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,
2023
2022
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
25,617
$
120,229
Inventory
13,700
—
Prepaid expenses and other
12,012
10,548
Total current assets
51,329
130,777
Property and equipment, net
95,717
93,814
Intangible assets, net
10,220
120
Goodwill
965
—
Right-of-use assets, net
1,213
715
Other non-current assets
292
264
Total assets
$
159,736
$
225,690
LIABILITIES, REDEEMBABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
7,673
$
8,068
Accrued expenses and other current liabilities
10,333
9,680
Lease liability, current
436
432
Total current liabilities
18,442
18,180
Lease liability, net of current portion
831
328
Total liabilities
19,273
18,508
Commitments (See Note 21)
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized
Series B Convertible Preferred stock, 0 shares
designated as of both June 30, 2023 and December 31, 2022; issued and outstanding - none
—
—
Series A Convertible Preferred stock, 0 shares designated as of both June 30, 2023 and December 31, 2022; issued and outstanding - none
—
—
Stockholders’ equity:
Common stock, $ 0.001 par value; 160,000,000 shares authorized; 10,762,341 and 12,368,620 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively and 14,999 shares to be issued as of December 31, 2022
11
12
Additional paid in capital
686,025
677,375
Accumulated deficit
( 545,361
)
( 470,038
)
Accumulated other comprehensive loss
( 212
)
( 167
)
Total stockholders’ equity
140,463
207,182
Total liabilities, redeemable convertible preferred stock and stockholders’ equity
$
159,736
$
225,690
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,
2023
2022
2023
2022
COSTS AND EXPENSES:
Research and development
$
21,976
$
16,579
$
48,487
$
35,001
General and administrative
7,026
6,757
14,417
14,771
Costs and Expenses
29,002
23,336
62,904
49,772
Operating loss
( 29,002
)
( 23,336
)
( 62,904
)
( 49,772
)
Interest and other income, net
646
196
1,543
215
Net loss
( 28,356
)
( 23,140
)
( 61,361
)
( 49,557
)
Preferred stock deemed dividend
—
4,255
—
4,255
Net loss available to common stockholders
$
( 28,356
)
$
( 27,395
)
$
( 61,361
)
$
( 53,812
)
Net loss per common share, basic and diluted
$
( 2.68
)
$
( 7.64
)
$
( 5.88
)
$
( 17.28
)
Weighted average common shares outstanding, basic and diluted
10,587,096
3,584,699
10,428,678
3,113,965
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,
2023
2022
2023
2022
Net loss
$
( 28,356
)
$
( 23,140
)
$
( 61,361
)
$
( 49,557
)
Other comprehensive loss:
Foreign currency translation loss
( 1
)
( 25
)
( 45
)
( 51
)
Comprehensive loss
$
( 28,357
)
$
( 23,165
)
$
( 61,406
)
$
( 49,608
)
See the accompanying notes to the condensed
consolidated financial statements
5
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
(In Thousands, Except Share and Per
Share Amounts)
(unaudited)
Accumulated
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2022
12,368,620
$
12
$
677,375
$
( 167
)
$
( 470,038
)
$
207,182
Repurchase of common stock under share repurchase program, including transactional expenses of $ 334
( 2,672,044 )
( 3 )
—
—
( 13,962 )
( 13,965 )
Issuance of common stock under 2022 Purchase agreement with Lincoln Park
96,000
—
441
—
—
441
Issuance of common stock net of transactional expenses of $ 101
514,502
1
1,994
—
—
1,995
Employee stock purchase plan
14,999
—
29
—
—
29
Stock-based compensation
—
—
2,794
—
—
2,794
Foreign currency transaction gain
—
—
—
( 44
)
—
( 44
)
Net loss
—
—
—
—
( 33,005
)
( 33,005
)
Balance, March 31, 2023
10,322,077
10
682,633
( 211
)
( 517,005
)
165,427
Issuance of common stock net of transactional expenses of $ 36
440,264
1
1,028
—
—
1,029
Stock-based compensation
—
—
2,364
—
—
2,364
Foreign currency transaction gain
—
—
—
( 1
)
—
( 1
)
Net loss
—
—
—
—
( 28,356
)
( 28,356
)
Balance, June 30, 2023
10,762,341
$
11
$
686,025
$
( 212
)
$
( 545,361
)
$
140,463
See the accompanying
notes to the condensed consolidated financial statements
6
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
(In Thousands, Except Share and Per
Share Amounts)
(unaudited)
Accumulated
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2021
2,634,110
$
3
$
578,626
$
( 92
)
$
( 359,820
)
$
218,717
Issuance of common stock in January and March 2022 under At-the-market offering, net of transactional expenses of $ 507
172,276
—
8,488
—
—
8,488
Issuance of common stock under 2021 Purchase agreement
110,000
—
4,535
—
—
4,535
Employee stock purchase plan
646
—
40
—
—
40
Stock-based compensation
—
—
2,620
—
—
2,620
Foreign currency transaction gain
—
—
—
( 26
)
—
( 26
)
Net loss
—
—
—
—
( 26,417
)
( 26,417
)
Balance, March 31, 2022
2,917,032
3
594,309
( 118
)
( 386,237
)
207,957
Issuance of common stock in April, May and June 2022 under At-the-market offering, net of transactional expenses of $ 1,426
2,220,699
2
42,966
—
—
42,968
Issuance of common stock under 2021 Purchase Agreement
65,000
—
1,964
—
—
1,964
Preferred stock deemed dividend
—
—
( 4,255
)
—
—
( 4,255
)
Stock-based compensation
—
—
2,813
—
—
2,813
Foreign currency transaction gain
—
—
—
( 25
)
—
( 25
)
Net loss
—
—
—
—
( 23,140
)
( 23,140
)
Balance, June 30, 2022
5,202,731
$
5
$
637,797
$
( 143
)
$
( 409,377
)
$
228,282
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,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 61,361
)
$
( 49,557
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
1,814
165
Stock-based compensation
5,158
5,433
Changes in operating assets and liabilities:
Prepaid expenses and other
268
( 4,381
)
Accounts payable
( 571
)
( 1,564
)
Lease liabilities and ROU asset, net
7
2
Accrued expenses and other current liabilities
( 1,593 )
( 2,315
)
Net cash used in operating activities
( 56,278
)
( 52,217
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of a business
( 22,174 )
—
Purchase of property and equipment
( 5,644
)
( 34,656
)
Net cash used in investing activities
( 27,818
)
( 34,656
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Repurchase of common stock
( 13,965 )
—
Proceeds from ESPP
29
40
Proceeds, net of $ 4,255 , from sale of convertible redeemable preferred stock
—
27,245
Proceeds, net of $ 137 and $ 1,933 expenses, from sale of common stock and warrants
3,465
57,955
Net cash (used in)/ provided by financing activities
( 10,471 )
85,240
Effect of currency rate change on cash
( 43
)
( 49
)
Net decrease in cash, cash equivalents and restricted cash
( 94,610
)
( 1,682
)
Cash, cash equivalents and restricted cash beginning of the period
120,470
178,900
Cash, cash equivalents and restricted cash end of period
$
25,860
$
177,218
Supplemental disclosures of cash flow information:
Non-cash financing and investing activities:
Purchases of property and equipment included in accounts payable and accrued liabilities
$
1,164
$
( 1,950
)
Preferred stock deemed dividend
$
—
$
4,255
See the accompanying
notes to the condensed consolidated financial statements
8
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
NOTE 1 –
BUSINESS
Tonix Pharmaceuticals Holding
Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a biopharmaceutical company focused
on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. The
therapeutics under development include both small molecules and biologics. Tonix, through its recent acquisition, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace® SymTouch® and Tosymra®,
which were acquired as of June 30, 2023 (See Note 8), are each indicated for the treatment of acute migraine with or without aura
in adults. All other drug product and vaccine candidates are still in development, and are not approved or marketed.
