Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
Thousands, Except Par Value and Share Amounts)
June
30,
December
31,
2020
2019
(unaudited)
ASSETS
Current
assets:
Cash
$ 55,022
$ 11,249
Prepaid
expenses and other
2,605
2,699
Total
current assets
57,627
13,948
Property
and equipment, net
37
34
Right-of-use
assets, net
441
356
Security
Deposit
20
—
Restricted
cash
100
100
Intangible
Asset
120
120
Total
assets
$ 58,345
$ 14,558
LIABILITIES
AND STOCKHOLDERS' EQUITY
Current
liabilities:
Accounts
payable
$ 3,189
$ 3,070
Accrued
expenses and other current liabilities
1,143
1,713
Lease
liability, current
346
352
Total
current liabilities
4,678
5,135
Lease
liability, net of current portion
95
6
Total
liabilities
4,773
5,141
Commitments
(See Note 12)
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; 0 issued and outstanding as of June 30, 2020, Series A Convertible Preferred stock, $0.001 par value; 7,938 shares designated; 0 issued and outstanding as of December 31, 2019
—
—
Common
stock, $0.001 par value; 150,000,000 shares authorized; 104,803,906 and 8,531,504 shares
issued and outstanding as of June 30, 2020 and December 31, 2019, respectively, and 1,578
shares to be issued as of December 31, 2019
105
9
Additional
paid in capital
292,058
226,524
Accumulated
deficit
(238,522 )
(217,070 )
Accumulated
other comprehensive loss
(69 )
(46 )
Total
stockholders' equity
53,572
9,417
Total
liabilities and stockholders' equity
$ 58,345
$ 14,558
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 June 30,
Six Months Ended June 30,
2020
2019
2020
2019
COSTS AND EXPENSES:
Research and development
$ 10,571
$ 3,554
$ 15,247
$ 7,450
General and administrative
3,621
2,352
6,242
4,753
14,192
5,906
21,489
12,203
Operating Loss
(14,192 )
(5,906 )
(21,489 )
(12,203 )
Interest income, net
13
66
37
130
Net loss
(14,179 )
(5,840 )
(21,452 )
(12,073 )
Warrant deemed dividend
—
—
451
—
Preferred stock deemed dividend
—
—
1,260
—
Net loss available to common stockholders
$ (14,179 )
$ (5,840 )
$ (23,163 )
$ (12,073 )
Net loss per common share, basic and diluted
$ (0.23 )
$ (9.42 )
$ (0.54 )
$ (21.77 )
Weighted average common shares outstanding, basic and diluted
62,391,006
620,204
43,209,988
554,624
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 June 30,
Six Months Ended June 30,
2020
2019
2020
2019
Net loss
$ (14,179 )
$ (5,840 )
$ (21,452 )
$ (12,073 )
Other comprehensive loss:
Foreign currency translation loss
(9 )
—
(23 )
2
Comprehensive loss
$ (14,188 )
$ (5,840 )
$ (21,475 )
$ (12,071 )
See
the accompanying notes to the condensed consolidated financial statements
5
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
SIX
MONTHS ENDED JUNE 30, 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
Issuance of common stock under 2019 Purchase Agreement
464,471
1
277
278
Issuance of common stock in May and June 2020 under At-the-market offering, net of transaction expenses of $1,131
—
—
52,986,301
53
34,089
—
—
34,142
Issuance of common stock in the acquisition of Trigemina assets
—
—
2,000,000
2
1,358
—
—
1,360
Stock-based compensation
—
—
—
—
733
—
—
733
Foreign currency transaction gain
—
—
—
—
—
(9 )
—
(9 )
Net loss
—
—
—
—
—
—
(14,179 )
(14,179 )
Balance, June 30, 2020
—
$ —
104,803,906
$ 105
$ 292,058
$ (69 )
$ (238,522 )
$ 53,572
See
the accompanying notes to the condensed consolidated financial statements
6
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
SIX
MONTHS ENDED JUNE 30, 2019
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
Accumulated
Series A Convertible
Additional
Other
Preferred stock
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2018
9,856
$ —
328,689
$ —
$ 212,157
$ (41 )
$ (188,452 )
$ 23,664
Issuance of common stock upon conversion of Series A Convertible preferred stock
(9,856 )
—
281,610
1
(1 )
—
—
—
Issuance of common stock in exchange for exercise of warrants in March 2019 ($35.00 per share)
—
—
2,000
—
70
—
—
70
Employee stock purchase plan
—
—
177
—
3
—
—
3
Stock-based compensation
—
—
—
—
305
—
—
305
Foreign currency transaction gain
—
—
—
—
—
2
—
2
Net loss
—
—
—
—
—
—
(6,233 )
(6,233 )
Balance, March 31, 2019
$ —
$ —
$ 612,476
$ 1
$ 212,534
$ (39 )
$ (194,685 )
$ 17,811
Issuance of common stock under 2018 Purchase Agreement
—
—
22,754
—
387
—
—
387
Issuance of common stock under At-the-market offering, net of transactional expenses of $1
—
—
2,105
—
33
—
—
33
Stock-based compensation
—
—
—
—
431
—
—
431
Foreign currency transaction loss
—
—
—
—
—
—
—
—
Net loss
—
—
—
—
—
—
(5,840 )
(5,840 )
Balance, June 30, 2019
—
$ —
637,335
$ 1
$ 213,385
$ (39 )
$ (200,525 )
$ 12,822
See
the accompanying notes to the condensed consolidated financial statements
7
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
Thousands)
(unaudited)
Six Months Ended June 30,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ (21,452 )
$ (12,073 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
12
16
Common stock issued to acquire in-process research and development
1,360
—
Stock-based compensation
1,093
736
Changes in operating assets and liabilities:
Prepaid expenses and other
74
(987 )
Accounts payable
118
(358 )
Lease liabilities and ROU asset, net
(2 )
2
Accrued expenses and other current liabilities
(570 )
(691 )
Net cash used in operating activities
(19,367 )
(13,355 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of furniture and fixtures
(14 )
(10 )
Net cash used by investing activities
(14 )
(10 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants
7,474
70
Proceeds from ESPP
2
—
Proceeds, net of $711 and $0 expenses, from sale of preferred stock
4,602
—
Proceeds, net of $2,644 and $1 expenses, from sale of common stock and warrants
51,099
420
Net cash provided by financing activities
63,177
490
Effect of currency rate change on cash
(23 )
(9 )
Net increase (decrease) in cash, cash equivalents and restricted cash
43,773
(12,884 )
Cash, cash equivalents and restricted cash beginning of the period
11,349
25,134
Cash, cash equivalents and restricted cash end of period
$ 55,122
$ 12,250
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Warrants deemed dividend
$ 451
$ —
Series B Convertible preferred stock deemed dividend
$ 1,260
$ —
See
the accompanying notes to the condensed consolidated financial statements
8
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
NOTE
1 – BUSINESS
Tonix
Pharmaceuticals Holding Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a
clinical-stage biopharmaceutical 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
condensed 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., 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 June 30, 2020, the Company had working capital
of approximately $53.0 million. At June 30, 2020, the Company had an accumulated deficit of approximately $238.5 million. The Company
held cash and cash equivalents of approximately $55.0 million as of June 30, 2020.
