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,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 4,156
$ 24,948
Accounts receivable, net
3,339
—
Inventory
9,457
13,639
Prepaid expenses and other current assets
8,335
9,181
Total current assets
25,287
47,768
Property and equipment, net
43,247
94,028
Intangible assets, net
120
9,743
Goodwill
—
965
Operating lease right-to-use assets
692
824
Other non-current assets
961
1,129
Total assets
$ 70,307
$ 154,457
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 10,406
$ 3,782
Accrued expenses and other current liabilities
8,540
12,482
Term loan payable, short term
2,820
2,350
Lease liability, short term
277
270
Total current liabilities
22,043
18,884
Term loan payable, long term
5,668
6,561
Series C warrant liabilities
—
14,595
Series D warrant liabilities
—
8,260
Lease liability, long term
493
632
Total liabilities
28,204
48,932
Commitments (See Note 17)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized, 0 shares designated as of both June 30, 2024, and December 31, 2023; 0 shares issued and outstanding - as of both June 30, 2024 and December 31, 2023
—
—
Common stock, $ 0.001 par value; 1,000,000,000 shares authorized; 9,832,587 and 2,077,088 shares issued and outstanding as of June 30, 2024, and December 31, 2023, respectively and 2,074 shares to be issued as of December 31, 2023
10
3
Additional paid in capital
736,709
706,412
Accumulated deficit
( 694,373 )
( 600,658 )
Accumulated other comprehensive loss
( 243 )
( 232 )
Total stockholders’ equity
42,103
105,525
Total liabilities and stockholders’ equity
$ 70,307
$ 154,457
See
the accompanying notes to the condensed consolidated financial statements
3
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
REVENUE:
Product revenue, net
$ 2,208
$ —
$ 4,690
$ —
COSTS AND EXPENSES:
Cost of revenue
$ 3,367
$ —
$ 5,027
$ —
Research and development
9,698
21,976
22,561
48,487
Selling, general and administrative
7,502
7,026
16,812
14,417
Asset impairment charges
58,957
—
58,957
—
79,524
29,002
103,357
62,904
Operating loss
( 77,316 )
( 29,002 )
( 98,667 )
( 62,904 )
(Loss) gain on change in fair value of warrant liabilities
( 855 )
—
6,150
—
Other (expense) income, net
( 605 )
646
( 1,198 )
1,543
Net loss available to common stockholders
$ ( 78,776 )
$ ( 28,356 )
$ ( 93,715 )
$ ( 61,361 )
Net loss per common share, basic and diluted
$ ( 19.28 )
$ ( 49.23 )
$ ( 27.33 )
$ ( 107.45 )
Weighted average common shares outstanding, basic and diluted
4,085,132
576,047
3,428,906
571,089
See
the accompanying notes to the condensed consolidated financial statements
4
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In
Thousands)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Net loss
$ ( 78,776 )
$ ( 28,356 )
$ ( 93,715 )
$ ( 61,361 )
Other comprehensive loss:
Foreign currency translation loss
( 3 )
( 1 )
( 11 )
( 45 )
Comprehensive loss
$ ( 78,779 )
$ ( 28,357 )
$ ( 93,726 )
$ ( 61,406 )
See
the accompanying notes to the condensed consolidated financial statements
5
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
Accumulated
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2023
2,077,088
$ 2
$ 706,413
$ ( 232 )
$ ( 600,658 )
$ 105,525
Issuance of common stock upon exercise of prefunded common warrants
470,102
1
( 1 )
—
—
—
Fair value of warrants reclassified from liabilities to equity
—
—
15,850
—
—
15,850
Employee stock purchase plan
2,074
—
23
—
—
23
Stock-based compensation
—
—
1,692
—
—
1,692
Foreign currency transaction loss
—
—
—
( 8 )
—
( 8 )
Net loss
—
—
—
—
( 14,939 )
( 14,939 )
Balance, March 31, 2024
2,549,264
3
723,977
( 240 )
( 615,597 )
108,143
Issuance of common stock, net of transactional expenses of $ 1,704
4,369,807
4
10,726
—
—
10,730
Issuance of common stock upon exercise of prefunded common warrants
2,913,516
3
( 3 )
—
—
—
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 loss
—
—
—
( 3 )
—
( 3 )
Net loss
—
—
—
—
( 78,776 )
( 78,776 )
Balance, June 30, 2024
9,832,587
$ 10
$ 736,709
$ ( 243 )
$ ( 694,373 )
$ 42,103
See
the accompanying notes to the condensed consolidated financial statements
6
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
Accumulated
Additional
Other
Common stock
Paid in
Comprehensive
Accumulated
Shares
Amount
Capital
Gain (loss)
Deficit
Total
Balance, December 31, 2022
631,704
$ 1
$ 677,386
$ ( 167 )
$ ( 470,038 )
$ 207,182
Repurchase of common stock under share repurchase program, including transactional expenses of $ 334
( 83,502 )
—
( 3 )
—
( 13,962 )
( 13,965 )
Issuance of common stock under 2022 Purchase agreement with Lincoln Park
3,000
—
441
—
—
441
Issuance of common stock net of transactional expenses of $ 101
16,089
—
1,995
—
—
1,995
Employee stock purchase plan
469
—
29
—
—
29
Stock-based compensation
—
—
2,794
—
—
2,794
Foreign currency transaction loss
—
—
—
( 44 )
—
( 44 )
Net loss
—
—
—
—
( 33,005 )
( 33,005 )
Balance, March 31, 2023
567,760
1
682,642
( 211 )
( 517,005 )
165,427
Issuance of common stock net of transactional expenses of $ 36
13,766
—
1,029
—
—
1,029
Stock-based compensation
—
—
2,364
—
—
2,364
Foreign currency transaction loss
—
—
—
( 1 )
—
( 1 )
Net loss
—
—
—
—
( 28,356 )
( 28,356 )
Balance, June 30, 2023
581,526
$ 1
$ 686,035
$ ( 212 )
$ ( 545,361 )
$ 140,463
See
the accompanying notes to the condensed consolidated financial statements
7
TONIX
PHARMACEUTICALS HOLDING CORP .
