)
(7,273
)
Balance,
March 31, 2020
—
$
—
49,353,134
$
49
$
255,601
$
(60
)
$
(224,343
)
$
31,247
See
the accompanying notes to the condensed consolidated financial statements
7
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(unaudited)
Three
Months Ended March 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
(20,653
)
$
(7,273
)
Adjustments to reconcile net loss to net cash used
in operating activities:
Depreciation and amortization
6
6
Stock-based compensation
1,212
360
Changes in operating assets and liabilities:
Prepaid expenses and other
1,971
(39
)
Accounts payable
(1,739
)
(1,662
)
Lease liabilities and ROU asset, net
(12
)
(2
)
Accrued expenses and other
current liabilities
(1,843
)
(716
)
Net
cash used in operating activities
(21,058
)
(9,326
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of
property and equipment
(505)
—
Net
cash used in investing activities
(505)
—
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the exercise of warrants
2
7,474
Proceeds from ESPP
28
2
Proceeds, net of expenses of $0 and $711, from the
sale of preferred stock
—
4,602
Proceeds, net of expenses
of $8,328 and $1,513, from sale of common stock and warrants
108,680
16,679
Net
cash provided by financing activities
108,710
28,757
Effect of currency rate
change on cash
(1
)
(15
)
Net increase in cash, cash equivalents and restricted
cash
87,146
19,416
Cash, cash equivalents
and restricted cash beginning of the period
77,308
11,349
Cash, cash equivalents
and restricted cash end of period
$
164,454
$
30,765
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Series B Convertible preferred stock deemed dividend
$
—
$
1,260
Warrants deemed dividend
$
—
$
451
See
the accompanying notes to the condensed consolidated financial statements
8
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
1 – BUSINESS
Tonix
Pharmaceuticals Holding Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a clinical-stage
biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent
human disease and alleviate suffering. All drug product candidates are still in development.
The
consolidated financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries,
Tonix Sub, Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner LLC, Tonix Pharma Holdings Limited and Tonix
Pharma Limited (collectively hereafter referred to as the “Company” or “Tonix”). All intercompany balances and
transactions have been eliminated in consolidation.
Going
Concern
The accompanying financial statements
have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of
assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from
operations and negative cash flows from operating activities. At March 31, 2021, the Company had working capital of approximately $167.1
million. At March 31, 2021, the Company had an accumulated deficit of approximately $288.2 million. The Company held unrestricted cash
and cash equivalents of approximately $164.2 million as of March 31, 2021.
The Company believes that its cash resources at March 31, 2021, and the
proceeds that it raised from equity offerings subsequent to the end of the first quarter of 2021 (See Note 11), will meet its operating
and capital expenditure requirements through March 31, 2022, but not beyond.
These factors raise substantial doubt about the Company’s ability
to continue as a going concern. The Company continues to face significant challenges and uncertainties and, as a result, its available
capital resources may be consumed more rapidly than currently expected due to changes it may make in its research and development spending
plans. The Company has the ability to obtain additional funding through public and private financing and collaborative arrangements with
strategic partners to increase the funds available to fund operations. However, the Company may not be able to raise capital with terms
acceptable to the Company. Without additional funds, it may be forced to delay, scale back or eliminate some of its research and development
activities, or other operations and potentially delay product development in an effort to provide sufficient funds to continue operations.
If any of these events occurs, our ability to achieve our development and commercialization goals would be adversely affected. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
NOTE
2 – SIGNIFICANT ACCOUNTING POLICIES
Interim
financial statements
The
unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and
Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation
have been included.
9
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
The
condensed consolidated balance sheet as of December 31, 2020 contained herein has been derived from audited financial statements.
Operating
results for the three months ended March 31, 2021 are not necessarily indicative of results that may be expected for the year ending
December 31, 2021. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K, filed with
the Securities and Exchange Commission (“SEC”) on March 15, 2021.
Risks
and uncertainties
The Company’s primary efforts are devoted to conducting research
and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced
net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.
Further, the Company does not have any commercial products available for sale and has not generated revenues, and there is no assurance
that if any of its product candidates are approved for sale, that the Company will be able to generate cash flow to fund operations. In
addition, there can be no assurance that the Company’s research and development will be successfully completed or that any product
candidate will be approved or commercially viable. Moreover, the extent to which COVID-19 impacts the Company’s operations will
depend on future developments, which are highly uncertain and cannot be predicted with confidence at this time.
In
December 2019, a novel strain of Coronavirus (“COVID-19”) emerged that has caused significant disruptions to the U.S. and
global economy. The spread of COVID-19 has led to regional quarantines, business shutdowns, labor shortages, disruptions to supply chains,
and overall economic instability. Any of these events may in the future have a material adverse effect on our business, operations and
financial condition. The extent to which COVID-19 impacts our operations will depend on future developments, which are highly uncertain
and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity
of COVID-19 and the actions taken to contain COVID-19 or treat its impact, among other things.
Use
of estimates
The
preparation of financial statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and
liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results
could differ from those estimates. Significant estimates include the assumptions used in the fair value of stock-based compensation and
other equity instruments, and the percent of completion of research and development contracts.