The Company believes that
its cash resources will be sufficient to meet its projected operating requirements through at least the end of 2020, but it will
not have enough resources to meet its operating requirements for the one-year period from the date of filing of this Form 10-Q.
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 or private financing or 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 our research and development activities, or other
operations and potentially delay product development in an effort to provide sufficient funds to continue our 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.
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.
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.
The
condensed consolidated balance sheet as of December 31, 2019 contained herein has been derived from audited financial statements.
Operating
results for the three and six months ended June 30, 2020 are not necessarily indicative of results that may be expected for
the year ending December 31, 2020. 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, 2019 included in the
Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on March
24, 2020.
9
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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 its products 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 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.
Use
of estimates
The
preparation of financial statements in accordance with 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 useful life of fixed assets, 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
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 June 30, 2020 and December 31, 2019, cash equivalents, which consisted of
money market funds, amounted to $22.4 million and $5.4 million, respectively. Restricted cash at both June 30, 2020 and December
31, 2019 of approximately $100,000 collateralizes a letter of credit issued in connection with the lease of office space in New
York City (see Note 11).
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 flow:
June 30,
2020
December 31,
2019
(in thousands)
Cash and cash equivalents
$ 55,022
$ 11,249
Restricted cash
100
100
Total
$ 55,122
$ 11,349
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 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 the three and six months ended June 30,
2020 was $6,000 and $12,000, respectively, and $7,000 and $16,000, respectively, for the three and six months ended
June 30, 2019. All property and equipment are 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 June 30, 2020, the Company
believed that no impairment existed.
10
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
Leases
The
Company determines if an arrangement is 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 condensed 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.
Stock-based
compensation
All
stock-based payments to employees and to nonemployee directors for their services as directors, including grants of restricted
stock units (“RSUs”), and stock options, are measured at fair value on the grant date and recognized in the condensed
consolidated statements of operations as compensation or other expense over the relevant service period. In addition, for awards
that vest immediately and are non-forfeitable, the measurement date is the date the award is issued.
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.
11
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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 June 30, 2020, 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.
On
March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).
The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side
social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net
interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax
depreciation methods for qualified improvement property. We continue to examine the impact that the CARES Act may have on
our business. Currently, we do not believe the CARES Act will have a material impact on our accounting for income taxes.
Per
Share Data
The
computation of basic and diluted loss per share as of June 30, 2020 and 2019 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
and six months ended June 30, 2020, as results of operations were a loss for the period.
Potentially
dilutive securities excluded from the computation of basic and diluted net loss per share, as of June 30, 2020 and 2019, are as
follows:
2020
2019
Warrants to purchase common stock
5,184,210
496,486
Options to purchase common stock
10,209,286
109,036
Totals
15,393,496
605,522
NOTE
3 – 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:
12
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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 June 30, 2020, and December 31, 2019, the Company used Level 1 quoted prices in active markets to value cash equivalents of
$22.4 million and $5.4 million, respectively.
NOTE
4 – STOCKHOLDERS’ EQUITY
On April 21, 2020, the
Company received a letter (the “Notice”) 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 per share, as set forth in Nasdaq Listing Rule
55450(a)(1) (the “Minimum Bid Price Requirement”).
On August 3, 2020, the
Company received a letter from Nasdaq stating that because the Company’s shares had a closing bid price at or above $1.00
per share for a minimum of ten consecutive business days, the Company’s stock had regained compliance with the minimum bid
price requirement of $1.00 per share for continued listing on the NASDAQ Global Market, as set forth in NASDAQ Listing Rule 5450(a)(1),
and that the matter is now closed.
13
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
NOTE
5 – ASSET PURCHASE AGREEMENT WITH TRIGEMINA
On June 11, 2020, the Company
entered into an asset purchase agreement (the “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 “Assets”). In connection with the acquisition of the 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 “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 has
agreed to pay $824,759 to Trigemina and issued to Trigemina 2,000,000 shares of the Company’s common stock, par value $0.001
per share (the “Common Stock”), and valued at $0.68 per share, based on the closing stock price on June 11 th
, and has agreed to pay to 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 (the “Voting Agreement”),
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, were recorded to research and development expenses in the statement of operations for the six months
ended June 30, 2020. Because the Trigemina intellectual property was acquired prior to United States Food and Drug Administration
approval (“FDA”), 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 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 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.
As of June 30, 2020, no
milestone payments have been accrued or paid in relation to this agreement.
NOTE
6 – ASSET PURCHASE AGREEMENT WITH TRIMARAN
On
August 19, 2019, the Company entered into an asset purchase agreement (the “TRImaran 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 TRImaran 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 TRImaran 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.
14
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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 June 30, 2020, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
7 – 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 has reserved for itself the right to practice
the TFF2 Technology for academic research and educational purposes.
The
Company has paid a five-digit license fee to Columbia as consideration for entering into the Columbia License Agreement, which
was recorded to non-clinical 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 has 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 June 30, 2020, no milestone payments have been accrued or paid in relation to this agreement.
15
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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 statement
of operations for the year ended December 31, 2019.
The Company has 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 June
30, 2020, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
8 – SALE OF COMMON STOCK
2020
At-the-Market Offering
On
April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”), with A.G.P/Alliance Global Partners
(“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. During the quarter ended June 30, 2020,
the Company sold approximately 53.0 million shares of common stock under the Sales Agreement, for gross proceeds of approximately
$35.3 million.
February
7 th Financing
On
February 7, 2020, the Company entered into an underwriting agreement (“the February 7 th Financing”) 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 warrants have an exercise price of $0.57, are immediately exercisable and expire five years
from the date of issuance.
The
February 7 th 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.
16
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (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 7 th financing, with an exercise price
of $0.57, were exercised for proceeds of approximately $6.2 million.
February
28 th Financing
On
February 28, 2020, the Company entered into an underwriting agreement (“the February 28th Financing”) with AGP, relating
to the issuance and sale of 14,550,000 shares of common stock, in a registered direct public offering. The public offering price
for each share of common stock was $1.10. The February 28th 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.
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 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.
With the February
7th financing, warrants that were issued as part of the November 2019 financing were repriced at $0.57. 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.
17
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
2019
Lincoln Park Transaction
On
August 20, 2019, the Company entered into a purchase agreement (the “2019 Purchase Agreement”) and a registration
rights agreement (the “2019 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
Pursuant to the terms of the 2019 Purchase Agreement, Lincoln Park has agreed to purchase from us up to $15,000,000 of the Company’s
common stock (subject to certain limitations) from time to time during the term of the 2019 Purchase Agreement. Pursuant to the
terms of the 2019 Registration Rights Agreement, the Company filed with the SEC a registration statement to register for resale
under the Securities Act the shares that have been or may be issued to Lincoln Park under the 2019 Purchase Agreement.