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., Jenner LLC, Tonix R&D Center LLC, Tonix Pharma
Holdings Limited and Tonix Pharma Limited (collectively hereafter referred to as the “Company” or “Tonix”).
All intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The accompanying financial
statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates
the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered
recurring losses from operations and negative cash flows from operating activities. At June 30, 2023, the Company had working capital
of approximately $ 32.9 million. At June 30, 2023, the Company had an accumulated deficit of approximately $ 545.4 million. The Company
held cash and cash equivalents of approximately $ 25.6 million as of June 30, 2023.
The Company believes
that its cash resources at June 30, 2023 and the proceeds that it raised from equity offerings in the third quarter of 2023 (See
Note 22), will meet its operating and capital expenditure requirements into the fourth quarter of 2023, but not beyond.
These factors raise
substantial doubt about the Company’s ability to continue as a going concern. The Company continues to face significant
challenges and uncertainties and, as a result, its available capital resources may be consumed more rapidly than currently expected
due to changes it may make in its research and development spending plans. The Company believes it has the ability to obtain
additional funding through public and private financing and collaborative arrangements with strategic partners to increase the funds
available to fund operations. However, the Company may not be able to raise capital on terms acceptable to the Company. Without
additional funds, it may be forced to delay, scale back or eliminate some of its research and development activities, or other
operations and potentially delay product development in an effort to provide sufficient funds to continue operations. If any of
these events occurs, our ability to achieve our development and commercialization goals would be adversely affected. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
Interim financial statements
The unaudited condensed
consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included.
The condensed consolidated
balance sheet as of December 31, 2022 contained herein has been derived from audited financial statements.
Operating results for
the three and six months ended June 30, 2023 are not necessarily indicative of results that may be expected for the year ending
December 31, 2023. 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, 2022 included in the Company’s Annual Report on Form
10-K, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2023.
9
TONIX PHARMACEUTICALS HOLDING
CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
Reverse Stock Split
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods
presented. Authorized preferred stock was not adjusted because of the reverse stock split.
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 has not previously had commercial products available
for sale, and has yet to generate revenues from a commercial product, and there is no assurance that the Company will be able
to generate cash flow to fund operations from any of its commercial products or products in development if and when approved. 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.
Use of estimates
The preparation of
financial statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets
and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual
results could differ from those estimates. Significant estimates include the assumptions used in the fair value of stock-based
compensation and other equity instruments, the percent of completion of research and development contracts, fair value estimates
for assets acquired in business combinations, and assessment of useful lives of acquired intangible assets.
Business Combinations
The Company accounts
for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations
(Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby
the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
Cash, Cash Equivalents and Restricted Cash
The Company considers
cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of
three months or less when purchased. At June 30, 2023 and December 31, 2022, cash equivalents, which consisted of money market
funds, amounted to $ 19.2 million and $ 116.3 million, respectively. Restricted cash, which is included in Other non-current assets
on the condensed consolidated balance sheet, at both June 30, 2023, and December 31, 2022, of approximately $ 243,000 and $ 241,000 ,
respectively, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and
New York, New York (see Note 20).
The following table
provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
June 30,
2023
June 30,
2022
(in thousands)
Cash and cash equivalents
$
25,617
$
145,478
Restricted cash – short term
—
31,500
Restricted cash
243
240
Total
$
25,860
$
177,218
10
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
Property and equipment
Property and equipment
are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s
estimated useful life, which ranges from 20 to 40 years for buildings, 15 years for land improvements and laboratory equipment,
three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
lease for leasehold improvements. Depreciation on assets begins when the asset is placed in service. Depreciation and amortization
expense for the three and six months ended June 30, 2023, was $ 900,000 and $ 1.8 million, respectively, and $ 102,000 and $ 165,000 ,
respectively, for the three and six months ended June 30, 2022. All property and equipment are located in the United States.
Intangible assets, net
Intangible assets deemed
to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived
intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
from Upsher Smith Laboratories, LLS (“USL Acquisition”) consummated on June 30, 2023 (See Note 8). The acquired intangible
assets are amortized using the straight-line method over the estimated useful lives of the respective assets.
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, which are included in Intangible assets, net on the condensed consolidated balance sheet, 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, 2023, the Company believed that no impairment existed.
Goodwill
Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances
indicate that the carrying amount of goodwill may be impaired. As of June 30, 2023, the Company has recognized goodwill in connection
with the USL Acquisition consummated on June 30, 2023 (See Note 8).
Leases
The Company determines
if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”)
assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s 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.
