Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Par Value and Share Amounts)
(unaudited)
June 30,
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
125,331
$
98,776
Accounts receivable, net
2,320
3,683
Inventory
5,986
8,408
Prepaid expenses and other current assets
9,898
8,135
Total current assets
143,535
119,002
Property and equipment, net
42,335
42,252
Intangible assets, net
120
120
Operating lease right-to-use assets
438
565
Other non-current assets
931
951
Total assets
$
187,359
$
162,890
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
7,783
$
4,546
Accrued expenses and other current liabilities
11,083
10,667
Term loan payable, short term
—
2,820
Lease liability, short term
195
274
Total current liabilities
19,061
18,307
Term loan payable, long term
—
4,667
Lease liability, long term
297
358
Total liabilities
19,358
23,332
Commitments (See Note 16)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized, 0 shares designated as of both June 30, 2025, and December 31, 2024; 0 shares issued and outstanding - as of both June 30, 2025 and December 31, 2024
—
—
Common stock, $ 0.001 par value; 1,000,000,000 shares authorized; 7,546,276 and 4,385,929 shares issued and outstanding as of June 30, 2025, and December 31, 2024, respectively
8
4
Additional paid in capital
944,058
870,503
Accumulated deficit
( 775,795
)
( 730,694
)
Accumulated other comprehensive loss
( 270
)
( 255
)
Total stockholders’ equity
168,001
139,558
Total liabilities and stockholders’ equity
$
187,359
$
162,890
See the accompanying notes to the condensed consolidated
financial statements
1
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,
2025
2024
2025
2024
REVENUE:
Product revenue, net
$
1,998
$
2,208
$
4,427
$
4,690
COSTS AND EXPENSES:
Cost of revenue
3,272
3,367
4,215
5,027
Research and development
10,820
9,698
18,256
22,561
Selling, general and administrative
16,202
7,502
26,306
16,812
Asset impairment charges
–
58,957
–
58,957
Total operating expenses
30,294
79,524
48,777
103,357
Operating loss
( 28,296
)
( 77,316
)
( 44,350
)
( 98,667
)
Grant income
1,036
–
1,959
–
(Loss) gain on change in fair value of warrant liabilities
–
( 855 )
–
6,150
Loss on extinguishment of debt
–
–
( 2,092 )
–
Interest income, net
943
1
1,571
3
Other expense, net
( 1,955 )
( 606 )
( 2,189 )
( 1,201 )
Net loss available to common stockholders
$
( 28,272
)
$
( 78,776
)
$
( 45,101
)
$
( 93,715
)
Net loss per common share, basic and diluted
$
( 3.86
)
$
( 1,920.85
)
$
( 6.80
)
$
( 2,720.40
)
Weighted average common shares outstanding, basic and diluted
7,327,257
41,011
6,631,111
34,449
See the accompanying notes to the condensed consolidated
financial statements
2
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(In Thousands)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Net loss
$
( 28,272
)
$
( 78,776
)
$
( 45,101
)
$
( 93,715
)
Other comprehensive loss:
Foreign currency translation loss
( 4
)
( 3
)
( 15
)
( 11
)
Comprehensive loss
$
( 28,276
)
$
( 78,779
)
$
( 45,116
)
$
( 93,726
)
See the accompanying notes to the condensed consolidated
financial statements
3
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, 2024
4,385,929
$
4
$
870,503
$
( 255
)
$
( 730,694
)
$
139,558
Repurchase of common stock under share repurchase program including transactional expenses of $ 8
( 250,000 )
—
( 3,047
)
—
—
( 3,047 )
Issuance of common stock under At-the-Market, net of transactional expenses of $ 2,182
2,741,887
3
59,840
—
—
59,843
Stock-based compensation
—
—
882
—
—
882
Foreign currency transaction gain
—
—
—
( 11
)
—
( 11
)
Net loss
—
—
—
—
( 16,829
)
( 16,829
)
Balance, March 31, 2025
6,877,816
7
928,178
( 266
)
( 747,523
)
180,396
Repurchase of common stock under share repurchase program including transactional expenses of $ 5
( 150,000 )
—
( 2,902
)
—
—
( 2,902 )
Issuance of common stock under At-the-Market, net of transactional expenses of $ 487
769,752
1
15,522
—
—
15,523
Issuance of common stock for 2025 Lincoln Park Transaction commitment shares
48,708
—
1,837
—
—
1,837
Stock-based compensation
—
—
1,423
—
—
1,423
Foreign currency transaction gain
—
—
—
( 4
)
—
( 4
)
Net loss
—
—
—
—
( 28,272
)
( 28,272
)
Balance, June 30, 2025
7,546,276
$
8
$
944,058
$
( 270
)
$
( 775,795
)
$
168,001
See the accompanying notes to the
condensed consolidated financial statements
4
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, 2023
20,926
$
—
$
706,415
$
( 232
)
$
( 600,658
)
$
105,525
Issuance of common stock upon exercise of prefunded common warrants
4,701
—
—
—
—
—
Fair value of warrants reclassified from liabilities to equity
—
—
15,850
—
—
15,850
Employee stock purchase plan
21
—
23
—
—
23
Stock-based compensation
—
—
1,692
—
—
1,692
Foreign currency transaction gain
—
—
—
( 8
)
—
( 8
)
Net loss
—
—
—
—
( 14,939
)
( 14,939
)
Balance, March 31, 2024
25,648
—
723,980
( 240
)
( 615,597
)
108,143
Issuance of common stock, net of transactional expenses of $ 1,704
43,699
—
10,730
—
—
10,730
Issuance of common stock upon exercise of prefunded common warrants
29,140
—
—
—
—
—
Fair value of warrants reclassified from equity to liabilities
—
—
( 9,977
)
—
—
( 9,977
)
Fair value of warrants reclassified from liabilities to equity
—
—
10,832
—
—
10,832
Stock-based compensation
—
—
1,154
—
—
1,154
Foreign currency transaction gain
—
—
—
( 3
)
—
( 3
)
Net loss
—
—
—
—
( 78,776
)
( 78,776
)
Balance, June 30, 2024
98,487
$
—
$
736,719
$
( 243
)
$
( 694,373
)
$
42,103
See the accompanying notes to the
condensed consolidated financial statements
5
TONIX PHARMACEUTICALS HOLDING CORP .
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(unaudited)
Six Months Ended June 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 45,101
)
$
( 93,715
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
976
2,415
Asset impairment charges
—
58,957
Change in fair value of warrant liabilities
—
( 6,150 )
Inventory write-off
2,280
1,738
Amortization of debt discount
65
431
Loss on extinguishment of debt
2,092
—
Stock-based compensation
2,305
2,846
Issuance costs from derivative instruments
1,837
—
Changes in operating assets and liabilities:
Accounts receivable
1,363
( 3,339 )
Inventory
142
2,444
Prepaid expenses and other current assets
( 483 )
1,011
Accounts payable
2,711
6,703
Lease liabilities and ROU asset, net
( 12
)
( 2 )
Accrued expenses and other current liabilities
413
( 833
)
Net cash used in operating activities
( 31,412
)
( 27,494
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Issuance of note
( 2,012
)
—
Purchase of property and equipment
( 533
)
( 108
)
Net cash used in investing activities
( 2,545
)
( 108
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Purchase of a business
—
( 3,000
)
Repurchase of common stock
( 5,949 )
—
Proceeds from ESPP
—
23
Payment of term loan
( 9,650
)
( 940 )
Proceeds, net of $ 2,757 and $ 1,704 expenses, from sale of common stock and warrants
76,125
10,730
Net cash provided by financing activities
60,526
6,813
Effect of currency rate change on cash
( 13
)
( 3
)
Net increase (decrease) in cash, cash equivalents and restricted cash
26,556
( 20,792
)
Cash, cash equivalents and restricted cash beginning of the period
99,680
25,850
Cash, cash equivalents and restricted cash end of period
$
126,236
$
5,058
Supplemental disclosures of cash flow information:
Interest paid
$
117
$
653
Non-cash financing and investing activities:
Issuance costs from derivative instruments
$
1,837
—
Net ATM proceeds received after quarter-end
$
1,629
$
—
Purchases of property and equipment included in accounts payable and accrued liabilities
$
526
$
106
See the accompanying notes to the
condensed consolidated financial statements
6
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 1 – BUSINESS
Tonix
Pharmaceuticals Holding Corp. (“Tonix” or the “Company”), through its wholly owned subsidiary Tonix Pharmaceuticals,
Inc. (“Tonix Sub”), and its wholly owned commercial subsidiary Tonix Medicines (“Tonix Medicines”), is
a fully- integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health
challenges.