Pursuant
to the terms of the 2019 Purchase Agreement, at the time the Company signed the 2019 Purchase Agreement and the 2019 Registration
Rights Agreement, the Company issued 35,529 shares of common stock to Lincoln Park
as consideration for its commitment to purchase shares of our common stock under the 2019 Purchase Agreement. The commitment shares
were valued at $200,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction
to equity as a cost of capital to be raised under the 2019 Purchase Agreement.
As
a result of receiving stockholder approval on January 16, 2020, the Company may sell more than 19.9% of it’s common stock
outstanding pursuant to the 2019 Purchase Agreement without violating Nasdaq Marketplace Rules, including Rule 5635(d), requiring
shareholder approval for the sale, issuance or potential issuance by an issuer of common stock (or securities convertible into
or exercisable for common stock) at a price less than the greater of book or market value.
During
the six months ended June 30, 2020, the Company sold an aggregate of approximately 464,471 shares of common stock under the 2019
Purchase Agreement, for gross proceeds of approximately $0.3 million.
December
2018 Financing
On
December 7, 2018, the Company entered into an underwriting agreement with AGP and Dawson James Securities, Inc. (collectively,
the “Underwriters”) pursuant to which the Company sold securities consisting of 86,171 Class A Units at a public offering
price of $35.00 per unit, with each unit consisting of one share of common stock and a warrant to purchase one share of common
stock, and 11,984 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 $35.00 per share convertible into 28.5714 shares of common stock, and
warrants to purchase 28.5714 shares of Common Stock. The warrants have an exercise price of $35.00, are immediately exercisable
and expire five years from the date of issuance.
The
Company also granted the Underwriters a 45-day option to purchase up to 64,286 shares of common stock and/or additional warrants
to purchase up to 64,286 additional shares of common stock.
The
December 2018 Financing closed on December 11, 2018. The Underwriters purchased the Class A and Class B Units at a seven-percent
discount to the public offering price, for an aggregate discount of approximately $1.1 million (or $2.40 per share). The Company
incurred other offering expenses of approximately $0.4 million. The Company received net proceeds from the December 2018 Financing
of approximately $13.6 million, after deducting the underwriting discount and other offering expenses.
Additionally,
the Underwriters fully exercised the over-allotment option related to the warrants and purchased additional warrants to acquire
64,000 shares of common stock for net proceeds of approximately $6,000.
On
December 13, 2018, the Underwriters partially exercised the over-allotment option and purchased 25,000 shares of common stock
for net proceeds of approximately $0.8 million, net of an aggregate discount of $0.1 million (or $2.40 per share).
18
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
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, after the bifurcation of the warrants, 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 $3.3 million, based on the intrinsic value, was charged to additional paid in capital as a “deemed dividend”
and included in net loss to common stockholders.
During
the first quarter of 2019, the remaining 9,856 shares of Series A Convertible Preferred Stock were converted into 281,610 shares
of common stock.
2018
Lincoln Park Transaction
On
October 18, 2018, the Company entered into a purchase agreement (the “2018 Purchase Agreement”) and a registration
rights agreement (the “2018 Registration Rights Agreement”) with Lincoln Park. Pursuant to the terms of the 2018 Purchase
Agreement, Lincoln Park has agreed to purchase from us up to $15,000,000 of the Company’s common stock (subject to certain
limitations) from time to time during the term of the 2018 Purchase Agreement. Pursuant to the terms of the 2018 Registration
Rights Agreement, the Company filed with the SEC a registration statement to register for resale under the Securities Act the
shares that have been or may be issued to Lincoln Park under the 2018 Purchase Agreement.
Pursuant
to the terms of the 2018 Purchase Agreement, at the time the Company signed the 2018 Purchase Agreement and the 2018 Registration
Rights Agreement, the Company issued 3,500 shares of common stock to Lincoln Park
as consideration for its commitment to purchase shares of our common stock under the 2018 Purchase Agreement. The commitment shares
were valued at $245,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction
to equity as a cost of capital to be raised under the 2018 Purchase Agreement.
During
the six months ended June 30, 2019, the Company sold an aggregate of approximately 22,754 shares of common stock under the 2018
Purchase Agreement, for gross proceeds of approximately $0.4 million.
Under
applicable rules of the NASDAQ Global Market, the Company could not issue or sell more than 19.99% of the shares of its common
stock outstanding immediately prior to the execution of the 2018 Purchase Agreement (approximately 26,200 shares) to Lincoln Park
under the 2018 Purchase Agreement without stockholder approval, unless the average price of all applicable sales of its common
stock to Lincoln Park under the 2018 Purchase Agreement equals or exceeds a threshold amount. As the Company has issued approximately
26,200 shares to Lincoln Park, by June 30, 2019, under the 2018 Purchase Agreement at less than the threshold amount, the Company
will not sell any additional shares under the 2018 Purchase Agreement without shareholder approval.
NOTE
9 – STOCK-BASED COMPENSATION
2019
Stock Incentive Plan
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.
2020
Stock Incentive 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.
Amended
and Restated 2020 Stock Incentive 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 2020 Plan provides 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
Amended and Restated 2020 Plan and the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the
Amended and Restated 2020 Plan). The Board of Directors determines the exercise price, vesting and expiration period of the grants
under the 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 June 30, 2020, 456,250 shares were available for future grants under the Amended and Restated 2020
Plan.
19
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
A
summary of the stock option activity and related information for the Plans for the six months ended June 30, 2020 is as follows:
Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding at December 31, 2019
109,036
$ 199.57
8.60
$ —
Grants
10,100,250
$ 0.81
Exercised
—
Forfeitures or expirations
—
Outstanding at June 30, 2020
10,209,286
$ 2.93
9.76
$ 95,385
Exercisable at June 30, 2020
141,144
$ 135.08
4.97
$ 120
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 during the three and six months ended June 2020 was $0.68 per share and $0.66
per share, respectively. The weighted average fair value of options granted during the three and six months ended June 2019
was $16.54 per share and $16.67 per share, respectively.
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. For employees
and directors, the fair value of the award is measured on the grant date. Most stock options granted pursuant to the Plans typically
vest 1/3rd 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 performance-based
options to executive officers, which vest when target parameters are met, and premium options which have an exercise price greater
than the grant date fair value, 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 vesting period using the straight-line method.
The
assumptions used in the valuation of stock options granted during the six months ended June 30, 2020 and 2019 were as follows:
Six
Months Ended
June 30, 2020
Six
Months Ended
June 30, 2019
Risk-free
interest rate
0.36%
to 1.25
%
2.15%
to 2.54
%
Expected term
of option
5.5
to 6 years
3.0
to 10.0 years
Expected stock
price volatility
124.11% - 130.00
%
107.12
-109.72
%
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.