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
Thousands)
(unaudited)
Six Months Ended June 30,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 93,715 )
$ ( 61,361 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
2,415
1,814
Asset impairment charges
58,957
—
Change in fair value of warrant liabilities
( 6,150 )
—
Inventory write-off
1,738
—
Amortization of debt discount
431
—
Stock-based compensation
2,846
5,158
Changes in operating assets and liabilities:
Accounts receivable
( 3,339 )
—
Inventory
2,444
—
Prepaid expenses and other
1,011
268
Accounts payable
6,703
( 571 )
Lease liabilities and ROU asset, net
( 2 )
7
Accrued expenses and other current liabilities
( 833 )
( 1,593 )
Net cash used in operating activities
( 27,494 )
( 56,278 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of a business
—
( 22,174 )
Purchase of property and equipment
( 108 )
( 5,644 )
Net cash used in investing activities
( 108 )
( 27,818 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Deferred payment related to purchase a business
( 3,000 )
—
Repurchase of common stock
—
( 13,965 )
Proceeds from ESPP
23
29
Payment of term loan
( 940 )
—
Proceeds, net of $ 1,704 and $ 137 expenses, from sale of common stock and warrants
10,730
3,465
Net cash provided by (used in) financing activities
6,813
( 10,471 )
Effect of currency rate change on cash
( 3 )
( 43 )
Net decrease in cash, cash equivalents and restricted cash
( 20,792 )
( 94,610 )
Cash, cash equivalents and restricted cash beginning of the period
25,850
120,470
Cash, cash equivalents and restricted cash end of period
$ 5,058
$ 25,860
Supplemental disclosures of cash flow information:
Interest expense paid
$ 653
$ —
Non-cash financing and investing activities:
Purchases of property and equipment included in accounts payable and accrued liabilities
$ 106
$ 1,164
See
the accompanying notes to the condensed consolidated financial statements
8
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
NOTE
1 – BUSINESS
Tonix Pharmaceuticals Holding Corp., through its wholly owned subsidiary
Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a fully-integrated biopharmaceutical company focused on developing and commercializing
therapeutics to treat and prevent human disease and alleviate suffering. Tonix aims to transform therapies for pain management and modernize
solutions for public health challenges.
Tonix’s development
portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the
FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102
SL for fibromyalgia. TNX-102 SL is also expected to be tested by the University of North Carolina under a physician IND for Acute Stress
Reaction in a trial funded by the U.S. Department of Defense (DoD), Congressionally Directed Medical Research Program, or CDMRP for approximately
$3 million. Tonix’s CNS portfolio also includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that
has FDA Breakthrough Therapy designation, in Phase 2 development that is funded by the U.S. National Institute of Drug Abuse or NIDA.
Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including
TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft
rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease
and infectious disease. Tonix is developing a broad-spectrum antiviral termed TNX-4200 under a contract for up to $34 million from the
DoD Defense Threat Reduction Agency. Tonix’s development candidates are investigational drugs or biologics and are not approved
for any indication. 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, 2024, the Company had working
capital of approximately $ 3.2 million. At June 30, 2024, the Company had an accumulated deficit of approximately $ 694.4 million. The
Company held cash and cash equivalents of approximately $ 4.2 million as of June 30, 2024. During the fourth quarter of 2023, the Company
engaged CBRE, an international real estate brokerage firm, to potentially find a strategic partner for, or buyer of, its Advanced Development
Center in North Dartmouth, Massachusetts (“ADC”), to align with the Company’s current business objectives and priorities.
As of June 30, 2024, the Company does not have a commitment in place to sell the ADC.
The
Company believes that its cash resources at June 30, 2024 and the gross proceeds of $ 4.4 million that it raised from an equity offering
in the third quarter of 2024 (See Note 18), will not meet its operating and capital expenditure requirements through the third quarter
of 2024.
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. Moreover, the
Company may default under the terms of its existing indebtedness. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
NOTE
2 – SIGNIFICANT ACCOUNTING POLICIES
Interim
financial statements
The
unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and
Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.
9
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
The
condensed consolidated balance sheet as of December 31, 2023, contained herein has been derived from audited financial statements.
Operating
results for the three and six months ended June 30, 2024 are not necessarily indicative of results that may be expected for the year
ending December 31, 2024. 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, 2023, included in the Company’s Annual Report on Form 10-K,
filed with the Securities and Exchange Commission (“SEC”) on April 1, 2024.
Reverse
Stock Split
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 the reverse stock
split 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 condensed consolidated financial statements, on a
retrospective basis, to reflect the reverse stock split for all periods presented. Authorized common and preferred stock were not adjusted
because of the reverse stock split.
Risks
and uncertainties
The
Company’s primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products
to address public health challenges. The Company has experienced net losses and negative cash flows from operations since inception and
expects these conditions to continue for the foreseeable future. Further, the Company 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 GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial
statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Significant estimates include, 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, the percent of completion of research and development contracts, fair value estimates for assets acquired in business
combinations, and assessment of useful lives of acquired intangible assets.
10
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
Business
Combinations
The
Company accounts for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01,
Business Combinations (Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the
acquisition method, whereby the consideration transferred is allocated to the net assets acquired based on their respective fair
values measured on the acquisition date. The difference between the fair value of these assets and the purchase price is recorded as
goodwill. Transaction costs other than those associated with the issue of debt or equity securities, and other direct costs of a
business combination are not considered part of the business acquisition transaction and are expensed as incurred.
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.
The
Company has two products that each accounted for more than 10 % of total revenues during the three and six months ended June 30, 2024.
These products collectively accounted for 100 % of revenues during the three and six months ended June 30, 2024.
As
of June 30, 2024, accounts receivable from five customers accounted for 31 % , 26 % , 23 % , 11 % and 9 % of total accounts receivable. 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. The Company had no commercialized products for the three and six months ended June 30, 2023, and therefore had no accounts
receivable or revenues in the comparative period.