Tonix’s
priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which a Prescription Drug User
Fee Act (“PDUFA”) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. A New
Drug Application (“NDA”) for TNX-102 SL was submitted to the U.S. Food and Drug Administration (“FDA”) based on two statistically
significant Phase 3 studies for the management of fibromyalgia. In March 2025 the FDA guided that no Advisory Committee Meeting
will be required for this NDA. The FDA had also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia
which indicates that the FDA views fibromyalgia as a serious condition that remains an unmet medical need. TNX-102 SL is also
being developed to treat acute stress reaction and acute stress disorder (ASR/ASD) under a Physician-Initiated Investigational
New Drug application (“IND”) at the University of North Carolina in the OASIS study funded by the U.S. Department
of Defense (“DoD”). The first patient was enrolled in the ASD/ASR study in May 2025 and topline results are expected
in the second half of 2026.
Tonix’s
immunology and immune-oncology pipeline consists of biologics to address organ transplant rejection, autoimmunity and cancer,
including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed
for the prevention of allograft rejection and for the treatment of autoimmune diseases. In February 2025, Tonix announced positive
topline results from a Phase 1 trial of TNX-1500 which supported proceeding to develop a Phase 2 trial for the prevention of kidney
transplant rejection. TNX-1700 is a stabilized recombinant version of Trefoil Factor 2 (TFF2) and is in the preclinical stages
of development to treat gastric and colorectal cancers.
Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development
to prevent mpox and smallpox, as well as TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention
or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix has a contract
with the DoD’s Defense Threat Reduction Agency (“DTRA”) for up to $ 34 million over five years to develop TNX-4200.
Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary,
markets Zembrace ® SymTouch ® (sumatriptan injection) 3 mg and Tosymra ® (sumatriptan nasal
spray) 10 mg for the treatment of acute migraine with or without aura in adults.
The consolidated financial statements
include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals
(Canada), Inc., Tonix Medicines, Inc., Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma
Limited (collectively, 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, 2025, the Company had working capital of approximately $ 124.5
million. At June 30, 2025, the Company had an accumulated deficit of approximately $775.8 million. The Company held cash and cash equivalents
of approximately $125.3 million as of June 30, 2025.
The Company believes that its
cash resources at June 30, 2025 and the net proceeds of $ 51.5 million that it received from equity offerings in the third quarter of 2025
(See Note 17), will meet its planned operating and capital expenditure requirements into the third quarter of 2026.
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 must 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, or at
all. Without additional funds, it may be forced to delay, scale back or eliminate some or all of its research and development activities
or other operations, and potentially delay product development in an effort to maintain sufficient funds to continue operations. If any
of these events occurs, the Company’s ability to achieve development and commercialization goals will be adversely affected and
the Company may be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
7
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
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, 2024, contained herein has been derived from audited financial statements.
Operating results for the
three and six months ended June 30, 2025 are not necessarily indicative of results that may be expected for the year ending December 31,
2025. 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, 2024, included in the Company’s Annual Report on Form 10-K, filed with the Securities
and Exchange Commission (“SEC”) on March 18, 2025.
On February 5, 2025, the Company
effected a 1-for-100 reverse stock split of its issued and outstanding shares of common stock. On June 10, 2024, the Company effected
a 1-for-32 reverse stock split of its issued and outstanding shares of common stock. The Company accounted for both reverse stock splits
on a retrospective basis pursuant to ASC 260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, stock
option awards, exercise prices and per share data have been adjusted in these consolidated financial statements, on a retrospective basis,
to reflect the reverse stock splits for all periods presented. Authorized common and preferred stock were not adjusted because of the
reverse stock splits.
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 now has commercial products available for sale, and generates revenue from
the sale of its Zembrace SymTouch and Tosymra products, with no assurance that the Company will be able to generate sufficient cash flow
to fund operations from 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include,
but are not limited to, impairments, provisions for product returns, coupons, rebates, chargebacks, discounts, allowances, inventory realization,
the assumptions used in the fair value of stock-based compensation and other equity instruments, and the percent of completion of research
and development contracts.
Segment Information and Concentrations
Operating segments are defined
as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker
(“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The Company considers
its chief executive officer to be the Company’s CODM. The CODM manages its operations and allocates resources based on the Company’s
consolidated results and therefore operates as one segment.
8
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Segment revenue, profit or loss, significant segment expenses and other
segment items - The accounting policies of the Company’s single operating and reportable segment are the same as those described
in the summary of significant accounting policies. The Company’s method for measuring segment profitability includes net income
(loss), which the CODM uses to assess performance and make decisions for resource allocation, consistent with the measurement principals
for net income (loss) as reported on the Company’s consolidated statements of operations. The significant expenses regularly reviewed
by the CODM are consistent with those reported on the Company’s consolidated statements of operations, and expenses are not regularly
reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources.
The Company has two products that
each accounted for more than 10% of total revenues during the three and six months ended June 30, 2025, and 2024. These products collectively
accounted for 100 % of revenues during the three and six months ended June 30, 2025, and 2024.
As of June 30, 2025, accounts
receivable from four customers accounted for 26 %, 23 %, 21 %, and 21 % of total accounts receivable. For the three months ended June 30,
2025, revenues from five customers accounted for 30 %, 19 %, 17 %, 17 % and 15 % of net product revenues, respectively. For the six months
ended June 30, 2025, revenues from five customers accounted for 22 %, 21 %, 21 %, 18 % and 14 % of net product revenues, respectively. For
the three months ended June 30, 2024, revenues from five customers accounted for 27 %, 26 %, 23 %, 18 % and 5 % of net product revenues, respectively.
For the six months ended June 30, 2024, revenues from five customers accounted for 24 %, 24 %, 22 %, 16 % and 13 % of net product revenues,
respectively.
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, 2025, and June 30, 2024, cash equivalents, which consisted of money market funds and other cash equivalents, amounted to approximately $ 101.5
million and $ 24,000 , respectively. Restricted cash, which is included in Other non-current assets on the consolidated balance sheet, at
both June 30, 2025, and December 31, 2024, of approximately $ 0.9 million collateralizes a letter of credit issued in connection with the
lease of office space in Chatham, New Jersey (see Note 15) and restricted cash held by vendors in escrow accounts for patient support
services.
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,
2025
June 30,
2024
(in thousands)
Cash and cash equivalents
$
125,331
$
4,156
Restricted cash
905
902
Total
$
126,236
$
5,058
9
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Accounts Receivable, net
Accounts receivable consists of
amounts due from our wholesale and other third-party distributors and pharmacies and have standard payment terms that generally require
payment within 30 to 90 days. For certain customers, the accounts receivable for the customer is net of cash discounts, chargebacks and
customer rebates. We do not adjust our receivables for the effects of a significant financing component at contract inception if we expect
to collect the receivables in one year or less from the time of sale. We provide reserves against accounts receivable for estimated losses
that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the
reserve.
As of June 30, 2025 and December
31, 2024, the Company did not have an allowance for credit losses, as the Company’s exposure to credit losses is de minimis. An
allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers
economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables
to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments
of collectability as these patterns are established over a longer period.