Cash, Cash Equivalents and Restricted Cash
The Company considers cash equivalents to be those investments which are
highly liquid, readily convertible to cash and have an original maturity of three months or less when purchased. At March 31, 2021 and
December 31, 2020, cash equivalents, which consisted of money market funds, amounted to $100.4 million and $40.4 million, respectively. Restricted
cash at both March 31, 2021 and December 31, 2020 of approximately $240,000 collateralizes a letter of credit issued in connection with
the lease of office space in Chatham, New Jersey and New York, New York (see Note 14).
The
following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance
sheets that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
March
31,
2021
December
31,
2020
(in thousands)
Cash and cash equivalents
$
164,214
$
77,068
Restricted cash
240
240
Total
$
164,454
$
77,308
10
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
Property
and equipment
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s
estimated useful life, which is 20 years for buildings, three years for computer assets, five years for furniture and all other equipment
and term of lease for leasehold improvements. Depreciation and amortization expense for both quarters ended March 31, 2021 and 2020
was $6,000. All property and equipment is located in the United States and Ireland.
Intangible
assets with indefinite lives
During
the year ended December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life.
Identifiable intangibles with indefinite lives are not amortized but are tested for impairment annually or whenever events or changes
in circumstances indicate that their carrying amount may be less than fair value. As of March 31, 2021, the Company believed that no
impairment existed.
Leases
The
Company determines if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use
(“ROU”) assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated
balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent
its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement
date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate,
the Company uses an incremental borrowing rate based on the information available at the transition date and subsequent lease commencement
dates in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized
basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives. The Company’s lease terms may
include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense
for lease payments made under operating leases is recognized on a straight-line basis over the lease term.
Research
and Development Costs
The
Company outsources certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing
products for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed
to patents and other intellectual property acquired has been expensed as research and development costs, as such property related to
particular research and development projects and had no alternative future uses.
The
Company estimates its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants
and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject
to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials
or services are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of
the trial. The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers
as to the progress or state of consummation of trials, or the services completed.
During
the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The
Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.
11
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
Stock-based
compensation
All stock-based payments to employees
and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock options, are measured
at fair value on the grant date and recognized in the consolidated statements of operations as compensation or other expense over the
requisite service period. The Company accounts for share-based awards in accordance with the provisions of the Accounting Standards Codification
(“ASC”) 718, Compensation – Stock Compensation.
Foreign
Currency Translation
Operations
of the Canadian subsidiary are conducted in local currency, which represents its functional currency. The U.S. dollar is the functional
currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary were translated from foreign currency
into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated at the average
rate of exchange prevailing during the period. Translation adjustments resulting from this process were included in accumulated
other comprehensive loss on the condensed consolidated balance sheets.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances
from non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
Income
Taxes
Deferred
income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at
the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more likely than
not that these deferred income tax assets will be realized.
The
Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained
on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the condensed consolidated
financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized
upon ultimate settlement. As of March 31, 2021, the Company has not recorded any unrecognized tax benefits. The Company’s policy
is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
12
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
Per
Share Data
The
computation of basic and diluted loss per share for the quarters ended March 31, 2021 and 2020 excludes potentially dilutive securities
when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock
during the period.
All warrants issued participate on a one-for-one basis with common stock
in the distribution of dividends, if and when declared by the Board of Directors, on the Company’s common stock. For purposes of
computing EPS, these warrants are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates
basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders
and participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated
to the warrants for the three months ended March 31, 2021 and March 31, 2020, as results of operations were a loss for the period.
Potentially
dilutive securities (See Note 12 and Note 13) excluded from the computation of basic and diluted net loss per share, as of March 31,
2021 and 2020, are as follows:
2021
2020
Warrants to purchase common stock
644,906
5,184,210
Options to purchase common
stock
22,983,353
665,536
Totals
23,628,259
5,849,746
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment, net consisted of the following (in thousands):
March 31
December
31
2021
2020
(in thousands)
Land
$
5,713
$
5,713
Construction in progress
3,290
2,800
Office furniture and equipment
400
385
Leasehold
improvements
23
23
9,426
8,921
Less:
Accumulated depreciation and amortization
(356
)
(350
)
$
9,070
$
8,571
On
September 28, 2020, the Company completed the purchase of its 40,000 square foot facility in Massachusetts for $4,000,000, to house its
new Advanced Development Center for accelerated development and manufacturing of vaccines. Of the total purchase price, $1.2 million was
allocated to the value of land acquired, and $2.8 million was allocated to construction in progress, as the building was not ready for
its intended use. As of March 31, 2021, the asset has not been placed in service.
On
December 23, 2020, the Company completed the purchase of its approximately 44-acre site in Hamilton, Montana for $4.4 million, for the
construction of a vaccine development and commercial scale manufacturing facility. As of March 31, 2021, the asset has not been placed
in service.
13
NOTE
4 – FAIR VALUE MEASUREMENTS
Fair
value measurements affect the Company’s accounting for certain of its financial assets. Fair value is defined as the price that
would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date and is measured according to a hierarchy that includes:
Level 1:
Observable
inputs, such as quoted prices in active markets.
Level 2:
Inputs, other
than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities include
debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category includes
U.S. government agency-backed debt securities and corporate-debt securities.