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, 2024 and June 30, 2023, cash equivalents, which consisted of money market
funds, amounted to $ 24,000 and $ 19.2 million, respectively. Restricted cash, which is included in Other non-current assets on the condensed
consolidated balance sheet, at June 30, 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 16) and restricted cash held by vendors in escrow accounts for patient support
services. Restricted cash at June 30, 2023, of approximately $ 243,000 , collateralizes a letter of credit issued in connection with the
lease of office space in Chatham, New Jersey and New York, New York.
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,
2024
June
30,
2023
(in
thousands)
Cash
and cash equivalents
$
4,156
$
25,617
Restricted
cash
902
243
Total
$
5,058
$
25,860
11
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (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, 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 accounts receivable.
We attempt to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
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, 2024, the Company recorded write-downs related to Tosymra and
Zembrace finished goods inventory of approximately $ 1.7 million based on an assessment of inventory on hand and projected sales
prior to the respective expiration dates. 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.
12
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
The
Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.
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, 2024, and 2023 was $ 0.9
million, for both reporting periods. Depreciation
and amortization expense for the six months ended June 30, 2024, and 2023 was $ 1.9
million and $ 1.8
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 consist 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
are amortized using the straight-line method over the estimated useful lives of the respective assets. 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 three months ended June 30, 2024, discussed further below.
During
the year ended December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite
life. Identifiable intangibles with indefinite lives, which are included in Intangible assets, net on the consolidated balance
sheet, are not amortized but are tested for impairment annually or whenever events or changes in circumstances indicate that their
carrying amount may be less than fair value. The Company completed the required annual impairment test for the indefinite-lived
intangible as of June 30, 2024, its annual impairment assessment date, by performing a qualitative assessment to evaluate whether it
is more likely than not that the fair value of its indefinite-lived intangible is less than its carrying amount, resulting in no
impairment.
13
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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.
During the three months ended June 30, 2024, the Company identified
certain triggering events related to the ADC and the decommissioning of the 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. The
Company recorded a non-cash impairment charge for the amount of $ 9.2
million, representing the excess carrying value over the fair value, 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.
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 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 .
14
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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.
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.
15
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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. The financial terms of these contracts are subject
to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials
or services are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of
the trial. The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers
as to the progress or state of consummation of trials, or the services completed.
During
the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The
Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.
Government
Grants
From
time to time, the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and
development activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under these
arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are incurred.
In August 2022, the Company 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 six months ended June 30, 2024, we received $ 0.5 million in funding as a reduction of related research and development
expense . Included in prepaid expenses and other current assets is an additional $ 0.3 million which was received in July 2024 and resulted
in a further reduction of research and development expense during the six months ended June 30, 2024. During the six months ended June
30, 2023, we received $ 1.9 million in funding as a reduction of related research and development expense.
16
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
Stock-based
Compensation.
All
stock-based payments to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”),
and stock options, are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation
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.
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, 2024, 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.
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.
17
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
Per
Share Data
The
computation of basic and diluted loss per share for the quarters ended June 30, 2024 and 2023 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. Prefunded warrants are assumed exercised on date of issuance and are included in the basic EPS calculation.
All warrants issued
participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the Board of
Directors, on the Company’s common stock. For purposes of computing EPS, these warrants are considered to participate with
common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS using the two-class method. Under
the two-class method, net income for the period is allocated between common stockholders and participating securities according to
dividends declared and participation rights in undistributed earnings. No income was allocated to the warrants for the three and six
months ended June 30, 2024, and 2023, as results of operations were a loss for the periods.
Potentially
dilutive securities excluded from the computation of basic and diluted net loss per share, as of June 30, 2024 and 2023, are as follows:
2024
2023
Warrants
to purchase common stock
10,535,363
101
Options
to purchase common stock
310,797
43,441
Totals
10,846,160
43,542
Recent
Accounting Pronouncements Not Yet Adopted
In
November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07,
Segment Reporting--Improvements to Reportable Segment Disclosures , which requires incremental disclosures about a public entity’s
reportable segments but does not change the definition of a segment or the guidance for determining reportable segments. The new guidance
requires disclosure of significant segment expenses that are (1) regularly provided to (or easily computed from information regularly
provided to) the chief operating decision maker and (2) included in the reported measure of segment profit or loss. The new standard
also allows companies to disclose multiple measures of segment profit or loss if those measures are used to assess performance and allocate
resources. The guidance will first be effective in our annual disclosures for the year ending December 31, 2024, and will be adopted
retrospectively unless impracticable. Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2023-07
on our disclosures.
In
December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires disaggregated information about
our effective tax rate reconciliation as well as information on income taxes paid. The guidance will first be effective in our annual
disclosures for the year ending December 31, 2025, and should be applied on a prospective basis with the option to apply retrospectively.
Early adoption is permitted. The Company is in the process of assessing the impact of ASU 2023-09 on our disclosures.
18
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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.
NOTE
3 – INVENTORY
The
components of inventory consisted of the following (in thousands):
June
30,
2024
December
31,
2023
(in
thousands)
Raw
Materials
$
3,351
$
3,611
Work-in-process
1,953
2,539
Finished
Goods
4,153
7,489
Total
Inventory
$
9,457
$
13,639
During the three months ended
June 30, 2024, the Company recorded write-downs related to Tosymra and Zembrace finished goods inventory of approximately $ 1.7 million
based on an assessment of inventory on hand and projected sales prior to the respective expiration dates.
NOTE
4 – PROPERTY AND EQUIPMENT, NET
Property
and equipment, net consisted of the following (in thousands):
June
30,
2024
December
31,
2023
(in
thousands)
Property
and equipment, net:
Land
$
8,011
$
8,011
Land
improvements
305
326
Buildings
24,504
66,749
Office
furniture and equipment
1,367
2,366
Laboratory
equipment
12,116
21,904
Leasehold
improvements
34
34
Property and equipment gross
46,337
99,390
Less:
Accumulated depreciation and amortization
( 3,090
)
( 5,362
)
Property and equipment, net
$
43,247
$
94,028
19
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
During
the three months ended June 30, 2024, primarily as a result of the Company’s decision to decommission its ADC facility in Dartmouth,
Massachusetts, the Company recognized 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. The 45,000 square foot facility was
purchased on September 28, 2020, for $ 4 .0 million and incurred approximately $ 61.6 million to the build-out of the facility.