20
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
Stock-based
compensation expense relating to options granted of $0.7 million and $1.1 million was recognized for the three and six-month periods
ended June 30, 2020, respectively, and $0.4 million and $0.7 million was recognized for the three and six-month periods ended
June 30, 2019, respectively.
As
of June 30, 2020, the Company had approximately $7.3 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 2.54 years.
2019
Employee Stock Purchase Plan
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.
2020
Employee Stock Purchase 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 June 30, 2020, 300,000 shares
were available for future sales under the 2020 ESPP.
The
2019 ESPP is considered compensatory plan with the related compensation cost expensed over the six-month offering period. For
the six months ended June 30, 2020 and 2019, $0 and $24,000, respectively were expensed. In January 2019, 177 shares that were
purchased as of December 31, 2018, under the 2018 ESPP, were issued. Accordingly, during the quarter ended March 31, 2019, approximately
$3,000 of employee payroll deductions accumulated at December 31, 2018, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. As of December 31, 2019, approximately $9,000 of employee payroll deductions,
which were withheld since July 1, 2019, the commencement of the offering period ending December 31, 2019, were included in accrued
expenses in the accompanying balance sheet. In January 2020, 1,578 shares that were purchased as of December 31, 2019, under the
2019 ESPP, were issued. Accordingly, during the six months ended June 30, 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.
21
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
NOTE
10 – STOCK WARRANTS
The
following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at June 30,
2020:
Exercise
Number
Expiration
Price
Outstanding
Date
$
0.57
2,500
November
2020
$
0.57
2,344,198
November 2024
$
0.57
2,341,026
February 2025
$
35.00
490,571
December 2023
$
630.00
5,441
October
2021
$
687.50
474
October
2021
5,184,210
During
the six months ended June 30, 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 six months ended June 30, 2020, 10.8 million warrants from the February 7 th financing, with an exercise price of
$0.57, were exercised for proceeds of approximately $6.2 million.
During
the six months ended June 30, 2019, 2,000 warrants with an exercise price of $35.00 were exercised for proceeds of approximately
$70,000.
During
the six months ended June 30, 2019, 24 warrants with an exercise price of $25,000 expired.
NOTE
11 – 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 June 30, 2020, the Company has right-of-use assets of $0.4 million and a total lease liability for operating leases of $0.4
million of which $0.1 million is included in long-term lease liabilities and $0.3 million is included in current lease liabilities.
At
June 30, 2020, 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 2020
$
221
2021
178
2022
37
2023
13
Included interest
(8
)
$
441
In January 2019,
the Company entered into a new operating lease, resulting in the Company recognizing an operating lease liability of approximately
$0.4 million based on the present value of the future minimum rental payments. The Company also recognized corresponding ROU assets
of approximately $0.4 million. In April 2019, the Company entered into a lease amendment, resulting in the Company recognizing
an additional operating lease liability of approximately $0.1 million based on the present value of the future minimum rental payments.
The Company also recognized a corresponding increase to ROU assets of approximately $0.1 million.
In February 2020, the Company
entered into a lease amendment, resulting in the Company recognizing an additional operating lease liability of approximately $35,000
based on the present value of the minimum rental payments. The Company also recognized a corresponding increase to ROU assets of
approximately $35,000. In April 2020, the Company entered into a new operating lease, resulting in the Company recognizing an operating
lease liability of approximately $71,000 based on the present value of the future minimum rental payments. The Company also recognized
corresponding ROU assets of approximately $71,000.
22
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2020 AND 2019 (UNAUDITED)
In June 2020, the Company
entered into a new operating lease, 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. In June 2020, the Company entered into lease amendments, resulting in the Company recognizing an additional operating
lease liability of approximately $167,000 based on the present value of the future minimum rental payments. The Company also recognized
a corresponding increase to ROU assets of approximately $167,000. Operating lease expense was $0.1 million and $0.2 million for
the three and six months ended June 30 for both reporting periods.
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities:
Six Months Ended
June 30, 2020
Six Months Ended
June 30, 2019
Operating cash flow from operating leases (in thousands)
$ 233
$ 221
Weighted Average Remaining Lease Term
Operating leases
1.43 years
1.77 years
Weighted Average Discount Rate
Operating leases
2.44 %
3.36 %
NOTE
12 – COMMITMENTS
Research
and development contracts
The
Company has entered into contracts with various contract research organizations with outstanding commitments aggregating approximately
$19.8 million at June 30, 2020 for future work to be performed.
Defined
contribution plan
The
Company has 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. The Company charged operations $29,000 and $79,000 for the three and six months ended June
30, 2020, respectively, and $19,000 and $65,000 for the three and six months ended June 30, 2019, respectively, for contributions
under the 401(k) Plan.
NOTE
13 – SUBSEQUENT EVENTS
On July 7, the Company
announced that it entered into a $4 million non-binding Purchase and Sales Agreement in connection with a setting
up a Massachusetts R&D facility to accelerate clinical development of vaccines and protein-based therapeutics.
On July 13, 2020, the Company
entered into an underwriting agreement (“the July 2020 Financing”) with AGP, relating to the issuance and sale of 20,940,000
shares of common stock, in a registered direct public offering. The public offering price for each share of common stock was $0.50.
The July 2020 Financing closed on July 15, 2020. AGP purchased the shares at a seven percent discount, for an aggregate discount
of $0.7 million. The Company expects to incur other offering expenses of approximately $0.2 million. The Company expects to receive
net proceeds of approximately $9.6 million, after deducting the underwriting discount and other offering expenses.
On July 13, the
Company entered into a research and exclusive license option Agreement with Kansas State University to develop TNX-2300 as a vaccine
to protect against COVID-19.
On July 16, 2020, the Company
announced a research collaboration and option agreement with Columbia University to develop precision medicine techniques for COVID-19
vaccines and therapeutics.
On July 29, 2020, Tonix
engaged Premier Research International to initiate a new $10.3 million Phase 3 trial, F306 or Rally study, to study TNX-102 SL
for the management of fibromyalgia. Tonix expects enrollment to begin in the third quarter of this year. The trial design
will be very similar to the ongoing Phase 3 RELIEF study. The FDA requires two registration-quality clinical studies to support
marketing approval.
Subsequent to the quarter
ended June 30, 2020, the Company raised approximately $2.4 million through warrant exercises.
23
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This
Management’s Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking
statements that reflect Management’s current views with respect to future events and financial performance. You can identify
these statements by forward-looking words such as “may” “will,” “expect,” “anticipate,”
“believe,” “estimate” and “continue,” or similar words. Those statements include statements
regarding the intent, belief or current expectations of us and members of its management team as well as the assumptions on which
such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of
future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by
such forward-looking statements.