Concentration of Credit Risk
Financial instruments that
potentially subject us to concentrations of credit risk include cash and cash equivalents, and receivables. We attempt to minimize the
risks related to cash and cash equivalents by investing in money market accounts, and we have established guidelines related to credit
ratings and maturities intended to safeguard principal balances and maintain liquidity. Concentrations of credit risk with respect to
receivables, which are typically unsecured, are somewhat mitigated due to the variety of customers using our products, as well as their
dispersion across different geographic areas.
We monitor the financial performance
and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We continue to monitor
these conditions and assess their possible impact on our business.
Inventories
Inventories are recorded at the
lower of cost or net realizable value, with cost determined by the weighted average cost method. Acquired inventory was valued at estimated
selling price less a reasonable margin. The Company periodically reviews the composition of inventory in order to identify excess, obsolete,
slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining
shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records
a write-down to net realizable value in the period that the decline in value is first recognized. During the three months ended June 30,
2025 and 2024, the Company recorded write-downs related to Tosymra and Zembrace finished goods inventory of approximately $ 2.3 million
and $ 1.7 million, respectively, based on an assessment of inventory on hand and projected sales.
Although the Company makes every effort to ensure the accuracy of forecasts of future product demand, any significant unanticipated decreases
in demand could have a material impact on the carrying value of inventories and reported operating results.
Property and equipment
Property and equipment are stated
at cost, less accumulated depreciation. Depreciation and amortization 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 and amortization on assets begin when the asset is placed in service. Depreciation and amortization expense
for the three months ended June 30, 2025, and 2024 was $ 0.5 million and $ 0.9 million, respectively. Depreciation and amortization expense
for the six months ended June 30, 2025, and 2024 was $ 1 .0 million and $ 1.9 million, respectively. The Company’s property and
equipment is 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 consisted of developed technology intangible assets acquired in connection with the acquisition of certain products from Upsher
Smith Laboratories, LLC (“Upsher Smith”) consummated on June 30, 2023 (See Note 5). The acquired intangible assets were amortized
using the straight-line method over the estimated useful lives of the respective assets.
10
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Amortization expense for the three
and six months ended June 30, 2024, was $ 0.2 million and $ 0.5 million, respectively. The Company recorded a full impairment of its developed technology
assets during the second quarter of 2024, therefore there is no amortization for the three and six months ended June 30, 2025.
Impairment testing of long-lived assets
The Company evaluates long-lived assets for impairment, including property
and equipment, finite-lived intangibles assets and operating lease right-to-use assets whenever events or changes in circumstances indicate
that their net book value may not be recoverable. When such factors and circumstances exist, the Company compares the projected undiscounted
future cash flows associated with the related asset or group of assets over their estimated useful lives against their respective carrying
amount. Impairment, if any, is based on the excess of the carrying amount over the fair value, based on market value when available, or
discounted expected cash flows, of those assets and is recorded in the period in which the determination is made. For the six months ended
June 30, 2025, the Company concluded that no impairment existed.
During the three months ended
June 30, 2024, the Company identified certain triggering events related to its decommissioned Advance Development Center in Dartmouth, Massachusetts (“ADC”). The Company determined
that the carrying value of the ADC was not recoverable and that the carrying value exceeded its fair value. As such, the Company recorded
a non-cash impairment charge of $ 48.8 million, which is reflected in asset impairment charges in the consolidated statements of operations
for the three and six months ended June 30, 2024.
Additionally, due to a sustained
decline in revenues and continued delays in building out the sales team for its commercialized products, the Company also tested its commercialized
products asset group for recoverability as of June 30, 2024. The Company determined that the carrying value was not recoverable and therefore
estimated the fair value of the asset group using a discounted cash flow analysis. As the carrying value of the asset group significantly
exceeded its fair value, the Company recorded a full non-cash impairment charge of $ 9.2 million, consisting of $ 6.2 million and $ 3 .0 million
for the Zembrace and Tosymra developed technology intangible assets, respectively, which is reflected in asset impairment charges in the
consolidated statements of operations for the three and six months ended June 30, 2024.
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. The Company previously recognized goodwill in connection with the USL Acquisition consummated on June 30,
2023 (See Note 5). The Company completed the required annual impairment test for goodwill as of June 30, 2024, which resulted in full
non-cash impairment of the Company’s $ 965,000 of goodwill, which is reflected in asset impairment charges in the consolidated statements
of operations for the three and six months ended June 30, 2024.
Leases
The Company determines if an arrangement
is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, operating
lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance sheets. ROU assets
represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make
lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present
value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental
borrowing rate based on the information available at the transition date and subsequent lease commencement dates in determining the present
value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to
each lease. The operating lease ROU asset excludes lease incentives. The Company’s lease terms may include options to extend or
terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments made under
operating leases is recognized on a straight-line basis over the lease term.
11
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Deferred financing costs
Deferred financing costs represent
the cost of obtaining financing arrangements and are amortized over the term of the related debt agreement using the effective interest
method. Deferred financing costs related to term debt arrangements are reflected as a direct reduction of the related debt liability on
the condensed consolidated balance sheet. Amortization of deferred financing costs are included in interest expense on the consolidated statements
of operations.
Original issue discount
Certain term debt issued by the
Company provides the debt holder with an original issue discount. Original issue discounts are reflected as a direct reduction of the
related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement using the effective
interest method. Amortization of original issue discounts are included in interest expense on the consolidated statements of operations.
Revenue Recognition
The Company records and recognizes
revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration
to which the Company expects to be entitled in exchange for those goods or services. The Company’s revenues primarily result from
contracts with customers, which are generally short-term and have a single performance obligation - the delivery of product. The Company’s
performance obligation to deliver products is satisfied at the point in time that the goods are received by the customer, which is when
the customer obtains title to and has the risks and rewards of ownership of the products, which is generally upon shipment or delivery
to the customer as stipulated by the terms of the sale agreements. The transaction price is the amount of consideration to which the Company
expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised in a contract with a customer
may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically 30 to 90 days.
Revenues from product sales, net
of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not
probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental
authorities and collected from customers are excluded from product sales. Shipping and handling activities are considered to be fulfillment
activities and not a separate performance obligation.
Many of the Company’s products
sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts, distributor
fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net deductions and
are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions are presented in the
consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset within accounts receivable,
net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue deductions can result from a
complex series of judgements about future events and uncertainties and can rely heavily on estimates and assumptions. The following section
briefly describes the nature of the Company’s provisions for variable consideration and how such provisions are estimated:
Chargebacks - The Company
sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with these indirect customers
to establish pricing for the Company’s products, and in-turn, the indirect customers and entities independently purchase these products.
Because the price paid by the indirect customers and/or entities is lower than the price paid by the wholesaler, the Company provides
a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the
wholesale customer’s purchase price. The Company’s provision for chargebacks is based on expected sell-through levels by the
Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels as well as historical chargeback
rates. The Company continually monitors its reserve for chargebacks and adjusts the reserve accordingly when expected chargebacks differ
from actual experience.
12
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Rebates - The Company participates
in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified recipients, and primarily
relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts, specialty pharmacy program
fees and other governmental rebates or applicable allowances.
●
Managed Care Rebates are processed in the quarter following the quarter in which they are earned. The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended for market growth assumptions.
●
Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month lag from the time of product sale until the rebate is paid.
●
Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a reserve amount is established to represent the proportionate rebate amount associated with product sales.
●
Coverage Gap refers to the Medicare prescription drug program and represents specifically the period between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review of the liability based on payment trends and any revision to the projected annual cost.
Prompt-Pay and other Sales
Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue and as a reduction
in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer sales discounts represent
programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher programs.