Convertible Preferred Stock
Preferred shares subject
to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally
redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as
temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
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 is related
to particular research and development projects and had no alternative future uses.
11
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
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.
Government Grants
From time to time,
the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received
under these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses
are incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute
on Drug Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product
candidate for the treatment of cocaine intoxication. During the three and six months ended June 30, 2023, we received $ 1.9 million
in funding as a reduction of related research and development expense.
Stock-based compensation
All stock-based payments
to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock
options, are measured at fair value on the grant date and recognized in the condensed consolidated statements of operations as
compensation or other expense over the requisite service period. The Company accounts for share-based awards in accordance with
the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
Foreign Currency Translation
Operations of the Company’s
Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., 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 consolidated condensed balance sheets.
Comprehensive Income (Loss)
Comprehensive income (loss) is
defined as the change in equity of a business during a period from transactions and other events and circumstances from non-owners
sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
Income Taxes
Deferred income tax
assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.
12
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
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, 2023, 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.
Per Share Data
The computation of
basic and diluted loss per share for the quarters ended June 30, 2023 and 2022 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 and preferred
stock 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 and preferred stock 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 and preferred stock for the three and six months ended June 30, 2023, and 2022, as results of operations were a
loss for the periods.
Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of June 30, 2023 and 2022, are as follows:
2023
2022
Warrants to purchase common stock
3,196
3,196
Series A convertible redeemable preferred stock
—
1,000,000
Series B convertible redeemable preferred stock
—
200,000
Options to purchase common stock
1,390,087
396,096
Totals
1,393,283
1,599,292
Recently Adopted Accounting Pronouncements
In August 2020, the
FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ,
which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU
also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception,
and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted ASU 2020-06 on January
1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company’s
financial position, results of operations or cash flows.
In June 2016, the FASB
issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide
financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments
and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace
the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13
will be effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal
years, using a modified retrospective approach. Early adoption is permitted. The Company adopted ASU 2016-13 and
related updates as of January 1, 2023. The adoption of ASU 2016-13 did not impact the Company’s financial
position, results of operations or cash flows.
13
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
NOTE 3 – PROPERTY AND EQUIPMENT,
NET
Property and equipment,
net consisted of the following (in thousands):
June 30,
2023
December 31,
2022
(in thousands)
Property and equipment, net:
Land
$
8,011
$
8,011
Land improvements
326
79
Buildings
66,223
65,644
Office furniture and equipment
2,297
1,893
Laboratory equipment
21,344
18,440
Leasehold improvements
34
34
Construction in progress
949
1,366
99,184
95,467
Less: Accumulated depreciation and amortization
( 3,467
)
( 1,653
)
$
95,717
$
93,814
On October 1, 2021,
the Company completed the acquisition of its approximately 45,000 square foot research and development facility in Frederick, Maryland
totaling $ 17.5 million, to process development activities. Of the total purchase price, $ 2.1 million was allocated to the value
of land acquired, and $13.9 million was allocated to buildings, and approximately $ 1.5 million was allocated to office furniture
and equipment and laboratory equipment. During 2022, the assets became ready for the intended use and were placed in service.
On September 28, 2020,
the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts for $ 4 .0 million,
to house its new Advanced Development Center for the development and manufacturing of vaccines. Of the total purchase price, $ 1.2
million was allocated to the value of land acquired, and $2.8 million was allocated to buildings. Additionally, the Company incurred
approximately $ 38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date to $ 61.6 million,
of which the majority related to the build-out of the facility. During 2022, the assets became ready for the intended use and were
placed in service.
On December 23, 2020,
the Company completed the purchase of its approximately 44 -acre site in Hamilton, Montana for $ 4.5 million, for the construction
of a vaccine development and commercial scale manufacturing facility. As of June 30, 2023, the asset was not ready for its intended
use.
NOTE 4 – GOODWILL AND INTANGIBLE ASSETS
The following table
provides the gross carrying value of goodwill as follows:
Amounts
(in thousands)
Balance at December 31, 2022
$ —
Acquired during the period (see Note 8)
965
Balance at June 30, 2023
$ 965
The following table
provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
June 30,
2023
December 31,
2022
(in thousands)
Intangible assets subject to amortization
Developed technology
$ 10,100
$ —
Less: Accumulated amortization
—
—
Total
$ 10,100
$ —
Intangible assets not subject to amortization
Internet domain rights
$ 120
$ 120
Total intangible assets, net
$ 10,220
$ 120
No amortization expense was recorded during
the six months ended June 30, 2023.
At June 30, 2023, the
related amortization for each of the next five years ended December 31 is as follows (in thousands):
Year Ending December 31,
Remainder of 2023
428
2024
856
2025
856
2026
856
2027 and beyond
7,104
$ 10,100
NOTE 5 – FAIR VALUE MEASUREMENTS
Fair value measurements
affect the Company’s accounting for certain of its financial assets. Fair value is defined as the price that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date
and is measured according to a hierarchy that includes:
Level 1:
Observable inputs, such as quoted prices in active markets.
Level 2:
Inputs, other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category includes U.S. government agency-backed debt securities and corporate-debt securities.
Level 3:
Unobservable inputs in which there is little or no market data.
As of June 30, 2023,
and December 31, 2022, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 19.2 million and
$ 116.3 million, respectively. The Company did not have any Level 2 or Level 3 assets or liabilities as of both June 30, 2023 and
December 31, 2022.
14
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
NOTE 6 – STOCKHOLDERS’ EQUITY
On May 9, 2023,
the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the
Certificate of Change, the Company effected a 1-for-6.25
reverse stock split of its issued and outstanding shares of common stock, whereby 64,627,246
outstanding shares of the Company’s common stock were exchanged for 10,340,506
shares of the Company’s common stock. In connection with the reverse stock split, the Company issued an additional 131,902
shares of the Company’s common stock due to fractional shares. Furthermore, pursuant to the Certificate of Change, the
number of authorized shares of common stock was reduced from 1,000,000,000
to 160,000,000 .
All per share amounts and number of shares in the condensed consolidated financial statements and related notes have been retroactively
restated to reflect the reverse stock split. As a result of the reverse-stock-split, on May 24, 2023, the Company’s
stock regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on the NASDAQ
Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2).