On
October 1, 2021, the Company completed the acquisition of its approximately 45,000 square foot research and development facility in Frederick,
Maryland totaling $ 17.5 million, to process development activities. Of the total purchase price, $ 2.1 million was allocated to the value
of land acquired, and $ 13.9 million was allocated to buildings, and approximately $ 1.5 million was allocated to office furniture and
equipment and laboratory equipment. As of August 1, 2022, the assets became ready for the intended use and were placed in service.
On
December 23, 2020, the Company completed the purchase of its approximately 44 -acre site in Hamilton, Montana for $ 4.5 million, for the
construction of a vaccine development and commercial scale manufacturing facility. As of June 30, 2024, the asset was not ready for
its intended use.
NOTE
5 – GOODWILL AND INTANGIBLE ASSETS
The
following table provides the gross carrying value of goodwill as follows:
Amounts
(in
thousands)
Balance
at December 31, 2023
$
965
Impairment
of goodwill
( 965 )
Balance
at June 30, 2024
$
-
The
Company completed its annual impairment test for goodwill as of June 30, 2024, which resulted in full 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.
The
following table provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
June 30,
2024
December
31,
2023
(in
thousands)
Intangible
assets subject to amortization
Developed
technology
$
10,100
$
10,100
Less: Impairment charge
9,147
—
Less:
Accumulated amortization
953
477
Total
$
—
$
9,623
Intangible
assets not subject to amortization
Internet
domain rights
$
120
$
120
Total
intangible assets, net
$
120
$
9,743
During
the three and six months ended June 30, 2024, the Company recorded amortization of $ 238,000
and $ 476,000 ,
respectively. No amortization was recorded during the same periods in 2023.
As
a result of certain triggering events identified impacting the Company’s commercialized products asset group during the three months
ended June 30, 2024, the Company tested the asset group for impairment as of June 30, 2024, resulting in a full impairment of its Zembrace
and Tosymra developed technology intangible assets, of $ 6.2 million and $ 3 .0 million, respectively, which is reflected in asset impairment
charges in the consolidated statements of operations for the three and six months ended June 30, 2024.
20
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (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, 2024, and December
31, 2023, the Company used Level 1 quoted prices in active markets to value cash equivalents which were de minimis for both periods
presented. The Company did not have any Level 2 or Level 3 assets or liabilities as of June 30, 2024. As of December 31, 2023, Level 3
liabilities included a portion of the Company’s outstanding Series D Warrants and all of the Company’s outstanding Series
C Warrants issued in December 2023, which did not meet the criteria for equity classification due to insufficient authorized shares to
settle the instruments and were therefore accounted for as liabilities at fair value. After the Company received stockholder approval
to increase the number of authorized shares on January 25, 2024, the 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 as
of December 31, 2023 and on the respective reclassification dates for the three and six months ended June 30, 2024:
Three
months ended
Six
months ended
As
of
June
30, 2024
June
30, 2024
December
31, 2023
Common
stock price
$
6.080
$
6.080
- 9.888
$
12.896
Risk-free
rate
4.39 %- 5.37 %
4.01 %
- 5.37 %
3.84 %
- 4.23 %
Expected
term (in years)
0.86
- 5.00
0.86
- 5.00
1.78
- 5.15
Expected
volatility
105.00 %
- 120.00 %
105.00 %
- 120.00 %
108.00 %
Discount
for lack of marketability
N/A
N/A
5.00 %
21
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (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
$ —
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, 2023. Changes in the fair value of the liability-classified warrants are recognized as a separate
component in the consolidated statement of operations.
NOTE
7 – DEBT FINANCING
Long-term
debt consists of the following:
June 30, 2024
December 31, 2023
Term Loan
$ 10,060
$ 11,000
Less: current portion
( 2,820 )
( 2,350 )
Total long-term debt
7,240
8,650
Less: unamortized debt discount and deferred financing costs
( 1,572 )
( 2,089 )
Total long-term debt, net
$ 5,668
$ 6,561
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 is being amortized over the term of the debt as an adjustment to the effective interest rate on the outstanding
borrowings.
Borrowings
under the Term Loan bear 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 is 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 June 30, 2024 totals $ 0.9 million, which is reflected in Prepaid expenses and other current assets on the consolidated
balance sheet.
Commencing
on March 8, 2024 and continuing monthly through the Maturity Date, the outstanding principal is 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 must pay 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 is being amortized over the term of the debt as
an adjustment to the effective interest rate on the outstanding borrowings.
22
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
The
Loan Agreement provides for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The Loan Agreement
contains customary affirmative and negative covenants by the Company, which among other things, will require the Borrowers to provide
certain financial reports to the lenders, to maintain a deposit account to fund interest payments, and limit the ability of the Company
to incur or guarantee additional indebtedness, pay dividends or make other equity distributions, sell assets, engage in certain transactions,
and effect a consolidation or merger. The obligations of the Company under the Loan Agreement may be accelerated upon customary events
of default, including non-payment of principal, interest, fees and other amounts, covenant default, insolvency, material judgements,
inaccuracy of representations and warranties, invalidity of guarantees. The Term Loan is 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.
As
of June 30, 2024 and December 31, 2023, the carrying amount of the Term Loan approximated its fair value as the contractual interest
rate for the Term Loan was representative of the then market interest rate.
Annual
future principal payments due on the Term Loan as of March 31, 2024 are as follows (in thousands):
Fiscal
years ending
Remainder
of 2024
$
1,410
2025
2,820
2026
5,830
$
10,060
23
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
NOTE
8 – STOCKHOLDERS’ EQUITY
On
June 10, 2024, the Company effected a 1-for-32 reverse stock split of its issued and outstanding shares of common stock, whereby 95,543,805
outstanding shares of the Company’s common stock were exchanged for 2,985,924 shares of the Company’s common stock. In connection
with the reverse stock split, the Company issued an additional 245,205 shares of the Company’s common stock due to fractional shares.