Product Returns - Consistent
with industry practice, the Company offers customers a right to return any unused product. The customer’s right of return commences
typically six months prior to product expiration date and ends one year after product expiration date. Products returned for expiration
are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount of its product sales
that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue in the period the related product
revenue is recognized. The Company estimates products returns as a percentage of sales to its customers. The rate is estimated by using
historical sales information, including its visibility and estimates into the inventory remaining in the distribution channel. Adjustments
are made to the current provision for returns when data suggests product returns may differ from original estimates.
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.
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.
13
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
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 and, in certain arrangements. U.S. GAAP does
not have specific accounting standards covering government grants to business entities. The Company applies International Accounting
Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance by analogy when
accounting for government grants. Under IAS 20, government grants are initially recognized when there is reasonable assurance
the conditions of the grant will be met and the grant will be received. After initial recognition, government grants received
are recognized in earnings in the same period the underlying costs for which the grant is intended to compensate are incurred.
The Company classifies government grants received under these arrangements as either a reduction to the related research and development
expense or as grant income in the consolidated statements of operations, depending on the fee structure of the arrangement.
The Company also applies the disclosure requirements of ASC 832, Government Assistance.
In August 2022, the Company
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, 2025, the Company recorded $ 0.6 million in funding as a reduction of related research and development expense, of which all is included
in prepaid expenses and other current assets . During the three and six months ended June 30, 2024, the Company received $ 0.2 million and $ 0.5 million, respectively, in funding as a reduction
of related research and development expense.
In June 2024, the Company
was awarded a prototype Other Transaction Agreement from the Defense Threat Reduction Agency (“DTRA”), an agency within the
U.S. Department of Defense, to fund the Company’s TNX-4200 program for the development of a small molecule broad-spectrum antiviral
for the prevention or treatment of viral infections to improve the medical readiness of military personnel in biological threat environments.
The DTRA grant provides for payments totaling up to $ 34.1 million over five years, which is subject to adjustment based on costs, scope,
budget, and other factors as the program advances. Funding under the DTRA grant is earned and recognized under a cost-plus-fixed-fee arrangement
in which the Company is reimbursed for all direct costs incurred plus allowable indirect costs and a fixed fee. During the three
and six months ended June 30, 2025, $1.1 million and $2.0 million, respectively, was recognized in grant income related to the DTRA grant.
As of June 30, 2025, $ 0.7 million of the grant income, included above, was earned but not yet received and is presented in prepaid expenses
and other current assets. No grant income was received during the three and six months ended June 30, 2024.
Stock-based Compensation.
All stock-based payments to employees
and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock options, are measured
at fair value on the grant date and recognized in the consolidated statements of operations as compensation 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 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.
14
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Income Taxes
Deferred income tax assets and
liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards and temporary differences
between the tax basis of assets and liabilities and their respective financial reporting amounts measured at the current enacted tax rates.
The Company records a valuation allowance on its deferred income tax assets if it is not more likely than not that these deferred income
tax assets will be realized.
The Company recognizes a tax benefit
from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities,
based on the technical merits of the position. The tax benefits recognized in the 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, 2025, the Company has not recorded any unrecognized tax benefits. The Company’s policy is to recognize interest and penalties
accrued on any unrecognized tax benefits as a component of income tax expense.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was
enacted in the United States. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions
of the Tax Cuts and Jobs Act, and the restoration of favorable tax treatment for certain business provisions. The legislation has
multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company is currently
assessing the impact on its condensed consolidated financial statements.
Derivative Instruments and Warrant Liabilities
The Company evaluates all of its
financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging, to determine
if such instruments are derivatives or contain features that qualify as embedded derivatives (See Note 13). For derivative financial instruments
that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each
reporting date, with changes in the fair value reported in the consolidated statements of operations. The Company uses the Black-Scholes
option pricing model to value the derivative instruments at inception and subsequent valuation dates, which is adjusted for instrument-specific
terms as applicable.
From time to time, certain equity-linked
instruments may be classified as derivative liabilities due to the variable exercise price of the shares to fully settle the equity-linked
financial instruments in shares. In such case, the Company has adopted a sequencing approach under ASC 815-40, Derivatives and Hedging
- Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent reporting
date.
In the event that reclassification
of contracts between equity and assets or liabilities is necessary, the Company first allocates remaining authorized shares to equity
on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation
of shares. In the event of identical issuance dates, shares are then allocated to equity beginning with instruments with the latest maturity
date first.
The classification of derivative
instruments is reassessed at each reporting date. If the classification changes as a result of events during a reporting period, the instrument
is reclassified as of the date of the event that caused the reclassification. There is no limit on the number of times a contract may
be reclassified. During the three and six months ended June 30, 2025, the Company recorded
$ 2 .0 million in issuance costs related to the equity line of credit with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
These costs were expensed, and are included in other expense, net on the condensed consolidated statement of operations, as the equity
line qualified as a derivative instrument.
The Company evaluated the contract that includes the right to require Lincoln
Park to purchase shares of Common Stock in the future (“purchased put right”) considering the guidance in ASC 815-40, and
concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting
as a derivative asset (liability). The Company has analyzed the terms of the purchased put right and has concluded that it had insignificant
value as of June 30, 2025.
Per Share Data
The computation of basic and diluted
loss per share for the quarters ended June 30, 2025 and 2024 excludes potentially dilutive securities when their inclusion would be anti-dilutive,
or if their exercise prices were greater than the average market price of the common stock during the period.
All warrants issued participate
on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the Board of Directors, on the Company’s
common stock. For purposes of computing EPS, these warrants are considered to participate with common stock in earnings of the Company.
Therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period
is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed
earnings. Prefunded warrants are assumed exercised on date of issuance and are included in the basic EPS calculation. No income was allocated
to the warrants for the three and six months ended June 30, 2025, and 2024, as results of operations were a loss for the periods.
15
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Potentially dilutive securities
excluded from the computation of basic and diluted net loss per share, as of June 30, 2025 and 2024, are as follows:
2025
2024
Warrants to purchase common stock
26,239
105,330
Options to purchase common stock
1,153,871
3,447
Totals
1,180,110
108,777
Recently
Adopted and Issued Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued
ASU 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective
tax rate reconciliations as well as expanded information on income taxes by jurisdiction. The standard is effective for fiscal years beginning
after December 15, 2024 on a prospective basis. The Company discloses its income tax rate reconciliation in its annual consolidated financial
statements only and does not expect the adoption to have a material impact on its consolidated financial statements.
Recently Issued Accounting Pronouncements
In March 2024, the SEC adopted
new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and opportunities. The
adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors and management oversee
climate-related risks and certain climate-related governance items, (ii) disclosure of information related to a registrant’s climate-related
targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related events and transition activities impact
line items above a threshold amount on a registrant’s consolidated financial statements, including the impact of the financial estimates
and the assumptions used. This new rule will first be effective in the Company’s disclosures for the year ending December 31, 2027.
The Company is in the process of assessing the impact on our consolidated financial statements and disclosures.
In November 2024, the FASB issued
ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to improve transparency
in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income
Statement. The guidance will first be effective for annual reporting periods beginning after December 15, 2026, and interim reporting
periods beginning after December 15, 2027. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2024-03
on our financial statements.