Level 3:
Unobservable
inputs in which there is little or no market data.
As
of March 31, 2021, and December 31, 2020, the Company used Level 1 quoted prices in active markets to value cash equivalents of $100.4
million and $40.4 million, respectively. The Company did not have any Level 2 or Level 3 assets or liabilities as of both March 31, 2021
and December 31, 2020.
14
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
5 – STOCKHOLDERS’ EQUITY
On March 26, 2021, the Company
filed an amendment to its articles of incorporation, as amended, to increase the number of shares of common stock authorized from 400,000,000
to 800,000,000.
On October 1, 2020, the Company
received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based
upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company no longer meets
the requirement to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum
Bid Price Requirement”). On March 3, 2021, the Company received a letter from Nasdaq stating that Company had regained compliance
with the Minimum Bid Price Requirement because the Company’s shares had a closing bid price at or above $1.00 per share for a minimum
of 20 consecutive business days.
NOTE
6 – ASSET PURCHASE AGREEMENT WITH KATANA
On
December 22, 2020, the Company entered into an asset purchase agreement (the “Katana Asset Purchase Agreement”) with Katana
Pharmaceuticals, Inc. (“Katana”) pursuant to which Tonix acquired Katana assets related to insulin resistance and related
syndromes, including obesity (the “Katana Assets”). In connection with the acquisition of the Katana Assets, Tonix assumed
Katana’s rights and obligations under that certain Exclusive License Agreement by and between Katana and The University of Geneva
(“Geneva”) (the “Geneva License “Agreement”) pursuant to an Assignment and Assumption Agreement with Geneva
(“Geneva Assignment and Assumption Agreement”), dated December 22, 2020. As consideration for entering into the Katana Asset
Purchase Agreement, Tonix paid $0.7 million to Katana. The costs associated with the cash payments were recorded to research and development
expenses in the statement of operations for the year ended December 31, 2020. Because the Katana intellectual property was acquired prior
to FDA approval, the cash consideration totaling $0.7 million, was expensed as research and development costs since there is no alternative
future use and the acquired intellectual property does not constitute a business.
Pursuant
to the terms of the Geneva Assignment and Assumption Agreement, Geneva has granted to Tonix an exclusive license, with the right to sublicense,
certain patents related to the Katana Assets. Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture,
and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for such
products. The Geneva License Agreement specifies developmental milestones and the period of time during which such milestones must be
completed and provides for an annual maintenance fee payable to Geneva.
As
of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
7 – ASSET PURCHASE AGREEMENT WITH TRIGEMINA
On
June 11, 2020, the Company entered into an asset purchase agreement (the “Trigemina Asset Purchase Agreement”) with Trigemina,
Inc. (“Trigemina”) and certain shareholders named therein (the “Executive Shareholders”) pursuant to which Tonix
acquired Trigemina assets related to migraine and pain treatment technologies (the “Trigemina Assets”). In connection with
the acquisition of the Trigemina Assets, Tonix assumed Trigemina’s rights and obligations under that certain Amended and Restated
Exclusive License Agreement, dated November 30, 2007, as amended, by and between Trigemina and The Board of Trustees of the Leland Stanford
Junior University (“Stanford”) (the “Stanford License “Agreement”) pursuant to an Assignment and Assumption
Agreement with Stanford (“Assignment and Assumption Agreement”), dated June 11, 2020. As consideration for entering into
the Asset Purchase Agreement, Tonix paid $824,759 to Trigemina and issued to Trigemina 2,000,000 shares of the Company’s common
stock, valued at $0.68 per share, based on the closing stock price on June 11, 2020, and paid Stanford $250,241 pursuant to the terms
of the Assignment and Assumption Agreement. The common stock is unregistered and subject to a 12-month lock-up and a Shareholder Voting
Agreement, dated June 11, 2020, pursuant to which Trigemina and the Executive Shareholders have agreed to vote the common stock on any
matter put to a vote of the shareholders of the Company in accordance with management’s recommendations. Both the costs associated
with the cash payments and share issuance, totaling $2.4 million, were recorded to research and development expenses in the statement
of operations for the year ended December 31, 2020. Because the Trigemina intellectual property was acquired prior to FDA approval, the
cash and stock consideration, was expensed as research and development costs since there is no alternative future use and the acquired
intellectual property does not constitute a business.
Pursuant
to the terms of the Assignment and Assumption Agreement, Stanford has granted to Tonix an exclusive license, with the right to sublicense,
certain patents related to the Trigemina Assets. Stanford has reserved for itself the right to practice under the patents
for academic research and educational purposes. Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture,
and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for such
products. The Trigemina License Agreement specifies developmental milestones and the period of time during which such milestones must
be completed and provides for an annual maintenance fee payable to Stanford.