NOTE 7 – TEMPORARY EQUITY
On
October 26, 2022, the Company closed on an offering (“the October offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 1,400,000
shares of the Company’s Series A Convertible Redeemable Preferred Stock, par value $ 0.001
per share (the “Series A Preferred Stock”), and 100,000
shares of the Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001
per share (the “Series B Preferred Stock,” and together with the Series A Preferred Stock, the “Preferred Stock”),
at an offering price of $ 9.50
per share, representing a 5 %
original issue discount (“OID) to the stated value of $ 10.00
per share, for gross proceeds of $ 14.3
million in the aggregate for the October offering, before the deduction of fees and offering expenses. The shares of Preferred Stock were
convertible, at a conversion price of $ 6.25
per share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the holders
and, in certain circumstances, by the Company.
On
December 13, 2022, an amendment (the “December Amendment”) to the Company’s Articles of Incorporation, as
amended, to increase the Company’s authorized shares of common stock from 24,000,000
to 160,000,000 , as
adjusted for the reverse split, was approved at a special meeting of shareholders. The Series A Preferred Stock had the right
to vote on such December Amendment on an as-converted to common stock basis. The shares of the Series B Preferred Stock were
automatically voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding
any shares of common stock that were not voted) and Series A Preferred Stock were voted to increase the Authorized Shares.
The December Amendment required the approval of the majority of the votes associated with the Company’s outstanding
stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically and without further action of
the purchaser voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding
any shares of common stock that were not voted) and Series A Preferred Stock were voted on the December Amendment,
abstentions by common stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock.
The Certificates of Designation for the Preferred Stock provides that the Preferred
Stock have no voting rights other than the right to vote on the December Amendment and as a class on certain other specified
matters , and, with respect to the Series B Certificate of Designation, the
right to cast 2,500 votes per share of Series B Preferred Stock on the December Amendment .
The
holders of Preferred Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares
of common stock. The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into
shares of common stock at a conversion price of $ 6.25
per share. The holders of the Preferred Stock had the right to require the Company to redeem their shares of preferred stock for cash
at 105 %
of the stated value of such shares through January 23, 2023. The Company had the option to redeem the Preferred Stock for cash at 105 %
of the stated value, subject to the holders’ rights to convert the shares prior to such redemption.
The $ 14.3 million in
gross proceeds of the October offering was held in an escrow account, along with an additional $ 1.5 million deposited by the Company
to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 % redemption price until the
expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders.
Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the Company.
15
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
Since
the Preferred Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred
Stock and Series B Preferred Stock was recorded at redemption value of approximately $ 14.7 million and $ 1.1 million, respectively,
as calculated in the following table (in thousands):
Series A Preferred Stock
Series B Preferred Stock
Gross Proceeds
$
13,300
$
950
Less:
Preferred stock issuance costs
( 844
)
( 60
)
Plus:
Accretion of carrying value to redemption value
2,244
160
Preferred stock subject to possible redemption
$
14,700
$
1,050
During December 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
December 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 15.8 million in the aggregate.
On
June 24, 2022, the Company closed on an offering (“the Offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 2,500,000
shares of the Company’s Series A Convertible Redeemable Preferred Stock, par value $ 0.001
per share (the “Series A Preferred Stock”), and 500,000
shares of the Company’s Series B Convertible Redeemable Preferred Stock, par value $ 0.001
per share (the “Series B Preferred Stock,” and together with the Series A Preferred Stock, the “Preferred Stock”),
at an offering price of $ 9.50
per share, representing a 5 %
OID to the stated value of $ 10.00
per share, for gross proceeds of $ 28.5
million in the aggregate for the Offering, before the deduction of fees and offering expenses. The shares of Preferred Stock were convertible,
at a conversion price of $ 25.00
per share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the holders
and, in certain circumstances, by the Company.
On
August 5, 2022, an amendment (the “Amendment”) to the Company’s Articles of Incorporation, as amended, to
increase the Company’s authorized shares of common stock from 8,000,000
to 24,000,000 ,
as adjusted for the reverse split, was approved at a special meeting of shareholders. The Series A Preferred Stock had the
right to vote on such Amendment on an as-converted to common stock basis. The shares of the Series B Preferred Stock were
automatically voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding
any shares of common stock that were not voted) and Series A Preferred Stock were voted to increase the Authorized Shares.
The Amendment required the approval of the majority of the votes associated with the Company’s outstanding stock
entitled to vote on the proposal. Because the Series B Preferred Stock were automatically and without further action of the
purchaser voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding any
shares of common stock that were not voted) and Series A Preferred Stock were voted on the Amendment, abstentions by common
stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock. The Certificates of
Designation for the Preferred Stock provides that the Preferred
Stock have no voting rights other than the right to vote on the Amendment and as a class on certain other specified
matters , and, with respect to the Series B Certificate of Designation, the
right to cast 2,500 votes per share of Series B Preferred Stock on the Amendment .
The
holders of Preferred Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares
of common stock. The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into
shares of common stock at a conversion price of $ 25.00
per share. The holders of the Preferred Stock had the right to require the Company to redeem their shares of preferred stock for cash
at 105 %
of the stated value of such shares through September 22, 2022. The Company had the option to redeem the Preferred Stock for cash at 105 %
of the stated value, subject to the holders’ rights to convert the shares prior to such redemption.
The
$ 28.5
million in gross proceeds of the Offering was held in an escrow account, along with an additional $ 3 .0
million deposited by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 %
redemption price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment
to redeeming holders. Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the
Company.
16
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
Since
the Preferred Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred
Stock and Series B Preferred Stock was recorded at redemption value of approximately $ 26.3 million and $ 5.2 million, respectively,
as calculated in the following table (in thousands):
Series A Preferred Stock
Series B Preferred Stock
Gross Proceeds
$
23,750
$
4,750
Less:
Preferred stock issuance costs
( 1,046
)
( 209
)
Plus:
Accretion of carrying value to redemption value
3,546
709
Preferred stock subject to possible redemption
$
26,250
$
5,250
During August 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
August 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 31.5 million in the aggregate.