16
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 3 – INVENTORY
The components of inventory consisted
of the following (in thousands):
June 30,
2025
December 31,
2024
(in thousands)
Raw Materials
$
2,345
$
3,071
Work-in-process
1,270
213
Finished Goods
2,371
5,124
Total Inventory
$
5,986
$
8,408
NOTE 4 – PROPERTY AND EQUIPMENT, NET
Property and equipment, net consisted
of the following (in thousands):
June 30,
2025
December 31,
2024
(in thousands)
Property and equipment, net:
Land
$
8,011
$
8,011
Land improvements
305
305
Buildings
24,504
24,504
Office furniture and equipment
1,443
1,371
Laboratory equipment
13,111
12,124
Leasehold improvements
34
34
Property and equipment gross
47,408
46,349
Less: Accumulated depreciation and amortization
( 5,073
)
( 4,097
)
Property and equipment, net
$
42,335
$
42,252
NOTE 5 – GOODWILL AND INTANGIBLE ASSETS
The following table provides the
gross carrying amount and accumulated amortization for each major class of intangible asset:
June 30,
2025
December 31,
2024
(in thousands)
Intangible assets subject to amortization
Developed technology
$
—
$
10,100
Less: Impairment charge
—
9,147
Less: Accumulated amortization
—
953
Total
$
—
$
—
Intangible assets not subject to amortization Internet domain rights
$
120
$
120
Total intangible assets, net
$
120
$
120
17
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 6 – 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, 2025, and December
31, 2024, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 101.5 million and $ 24,000 , respectively.
The Company did not have any Level 2 or Level 3 assets or liabilities as of June 30, 2025. The Company received stockholder approval to increase the number of authorized shares on January 25, 2024, at which time
previous liability classified Series D Warrants and the Series C Warrants met all requirements for equity classification, and,
as a result, the Company reclassified them to equity as of January 25, 2024.
The Company used the Black-Scholes
option pricing model to estimate the fair value of the Series D Warrants and the Series C Warrants using significant unobservable inputs,
which represent Level 3 measurements within the fair value hierarchy. For periods prior to the receipt of stockholder approval, the fair
value was then adjusted by applying a discount for lack of marketability (“DLOM”) based on the expected timing of receipt
of stockholder approval to increase the number of authorized shares and to allow the Warrants to become exercisable in accordance with
Nasdaq Listing Rule 5635. Additionally, between April 1, 2024 and May 22, 2024, Level 3 liabilities included a portion of the Company’s
outstanding August 2023 Warrants, Series A Warrants, Series B Warrants, Series C Warrants, and Series D Warrants (collectively, the “Existing
Warrants”), as a result of certain Warrant Amendments entered into upon the closing of an equity financing on April 1, 2024, which
provided for adjustments to the exercise prices of the Existing Warrants, contingent on approval by the Company’s stockholders of
a proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635. The Company determined that
the exercise price adjustment provision that is contingent on stockholder approval precluded the Existing Warrants from being indexed
to the Company’s own stock, and therefore were reclassified to liabilities at post-modification fair value on April 1, 2024. After
the Company received stockholder approval on May 22, 2024, thereby reducing the exercise prices of each of the Existing Warrants to $ 10.56
per share, the Existing Warrants met all requirements for equity classification and the Company reclassified them to equity as of May
22, 2024. To estimate the fair value of the Existing Warrants on the reclassification dates, the Company used a Black-Scholes option pricing
model, probability weighted for different scenarios as applicable.
The following table summarizes
the range of significant assumptions used in determining the fair value of liability-classified warrants on
the respective reclassification dates for the three and six months ended June 30, 2024:
Three months ended
Six months ended
June 30, 2024
June 30, 2024
Common stock price
$
6.080
$
6.080 - 9.888
Risk-free rate
4.39 % - 5.37 %
4.01 % - 5.37 %
Expected term (in years)
0.86 - 5.00
0.86 - 5.00
Expected volatility
105.00 % - 120.00 %
105.00 % - 120.00 %
Discount for lack of marketability
N/A
N/A
18
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
A reconciliation of the beginning
and ending balances for the liability-classified warrants measured at fair value on a recurring basis using significant unobservable inputs
(Level 3) is as follows for the three and six months ended June 30, 2024:
Warrant liabilities
Balance at December 31, 2023
$
22,855
Fair value - mark to market adjustment
( 7,005
)
Warrants reclassified from liabilities to equity
( 15,850
)
Balance at March 31, 2024
$
—
Warrants reclassified from equity to liabilities
9,977
Fair value - mark to market adjustment
855
Warrants reclassified from liabilities to equity
( 10,832
)
Balance at June 30, 2024
$
—
For
the three and six months ended June 30, 2024, the Company recognized a change in fair value resulting in a loss of $0.9 million
and gain of $6.2 million, respectively, related to the liability-classified warrants prior to meeting the criteria for equity
classification.
There were no liability-classified
warrants measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three or six months ended
June 30, 2025. Changes in the fair value of the liability-classified warrants are recognized as a separate component in the consolidated
statement of operations.
19
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 7 – OTHER BALANCE SHEET INFORMATION
Components of selected captions
in the consolidated balance sheets consist of:
June 30,
2025
December 31,
2024
Prepaid expenses and other current assets:
(in thousands)
Contract-related
$
1,898
$
881
Government grants
1,309
793
At-the-market receivable
1,629
2,387
Non-trade receivables
2,025
953
Debt interest and fees
—
180
Insurance
686
1,392
Other
2,351
1,549
$
9,898
$
8,135
Accrued expenses and other current liabilities:
Contract-related
$
3,007
$
1,816
Compensation and compensation-related
1,332
4,496
Gross-to-net deductions
5,343
3,658
Professional fees and other
1,401
697
$
11,083
$
10,667
NOTE
8 – DEBT FINANCING
Long-term debt consists of the
following:
June 30,
2025
December 31,
2024
Term Loan
$
—
$
8,650
Less: current portion
—
( 2,820
)
Total long-term debt
—
5,830
Less: unamortized debt discount and deferred financing costs
—
( 1,163
)
Total long-term debt, net
$
—
$
4,667
On
December 8, 2023, the Company entered into a Loan and Guaranty Agreement (the “Loan Agreement”) by and among the Company,
Krele LLC, Tonix Pharmaceuticals, Inc., Jenner and Tonix R&D Center (collectively, the “Loan Parties”), with JGB Capital,
LP, JGB Partners, LP, JGB (Cayman) Port Ellen Ltd., and any other lender from time to time party hereto (collectively, the “Lenders”),
and JGB Collateral LLC, as administrative agent and collateral agent for the Lenders (in such capacity, “JGB Agent”) for
a 36 -month term loan (the “Term Loan”) in the aggregate principal amount of $ 11 .0 million, with a maturity date of December
8, 2026 (the “Maturity Date”). The Term Loan was funded with an original issue discount of 9 % of the principal amount of
the Term Loan, or $ 1 .0 million, which was amortized over the term of the debt as an adjustment to the effective interest rate on
the outstanding borrowings.
Borrowings under the Term Loan
carried interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement plus 3.5 % and (ii)
12 %. Interest was payable monthly in arrears commencing in December 2023. In connection with the Term Loan, the Company deposited into
a reserve account $ 1.8 million to be used exclusively to fund interest payments related to the Term Loan. The remaining deposit as of
December 31, 2024 totaled $ 0.2 million, which was reflected in Prepaid expenses and other current assets on the consolidated balance sheet.
20
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Commencing on March 8, 2024 and
continuing monthly through the Maturity Date, the outstanding principal was due and payable in monthly installments of $ 0.2 million, with
the final remaining balance of unpaid principal and interest due and payable on the Maturity Date. In addition, the Company paid a monthly
collateral monitoring charge equal to 0.23 % of the outstanding principal amount of the term loan as of the date of payment. The Company
incurred $ 1.1 million in issuance costs, which was amortized over the term of the debt as an adjustment to the effective interest rate
on the outstanding borrowings.
The Loan Agreement provided
for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The Term Loan was secured by first priority
security interests in the Company’s R&D Center in Frederick, Maryland, the Advanced Development Center in North Dartmouth, Massachusetts,
and substantially all of the relevant deposit accounts.