15
As
of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
8 – ASSET PURCHASE AGREEMENT WITH TRIMARAN
On
August 19, 2019, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with TRImaran Pharma,
Inc. (“TRImaran”) and the selling shareholders named therein (the “Selling Shareholders”) pursuant to which Tonix
acquired TRImaran’s assets related to certain pyran-based compounds (the “Assets”). In connection with the acquisition
of the Assets, Tonix entered into a First Amended and Restated Exclusive License Agreement (the “WSU License Agreement”)
with Wayne State University (“WSU”) on August 19, 2019. As consideration for entering into the Asset Purchase Agreement,
Tonix paid $100,000 to TRImaran and has assumed certain liabilities of TRImaran totaling $68,500. Upon the achievement of specified development,
regulatory and sales milestones, Tonix also agreed to pay TRImaran and the Selling Shareholders, in restricted stock or cash, at Tonix’s
option, a total of approximately $3.4 million. Pursuant to the terms of the Asset Purchase Agreement, TRImaran and the Selling Shareholders
are prohibited from disclosing confidential information related to the Assets and are restricted from engaging, for a period of three
years, in the development or commercialization of any therapeutic containing any pyran-based drug compound for the treatment of post-traumatic
stress disorder, attention deficit hyperactivity disorder or major depressive disorder. Also for a period of three years, if TRImaran
or any Selling Shareholder engage in the research or development of any potential therapeutic compound for the treatment of any central
nervous system disorder, TRImaran or such Selling Shareholder is obliged to provide notice and opportunity to Tonix to make an offer
to acquire or license rights with respect to such product candidate.
Pursuant
to the terms of the WSU License Agreement, WSU has granted to Tonix an exclusive license, with the right to sublicense, certain patents,
technical information and material (collectively, the “Technology”) related to the Assets. WSU has reserved for itself the
right to practice the Technology for academic research and educational purposes. Tonix is obligated to use commercially reasonable efforts
to obtain regulatory approval for one or more products utilizing the Technology (“WSU Products”) and to use commercially
reasonable marketing efforts throughout the term of the WSU License Agreement. The WSU License Agreement specifies developmental milestones
and the period of time during which such milestones must be completed and provides for an annual maintenance fee payable to WSU. Tonix
is obligated to substantially manufacture WSU Products in the United States if WSU Products will be sold in the United States.
Pursuant
to the WSU License Agreement, Tonix has agreed to pay $75,000 to WSU as reimbursement of certain patent expenses, and, upon the achievement
of specified development, regulatory and sales milestones, the Company also agreed to pay WSU, milestone payments totaling approximately
$3.4 million. Tonix has also agreed to pay WSU single-digit royalties on net sales of WSU Products sold by Tonix or a sublicensee on
a tiered basis based on net sales, and additional sublicense fees on certain consideration received from sublicensees. Royalties on each
particular WSU Product are payable on a country-by-country and Product-by-Product basis until the date of expiration of the last valid
claim in the last to expire of the issued patents covered by the WSU License Agreement. Royalties payable on net sales of WSU Products
may be reduced by 50% of the royalties payable by Tonix to any third party for intellectual property rights which are necessary for the
practice of the rights licensed to Tonix under the WSU License Agreement, provided that the royalty payable on a WSU Product may not
be reduced by more than 50%. Each party also has the right to terminate the agreement for customary reasons such as material breach and
bankruptcy. The WSU License Agreement contains provisions relating to termination, indemnification, confidentiality and other customary
matters for an agreement of this kind.
As
of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
16
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
9 – LICENSE AGREEMENT WITH INSERM
On
February 11, 2021, the Company entered into a license agreement (the “Inserm License Agreement”) pursuant to
which it licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic
failure to thrive disease from Inserm (the French National Institute of Health and Medical Research), Aix-Marseille
Université and Centre Hospitalier Universitaire of Toulouse. The Inserm License Agreement provides for the payment of
annual fees and milestone payments upon the occurrence of specified sales milestones totaling approximately $0.4 million, as well
royalties on net sales of products based on the licensed technology, and assignment/transfer and sublicense
royalties.
As
of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
10 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
On
September 16, 2019, the Company entered into an exclusive License Agreement (the “Columbia License Agreement”) with the Trustees
of Columbia University in the City of New York (“Columbia”) pursuant to which Columbia granted to Tonix an exclusive license,
with the right to sublicense, certain patents and technical information (collectively, the “TFF2 Technology”) related to
a recombinant Trefoil Family Factor 2 (TFF2), and to develop and commercialize products thereunder (each, a “TFF2 Product”).
Pursuant to the terms of the Columbia License Agreement, Columbia reserved for itself the right to practice the TFF2 Technology for academic
research and educational purposes.
The
Company paid a five-digit license fee to Columbia as consideration for entering into the Columbia License Agreement, which was recorded
to research and development expenses in the statement of operations for the year ended December 31, 2019. The Company is obligated to
use Commercially Reasonable Efforts, as defined in the Columbia License Agreement, to develop and commercialize the TFF2 Product, and
to achieve specified developmental milestones.
The
Company agreed to pay Columbia single-digit royalties on net sales of (i) TFF2 Products sold by Tonix or a sublicensee and (ii) any other
products that involve material or technical information related to the TFF2 Product and transferred to Tonix pursuant to the Columbia
License Agreement (“Other Products”) sold by Tonix or a sublicensee. Royalties on each particular TFF2 Product are payable
on a country-by-country and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last
to expire of the issued patents covered by the Columbia License Agreement, and (ii) a specified period of time after the first commercial
sale of a TFF2 Product in the country in question. Royalties on each particular Other Product are payable on a country-by-country and
product-by-product basis until a specified period of time after the first commercial sale of such particular Other Product in such country.