Readers
are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with
the Securities and Exchange Commission. Important factors known to us could cause actual results to differ materially
from those in forward-looking statements. We undertake no obligation to update or revise forward-looking statements to reflect
changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time. We believe that
its assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made
that actual results of operations or the results of our future activities will not differ materially from its assumptions. Factors
that could cause differences include, but are not limited to: the COVID-19 pandemic, including its impact on the Company, substantial
competition; our possible need for additional financing; uncertainties of patent protection and litigation; uncertainties of government
or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related
to failure to obtain clearances or approvals from the United States Food and Drug Administration, or FDA, and noncompliance with
FDA regulations.
Business
Overview
We
are a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring, developing and manufacturing small
molecules and biologics to treat and prevent human disease and alleviate suffering. The immunology portfolio includes vaccines
to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes
both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. In Q1 2020, we announced a
program to develop a potential vaccine, TNX-1800, to protect against the novel coronavirus disease which emerged in 2019, or COVID-19.
TNX-1800 is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting
a T cell response. In Q2 2020, we announced a program to test and develop three additional potential vaccines, TNX-1810, TNX-1820
and TNX-1830 to protect against COVID-19. TNX-1800 is designed to elicit predominantly T cell responses and TNX-1810, TNX-1820
and TNX-1830 are designed to elicit almost pure T cell responses, based on technology licensed from the University of Alberta.
In Q2 2020, we announced the manufacturing partner for TNX-1800 is Fujifilm Diosynth Biotechnologies. We are also developing TNX-2300,
a second live replicating vaccine candidate for the prevention of COVID-19, but using bovine parainfluenza as the vector, based
on technology from Kansas State University for which Tonix has an exclusive license option agreement. Tonix’s lead CNS candidate,
TNX-102 SL, is a sublingual formulation of cyclobenzaprine designed for daily dosing at bedtime. TNX-102 SL is in Phase 3 development
with the goal of providing a safe and effective long-term treatment for fibromyalgia, or FM. FM is a pain disorder characterized
by chronic widespread pain, non-restorative sleep, fatigue and impaired cognition. FM is associated with chronic disability,
inadequate treatment options, high utilization of healthcare services, and significant economic burden. TNX-102 SL is also being
developed for the treatment of agitation in Alzheimer’s disease (AAD) and alcohol use disorder (AUD), both of which are
in Phase 2-ready stages. Finally, our product pipeline includes other clinical stage and pre-clinical stage programs.
.
Current
Operating Trends
Our
current research and development efforts are focused on developing TNX-1800, TNX-1810, TNX-1820, TNX-1830 and TNX-2300 as potential
vaccines to protect against COVID-19, TNX-801 as a potential smallpox and monkeypox vaccine, and TNX-102 SL for the treatment
of FM. We also plan to develop TNX-102 SL for AAD and AUD. Additionally, we plan to expend efforts and resources to develop
our other pipeline programs, primarily related to TNX-1300 for cocaine intoxication, TNX-601 for depression, TNX-701 for radioprotection,
TNX-1500 for organ transplant rejection/autoimmune conditions, TNX-1600 for daytime treatment for posttraumatic stress disorder,
depression and attention deficit hyperactivity disorder, TNX-1700 for gastric and pancreatic cancers and TNX-1900 for migraine
and craniofacial pain. In addition, we will continue to opportunistically discover, license or acquire therapeutics or capabilities
that diversify our pipeline or that strengthen our ability to develop therapeutics. Our research and development expenses consist
of manufacturing work and the cost of drug ingredients used in such work, fees paid to consultants for work related to clinical
trial design and regulatory activities, fees paid to providers for conducting various clinical studies as well as for the analysis
of the results of such studies, and for other medical research addressing the potential efficacy and safety of our study drugs.
We believe that significant investment in product development is a competitive necessity, and we plan to continue these investments
in order to be in a position to realize the potential of our product candidates and proprietary technologies.
24
We
expect that most of our research and development expenses in the near-term future will be incurred in support of our current and
future preclinical and clinical development programs. These expenditures are subject to numerous uncertainties relating to timing
and cost to completion. We test compounds in numerous preclinical studies for safety, toxicity and efficacy. At the appropriate
time, subject to the approval of regulatory authorities, we expect to conduct clinical trials for each drug candidate. We anticipate
funding these trials ourselves, and possibly with the assistance of federal grants, contracts or other agreements. As we obtain
results from trials, we may elect to discontinue or delay clinical trials for certain products in order to focus our resources
on more promising products.
Completion
of clinical trials may take several years, and the length of time generally varies substantially according to the type, complexity,
novelty and intended use of a product candidate.
The
commencement and completion of clinical trials for our products may be delayed by many factors, including the global COVID-19
pandemic, lack of efficacy during clinical trials, unforeseen safety issues, slower than expected participant recruitment, lack
of funding or government delays. In addition, we may encounter regulatory delays or rejections as a result of many factors, including
results that do not support the intended safety or efficacy of our product candidates, perceived defects in the design of clinical
trials and changes in regulatory policy during the period of product development. As a result of these risks and uncertainties,
we are unable to accurately estimate the specific timing and costs of our clinical development programs or the timing of material
cash inflows, if any, from our product candidates. Our business, financial condition and results of operations may be materially
adversely affected by any delays in, or termination of, our clinical trials or a determination by the FDA that the results of
our trials are inadequate to justify regulatory approval, insofar as cash in-flows from the relevant drug or program would be
delayed or would not occur.
Results
of Operations
We
anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the progress
of our research and development efforts and the timing and outcome of regulatory submissions. Due to these uncertainties, accurate
predictions of future operations are difficult or impossible to make.
Three
Months Ended June 30, 2020 Compared to Three Months Ended June 30, 2019
Research
and Development Expenses . Research and development expenses for the three months ended June 30, 2020 were $10.6 million,
an increase of $7.0 million, or 194%, from $3.6 million for the three months ended June 30, 2019. This increase is predominately
due to the acquisition of the Trigemina asset for $2.4 million, timing of development milestones related to the FM RELIEF study
in 2020; increased activities developing TNX-1800 and TNX-801 and increased spending related to our development pipeline.
General
and Administrative Expenses . General and administrative expenses for the three months ended June
30, 2020 were $3.6 million, an increase of $1.2 million, or 50%, from $2.4 million incurred in the three months ended June 30,
2019. The increase in primarily due to an increase in legal fees of $0.6 million due to increased patent prosecution costs, an
increase in accounting fees of $0.1 million, an increase in financial reporting expenses of $0.2 million and an increase non-cash
compensation expense of $0.2 million.
Net
Loss . As a result of the forgoing, the net loss for the three months ended June 30, 2020 was $14.2 million, compared
to a net loss of $5.8 million for the three months ended June 30, 2019.
Six
Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019
Research
and Development Expenses . Research and development expenses for the six months ended June 30, 2020 were $15.3 million,
an increase of $7.8 million, or 104%, from $7.5 million for the six months ended June 30, 2019. This increase is predominately
due to the acquisition of the Trigemina asset for $2.4 million, timing of development milestones related to the FM RELIEF study
in 2020; increased activities developing TNX-1800 and TNX-801 and increased spending related to our development pipeline.