NOTE 8 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
On June 30, 2023 (the
“Closing”), pursuant to an Asset Purchase Agreement (the “Asset Purchase Agreement”) entered into on June
23, 2023 with USL, the Company completed the acquisition
of certain assets related to Zembrace® SymTouch® (sumatriptan injection) 3 mg (“Zembrace”) and Tosymra®
(sumatriptan nasal spray) 10 mg (“Tosymra”) products (such businesses collectively, the “Business”) and
certain inventory related to the Business for an aggregate purchase price of approximately $ 26.5 million, including certain deferred
payments and subject to customary adjustments (such transaction, the “USL Acquisition”).
On June 30, 2023, in
connection with the USL Acquisition, the Company and USL entered into a Transition Services Agreement (the “Transition
Services Agreement”), pursuant to which USL will provide certain transition services to the Company for base fees equal
to $ 100,000 per month for the first six months, and $ 150,000 per months for the seventh through ninth months, plus additional monthly
fees for each service category totaling up to $ 150,000 per month.
As consideration for
acquisition of the Business and certain product-related inventories, the Company paid an aggregate upfront purchase price
of approximately $ 22.2 million in cash. The closing cash consideration was later adjusted upwards by approximately
$ 1.3 million upon the determination of the value of the acquired inventory on hand as of June 30, 2023. The inventory adjustment
payment is expected to be settled in the third quarter of 2023. On the earlier of March 2024 and the completion of the transition
services to be provided by USL, as described above, the Company agreed to pay an additional deferred payment of $ 3 .0 million in
cash. The following table summarizes the components of the purchase consideration (in thousands):
Preliminary purchase consideration
Amount
Closing cash consideration
$ 22,174
Inventory adjustment payment liability
1,348
Deferred payment liability
3,000
Purchase price to be allocated
$
26,522
The USL Acquisition
was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business
Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The tangible
and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between
the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon
preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information
about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets
may be adjusted, with the offset recorded to goodwill. The acquisition-date fair value analyses will be finalized as soon as practicable,
but in no event later than one year after the acquisition date.
The following table
represents the preliminary allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized
in the Company’s consolidated balance sheets (in thousands):
Preliminary purchase price allocation
Amount
Inventory
$ 13,700
Prepaid expenses and other
1,757
Intangible assets, net
10,100
Goodwill
965
Fair value of assets acquired
$ 26,522
17
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
The acquired inventory
consists of USL’s raw materials, semi-finished goods, and finished goods inventory as of the Closing date. The fair value
was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort
and holding costs.
The $ 1.0 million of
goodwill arising from the USL Acquisition represents expected synergies from combining
operations, intangible assets that do not qualify for separate recognition, and other factors, of which all is expected to be deductible
for tax purposes, subject to any limitations.
Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):
Fair Value
Useful Life
(years)
Developed technology - Tosymra
$ 3,400
9
Developed technology - Zembrace
6,700
14
Total
$ 10,100
The developed technology
intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite
assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key
assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
cost of capital, customer retention rates, and certain other assumptions.
The fair values assigned
to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may
differ from these estimates and assumptions.
As the Closing occurred
on the last day of the second quarter of 2023, the operations of the Business had no impact on the Company’s operating results
for the three or six months ended June 30, 2023.
Supplemental Pro Forma Information
The following unaudited
pro forma consolidated financial information reflects the results of operations of the Company for the three and six months ended
June 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to transactions that are directly
attributable to the acquisition. These amounts are based on financial information of the acquired business and are not necessarily
indicative of what the Company’s operating results would have been had the acquisition taken place on the date presented,
nor is it indicative of the Company’s future operating results.
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net Product Sales
$ 3,544
$ 4,735
$ 7,621
$ 3,977
Net Loss
$ ( 29,730 )
$ ( 26,364 )
$ ( 64,180 )
$ ( 61,375 )
The pro forma information for all periods presented include additional
amortization expense related to the fair value of the acquired intangible assets as if such assets were acquired on January 1, 2022. The
pro forma financial information for the three and six months ended June 30, 2022 also reflects an increase in Cost of Sales related to
the preliminary acquisition-date fair value adjustment to inventory. This adjustment is not reflected in the three or six months ended
June 30, 2023 as the acquired inventory is expected to be sold within one year from the acquisition date.
18
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
NOTE 9 – ASSET PURCHASE AGREEMENT
WITH HEALION
On
February 2, 2023, the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”)
with Healion Bio Inc., (“Healion”) pursuant to which the Company acquired all
the pre-clinical infectious disease assets of Healion, including its portfolio of next-generation antiviral technology assets.
Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed
mechanism of action, including TNX-3900, formerly known as HB-121. As consideration for entering into the Healion Asset
Purchase Agreement, the Company paid $ 1.2 million to Healion. Because the Healion intellectual property was acquired prior to U.S.
Food and Drug Administration (FDA) approval, the cash consideration totaling $ 1.2 million, was expensed as research and development
costs since there is no alternative future use and the acquired intellectual property does not constitute a business.
NOTE 10 – ASSET PURCHASE AGREEMENT
WITH KATANA
On December 22, 2020,
the Company entered into an asset purchase agreement (the “Katana Asset Purchase Agreement”) with Katana Pharmaceuticals,
Inc. (“Katana”) pursuant to which Tonix acquired Katana assets related to insulin resistance and related syndromes,
including obesity (the “Katana Assets”). In connection with the acquisition of the Katana Assets, Tonix assumed Katana’s
rights and obligations under that certain Exclusive License Agreement by and between Katana and The University of Geneva (“Geneva”)
(the “Geneva License “Agreement”) pursuant to an Assignment and Assumption Agreement with Geneva (“Geneva
Assignment and Assumption Agreement”), dated December 22, 2020. As consideration for entering into the Katana Asset Purchase
Agreement, Tonix paid $ 0.7 million to Katana. The costs associated with the cash payments were previously recorded to research
and development expenses in the statement of operations. Because the Katana intellectual property was acquired prior to FDA approval,
the cash consideration totaling $ 0.7 million, was expensed as research and development costs since there is no alternative future
use and the acquired intellectual property does not constitute a business.