Royalties payable on net sales of the TFF2 Product and Other Products may be reduced by 50% of the royalties payable by Tonix to any
third party for intellectual property rights which are necessary for the practice of the rights licensed to Tonix under the Columbia
License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced by more than 50%.
The
Company is also obligated to make contingent milestone payments to Columbia totaling $4.1 million on a Product-by-Product basis upon
the achievement of certain development, approval and sales milestones related to a TFF2 Product. In addition, the Company shall pay Columbia
5% of consideration, other than royalty payments and certain other categories of consideration, payable to the Company by a sublicensee.
As of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
On
May 20, 2019, the Company entered into an exclusive License Agreement (the “License Agreement”) with Columbia pursuant to
which Columbia, for itself and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”)
granted to the Company an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively,
the “Technology”) related to a double-mutant cocaine esterase, and to develop and commercialize products thereunder (each,
a “Product”). Pursuant to the terms of the License Agreement, Columbia has reserved for itself and the Institutions the right
to practice the Technology for academic research and educational purposes.
The
Company agreed to pay a six-digit license fee to Columbia as consideration for entering into the License Agreement. The Company is obligated
to use Commercially Reasonable Efforts, as defined in the License Agreement, to develop and commercialize the Product, and to achieve
specified developmental milestones. The first 50% of the license fee was paid by June 30, 2019, while the remaining 50% license fee,
was paid during the second quarter of 2020. Both installments of the license fee were recorded to research and development expenses in
the 2019 statement of operations.
17
The
Company agreed to pay Columbia single-digit royalties on net sales of (i) Products sold by the Company or a sublicensee and (ii) any
other products that involve material or technical information related to the Product and transferred to the Company pursuant to the License
Agreement (“Other Products”) sold by the Company or a sublicensee. Royalties on each particular Product are payable on a
country-by-country and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to
expire of the issued patents covered by the License Agreement, (ii) a specified period of time after the first commercial sale of a Product
in the country in question, or (iii) expiration of any market exclusivity period granted by a regulatory agency. Royalties on each particular
Other Product are payable on a country-by-country and product-by-product basis until the later of (i) a specified period of time after
the first commercial sale of such particular Other Product in such country or (ii) expiration of any market exclusivity period granted
by a regulatory agency. Royalties payable on net sales of the Product and Other Products may be reduced by 50% of the royalties payable
by the Company to any third party for intellectual property rights which are necessary for the practice of the rights licensed to the
Company under the License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced by more than
50%.
The
Company is also obligated to make contingent milestone payments to Columbia totaling $3 million on a Product-by-Product basis upon the
achievement of certain development, approval and sales milestones related to a Product. In addition, the Company shall pay Columbia 5%
of consideration, other than royalty payments and certain other categories of consideration, payable to the Company by a sublicensee.
As of March 31, 2021, no milestone payments have been accrued or paid in relation to this agreement.
18
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
11 – SALE OF COMMON STOCK
February
2021 Financing
On February 8, 2021, the Company entered into a securities purchase agreement
with certain institutional investors relating to the issuance and sale of 58,333,334 shares of its common stock , in a
registered direct public offering (“the February 2021 Financing”), with A.G.P/Alliance Global Partners (“AGP”),
acting as placement agent. The public offering price for each share of common stock was $1.20. The February 2021 Financing closed on February
9, 2021. AGP received a cash fee of 7% of the gross proceeds, for an aggregate of $4.9 million. The Company incurred other offering expenses
of approximately $0.1 million. The Company received net proceeds of approximately $65.0 million, after deducting the fees and other offering
expenses.
January
2021 Financing
On
January 11, 2021, the Company entered into a securities purchase agreement with certain institutional investors relating to the issuance
and sale of 50,000,000 shares of its common stock in a registered direct public offering (“the January 2021 Financing”),
with AGP as placement agent. The public offering price for each share of common stock was $0.80. The January 2021 Financing closed on
January 13, 2021. AGP received a cash fee of 7% of the gross proceeds, for an aggregate of $2.8 million. The Company incurred other offering
expenses of approximately $0.3 million. The Company received net proceeds of approximately $36.9 million, after deducting the fees and
other offering expenses.
At-the-Market Offerings
On April 8, 2020, the Company
entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company may issue and sell, from time
to time, shares of the Company’s common stock having an aggregate offering price of up to $50.0 million in at-the-market offerings
(“ATM”) sales. On the same day, the Company filed a prospectus supplement under a shelf registration relating to the Sales
Agreement. AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales Agreement. The Company’s common
stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. On September 4, 2020, the
Company filed an amended prospectus supplement under a shelf registration relating to the Sales Agreement to increase the aggregate offering
price to $100.0 million in ATM sales under the Sales Agreement. During the quarter ended March 31, 2021, the Company sold approximately
9.5 million shares of common stock under the Sales Agreement, for gross proceeds of approximately $7.0 million. Subsequent to March 31,
2021, the Company has sold 2.6 million shares of common stock under the Sales Agreement, for gross proceeds of approximately $3.2 million.
On April 19, 2021, the Company filed an amended prospectus supplement under a shelf registration relating to the Sales Agreement to increase
the aggregate offering price to $170.0 million in ATM sales under the Sales Agreement.