All per share amounts and number of shares in the condensed consolidated financial statements and related notes have been retroactively
restated to reflect the reverse stock split. As a result of the reverse-stock-split, on June 26, 2024, 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
January 25, 2024, the Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State
of the State of Nevada to increase the number of authorized shares of the Company’s common stock from 160,000,000 to 1,000,000,000
shares (the “Charter Amendment”). The Charter Amendment was approved by the Company’s shareholders at a special meeting
of shareholders held on January 25, 2024.
NOTE
9 – REVENUES
Disaggregation
of Net Revenues
The
Company’s net product revenues are summarized below:
Three
months ended
June
30,
2024
2023
Zembrace
Symtouch
$
1,727
$
—
Tosymra
481
—
Total
product revenues
$
2,208
$
—
Six
months ended
June
30,
2024
2023
Zembrace
Symtouch
$
3,574
$
—
Tosymra
1,116
—
Total
product revenues
$
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.
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
10 – 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 and subject to customary adjustments (such transaction, the “USL Acquisition”).
On
June 30, 2023, in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement (the
“Transition Services Agreement”), pursuant to which Upsher Smith provided certain transition services to the Company
for base fees equal to $ 100,000 per month for the first six months, and $ 150,000 per months for the seventh through ninth months, plus
additional monthly fees for each service category totaling up to $ 150,000 per month. The Company has amended the transitional services
agreement with Upsher Smith so that Upsher Smith can continue to provide for the management of certain government rebates. Upsher Smith
will be reimbursed by the Company at cost for any rebates they pay on the Company’s behalf.
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.
24
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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.
As
consideration for acquisition of the Business and certain product-related inventories, the Company paid approximately $ 23.5 million in
cash upfront. In April 2024, the Company paid the additional deferred payment of $ 3.0 million in cash.
The
following table summarizes the components of the purchase consideration (in thousands):
Purchase
consideration
Amount
Closing
cash consideration
$
22,174
Inventory
adjustment payment liability
1,348
Deferred
payment liability
3,000
Purchase
price to be allocated
$
26,522
The
USL Acquisition was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805,
Business Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business.
The tangible and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference
between the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon
preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information about
facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets may be
adjusted, with the offset recorded to goodwill.
The
following table represents the allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized
in the Company’s consolidated balance sheets (in thousands):
Purchase
price allocation
Amount
Inventory
$
13,700
Prepaid
expenses and other
1,757
Intangible
assets, net
10,100
Goodwill
965
Fair
value of assets acquired
$
26,522
The
acquired inventory consists of Upsher Smith’s raw materials, semi-finished goods, and finished goods inventory as of the Closing
date. The fair value was determined based on the estimated selling price of the inventory, less the estimated total costs to complete,
disposal effort and holding costs.
Intangible
assets eligible for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization are
as follows (in thousands):
Fair
Value
Useful
Life
(years)
Developed
technology - Tosymra
$
3,400
8
Developed
technology - Zembrace
6,700
13
Total
$
10,100
The
developed technology intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer
relationships, and trademarks and trade names associated with the technology. The developed technology intangible assets were valued
as composite assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from
the technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key assumptions
used in estimating the fair values of intangible assets include forecasted financial information, the weighted average cost of capital,
customer retention rates, and certain other assumptions.
25
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
The
fair values assigned to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual
results may differ from these estimates and assumptions.
As
the Closing occurred on the last day of the second quarter of 2023, the operations of the Business had no impact on the Company’s
operating results for the three or six months ended June 30, 2023.
Supplemental
Pro Forma Information
The
following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the three and
six months ended June 30, 2023 as if the USL Acquisition had occurred as of January 1, 2023, and gives effect to transactions that are
directly attributable to the acquisition, including additional amortization expense related to the fair value of intangible assets acquired
and an increase in Cost of Sales related to the acquisition-date fair value adjustment to inventory. On an unaudited pro forma basis,
consolidated Net Product Sales and Net Loss for the three and six months ended June 30, 2023, would have been $ 3.5 million and $ 29.7
million, and $ 7.6 million and $ 64.2 million, respectively. These amounts are based on financial information of the acquired business
and are not necessarily indicative of what the Company’s operating results would have been had the acquisition taken place on the
date presented, nor is it indicative of the Company’s future operating results. The net loss of USL Acquisition business is included
in the Company’s consolidated results since the date of acquisition. The revenue and net loss of the USL Acquisition business reflected
in the condensed consolidated statements for the three and six months ended June 30, 2024, is $ 2.2 million and $ 13.3 million, and $ 4.7
million and $ 14.8 million, respectively.
As
described above, in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement
with Upsher Smith related to providing ongoing services associated with the assets acquired, such as procuring and selling migraine
therapy products, providing accounting, and billing services and collecting accounts receivable and paying trade payables. Upsher
Smith collected and will continue to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June
30, 2023, through the transition period and the Seller is obligated to transfer cash generated by such sales to the Company. On
April 1, 2024, the Company amended the transitional services agreement with Upsher Smith so that Upsher Smith will only provide for
the management of certain government rebates. Upsher Smith will be reimbursed by the Company at cost for any rebates they pay on the
Company’s behalf.
NOTE
11 – ASSET PURCHASE AGREEMENT WITH HEALION
On
February 2, 2023, the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”) with Healion
Bio Inc., (“Healion”) pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including
its portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small
molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known as HB-121.
As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $ 1.2 million to Healion. Because the Healion
intellectual property was acquired prior to U.S. Food and Drug Administration (FDA) approval, the cash consideration totaling $ 1.2 million,
was expensed as research and development costs since there is no alternative future use and the acquired intellectual property does not
constitute a business.
NOTE
12 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
On
February 13, 2023, Tonix exercised an option to obtain an exclusive license from Columbia University (“Columbia) for the development
of a portfolio of both fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and
TNX-4100 product candidates, respectively. The licensed mAbs were developed as part of a research collaboration and option agreement
between Tonix and Columbia. As of June 30, 2024, other than the upfront fee, no payments have been accrued or paid in relation to this
agreement.