During the first
quarter of 2025, the Company paid $ 9.6
million as a result of a pay-off of the above-mentioned loan. The pay-off amount paid by the Company in connection with the
termination of the Loan Agreement was pursuant to a pay-off letter and includes a prepayment fee of $ 1 .0
million in accordance with the terms and provisions of the Loan Agreement. In connection with the pay-off of the loan, the Company
incurred a loss on extinguishment of the debt amounting to $ 0 and $ 2.1
million, respectively, during the three and six months ended June 30, 2025.
NOTE 9 – STOCKHOLDERS’ EQUITY
On February 5, 2025, the Company
effected a 1-for-100 reverse stock split of its issued and outstanding shares of common stock, whereby 559,044,486 outstanding shares
of the Company’s common stock were exchanged for 5,590,667 shares of the Company’s common stock. All per share amounts and
number of shares in the 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 February 20, 2025, 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).
On February 20, 2025,
the Company received a letter from The NASDAQ Stock Market LLC stating that because the Company’s shares had a closing bid price
at or above $ 1.00 per share for a minimum of 10 consecutive business days, the Company’s stock had regained compliance with the
minimum bid price requirement of $ 1.00 per share for continued listing on the NASDAQ Capital Market, as set forth in NASDAQ Listing Rule
5550(a)(2), and that the matter is now closed.
NOTE 10 – REVENUES
Disaggregation of Net Revenues
The Company’s net product revenues are summarized
below:
Three months ended
June 30,
2025
2024
Zembrace Symtouch
$
1,570
$
1,727
Tosymra
428
481
Total product revenues
$
1,998
$
2,208
Six months ended
June 30,
2025
2024
Zembrace Symtouch
$
3,596
$
3,574
Tosymra
831
1,116
Total product revenues
$
4,427
$
4,690
Gross-to-Net Sales Accruals
We record gross-to-net sales accruals
for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical industry.
21
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Our provision for gross-to-net
allowances was $ 5.8 million at June 30, 2025, $ 0.5 million of which was recorded as a reduction to accounts receivable and $ 5.3 million
recorded as a component of accrued expenses. Our provision for gross-to-net allowances was $ 4.3 million at June 30, 2024, $ 0.6 million
of which was recorded as a reduction to accounts receivable and $ 3.7 million recorded as a component of accrued expenses.
NOTE 11 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
On June 30, 2023, the Company
completed the acquisition of certain assets from Upsher Smith 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 (such transaction, the “USL Acquisition”). The Company paid the $ 3 .0 million deferred payment to Upsher Smith in
April 2024.
The Company
has assumed certain obligations of Upsher Smith, including the payment of quarterly royalty payments on annual net sales from the Business
in the U.S. as follows: for Tosymra, 4 % for net sales of $ 0 to $ 30 million, 7 % of net sales of $ 30 to $ 75 million; 9 % for net sales of
$ 75 to $ 100 million; 12 % for net sales of $ 100 to $ 150 million; and 15 % for net sales greater than $ 150 million. Royalty payments with
respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to
the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of
the territory.
For Zembrace,
royalty payments on annual net sales in the U.S. are 3 % for net sales of $ 0 to $ 30 million, 6 % of net sales of $ 30 to $ 75 million; 12 %
for net sales of $ 75 to $ 100 million; 16 % for net sales of greater than $ 100 million. Such royalty payments are payable until July 19,
2025. Upon the entry of a generic version of the relevant product, the applicable royalty rates shall be reduced by 90 % percent with respect
to Zembrace, and by 66.7 % percent for Tosymra. Prior to Purchaser or a licensee filing an application for marketing authorization for
either of the products in a permitted country outside the U.S., the parties will negotiate in good faith the royalty payment rates annual
net sales tiers that will apply for such country, based on the market opportunity for the product in such country. If the parties fail
to agree, then the royalty payment rates and annual net sales tiers described above will apply.
In addition,
the Company has assumed the obligation to pay an additional 3 % royalty on net sales of Tosymra, plus an additional 3 % if a patent containing
certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the applicable country
or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed patent, and up to
$ 15 million per Tosymra product on the achievement of sales milestones.
NOTE 12 – SALE AND PURCHASE OF COMMON STOCK
2025 Lincoln Park Transaction
On June 11, 2025, the Company
entered into a purchase agreement (the “2025 Purchase Agreement”) and a registration rights agreement (the “2025 Registration
Rights Agreement”) with Lincoln Park. Pursuant to the terms of the 2025 Purchase
Agreement, Lincoln Park has agreed to purchase from the Company up to $ 75,000,000 of the Company’s common stock (subject to certain
limitations) from time to time during the term of the 2025 Purchase Agreement. Pursuant to the terms of the 2025 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 2025 Purchase Agreement.
Pursuant to the terms
of the 2025 Purchase Agreement, at the time the Company signed the 2025 Purchase Agreement and the 2025 Registration Rights
Agreement, the Company issued 48,708
shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock
under the 2025 Purchase Agreement. The commitment shares were valued at $ 1.8
million and recorded as an addition to equity for the issuance of the common stock and treated as other expense, net on the
condensed consolidated statement of operations under the 2025 Purchase Agreement. No shares were sold during the second quarter ending June 30, 2025, under the 2025 Purchase Agreement.
The Company evaluated the
2025 Purchase Agreement under ASC 815-40 Derivatives and Hedging-Contracts on an Entity's Own Equity as it
represents the right to require Lincoln Park to purchase shares of common stock in the future, similar to a put option. The
Company concluded that the 2025 Purchase Agreement represents a freestanding derivative instrument that does not qualify for
equity classification and therefore requires fair value accounting. The Company analyzed the terms of the contract and concluded that
the derivative instrument had insignificant value as of June 30, 2025.
22
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
2025 At-the-Market Offerings
On June 11, 2025, the Company
entered into a Sales Agreement (the “2025 Sales Agreement”), with A.G.P./Alliance Global Partners (“AGP”) pursuant
to which the Company may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $ 150 .0
million in sales. AGP is sales agent under the ATM and paid a 3 % commission on each sale under the 2025 Sales Agreement. The Company’s
common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. No shares were sold during
the quarter ended June 30, 2025 under the 2025 Sales Agreement. Subsequent to June 30, 2025, the Company sold 0.3 million shares
of common stock under the 2025 Sales Agreement, for net proceeds of approximately $ 12.3 million.
2024 At-the-Market Offerings
On July 30, 2024, the Company
entered into a Sales Agreement (the “2024 Sales Agreement”), with AGP pursuant
to which the Company may issue and sell, from time to time, shares of common stock having an aggregate offering price of up to $ 250 .0
million in sales. AGP is sales agent under the ATM and paid a 3 % commission on each sale under the 2024 Sales Agreement. The Company’s
common stock is 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, 2025, the Company sold approximately 0.8 million and 3.5 million shares, respectively, of common stock under the
Sales Agreement for net proceeds of approximately $ 15.5 million and $ 75.4 million, respectively. Subsequent to June 30, 2025, the Company
sold 0.9 million shares of common stock under the Sales Agreement, for net proceeds of approximately $ 37.5 million. The Company can no longer sell shares under the 2024 Sales Agreement as the Company has reached the aggregate $ 250 million in sales.
June 2024 Financings
On June 12, 2024, the Company
entered into a securities purchase agreement with certain investors, pursuant to which the Company sold 11,995 shares of common stock
and pre-funded warrants to purchase up to 25,682 shares of common stock. The offering price per share of common stock was $ 106.50 , and
the offering price per share of pre-funded warrant was $ 106.40 .
The offering closed on June 13,
2024. The Company incurred offering expenses of approximately $ 0.6 million, including placement agent fees of approximately $ 0.3 million.
The Company received net proceeds of approximately $ 3.4 million, after deducting the underwriting discount and other offering expenses.
On June 27, 2024, the Company
entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which the Company sold 28,339
shares of common stock and pre-funded warrants to purchase up to 42,282 shares of common stock. The offering price per share of common
stock was $ 57.00 , and the offering price per share of pre-funded warrant was $ 56.99 .