Pursuant to the terms
of the Geneva Assignment and Assumption Agreement, Geneva has granted to Tonix an exclusive license, with the right to sublicense,
certain patents related to the Katana Assets. Tonix is obligated to use commercially reasonable efforts to diligently develop,
manufacture, and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop
markets for such products. The Geneva License Agreement specifies developmental milestones and the period of time during which
such milestones must be completed and provides for an annual maintenance fee payable to Geneva. As of June 30, 2023, no milestone
payments have been accrued or paid in relation to this agreement.
NOTE 11 – ASSET PURCHASE AGREEMENT
WITH TRIGEMINA
On
June 11, 2020, the Company entered into an asset purchase agreement (the “Trigemina Asset Purchase Agreement”) with Trigemina,
Inc. (“Trigemina”) and certain shareholders named therein (the “Executive Shareholders”) pursuant to which Tonix
acquired Trigemina assets related to migraine and pain treatment technologies (the “Trigemina Assets”). In connection with
the acquisition of the Trigemina Assets, Tonix assumed Trigemina’s rights and obligations under that certain Amended and Restated
Exclusive License Agreement, dated November 30, 2007, as amended, by and between Trigemina and The Board of Trustees of the Leland Stanford
Junior University (“Stanford”) (the “Stanford License “Agreement”) pursuant to an Assignment and Assumption
Agreement with Stanford (“Assignment and Assumption Agreement”), dated June 11, 2020. As consideration for entering into the
Trigemina Asset Purchase Agreement, Tonix paid $ 824,759
to Trigemina and issued to Trigemina 10,000
shares of the Company’s common stock, valued at $ 136.00
per share, based on the closing stock price on June 11, 2020, and paid Stanford $ 250,241
pursuant to the terms of the Assignment and Assumption Agreement. The common stock is unregistered and subject to a 12-month lock-up and
a Shareholder Voting Agreement, dated June 11, 2020, pursuant to which Trigemina and the Executive Shareholders have agreed to vote the
common stock on any matter put to a vote of the shareholders of the Company in accordance with management’s recommendations. Both
the costs associated with the cash payments and share issuance, totaling $ 2.4
million, were previously recorded to research and development expenses in the statement of operations. Because the Trigemina intellectual
property was acquired prior to FDA approval, the cash and stock consideration, was expensed as research and development costs since there
is no alternative future use and the acquired intellectual property does not constitute a business.
Pursuant to the terms
of the Assignment and Assumption Agreement, Stanford has granted to Tonix an exclusive license, with the right to sublicense, certain
patents related to the Trigemina Assets. Stanford has reserved for itself the right to practice under the patents for academic
research and educational purposes. Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture,
and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for
such products.
19
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
The Trigemina License
Agreement specifies developmental milestones and the period of time during which such milestones must be completed and provides
for an annual maintenance fee payable to Stanford. As of June 30, 2023, other than the annual maintenance fee, no milestone payments
have been accrued or paid in relation to this agreement.
NOTE 12 – 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 subsequently amended. 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 .
The $ 168,500
was previously recorded to research and development expenses in the statement of operations. 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 Our 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.
Pursuant to the WSU
License Agreement, Tonix paid $ 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, 2023, no milestone payments have been
accrued or paid in relation to this agreement.
NOTE 13 – LICENSE AGREEMENT WITH CURIA
On December 12, 2022,
the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
or prophylaxis of SARS-CoV-2 infection. We believe that the licensing of these mAbs strengthens our pipeline of next-generation
therapeutics to treat COVID-19, which is caused by SARS-CoV-2. As consideration for entering into the License Agreement, we paid
a license fee of approximately $ 0.4 million to Curia. The License Agreement also provides for single-digit royalties and contingent
milestone payments. As of June 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this
agreement.
NOTE 14 – LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA
On May 18, 2022, the
Company entered into an exclusive License Agreement with the University of Alberta focused on identifying and testing broad-spectrum
antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering into the License
Agreement, Tonix paid a low-five digit license fee to University of Alberta. The License Agreement also provides for single-digit
royalties and contingent milestone payments. As of June 30, 2023, other than the upfront fee, no milestone payments have been accrued
or paid in relation to this agreement.
20
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
NOTE 15 – LICENSE AGREEMENT WITH
INSERM
On February 11, 2021,
the Company entered into a license agreement (the “Inserm License Agreement”) pursuant to which it licensed technology
using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm
(the French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire
of Toulouse. The Inserm License Agreement provides for the payment of annual fees and milestone payments upon the occurrence of
specified sales milestones totaling approximately $ 0.4 million, as well royalties on net sales of products based on the licensed
technology, and assignment/transfer and sublicense royalties. As of June 30, 2023, no milestone payments have been accrued or paid
in relation to this agreement.
NOTE 16 – 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”), as subsequently amended, pursuant to which Columbia granted to Tonix
an exclusive license, with the right to sublicense, certain patents and technical information (collectively, the “TFF2 Technology”)
related to a recombinant Trefoil Family Factor 2 (TFF2), and to develop and commercialize products thereunder (each, a “TFF2
Product”). Pursuant to the terms of the Columbia License Agreement, Columbia reserved for itself the right to practice the
TFF2 Technology for academic research and educational purposes.
The Company paid a
five-digit license fee to Columbia as consideration for entering into the Columbia License Agreement, which was previously recorded
to research and development expenses in the statement of operations. 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 is obligated
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, 2023, no milestone payments have been accrued or paid in relation to this agreement.
On May 20, 2019, the
Company entered into an exclusive License Agreement (the “License Agreement”) with Columbia pursuant to which Columbia,
for itself and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”)
granted to the Company an exclusive license, with the right to sublicense, certain patents, technical information and material
(collectively, the “Technology”) related to a double-mutant cocaine esterase, and to develop and commercialize products
thereunder (each, a “Product”). Pursuant to the terms of the License Agreement, Columbia has reserved for itself and
the Institutions the right to practice the Technology for academic research and educational purposes.