General
and Administrative Expenses . General and administrative expenses for the six months ended June 30, 2020 were $6.2
million, an increase of $1.4 million, or 29%, from $4.8 million incurred in the six months ended June 30, 2019. The increase in
primarily due to an increase in legal fees of $0.7 million due to increased patent prosecution costs, increase in insurance premiums
of $0.1 million and an increase non-cash compensation expense of $0.2 million.
Net
Loss . As a result of the foregoing, the net loss for the six months ended June 30, 2020 was $21.5 million, compared to
a net loss of $12.1 million for the six months ended June 30, 2019.
25
License
Agreements
On
September 16, 2019, we 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 us 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 has reserved for itself the right to practice
the TFF2 Technology for academic research and educational purposes.
We
paid a five-digit license fee to Columbia as consideration for entering into the Columbia License Agreement, which was recorded
to non-clinical expenses in the statement of operations for the year ended December 31, 2019. We are 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.
We
have agreed to pay Columbia single-digit royalties on net sales of (i) TFF2 Products sold by us or a sublicensee and (ii) any
other products that involve material or technical information related to the TFF2 Product and transferred to us pursuant to the
License Agreement (“Other Products”) sold by us 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 us to any third party for intellectual property rights which are necessary for the practice
of the rights licensed to us under the Columbia License Agreement, provided that the royalty payable on a TFF2 Product or Other
Product may not be reduced by more than 50%.
We
are 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, we shall pay Columbia
5% of consideration, other than royalty payments and certain other categories of consideration, payable to us by a sublicensee.
As of June 30, 2020, no milestone payments have been accrued or paid in relation to this agreement.
On
May 20, 2019, we 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 us 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.
26
We agreed to pay a six-digit
license fee to Columbia as consideration for entering into the License Agreement. We are 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 statement
of operations for the year ended December 31, 2019.
We agreed to pay Columbia
single-digit royalties on net sales of (i) Products sold by us or a sublicensee and (ii) any other products that involve material
or technical information related to the Product and transferred to us pursuant to the License Agreement (“Other Products”)
sold by us 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 us to any third party for intellectual property rights which are necessary for the practice of the rights licensed to us under
the License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced by more than 50%.
We are 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, we shall pay Columbia 5% of consideration, other
than royalty payments and certain other categories of consideration, payable to us by a sublicensee. As of June 30, 2020, no milestone
payments have been accrued or paid in relation to this agreement.
On June 11, 2020, we entered
into an asset purchase agreement (the “Asset Purchase Agreement”) with Trigemina, Inc. (“Trigemina”) and
certain shareholders named therein (the “Executive Shareholders”) pursuant to which we acquired Trigemina assets related
to migraine and pain treatment technologies (the “Assets”). In connection with the acquisition of the Assets, we 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 “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, we have
agreed to pay $824,759 to Trigemina and issued to Trigemina 2,000,000 shares of our common stock, par value $0.001 per share (the
“Common Stock”),, and valued at $0.68 per share, based on the closing stock price on June 11 th and has
agreed to pay to 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 (the “Voting Agreement”),
pursuant to which Trigemina and the Executive Shareholders have agreed to vote the Common Stock on any matter put to a vote of
our shareholders in accordance with management’s recommendations. Both the costs associated with the cash payments and share
issuance, were recorded to research and development in the statement of operations for the six months ended June 30, 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 us an exclusive license, with the right to sublicense, certain patents
related to the Assets. Stanford has reserved for itself the right to practice under the patents for academic research and educational
purposes. We are 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 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.
As of June 30, 2020, no
milestone payments have been accrued or paid in relation to this agreement.
On August 19, 2019, we
entered into an asset purchase agreement (the “TRImaran Asset Purchase Agreement”) with TRImaran Pharma, Inc. (“TRImaran”)
and the selling shareholders named therein (the “Selling Shareholders”) pursuant to which we acquired TRImaran’s
assets related to certain pyran-based compounds (the “Assets”). In connection with the acquisition of the Assets,
we 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 TRImaran Asset Purchase Agreement,
we paid $100,000 to TRImaran and have assumed certain liabilities of TRImaran totaling $68,500. Upon the achievement of specified
development, regulatory and sales milestones, we also agreed to pay TRImaran and the Selling Shareholders, in restricted stock
or cash, at our option, a total of approximately $3.4 million. As of June 30, 2020, no milestone payments have been accrued or
paid in relation to this agreement.
27
Pursuant
to the terms of the WSU License Agreement, WSU has granted us 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. We are 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. We are 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, we have agreed to pay $75,000 to WSU as reimbursement of certain patent expenses, and, upon the
achievement of specified development, regulatory and sales milestones, we also agreed to pay WSU, milestone payments totaling
approximately $3.4 million. We have also agreed to pay WSU single-digit royalties on net sales of WSU Products sold by us 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 us to any third party for intellectual property rights
which are necessary for the practice of the rights licensed to us 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 June 30, 2020, no milestone payments have been
accrued or paid in relation to this agreement.
28
Liquidity
and Capital Resources
As of June 30, 2020, we
had working capital of $53.0 million, comprised primarily of cash and cash equivalents of $55.0 million and prepaid expenses and
other of $2.6 million, offset by $3.2 million of accounts payable, $1.1 million of accrued expenses and current lease liabilities
of $0.3 million. A significant portion of the accounts payable and accrued expenses are due to work performed in relation to our
Phase 3 clinical trial in FM and TNX-1800. For the six months ended June, 2020 and 2019, we used approximately $19.4 million and
$13.4 million of cash in operating activities, respectively, which represents cash outlays for research and development and general
and administrative expenses in such periods. The increase in cash outlays principally resulted from an increase in research and
development activities. For the six months ended June 30, 2020 and 2019, net proceeds from financing activities were $63.2 million
and $0.5 million, respectively, predominately from the sale of our common stock and warrants.
Cash used by investing
activities for the six months ended June 30, 2020 and 2019, was $14,000 and $10,000 respectively, related to the purchase of property
and equipment.
We believe that our cash
resources will be sufficient to meet our projected operating requirements through at least the end of 2020, but we do not have
enough resources to meet our operating requirements for the one-year from the date of filing of this Form 10-Q.
We continue to face significant
challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected
due to changes we may make in our research and development spending plans. These factors raise substantial doubt about our ability
to continue as a going concern for the one year from the date of filing of this Form 10-Q. We have the ability to obtain additional
funding through public or private financing or collaborative arrangements with strategic partners to increase the funds available
to fund operations. However, we may not be able to raise capital with terms acceptable to us. Without additional funds, we may
be forced to delay, scale back or eliminate some of our research and development activities, or other operations and potentially
delay product development in an effort to provide sufficient funds to continue our 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.
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 have a material adverse effect on our business, operations and financial
condition. The extent to which the Coronavirus 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.