26
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
NOTE
13 – SALE AND PURCHASE OF COMMON STOCK
June
2024 Financings
On
June 12, 2024, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company sold 1,199,448
shares of common stock and pre-funded warrants to purchase up to 2,568,110 shares of common stock. The offering price per share of common
stock was $ 1.065 , and the offering price per share of pre-funded warrant was $ 1.064 .
The
offering closed on June 13, 2024. The Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees
of approximately $ 0.3 million. The Company received net proceeds of approximately $ 3.5 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 2,833,900 shares of common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock. The
offering price per share of common stock was $ 0.57 , and the offering price per share of pre-funded warrant was $ 0.5699 .
The
offering closed on June 28, 2024. The Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees
of approximately $ 0.3 million. The Company received net proceeds of approximately $ 3.5 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 336,459
shares of common stock, pre-funded warrants to
purchase up to 121,875
shares of common stock, and accompanying Series
E warrants to purchase up to 458,334
shares of common stock with an exercise price
of $ 10.56
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 $ 9.60 ,
and the offering price per share of pre-funded warrants was $ 9.5968 .
The
Company incurred offering 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.
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 $ 10.56 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 217,188 shares was amended to April 1, 2029 ; the termination date for Series A Warrants to purchase
up to an aggregate of approximately 278,125 shares is April 1, 2029 ; the termination date for Series B Warrants to purchase up to
an aggregate of approximately 278,125 shares is April 1, 2025 ; the termination date for Series C Warrants to purchase up to an aggregate
of approximately 1,088,248 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 1,088,248 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 Warrant Amendments as a direct and
incremental cost of the March 2024 financing and recognized the incremental fair value resulting from the modified terms of approximately
$ 3 .0 million 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 condensed 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.
27
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
On
May 22, 2024, at the annual meeting of the Company’s stockholders, the Company’s stockholders approved the proposal to amend
the exercise prices of the Existing Warrants to $ 10.56 per share and extend the expiration dates. The Company determined the Existing
Warrants met all of the criteria for equity classification as of the approval date. The Existing Warrants were adjusted to fair value
through May 22, 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.
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) 791,977 shares of the Company’s common stock, (ii) pre-funded warrants
(the “Pre-Funded Warrants”) to purchase up to 897,213 shares of common stock and (iii) Series C warrants to purchase up to
2,533,784 shares of common stock (the “Series C Warrants”), and (iv) Series D warrants to purchase up to 2,533,784 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 $ 17.76 , and the offering price per Pre-Funded Warrant and accompanying Common Warrants was $ 17.7568 . 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, 203,407 Pre-Funded Warrants were immediately exercised into shares of common
stock for nominal proceeds.
The
Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are 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 $ 17.76 per share, and are 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 will expire 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 $ 27.20 per share and are 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’s
authorized and unissued shares were applied to the Pre-Funded Warrants and the Common Warrants in the following order: (i) the Pre-Funded
Warrants, (ii) the Series D Warrants, and (iii) the Series C Warrants. Based on this analysis, the Company determined that the authorized
shares are sufficient to settle the remaining Pre-Funded Warrants and 1,591,665 Series D Warrants and were therefore classified in equity.
The remaining 942,120 Series D Warrants and the Series C Warrants associated with the deficit shares were classified as liabilities and
are accounted for at fair value.
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 of approximately $ 14.4 million and $ 8.1 million, respectively. The residual proceeds of approximately
$ 7.5 million were allocated to 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 totaling $ 2.3 million were allocated between the equity and liability-classified instruments
on a relative fair value basis. Issuance costs of $ 1.4 million allocated to the shares, the Pre-Funded Warrants, and the equity-classified
Series D Warrants were recognized as a discount to the proceeds allocated to the equity-classified instruments. Issuance costs of $ 0.9
million were allocated to the liability-classified Series D Warrants and the Series C Warrants and expensed within Selling, general and
administrative expense on the consolidated statements of operations.
28
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
On
January 25, 2024, 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 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.
September
2023 Financing
On
September 28, 2023, the Company sold 126,563 shares of common stock; pre-funded warrants to purchase up to 154,687 shares of common stock,
and accompanying Series A warrants to purchase up to 281,250 shares of common stock with an exercise price of $ 16.00 per share and expiring
five years from date of issuance, and Series B warrants to purchase up to 281,250 shares of common stock with an exercise price of $ 16.00
per share and expiring one year from date of issuance in a public offering, which closed on October 3, 2023. The offering price per share
of common stock and accompanying warrants was $ 16.00 , and the offering price per share of pre-funded warrant and accompanying warrants
was $ 15.99 .
The
Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million. The Company
received net proceeds of approximately $ 4 .0 million, after deducting the underwriting discount and other offering expenses.
July
2023 Financing
On
July 27, 2023, the Company sold 79,062 shares of common stock; pre-funded warrants to purchase up to 139,688 shares of common stock and
accompanying common warrants to purchase up to 218,750 shares of common stock with an exercise price of $ 32.00 per share in a public
offering that closed on August 1, 2023. The offering price per share of common stock and accompanying common warrant was $ 32.00 , and
the offering price per share of pre-funded warrant and accompanying common warrant was $ 31.99 .
The
Company incurred offering expenses of approximately $ 0.7 million, including placement agent fees of approximately $ 0.5 million. The Company
received net proceeds of approximately $ 6.3 million, after deducting the underwriting discount and other offering expenses.
2022
Lincoln Park Transaction
On
August 16, 2022, the Company entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights
agreement (the “2022 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant
to the terms of the 2022 Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $ 50,000,000 of the Company’s
common stock (subject to certain limitations) from time to time during the term of the 2022 Purchase Agreement. Pursuant to the terms
of the 2022 Registration Rights Agreement, the Company filed with the SEC a registration statement to register for resale under the Securities
Act the shares that have been or may be issued to Lincoln Park under the 2022 Purchase Agreement.
Pursuant
to the terms of the 2022 Purchase Agreement, at the time the Company signed the 2022 Purchase Agreement and the 2022 Registration Rights
Agreement, the Company issued 3,125 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of
the Company’s common stock under the 2022 Purchase Agreement. The commitment shares were valued at $ 1,000,000 and recorded as an
addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under
the 2022 Purchase Agreement.