The Company paid 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 Company agreed to
pay Columbia single-digit royalties on net sales of (i) Products sold by the Company or a sublicensee and (ii) any other products
that involve material or technical information related to the Product and transferred to the Company pursuant to the License Agreement
(“Other Products”) sold by the Company or a sublicensee. Royalties on each particular Product are payable on a country-by-country
and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the
issued patents covered by the License Agreement, (ii) a specified period of time after the first commercial sale of a Product in
the country in question, or (iii) expiration of any market exclusivity period granted by a regulatory agency. Royalties on each
particular Other Product are payable on a country-by-country and product-by-product basis until the later of (i) a specified period
of time after the first commercial sale of such particular Other Product in such country or (ii) expiration of any market exclusivity
period granted by a regulatory agency. Royalties payable on net sales of the Product and Other Products may be reduced by 50 % of
the royalties payable by the Company to any third party for intellectual property rights which are necessary for the practice of
the rights licensed to the Company under the License Agreement, provided that the royalty payable on a Product or Other Product
may not be reduced by more than 50 %.
21
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND
2022 (UNAUDITED)
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, 2023 no milestone payments have been accrued or paid in relation to this agreement.
On February 13, 2023,
Tonix exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of both fully human and
murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.
The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia.
NOTE 17 – SALE AND PURCHASE OF COMMON STOCK
2022 Lincoln Park Transaction
On August 16, 2022,
the Company entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement (the
“2022 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to
the terms of the 2022 Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $ 50,000,000 of the Company’s
common stock (subject to certain limitations) from time to time during the term of the 2022 Purchase Agreement. Pursuant to the
terms of the 2022 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 2022 Purchase Agreement.
Pursuant to the terms
of the 2022 Purchase Agreement, at the time the Company signed the 2022 Purchase Agreement and the 2022 Registration Rights Agreement,
the Company issued 100,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of the
Company’s common stock under the 2022 Purchase Agreement. The commitment shares were valued at $ 1,000,000 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 2022 Purchase Agreement.
During the three and
six months ended June 30, 2023, the Company sold 0 and 0.1 million shares, respectively, of common stock under the 2022 Purchase
Agreement, for net proceeds of approximately $ 0 and $ 0.4 million, respectively.
22
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
Purchase Agreement with Lincoln Park
On December 3, 2021,
the Company entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a registration rights
agreement (the “Lincoln Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase from the Company up to $ 80,000,000
of the Company’s common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement
with Lincoln Park. Pursuant to the terms of the Lincoln Park 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
Purchase Agreement with Lincoln Park.
Pursuant to the terms
of the Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park and the Lincoln
Park Registration Rights Agreement, the Company issued 14,546 shares of common stock to Lincoln Park as consideration for its commitment
to purchase shares of our common stock under the Purchase Agreement with Lincoln Park. The commitment shares were valued at $ 1.6
million 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 Purchase Agreement with Lincoln Park.
During the three and
six months ended June 30, 2022, the Company sold 0.1 million and 0.2 million shares, respectively, of common stock under the
Purchase Agreement with Lincoln Park, for net proceeds of approximately $ 2 .0 million and $ 6.5 million, respectively. No sales occurred
in 2023.
At-the-Market Offerings
On April 8, 2020,
the Company entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company may issue
and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $ 320 .0 million
in at-the-market offerings (“ATM”) sales. 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 three and six months ended June 30, 2023, the Company sold approximately 0.4 million
and 1.0 million shares, respectively, of common stock under the Sales Agreement, for net proceeds of approximately $ 1 .0 million
and $ 3 .0 million, respectively. During the three and six months ended June 30, 2022, the Company sold approximately 2.2 million
and 2.4 million shares, respectively, of common stock under the Sales Agreement, for net proceeds of approximately $ 43 .0 million
and $ 51.5 million, respectively.
Stock Repurchases
During the first quarter of 2023, the Company has repurchased 2,512,044 of its shares of common stock outstanding under the 2022 share repurchase
program for up to $ 12.5 million at prices ranging from $ 2.75 to $ 8.61 per share for a gross aggregate cost of approximately $ 12.5
million . In addition, the Company incurred expenses of $ 0.3 million.
In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant
to which the Company may repurchase up to an additional $ 12.5 million in value of its outstanding common stock from time
to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors. During the first quarter of 2023, the Company has repurchased 160,000 of our shares of common stock
outstanding under the new 2023 share repurchase program at $ 7.12 per share for a gross aggregate cost of $ 1.1 million .
The
timing and amount of any shares repurchased will be determined based on
the Company’s evaluation of market conditions and other factors and the New Share Repurchase Program may
be discontinued or suspended at any time. Repurchases will be made in accordance
with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which
the Company may be subject. Repurchases may be made, in part, under a Rule
10b5-1 plan, which allows stock repurchases when the Company might otherwise
be precluded from doing so.
23
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
NOTE 18 – STOCK-BASED COMPENSATION
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 700 shares of common stock. With the adoption of the 2020 Plan (as defined below),
no further grants may be made under the 2019 Plan. On January 16, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals
Holding Corp. 2020 Stock Incentive Plan (the “2020 Plan”). The 2020 Plan provided for the issuance of up to 3,000
shares of common stock. With the adoption of the Amended and Restated 2020 Plan (as defined below), no further grants may be made
under the 2020 Plan.
On May 1, 2020,
the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan
(“Amended and Restated 2020 Plan”), and together with the 2020 Plan and the 2019 Plan, the “Plans”).
Under the terms of
the Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock,
(3) stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended
and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased
to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in
the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”
providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January
1, 2030, in an amount equal to the difference between (x) twenty percent ( 20 %) of the total number of shares of common stock outstanding
on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended
and Restated 2020 Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards,
issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration
period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not
be less than 110 % of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100 % of fair value
for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in
absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under
the Amended and Restated 2020 Plan may not be more than ten years . As of June 30, 2023, 1,057,051 options were available for future
grants under the Amended and Restated 2020 Plan.
General
A summary of the stock option activity and
related information for the Plans for the three months ended June 30, 2023 is as follows:
Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding at December 31, 2022
392,643
$
334.08
8.70
$
—
Grants
1,011,630
4.66
Exercised
—
—
Forfeitures or expirations
( 14,186
)
874.50
Outstanding at June 30, 2023
1,390,087
$
88.77
9.26
$
—
Exercisable at June 30, 2023
237,227
$
404.34
8.02
$
The weighted average
fair value of options granted during the three and six months ended June 2023 was $ 2.73 per share and $ 4.01 per share, respectively.