Future
Liquidity Requirements
We
expect to incur losses from operations for the near future. We expect to incur increasing research and development expenses, including
expenses related to additional clinical trials. We will not have enough resources to meet our operating requirements for the one-year
from filing date of this report.
Our
future capital requirements will depend on a number of factors, including the progress of our research and development of product
candidates, the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability
of financing and our success in developing markets for our product candidates.
We
will need to obtain additional capital in order to fund future research and development activities. Future financing may include
the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms. Even if we are able to
raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant amounts
owed to us, or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we issue
additional equity or debt securities, shareholders may experience additional dilution or the new equity securities may have rights,
preferences or privileges senior to those of existing holders of our common stock.
29
If
additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of
or eliminate our research and development programs, reduce our commercialization efforts or obtain funds through arrangements
with collaborative partners or others that may require us to relinquish rights to certain product candidates that we might otherwise
seek to develop or commercialize independently.
Subsequent
to the quarter ended June 30, 2020, the Company raised approximately $2.4 million through warrant exercises.
July
2020 Financing
On
July 13, 2020, we entered into an underwriting agreement (“the July 2020 Financing”) with AGP, relating to the issuance
and sale of 20,940,000 shares of common stock, in a registered direct public offering. The public offering price for each share
of common stock was $0.50. The July 2020 Financing closed on July 15, 2020. AGP purchased the shares at a seven percent discount,
for an aggregate discount of $0.7 million. We expect to incur other offering expenses of approximately $0.3 million. We expect
to receive net proceeds of approximately $9.5 million, after deducting the underwriting discount and other offering expenses.
2020
At-the-Market Offering
On
April 8, 2020, we entered into a sales agreement (the “Sales Agreement”), with A.G.P/Alliance Global Partners (“AGP”),
pursuant to which we may issue and sell, from time to time, shares of the our common stock having an aggregate offering price
of up to $50.0 million in at-the-market offerings (“ATM”) sales. On the same day, we 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. Our common stock will be sold at prevailing market prices at the time of the sale, and, as a result,
prices will vary. During the quarter ended June 30, 2020, we sold approximately 53.0 million shares of common stock under the
Sales Agreement, for gross proceeds of approximately $35.3 million.
February
7 th Financing
On
February 7, 2020, we entered into an underwriting agreement (“the February 7 th Financing”) with AGP pursuant
to which we 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 our common
stock. The warrants have an exercise price of $0.57, are immediately exercisable and expire five years from the date of issuance.
The
February 7 th 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. We incurred other offering expenses
of approximately $0.5 million. We received net proceeds of approximately $6.5 million, after deducting the underwriting discount
and other offering expenses.
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 7 th financing, with an exercise price
of $0.57, were exercised for proceeds of approximately $6.2 million.
February
28 th Financing
On
February 28, 2020, we entered into an underwriting agreement (“the February 28th Financing”) with AGP, relating to
the issuance and sale of 14,550,000 shares of our common stock, in a registered direct public offering. The public offering price
for each share of common stock was $1.10. The February 28th 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. We incurred other offering expenses
of approximately $0.1 million. We received net proceeds of approximately $14.8 million, after deducting the underwriting discount
and other offering expenses.
30
November
2019 Financing
On
November 14, 2019, we entered into an underwriting agreement with AGP pursuant to which we 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 our common stock. 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. We incurred other offering expenses of approximately
$0.5 million. We 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.
With
the February 7th financing, warrants that were issued as part of the November 2019 financing were repriced at $0.57. 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. We 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.
2019
Lincoln Park Transaction
On
August 20, 2019, we entered into a purchase agreement (the “2019 Purchase Agreement”) and a registration rights agreement
(the “2019 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant
to the terms of the 2019 Purchase Agreement, Lincoln Park has agreed to purchase from us up to $15,000,000 of our common stock
(subject to certain limitations) from time to time during the term of the 2019 Purchase Agreement. Pursuant to the terms of the
2019 Registration Rights Agreement, we filed with the SEC a registration statement to register for resale under the Securities
Act the shares that have been or may be issued to Lincoln Park under the 2019 Purchase Agreement.
Pursuant
to the terms of the 2019 Purchase Agreement, at the time we signed the 2019 Purchase Agreement and the 2019 Registration Rights
Agreement, we issued 35,529 shares of common stock to Lincoln Park as consideration
for its commitment to purchase shares of our common stock under the 2019 Purchase Agreement. The commitment shares were valued
at $200,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as
a cost of capital to be raised under the 2019 Purchase Agreement.
As
a result of receiving stockholder approval on January 16, 2020, we may sell more than 19.9% of its common stock outstanding
pursuant to the 2019 Purchase Agreement without violating Nasdaq Marketplace Rules, including Rule 5635(d), requiring shareholder
approval for the sale, issuance or potential issuance by an issuer of common stock (or securities convertible into or exercisable
for common stock) at a price less than the greater of book or market value.
During the six months ended June 30, 2020, we sold an aggregate
of approximately 464,471 shares of common stock under the 2019 Purchase Agreement, for gross proceeds of approximately $0.3 million.
31
2018
Lincoln Park Transaction
On
October 18, 2018, we entered into a purchase agreement (the “2018 Purchase Agreement”) and a registration rights agreement
(the “2018 Registration Rights Agreement”) with Lincoln Park. Pursuant to the terms of the 2018 Purchase Agreement,
Lincoln Park has agreed to purchase from us up to $15,000,000 of our common stock (subject to certain limitations) from time to
time during the term of the 2018 Purchase Agreement. Pursuant to the terms of the 2018 Registration Rights Agreement, we filed
with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued
to Lincoln Park under the 2018 Purchase Agreement.
Pursuant
to the terms of the 2018 Purchase Agreement, at the time we signed the 2018 Purchase Agreement and the 2018 Registration Rights
Agreement, we issued 3,500 shares of common stock to Lincoln Park as consideration
for its commitment to purchase shares of our common stock under the 2018 Purchase Agreement. The commitment shares were valued
at $245,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as
a cost of capital to be raised under the 2018 Purchase Agreement.
During
the six months ended June 30, 2019, we sold an aggregate of approximately 22,754 shares of common stock under the 2018 Purchase
Agreement, for gross proceeds of approximately $0.4 million.
Under
applicable rules of the NASDAQ Global Market, we could not issue or sell more than 19.99% of the shares of its common stock outstanding
immediately prior to the execution of the 2018 Purchase Agreement (approximately 26,200 shares) to Lincoln Park under the 2018
Purchase Agreement without stockholder approval, unless the average price of all applicable sales of its common stock to Lincoln
Park under the 2018 Purchase Agreement equals or exceeds a threshold amount. As we have issued approximately 26,200 shares to Lincoln
Park, by June 30, 2019, under the 2018 Purchase Agreement at less than the threshold amount, we will not sell any additional shares
under the 2018 Purchase Agreement without shareholder approval.