March 2020 Financing
On February 28, 2020, the Company
entered into an underwriting agreement with AGP, relating to the issuance and sale of 14,550,000 shares of common stock, in a registered
direct public offering (“the March 2020 Financing”). The public offering price for each share of common stock was $1.10. The
March 2020 Financing closed on March 3, 2020. AGP purchased the shares at a seven percent discount to the then current public price, for
an aggregate discount of $1.1 million. The Company incurred other offering expenses of approximately $0.1 million. The Company received
net proceeds of approximately $14.8 million, after deducting the underwriting discount and other offering expenses.
February
2020 Financing
On
February 7, 2020, the Company entered into an underwriting agreement with AGP pursuant to which the Company sold securities consisting
of 3,837,000 Class A Units at a public offering price of $0.57 per unit, with each unit consisting of one share of common stock and one
warrant to purchase one share of common stock, and 5,313 Class B Units at a public offering price of $1,000 per unit, with each unit
consisting of one share of Series B Convertible Preferred Stock, with a conversion price of $0.57 per share, convertible into 1,754.386
shares of common stock and warrants to purchase 1,754.386 shares of common stock (“the February 2020 Financing”). The warrants
have an exercise price of $0.57, are immediately exercisable and expire five years from the date of issuance.
The
February 2020 Financing closed on February 11, 2020. AGP purchased the Class A and Class B Units at a seven-percent discount to the public
offering price, for an aggregate discount of approximately $0.5 million. The Company incurred other offering expenses of approximately
$0.5 million. The Company received net proceeds of approximately $6.5 million, after deducting the underwriting discount and other offering
expenses.
19
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
After allocating proceeds to the
warrants issued with the Series B Convertible Preferred Stock, the effective conversion price of the Series B Convertible Preferred Stock
was determined to be less than the fair value of the underlying common stock at the date of commitment, resulting in a beneficial conversion
feature (“BCF”) at that date. Since the Series B Preferred Stock has no stated maturity or redemption date and is immediately
convertible at the option of the holder, the discount created by the BCF of $1.3 million, based on intrinsic value, was charged to additional
paid in capital as a non-cash “deemed dividend” and included in net loss to common stockholders.
During the first quarter of 2020,
all 5,313 shares of Series B Convertible Preferred Stock were converted into common stock.
During February and March 2020,
10.8 million of the warrants issued in the February 2020 Financing, with an exercise price of $0.57, were exercised for proceeds of approximately
$6.2 million.
November
2019 Financing
On
November 14, 2019, the Company entered into an underwriting agreement with AGP pursuant to which the Company sold securities consisting
of 547,420 Class A Units at a public offering price of $1.94 per unit, with each unit consisting of one share of common stock, one warrant
to purchase one share of common stock (“primary warrant”) and one-half of one warrant to purchase one half of one share common
stock (“common warrant”), and 7,938 Class B Units at a public offering price of $1,000 per unit, with each unit consisting
of one share of Series A Convertible Preferred Stock, with a conversion price of $1.94 per share, convertible into 515.464 shares of
common stock, primary warrants to purchase 515.464 shares of common stock, and common warrants to purchase 257.732 shares of common stock
(the “November 2019 Financing”). The primary warrants have an exercise price of $1.94, are immediately exercisable and expire
five years from the date of issuance. The common warrants have an exercise price of $1.94, are exercisable and expire 12 months from
the date of issuance. The common warrants are exercisable on a cashless basis at the option of the holder on the earlier of 30 days from
issuance and the date by which an aggregate of $9.0 million of our securities were traded.
The
November 2019 Financing closed on November 19, 2019. AGP purchased the Class A and Class B Units at a seven-percent discount to the public
offering price, for an aggregate discount of approximately $0.6 million. The Company incurred other offering expenses of approximately
$0.5 million. The Company received net proceeds from the November 2019 Financing of approximately $7.9 million, after deducting the underwriting
discount and other offering expenses.
After
allocating proceeds to the warrants issued with the Series A Convertible Preferred Stock, the effective conversion price of the Series
A Convertible Preferred Stock was determined to be less than the fair value of the underlying common stock at the date of commitment,
resulting in a BCF at that date. Since the Series A Preferred Stock has no stated maturity or redemption date and is immediately convertible
at the option of the holder, the discount created by the BCF of $2.5 million, based on the intrinsic value, was charged to additional
paid in capital as a non-cash “deemed dividend” and included in net loss to common stockholders.
As
of December 31, 2019, all 7,938 shares of Series A Convertible Preferred Stock were converted into common stock.
As
a result of the issuance of common stock in February 2020 for less than the November 2019 warrant exercise price, a repricing of the
warrants issued in the November 2019 Financing was triggered. The Company recognized a one-time non-cash “deemed dividend”
of $0.5 million, representing the increase in the fair value of the warrants. The non-cash “deemed dividend” was charged
to additional paid in capital and included in net loss to stockholders. During February and March 2020, 2.3 million of the warrants issued
in the November 2019 financing, with an exercise price of $0.57, were exercised for proceeds of approximately $1.3 million.