29
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
During
the three and six months ended June 30, 2023, the Company sold 0 and 3,000 shares, respectively, of common stock under the 2022 Purchase
Agreement, for net proceeds of approximately $ 0 and $ 0.4 million, respectively. No shares were sold during 2024 under the 2022 Purchase
Agreement.
At-the-Market
Offerings
On
April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company
may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $ 320 .0
million in at-the-market offerings (“ATM”) sales. AGP will act as sales agent and will be paid a 3 % commission on each sale
under the Sales Agreement. The Company’s common stock will be sold at prevailing market prices at the time of the sale, and, as
a result, prices will vary. There were no sales under the Sales Agreement during the three and six months ended June 30, 2024. During
the three and six months ended June 30, 2023, the Company sold approximately 13,766 and 29,855 shares, respectively, of common stock
under the Sales Agreement, for net proceeds of approximately $ 1 .0 million and $ 3 .0 million, respectively. There will be no more sales under the 2020 ATM.
Stock
repurchases.
During
the quarter ended March 31, 2023, the Company repurchased 78,502
of its shares of common stock outstanding under its 2022 share repurchase program for $ 12.5 million at prices ranging from $ 88.00
to $ 275.52 per share for a gross aggregate cost of approximately $ 12.5 million.
In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant
to which the Company may repurchase up to $ 12.5 million in value of its outstanding common stock from time to time on the open
market and in privately negotiated transactions subject to market conditions, share price and other factors. During
the quarter ended March 31, 2023, the Company repurchased 5,000 of its shares of common
stock outstanding under the new 2023 share repurchase program at $ 227.84 per share for a gross aggregate cost of $ 1.1 million.
The
timing and amount of any shares repurchased will
be determined based on the Company’s evaluation of market conditions and other factors and the New Share Repurchase
Program may be discontinued or suspended at any time. Repurchases will
be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements
to which the Company may be subject. Repurchases may be made, in part, under a
Rule 10b5-1 plan, which allows stock repurchases when the Company might otherwise
be precluded from doing so.
NOTE
14 – 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 1,563 shares of common stock, which amount will be increased
to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the
Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision” providing
for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated 2020 Plan on
January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January 1, 2030, in an
amount equal to the difference between (x) twenty percent ( 20 %) of the total number of shares of common stock outstanding on December
31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended and Restated 2020
Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards, issued pursuant to
awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration period of the grants
under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not be less than 110 % of fair
value of the common stock at the date of the grant for a 10% or more shareholder and 100 % of fair value for a grantee who is not a 10%
shareholder. The fair value of the common stock is determined based on quoted market price or in absence of such quoted market price,
by the Board of Directors in good faith. Additionally, the expiration period of grants under the Amended and Restated 2020 Plan may not
be more than ten years . As of June 30, 2024, 55,544 options were available for future grants under the Amended and Restated 2020 Plan.
30
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
General
A
summary of the stock option activity and related information for the Plans for the six months ended June 30, 2024, is as follows:
Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value
Outstanding
at December 31, 2023
43,245
$
50,542.10
8.75
$
—
Grants
288,934
12.19
Exercised
—
—
Forfeitures
or expirations
( 21,382
)
42,044.88
Outstanding
at June 30, 2024
310,797
$
4,151.95
9.44
$
—
Exercisable
at June 30, 2024
22,609
$
51,345.40
7.75
$
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 2024 was $ 5.06 per share and $ 10.16 per share,
respectively. The weighted average fair value of options granted during the three and six months ended June 2023 was $ 87.36 per share
and $ 128.32 per share, respectively.
The
Company measures the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain
assumptions discussed below, and the closing market price of the Company’s common stock on the date of the grant. 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 1/36 th 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, 2024, and 2023 were as follows:
Six
Months Ended
June 30, 2024
Six
Months Ended
June 30, 2023
Risk-free
interest rate
4.23 %
to 5.33
%
3.42 %
to 4.02
%
Expected
term of option
5.25
to 10.00 years
5.0
to 10 years
Expected
stock price volatility
111.89 %
to 137.79
%
121.26 %
- 142.72
%
Expected
dividend yield
0.0
0.0
The
risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options
as of the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
31
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
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 $ 2.4 million, of which $ 1.6 million and $ 0.8 million, related to General and Administration and Research
and Development, respectively was recognized for the quarter ended June 30, 2023.
Stock-based
compensation expense relating to options granted of $ 2.8 million, of which $ 2 .0 million and $ 0.8 million, related to General and Administration
and Research and Development, respectively was recognized for the six-month period ended June 30, 2024. Stock-based compensation expense
relating to options granted of $ 5.2 million, of which $ 3.6 million and $ 1.6 million, related to General and Administration and Research
and Development, respectively was recognized for the six-month period ended June 30, 2023.
As
of June 30, 2024, the Company had approximately $ 5.5 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 1.87 years.
Employee
Stock Purchase Plans
On
May 6, 2022, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan.
(the “2022 ESPP”), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan (the
“2023 ESPP”, and together with the 2022 ESPP, the “ESPP Plans”), which was approved by the Company’s stockholders
on May 5, 2023.
The
2023 ESPP allows eligible employees to purchase up to an aggregate of 25,000 shares of the Company’s common stock. Under
the 2023 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 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, 2024, 22,926 shares were available for future sales under the 2023 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, 2024 and 2023, $ 27,000 and $ 0 , respectively, was expensed. In January 2023, 469 shares that were purchased
as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023, approximately $ 29,000 of employee
payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from accrued expenses to additional
paid in capital. The remaining $ 14,000 was returned to the employees. As of December 31, 2023, approximately $ 44,000 of employee payroll
deductions had accumulated and had been recorded in accrued expenses. In January 2024, 2,074 shares that were purchased as of December
31, 2023, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2024, approximately $ 24,000 of employee payroll
deductions accumulated at December 31, 2023, related to acquiring such shares, was transferred from accrued expenses to additional paid
in capital. The remaining $ 20,000 was returned to the employees. As of June 30, 2024, approximately $ 33,000 of employee payroll deductions
had accumulated and had been recorded in accrued expenses. In July 2024, 6,927 shares that were purchased as of June 30, 2024, under
the 2023 ESPP, were issued. Accordingly, during the third quarter of 2024, approximately $ 5,000 of employee payroll deductions accumulated
at June 30, 2024, related to acquiring such shares, was transferred from accrued expenses to additional paid in capital. The remaining
$ 28,000 was returned to the employees.