The offering closed on June 28,
2024. The Company incurred offering expenses of approximately $ 0.6 million, including placement agent fees of approximately $ 0.3 million.
The Company received net proceeds of approximately $ 3.4 million, after deducting the underwriting discount and other offering expenses.
March 2024 Financing
On March 28, 2024, the Company
entered into an agreement to sell 3,365 shares of common stock, pre-funded warrants to purchase up to 1,219 shares of common stock, and
accompanying Series E warrants to purchase up to 4,584 shares of common stock with an exercise price of $ 1,056.00 per share and expiring
five and a half years from date of issuance in a public offering, which closed on April 1, 2024. The offering price per share of common
stock was $ 960.00 , and the offering price per share of pre-funded warrants was $ 959.68 .
The Company incurred expenses
of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million. The Company received net proceeds of approximately
$ 3.9 million, after deducting the underwriting discount and other offering expenses.
23
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
Additionally, with the closing
of the financing on April 1, 2024, the Company entered into warrant amendments (collectively, the “Warrant Amendments”) with
certain holders of its common warrants (referred to herein as the “Existing Warrants”). The Company agreed to amend the exercise
price of each Existing Warrant to $ 1,056.00 upon approval by the Company’s stockholders of a proposal to allow the Existing Warrants
to become exercisable in accordance with Nasdaq Listing Rule 5635 or, if stockholder approval is not obtained by October 1, 2024, the
Company agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule
5635(d)) of the Company’s common stock on October 1, 2024, if and only if the Minimum Price is below the then current exercise price.
Upon stockholder approval, the termination date for the warrants issued August 2023 (the “August Warrants”) to purchase up
to an aggregate of 2,172 shares was amended to April 1, 2029 ; the termination date for Series A Warrants to purchase up to an aggregate
of approximately 2,782 shares is April 1, 2029 ; the termination date for Series B Warrants to purchase up to an aggregate of approximately
2,782 shares is April 1, 2025 ; the termination date for Series C Warrants to purchase up to an aggregate of approximately 10,884 shares
is the earlier of (i) April 1, 2026 and (ii) 10 trading days following notice by the Company to the Series C Warrant holders of the Company’s
public announcement of the FDA’s acknowledgement and acceptance of the Company’s NDA relating to TNX-102 SL in patients with
Fibromyalgia; the termination date for Series D Warrants to purchase up to an aggregate of approximately 10,884 shares is April 1, 2029 .
The other terms of the Existing Warrants remained unchanged.
The Company evaluated the Warrant
Amendments as of April 1, 2024, and determined that the potential adjustment to the exercise price that is contingent on stockholder approval
precluded the Existing Warrants from being indexed to the Company’s own stock, and as a result, did not meet the criteria for equity
classification under ASC 815-40. The Company accounted for the incremental fair value of the Warrant Amendments of $ 3 .0 million as a direct
and incremental cost of the March 2024 financing as an offset to the proceeds received. As all of the Existing Warrants were equity-classified
prior to the Warrant Amendments, the net impact to the consolidated statement of stockholders’ equity was zero. The Company then
reclassified the Existing Warrants from equity to liabilities at post-modification fair value on April 1, 2024. On May 22, 2024, the date
the Company’s stockholders approved the proposal to fix the exercise prices at $ 1,056.00 per share, the Existing Warrants were adjusted
to fair value and reclassified back to equity.
December 2023 Financing
On December 20, 2023, the Company
entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to
which the Company sold and issued (i) 7,920 shares of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to 8,973 shares of common stock and (iii) Series C warrants to purchase up to 25,338 shares of common
stock (the “Series C Warrants”), and (iv) Series D warrants to purchase up to 25,338 shares of common stock (the “Series
D Warrants” and, together with the Series C Warrants, the “Common Warrants”). The securities sold in the offering were
sold in fixed combinations as units. The offering price per share of common stock and accompanying Common Warrants was $ 1,776.00 , and
the offering price per Pre-Funded Warrant and accompanying Common Warrants was $ 1,775.68 . The offering closed on December 22, 2023, generating
gross proceeds of approximately $ 30 .0 million, before deducting offering expenses of $ 2.3 million payable by the Company. At the closing
of the offering, 2,034 Pre-Funded Warrants were immediately exercised into shares of common stock for nominal proceeds.
The Pre-Funded Warrants have an
exercise price of $ 0.32 per share, were immediately exercisable subject to certain ownership limitations, and can be exercised at any
time until exercised in full. The Series C Warrants have an exercise price of $ 1,776.00 per share, and were exercisable on the later of
approval by the Company’s stockholders of (i) a proposal to approve the filing of an amendment to the Company’s Articles of
Incorporation, increasing the number of authorized shares of common stock from 160,000,000 to 1,000,000,000 and (ii) a proposal to allow
the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the later of such events, the “Approval Date”)
and initially expired on the later of (a) 10 trading days following the Approval Date and (b) the earlier of (x) the two year anniversary
of the Approval Date and (y) 10 trading days following the public announcement of the U.S. Food and Drug Administration’s (“FDA”)
acknowledgement and acceptance of the New Drug Application (“NDA”) relating to the Company’s TNX-102 SL product candidate
in patients with fibromyalgia. The Series D Warrants have an exercise price of $ 2,720.00 per share and were exercisable beginning on the
Approval Date through the five-year anniversary of the Approval Date.
Upon the closing of the offering,
the Company determined that certain of the Common Warrants did not meet the criteria for equity classification due to the lack of sufficient
authorized and unissued shares to settle the instruments. The Company has adopted a sequencing approach under ASC 815-40, Derivatives
and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent
reporting date, whereby shares are allocated based on the earliest issuance date of potentially dilutive instruments, with the earliest
issuance date receiving the first allocation of shares. In the event of identical issuance dates, shares are then allocated beginning
with instruments with the latest maturity date first. Pursuant to this sequencing approach, the Company determined that the authorized
shares were sufficient to settle all remaining Pre-Funded Warrants and 15,917 Series D Warrants and were therefore classified in equity.
The remaining 9,422 Series D Warrants and the Series C Warrants associated with the deficit shares were initially classified as liabilities
at fair value and presented within non-current liabilities on the consolidated balance sheet as of December 31, 2023.
24
The $ 30 .0 million in gross proceeds
received by the Company were first allocated to the Series C Warrants and the liability-classified Series D Warrants at their respective
fair values, and the residual proceeds were allocated between the shares of common stock, the Pre-Funded Warrants, and the equity-classified
Series D Warrants on a relative fair value basis. The issuance costs were allocated between the equity and liability-classified instruments
on a relative fair value basis, resulting in issuance costs of $ 1.4 million recognized as a discount to the equity-classified instruments,
and $ 0.9 million allocated to the liability-classified instruments and immediately expensed within Selling, general and administrative
expense on the consolidated statements of operations.
On January 25, 2024, the date
the Company’s stockholders approved the proposal to file an amendment to the Company’s Articles of Incorporation to increase
the number of authorized shares of common stock from 160,000,000 to 1,000,000,000 , the liability-classified Series D Warrants and the
Series C Warrants were adjusted to fair value and reclassified to equity.
The liability-classified Series
D Warrants and all of the Series C Warrants were presented within non-current liabilities on the consolidated balance sheets as of December
31, 2023, and were adjusted to fair value through January 25, 2024, when the warrants were reclassified to equity. Changes in the fair
value of the liability-classified warrants were recognized as a separate component in the consolidated statement of operations.
Stock repurchases
In September 2024,
the Board of Directors approved a 2024 share repurchase program pursuant to which the Company may repurchase up
to $ 10 .0
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 three months ended June 30, 2025, the Company
repurchased 150,000
shares of its common stock outstanding under the 2024 share repurchase at prices ranging from $ 18.25
to $ 20.47
per share for a gross aggregate cost of approximately $ 2.9
million. The repurchased shares were immediately retired.