The weighted average fair value of options granted during the three and six months ended June 2022 was $ 23.63 per share and $ 32.81
per share, respectively.
24
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
The Company measures
the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair value of the
award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date
of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues
options to directors which vest over a one -year period. The Company also issues premium options to executive officers which have
an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters
are met or probable of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation
expense related to awards is amortized over the applicable service period using the straight-line method.
The assumptions used
in the valuation of stock options granted during the six months ended June 30, 2023 and 2022 were as follows:
Six Months Ended
June 30, 2023
Six Months Ended
June 30, 2022
Risk-free interest rate
3.42 % to 4.02
%
1.67 % to 3.05
%
Expected term of option
5.0 to 10 years
5.5 to 10 years
Expected stock price volatility
121.26 % - 142.72
%
120.32 % - 133.22
%
Expected dividend yield
0.0
0.0
The risk-free interest
rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of
the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based compensation
expense relating to options granted of $ 2.4 million, of which $ 1.6 million and $ 0.8 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended June 30, 2023. Stock-based compensation expense
relating to options granted of $ 2.8 million, of which $ 2.0 million and $ 0.8 million, related to General and Administration and
Research and Development, respectively was recognized for the quarter ended June 30, 2022.
Stock-based compensation
expense relating to options granted of $ 5.2 million, of which $ 3.6 million and $ 1.6 million, related to General and Administration
and Research and Development, respectively was recognized for the six-month period ended June 30, 2023. Stock-based compensation
expense relating to options granted of $ 5.4 million, of which $ 3.9 million and $ 1.5 million, related to General and Administration
and Research and Development, respectively was recognized for the six-month period ended June 30, 2022.
As of June 30, 2023,
the Company had approximately $ 10.3 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 1.87 years.
Employee Stock Purchase Plans
On May 3, 2019, the
Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2019 Employee Stock Purchase Plan (the “2019
ESPP”). As a result of adoption of the 2020 ESPP, as defined below, by the stockholders, no further grants may be made under
the 2019 ESPP Plan. On May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2020 Employee
Stock Purchase Plan (the “2020 ESPP”). No further grants may be made under the 2020 ESPP Plan. On May 6, 2022, the
Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan (the “2022
ESPP”, and together with the 2019 ESPP and the 2020 ESPP, the “ESPP Plans”)).
The 2022 ESPP allows
eligible employees to purchase up to an aggregate of 15,000 shares of the Company’s common stock. Under the 2022
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 2022 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 2022 ESPP, subject to the statutory limit under the Code. As of June 30, 2023, 1 share were available for future
sales under the 2022 ESPP.
25
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
The 2022 and
2020 ESPP are considered compensatory plans with the related compensation cost expensed over the six-month offering period. No
expenditure was recorded during either the six months ended June 30, 2023 and 2022. In January 2022, 646 shares that were purchased
as of December 31, 2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022, approximately $ 40,000
of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued
expenses to additional paid in capital. The remaining $ 30,000 was returned to the employees. In January 2023, 14,999 shares that
were purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023, approximately
$ 29,000 of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. The remaining $ 14,000 was returned to the employees.
NOTE 19 – STOCK WARRANTS
The following table
summarizes information with respect to outstanding warrants to purchase common stock of the Company at June 30, 2023:
Exercise
Number
Expiration
Price
Outstanding
Date
$
100.00
125
November 2024
$
114.00
618
February 2025
$
7,000.00
2,453
December 2023
3,196
No warrants were exercised
during either of the six months ended June 30, 2023, and 2022.
NOTE 20 – 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, 2023, the
Company has right-of-use assets of $ 1.2 million and a total lease liability for operating leases of $ 1.2 million of which $ 0.8
million is included in long-term lease liabilities and $ 0.4 million is included in current lease liabilities.
At June 30, 2023, 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,
2023
$
237
2024
460
2025
299
2026
142
2027 and beyond
246
1,384
Included interest
( 117
)
$
1,267
During the six months
ended June 30, 2023, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
additional operating lease liability of approximately $ 898,000 based on the present value of the minimum rental payments. The Company
also recognized a corresponding increase to ROU assets of approximately $ 898,000 , which represents a non-cash investing and financing
activity.
During the six months
ended June 30, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
additional operating lease liability of approximately $ 334,000 based on the present value of the minimum rental payments. The Company
also recognized a corresponding increase to ROU assets of approximately $ 334,000 , which represents a non-cash investing and financing
activity.
Operating lease expense
was $ 0.2 and $ 0.1 million for the quarters ended June 30, 2023, and 2022, respectively.
26
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2023 AND 2022 (UNAUDITED)
Operating lease expense
was $ 0.3 million for both six-months ended June 30, 2023, and 2022.
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities:
Six Months Ended
June 30, 2023
Six Months Ended
June 30, 2022
Operating cash flow from operating leases (in thousands)
$
289
$
309
Weighted Average Remaining Lease Term
Operating leases
3.52 years
2.49 years
Weighted Average Discount Rate
Operating leases
4.55 %
2.31 %
NOTE 21 – COMMITMENTS
Contractual agreements
The Company has entered
into contracts with various contract research organizations with outstanding commitments aggregating approximately $ 62.8 million
at June 30, 2023 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 $ 200,000 and $ 500,000 for the three and six months ended June 30, 2023, respectively, and $ 115,000 and $ 306,000
for the three and six months ended June 30, 2022, respectively, for contributions under the 401(k) Plan.
NOTE 22 – SUBSEQUENT EVENTS
On July 27, 2023,
the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional
investors (collectively, the “Purchasers”), pursuant to which the Company sold 2,530,000
shares of common stock; pre-funded warrants to purchase up to 4,470,000
shares of common stock, and accompanying common warrants to purchase up to 7,000,000
shares of common stock with an exercise price of $ 1.00 per share. The offering price per share of common stock and
accompanying common warrant was $ 1.00 ,
and the offering price per share of pre-funded warrant and accompanying common warrant was $ 0.9999 .
The offering closed
on August 1, 2023. The Company incurred offering expenses of approximately $ 0.8 million, including placement agent fees of approximately $ 0.5 million. The Company received net proceeds
of approximately $ 6.2 million, after deducting the underwriting discount and other offering expenses.
27
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.