32
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
NOTE
15 – 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, 2024:
Exercise
Number
Expiration
Price
Outstanding
Date
$
0.001
4,228,158
N/A
$
10.56
458,334
April
2029
$
10.56
278,125
April
2029
$
10.56
278,125
April
2025
$
10.56
217,188
April
2029
$
10.56
1,088,263
April
2026
$
10.56
1,088,263
April
2029
$
16.00
3,131
October
2024
$
16.00
3,131
October
2028
$
17.76
1,445,526
December
2025
$
27.20
1,445,526
December
2028
$
32.00
1,569
August
2028
$
3,200.00
4
November
2024
$
3,648.00
20
February
2025
10,535,363
During
the six months ended June 30, 2024, 3,383,792 prefunded common warrants were exercised. Subsequent to the quarter ended June 30, 2024,
4,228,158 prefunded warrants were exercised.
No
warrants were exercised during the six months ended June 30, 2023.
Additionally,
with the closing of the financing on April 1, 2024, the Company entered into the Warrant Amendments (as defined in Note 13) with certain
holders of its warrants to purchase common stock, agreeing to amend the exercise price of each Existing Warrant to $ 10.56 upon approval
by the Company’s stockholders of a proposal to allow the warrants to become exercisable in accordance with Nasdaq Listing Rule
5635 or, if stockholder approval is not obtained by October 1, 2024, the exercise price would be automatically amended 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. The Company’s stockholders approved the proposal to amend the exercise prices of
the Existing Warrants to $ 10.56 per share and extend the termination dates at the annual meeting of the Company’s stockholders held
on May 22, 2024. As such, the table above reflects the modified terms of the Existing Warrants in effect as of June 30, 2024. See Note
13 for further details.
NOTE
16 – 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, 2024,
the Company has right-of-use assets of $ 0.7 million and a total lease liability for operating leases of $ 0.7 million of which $ 0.4 million
is included in long-term lease liabilities and $ 0.3 million is included in current lease liabilities.
At
June 30, 2024, 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 2024
$
153
2025
299
2026
142
2027
139
2028
and beyond
108
841
Included
interest
( 71
)
$
770
33
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2024 AND 2023 (UNAUDITED)
No
new leases or amendments were entered into during the six months ended June 30, 2024. During the six months ended June 30, 2023, the
Company entered into new operating leases and lease amendments, resulting in the Company recognizing an additional operating lease liability
of approximately $ 898,000 based on the present value of the minimum rental payments. The Company also recognized a corresponding increase
to ROU assets of approximately $ 898,000 , which represents a non-cash investing and financing activity.
Operating
lease expense was $ 0.1 and $ 0.2 million for the quarter ended June 30, 2024, and 2023, respectively.
Operating
lease expense was $ 0.2 million and $ 0.3 million for the six-months ended June 30, 2024, and 2023, respectively.
Other
information related to leases is as follows:
Cash
paid for amounts included in the measurement of lease liabilities:
Six
Months Ended
June 30, 2024
Six
Months Ended
June 30, 2023
Operating
cash flow from operating leases (in thousands)
$
148
$
289
Weighted
Average Remaining Lease Term
Operating
leases
3.43
years
3.52
years
Weighted
Average Discount Rate
Operating
leases
4.71 %
4.55 %
NOTE
17 – COMMITMENTS
Contractual
agreements
The
Company has entered into contracts with various contract research organizations with outstanding commitments aggregating approximately
$ 16.9 million at June 30, 2024 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, and the Company is also required to make a contribution
equal to three percent of each participant’s salary, on an annual basis, subject to limitations under the Code. The Company charged
operations $ 200,000 and $ 500,000 for the three and six months ended June 30, 2024, respectively, and $ 200,000 and $ 500,000 for the three
and six months ended June 30, 2023, respectively, for contributions under the 401(k) Plan.
NOTE
18 – SUBSEQUENT EVENTS
On
July 9, 2024, the Company entered into a securities purchase agreement with certain institutional and retail investors, pursuant to which
the Company sold 3,393,600 shares of common stock and pre-funded warrants to purchase up to 3,703,140 shares of common stock. The offering
price per share of common stock was $ 0.57 , and the offering price per share of pre-funded warrant was $ 0.5699 .
The
offering closed on July 10, 2024. The Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees
of approximately $ 0.3 million. The Company received net proceeds of approximately $ 3.5 million, after deducting the underwriting discount
and other offering expenses.
On July 30, 2024, the
Company entered into a Sales Agreement with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s
common stock having an aggregate offering price of up to $ 50 .0 million in ATM sales. AGP will act as sales agent and will be paid a 3 %
commission on each sale under the Sales Agreement. The Company’s common stock will be sold at prevailing market prices at the time
of the sale, and, as a result, prices will vary. Subsequent to June 30, 2024, the Company has sold 0.8 million shares
of common stock under the Sales Agreement, for net proceeds of approximately $ 0.4 million.
On August 9, 2024, the Company received a letter from Nasdaq indicating that, based upon the closing bid price of the Company’s
common stock for the last 30 consecutive business days, the Company no longer meets the requirement to maintain a minimum bid price of
$ 1 per share, as set forth in Nasdaq Listing Rule 55450(a)(1) (the “Minimum Bid Price Requirement”). The Company was initially
provided with a 180 calendar day period, or until February 5, 2024, in which to regain compliance. In the event that the Company does
not regain compliance within this 180 -day period, the Company may be eligible to seek an additional 180 day compliance period if it meets
the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital
Market, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq of its intent to cure the deficiency
during this second compliance period, by effecting a reverse stock split, if necessary.
34
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.