32
Stock
Compensation
2019
Stock Incentive Plan
On
May 3, 2019, our 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.
2020
Stock Incentive Plan
On
January 16, 2020, our 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.
Amended
and Restated 2020 Stock Incentive Plan
On
May 1, 2020, our 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, we 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 2020 Plan provides 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 Amended and
Restated 2020 Plan and the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended and
Restated 2020 Plan). The Board of Directors determines the exercise price, vesting and expiration period of the grants under the
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 June 30, 2020, 456,250 shares were available for future grants under the Amended and Restated 2020
Plan.
We measure 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 our common stock on the date of the grant. For employees and directors,
the fair value of the award is measured on the grant date. Most stock options granted pursuant to the Plans typically vest 1/3rd
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, we issue options to directors which vest over a one-year period. We also issue premium options to executive officers,
which have an exercise price greater than the grant date fair value, subject to a one year minimum service period prior to vesting.
Stock-based compensation expense related to awards is amortized over the applicable vesting period using the straight-line method.
The
weighted average fair value of options granted during the three and six months ended June 2020 was $0.68 per share and $0.66
per share, respectively. The weighted average fair value of options granted during the three and six months ended June 2019
was $16.54 per share and $16.67 per share, respectively.
Stock-based
compensation expense relating to options granted of $0.7 million and $1.1 million was recognized for the three and six-month periods
ended June 30, 2020, respectively, and $0.4 million and $0.7 million was recognized for the three and six-month periods ended
June 30, 2019, respectively.
As
of June 30, 2020, we had approximately $7.3 million of total unrecognized compensation cost related to non-vested awards granted
under the Plans, which we expect to recognize over a weighted average period of 2.54 years.
2019
Employee Stock Purchase Plan
On
May 3, 2019, our 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.
2020
Employee Stock Purchase Plan
On
May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2020 Employee Stock Purchase Plan (the “2020
ESPP”).
33
The
2020 ESPP allows eligible employees to purchase up to an aggregate of 300,000 shares of our 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 our 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 June 30, 2020, 300,000 shares were available
for future sales under the 2020 ESPP.
The
2019 ESPP is considered compensatory plan with the related compensation cost expensed over the six-month offering period. For
the six months ended June 30, 2020 and 2019, $0 and $24,000, respectively were expensed. In January 2019, 177 shares that were
purchased as of December 31, 2018, under the 2018 ESPP, were issued. Accordingly, during the quarter ended March 31, 2019, approximately
$3,000 of employee payroll deductions accumulated at December 31, 2018, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. As of December 31, 2019, approximately $9,000 of employee payroll deductions,
which were withheld since July 1, 2019, the commencement of the offering period ending December 31, 2019, were included in accrued
expenses in the accompanying balance sheet. In January 2020, 1,578 shares that were purchased as of December 31, 2019, under the
2019 ESPP, were issued. Accordingly, during the six months ended June 30, 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.
Commitments
Research
and development contracts
We
have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately
$19.8 million at June 30, 2020 for future work to be performed.
Operating
leases
As
of June 30, 2020, future minimum lease payments are as follows (in thousands):
Year Ending December 31,
Remainder of 2020
$ 221
2021
178
2022
37
2023
13
Included interest
(8 )
$ 441
34
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial
statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation
of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities
and expenses. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and
on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ
from these estimates.
We
believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation
of our condensed consolidated financial statements.
Research
and Development . We outsource our research and development efforts and expense the related costs as incurred, including the
cost of manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials. The
value ascribed to patents and other intellectual property acquired was expensed as research and development costs, as it related
to particular research and development projects and had no alternative future uses.
We
estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations
under contracts with vendors, consultants and clinical research organizations and 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 to us under such contracts.
We account for trial expenses according to the progress of the trial as measured by participant progression and the timing of
various aspects of the trial. We determine accrual estimates that take into account discussions with applicable personnel and
outside service providers as to the progress or state of completion of trials, or the services completed. During the course of
a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of
our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical
trial accruals and prepaid assets are dependent upon the timely and accurate reporting of contract research organizations and
other third-party vendors.
Stock-Based
Compensation . All stock-based payments to employees and to nonemployee directors for their services as directors consisted
of grants of restricted stock and stock options, which are measured at fair value on the grant date and recognized in the condensed
consolidated statements of operations as compensation expense over the relevant vesting period. In addition, for awards that vest
immediately and are nonforfeitable, the measurement date is the date the award is issued.
Accounting
for sale of Class B Units in December 2018, November 2019 and February 2020 including beneficial conversion feature. In connection
with the December 2018, November 2019 and February 2020 underwritten offerings, we issued warrants to purchase our common stock
and convertible preferred stock. To account for the transaction, we calculated the relative fair value of each instrument issued
in the financing. We also determined if a beneficial conversion feature existed. A beneficial conversion feature is defined as
a nondetachable conversion feature that is in the money at the commitment date. A conversion feature is in the money if its conversion
price is less than the current fair value of the share. For purposes of measuring a beneficial conversion feature, the effective
conversion price should be based on the proceeds allocated to the convertible instrument.
We
determined the fair value of the warrants to purchase common stock, using a Monte Carlo simulation, for the December 2018 and
November 2019 financings, which is a statistical method used to generate a defined number of share price paths to develop a reasonable
estimate of the range of future expected share prices. We determined the fair value of the warrants, using the black-scholes method,
for the February 2020 warrants. Estimates and assumptions impacting the fair value measurement include the warrant’s callable
feature for the December 2018 offering, the number of shares for which the warrants are exercisable, remaining contractual term
of the warrants, risk-free interest rate, expected dividend yield and expected volatility of the price of the underlying common
shares. We estimate expected share volatility based on our historical volatility for a term equal to the contractual term of the
warrants adjusted for a discount that a market participant would have taken when pricing the instrument. The risk-free interest
rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual
term of the warrants. We estimated a 0% expected dividend yield based on the fact that we have never paid or declared dividends
and do not intend to do so in the foreseeable future. In general, the assumptions used in calculating the fair value of the warrant
represent management’s best estimates, but the estimates involve inherent uncertainties and the application of management
judgment. We determine the fair value of the convertible preferred stock utilizing the price of the common stock on the commitment
date. We then allocated the relative fair value between the preferred shares and the warrants. Since the effective conversion
price of the Preferred Stock is less than the fair value of the underlying common stock at the date of commitment, there is a
beneficial conversion feature at the commitment date. Since the Preferred Stock has no stated maturity or redemption date and
is immediately convertible at the option of the holder, the discount created by the beneficial conversion feature was charged
to additional paid in capital as a “deemed dividend” and impacted earnings per share, reflected as an increase to
loss to common stockholders.
Off-Balance
Sheet Arrangements
Other
than contractual obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements
or liabilities, guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material
variable interest in an unconsolidated entity.
35
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required under Regulation S-K for “smaller reporting companies.”
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.