20
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
12 – STOCK-BASED COMPENSATION
Stock
Incentive Plans
On
May 3, 2019, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. 2019 Stock Incentive Plan (the “2019
Plan”). The 2019 Plan provided for the issuance of up to 140,000 shares of common stock. With the adoption of the 2020 Plan (as
defined below), no further grants may be made under the 2019 Plan. On January 16, 2020, the Company’s stockholders approved the
Tonix Pharmaceuticals Holding Corp. 2020 Stock Incentive Plan (the “2020 Plan”). The 2020 Plan provided for the issuance
of up to 600,000 shares of common stock. With the adoption of the Amended and Restated 2020 Plan (as defined below), no further grants
may be made under the 2020 Plan.
On
May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive
Plan (“Amended and Restated 2020 Plan”), and together with the 2020 Plan and the 2019 Plan, the “Plans”).
Under
the terms of the Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted
stock, (3) SARs, (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended and Restated 2020 Plan initially provided
for the issuance of up to 10,000,000 shares of common stock, which amount will be increased to the extent that awards granted under
the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended and Restated 2020 Plan). In addition,
the Amended and Restated 2020 Plan contains an “evergreen provision” providing for an annual increase in the number of shares
of our common stock available for issuance under the Amended and Restated 2020 Plan on January 1 of each year for a period of ten years,
commencing on January 1, 2021 and ending on (and including) January 1, 2030, in an amount equal to the difference between (x) twenty
percent (20%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, and (y) the
total number of shares of common stock reserved under the Amended and Restated 2020 Plan on December 31st of such preceding calendar
year (including shares subject to outstanding awards, issued pursuant to awards or available for future awards). The Board of Directors
determines the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 Plan. However, the exercise
price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or
more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined
based on quoted market price or in absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration
period of grants under the Amended and Restated 2020 Plan may not be more than ten years. As of March 31, 2021, 18,883,676 shares were
available for future grants under the Amended and Restated 2020 Plan.
General
A
summary of the stock option activity and related information for the Plans for the three months ended March 31, 2021 is as follows:
Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding
at December 31, 2020
10,209,286
$
2.93
9.26
$
131,558
Grants
12,774,310
$
1.34
Exercised
—
—
Forfeitures or expirations
(243)
2,937.37
Outstanding at March
31, 2021
22,983,353
$
2.02
9.51
$
5,198,480
Exercisable at March
31, 2021
362,874
$
54.08
7.04
$
210,218
The
aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on options with an exercise price
less than the Company’s closing stock price at the respective dates.
The
weighted average fair value of options granted for the three-month periods ended March 31, 2021 and 2020 was $1.10 and $0.35 per share,
respectively.
21
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
The
Company measures the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain
assumptions discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair value
of the award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date
of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues
options to directors which vest over a one-year period. The Company also issues premium options to executive officers which have an exercise
price greater than the grant date fair value and has issued performance-based options which vest when target parameters are met or probable
of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation expense related to
awards is amortized over the applicable service period using the straight-line method.
The
assumptions used in the valuation of stock options granted during the three months ended March 31, 2021 and 2020 were as follows:
Three
Months Ended
March 31, 2021
Three
Months Ended
March 31, 2020
Risk-free
interest rate
1.00%
to 1.34
%
0.49%
to 1.25
%
Expected term of option
6.00
years
5.50
to 6.00 years
Expected stock price
volatility
132.23%
to 132.78
%
124.11%
to 127.83
%
Expected dividend yield
0.0
0.0
The
risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options
as of the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based
compensation expense relating to options granted of $1.2 million, of which $0.8 million and $0.4 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended March 31, 2021.
Stock-based
compensation expense relating to options granted of $0.4 million, of which $0.3 million and $0.1 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended March 31, 2020.
As
of March 31, 2021, the Company had approximately $18.4 million of total unrecognized compensation cost related to non-vested awards granted
under the Plans, which the Company expects to recognize over a weighted average period of 2.67 years.
Employee
Stock Purchase Plans
On
May 3, 2019, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2019 Employee Stock Purchase Plan (the
“2019 ESPP”). As a result of adoption of the 2020 ESPP, as defined below, by the stockholders, no further grants may be made
under the 2019 ESPP Plan. On May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2020 Employee
Stock Purchase Plan (the “2020 ESPP”).
The
2020 ESPP allows eligible employees to purchase up to an aggregate of 300,000 shares of the Company’s common stock. Under
the 2020 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for
that offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering
period. Each offering period under the 2020 ESPP is for six months, which can be modified from time-to-time. Subject to limitations,
each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated payroll deductions
for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value of our common
stock at the beginning or end of each offering period, whichever is less. A participant must designate in his or her enrollment package
the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2020 ESPP, subject
to the statutory limit under the Code. As of March 31, 2021, 245,553 shares were available for future sales under the 2020 ESPP.
22
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
The
2020 and 2019 ESPP are considered compensatory plans with the related compensation cost expensed over the six-month offering period.
For the quarters ended March 31, 2021 and 2020, $47,000 and $0, respectively were expensed. In January 2020, 1,578 shares that were purchased as of December 31, 2019, under the 2019 ESPP, were issued. Accordingly,
during the first quarter of 2020, approximately $2,000 of employee payroll deductions accumulated at December 31, 2019, related to acquiring
such shares, was transferred from accrued expenses to additional paid in capital. The remaining $7,000 was returned to the employees.