The Company repurchased the following
capital stock:
Three Months
Ended
June 30, 2025
Three Months
Ended
June 30, 2024
Total cost of repurchased shares (in thousands)
$
2,902
$
—
Shares repurchased
150,000
—
Weighted average price per share
$
19.31
—
During the six
months ended June 30, 2025, the Company repurchased 400,000
of shares of its common stock outstanding under the 2024 share repurchase at prices ranging from $ 9.98
to $ 20.47
per share for a gross aggregate cost of approximately $ 5.9
million. The repurchased shares were immediately retired.
The Company repurchased the following
capital stock:
Six Months Ended
June 30, 2025
Six Months Ended
June 30, 2024
Total cost of repurchased shares (in thousands)
$
5,949
$
—
Shares repurchased
400,000
—
Weighted average price per share
$
14.84
—
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.
25
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
NOTE 13 – STOCK-BASED COMPENSATION
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”).
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). On May 8, 2025,
the Company's stockholders approved the addition of 1,000,000 shares to the Company's Amended and Restated 2020 Plan.
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, 2025, there were 723,113 options 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 six months ended June 30, 2025, is as follows:
Shares
Weighted-
Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding at December 31, 2024
3,865
$
27,540,609
8.74
$
—
Grants
1,150,041
13.76
25,602,203
Exercised
—
—
Forfeitures or expirations
( 35
)
1,102,887,011
Outstanding at June 30, 2025
1,153,871
$
57,751
9.74
$
25,611,938
Exercisable at June 30, 2025
2,294
$
24,152,300
8.11
$
The aggregate intrinsic value
in the preceding table represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s
closing stock price at the respective dates.
The weighted average
fair value of options granted during the three and six months ended June 30, 2025 was $ 19.63
per share and $ 12.59
per share, respectively. The weighted average fair value of options granted during the three and six months ended June 2024 was
$ 506.04
per share and $ 1,015.52
per share, respectively.
26
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (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, 2025, and 2024 were as follows:
Six Months Ended
June 30, 2025
Six Months Ended
June 30, 2024
Risk-free interest rate
3.81 % to 4.30
%
4.23 % to 5.33
%
Expected term of option
5.50 to 6.08 years
5.25 to 10.00 years
Expected stock price volatility
149.34 % to 153.44
%
111.89 % - 137.79
%
Expected dividend yield
0.0
0.0
The risk-free interest rate is
based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of the grant date.
The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting Bulletin, and the expected
stock price volatility is based on the Company’ historical stock price volatility.
Stock-based compensation expense
relating to options granted of $ 1.4 million, of which $ 1 .0 million and $ 0.4 million, related to General and Administration and Research
and Development, respectively was recognized for the quarter ended June 30, 2025. Stock-based compensation expense relating to options
granted of $ 1.1 million, of which $ 0.8 million and $ 0.3 million, related to General and Administration and Research and Development, respectively
was recognized for the quarter ended June 30, 2024.
Stock-based compensation expense
relating to options granted of $ 2.3 million, of which $ 1.6 million and $ 0.7 million, related to General and Administration and Research
and Development, respectively was recognized for the six-month period ended June 30, 2025. 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 six-month period ended June 30, 2024.
As of June 30, 2025, the Company
had approximately $ 15.5 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 3.08 years.
Employee Stock Purchase Plans
On May 5, 2023, the Company’s
stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan. (the “2023 ESPP”),
which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2025 Employee Stock Purchase Plan (the “2025 ESPP”, and together
with the 2023 ESPP, the “ESPP Plans”), which was approved by the Company’s stockholders on May 8, 2025.
The 2025 ESPP allows eligible
employees to purchase up to an aggregate of 2,000,000 shares of the Company's common stock. Under the 2025 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 2025 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 2025 ESPP, subject to the statutory limit under the Code.
27
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED
The 2023 ESPP allows eligible
employees to purchase up to an aggregate of 250 shares of the Company's common stock. Under the 2023 ESPP, on the first day of each offering
period, each employee eligible 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 2023 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 2023 ESPP, subject to the statutory limit under the Code. As of June 30, 2025, 159 shares were
available for future sales under the 2023 ESPP and 2,000,000 shares were available under the 2025 ESPP.
The ESPP Plans are considered
compensatory plans with the related compensation cost expensed over the six-month offering period. For the six months ended June 30, 2025,
and 2024, $ 0 and $ 27,000 , respectively, was expensed. In January 2024, 21 shares that were purchased as of December 31, 2023, under the
2022 ESPP, were issued. As of June 30, 2024, approximately $ 33,000 of employee payroll deductions had accumulated and had been recorded
in accrued expenses. In July 2024, 70 shares that were purchased as of June 30, 2024, under the 2022 ESPP, were issued.
NOTE 14 – WARRANTS TO PURCHASE COMMON STOCK
The following table summarizes
information with respect to outstanding warrants to purchase common stock of the Company at June 30, 2025:
Exercise
Number
Expiration
Price
Outstanding
Date
$
1,056.00
4,585
April 2029
$
1,056.00
2,782
April 2029
$
1,056.00
2,172
April 2029
$
1,056.00
10,884
April 2029
$
1,600.00
36
October 2028
$
2,720.00
5,758
December 2028
$
3,200.00
22
August 2028
26,239
During the six months
ended June 30, 2025, 13,666 ;
5,758
(as the Company received FDA acceptance of our NDA filing), and 1
warrants with an exercise price of $ 1,056 ,
$ 1,776
and $ 364,800 ,
respectively, expired.
During the six months ended June
30, 2024, 33,841 prefunded common warrants were exercised.
NOTE 15 – 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, 2025, the Company has right-of-use assets
of $ 0.5 million and a total lease liability for operating leases of $ 0.5 million of which $ 0.3 million is included in long-term lease
liabilities and $ 0.2 million is included in current lease liabilities.
At June 30, 2025, future minimum
lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
Year Ending December 31,
Remainder of 2025
$
146
2026
142
2027
139
2028
100
2029
7
534
Included interest
( 42
)
$
492
28
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025 AND 2024 (UNAUDITED)
No new leases or amendments were
entered into during the six months ended June 30, 2025 and 2024.
Operating lease expense was $ 0.1
million for both the three-months ended June 30, 2025, and 2024.
Operating lease expense was $ 0.2
million for both the six-months ended June 30, 2025 and 2024.
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities:
Six Months Ended
June 30, 2025
Six Months Ended
June 30, 2024
Operating cash flow from operating leases (in thousands)
$
141
$
148
Weighted Average Remaining Lease Term
Operating leases
2.87 years
3.43 years
Weighted Average Discount Rate
Operating leases
5.27 %
4.71 %
NOTE 16 – COMMITMENTS
Contractual agreements
The Company has entered into contracts
with various contract research organizations with outstanding commitments aggregating approximately $ 21.7 million at June 30, 2025 for
future work to be performed.
Defined contribution plan
The Company established a qualified
defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible employees may participate.
Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan, subject to defined limitations. The
Company is required to make contributions to the 401(k) Plan equal to 100 percent of each participant’s pretax contributions of
up to six percent of his or her eligible compensation. The Company charged operations $ 0.2 million and $ 0.4 million for the three and six months
ended June 30, 2025, respectively, and $ 0.2 million and $ 0.5 million for the three and six months ended June 30, 2024, respectively, for contributions
under the 401(k) Plan.
NOTE 17 – SUBSEQUENT EVENTS
Subsequent to June 30, 2025, the
Company sold 0.3 million shares of common stock under the 2025 Sales Agreement, for net proceeds of approximately $ 12.3 million.
Subsequent to June 30, 2025, the
Company sold 0.9 million shares of common stock under the 2024 Sales Agreement, for net proceeds of approximately $ 37.5 million.
29
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.