As of December 31, 2020, approximately $32,000 of employee payroll deductions have accumulated and have been recorded in accrued expenses.
In January 2021, 54,447 shares that were purchased as of December 31, 2020, under the 2020 ESPP, were issued. Accordingly, during the
first quarter of 2021, approximately $28,000 of employee payroll deductions accumulated at December 31, 2020, related to acquiring such
shares, was transferred from accrued expenses to additional paid in capital. The remaining $4,000 was returned to the employees.
NOTE
13 – WARRANTS TO PURCHASE COMMON STOCK
The
following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at March 31, 2021:
Exercise
Number
Expiration
Price
Outstanding
Date
$
0.50
24,920
November 2024
$
0.57
123,500
February 2025
$
35.00
490,571
December 2023
$
630.00
5,441
October
2021
$
687.50
474
October
2021
644,906
During the quarter ended
March 31, 2021, 3,400 warrants from the February 2020 Financing, with an exercise price of $0.57, were exercised for proceeds of approximately
$2,000.
During the quarter ended
March 31, 2020, 2.3 million warrants from the November 2019 Financing, with an exercise price of $0.57, were exercised for proceeds of
approximately $1.3 million.
During the quarter ended
March 31, 2020, 10.8 million warrants from the February 2020 Financing, with an exercise price of $0.57, were exercised for proceeds of
approximately $6.2 million.
23
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
14 – LEASES
The
Company has various operating lease agreements, which are primarily for office space. These agreements frequently include one or more
renewal options and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement imposes a
restriction on the Company’s ability to engage in financing transactions or enter into further lease agreements. At March 31, 2021,
the Company has right-of-use assets of $0.9 million and a total lease liability for operating leases of $1.0 million of which $0.6 million
is included in long-term lease liabilities and $0.4 million is included in current lease liabilities.
At
March 31, 2021, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in
thousands):
Year Ending December 31,
Remainder of 2021
$
350
2022
186
2023
158
2024
145
2025
149
988
Included interest
(25
)
$
963
During
the quarter ended March 31, 2020, the Company entered into a lease amendment, resulting in the Company recognizing
an operating lease liability of approximately $35,000 based on the present value of the future minimum rental payments. The Company also
recognized corresponding ROU assets of approximately $35,000. No new and amendments to operating leases were entered into by the Company
during the quarter ended March 31, 2021.
Operating
lease expense was $0.2 and $0.1 million for the quarters ended March 31, 2021 and 2020, respectively.
Other
information related to leases is as follows:
Cash paid for amounts included
in the measurement of lease liabilities:
Three
Months Ended
March 31, 2021
Three
Months Ended
March 31, 2020
Operating
cash flow from operating leases (in thousands)
$
158
$
115
Weighted Average Remaining Lease Term
Operating
leases
3.54 years
0.84 years
Weighted Average Discount Rate
Operating
leases
1.47%
3.52%
24
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2021 AND 2020 (UNAUDITED)
NOTE
15 – COMMITMENTS
Contractual agreements
The
Company has entered into contracts with various contract research organizations with outstanding commitments aggregating approximately
$30.0 million at March 31, 2021 for future work to be performed.
On March 3, 2021, the Company entered into a $2.9 million contingent non-binding Purchase and Sales Agreement in connection with a property
in Massachusetts. The property is intended for process development activities.
Defined
contribution plan
The
Company established a qualified defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby
all eligible employees may participate. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k)
Plan, subject to defined limitations. The Company is required to make contributions to the 401(k) Plan equal to 100 percent of each participant’s
pretax contributions of up to six percent of his or her eligible compensation, and the Company is also required to make a contribution
equal to three percent of each participant’s salary, on an annual basis, subject to limitations under the Code. For the three months
ended March 31, 2021 and 2020, the Company charged operations $70,000 and $50,000, respectively, for contributions under the 401(k) Plan.
NOTE
16 – SUBSEQUENT EVENTS
On April 14, 2021, the Company
and OyaGen, Inc. (“OyaGen”) entered into an exclusive License Agreement (the “OyaGen License Agreement”) pursuant
to which OyaGen granted to Tonix an exclusive license to certain patents and technical information related to an antiviral inhibitor of
SARS-CoV-2, sangivamycin, and to develop and commercialize products thereunder, and to acquire rights to any technology based on the thereon
for the prevention or treatment of Covid-19 developed by OyaGen during the term of the License Agreement.
As consideration for entering
into the License Agreement, Tonix agreed to pay a low-seven digit license fee to OyaGen, and agreed to issue to OyaGen and an affiliated
entity an aggregate of 2,752,294 shares of the Company’s common stock, which is unregistered and subject to a six-month lock-up
and a voting agreement, pursuant to which OyaGen and the affiliated entity have agreed to vote the common stock on any matter put to a
vote of the shareholders of the Company in accordance with management’s recommendations. The OyaGen License also provides for single-digit
royalties and contingent milestone payments.
Subsequent to March 31, 2021, the Company has sold 2.6 million shares of common stock under the ATM Sales Agreement, for gross proceeds
of approximately $3.2 million.
On April 19, 2021,
the Company filed an amended prospectus supplement under a shelf registration relating to the ATM Sales Agreement to increase
the aggregate offering price to $170.0 million in ATM sales under the ATM Sales Agreement.
25
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.